21 USC CHAPTER 9, SUBCHAPTER VII: GENERAL AUTHORITY

From Title 21—FOOD AND DRUGSCHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER VII—GENERAL AUTHORITY

Part A—General Administrative Provisions

§371. Regulations and hearings

(a) Authority to promulgate regulations

The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary.

(b) Regulations for imports and exports

The Secretary of the Treasury and the Secretary of Health and Human Services shall jointly prescribe regulations for the efficient enforcement of the provisions of section 381 of this title, except as otherwise provided therein. Such regulations shall be promulgated in such manner and take effect at such time, after due notice, as the Secretary of Health and Human Services shall determine.

(c) Conduct of hearings

Hearings authorized or required by this chapter shall be conducted by the Secretary or such officer or employee as he may designate for the purpose.

(d) Effectiveness of definitions and standards of identity

The definitions and standards of identity promulgated in accordance with the provisions of this chapter shall be effective for the purposes of the enforcement of this chapter, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder.

(e) Procedure for establishment

(1) Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) shall be begun by a proposal made (A) by the Secretary on his own initiative, or (B) by petition of any interested person, showing reasonable grounds therefor, filed with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph.

(2) On or before the thirtieth day after the date on which an order entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact.

(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.

(f) Review of order

(1) In a case of actual controversy as to the validity of any order under subsection (e), any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based his order, as provided in section 2112 of title 28.

(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation and such order is not in accordance with law the court shall by its judgment order the Secretary to take action, with respect to such regulation, in accordance with law. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.

(4) The judgment of the court affirming or setting aside, in whole or in part, any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28.

(5) Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.

(g) Copies of records of hearings

A certified copy of the transcript of the record and proceedings under subsection (e) shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, libel for condemnation, exclusion of imports, or other proceeding arising under or in respect to this chapter, irrespective of whether proceedings with respect to the order have previously been instituted or become final under subsection (f).

(h) Guidance documents

(1)(A) The Secretary shall develop guidance documents with public participation and ensure that information identifying the existence of such documents and the documents themselves are made available to the public both in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for or on any person, although they present the views of the Secretary on matters under the jurisdiction of the Food and Drug Administration.

(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use guidance documents and shall monitor the development and issuance of such documents.

(C)(i) For guidance documents that set forth initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues, the Secretary shall ensure public participation prior to implementation of guidance documents, unless the Secretary determines that such prior public participation is not feasible or appropriate. In such cases, the Secretary shall provide for public comment upon implementation and take such comment into account.

(ii) With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.

(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary shall provide for public comment upon implementation.

(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents and revisions of such documents are properly dated and indicate the nonbinding nature of the documents. The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.

(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public.

(4) The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents in accordance with this subsection.

(5) Not later than July 1, 2000, the Secretary after evaluating the effectiveness of the Good Guidance Practices document, published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation consistent with this subsection specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.

(June 25, 1938, ch. 675, §701, 52 Stat. 1055; June 25, 1948, ch. 646, §32, 62 Stat. 991; Apr. 15, 1954, ch. 143, §2, 68 Stat. 55; Aug. 1, 1956, ch. 861, §2, 70 Stat. 919; Pub. L. 85–791, §21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86–618, title I, §103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101–535, §8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §§3(y), (dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103–396, §3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105–115, title IV, §405, Nov. 21, 1997, 111 Stat. 2368; Pub. L. 112–144, title VI, §619, July 9, 2012, 126 Stat. 1063.)

Editorial Notes

Amendments

2012—Subsec. (h)(1)(C). Pub. L. 112–144 designated existing provisions as cl. (i) and added cl. (ii).

1997—Subsec. (h). Pub. L. 105–115 added subsec. (h).

1994—Subsec. (e)(1). Pub. L. 103–396 which directed the amendment of par. (1) by striking out "or maple syrup (regulated under section 168.140 of title 21, Code of Federal Regulations).", was executed by striking out "or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" before "shall be begun by a proposal", to reflect the probable intent of Congress.

1993—Subsec. (b). Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture" in two places.

Subsec. (e)(1). Pub. L. 103–80, §4(c), made technical correction to directory language of Pub. L. 101–535, §8. See 1990 Amendment note below.

Pub. L. 103–80, §3(y)(1), struck out period after second reference to "Regulations)".

Subsec. (f)(4). Pub. L. 103–80, §3(y)(2), substituted reference to section 1254 of title 28 for "sections 239 and 240 of the Judicial Code, as amended".

1992—Subsec. (b). Pub. L. 102–300, which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

1990—Subsec. (e)(1). Pub. L. 101–535, §8, as amended by Pub. L. 103–80, §4(c), substituted "Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" for "Any action for the issuance, amendment, or repeal of any regulation under section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title".

1960—Subsec. (e). Pub. L. 86–618 substituted "section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title" for "section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h), 354 or 364 of this title".

1958—Subsec. (f)(1). Pub. L. 85–791, §21(a), substituted provisions requiring transmission of a copy of the petition by clerk to Secretary, and filing of the record by Secretary, for provisions which permitted service of summons and petition any place in United States and required Secretary to certify and file transcript of the proceedings and record upon service.

Subsec. (f)(3). Pub. L. 85–791, §21(b), inserted "Upon the filing of the petition referred to in paragraph (1) of this subsection".

1956—Subsec. (e). Act Aug. 1, 1956, simplified procedures governing prescribing of regulations under certain provisions of this chapter.

1954—Subsec. (e). Act Apr. 15, 1954, struck out reference to section 341 of this title, before "343(j)", such section 341 now containing its own provisions with respect to hearings regarding the establishment of food standards.

Statutory Notes and Related Subsidiaries

Change of Name

Circuit Court of Appeals of the United States changed to United States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

Savings Provision

Savings clause of act Aug. 1, 1956, see note set out under section 341 of this title.

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

Notification of FDA Intent To Regulate Laboratory-Developed Tests

Pub. L. 112–144, title XI, §1143, July 9, 2012, 126 Stat. 1130, provided that the Food and Drug Administration could not issue any draft or final guidance on the regulation of laboratory-developed tests under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, at least 60 days prior to such issuance, notifying the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the Administration's intent to take such action and including in such notification the anticipated details of such action, and that such provision ceased to have force or effect on the date that was 5 years after the date of enactment of Pub. L. 112–144, which was approved July 9, 2012.

Approval of Supplemental Applications for Approved Products

Pub. L. 105–115, title IV, §403, Nov. 21, 1997, 111 Stat. 2367, provided that:

"(a) Standards.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall publish in the Federal Register standards for the prompt review of supplemental applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262).

"(b) Guidance to Industry.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary shall issue final guidances to clarify the requirements for, and facilitate the submission of data to support, the approval of supplemental applications for the approved articles described in subsection (a). The guidances shall—

"(1) clarify circumstances in which published matter may be the basis for approval of a supplemental application;

"(2) specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application; and

"(3) define supplemental applications that are eligible for priority review.

"(c) Responsibilities of Centers.—The Secretary shall designate an individual in each center within the Food and Drug Administration (except the Center for Food Safety and Applied Nutrition) to be responsible for—

"(1) encouraging the prompt review of supplemental applications for approved articles; and

"(2) working with sponsors to facilitate the development and submission of data to support supplemental applications.

"(d) Collaboration.—The Secretary shall implement programs and policies that will foster collaboration between the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supplemental applications or conduct further research in support of a supplemental application based, in whole or in part, on such studies."

Hearings Pending on April 15, 1954, With Respect to Food Standards

Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, regarding food standards, see Savings Provisions note set out under section 341 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

§372. Examinations and investigations

(a) Authority to conduct

(1)(A) The Secretary is authorized to conduct examinations and investigations for the purposes of this chapter through officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department.

(B)(i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this chapter.

(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this chapter on Indian country without the express written consent of the Indian tribe involved.

(2)(A) In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this chapter through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency.

(B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency.

(C) For any fiscal year in which the Secretary and the head of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year—

(i) the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum;

(ii) the number of additional articles that were inspected or examined as a result of such memorandum; and

(iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum.

(3) In the case of food packed in the Commonwealth of Puerto Rico or a Territory the Secretary shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all the provisions of this chapter, the facilities at his disposal will permit of such inspection.

(4) For the purposes of this subsection, the term "United States" means the States and the District of Columbia.

(b) Availability to owner of part of analysis samples

Where a sample of a food, drug, or cosmetic is collected for analysis under this chapter the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this subsection as he finds necessary for the proper administration of the provisions of this chapter.

(c) Records of other departments and agencies

For purposes of enforcement of this chapter, records of any department or independent establishment in the executive branch of the Government shall be open to inspection by any official of the Department duly authorized by the Secretary to make such inspection.

(d) Information on patents for drugs

The Secretary is authorized and directed, upon request from the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, to furnish full and complete information with respect to such questions relating to drugs as the Director may submit concerning any patent application. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required.

(e) Powers of enforcement personnel

Any officer or employee of the Department designated by the Secretary to conduct examinations, investigations, or inspections under this chapter relating to counterfeit drugs may, when so authorized by the Secretary—

(1) carry firearms;

(2) execute and serve search warrants and arrest warrants;

(3) execute seizure by process issued pursuant to libel under section 334 of this title;

(4) make arrests without warrant for offenses under this chapter with respect to such drugs if the offense is committed in his presence or, in the case of a felony, if he has probable cause to believe that the person so arrested has committed, or is committing, such offense; and

(5) make, prior to the institution of libel proceedings under section 334(a)(2) of this title, seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or he has reasonable grounds to believe that they are, subject to seizure and condemnation under such section 334(a)(2). In the event of seizure pursuant to this paragraph (5), libel proceedings under section 334(a)(2) of this title shall be instituted promptly and the property seized be placed under the jurisdiction of the court.

(June 25, 1938, ch. 675, §702, 52 Stat. 1056; Pub. L. 87–781, title III, §§307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L. 89–74, §8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91–513, title II, §701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106–113, div. B, §1000(a)(9) [title IV, §4732(b)(12)], Nov. 29, 1999, 113 Stat. 1536, 1501A-584; Pub. L. 107–188, title III, §314, June 12, 2002, 116 Stat. 674; Pub. L. 111–31, div. A, title I, §103(g), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (a)(1). Pub. L. 111–31 designated existing provisions as subpar. (A) and added subpar. (B).

2002—Subsec. (a). Pub. L. 107–188 inserted "(1)" before "The Secretary is authorized to conduct", added par. (2), inserted "(3)" before "In the case of food packed", and substituted "(4) For the purposes of this subsection," for "For the purposes of this subsection".

1999—Subsec. (d). Pub. L. 106–113, in first sentence, substituted "Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office" for "Commissioner of Patents" and "Director" for "Commissioner".

1993—Subsec. (c). Pub. L. 103–80 struck out "of Agriculture" after "Department".

1992—Subsec. (c). Pub. L. 102–300, which directed the amendment of subsec. (c) by striking out "of Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

1970—Subsec. (e). Pub. L. 91–513 struck out reference to depressant or stimulant drugs.

1965—Subsec. (e). Pub. L. 89–74 added subsec. (e).

1962—Subsec. (a). Pub. L. 87–781, §307(b), inserted "the Commonwealth of Puerto Rico or" before "a Territory the Secretary".

Subsec. (d). Pub. L. 87–781, §308, added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 1999 Amendment

Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, §4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, Patents.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective July 15, 1965, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Executive Documents

Transfer of Functions

§372a. Transferred

Editorial Notes

Codification

Section, act June 25, 1938, ch. 675, §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to examination of sea food, was renumbered section 706 of act June 25, 1938, by Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 376 of this title.

§373. Records

(a) In general

For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in interstate commerce or holding such articles so received, shall, upon the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times, to have access to and to copy all records showing the movement in interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding thereof during or after such movement, and the quantity, shipper, and consignee thereof; and it shall be unlawful for any such carrier or person to fail to permit such access to and copying of any such record so requested when such request is accompanied by a statement in writing specifying the nature or kind of food, drug, device, tobacco product, or cosmetic to which such request relates, except that evidence obtained under this section, or any evidence which is directly or indirectly derived from such evidence, shall not be used in a criminal prosecution of the person from whom obtained, and except that carriers shall not be subject to the other provisions of this chapter by reason of their receipt, carriage, holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual course of business as carriers, except as provided in subsection (b).

(b) Food transportation records

A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to section 350e of this title shall, on request of an officer or employee designated by the Secretary, permit the officer or employee, at reasonable times, to have access to and to copy all records that the Secretary requires to be kept under section 350e(c)(1)(E) of this title.

(June 25, 1938, ch. 675, §703, 52 Stat. 1057; Pub. L. 91–452, title II, §230, Oct. 15, 1970, 84 Stat. 930; Pub. L. 103–80, §3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109–59, title VII, §7202(c), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 111–31, div. A, title I, §103(h), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (a). Pub. L. 111–31 inserted "tobacco product," after "device," in two places and "tobacco products," after "devices," in two places.

2005—Pub. L. 109–59 struck out "of interstate shipment" after "Records" in section catchline, designated existing provisions as subsec. (a), inserted subsec. heading, substituted "carriers, except as provided in subsection (b)" for "carriers" before period at end, and added subsec. (b).

1993—Pub. L. 103–80 substituted ", except that" for ": Provided, That" and ", and except that" for ": Provided further, That".

1970—Pub. L. 91–452 inserted ", or any evidence which is directly or indirectly derived from such evidence," after "under this section".

Statutory Notes and Related Subsidiaries

Effective Date of 2005 Amendment

Amendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–452 effective on sixtieth day following Oct. 15, 1970, and not to affect any immunity to which any individual is entitled under this section by reason of any testimony given before sixtieth day following Oct. 15, 1970, see section 260 of Pub. L. 91–452, set out as an Effective Date; Savings Provision note under section 6001 of Title 18, Crimes and Criminal Procedure.

Executive Documents

Transfer of Functions

§374. Inspection

(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions

(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to the limitations established in section 350c(d) of this title. In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products are manufactured, processed, packed, or held, the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter. No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data (other than data relating to new drugs, antibiotic drugs, devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 355(j) of this title). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

(2) The provisions of the third sentence of paragraph (1) shall not apply to—

(A) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail;

(B) practitioners licensed by law to prescribe or administer drugs, or prescribe or use devices, as the case may be, and who manufacture, prepare, propagate, compound, or process drugs, or manufacture or process devices, solely for use in the course of their professional practice;

(C) persons who manufacture, prepare, propagate, compound, or process drugs or manufacture or process devices, solely for use in research, teaching, or chemical analysis and not for sale;

(D) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that inspection as applied to such classes of persons in accordance with this section is not necessary for the protection of the public health.

(3) An officer or employee making an inspection under paragraph (1) for purposes of enforcing the requirements of section 350a of this title applicable to infant formulas shall be permitted, at all reasonable times, to have access to and to copy and verify any records—

(A) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of section 350a of this title, or

(B) required to be maintained under section 350a of this title.

(4)(A) Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C), shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary's request shall include a sufficient description of the records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.

(B) Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of receipt.

(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections, if applicable and appropriate.

(D) Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.

(5)(A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.], enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information.

(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies.

(C)(i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with—

(I) developing an application or other submission to the Secretary under this chapter or the Public Health Service Act related to marketing authorization for a product described in paragraph (1);

(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or

(III) holding any records or other information described in subparagraph (B).

(ii) A person described in this clause is—

(I) the sponsor of an application or submission specified in subparagraph (E);

(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor;

(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or

(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B).

(D)(i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including—

(I) permitting the Secretary to record or copy such information for purposes of this paragraph;

(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and

(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred.

(ii) Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret.

(iii) An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner.

(E) The studies and submissions described in this subparagraph are each of the following:

(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this chapter or the Public Health Service Act for marketing authorization of a product described in paragraph (1).

(ii) Postmarket safety activities conducted under this chapter or the Public Health Service Act.

(iii) Any other clinical investigation of—

(I) a drug subject to section 355 or 360b of this title or section 262 of title 42; or

(II) a device subject to section 360j(g) of this title.

(iv) Any other submissions made under this chapter or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health.

(F) This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to December 29, 2022, the Secretary lacked the authority to conduct such inspections, including under this chapter or the Public Health Service Act.

(b) Written report to owner; copy to Secretary

(1) Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, tobacco product, or cosmetic in such establishment (A) consists in whole or in part of any filthy, putrid, or decomposed substance, or (B) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.

(2) In carrying out this subsection with respect to any establishment manufacturing a drug approved under subsection (c) or (j) of section 355 of this title for which a notification has been submitted in accordance with section 356c of this title is, or has been in the last 5 years, listed on the drug shortage list under section 356e of this title, or that is described in section 355(j)(11)(A) of this title, a copy of the report shall be sent promptly to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages.

(c) Receipt for samples taken

If the officer or employee making any such inspection of a factory, warehouse, or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained.

(d) Analysis of samples furnished owner

Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge.

(e) Accessibility of records

Every person required under section 360i or 360j(g) of this title to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records.

(f) Recordkeeping

(1) An accredited person described in paragraph (3) shall maintain records documenting the training qualifications of the person and the employees of the person, the procedures used by the person for handling confidential information, the compensation arrangements made by the person, and the procedures used by the person to identify and avoid conflicts of interest. Upon the request of an officer or employee designated by the Secretary, the person shall permit the officer or employee, at all reasonable times, to have access to, to copy, and to verify, the records.

(2) Within 15 days after the receipt of a written request from the Secretary to an accredited person described in paragraph (3) for copies of records described in paragraph (1), the person shall produce the copies of the records at the place designated by the Secretary.

(3) For purposes of paragraphs (1) and (2), an accredited person described in this paragraph is a person who—

(A) is accredited under subsection (g); or

(B) is accredited under section 360m of this title.

(g) Inspections by accredited persons

(1) The Secretary shall, subject to the provisions of this subsection, accredit persons for the purpose of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title. The owner or operator of such an establishment that is eligible under paragraph (6) may, from the list published under paragraph (4), select an accredited person to conduct such inspections.

(2) The Secretary shall publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1). Thereafter, the Secretary shall inform those requesting accreditation, within 60 days after the receipt of such request, whether the request for accreditation is adequate for review, and the Secretary shall promptly act on the request for accreditation. Any resulting accreditation shall state that such person is accredited to conduct inspections at device establishments identified in paragraph (1). The accreditation of such person shall specify the particular activities under this subsection for which such person is accredited.

(3) An accredited person shall, at a minimum, meet the following requirements:

(A) Such person may not be an employee of the Federal Government.

(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of articles regulated under this chapter and which has no organizational, material, or financial affiliation (including a consultative affiliation) with such a manufacturer, supplier, or vendor.

(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.

(D) Such person shall not engage in the design, manufacture, promotion, or sale of articles regulated under this chapter.

(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices, and such person shall agree in writing that at a minimum the person will—

(i) certify that reported information accurately reflects data reviewed, inspection observations made, other matters that relate to or may influence compliance with this chapter, and recommendations made during an inspection or at an inspection's closing meeting;

(ii) limit work to that for which competence and capacity are available;

(iii) treat information received, records, reports, and recommendations as confidential commercial or financial information or trade secret information, except such information may be made available to the Secretary;

(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and

(v) protect against the use, in carrying out paragraph (1), of any officer or employee of the accredited person who has a financial conflict of interest regarding any product regulated under this chapter, and annually make available to the public disclosures of the extent to which the accredited person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest.

(F) Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems standard referred to in paragraph (7) for any device establishment that such person inspects under this subsection not later than 30 days after such withdrawal, suspension, restriction, or expiration.

(G) Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph (7).

(4) The Secretary shall publish on the Internet site of the Food and Drug Administration a list of persons who are accredited under paragraph (2). Such list shall be updated to ensure that the identity of each accredited person, and the particular activities for which the person is accredited, is known to the public. The updating of such list shall be no later than one month after the accreditation of a person under this subsection or the suspension or withdrawal of accreditation, or the modification of the particular activities for which the person is accredited.

(5)(A) To ensure that persons accredited under this subsection continue to meet the standards of accreditation, the Secretary shall (i) audit the performance of such persons on a periodic basis through the review of inspection reports and inspections by persons designated by the Secretary to evaluate the compliance status of a device establishment and the performance of accredited persons, and (ii) take such additional measures as the Secretary determines to be appropriate.

(B) The Secretary may withdraw accreditation of any person accredited under paragraph (2), after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the standards of accreditation, poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection. The Secretary may suspend the accreditation of such person during the pendency of the process under the preceding sentence.

(6)(A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met:

(i) The Secretary classified the results of the most recent inspection of the establishment as "no action indicated" or "voluntary action indicated".

(ii) With respect to inspections of the establishment to be conducted by an accredited person, the owner or operator of the establishment submits to the Secretary a notice that—

(I) provides the date of the last inspection of the establishment by the Secretary and the classification of that inspection;

(II) states the intention of the owner or operator to use an accredited person to conduct inspections of the establishment;

(III) identifies the particular accredited person the owner or operator intends to select to conduct such inspections; and

(IV) includes a certification that, with respect to the devices that are manufactured, prepared, propagated, compounded, or processed in the establishment—

(aa) at least 1 of such devices is marketed in the United States; and

(bb) at least 1 of such devices is marketed, or is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause (III) as a person authorized to conduct inspections of device establishments.

(B)(i) Except with respect to the requirement of subparagraph (A)(i), a device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 30 days after receiving such notice, issues a response that—

(I) denies clearance to participate as provided under subparagraph (C); or

(II) makes a request under clause (ii).

(ii) The Secretary may request from the owner or operator of a device establishment in response to the notice under subparagraph (A)(ii) with respect to the establishment, or from the particular accredited person identified in such notice—

(I) compliance data for the establishment in accordance with clause (iii)(I); or

(II) information concerning the relationship between the owner or operator of the establishment and the accredited person identified in such notice in accordance with clause (iii)(II).

The owner or operator of the establishment, or such accredited person, as the case may be, shall respond to such a request not later than 60 days after receiving such request.

(iii)(I) The compliance data to be submitted by the owner or operator of a device establishment in response to a request under clause (ii)(I) are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of section 351(h) of this title and with other applicable provisions of this chapter. Such data shall include complete reports of inspectional findings regarding good manufacturing practice or other quality control audits that, during the preceding 2-year period, were conducted at the establishment by persons other than the owner or operator of the establishment, together with all other compliance data the Secretary deems necessary. Data under the preceding sentence shall demonstrate to the Secretary whether the establishment has facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections.

(II) A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1).

(iv) A device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 60 days after receiving the information requested under clause (ii), issues a response that denies clearance to participate as provided under subparagraph (C).

(C)(i) The Secretary may deny clearance to a device establishment if the Secretary has evidence that the certification under subparagraph (A)(ii)(IV) is untrue and the Secretary provides to the owner or operator of the establishment a statement summarizing such evidence.

(ii) The Secretary may deny clearance to a device establishment if the Secretary determines that the establishment has failed to demonstrate consistent compliance for purposes of subparagraph (B)(iii)(I) and the Secretary provides to the owner or operator of the establishment a statement of the reasons for such determination.

(iii)(I) The Secretary may reject the selection of the accredited person identified in the notice under subparagraph (A)(ii) if the Secretary provides to the owner or operator of the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person.

(II) If the Secretary rejects the selection of an accredited person by the owner or operator of a device establishment, the owner or operator may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph (A)(ii).

(iv) In the case of a device establishment that is denied clearance under clause (i) or (ii) or with respect to which the selection of the accredited person is rejected under clause (iii), the Secretary shall designate a person to review the statement of reasons, or statement summarizing such evidence, as the case may be, of the Secretary under such clause if, during the 30-day period beginning on the date on which the owner or operator of the establishment receives such statement, the owner or operator requests the review. The review shall commence not later than 30 days after the owner or operator requests the review, unless the Secretary and the owner or operator otherwise agree.

(7)(A) Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report in a form and manner designated by the Secretary to conduct inspections, taking into consideration the goals of international harmonization of quality systems standards. Any official classification of the inspection shall be determined by the Secretary.

(B) At a minimum, an inspection report under subparagraph (A) shall identify the persons responsible for good manufacturing practice compliance at the inspected device establishment, the dates of the inspection, the scope of the inspection, and shall describe in detail each observation identified by the accredited person, identify other matters that relate to or may influence compliance with this chapter, and describe any recommendations during the inspection or at the inspection's closing meeting.

(C) An inspection report under subparagraph (A) shall be sent to the Secretary and to the designated representative of the inspected device establishment at the same time, but under no circumstances later than three weeks after the last day of the inspection. The report to the Secretary shall be accompanied by all written inspection observations previously provided to the designated representative of the establishment.

(D) Any statement or representation made by an employee or agent of a device establishment to a person accredited under paragraph (2) to conduct inspections shall be subject to section 1001 of title 18.

(E) If at any time during an inspection by an accredited person the accredited person discovers a condition that could cause or contribute to an unreasonable risk to the public health, the accredited person shall immediately notify the Secretary of the identification of the device establishment subject to inspection and such condition.

(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality systems standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.

(8) Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services.

(9) Nothing in this subsection affects the authority of the Secretary to inspect any device establishment pursuant to this chapter.

(10)(A) For fiscal year 2005 and each subsequent fiscal year, no device establishment may be inspected during the fiscal year involved by a person accredited under paragraph (2) if—

(i) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the preceding fiscal year (referred to in this subparagraph as the "first prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such first prior fiscal year; and

(ii) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the fiscal year preceding the first prior fiscal year (referred to in this subparagraph as the "second prior fiscal year"), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such second prior fiscal year.

(B)(i) Subject to clause (ii), the Comptroller General of the United States shall determine the amount that was obligated by the Secretary for fiscal year 2002 for compliance activities of the Food and Drug Administration with respect to devices (referred to in this subparagraph as the "compliance budget"), and of such amount, the amount that was obligated for inspections by the Secretary of device establishments (referred to in this subparagraph as the "inspection budget").

(ii) For purposes of determinations under clause (i), the Comptroller General shall not include in the compliance budget or the inspection budget any amounts obligated for inspections of device establishments conducted as part of the process of reviewing applications under section 360e of this title.

(iii) Not later than March 31, 2003, the Comptroller General shall complete the determinations required in this subparagraph and submit to the Secretary and the Congress a report describing the findings made through such determinations.

(i) The term "base amount" means the inspection budget determined under subparagraph (B) for fiscal year 2002.

(ii) The term "adjusted base amount", in the case of applicability to fiscal year 2003, means an amount equal to the base amount increased by 5 percent.

(iii) The term "adjusted base amount", with respect to applicability to fiscal year 2004 or any subsequent fiscal year, means the adjusted base amount applicable to the preceding year increased by 5 percent.

(11) The authority provided by this subsection terminates on October 1, 2027.

(12) No later than four years after October 26, 2002, the Comptroller General shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate—

(A) the number of inspections conducted by accredited persons pursuant to this subsection and the number of inspections conducted by Federal employees pursuant to section 360(h) of this title and of device establishments required to register under section 360(i) of this title;

(B) the number of persons who sought accreditation under this subsection, as well as the number of persons who were accredited under this subsection;

(D) the number of audits conducted by the Secretary of accredited persons, the quality of inspections conducted by accredited persons, whether accredited persons are meeting their obligations under this chapter, and whether the number of audits conducted is sufficient to permit these assessments;

(E) whether this subsection is achieving the goal of ensuring more information about device establishment compliance is being presented to the Secretary, and whether that information is of a quality consistent with information obtained by the Secretary pursuant to inspections conducted by Federal employees;

(F) whether this subsection is advancing efforts to allow device establishments to rely upon third-party inspections for purposes of compliance with the laws of foreign governments; and

(G) whether the Congress should continue, modify, or terminate the program under this subsection.

(13) The Secretary shall include in the annual report required under section 393(g) of this title the names of all accredited persons and the particular activities under this subsection for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year.

(14) Notwithstanding any provision of this subsection, this subsection does not have any legal effect on any agreement described in section 383(b) of this title between the Secretary and a foreign country.

(15)(A) Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of—

(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 262 of title 42), as required under section 360(h) of this title; or

(ii) establishments required to register pursuant to section 360(i) of this title.

(B) Nothing in this paragraph affects—

(i) the authority of the Secretary to inspect any device establishment pursuant to this chapter; or

(ii) the authority of the Secretary to determine the official classification of an inspection.

(h) Improvements to inspections process for device establishments

(1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of August 18, 2017, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for—

(A) exceptions to such processes and standards, as appropriate;

(B) announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection;

(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and

(D) regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent.

(2)(A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request.

(B) A request described in this subparagraph is a request for feedback—

(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and

(ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary).

(3) Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this chapter in order to ensure compliance with this chapter.

(June 25, 1938, ch. 675, §704, 52 Stat. 1057; Aug. 7, 1953, ch. 350, §1, 67 Stat. 476; Pub. L. 87–781, title II, §201(a), (b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94–295, §6, May 28, 1976, 90 Stat. 581; Pub. L. 96–359, §4, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 103–80, §3(aa), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title I, §125(b)(2)(L), title II, §210(b), title IV, §412(b), Nov. 21, 1997, 111 Stat. 2326, 2344, 2375; Pub. L. 107–188, title III, §306(b), June 12, 2002, 116 Stat. 670; Pub. L. 107–250, title II, §201(a), (b), Oct. 26, 2002, 116 Stat. 1602, 1609; Pub. L. 108–214, §2(b)(1), Apr. 1, 2004, 118 Stat. 573; Pub. L. 110–85, title II, §228, Sept. 27, 2007, 121 Stat. 855; Pub. L. 111–31, div. A, title I, §103(i), June 22, 2009, 123 Stat. 1837; Pub. L. 111–353, title I, §101(b), Jan. 4, 2011, 124 Stat. 3887; Pub. L. 112–144, title VI, §612, title VII, §706, July 9, 2012, 126 Stat. 1060, 1067; Pub. L. 115–52, title VII, §§702(a), 703, 705, Aug. 18, 2017, 131 Stat. 1055–1057; Pub. L. 116–136, div. A, title III, §3112(d), Mar. 27, 2020, 134 Stat. 362; Pub. L. 117–180, div. F, title V, §5007, Sept. 30, 2022, 136 Stat. 2168; Pub. L. 117–229, div. C, title III, §306, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title II, §2515(a)(2), title III, §§3106, 3504, 3611(a), (b)(1), 3612(a), 3613(b), Dec. 29, 2022, 136 Stat. 5806, 5807, 5859, 5869, 5872.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (a)(5), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–328, §3611(a), substituted "devices" for "restricted devices" in two places.

Pub. L. 117–328, §3504, inserted "In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies." after "limitations established in section 350c(d) of this title."

Subsec. (a)(4)(A). Pub. L. 117–328, §3611(b)(1), substituted "an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C)," for "an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug" and "records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection." for "records requested."

Subsec. (a)(4)(C), (D). Pub. L. 117–328, §3613(b), added subpar. (C) and redesignated former subpar. (C) as (D).

Subsec. (a)(5). Pub. L. 117–328, §3612(a), added par. (5).

Subsec. (b). Pub. L. 117–328, §2515(a)(2), made technical amendment to directory language of Pub. L. 116–136, §3112(d)(1). See 2020 Amendment note below.

Subsec. (g)(11). Pub. L. 117–328, §3106, substituted "October 1, 2027" for "December 24, 2022".

Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022".

Pub. L. 117–180 substituted "December 17" for "October 1".

2020—Subsec. (b). Pub. L. 116–136, §3112(d)(1), as amended by Pub. L. 117–328, §2515(a)(2), designated existing provisions as par. (1), redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).

2017—Subsec. (g)(11). Pub. L. 115–52, §703, substituted "October 1, 2022" for "October 1, 2017".

Subsec. (g)(15). Pub. L. 115–52, §705, added par. (15).

Subsec. (h). Pub. L. 115–52, §702(a), added subsec. (h).

2012—Subsec. (a)(4). Pub. L. 112–144, §706, added par. (4).

Subsec. (g)(11). Pub. L. 112–144, §612, substituted "October 1, 2017" for "October 1, 2012".

2011—Subsec. (a)(1). Pub. L. 111–353, which directed the amendment of subsec. (a)(1)(B) by substituting "section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to" for "section 350c of this title when" and all that follows through "subject to", was executed by making the substitution for "section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to" in the sentence following subpar. (B) of subsec. (a)(1), to reflect the probable intent of Congress.

2009—Subsec. (a)(1). Pub. L. 111–31, §103(i)(1)(C), substituted "devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products" for "and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) section 360i, or 360j(g) of this title, and data relating to other drugs or devices".

Pub. L. 111–31, §103(i)(1)(B), substituted "restricted devices, or tobacco products" for "or restricted devices" in two places.

Subsec. (a)(1)(A). Pub. L. 111–31, §103(i)(1)(A), substituted "devices, tobacco products, or cosmetics" for "devices, or cosmetics" in two places.

Subsec. (b). Pub. L. 111–31, §103(i)(2), inserted "tobacco product," after "device,".

Subsec. (g)(13). Pub. L. 111–31, §103(i)(3), made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title.

2007—Subsec. (g)(1). Pub. L. 110–85, §228(1), substituted "The Secretary" for "Not later than one year after October 26, 2002, the Secretary".

Subsec. (g)(2). Pub. L. 110–85, §228(2), substituted "The Secretary" for "Not later than 180 days after October 26, 2002, the Secretary" and struck out at end "In the first year following the publication in the Federal Register of criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1), the Secretary shall accredit no more than 15 persons who request to perform duties specified in paragraph (1)."

Subsec. (g)(3)(F), (G). Pub. L. 110–85, §228(3), added subpars. (F) and (G).

Subsec. (g)(6). Pub. L. 110–85, §228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C).

Subsec. (g)(7)(A). Pub. L. 110–85, §228(5)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: "Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment's designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report (including for inspections classified as 'no action indicated') in a form and manner consistent with such reports prepared by employees and officials designated by the Secretary to conduct inspections."

Subsec. (g)(7)(F). Pub. L. 110–85, §228(5)(B), added subpar. (F).

Subsec. (g)(10)(C)(iii). Pub. L. 110–85, §228(6), substituted "base amount applicable" for "based amount applicable".

2004—Subsec. (g)(1). Pub. L. 108–214, §2(b)(1)(A), in first sentence, substituted "conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title." for "conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices that are required in section 360(h) of this title, or inspections of such establishments required to register pursuant to section 360(i) of this title."

Subsec. (g)(5)(B). Pub. L. 108–214, §2(b)(1)(B), in first sentence, substituted "poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection." for "or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this subsection."

Subsec. (g)(6)(A)(i). Pub. L. 108–214, §2(b)(1)(C)(i), substituted "described in paragraph (1)" for "of the establishment pursuant to subsection (h) or (i) of section 360 of this title".

Subsec. (g)(6)(A)(ii). Pub. L. 108–214, §2(b)(1)(C)(ii)(I), substituted "inspections" for "each inspection" and inserted "during a 2-year period" after "person" in introductory provisions.

Subsec. (g)(6)(A)(ii)(I). Pub. L. 108–214, §2(b)(1)(C)(ii)(II), substituted "an accredited person" for "such a person".

Subsec. (g)(6)(A)(iii). Pub. L. 108–214, §2(b)(1)(C)(iii)(I), substituted "and 1 or both of the following additional conditions are met:" for "and the following additional conditions are met:" in introductory provisions.

Subsec. (g)(6)(A)(iii)(I). Pub. L. 108–214, §2(b)(1)(C)(iii)(II), substituted "(accredited under paragraph (2) and identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments." for "accredited under paragraph (2) and identified under subclause (II) of this clause."

Subsec. (g)(6)(A)(iii)(II). Pub. L. 108–214, §2(b)(1)(C)(iii)(III), inserted "or by a person accredited under paragraph (2)" after "by the Secretary".

Subsec. (g)(6)(A)(iv)(I). Pub. L. 108–214, §2(b)(1)(C)(iv), in first sentence, inserted "section" after "pursuant to" and substituted "inspections of the establishment during the previous 4 years" for "the two immediately preceding inspections of the establishment", in third sentence, struck out "the petition states a commercial reason for the waiver;" after "granted only if" and inserted "not" after "the Secretary has not determined that the public health would", and, in last sentence, substituted "granted or deemed to be granted until" for "granted until".

Subsec. (g)(6)(A)(iv)(II). Pub. L. 108–214, §2(b)(1)(C)(v), inserted "of a device establishment required to register" after "to be conducted" and "section" after "pursuant to".

Subsec. (g)(6)(B)(iii). Pub. L. 108–214, §2(b)(1)(D), in first sentence, substituted "and with other" for ", and data otherwise describing whether the establishment has consistently been in compliance with sections 351 and 352 of this title and other" and, in second sentence, substituted "inspectional findings" for "inspections" and inserted "relevant" after "together with all other".

Subsec. (g)(6)(B)(iv). Pub. L. 108–214, §2(b)(1)(E), designated existing provisions as subcl. (I) and added subcl. (II).

Subsec. (g)(6)(C)(ii). Pub. L. 108–214, §2(b)(1)(F), struck out "in accordance with section 360(h) of this title, or has not during such period been inspected pursuant to section 360(i) of this title, as applicable" after "inspected by the Secretary".

Subsec. (g)(10)(B)(iii). Pub. L. 108–214, §2(b)(1)(G), substituted "a report" for "a reporting".

Subsec. (g)(12)(A). Pub. L. 108–214, §2(b)(1)(H)(i), added subpar. (A) and struck out former subpar. (A) which read as follows: "the number of inspections pursuant to subsections (h) and (i) of section 360 of this title conducted by accredited persons and the number of inspections pursuant to such subsections conducted by Federal employees;".

Subsec. (g)(12)(E). Pub. L. 108–214, §2(b)(1)(H)(ii), substituted "obtained by the Secretary pursuant to inspections conducted by Federal employees;" for "obtained by the Secretary pursuant to subsection (h) or (i) of section 360 of this title;".

2002—Subsec. (a)(1). Pub. L. 107–188, §306(b)(1), inserted after first sentence "In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 350c(d) of this title."

Subsec. (a)(2). Pub. L. 107–188, §306(b)(2), substituted "third sentence" for "second sentence" in introductory provisions.

Subsec. (f)(1). Pub. L. 107–250, §201(b)(1), in first sentence, substituted "An accredited person described in paragraph (3) shall maintain records" for "A person accredited under section 360m of this title to review reports made under section 360(k) of this title and make recommendations of initial classifications of devices to the Secretary shall maintain records".

Subsec. (f)(2). Pub. L. 107–250, §201(b)(2), substituted "an accredited person described in paragraph (3)" for "a person accredited under section 360m of this title".

Subsec. (f)(3). Pub. L. 107–250, §201(b)(3), added par. (3).

Subsec. (g). Pub. L. 107–250, §201(a), added subsec. (g).

1997—Subsec. (a)(1). Pub. L. 105–115, §412(b), substituted "prescription drugs, nonprescription drugs intended for human use," for "prescription drugs" in two places.

Pub. L. 105–115, §125(b)(2)(L), struck out ", section 357(d) or (g)," before "section 360i".

Subsec. (f). Pub. L. 105–115, §210(b), added subsec. (f).

1993—Subsec. (a)(1). Pub. L. 103–80 substituted a comma for semicolon after "finished and unfinished materials" and "section 355(i) or (k)" for "section 355(i) or (j)".

1980—Subsec. (a)(1). Pub. L. 96–359, §4(1), (2), restructured first five sentences of former subsec. (a) as par. (1) and, as so restructured, inserted reference to paragraph (3) and substituted "(A)" and "(B)" for "(1)" and "(2)", respectively.

Subsec. (a)(2). Pub. L. 96–359, §4(3), redesignated sixth sentence of former subsec. (a) as par. (2) and, as so redesignated, substituted reference to second sentence of paragraph (1) for reference to former second sentence of this subsection, and "(A)", "(B)", "(C)", and "(D)", for "(1)", "(2)", "(3)", and "(4)", respectively.

Subsec. (a)(3). Pub. L. 96–359, §4(4), added par. (3).

1976—Subsec. (a). Pub. L. 94–295, §6(a)–(c), expanded existing provisions to encompass medical devices by inserting references to factories, warehouses, establishments, and consulting laboratories in which restricted devices are manufactured, processed, packed, or held, inspections relating to devices, reporting and inspection regulations issued pursuant to sections 360i and 360j(g) of this title, and the manufacture and processing of devices.

Subsec. (e). Pub. L. 94–295, §6(d), added subsec. (e).

1962—Subsec. (a). Pub. L. 87–781, §201(a), extended the inspection, where prescription drugs are manufactured, processed, packed, or held, to all things bearing on whether adulterated or misbranded drugs, or any which may not be manufactured, introduced in interstate commerce, or sold or offered for sale under any provision of this chapter, have been or are being manufactured, processed, packed, transported or held in any such place, or otherwise bearing on violation of this chapter, but excluded from such inspection, data concerning finance, sales other than shipment, pricing, personnel other than qualifications of technical and professional personnel, research other than relating to new drugs subject to reporting, provided that provisions of second sentence of this subsection shall be inapplicable to pharmacies, practitioners and other persons enumerated in pars. (1) to (4), and struck out "are held" before "after such introduction".

Subsec. (b). Pub. L. 87–781, §201(b), inserted "consulting laboratory" after "warehouse".

1953—Act Aug. 7, 1953, designated existing provisions as subsec. (a) and amended them by substituting provisions permitting entry and inspection upon presentation of appropriate credentials and a written notice to the owner, operator, or agent in charge for provisions which authorized entry and inspection only after making a request and obtaining permission from the owner, operator, or custodian, and inserting provisions requiring a separate written notice for each inspection but not for each entry made during the period covered by the inspection, and directing that the inspection shall be conducted within reasonable limits, in a reasonable manner and completed with reasonable promptness, and added subsecs. (b) to (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2020 Amendment

Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.

Effective Date of 1997 Amendment

Amendment by sections 210(b) and 412(b) of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 203 of Pub. L. 87–781, set out as a note under section 332 of this title.

Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Review of Processes and Practices; Guidance for Industry

Pub. L. 117–328, div. FF, title III, §3612(b), Dec. 29, 2022, 136 Stat. 5871, provided that:

"(1) In general.—The Secretary [of Health and Human Services] shall—

"(A) review processes and practices in effect as of the date of enactment of this Act [Dec. 29, 2022] applicable to inspections of foreign and domestic sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(a)(5)], as added by subsection (a); and

"(B) evaluate whether any updates are needed to facilitate the consistency of such processes and practices.

"(2) Guidance.—

"(A) In general.—The Secretary shall issue guidance describing the processes and practices applicable to inspections of sites and facilities described in subparagraph (C)(i) of section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including with respect to the types of records and information required to be provided, best practices for communication between the Food and Drug Administration and industry in advance of or during an inspection or request for records or other information, and other inspections-related conduct, to the extent not specified in existing publicly available Food and Drug Administration guides and manuals for such inspections.

"(B) Timing.—The Secretary shall—

"(i) not later than 18 months after the date of enactment of this Act, issue draft guidance under subparagraph (A); and

"(ii) not later than 1 year after the close of the public comment period for such draft guidance, issue final guidance under subparagraph (A)."

Unannounced Foreign Facility Inspections Pilot Program

Pub. L. 117–328, div. FF, title III, §3615, Dec. 29, 2022, 136 Stat. 5873, provided that:

"(a) In General.—The Secretary [of Health and Human Services] shall conduct a pilot program under which the Secretary increases the conduct of unannounced surveillance inspections of foreign human drug establishments and evaluates the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection. Such pilot program shall evaluate—

"(1) differences in the number and type of violations of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) identified as a result of unannounced and announced inspections of foreign human drug establishments and any other significant differences between each type of inspection;

"(2) costs and benefits associated with conducting announced and unannounced inspections of foreign human drug establishments;

"(3) barriers to conducting unannounced inspections of foreign human drug establishments and any challenges to achieving parity between domestic and foreign human drug establishment inspections; and

"(4) approaches for mitigating any negative effects of conducting announced inspections of foreign human drug establishments.

"(b) Pilot Program Scope.—The inspections evaluated under the pilot program under this section shall be routine surveillance inspections and shall not include inspections conducted as part of the Secretary's evaluation of a request for approval to market a drug submitted under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.).

"(c) Pilot Program Initiation.—The Secretary shall initiate the pilot program under this section not later than 180 days after the date of enactment of this Act [Dec. 29, 2022].

"(d) Report.—The Secretary shall, not later than 180 days following the completion of the pilot program under this section, make available on the website of the Food and Drug Administration a final report on the pilot program under this section, including—

"(1) findings and any associated recommendations with respect to the evaluation under subsection (a), including any recommendations to address identified barriers to conducting unannounced inspections of foreign human drug establishments;

"(2) findings and any associated recommendations regarding how the Secretary may achieve parity between domestic and foreign human drug inspections; and

"(3) the number of unannounced inspections during the pilot program that would not be unannounced under practices in use as of the date of the enactment of this Act."

Guidance

Pub. L. 117–328, div. FF, title III, §3611(b)(2), Dec. 29, 2022, 136 Stat. 5869, provided that:

"(A) In general.—The Secretary [of Health and Human Services] shall issue or update guidance describing—

"(i) circumstances in which the Secretary intends to issue requests for records or other information in advance of, or in lieu of, an inspection under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 374(a)(4)], as amended by paragraph (1);

"(ii) processes for responding to such requests electronically or in physical form; and

"(iii) factors the Secretary intends to consider in evaluating whether such records and other information are provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, accounting for resource and other limitations that may exist, including for small businesses.

"(B) Timing.—The Secretary shall—

"(i) not later than 1 year after the date of enactment of this Act [Dec. 29, 2022], issue draft guidance under subparagraph (A); and

"(ii) not later than 1 year after the close of the comment period for such draft guidance, issue final guidance under subparagraph (A)."

Pub. L. 115–52, title VII, §702(b), Aug. 18, 2017, 131 Stat. 1055, provided that:

"(1) Draft guidance.—Not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance that—

"(A) specifies how the Food and Drug Administration will implement the processes and standards described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a), and the requirements described in paragraph (2) of such subsection (h);

"(B) provides for standardized methods for communications described in such paragraphs;

"(C) establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360(h)(2)], as amended by subsection (a) [of section 701 of Pub. L. 115–52]), a standard timeframe for such inspections—

"(i) that occurs over consecutive days; and

"(ii) to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and

"(D) identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

"(2) Final guidance.—Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a)."

Inspections

Pub. L. 115–52, title VIII, §806, Aug. 18, 2017, 131 Stat. 1073, provided that:

"Within 6 months of the date of enactment of this Act [Aug. 18, 2017], the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall—

"(1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)—

"(A) for which the approval is dependent upon remediation of conditions identified in the report;

"(B) for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and

"(C) where the drug that is the subject of the application is a drug—

"(i) for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or

"(ii) that is included on the list under section 506E of such Act (21 U.S.C. 356e);

"(2) address expedited re-inspection of facilities, as appropriate; and

"(3) establish a 6-month timeline for completion of review of such responses to such reports."

Authority of Secretary Prior to October 10, 1962

Pub. L. 87–781, title II, §201(d), Oct. 10, 1962, 76 Stat. 793, provided that: "Nothing in the amendments made by subsections (a) and (b) of this section [amending this section] shall be construed to negate or derogate from any authority of the Secretary existing prior to the enactment of this Act [Oct. 10, 1962]."

Executive Documents

Transfer of Functions

§374a. Inspections relating to food allergens

The Secretary of Health and Human Services shall conduct inspections consistent with the authority under section 374 of this title of facilities in which foods are manufactured, processed, packed, or held—

(1) to ensure that the entities operating the facilities comply with practices to reduce or eliminate cross-contact of a food with residues of major food allergens that are not intentional ingredients of the food; and

(2) to ensure that major food allergens are properly labeled on foods.

(Pub. L. 108–282, title II, §205, Aug. 2, 2004, 118 Stat. 909.)

Editorial Notes

Codification

Section was enacted as a part of the Food Allergen Labeling and Consumer Protection Act of 2004, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§375. Publicity

(a) Reports

The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this chapter, including the nature of the charge and the disposition thereof.

(b) Information regarding certain goods

The Secretary may also cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.

(June 25, 1938, ch. 675, §705, 52 Stat. 1057; Pub. L. 111–31, div. A, title I, §103(j), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (b). Pub. L. 111–31 inserted "tobacco products," after "devices,".

Executive Documents

Transfer of Functions

§376. Examination of sea food on request of packer; marking food with results; fees; penalties

The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary for expenditures incurred in carrying out the purposes of this section, including expenditures for salaries of additional inspectors when necessary to supplement the number of inspectors for whose salaries Congress has appropriated. The Secretary is authorized to promulgate regulations governing the sanitary and other conditions under which the service herein provided shall be granted and maintained, and for otherwise carrying out the purposes of this section. Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized or required by the provisions of this section or regulations thereunder, shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.

(June 25, 1938, ch. 675, §706, formerly §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204; amended Aug. 27, 1935, ch. 739, 49 Stat. 871; June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059, renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784; renumbered §702A of act June 25, 1938, July 12, 1943, ch. 221, title II, 57 Stat. 500; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; renumbered §706, Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103–80, §3(dd)(2), Aug. 13, 1993, 107 Stat. 779.)

Editorial Notes

Codification

Section was formerly classified to section 372a of this title prior to renumbering by Pub. L. 102–571.

Section, which formerly was not a part of the Federal Food, Drug, and Cosmetic Act, originally was classified to section 14a of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that the section should remain in force and effect and be applicable to the provisions of this chapter. Act July 12, 1943, renumbered this section as 702A of the Federal Food, Drug, and Cosmetic Act.

Prior Provisions

A prior section 376, act June 25, 1938, ch. 675, §706, 52 Stat. 1058, as amended, which related to listing and certification of color additives for foods, drugs, devices, and cosmetics, was renumbered section 721 of act June 25, 1938, by Pub. L. 102–571, title I, §106(4), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 379e of this title.

Amendments

1993—Pub. L. 103–80 struck out "of Agriculture" after "Secretary" in two places.

1992—Pub. L. 102–300, which directed the amendment of the section by striking out "of Health, Education, and Welfare" wherever appearing, could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

Statutory Notes and Related Subsidiaries

Transfer of Functions

Executive Documents

Transfer of Functions

§377. Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests

The Secretary, in carrying into effect the provisions of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], is authorized on and after July 12, 1943, to cooperate with associations and scientific societies in the revision of the United States Pharmacopoeia and in the development of methods of analysis and mechanical and physical tests necessary to carry out the work of the Food and Drug Administration.

(July 12, 1943, ch. 221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Codification

Section was enacted as part of the Labor-Federal Security Appropriation Act, 1944, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Executive Documents

Transfer of Functions

§378. Advertising of foods

(a) Determination of misbranding; notification of Federal Trade Commission by Secretary; contents

(1) Except as provided in subsection (c), before the Secretary may initiate any action under subchapter III—

(A) with respect to any food which the Secretary determines is misbranded under section 343(a)(2) of this title because of its advertising, or

(B) with respect to a food's advertising which the Secretary determines causes the food to be so misbranded,

the Secretary shall, in accordance with paragraph (2), notify in writing the Federal Trade Commission of the action the Secretary proposes to take respecting such food or advertising.

(2) The notice required by paragraph (1) shall—

(A) contain (i) a description of the action the Secretary proposes to take and of the advertising which the Secretary has determined causes a food to be misbranded, (ii) a statement of the reasons for the Secretary's determination that such advertising has caused such food to be misbranded, and

(B) be accompanied by the records, documents, and other written materials which the Secretary determines supports his determination that such food is misbranded because of such advertising.

(b) Action by Federal Trade Commission precluding action by Secretary; exception

(1) If the Secretary notifies the Federal Trade Commission under subsection (a) of action proposed to be taken under subchapter III with respect to a food or food advertising and the Commission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that—

(A) it has initiated under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] an investigation of such advertising to determine if it is prohibited by such Act or any order or rule under such Act,

(B) it has commenced (or intends to commence) a civil action under section 5, 13, or 19 [15 U.S.C. 45, 53, or 57b] with respect to such advertising or the Attorney General has commenced (or intends to commence) a civil action under section 5 [15 U.S.C. 45] with respect to such advertising,

(C) it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act [15 U.S.C. 45(b)] respecting such advertising, or

(D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it has made a certification to the Attorney General respecting such advertising,

the Secretary may not, except as provided by paragraph (2), initiate the action described in the Secretary's notice to the Federal Trade Commission.

(2) If, before the expiration of the 60-day period beginning on the date the Secretary receives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)—

(A) the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this subsection respecting the advertising described in the Secretary's notice,

(B) the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or

(C) the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respecting such advertising, or, if the Commission does make such a certification to the Attorney General respecting such advertising, the Attorney General, before the expiration of such period, does not cause appropriate criminal proceedings to be brought against such advertising,

the Secretary may, after the expiration of such period, initiate the action described in the notice to the Commission pursuant to subsection (a). The Commission shall promptly notify the Secretary of the commencement by the Commission of such a civil action, the issuance and service by it of such a complaint, or the causing by the Attorney General of criminal proceedings to be brought against such advertising.

(c) Secretary's determination of imminent hazard to health as suspending applicability of provisions

The requirements of subsections (a) and (b) do not apply with respect to action under subchapter III with respect to any food or food advertising if the Secretary determines that such action is required to eliminate an imminent hazard to health.

(d) Coordination of action by Secretary with Federal Trade Commission

For the purpose of avoiding unnecessary duplication, the Secretary shall coordinate any action taken under subchapter III because of advertising which the Secretary determines causes a food to be misbranded with any action of the Federal Trade Commission under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] with respect to such advertising.

(June 25, 1938, ch. 675, §707, as added Pub. L. 94–278, title V, §502(b), Apr. 22, 1976, 90 Stat. 412.)

Editorial Notes

References in Text

The Federal Trade Commission Act, referred to in subsecs. (b) and (d), is act Sept. 26, 1914, ch. 311, 38 Stat. 717, which is classified generally to subchapter I (§41 et seq.) of chapter 2 of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see section 58 of Title 15 and Tables.

§379. Confidential information

(a) Contractors

The Secretary may provide any information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section to a person other than an officer or employee of the Department if the Secretary determines such other person requires the information in connection with an activity which is undertaken under contract with the Secretary, which relates to the administration of this chapter, and with respect to which the Secretary (or an officer or employee of the Department) is not prohibited from using such information. The Secretary shall require as a condition to the provision of information under this section that the person receiving it take such security precautions respecting the information as the Secretary may by regulation prescribe.

(b) Ability to receive and protect confidential information obtained from foreign governments

(1) In general

The Secretary shall not be required to disclose under section 552 of title 5 (commonly referred to as the "Freedom of Information Act"), or any other provision of law, any information relating to drugs obtained from a foreign government agency, if—

(A) the information concerns the inspection of a facility, is part of an investigation, alerts the United States to the potential need for an investigation, or concerns a drug that has a reasonable probability of causing serious adverse health consequences or death to humans or animals;

(B) the information is provided or made available to the United States Government voluntarily on the condition that it not be released to the public; and

(2) Time limitations

The written agreement described in paragraph (1)(C) shall specify the time period for which paragraph (1) shall apply to the voluntarily disclosed information. Paragraph (1) shall not apply with respect to such information after the date specified in such agreement, but all other applicable legal protections, including the provisions of section 552 of title 5 and section 247d–7e(e)(1) of title 42, as applicable, shall continue to apply to such information. If no date is specified in the written agreement, paragraph (1) shall not apply with respect to such information for a period of more than 36 months.

(3) Disclosures not affected

Nothing in this section authorizes any official to withhold, or to authorize the withholding of, information from Congress or information required to be disclosed pursuant to an order of a court of the United States.

(4) Relation to other law

For purposes of section 552 of title 5, this subsection shall be considered a statute described in subsection (b)(3)(B) of such section 552.

(c) Authority to enter into memoranda of understanding for purposes of information exchange

The Secretary may enter into written agreements to provide information referenced in section 331(j) of this title to foreign governments subject to the following criteria:

(1) Certification

The Secretary may enter into a written agreement to provide information under this subsection to a foreign government only if the Secretary has certified such government as having the authority and demonstrated ability to protect trade secret information from disclosure. Responsibility for this certification shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs.

(2) Written agreement

The written agreement to provide information to the foreign government under this subsection shall include a commitment by the foreign government to protect information exchanged under this subsection from disclosure unless and until the sponsor gives written permission for disclosure or the Secretary makes a declaration of a public health emergency pursuant to section 247d of title 42 that is relevant to the information.

(3) Information exchange

The Secretary may provide to a foreign government that has been certified under paragraph (1) and that has executed a written agreement under paragraph (2) information referenced in section 331(j) of this title in only the following circumstances:

(A) Information concerning the inspection of a facility may be provided to a foreign government if—

(i) the Secretary reasonably believes, or the written agreement described in paragraph (2) establishes, that the government has authority to otherwise obtain such information; and

(ii) the written agreement executed under paragraph (2) limits the recipient's use of the information to the recipient's civil regulatory purposes.

(B) Information not described in subparagraph (A) may be provided as part of an investigation, or to alert the foreign government to the potential need for an investigation, if the Secretary has reasonable grounds to believe that a drug has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

(4) Effect of subsection

Nothing in this subsection affects the ability of the Secretary to enter into any written agreement authorized by other provisions of law to share confidential information.

(June 25, 1938, ch. 675, §708, as added Pub. L. 94–295, §8, May 28, 1976, 90 Stat. 582; amended Pub. L. 112–144, title VII, §710, July 9, 2012, 126 Stat. 1070.)

Editorial Notes

Amendments

2012—Pub. L. 112–144 designated existing provisions as subsec. (a), inserted heading, and added subsecs. (b) and (c).

§379a. Presumption of existence of jurisdiction

In any action to enforce the requirements of this chapter respecting a device, tobacco product, food, drug, or cosmetic the connection with interstate commerce required for jurisdiction in such action shall be presumed to exist.

(June 25, 1938, ch. 675, §709, as added Pub. L. 94–295, §8, May 28, 1976, 90 Stat. 583; amended Pub. L. 105–115, title IV, §419, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 111–31, div. A, title I, §103(k), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Pub. L. 111–31 inserted "tobacco product," after "device,".

1997—Pub. L. 105–115 substituted "a device, food, drug, or cosmetic" for "a device".

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

§379b. Consolidated administrative and laboratory facility

(a) Authority

The Secretary, in consultation with the Administrator of the General Services Administration, shall enter into contracts for the design, construction, and operation of a consolidated Food and Drug Administration administrative and laboratory facility.

(b) Awarding of contract

The Secretary shall solicit contract proposals under subsection (a) from interested parties. In awarding contracts under such subsection, the Secretary shall review such proposals and give priority to those alternatives that are the most cost effective for the Federal Government and that allow for the use of donated land, federally owned property, or lease-purchase arrangements. A contract under this subsection shall not be entered into unless such contract results in a net cost savings to the Federal Government over the duration of the contract, as compared to the Government purchase price including borrowing by the Secretary of the Treasury.

(c) Donations

In carrying out this section, the Secretary shall have the power, in connection with real property, buildings, and facilities, to accept on behalf of the Food and Drug Administration gifts or donations of services or property, real or personal, as the Secretary determines to be necessary.

(d) Authorization of appropriations

There are authorized to be appropriated to carry out this section $100,000,000 for fiscal year 1991, and such sums as may be necessary for each of the subsequent fiscal years, to remain available until expended.

(June 25, 1938, ch. 675, §710, as added Pub. L. 101–635, title I, §101, Nov. 28, 1990, 104 Stat. 4583.)

§379c. Transferred

Editorial Notes

Codification

Section, act June 25, 1938, ch. 675, §711, as added Nov. 28, 1990, Pub. L. 101–635, title II, §201, 104 Stat. 4584, which related to recovery and retention of fees for freedom of information requests, was renumbered section 731 of act June 25, 1938, by Pub. L. 102–571, title I, §106(6), Oct. 29, 1992, 106 Stat. 4499, and transferred to section 379f of this title.

§379d. Automation of Food and Drug Administration

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs, shall automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this chapter.

(b) Authorization of appropriations

There are authorized to be appropriated each fiscal year such sums as are necessary to carry out this section.

(June 25, 1938, ch. 675, §711, formerly §712, as added Pub. L. 101–635, title IV, §401, Nov. 28, 1990, 104 Stat. 4585; renumbered §711, Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498.)

Editorial Notes

Prior Provisions

A prior section 711 of act June 25, 1938, was renumbered section 731 by Pub. L. 102–571 and is classified to section 379f of this title.

§379d–1. Conflicts of interest

(a) Definitions

For purposes of this section:

(1) Advisory committee

The term "advisory committee" means an advisory committee under chapter 10 of title 5 that provides advice or recommendations to the Secretary regarding activities of the Food and Drug Administration.

(2) Financial interest

The term "financial interest" means a financial interest under section 208(a) of title 18.

(b) Recruitment for advisory committees

(1) In general

The Secretary shall—

(A) develop and implement strategies on effective outreach to potential members of advisory committees at universities, colleges, other academic research centers, professional and medical societies, and patient and consumer groups;

(B) seek input from professional medical and scientific societies to determine the most effective informational and recruitment activities;

(C) at least every 180 days, request referrals for potential members of advisory committees from a variety of stakeholders, including—

(i) product developers, patient groups, and disease advocacy organizations; and

(ii) relevant—

(I) professional societies;

(II) medical societies;

(III) academic organizations; and

(IV) governmental organizations; and

(D) in carrying out subparagraphs (A) and (B), take into account the levels of activity (including the numbers of annual meetings) and the numbers of vacancies of the advisory committees.

(2) Recruitment activities

The recruitment activities under paragraph (1) may include—

(A) advertising the process for becoming an advisory committee member at medical and scientific society conferences;

(B) making widely available, including by using existing electronic communications channels, the contact information for the Food and Drug Administration point of contact regarding advisory committee nominations; and

(C) developing a method through which an entity receiving funding from the National Institutes of Health, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, or the Veterans Health Administration can identify a person whom the Food and Drug Administration can contact regarding the nomination of individuals to serve on advisory committees.

(3) Expertise

In carrying out this subsection, the Secretary shall seek to ensure that the Secretary has access to the most current expert advice.

(c) Disclosure of determinations and certifications

Notwithstanding section 13109(a)(2) of title 5, the following shall apply:

(1) 15 or more days in advance

As soon as practicable, but (except as provided in paragraph (2)) not later than 15 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title, applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or section 552a of title 5 (popularly known as the Freedom of Information Act and the Privacy Act of 1974, respectively)) on the Internet Web site of the Food and Drug Administration—

(A) the type, nature, and magnitude of the financial interests of the advisory committee member to which such determination or certification applies; and

(B) the reasons of the Secretary for such determination or certification, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter before the advisory committee.

(2) Less than 30 days in advance

In the case of a financial interest that becomes known to the Secretary less than 30 days prior to a meeting of an advisory committee to which a written determination as referred to in section 208(b)(1) of title 18 or a written certification as referred to in section 208(b)(3) of such title applies, the Secretary shall disclose (other than information exempted from disclosure under section 552 or 552a of title 5) on the Internet Web site of the Food and Drug Administration, the information described in subparagraphs (A) and (B) of paragraph (1) as soon as practicable after the Secretary makes such determination or certification, but in no case later than the date of such meeting.

(d) Public record

The Secretary shall ensure that the public record and transcript of each meeting of an advisory committee includes the disclosure required under subsection (c) (other than information exempted from disclosure under section 552 of title 5 and section 552a of title 5).

(e) Annual report

(1) In general

Not later than February 1 of each year, the Secretary shall submit to the Committee on Appropriations and the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Appropriations and the Committee on Energy and Commerce of the House of Representatives, a report that describes—

(A) with respect to the fiscal year that ended on September 30 of the previous year, the number of persons nominated for participation at meetings for each advisory committee, the number of persons so nominated, and willing to serve, the number of vacancies on each advisory committee, and the number of persons contacted for service as members on each advisory committee meeting for each advisory committee who did not participate because of the potential for such participation to constitute a disqualifying financial interest under section 208 of title 18;

(B) with respect to such year, the number of persons contacted for service as members for each advisory committee meeting for each advisory committee who did not participate because of reasons other than the potential for such participation to constitute a disqualifying financial interest under section 208 of title 18;

(D) with respect to such year, the aggregate number of disclosures required under subsection (d) and the percentage of individuals to whom such disclosures did not apply who served on such committee.

(2) Public availability

Not later than 30 days after submitting any report under paragraph (1) to the committees specified in such paragraph, the Secretary shall make each such report available to the public.

(f) Periodic review of guidance

Not less than once every 5 years, the Secretary shall—

(1) review guidance of the Food and Drug Administration with respect to advisory committees regarding disclosure of conflicts of interest and the application of section 208 of title 18; and

(2) update such guidance as necessary to ensure that the Food and Drug Administration receives appropriate access to needed scientific expertise, with due consideration of the requirements of such section 208.

(g) Guidance on reported disclosed financial interest or involvement

The Secretary shall issue guidance that describes how the Secretary reviews the financial interests and involvement of advisory committee members that are disclosed under subsection (c) but that the Secretary determines not to meet the definition of a disqualifying interest under section 208 of title 18 for the purposes of participating in a particular matter.

(June 25, 1938, ch. 675, §712, as added Pub. L. 110–85, title VII, §701(a), Sept. 27, 2007, 121 Stat. 900; amended Pub. L. 112–144, title XI, §1142(a), July 9, 2012, 126 Stat. 1127; Pub. L. 114–255, div. A, title III, §3101(a)(2)(U), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 117–286, §4(a)(159), (c)(29), Dec. 27, 2022, 136 Stat. 4323, 4357.)

Editorial Notes

References in Text

The Privacy Act of 1974, referred to in subsec. (c)(3)(A), is Pub. L. 93–579, Dec. 31, 1974, 88 Stat. 1896, which enacted section 552a of Title 5, Government Organization and Employees, and provisions set out as notes under section 552a of Title 5. For complete classification of this Act to the Code, see Short Title of 1974 Amendment note set out under section 552a of Title 5 and Tables.

Prior Provisions

A prior section 712 of act June 25, 1938, was renumbered section 711 by Pub. L. 102–571 and is classified to section 379d of this title.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–286, §4(a)(159), substituted "chapter 10 of title 5" for "the Federal Advisory Committee Act".

Subsec. (c). Pub. L. 117–286, §4(c)(29), substituted "section 13109(a)(2) of title 5," for "section 107(a)(2) of the Ethics in Government Act of 1978,".

2016—Subsec. (e)(1)(B). Pub. L. 114–255 substituted "service as members" for "services as members".

2012—Subsecs. (b), (c). Pub. L. 112–144, §1142(a)(1), added subsecs. (b) and (c) and struck out former subsecs. (b) and (c) which related to appointments to advisory committees and disclosures, prohibitions on participation, and waivers.

Subsec. (d). Pub. L. 112–144, §1142(a)(2), substituted "subsection (c)" for "subsection (c)(3)".

Subsec. (e). Pub. L. 112–144, §1142(a)(3), amended subsec. (e) generally. Prior to amendment, subsec. (e) related to annual report.

Subsec. (f). Pub. L. 112–144, §1142(a)(4), substituted "shall—" for "shall review guidance of the Food and Drug Administration regarding conflict of interest waiver determinations with respect to advisory committees and update such guidance as necessary." and added pars. (1) and (2).

Subsec. (g). Pub. L. 112–144, §1142(a)(5), added subsec. (g).

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Pub. L. 112–144, title XI, §1142(b), July 9, 2012, 126 Stat. 1130, provided that: "The amendments made by subsection (a) [amending this section] apply beginning on October 1, 2012."

Effective Date

Section effective Oct. 1, 2007, see section 701(c) of Pub. L. 110–85, set out as an Effective Date of 2007 Amendment note under section 355 of this title.

§379d–2. Policy on the review and clearance of scientific articles published by FDA employees

(a) Definition

In this section, the term "article" means a paper, poster, abstract, book, book chapter, or other published writing.

(b) Policies

The Secretary, through the Commissioner of Food and Drugs, shall establish and make publicly available clear written policies to implement this section and govern the timely submission, review, clearance, and disclaimer requirements for articles.

(c) Timing of submission for review

If an officer or employee, including a Staff Fellow and a contractor who performs staff work, of the Food and Drug Administration is directed by the policies established under subsection (b) to submit an article to the supervisor of such officer or employee, or to some other official of the Food and Drug Administration, for review and clearance before such officer or employee may seek to publish or present such an article at a conference, such officer or employee shall submit such article for such review and clearance not less than 30 days before submitting the article for publication or presentation.

(d) Timing for review and clearance

The supervisor or other reviewing official shall review such article and provide written clearance, or written clearance on the condition of specified changes being made, to such officer or employee not later than 30 days after such officer or employee submitted such article for review.

(e) Non-timely review

If, 31 days after such submission under subsection (c), the supervisor or other reviewing official has not cleared or has not reviewed such article and provided written clearance, such officer or employee may consider such article not to have been cleared and may submit the article for publication or presentation with an appropriate disclaimer as specified in the policies established under subsection (b).

(f) Effect

Nothing in this section shall be construed as affecting any restrictions on such publication or presentation provided by other provisions of law.

(June 25, 1938, ch. 675, §713, as added Pub. L. 110–85, title XI, §1101, Sept. 27, 2007, 121 Stat. 971.)

§379d–3. Streamlined hiring authority

(a) In general

In addition to any other personnel authorities under other provisions of law, the Secretary may, without regard to the provisions of title 5 governing appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives specified in subsection (c).

(b) Activities described

The activities described in this subsection are—

(1) activities under this chapter related to the process for the review of device applications (as defined in section 379i(9) of this title); and

(2) activities under this chapter related to human generic drug activities (as defined in section 379j–41 of this title).

(c) Objectives specified

The objectives specified in this subsection are—

(1) with respect to the activities under subsection (b)(1), the goals referred to in section 379j–1(a)(1) of this title; and

(2) with respect to the activities under subsection (b)(2), the goals referred to in section 379j–43(a) of this title.

(d) Internal controls

The Secretary shall institute appropriate internal controls for appointments under this section.

(e) Sunset

The authority to appoint employees under this section shall terminate on the date that is 3 years after July 9, 2012.

(June 25, 1938, ch. 675, §714, as added and amended Pub. L. 112–144, title II, §208, title III, §307, July 9, 2012, 126 Stat. 1007, 1025; Pub. L. 115–52, title II, §202(b), Aug. 18, 2017, 131 Stat. 1013.)

Editorial Notes

Amendments

2017—Subsec. (b)(1). Pub. L. 115–52 substituted "379i(9)" for "379i(8)".

2012—Subsec. (b). Pub. L. 112–144, §307(1), amended subsec. (b) generally. Prior to amendment, text read as follows: "The activities described in this subsection are activities under this chapter related to the process for the review of device applications (as defined in section 379i(8) of this title)."

Subsec. (c). Pub. L. 112–144, §307(2), amended subsec. (c) generally. Prior to amendment, text read as follows: "The objectives specified in this subsection are with respect to the activities under subsection (b), the goals referred to in section 379j–1(a)(1) of this title."

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of this subchapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by section 307 of Pub. L. 112–144 effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title.

Effective Date

Section effective Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as an Effective Date of 2012 Amendment note under section 379i of this title.

§379d–3a. Hiring authority for scientific, technical, and professional personnel

(a) In general

The Secretary may, notwithstanding title 5, governing appointments in the competitive service, appoint outstanding and qualified candidates to scientific, technical, or professional positions, including cross-cutting operational positions, that support the development, review, and regulation of medical products and the regulation of food and cosmetics. Such positions shall be within the competitive service.

(b) Compensation

(1) In general

Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, and consistent with the requirements of paragraph (2), the Commissioner of Food and Drugs may determine and set—

(A) the annual rate of pay of any individual appointed under subsection (a); and

(B) for purposes of retaining qualified employees, the annual rate of pay for any qualified scientific, technical, or professional personnel appointed to a position described in subsection (a) before December 13, 2016.

(2) Limitation

The annual rate of pay established pursuant to paragraph (1) may not exceed the amount of annual compensation (excluding expenses) specified in section 102 of title 3.

(3) Public availability

The annual rate of pay provided to an individual in accordance with this section shall be publicly available information.

(c) Rule of construction

The authorities under this section shall not be construed to affect the authority provided under section 379d–3 of this title.

(d) Report on workforce planning

(1) In general

Not later than 18 months after December 29, 2022, the Secretary shall submit a report on workforce planning to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes—

(A) an updated analysis of the workforce needs at the Food and Drug Administration and the Secretary's strategic plan for addressing such needs, including through use of the authority under this section;

(B) an analysis of how the Secretary has used the authorities provided under this section, and a plan for how the Secretary will use the authority under this section, and other applicable hiring authorities, for employees of the Food and Drug Administration; and

(C) an updated recruitment and retention plan for hiring qualified scientific, technical, and professional candidates, which may include the use of—

(i) recruitment through nongovernmental recruitment or placement agencies;

(ii) recruitment through academic institutions;

(iii) recruitment or hiring bonuses, if applicable;

(iv) recruitment using targeted direct hiring authorities; and

(v) retention of qualified scientific, technical, and professional employees using the authority under this section, or other applicable authorities of the Secretary.

(2) Recommendations

The report under paragraph (1) may include the recommendations of the Commissioner of Food and Drugs that would help the Food and Drug Administration to better recruit and retain qualified individuals for scientific, technical, or professional positions at the agency.

(June 25, 1938, ch. 675, §714A, as added Pub. L. 114–255, div. A, title III, §3072(a), Dec. 13, 2016, 130 Stat. 1134; amended Pub. L. 117–328, div. FF, title III, §3624, Dec. 29, 2022, 136 Stat. 5879.)

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–328, §3624(1), inserted ", including cross-cutting operational positions," after "professional positions" and "and the regulation of food and cosmetics" after "medical products".

Subsec. (d)(1). Pub. L. 117–328, §3624(2)(A), in introductory provisions, substituted "December 29, 2022" for "December 13, 2016" and "that includes" for "that examines the extent to which the Food and Drug Administration has a critical need for qualified individuals for scientific, technical, or professional positions, including".

Subsec. (d)(1)(A). Pub. L. 117–328, §3624(2)(B), inserted "updated" before "analysis" and substituted semicolon for "; and".

Subsec. (d)(1)(B). Pub. L. 117–328, §3624(2)(D), added subpar. (B). Former subpar. (B) redesignated (C).

Subsec. (d)(1)(C). Pub. L. 117–328, §3624(2)(C), (E), redesignated subpar. (B) as (C) and substituted "an updated recruitment" for "a recruitment" in introductory provisions.

§379d–3b. Strategic Workforce Plan and report

(a) In general

Not later than September 30, 2023, and at least every 4 years thereafter, the Secretary shall develop, begin implementation of, and submit to the appropriate committees of Congress and post on the website of the Food and Drug Administration, a coordinated strategy and report to provide direction for the activities and programs of the Secretary to recruit, hire, train, develop, and retain the workforce needed to fulfill the public health mission of the Food and Drug Administration, including to facilitate collaboration across centers, to keep pace with new biomedical, technological, and scientific advancements, and support the development, review, and regulation of medical products. Each such report shall be known as the "Food and Drug Administration Strategic Workforce Plan".

(b) Use of the Food and Drug Administration Strategic Workforce Plan

Each center within the Food and Drug Administration shall develop and update, as appropriate, a strategic plan that will be informed by the Food and Drug Administration Strategic Workforce Plans developed under subsection (a).

(c) Contents of the Food and Drug Administration Strategic Workforce Plan

Each Food and Drug Administration Strategic Workforce Plan under subsection (a) shall—

(1) include agency-wide human capital strategic goals and priorities for recruiting, hiring, training, developing, and retaining a qualified workforce for the Food and Drug Administration;

(2) establish specific actions the Secretary will take to achieve such strategic goals and priorities and address the workforce needs of the Food and Drug Administration in the forthcoming fiscal years;

(3) identify challenges and risks the Secretary will face in meeting its strategic goals and priorities, and the actions the Secretary will take to overcome those challenges and mitigate those risks;

(4) establish performance measures, benchmarks, or other elements that the Secretary will use to measure and evaluate progress in achieving such strategic goals and priorities and the effectiveness of such strategic goals and priorities; and

(5) define functions, capabilities, and gaps in such workforce and identify strategies to recruit, hire, train, develop, and retain such workforce.

(d) Considerations

In developing each Food and Drug Administration Strategic Workforce Plan under subsection (a), the Secretary shall consider—

(1) the number of employees (including senior leadership and non-senior leadership employees) eligible for retirement, the expertise of such employees, and the employing center of such employees;

(2) the vacancy and turnover rates for employees with different types of expertise and from different centers, including any changes or trends related to such rates;

(3) the results of the Federal Employee Viewpoint Survey for employees of the Food and Drug Administration, including any changes or trends related to such results;

(4) rates of pay for different types of positions, including rates for different types of expertise within the same field (such as differences in pay between different medical specialists), and how such rates of pay impact the ability of the Secretary to achieve the strategic goals and priorities described in subsection (c);

(5) the statutory hiring authorities used to hire Food and Drug Administration employees, and the time to hire across different hiring authorities; and

(6) any other timely and relevant information, as the Secretary determines appropriate.

(e) Evaluation of progress

Each Food and Drug Administration Strategic Workforce Plan issued pursuant to subsection (a), with the exception of the first such Food and Drug Administration Strategic Workforce Plan, shall include an evaluation of—

(1) the progress the Secretary has made, based on the performance measures, benchmarks, and other elements that measure successful recruitment, hiring, training, development, and retention activities; and

(2) whether actions taken in response to the Plan improved the capacity of the Food and Drug Administration to achieve the strategic goals and priorities described in subsection (c)(1).

(f) Additional considerations

The Food and Drug Administration Strategic Workforce Plan issued in fiscal year 2023 shall address the effect of the COVID–19 pandemic on hiring, retention, and other workforce challenges for the Food and Drug Administration, including protecting such workforce during public health emergencies.

(June 25, 1938, ch. 675, §714B, as added Pub. L. 117–328, div. FF, title III, §3623, Dec. 29, 2022, 136 Stat. 5878.)

§379d–4. Reporting requirements

(a) Generic drugs

Beginning with fiscal year 2013 and ending after fiscal year 2017, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 7 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning, for all applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year—

(1) the number of such applications that met the goals identified for purposes of subpart 7 of part C, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record;

(2) the average total time to decision by the Secretary for applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year, including the number of calendar days spent during the review by the Food and Drug Administration and the number of calendar days spent by the sponsor responding to a complete response letter;

(3) the total number of applications under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications that were pending with the Secretary for more than 10 months on July 9, 2012; and

(4) the number of applications described in paragraph (3) on which the Food and Drug Administration took final regulatory action in the previous fiscal year.

(b) Biosimilar biological products

(1) In general

Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 8 of part C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning—

(A) the number of applications for approval filed under section 262(k) of title 42; and

(B) the percentage of applications described in subparagraph (A) that were approved by the Secretary.

(2) Additional information

As part of the performance report described in paragraph (1), the Secretary shall include an explanation of how the Food and Drug Administration is managing the biological product review program to ensure that the user fees collected under subpart 2 ¹ are not used to review an application under section 262(k) of title 42.

(June 25, 1938, ch. 675, §715, as added and amended Pub. L. 112–144, title III, §308, title IV, §408, July 9, 2012, 126 Stat. 1025, 1039.)

Editorial Notes

Amendments

2012—Subsec. (b). Pub. L. 112–144, §408, added subsec. (b).

Statutory Notes and Related Subsidiaries

Effective Date of 2012 Amendment

Amendment by section 408 of Pub. L. 112–144 effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–51 of this title.

Effective Date

Section effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as an Effective and Termination Dates note under section 379j–41 of this title.

¹ So in original. Probably means subpart 2 of part C.

§379d–5. Guidance document regarding product promotion using the Internet

Not later than 2 years after July 9, 2012, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration.

(Pub. L. 112–144, title XI, §1121, July 9, 2012, 126 Stat. 1112.)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Part B—Colors

§379e. Listing and certification of color additives for foods, drugs, devices, and cosmetics

(a) Unsafe color additives

A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless—

(1)(A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or

(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.

While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of section 342(a) of this title if such article is a food, or within the meaning of section 361(a) of this title if such article is a cosmetic other than a hair dye (as defined in the last sentence of section 361(a) of this title). A color additive for use in or on a device shall be subject to this section only if the color additive comes in direct contact with the body of man or other animals for a significant period of time. The Secretary may by regulation designate the uses of color additives in or on devices which are subject to this section.

(b) Listing of colors; regulations; issuance, amendment or repeal; referral to advisory committee; report and recommendations; appointment and compensation of advisory committee

(1) The Secretary shall, by regulation, provide for separately listing color additives for use in or on food, color additives for use in or on drugs, or devices, and color additives for use in or on cosmetics, if and to the extent that such additives are suitable and safe for any such use when employed in accordance with such regulations.

(2)(A) Such regulations may list any color additive for use generally in or on food, or in or on drugs or devices, or in or on cosmetics, if the Secretary finds that such additive is suitable and may safely be employed for such general use.

(B) If the data before the Secretary do not establish that the additive satisfies the requirements for listing such additive on the applicable list pursuant to subparagraph (A) of this paragraph, or if the proposal is for listing such additive for a more limited use or uses, such regulations may list such additive only for any more limited use or uses for which it is suitable and may safely be employed.

(3) Such regulations shall, to the extent deemed necessary by the Secretary to assure the safety of the use or uses for which a particular color additive is listed, prescribe the conditions under which such additive may be safely employed for such use or uses (including, but not limited to, specifications, hereafter in this section referred to as tolerance limitations, as to the maximum quantity or quantities which may be used or permitted to remain in or on the article or articles in or on which it is used; specifications as to the manner in which such additive may be added to or used in or on such article or articles; and directions or other labeling or packaging requirements for such additive).

(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe: Provided, however, That a color additive shall be deemed to be suitable and safe for the purpose of listing under this subsection for use generally in or on food, while there is in effect a published finding of the Secretary declaring such substance exempt from the term "food additive" because of its being generally recognized by qualified experts as safe for its intended use, as provided in section 321(s) of this title.

(5)(A) In determining, for the purposes of this section, whether a proposed use of a color additive is safe, the Secretary shall consider, among other relevant factors—

(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs or devices, or cosmetics because of the use of the additive;

(ii) the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet;

(iii) safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and

(iv) the availability of any needed practicable methods of analysis for determining the identity and quantity of (I) the pure dye and all intermediates and other impurities contained in such color additive, (II) such additive in or on any article of food, drug or device, or cosmetic, and (III) any substance formed in or on such article because of the use of such additive.

(B) A color additive (i) shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal, and (ii) shall be deemed unsafe, and shall not be listed, for any use which will not result in ingestion of any part of such additive, if, after tests which are appropriate for the evaluation of the safety of additives for such use, or after other relevant exposure of man or animal to such additive, it is found by the Secretary to induce cancer in man or animal: Provided, That clause (i) of this subparagraph (B) shall not apply with respect to the use of a color additive as an ingredient of feed for animals which are raised for food production, if the Secretary finds that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsection (d)) in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animal.

(C)(i) In any proceeding for the issuance, amendment, or repeal of a regulation listing a color additive, whether commenced by a proposal of the Secretary on his own initiative or by a proposal contained in a petition, the petitioner, or any other person who will be adversely affected by such proposal or by the Secretary's order issued in accordance with paragraph (1) of section 371(e) of this title if placed in effect, may request, within the time specified in this subparagraph, that the petition or order thereon, or the Secretary's proposal, be referred to an advisory committee for a report and recommendations with respect to any matter arising under subparagraph (B) of this paragraph, which is involved in such proposal or order and which requires the exercise of scientific judgment. Upon such request, or if the Secretary within such time deems such a referral necessary, the Secretary shall forthwith appoint an advisory committee under subparagraph (D) of this paragraph and shall refer to it, together with all the data before him, such matter arising under subparagraph (B) for study thereof and for a report and recommendations on such matter. A person who has filed a petition or who has requested the referral of a matter to an advisory committee pursuant to this subparagraph (C), as well as representatives of the Department, shall have the right to consult with such advisory committee in connection with the matter referred to it. The request for referral under this subparagraph, or the Secretary's referral on his own initiative, may be made at any time before, or within thirty days after, publication of an order of the Secretary acting upon the petition or proposal.

(ii) Within sixty days after the date of such referral, or within an additional thirty days if the committee deems such additional time necessary, the committee shall, after independent study of the data furnished to it by the Secretary and other data before it, certify to the Secretary a report and recommendations, together with all underlying data and a statement of the reasons or basis for the recommendations. A copy of the foregoing shall be promptly supplied by the Secretary to any person who has filed a petition, or who has requested such referral to the advisory committee. Within thirty days after such certification, and after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, and to any prior order issued by him in connection with such matter, the Secretary shall by order confirm or modify any order theretofore issued or, if no such prior order has been issued, shall by order act upon the petition or other proposal.

(iii) Where—

(I) by reason of subparagraph (B) of this paragraph, the Secretary has initiated a proposal to remove from listing a color additive previously listed pursuant to this section; and

(II) a request has been made for referral of such proposal to an advisory committee;

the Secretary may not act by order on such proposal until the advisory committee has made a report and recommendations to him under clause (ii) of this subparagraph and he has considered such recommendations, unless the Secretary finds that emergency conditions exist necessitating the issuance of an order notwithstanding this clause.

(D) The advisory committee referred to in subparagraph (C) of this paragraph shall be composed of experts selected by the National Academy of Sciences, qualified in the subject matter referred to the committee and of adequately diversified professional background, except that in the event of the inability or refusal of the National Academy of Sciences to act, the Secretary shall select the members of the committee. The size of the committee shall be determined by the Secretary. Members of any advisory committee established under this chapter, while attending conferences or meetings of their committees or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary but at rates not exceeding the daily equivalent of the rate specified at the time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 for persons in the Government service employed intermittently. The members shall not be subject to any other provisions of law regarding the appointment and compensation of employees of the United States. The Secretary shall furnish the committee with adequate clerical and other assistance, and shall by rules and regulations prescribe the procedure to be followed by the committee.

(6) The Secretary shall not list a color additive under this subsection for a proposed use if the data before him show that such proposed use would promote deception of the consumer in violation of this chapter or would otherwise result in misbranding or adulteration within the meaning of this chapter.

(7) If, in the judgment of the Secretary, a tolerance limitation is required in order to assure that a proposed use of a color additive will be safe, the Secretary—

(A) shall not list the additive for such use if he finds that the data before him do not establish that such additive, if used within a safe tolerance limitation, would achieve the intended physical or other technical effect; and

(B) shall not fix such tolerance limitation at a level higher than he finds to be reasonably required to accomplish the intended physical or other technical effect.

(8) If, having regard to the aggregate quantity of color additive likely to be consumed in the diet or to be applied to the human body, the Secretary finds that the data before him fail to show that it would be safe and otherwise permissible to list a color additive (or pharmacologically related color additives) for all the uses proposed therefor and at the levels of concentration proposed, the Secretary shall, in determining for which use or uses such additive (or such related additives) shall be or remain listed, or how the aggregate allowable safe tolerance for such additive or additives shall be allocated by him among the uses under consideration, take into account, among other relevant factors (and subject to the paramount criterion of safety), (A) the relative marketability of the articles involved as affected by the proposed uses of the color additive (or of such related additives) in or on such articles, and the relative dependence of the industries concerned on such uses; (B) the relative aggregate amounts of such color additive which he estimates would be consumed in the diet or applied to the human body by reason of the various uses and levels of concentration proposed; and (C) the availability, if any, of other color additives suitable and safe for one or more of the uses proposed.

(c) Certification of colors

The Secretary shall further, by regulation, provide (1) for the certification, with safe diluents or without diluents, of batches of color additives listed pursuant to subsection (b) and conforming to the requirements for such additives established by regulations under such subsection and this subsection, and (2) for exemption from the requirement of certification in the case of any such additive, or any listing or use thereof, for which he finds such requirement not to be necessary in the interest of the protection of the public health: Provided, That, with respect to any use in or on food for which a listed color additive is deemed to be safe by reason of the proviso to paragraph (4) of subsection (b), the requirement of certification shall be deemed not to be necessary in the interest of public health protection.

(d) Procedure for issuance, amendment, or repeal of regulations

The provisions of section 371(e), (f), and (g) of this title shall, subject to the provisions of subparagraph (C) of subsection (b)(5) of this section, apply to and in all respects govern proceedings for the issuance, amendment, or repeal of regulations under subsection (b) or (c) of this section (including judicial review of the Secretary's action in such proceedings) and the admissibility of transcripts of the record of such proceedings in other proceedings, except that—

(1) if the proceeding is commenced by the filing of a petition, notice of the proposal made by the petition shall be published in general terms by the Secretary within thirty days after such filing, and the Secretary's order (required by paragraph (1) of section 371(e) of this title) acting upon such proposal shall, in the absence of prior referral (or request for referral) to an advisory committee, be issued within ninety days after the date of such filing, except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition;

(2) any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee appointed pursuant to subparagraph (D) of subsection (b)(5) of this section, shall be made a part of the record of any hearing if relevant and material, subject to the provisions of section 556(d) of title 5. The advisory committee shall designate a member to appear and testify at any such hearing with respect to the report and recommendations of such committee upon request of the Secretary, the petitioner, or the officer conducting the hearing, but this shall not preclude any other member of the advisory committee from appearing and testifying at such hearing;

(3) the Secretary's order after public hearing (acting upon objections filed to an order made prior to hearing) shall be subject to the requirements of section 348(f)(2) of this title; and

(4) the scope of judicial review of such order shall be in accordance with the fourth sentence of paragraph (2), and with the provisions of paragraph (3), of section 348(g) of this title.

(e) Fees

The admitting to listing and certification of color additives, in accordance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes.

(f) Exemptions

The Secretary shall by regulations (issued without regard to subsection (d)) provide for exempting from the requirements of this section any color additive or any specific type of use thereof, and any article of food, drug, or device, or cosmetic bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.

(June 25, 1938, ch. 675, §721, formerly §706, 52 Stat. 1058; Pub. L. 86–618, title I, §103(b), July 12, 1960, 74 Stat. 399; Pub. L. 87–781, title I, §104(f)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–515, title VI, §601(d)(2), Oct. 30, 1970, 84 Stat. 1311; Pub. L. 94–295, §9(a), May 28, 1976, 90 Stat. 583; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; renumbered §721, Pub. L. 102–571, title I, §106(4), Oct. 29, 1992, 106 Stat. 4498; Pub. L. 103–80, §3(bb), Aug. 13, 1993, 107 Stat. 778.)

Editorial Notes

Codification

Section was formerly classified to section 376 of this title prior to renumbering by Pub. L. 102–571.

In subsec. (d)(2), "section 556(d) of title 5" substituted for "section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))" on authority of Pub. L. 89–554, §7(b), Sept. 6, 1966, 80 Stat. 631, the first section of which enacted Title 5, Government Organization and Employees.

Amendments

1993—Subsec. (b)(5)(D). Pub. L. 103–80 substituted "section 5703" for "section 5703(b)".

1992—Subsec. (b)(5)(C)(i). Pub. L. 102–300 struck out "of Health, Education, and Welfare" after "representatives of the Department".

1976—Subsec. (a). Pub. L. 94–295, §9(a)(2), (3), inserted reference to devices and inserted provisions directing that color additives for use in or on devices be subject to this section only if the color additives come in direct contact with the body of man or other animals for a significant period of time and authorizing the Secretary to designate by regulation the uses of color additives in or on devices which are subject to this section.

Subsec. (b). Pub. L. 94–295, §9(a)(1), (2), substituted "drug or device" for "drug" and "drugs or devices" for "drugs" wherever appearing.

Subsec. (f). Pub. L. 94–295, §9(a)(1), substituted "drug or device" for "drug".

1970—Subsec. (b)(5)(D). Pub. L. 91–515 substituted provisions authorizing members of an advisory committee to receive compensation at rates fixed by the Secretary, with a specific maximum amount, and travel expenses, including per diem in lieu of subsistence, as authorized by section 5703(b) of Title 5, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on committee work, and necessary traveling and subsistence expenses while serving away from their places of residence.

1962—Subsec. (b)(5)(B). Pub. L. 87–781 provided that clause (i) of this subparagraph shall not apply to a color additive in feed of animals raised for food production, if under the conditions of use specified in proposed labeling, and which conditions are reasonably certain to be followed in practice, such additive will not adversely affect the animals and no residue will be found in any edible portion of such animal after slaughter or in any food from the living animal.

1960—Pub. L. 86–618 amended section generally. Prior to amendment, section read as follows: "The admitting to listing and certification of coal-tar colors, in accordance with regulations prescribed under this chapter, shall be performed only upon payment of such fees, which shall be specified in such regulations, as may be necessary to provide, maintain, and equip an adequate service for such purposes."

Statutory Notes and Related Subsidiaries

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment, Transitional Provisions, and Effect on Other Laws

Pub. L. 86–618, title II, July 12, 1960, 74 Stat. 404, provided that:

"Sec. 201. [Definitions.] As used in this title, the term 'basic Act' means the Federal Food, Drug, and Cosmetic Act [this chapter]; the term 'enactment date' means the date of enactment of this Act [July 12, 1960]; and other terms, insofar as also used in the basic Act (whether before or after enactment of this Act) shall have the same meaning as they have, or had when in effect, under the basic Act.

"Sec. 202. [Effective Date.] This Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repealing sections 354 and 364 of this title] shall, subject to the provisions of section 203, take effect on the enactment date [July 12, 1960].

"Sec. 203. [Provisional Listings of Commercially Established Colors.] (a)(1) The purpose of this section is to make possible, on an interim basis for a reasonable period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the completion of the scientific investigations needed as a basis for making determinations as to listing of such additives under the basic Act as amended by this Act. A provisional listing (including a deemed provisional listing) of a color additive under this section for any use shall, unless sooner terminated or expiring under the provisions of this section, expire (A) on the closing date (as defined in paragraph (2) of this subsection) or (B) on the effective date of a listing of such additive for such use under section 706 [now 721] of the basic Act, [this section], whichever date first occurs.

"(2) For the purposes of this section, the term 'closing date' means (A) the last day of the two and one-half year period beginning on the enactment date [July 12, 1960] or (B), with respect to a particular provisional listing (or deemed provisional listing) of a color additive or use thereof, such later closing date as the Secretary may from time to time establish pursuant to the authority of this paragraph. The Secretary may by regulation, upon application of an interested person or on his own initiative, from time to time postpone the original closing date with respect to a provisional listing (or deemed provisional listing) under this section of a specified color additive, or of a specified use or uses of such additive, for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary's judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive, or such specified use or uses thereof, under section 706 [now 721] of the basic Act [this section]. The Secretary may terminate a postponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such postponement.

"(b) Subject to the other provisions of this section—

"(1) any color additive which, on the day preceding the enactment date [July 12, 1960], was listed and certifiable for any use or uses under section 406(b), 504, or 604 [section 346(b), 354, or 364 of this title], or under the third proviso of section 402(c) [section 342(c) of this title], of the basic Act, and of which a batch or batches had been certified for such use or uses prior to the enactment date [July 12, 1960], and

"(2) any color additive which was commercially used or sold prior to the enactment date [July 12, 1960] for any use or uses in or on any food, drug, or cosmetic, and which either, (A), on the day preceding the enactment date [July 12, 1960], was not a material within the purview of any of the provisions of the basic Act enumerated in paragraph (1) of this subsection, or (B) is the color additive known as synthetic beta-carotene,

shall, beginning on the enactment date [July 12, 1960], be deemed to be provisionally listed under this section as a color additive for such use or uses.

"(c) Upon request of any person, the Secretary, by regulations issued under subsection (d), shall without delay, if on the basis of the data before him he deems such action consistent with the protection of the public health, provisionally list a material as a color additive for any use for which it was listed, and for which a batch or batches of such material had been certified, under section 406(b), 504, or 604 of the basic Act [section 346(b), 354, or 364 of this title] prior to the enactment date [July 12, 1960], although such color was no longer listed and certifiable for such use under such sections on the day preceding the enactment date. Such provisional listing shall take effect on the date of publication.

"(d)(1) The Secretary shall, by regulations issued or amended from time to time under this section—

"(A) insofar as practicable promulgate and keep current a list or lists of the color additives, and of the particular uses thereof, which he finds are deemed provisionally listed under subsection (b), and the presence of a color additive on such a list with respect to a particular use shall, in any proceeding under the basic Act, be conclusive evidence that such provisional listing is in effect;

"(B) provide for the provisional listing of the color additives and particular uses thereof specified in subsection (c);

"(C) provide, with respect to particular uses for which color additives are or are deemed to be provisionally listed, such temporary tolerance limitations (including such limitations at zero level) and other conditions of use and labeling or packaging requirements, if any, as in his judgment are necessary to protect the public health pending listing under section 706 [now 721] of the basic Act [this section];

"(D) provide for the certification of batches of such color additives (with or without diluents) for the uses for which they are so listed or deemed to be listed under this section, except that such an additive which is a color additive deemed provisionally listed under subsection (b)(2) of this section shall be deemed exempt from the requirement of such certification while not subject to a tolerance limitation; and

"(E) provide for the termination of a provisional listing (or deemed provisional listing) of a color additive or particular use thereof forthwith whenever in his judgment such action is necessary to protect the public health.

"(2)(A) Except as provided in subparagraph (C) of this paragraph, regulations under this section shall, from time to time, be issued, amended, or repealed by the Secretary without regard to the requirements of the basic Act [subsec. (e) of this section], but for the purposes of the application of section 706(e) [now 721(e)] of the basic Act (relating to fees) and of determining the availability of appropriations of fees (and of advance deposits to cover fees), proceedings, regulations, and certifications under this section shall be deemed to be proceedings, regulations, and certifications under such section 706 [now 721, this section]. Regulations providing for fees (and advance deposits to cover fees), which on the day preceding the enactment date [July 12, 1960] were in effect pursuant to section 706 [now 721] of the basic Act [this section], shall be deemed to be regulations under such section 706 [now 721, this section] as amended by this Act, and appropriations of fees (and advance deposits) available for the purposes specified in such section 706 [now 721] as in effect prior to the enactment date [July 12, 1960] shall be available for the purposes specified in such section 706 [now 721, this section] as so amended.

"(B) If the Secretary, by regulation—

"(i) has terminated a provisional listing (or deemed provisional listing) of a color additive or particular use thereof pursuant to paragraph (1)(E) of this subsection; or

"(ii) has, pursuant to paragraph (1)(C) or paragraph (3) of this subsection, initially established or rendered more restrictive a tolerance limitation or other restriction or requirement with respect to a provisional listing (or deemed provisional listing) which listing had become effective prior to such action,

any person adversely affected by such action may, prior to the expiration of the period specified in clause (A) of subsection (a)(2) of this section, file with the Secretary a petition for amendment of such regulation so as to revoke or modify such action of the Secretary, but the filing of such petition shall not operate to stay or suspend the effectiveness of such action. Such petition shall, in accordance with regulations, set forth the proposed amendment and shall contain data (or refer to data which are before the Secretary or of which he will take official notice), which show that the revocation or modification proposed is consistent with the protection of the public health. The Secretary shall, after publishing such proposal and affording all interested persons an opportunity to present their views thereon orally or in writing, act upon such proposal by published order.

"(C) Any person adversely affected by an order entered under subparagraph (B) of this paragraph may, within thirty days after its publication, file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds for such objections, and requesting a public hearing upon such objections. The Secretary shall hold a public hearing on such objections and shall, on the basis of the evidence adduced at such hearing, act on such objections by published order. Such order may reinstate a terminated provisional listing, or increase or dispense with a previously established temporary tolerance limitation, or make less restrictive any other limitation established by him under paragraph (1) or (3) of this subsection, only if in his judgment the evidence so adduced shows that such action will be consistent with the protection of the public health. An order entered under this subparagraph shall be subject to judicial review in accordance with section 701(f) of the basic Act [section 371(f) of this title] except that the findings and order of the Secretary shall be sustained only if based upon a fair evaluation of the entire record at such hearing. No stay or suspension of such order shall be ordered by the court pending conclusion of such judicial review.

"(D) On and after the enactment date [July 12, 1960], regulations, provisional listings, and certifications (or exemptions from certification) in effect under this section shall, for the purpose of determining whether an article is adulterated or misbranded within the meaning of the basic Act by reason of its being, bearing, or containing a color additive, have the same effect as would regulations, listings, and certifications (or exemptions from certification) under section 706 [now 721] of the basic Act [this section]. A regulation, provisional listing or termination thereof, tolerance limitation, or certification or exemption therefrom, under this section shall not be the basis for any presumption or inference in any proceeding under section 706(b) or (c) [now 721(b), (c)] of the basic Act [subsec. (b) or (c) of this section].

"(3) For the purpose of enabling the Secretary to carry out his functions under paragraphs (1)(A) and (C) of this subsection with respect to color additives deemed provisionally listed, he shall, as soon as practicable after enactment of this Act [July 12, 1960], afford by public notice a reasonable opportunity to interested persons to submit data relevant thereto. If the data so submitted or otherwise before him do not, in his judgment, establish a reliable basis for including such a color additive or particular use or uses thereof in a list or lists promulgated under paragraph (1)(A), or for determining the prevailing level or levels of use thereof prior to the enactment date [July 12, 1960] with a view to prescribing a temporary tolerance or tolerances for such use or uses under paragraph (1)(C), the Secretary shall establish a temporary tolerance limitation at zero level for such use or uses until such time as he finds that it would not be inconsistent with the protection of the public health to increase or dispense with such temporary tolerance limitation.

"Sec. 204. [Effect on Meat Inspection and Poultry Products Inspection Acts.] Nothing in this Act [amending this section and sections 321, 331, 333, 342, 343, 346, 351, 352, 361, 362, and 371 of this title and repealing sections 354 and 364 of this title] shall be construed to exempt any meat or meat food product, poultry or poultry product, or any person from any requirement imposed by or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended or extended (21 U.S.C. 71 and the following) [see section 601 et seq. of this title] or the Poultry Products Inspection Act (21 U.S.C. 451 and the following)."

Effective Date; Acceleration

This section was made "immediately effective" by act May 2, 1939, ch. 107, title I, §1, 53 Stat. 631.

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

Part C—Fees

subpart 1—freedom of information fees

§379f. Recovery and retention of fees for freedom of information requests

(a) In general

The Secretary, acting through the Commissioner of Food and Drugs, may—

(1) set and charge fees, in accordance with section 552(a)(4)(A) of title 5, to recover all reasonable costs incurred in processing requests made under section 552 of title 5 for records obtained or created under this chapter or any other Federal law for which responsibility for administration has been delegated to the Commissioner by the Secretary;

(2) retain all fees charged for such requests; and

(3) establish an accounting system and procedures to control receipts and expenditures of fees received under this section.

(b) Use of fees

The Secretary and the Commissioner of Food and Drugs shall not use fees received under this section for any purpose other than funding the processing of requests described in subsection (a)(1). Such fees shall not be used to reduce the amount of funds made to carry out other provisions of this chapter.

(c) Waiver of fees

Nothing in this section shall supersede the right of a requester to obtain a waiver of fees pursuant to section 552(a)(4)(A) of title 5.

(June 25, 1938, ch. 675, §731, formerly §711, as added Pub. L. 101–635, title II, §201, Nov. 28, 1990, 104 Stat. 4584; renumbered §731, Pub. L. 102–571, title I, §106(6), Oct. 29, 1992, 106 Stat. 4499.)

Editorial Notes

Codification

Section was formerly classified to section 379c of this title prior to renumbering by Pub. L. 102–571.

subpart 2—fees relating to drugs

§379g. Definitions

For purposes of this subpart:

(1) The term "human drug application" means an application for—

(A) approval of a new drug submitted under section 355(b) of this title, or

(B) licensure of a biological product under subsection (a) of section 262 of title 42.

Such term does not include a supplement to such an application, does not include an application with respect to whole blood or a blood component for transfusion, does not include an application with respect to a bovine blood product for topical application licensed before September 1, 1992, does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to an in vitro diagnostic biologic product licensed under section 262 of title 42, does not include an application with respect to a large volume parenteral drug product approved before September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (B), of a large volume biological product intended for single dose injection for intravenous use or infusion.

(2) The term "supplement" means a request to the Secretary to approve a change in a human drug application which has been approved.

(3)(A) The term "prescription drug product" means a specific strength or potency of a drug in final dosage form—

(i) for which a human drug application has been approved,

(ii) which may be dispensed only under prescription pursuant to section 353(b) of this title, and

(iii) which is on the list of products described in section 355(j)(7)(A) of this title (not including the discontinued section of such list) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 262 of title 42 (not including the discontinued section of such list).

(B) Such term does not include whole blood or a blood component for transfusion, does not include a bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, or an in vitro diagnostic biologic product licensed under section 262 of title 42. Such term does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.

(C)(i) If a written request to place a product in the discontinued section of either of the lists referenced in subparagraph (A)(iii) is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the prescription drug program fee under section 379h(a)(2) of this title, the Secretary shall consider such product to have been included in the discontinued section on the later of—

(I) the date such request was received; or

(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

(ii) For purposes of this subparagraph, a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.

(4) The term "final dosage form" means, with respect to a prescription drug product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).

(5) The term "prescription drug establishment" means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form. For purposes of this paragraph, the term "manufactured" does not include packaging.

(6) The term "process for the review of human drug applications" means the following activities of the Secretary with respect to the review of human drug applications and supplements:

(A) The activities necessary for the review of human drug applications and supplements.

(B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.

(C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary's review of pending human drug applications and supplements.

(D) Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such section.

(E) Monitoring of research conducted in connection with the review of human drug applications.

(F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities:

(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.

(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies).

(v) Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).

(7) The term "costs of resources allocated for the process for the review of human drug applications" means the expenses in connection with the process for the review of human drug applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors,

(B) management of information, and the acquisition, maintenance, and repair of computer resources,

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies, and

(D) collecting fees under section 379h of this title and accounting for resources allocated for the review of human drug applications and supplements.

(8) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 1996.

(9) The term "person" includes an affiliate thereof.

(10) The term "active", with respect to a commercial investigational new drug application, means such an application to which information was submitted during the relevant period.

(11) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(12) The term "skin-test diagnostic product"—

(A) means a product—

(i) for prick, scratch, intradermal, or subcutaneous administration;

(ii) expected to produce a limited, local reaction at the site of administration (if positive), rather than a systemic effect;

(iii) not intended to be a preventive or therapeutic intervention; and

(iv) intended to detect an immediate- or delayed-type skin hypersensitivity reaction to aid in the diagnosis of—

(I) an allergy to an antimicrobial agent;

(II) an allergy that is not to an antimicrobial agent, if the diagnostic product was authorized for marketing prior to October 1, 2022; or

(III) infection with fungal or mycobacterial pathogens; and

(B) includes positive and negative controls required to interpret the results of a product described in subparagraph (A).

(June 25, 1938, ch. 675, §735, as added Pub. L. 102–571, title I, §103, Oct. 29, 1992, 106 Stat. 4491; amended Pub. L. 105–115, title I, §§102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat. 2298, 2326; Pub. L. 107–188, title V, §503, June 12, 2002, 116 Stat. 688; Pub. L. 110–85, title I, §102, Sept. 27, 2007, 121 Stat. 825; Pub. L. 111–148, title VII, §7002(f)(3)(A), Mar. 23, 2010, 124 Stat. 818; Pub. L. 112–144, title I, §102, title IV, §407, July 9, 2012, 126 Stat. 996, 1039; Pub. L. 117–180, div. F, title I, §1002, Sept. 30, 2022, 136 Stat. 2140.)

Termination of Section

For termination of section by section 1005(a) of Pub. L. 117–180, see Termination Date note below.

Editorial Notes

Amendments

2022—Par. (1). Pub. L. 117–180, §1002(a), substituted "does not include an application with respect to an allergenic extract product licensed before October 1, 2022, does not include an application with respect to a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022, does not include an application with respect to" for "an allergenic extract product, or" in concluding provisions.

Par. (3). Pub. L. 117–180, §1002(b), substituted "(3)(A) The term" for "(3) The term", redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), designated concluding provisions as subpar. (B) and substituted "an allergenic extract product licensed before October 1, 2022, a standardized allergenic extract product submitted pursuant to a notification to the applicant from the Secretary regarding the existence of a potency test that measures the allergenic activity of an allergenic extract product licensed by the applicant before October 1, 2022," for "an allergenic extract product,", and added subpar. (C).

Par. (12). Pub. L. 117–180, §1002(c), added par. (12).

2012—Par. (1)(B). Pub. L. 112–144, §407, struck out "or (k)" after "subsection (a)".

Par. (7). Pub. L. 112–144, §102, substituted "expenses in connection with" for "expenses incurred in connection with".

2010—Par. (1)(B). Pub. L. 111–148 substituted "subsection (a) or (k) of section 262 of title 42" for "section 262 of title 42".

2007—Pub. L. 110–85, §102(1), in introductory provisions, substituted "For purposes of this subpart" for "For purposes of this part".

Par. (1). Pub. L. 110–85, §102(2)(D), substituted "subparagraph (B)" for "subparagraph (C)" in concluding provisions.

Par. (1)(A). Pub. L. 110–85, §102(2)(A), substituted "355(b) of this title, or" for "355(b)(1) of this title,".

Par. (1)(B), (C). Pub. L. 110–85, §102(2)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B) which read as follows: "approval of a new drug submitted under section 355(b)(2) of this title after September 30, 1992, which requests approval of—

"(i) a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or

"(ii) an indication for a use,

that had not been approved under an application submitted under section 355(b) of this title, or".

Par. (3)(C). Pub. L. 110–85, §102(3), substituted "355(j)(7)(A) of this title (not including the discontinued section of such list)" for "355(j)(7)(A) of this title" and inserted "(not including the discontinued section of such list)" before period at end.

Par. (4). Pub. L. 110–85, §102(4), inserted "(such as capsules, tablets, or lyophilized products before reconstitution)" before period at end.

Par. (6)(F). Pub. L. 110–85, §102(5), amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: "In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years."

Par. (8). Pub. L. 110–85, §102(6), substituted "October of the preceding fiscal year" for "April of the preceding fiscal year" and "October 1996" for "April 1997".

Pars. (9) to (11). Pub. L. 110–85, §102(7), (8), added pars. (9) and (10) and redesignated former par. (9) as (11).

2002—Par. (1). Pub. L. 107–188, §503(1), substituted "licensure, as described in subparagraph (C)" for "licensure, as described in subparagraph (D)" in concluding provisions.

Par. (3). Pub. L. 107–188, §503(2)(D), which directed the amendment of concluding provisions of par. (3) by striking "section 262 of title 42" and all that follows through "biological product" and inserting "section 262 of title 42. Such term does not include a biological product", was executed by striking language ending with "biological product" the first time appearing, thereby making the substitution for "section 262 of title 42, does not include a large volume parenteral drug product approved before September 1, 1992, does not include a biological product", to reflect the probable intent of Congress.

Par. (3)(C). Pub. L. 107–188, §503(2)(A)–(C), added subpar. (C).

Par. (6)(F). Pub. L. 107–188, §503(3), added subpar. (F).

Par. (8). Pub. L. 107–188, §503(4), struck out designations of subpars. (A) and (B) and text of subpar. (B) and concluding provisions, substituting definition of "adjustment factor" as the Consumer Price Index for definition of Index as the lower of the Consumer Price Index or the total of discretionary budget authority provided for programs in the domestic category for the immediately preceding fiscal year divided by such budget authority for fiscal year 1997.

1997—Par. (1). Pub. L. 105–115, §102(1), in closing provisions, struck out "and" before "does not include an application" and substituted "September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion" for "September 1, 1992" before period at end.

Par. (1)(B) to (D). Pub. L. 105–115, §125(b)(2)(M), inserted "or" at end of subpar. (B), redesignated subpar. (D) as (C), and struck out former subpar. (C) which read as follows: "initial certification or initial approval of an antibiotic drug under section 357 of this title, or".

Par. (3). Pub. L. 105–115, §102(2), in closing provisions, struck out "and" before "does not include a large volume parenteral drug" and substituted "September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion" for "September 1, 1992" before period at end.

Par. (4). Pub. L. 105–115, §102(3), substituted "without substantial further manufacturing" for "without further manufacturing".

Par. (5). Pub. L. 105–115, §102(4), amended first sentence generally. Prior to amendment, first sentence read as follows: "The term 'prescription drug establishment' means a foreign or domestic place of business which is—

"(A) at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more prescription drug products are manufactured in final dosage form, and

"(B) under the management of a person that is listed as the applicant in a human drug application for a prescription drug product with respect to at least one such product."

Par. (7)(A). Pub. L. 105–115, §102(5), substituted "contractors of the Food and Drug Administration," for "employees under contract with the Food and Drug Administration who work in facilities owned or leased for the Food and Drug Administration," and "and committees and to contracts with such contractors," for "and committees,".

Par. (8)(A). Pub. L. 105–115, §102(6)(A), substituted "April of the preceding fiscal year" for "August of the preceding fiscal year" and "April 1997" for "August 1992".

Par. (8)(B). Pub. L. 105–115, §102(6)(B), substituted "section 254(c)" for "section 254(d)", "fiscal year 1997" for "fiscal year 1992", and "105th Congress, 1st Session" for "102d Congress, 2d Session".

Par. (9). Pub. L. 105–115, §102(7), added par. (9).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title I, §1006, Sept. 30, 2022, 136 Stat. 2147, provided that: "The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for all human drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act."

Effective Date of 2017 Amendment

Pub. L. 115–52, title I, §105, Aug. 18, 2017, 131 Stat. 1012, provided that: "The amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] shall be assessed for all human drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective Date of 2012 Amendment

Pub. L. 112–144, title I, §106, July 9, 2012, 126 Stat. 1002, provided that: "The amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] shall take effect on October 1, 2012, or the date of the enactment of this Act [July 9, 2012], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applications received on or after October 1, 2012, regardless of the date of the enactment of this Act."

Amendment by section 407 of Pub. L. 112–144 effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.

Effective and Termination Dates of 2007 Amendment

Pub. L. 110–85, title I, §106(a), Sept. 27, 2007, 121 Stat. 842, which provided that the amendments made by sections 102, 103, and 104 of Pub. L. 110–85 (enacting section 379h–1 of this title and amending this section and section 379h of this title) would cease to be effective Oct. 1, 2012, was repealed by Pub. L. 112–144, title I, §105(c)(1), July 9, 2012, 126 Stat. 1001.

Pub. L. 110–85, title I, §107, Sept. 27, 2007, 121 Stat. 842, provided that: "The amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] shall take effect on October 1, 2007, or the date of the enactment of this Act [Sept. 27, 2007], whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all human drug applications received on or after October 1, 2007, regardless of the date of the enactment of this Act."

Effective and Termination Dates of 2002 Amendment

Amendment by Pub. L. 107–188 effective Oct. 1, 2002, see section 508 of Pub. L. 107–188, set out as an Effective Date of 2002 Amendment note under section 356b of this title.

Pub. L. 107–188, title V, §509, June 12, 2002, 116 Stat. 694, which provided that the amendments made by sections 503 and 504 of Pub. L. 107–188 (amending this section and section 379h of this title) would cease to be effective Oct. 1, 2007, and the amendment by section 505 of Pub. L. 107–188 (enacting provisions set out as a note below) would cease to be effective 120 days after Oct. 1, 2007, was repealed by Pub. L. 112–144, title I, §105(d)(1)(A), July 9, 2012, 126 Stat. 1001.

[Pub. L. 112–144, title I, §105(d)(1), July 9, 2012, 126 Stat. 1001, provided that the repeal of section 509 of Pub. L. 107–188, formerly set out above, is effective Sept. 30, 2007.]

Effective and Termination Dates of 1997 Amendment

Pub. L. 105–115, title I, §106, Nov. 21, 1997, 111 Stat. 2305, provided that: "The amendments made by this subtitle [subtitle A (§§101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] shall take effect October 1, 1997."

Pub. L. 105–115, title I, §107, Nov. 21, 1997, 111 Stat. 2305, which provided that the amendments by sections 102 and 103 of Pub. L. 105–115 (amending this section and section 379h of this title) would cease to be effective Oct. 1, 2002, and the amendment by section 104 (enacting provisions set out as a note below) would cease to be effective 120 days after Oct. 1, 2002, was repealed by Pub. L. 112–144, title I, §105(d)(2)(A), July 9, 2012, 126 Stat. 1001.

[Pub. L. 112–144, title I, §105(d)(2), July 9, 2012, 126 Stat. 1001, provided that the repeal of section 107 of Pub. L. 105–115, formerly set out above, is effective Sept. 30, 2002.]

Termination Date

Pub. L. 117–180, div. F, title I, §1005(a), Sept. 30, 2022, 136 Stat. 2147, provided that: "Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title I, §104(a), Aug. 18, 2017, 131 Stat. 1012, which provided that this section and section 379h of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147.

[Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147, provided that the repeal of section 104(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title I, §105(a), July 9, 2012, 126 Stat. 1001, which provided that this section and section 379h of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012.

[Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012, provided that the repeal of section 105(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 102–571, title I, §105, Oct. 29, 1992, 106 Stat. 4498, which provided that the amendment by section 103 of Pub. L. 102–571 (enacting this subpart) would not be in effect after Oct. 1, 1997, and the amendment by section 104 of Pub. L. 102–571 (enacting provisions set out as a note below) would not be in effect after 120 days after Oct. 1, 1997, was repealed by Pub. L. 112–144, title I, §105(d)(3), July 9, 2012, 126 Stat. 1002.

[Pub. L. 112–144, title I, §105(d)(3), July 9, 2012, 126 Stat. 1002, provided that the repeal of section 105 of Pub. L. 102–571, formerly set out above, is effective Sept. 30, 1997.]

Savings Provision

Pub. L. 117–180, div. F, title I, §1007, Sept. 30, 2022, 136 Stat. 2147, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title I, §106, Aug. 18, 2017, 131 Stat. 1013, provided that: "Notwithstanding the amendments made by this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Pub. L. 112–144, title I, §107, July 9, 2012, 126 Stat. 1002, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2012."

Pub. L. 112–144, title IV, §406, July 9, 2012, 126 Stat. 1039, provided that: "Notwithstanding the amendments made by this title [enacting sections 379j–51 to 379j–53 of this title and amending this section and section 379d–4 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2007, but before October 1, 2012, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013."

Pub. L. 110–85, title I, §108, Sept. 27, 2007, 121 Stat. 842, provided that: "Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 [Pub. L. 107–188] ([former] 21 U.S.C. 379g note), and notwithstanding the amendments made by this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this title [Sept. 27, 2007], shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008."

Pub. L. 107–188, title V, §507, June 12, 2002, 116 Stat. 694, provided that: "Notwithstanding section 107 of the Food and Drug Administration Modernization Act of 1997 [section 107 of Pub. L. 105–115, formerly set out as an Effective and Termination Dates of 1997 Amendment note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title], part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as in effect on the day before the date of the enactment of this Act [June 12, 2002], continues to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that, on or after October 1, 1997, but before October 1, 2002, were accepted by the Food and Drug Administration for filing and with respect to assessing and collecting any fee required by such Act for a fiscal year prior to fiscal year 2003."

Pub. L. 105–115, title I, §105, Nov. 21, 1997, 111 Stat. 2305, provided that: "Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992 [section 105 of Pub. L. 102–571, formerly set out as a Termination Date note above], the Secretary shall retain the authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] for a human drug application or supplement accepted for filing prior to October 1, 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998."

Accountability and Reports

Pub. L. 107–188, title V, §505, June 12, 2002, 116 Stat. 692, provided that:

"(a) Public Accountability.—

"(1) Consultation.—In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of human drug applications for the fiscal years after fiscal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g, 379h], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.

"(2) Recommendations.—The Secretary shall publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.

"(b) Performance Report.—Beginning with fiscal year 2003, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the President, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) [section 502(4) of Pub. L. 107–188, set out below] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

"(c) Fiscal Report.—Beginning with fiscal year 2003, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (b), the Secretary of Health and Human Services shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made."

Congressional Findings Concerning Fees Relating to Drugs

Pub. L. 117–180, div. F, title I, §1001(b), Sept. 30, 2022, 136 Stat. 2140, provided that: "Congress finds that the fees authorized by the amendments made by this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title I, §101(b), Aug. 18, 2017, 131 Stat. 1006, provided that: "The Congress finds that the fees authorized by the amendments made in this title [see section 101(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title I, §101(b), July 9, 2012, 126 Stat. 996, provided that: "The Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 379h and 379h–2 of this title and repealing provisions set out as notes under this section and section 379h–2 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 110–85, title I, §101(c), Sept. 27, 2007, 121 Stat. 825, provided that: "The Congress finds that the fees authorized by the amendments made in this title [enacting sections 379h–1 and 379h–2 of this title and amending this section and sections 379h and 379j–11 of this title] will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 107–188, title V, §502, June 12, 2002, 116 Stat. 687, provided that: "The Congress finds that—

"(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of human drug applications and the assurance of drug safety;

"(3) the provisions added by the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title], as amended by the Food and Drug Administration Modernization Act of 1997 [see Short Title of 1997 Amendment note set out under section 301 of this title], have been successful in substantially reducing review times for human drug applications and should be—

"(A) reauthorized for an additional 5 years, with certain technical improvements; and

"(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration, including—

"(i) strengthening and improving the review and monitoring of drug safety;

"(ii) considering greater interaction between the agency and sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and

"(iii) developing principles for improving first-cycle reviews; and

"(4) the fees authorized by amendments made in this subtitle [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending this section and sections 356b and 379h of this title] will be dedicated towards expediting the drug development process and the process for the review of human drug applications as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Energy and Commerce of the House of Representatives and the chairman of the Committee on Health, Education, Labor and Pensions of the Senate, as set forth in the Congressional Record."

Pub. L. 105–115, title I, §101, Nov. 21, 1997, 111 Stat. 2298, provided that: "Congress finds that—

"(A) reauthorized for an additional 5 years, with certain technical improvements; and

"(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration; and

"(4) the fees authorized by amendments made in this subtitle [subtitle A (§§101–107) of title I of Pub. L. 105–115, amending this section and section 379h of this title] will be dedicated toward expediting the drug development process and the review of human drug applications as set forth in the goals identified, for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the House of Representatives and the chairman of the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate, as set forth in the Congressional Record."

Pub. L. 102–571, title I, §102, Oct. 29, 1992, 106 Stat. 4491, provided that: "The Congress finds that—

"(1) prompt approval of safe and effective new drugs is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

"(3) the fees authorized by this title [see Short Title of 1992 Amendment note, set out under section 301 of this title] will be dedicated toward expediting the review of human drug applications as set forth in the goals identified in the letters of September 14, 1992, and September 21, 1992, from the Commissioner of Food and Drugs to the Chairman of the Energy and Commerce Committee of the House of Representatives and the Chairman of the Labor and Human Resources Committee of the Senate, as set forth at 138 Cong. Rec. H9099–H9100 (daily ed. September 22, 1992) [Cong. Rec., vol. 138, pt. 18, p. 26928, Sept. 22, 1992]."

Annual Reports

Pub. L. 105–115, title I, §104, Nov. 21, 1997, 111 Stat. 2304, provided that:

"(a) Performance Report.—Beginning with fiscal year 1998, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(4) [section 101(4) of Pub. L. 105–115, set out above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

"(b) Fiscal Report.—Beginning with fiscal year 1998, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (a), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made."

Pub. L. 102–571, title I, §104, Oct. 29, 1992, 106 Stat. 4498, provided that:

"(a) First Report.—Within 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], the Secretary of Health and Human Services shall submit a report stating the Food and Drug Administration's progress in achieving the goals identified in section 102(3) of this Act [set out as a note above] during such fiscal year and that agency's future plans for meeting such goals.

"(b) Second Report.—Within 120 days after the end of each fiscal year during which such fees are collected, the Secretary of Health and Human Services shall submit a report on the implementation of the authority for such fees during such fiscal year and on the use the Food and Drug Administration made of the fees collected during such fiscal year for which the report is made.

"(c) Committees.—The reports described in subsections (a) and (b) shall be submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate."

Animal Drug User Fee Study

Pub. L. 102–571, title I, §108, Oct. 29, 1992, 106 Stat. 4500, directed Secretary, in consultation with manufacturers of animal drug products and other interested persons, to undertake study to evaluate whether, and under what conditions, to impose user fees to supplement appropriated funds in order to improve process of reviewing applications (including abbreviated and supplemental applications) for new animal drugs under section 360b of this title, and further provided for submission of study to Congress no later than Jan. 4, 1994.

§379h. Authority to assess and use drug fees

(a) Types of fees

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Human drug application fee

(A) In general

Each person that submits, on or after September 1, 1992, a human drug application shall be subject to a fee as follows:

(i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval.

(ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).

(B) Payment

The fee required by subparagraph (A) shall be due upon submission of the application.

(C) Exception for previously filed application

If a human drug application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(D) Refund of fee if application refused for filing or withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application which is refused for filing or withdrawn without a waiver before filing.

(E) Fees for applications previously refused for filing or withdrawn before filing

A human drug application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).

(F) Exception for designated orphan drug

A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to section 360bb of this title shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition.

(G) Refund of fee if application withdrawn

If an application is withdrawn after the application was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.

(H) Exception for skin-test diagnostic products

A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A).

(2) Prescription drug program fee

(A) In general

(i) Payment of fees

Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.

(ii) Special rule for previously discontinued drug products

If a drug product that is identified in a human drug application approved as of October 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable.

(B) Exception for certain prescription drug products

A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

(i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume greater than or equal to 100 mL, not including powders for reconstitution or pharmacy bulk packages) identified on the list compiled under section 355(j)(7) of this title;

(ii) pharmaceutically equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations (or any successor regulation)) to another product on the list of products compiled under section 355(j)(7) of this title (not including the discontinued section of such list); or

(iii) a skin-test diagnostic product.

(C) Limitation

A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.

(b) Fee revenue amounts

(1) In general

For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(C) the dollar amount equal to the strategic hiring and retention adjustment for the fiscal year (as determined under subsection (c)(2));

(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));

(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));

(F) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and

(G) additional dollar amounts for each fiscal year as follows:

(i) $65,773,693 for fiscal year 2023.

(ii) $25,097,671 for fiscal year 2024.

(iii) $14,154,169 for fiscal year 2025.

(iv) $4,864,860 for fiscal year 2026.

(v) $1,314,620 for fiscal year 2027.

(2) Types of fees

Of the total revenue amount determined for a fiscal year under paragraph (1)—

(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and

(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).

(3) Annual base revenue

For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2023, $1,151,522,958; and

(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(4) or (c)(5).

(c) Adjustments; annual fee setting

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

(ii) the inflation adjustment percentage under subparagraph (B).

(B) Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years; and

(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years.

(2) Strategic hiring and retention adjustment

For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by the following amounts:

(A) For fiscal year 2023, $9,000,000.

(B) For each of fiscal years 2024 through 2027, $4,000,000.

(3) Capacity planning adjustment

(A) In general

For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.

(B) Methodology

For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled "Prescription Drug User Fee Rates for Fiscal Year 2021" published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.

(C) Limitation

Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fiscal year).

(D) Publication in Federal Register

The Secretary shall publish in the Federal Register notice under paragraph (6) of ¹ the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

(4) Operating reserve adjustment

(A) Increase

For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts:

(i) For fiscal year 2023, at least 8 weeks of operating reserves.

(ii) For fiscal year 2024, at least 9 weeks of operating reserves.

(iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves.

(B) Decrease

If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.

(C) Notice of rationale

If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (6) establishing fee revenue and fees for the fiscal year involved.

(5) Additional direct cost adjustment

(A) Increase

The Secretary shall, in addition to adjustments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees—

(i) for fiscal year 2023, by $44,386,150; and

(ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as applicable, multiplied by the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2021.

(B) Applicable amounts

The amounts referred to in subparagraph (A)(ii) are the following:

(i) For fiscal year 2024, $60,967,993.

(ii) For fiscal year 2025, $35,799,314.

(iii) For fiscal year 2026, $35,799, 314.

(iv) For fiscal year 2027, $35,799,314.

(6) Annual fee setting

The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2022—

(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue and fees in the Federal Register.

(7) Limit

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.

(d) Fee waiver or reduction

(1) In general

The Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) where the Secretary finds that—

(A) such waiver or reduction is necessary to protect the public health,

(B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or

(2) Considerations

In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.

(3) Rules relating to small businesses

(A) "Small business" defined

In paragraph (1)(C), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.

(B) Waiver of application fee

The Secretary shall waive under paragraph (1)(C) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.

(e) Effect of failure to pay fees

A human drug application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.

(f) Limitations

(1) In general

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 1997 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2) Authority

(3) Limitation

Beginning on October 1, 2023, the authorities under section 379g(7)(C) of this title shall include only expenditures for leasing and necessary scientific equipment.

(g) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and

(ii) shall be available—

(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of human drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the adjustment factor; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of human drug applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor.

(B) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable—

(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and

(II) such costs are not more than 5 percent below the level specified in such subparagraph.

(C) Provision for early payments

Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).

(h) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(i) Written requests for waivers, reductions, exemptions, and returns; disputes concerning fees

To qualify for consideration for a waiver or reduction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall—

(1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and

(2) include in the request any legal authorities under which the request is made.

(j) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(k) Orphan drugs

(1) Exemption

A drug designated under section 360bb of this title for a rare disease or condition and approved under section 355 of this title or under section 262 of title 42 shall be exempt from prescription drug program fees under this section, if the drug meets all of the following conditions:

(A) The drug meets the public health requirements contained in this chapter as such requirements are applied to requests for waivers for prescription drug program fees.

(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue as determined under paragraph (2).

(2) Evidence of qualification

An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that the applicant's gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemption is requested. Such certification shall be supported by—

(A) tax returns submitted to the United States Internal Revenue Service; or

(B) as necessary, other appropriate financial information.

(June 25, 1938, ch. 675, §736, as added Pub. L. 102–571, title I, §103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105–115, title I, §103(a)–(g), Nov. 21, 1997, 111 Stat. 2299–2304; Pub. L. 107–109, §5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–188, title V, §504, June 12, 2002, 116 Stat. 689; Pub. L. 110–85, title I, §103(a)–(h)(1), Sept. 27, 2007, 121 Stat. 826–832; Pub. L. 112–144, title I, §103, July 9, 2012, 126 Stat. 996; Pub. L. 115–52, title I, §102(a)(1), (b)–(h), title IX, §905(b)(1), Aug. 18, 2017, 131 Stat. 1007–1012, 1090; Pub. L. 117–180, div. F, title I, §1003, Sept. 30, 2022, 136 Stat. 2142; Pub. L. 117–328, div. FF, title III, §3625(a), Dec. 29, 2022, 136 Stat. 5880.)

Termination of Section

For termination of section by section 1005(a) of Pub. L. 117–180, see Termination Date note below.

Editorial Notes

References in Text

Section 357 of this title, referred to in subsec. (a)(2)(B)(iii), was repealed by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (a)(2)(B)(iv), is Pub. L. 98–417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.

Section 101(b) of the Prescription Drug User Fee Amendments of 2017, referred to in subsec. (c)(2)(B)(ii)(III), is section 101(b) of Pub. L. 115–52, set out as a note under section 379g of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–180, §1003(a)(1)(A), substituted "fiscal year 2023" for "fiscal year 2018" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 117–180, §1003(a)(1)(B), substituted "(c)(6)" for "(c)(5)" in cls. (i) and (ii).

Subsec. (a)(1)(C). Pub. L. 117–180, §1003(a)(1)(C), inserted "prior to approval" after "or was withdrawn".

Subsec. (a)(1)(H). Pub. L. 117–180, §1003(a)(1)(D), added subpar. (H).

Subsec. (a)(2)(A). Pub. L. 117–180, §1003(a)(2)(A), designated existing provisions as cl. (i) and inserted heading, substituted "subsection (c)(6)" for "subsection (c)(5)", and added cl. (ii).

Subsec. (a)(2)(B). Pub. L. 117–180, §1003(a)(2)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: "A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is—

"(i) identified on the list compiled under section 355(j)(7) of this title with a potency described in terms of per 100 mL;

"(ii) the same product as another product that—

"(I) was approved under an application filed under section 355(b) or 355(j) of this title; and

"(II) is not in the list of discontinued products compiled under section 355(j)(7) of this title;

"(iii) the same product as another product that was approved under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997); or

"(iv) the same product as another product that was approved under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984."

Subsec. (b)(1). Pub. L. 117–180, §1003(b)(1), amended par. (1) generally. Prior to amendment, par. (1) related to fees for fiscal years 2018 through 2022.

Subsec. (b)(3). Pub. L. 117–180, §1003(b)(2), amended par. (3) generally. Prior to amendment, par. (3) related to annual base revenue for fiscal years 2018 through 2022.

Subsec. (c)(1)(B)(ii). Pub. L. 117–180, §1003(c)(1), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2). Pub. L. 117–180, §1003(c)(2)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Pub. L. 117–180, §1003(c)(2)(A), (3), redesignated par. (2) as (3) and amended it generally. Prior to amendment, par. related to establishment of a capacity planning methodology and interim methodology. Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 117–180, §1003(c)(2)(A), redesignated par. (3) as (4). Former par. (4) redesignated (5).

Subsec. (c)(4)(A). Pub. L. 117–180, §1003(c)(4)(A), amended subpar. (A) generally. Prior to amendment, text read as follows: "For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications."

Subsec. (c)(4)(C). Pub. L. 117–180, §1003(c)(4)(B), substituted "paragraph (6)" for "paragraph (5)".

Subsec. (c)(5). Pub. L. 117–180, §1003(c)(2)(A), (5), redesignated par. (4) as (5) and amended it generally. Prior to amendment, par. related to additional direct cost adjustment for fiscal years 2018, 2019, and subsequent fiscal years. Former par. (5) redesignated (6).

Subsec. (c)(6). Pub. L. 117–180, §1003(c)(2)(A), (6), redesignated par. (5) as (6) and substituted "September 30, 2022" for "September 30, 2017" in introductory provisions. Former par. (6) redesignated (7).

Subsec. (c)(7). Pub. L. 117–180, §1003(c)(2)(A), redesignated par. (6) as (7).

Subsec. (g)(2)(A)(ii). Pub. L. 117–328, §3625(a)(1), substituted "shall be available—" for "shall be available to defray", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023, to defray" before "increases in the costs", and added subcl. (II).

Subsec. (g)(2)(B). Pub. L. 117–328, §3625(a)(2), substituted "as described in subclause (I) or (II) of such subparagraph, as applicable" for "for the process for the review of human drug applications" in introductory provisions.

Subsec. (g)(3). Pub. L. 117–180, §1003(d), substituted "fiscal years 2023 through 2027" for "fiscal years 2018 through 2022".

Subsec. (i). Pub. L. 117–180, §1003(e), amended subsec. (i) generally. Prior to amendment, text read as follows: "To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due."

Subsec. (k)(1)(B). Pub. L. 117–180, §1003(f)(1), substituted "as determined under paragraph (2)" for "during the previous year".

Subsec. (k)(2). Pub. L. 117–180, §1003(f)(2), amended par. (2) generally. Prior to amendment, text read as follows: "An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested."

2017—Subsec. (a). Pub. L. 115–52, §102(a)(1)(A), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.

Subsec. (a)(1). Pub. L. 115–52, §102(a)(1)(B), (C), struck out "and supplement" before "fee" in heading and struck out "or a supplement" and "or supplement" wherever appearing in text.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §102(a)(1)(D)(i), substituted "(c)(5)" for "(c)(4)".

Subsec. (a)(1)(A)(ii). Pub. L. 115–52, §102(a)(1)(C), (D)(ii), substituted "A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval." for "A fee established under subsection (c)(4) for a human drug application for which clinical data with respect to safety or effectiveness are not required for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required."

Subsec. (a)(1)(C). Pub. L. 115–52, §102(a)(1)(E), struck out "or supplement" after "application" in heading.

Subsec. (a)(1)(F). Pub. L. 115–52, §102(a)(1)(F), struck out "or indication" after "drug" in heading and "A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section 360bb of this title as a drug for a rare disease or condition with regard to the indication proposed in such supplement." in text.

Subsec. (a)(2). Pub. L. 115–52, §102(a)(1)(G)–(I), redesignated par. (3) as (2), substituted "Prescription drug program fee" for "Prescription drug product fee" in heading, and struck out former par. (2) which related to prescription drug establishment fee.

Subsec. (a)(2)(A). Pub. L. 115–52, §102(a)(1)(J), substituted "Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year." for "Except as provided in subparagraph (B), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4)."

Subsec. (a)(2)(B). Pub. L. 115–52, §102(a)(1)(K), inserted "for certain prescription drug products" after "Exception" in heading and substituted "A prescription drug program fee shall not be assessed for a prescription drug product" for "A prescription drug product shall not be assessed a fee" in introductory provisions.

Subsec. (a)(2)(C). Pub. L. 115–52, §102(a)(1)(L), added subpar. (C).

Subsec. (a)(3). Pub. L. 115–52, §102(a)(1)(H), redesignated par. (3) as (2).

Subsec. (b). Pub. L. 115–52, §102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee revenue amounts for fiscal years 2013 through 2017.

Subsec. (c). Pub. L. 115–52, §102(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to adjustment of revenues for inflation and changes in workload, final year adjustment, setting of annual fee, and limit on total amount of fees charged.

Subsec. (d)(1)(C), (D). Pub. L. 115–52, §102(d)(1), redesignated subpar. (D) as (C) and struck out former subpar. (C) which read as follows: "the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of human drug applications for such person, or".

Subsec. (d)(3). Pub. L. 115–52, §102(d)(2), (3), redesignated par. (4) as (3) and struck out former par. (3). Text read as follows: "In making the finding in paragraph (1)(C), the Secretary may use standard costs."

Subsec. (d)(3)(A). Pub. L. 115–52, §102(d)(4)(A), substituted "paragraph (1)(C)" for "paragraph (1)(D)".

Subsec. (d)(3)(B). Pub. L. 115–52, §102(d)(4), substituted "paragraph (1)(C)" for "paragraph (1)(D)", struck out cl. (i) designation before "application fees", substituted a period for "; and" after "qualify as a small business", and struck out cl. (ii), which read as follows: "all supplement fees for all supplements to human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business."

Subsec. (d)(4). Pub. L. 115–52, §102(d)(3), redesignated par. (4) as (3).

Subsec. (e). Pub. L. 115–52, §102(e), substituted "all such fees" for "all fees".

Subsec. (f)(2). Pub. L. 115–52, §102(f), substituted "prescription drug program fees" for "supplements, prescription drug establishments, and prescription drug products".

Subsec. (f)(3). Pub. L. 115–52, §905(b)(1), added par. (3).

Subsec. (g)(3). Pub. L. 115–52, §102(g)(1), substituted "2018 through 2022" for "2013 through 2017" and struck out "and paragraph (4) of this subsection" after "subsection (c)".

Subsec. (g)(4). Pub. L. 115–52, §102(g)(2), struck out par. (4). Prior to amendment, text read as follows: "If the sum of the cumulative amount of fees collected under this section for the fiscal years 2013 through 2015 and the amount of fees estimated to be collected under this section for fiscal year 2016 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2013 through 2016, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017."

Subsec. (k)(1). Pub. L. 115–52, §102(h), substituted "prescription drug program fees" for "product and establishment fees" in two places.

2012—Subsec. (a). Pub. L. 112–144, §103(1)(A), substituted "fiscal year 2013" for "fiscal year 2008" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 112–144, §103(1)(B), substituted "(c)(4)" for "(c)(5)" in cls. (i) and (ii).

Subsec. (a)(2)(A). Pub. L. 112–144, §103(1)(C), substituted "(c)(4)" for "(c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section" for "payable on or before October 1 of each year" in concluding provisions.

Subsec. (a)(3)(A). Pub. L. 112–144, §103(1)(D)(i), substituted "subsection (c)(4)" for "subsection (c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section." for "payable on or before October 1 of each year."

Subsec. (a)(3)(B). Pub. L. 112–144, §103(1)(D)(ii), amended subpar. (B) generally. Prior to amendment, text read as follows: "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 355(b) or 355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984."

Subsec. (b)(1). Pub. L. 112–144, §103(2)(A)(i), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012" in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 112–144, §103(2)(A)(ii), substituted "$693,099,000;" for "$392,783,000; and".

Subsec. (b)(1)(B), (C). Pub. L. 112–144, §103(2)(A)(iii), added subpars. (B) and (C) and struck out former subpar. (B) which read as follows: "an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3))."

Subsec. (b)(3), (4). Pub. L. 112–144, §103(2)(B), added par. (3) and struck out former pars. (3) and (4) which related to the modified workload adjustment factor for fiscal year 2007 and additional fee revenues for drug safety for fiscal years 2008 through 2012, respectively.

Subsec. (c). Pub. L. 112–144, §103(3), added subsec. (c) and struck out former subsec. (c) which related to inflation adjustment for fiscal year 2009 and subsequent fiscal years, workload adjustment for fiscal year 2009 and subsequent fiscal years, rent and rent-related cost adjustment for fiscal year 2010 and each subsequent fiscal year, final year adjustment for fiscal year 2012, annual fee setting for each fiscal year that began after Sept. 30, 2007, and the limit on the total amount of fees charged for a fiscal year.

Subsec. (g)(1). Pub. L. 112–144, §103(4)(A), substituted "Subject to paragraph (2)(C), fees authorized" for "Fees authorized".

Subsec. (g)(2)(A)(i). Pub. L. 112–144, §103(4)(B)(i), substituted "subject to subparagraph (C), shall be collected and available" for "shall be retained".

Subsec. (g)(2)(A)(ii). Pub. L. 112–144, §103(4)(B)(ii), substituted "shall be available" for "shall only be collected and available".

Subsec. (g)(2)(C). Pub. L. 112–144, §103(4)(B)(iii), added subpar. (C).

Subsec. (g)(3). Pub. L. 112–144, §103(4)(C), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012".

Subsec. (g)(4). Pub. L. 112–144, §103(4)(D), substituted "fiscal years 2013 through 2015" for "fiscal years 2008 through 2010", "fiscal year 2016" for "fiscal year 2011", "fiscal years 2013 through 2016" for "fiscal years 2008 through 2011", and "fiscal year 2017" for "fiscal year 2012".

2007—Subsec. (a). Pub. L. 110–85, §103(a)(1), substituted "2008" for "2003" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)" in cls. (i) and (ii).

Subsec. (a)(1)(D). Pub. L. 110–85, §103(a)(2)(A), inserted "or withdrawn before filing" after "refused for filing" in heading and "or withdrawn without a waiver before filing" before period at end of text.

Subsec. (a)(1)(E) to (G). Pub. L. 110–85, §103(a)(2)(B), (C), added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively.

Subsec. (a)(2)(A). Pub. L. 110–85, §103(a)(3)(A), (g), substituted "subparagraphs (B) and (C)" for "subparagraph (B)" in introductory provisions and "(c)(5)" for "(c)(4)" in concluding provisions.

Subsec. (a)(2)(C). Pub. L. 110–85, §103(a)(3)(B), added subpar. (C).

Subsec. (a)(3)(A). Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)".

Subsec. (b). Pub. L. 110–85, §103(b), amended subsec. (b) generally, substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions relating to fee schedules for fiscal years 2003 to 2007.

Subsec. (c)(1). Pub. L. 110–85, §103(c)(1), amended par. (1) by substituting "For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)" for "The revenues established in subsection (b)" in introductory provisions, adding subpar. (C), and substituting "fiscal year 2008" for "fiscal year 2003" in concluding provisions.

Subsec. (c)(2). Pub. L. 110–85, §103(c)(2)(A), substituted "For fiscal year 2009 and subsequent fiscal years," for "Beginning with fiscal year 2004," in introductory provisions.

Subsec. (c)(2)(A). Pub. L. 110–85, §103(c)(2)(B), substituted "human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available." for "human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary." in first sentence.

Subsec. (c)(2)(B). Pub. L. 110–85, §103(c)(2)(C), inserted at end "Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities."

Subsec. (c)(2)(C). Pub. L. 110–85, §103(c)(2)(D), added subpar. (C).

Subsec. (c)(3). Pub. L. 110–85, §103(c)(3), added par. (3). Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 110–85, §103(c)(3)(A), (4), redesignated par. (3) as (4) and amended it generally. Prior to amendment, text read as follows: "For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) of this section if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made." Former par. (4) redesignated (5).

Subsec. (c)(5). Pub. L. 110–85, §103(c)(3)(A), (5), redesignated par. (4) as (5) and substituted "2007" for "2002". Former par. (5) redesignated (6).

Subsec. (c)(6). Pub. L. 110–85, §103(c)(3)(A), redesignated par. (5) as (6).

Subsec. (d)(1). Pub. L. 110–85, §103(d)(1), inserted "to a person who is named as the applicant in a human drug application" after "The Secretary shall grant" and "to that person" after "one or more fees assessed" in introductory provisions.

Subsec. (d)(2), (3). Pub. L. 110–85, §103(d)(2), (3), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

Subsec. (d)(4). Pub. L. 110–85, §103(d)(2), redesignated par. (3) as (4).

Subsec. (d)(4)(A). Pub. L. 110–85, §103(d)(4), inserted before period at end ", and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce".

Subsec. (g)(1). Pub. L. 110–85, §103(h)(1), substituted "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended." for "Fees collected for a fiscal year pursuant to subsection (a) of this section shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriation Acts until expended without fiscal year limitation."

Subsec. (g)(3). Pub. L. 110–85, §103(e)(1), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007.

Subsec. (g)(4). Pub. L. 110–85, §103(e)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

Subsec. (k). Pub. L. 110–85, §103(f), added subsec. (k).

2002—Subsec. (a). Pub. L. 107–188, §504(a)(1), substituted "fiscal year 2003" for "fiscal year 1998" in introductory provisions.

Subsec. (a)(1)(A)(i). Pub. L. 107–188, §504(a)(2)(A), substituted "under subsection (c)(4)" for "in subsection (b)".

Subsec. (a)(1)(A)(ii). Pub. L. 107–188, §504(a)(2), substituted "under subsection (c)(4)" for "in subsection (b)" and inserted "Such fee shall be half of the amount of the fee established under clause (i)." at end.

Subsec. (a)(1)(F), (G). Pub. L. 107–109 redesignated subpar. (G) as (F) and struck out heading and text of former subpar. (F). Text read as follows: "A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A)."

Subsec. (a)(2)(A). Pub. L. 107–188, §504(a)(3), in concluding provisions, substituted "under subsection (c)(4)" for "in subsection (b)" and "payable on or before October 1" for "payable on or before January 31".

Subsec. (a)(3)(A). Pub. L. 107–188, §504(a)(4)(A), amended heading and text of subpar. (A) generally. Prior to amendment, text read as follows: "Except as provided in subparagraph (B), each person—

"(i) who is named as the applicant in a human drug application for a prescription drug product which has been submitted for listing under section 360 of this title, and

"(ii) who, after September 1, 1992, had pending before the Secretary a human drug application or supplement,

shall pay for each such prescription drug product the annual fee established in subsection (b) of this section. Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable."

Subsec. (a)(3)(B). Pub. L. 107–188, §504(a)(4)(B), substituted "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 355(b)" for "The listing of a prescription drug product under section 360 of this title shall not require the person who listed such product to pay the fee prescribed by subparagraph (A) if such product is the same product as a product approved under an application filed under section 355(b)(2)".

Subsec. (b). Pub. L. 107–188, §504(b), amended heading and text of subsec. (b) generally, substituting "Fee revenue amounts" for "Fee amounts" in heading and substituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002.

Subsec. (c)(1). Pub. L. 107–188, §504(c)(1)(A), (D), substituted "revenues" for "fees and total fee revenues" in introductory provisions and "fiscal year 2003" for "fiscal year 1997" in concluding provisions.

Subsec. (c)(1)(A). Pub. L. 107–188, §504(c)(1)(B), struck out "during the preceding fiscal year" before "in the Consumer Price Index" and substituted "for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or" for ", or".

Subsec. (c)(1)(B). Pub. L. 107–188, §504(c)(1)(C), substituted "for the previous fiscal year" for "for such fiscal year".

Subsec. (c)(2) to (5). Pub. L. 107–188, §504(c)(2)–(4), added pars. (2) and (3), redesignated former pars. (2) and (3) as (4) and (5), respectively, and amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: "Subject to the amount appropriated for a fiscal year under subsection (g) of this section, the Secretary shall, within 60 days after the end of each fiscal year beginning after September 30, 1997, adjust the establishment and product fees described in subsection (b) of this section for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) of this section shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b) of this section."

Subsec. (d)(1)(C) to (E). Pub. L. 107–188, §504(d)(1), inserted "or" at end of subpar. (C), redesignated subpar. (E) as (D), and struck out former subpar. (D) which read as follows: "assessment of the fee for an application or a supplement filed under section 355(b)(1) of this title pertaining to a drug containing an active ingredient would be inequitable because an application for a product containing the same active ingredient filed by another person under section 355(b)(2) of this title could not be assessed fees under subsection (a)(1) of this section, or".

Subsec. (d)(3)(A), (B). Pub. L. 107–188, §504(d)(2), substituted "paragraph (1)(D)" for "paragraph (1)(E)".

Subsec. (f). Pub. L. 107–188, §504(e)(1), substituted "Limitations" for "Assessment of fees" in heading.

Subsec. (f)(1). Pub. L. 107–188, §504(e)(2), substituted "In general" for "Limitation" in heading and "Fees under subsection (a) shall be refunded for a fiscal year beginning" for "Fees may not be assessed under subsection (a) for a fiscal year beginning" in text.

Subsec. (g)(1). Pub. L. 107–188, §504(f)(1), which directed the amendment of par. (1) by striking "Fees collected for a fiscal year" and all that follows through "fiscal year limitation." and inserting "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.", was not executed because the phrase "fiscal year limitation." appeared in two places and because of the corrective amendment by Pub. L. 110–85, §103(h)(1), which is effective as if included in Pub. L. 107–188, §504. See 2007 Amendment note above and Effective Date of 2007 Amendment note below.

Subsec. (g)(2). Pub. L. 107–188, §504(f)(2), amended par. (2) by designating existing provisions as subpar. (A), inserting subpar. (A) heading, adding subpar. (B), redesignating former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), substituting "shall be retained in each fiscal year in an amount not to exceed the amount specified" for "shall be collected in each fiscal year in an amount equal to the amount specified" in cl. (i), and realigning margin of cl. (ii).

Subsec. (g)(3)(A) to (E). Pub. L. 107–188, §504(f)(3), added subpars. (A) to (E) and struck out former subpars. (A) to (E) which read as follows:

"(A) $106,800,000 for fiscal year 1998;

"(B) $109,200,000 for fiscal year 1999;

"(C) $109,200,000 for fiscal year 2000;

"(D) $114,000,000 for fiscal year 2001; and

"(E) $110,100,000 for fiscal year 2002,".

1997—Subsec. (a). Pub. L. 105–115, §103(a)(1), substituted "Beginning in fiscal year 1998" for "Beginning in fiscal year 1993" in introductory provisions.

Subsec. (a)(1)(B). Pub. L. 105–115, §103(a)(2)(A), amended heading and text of subpar. (B) generally. Prior to amendment, text read as follows:

"(i) First payment.—50 percent of the fee required by subparagraph (A) shall be due upon submission of the application or supplement.

"(ii) Final payment.—The remaining 50 percent of the fee required by subparagraph (A) shall be due upon—

"(I) the expiration of 30 days from the date the Secretary sends to the applicant a letter designated by the Secretary as an action letter described in section 379g(6)(B) of this title, or

"(II) the withdrawal of the application or supplement after it is filed unless the Secretary waives the fee or a portion of the fee because no substantial work was performed on such application or supplement after it was filed.

The designation under subclause (I) or the waiver under subclause (II) shall be solely in the discretion of the Secretary and shall not be reviewable."

Subsec. (a)(1)(D). Pub. L. 105–115, §103(a)(2)(B), substituted "refused" for "not accepted" in heading and "75 percent" for "50 percent", "subparagraph (B)" for "subparagraph (B)(i)", and "refused" for "not accepted" in text.

Subsec. (a)(1)(E) to (G). Pub. L. 105–115, §103(a)(2)(C), added subpars. (E) to (G).

Subsec. (a)(2). Pub. L. 105–115, §103(a)(3), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Each person that—

"(A) owns a prescription drug establishment, at which is manufactured at least 1 prescription drug product which is not the, or not the same as a, product approved under an application filed under section 355(b)(2) or 355(j) of this title, and

"(B) after September 1, 1992, had pending before the Secretary a human drug application or supplement,

shall be subject to the annual fee established in subsection (b) of this section for each such establishment, payable on or before January 31 of each year."

Subsec. (a)(3)(A). Pub. L. 105–115, §103(a)(4)(A), substituted, in cl. (i), "has been submitted for listing" for "is listed" and, in closing provisions, "Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable." for "Such fee shall be payable at the time of the first such listing of such product in each calendar year. Such fee shall be paid only once each year for each listed prescription drug product irrespective of the number of times such product is listed under section 360 of this title."

Subsec. (a)(3)(B). Pub. L. 105–115, §103(a)(4)(B), substituted "355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984." for "355(j) of this title.".

Subsec. (b). Pub. L. 105–115, §103(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2).

Subsec. (c). Pub. L. 105–115, §103(c)(1), substituted "Adjustments" for "Increases and adjustments" in heading.

Subsec. (c)(1). Pub. L. 105–115, §103(c)(2), substituted "Inflation adjustment" for "Revenue increase" in heading, "The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary" for "The total fee revenues established by the schedule in subsection (b)(1) shall be increased by the Secretary" in introductory provisions, and "change" for "increase" after "total percentage" in subpars. (A) and (B), and inserted at end "The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 1997 under this subsection."

Subsec. (c)(2). Pub. L. 105–115, §103(c)(3), substituted "September 30, 1997, adjust the establishment and product fees described in subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b)." for "October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) for the following fiscal year to achieve the total fee revenues, as may be increased under paragraph (1). Such fees shall be adjusted under this paragraph to maintain the proportions established in such schedule."

Subsec. (c)(3). Pub. L. 105–115, §103(c)(4), substituted "this subsection" for "paragraph (2)".

Subsec. (d). Pub. L. 105–115, §103(d), struck out introductory provisions which read "The Secretary shall grant a waiver from or a reduction of 1 or more fees under subsection (a) of this section where the Secretary finds that—" and closing provisions which read "In making the finding in paragraph (3), the Secretary may use standard costs.", inserted designation, heading, and introductory provisions of par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, of par. (1), and added pars. (1)(E), (2), and (3).

Subsec. (f)(1). Pub. L. 105–115, §103(e), substituted "fiscal year 1997" for "fiscal year 1993" and "fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)" for "fiscal year 1992".

Subsec. (g)(1). Pub. L. 105–115, §103(f)(1), inserted at end "Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications."

Subsec. (g)(2)(A). Pub. L. 105–115, §103(f)(2)(A), substituted "Acts, or otherwise made available for obligation," for "Acts".

Subsec. (g)(2)(B). Pub. L. 105–115, §103(f)(2)(B), substituted "over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997" for "over such costs for fiscal year 1992".

Subsec. (g)(3), (4). Pub. L. 105–115, §103(f)(3), added pars. (3) and (4) and struck out heading and text of former par. (3). Text read as follows: "There are authorized to be appropriated for fees under this section—

"(A) $36,000,000 for fiscal year 1993,

"(B) $54,000,000 for fiscal year 1994,

"(C) $75,000,000 for fiscal year 1995,

"(D) $78,000,000 for fiscal year 1996, and

"(E) $84,000,000 for fiscal year 1997,

as adjusted to reflect increases in the total fee revenues made under subsection (c)(1) of this section."

Subsecs. (i), (j). Pub. L. 105–115, §103(g), added subsec. (i) and redesignated former subsec. (i) as (j).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title.

Effective Date of 2017 Amendment

Amendment by section 102 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2012, see section 106 of Pub. L. 112–144, set out as a note under section 379g of this title.

Effective Date of 2007 Amendment

Pub. L. 110–85, title I, §103(h)(2), Sept. 27, 2007, 121 Stat. 832, provided that: "Paragraph (1) [amending this section] shall take effect as if included in section 504 of the Prescription Drug User Fee Amendments of 2002 (Public Law 107–188; 116 Stat. 687) [amending this section]."

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

Effective Date of 2002 Amendment

Amendment by Pub. L. 107–188 effective Oct. 1, 2002, see section 508 of Pub. L. 107–188, set out as a note under section 356b of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective Oct. 1, 1997, see section 106 of Pub. L. 105–115, set out as an Effective and Termination Dates of 1997 Amendment note under section 379g of this title.

Termination Date

Section ceases to be effective Oct. 1, 2027, see section 1005(a) of Pub. L. 117–180, set out as a note under section 379g of this title.

Special Rule for Waivers and Refunds

Pub. L. 105–115, title I, §103(h), Nov. 21, 1997, 111 Stat. 2304, provided that: "Any requests for waivers or refunds for fees assessed under section 736 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the date of enactment of this Act [Nov. 21, 1997] shall be submitted in writing to the Secretary of Health and Human Services within 1 year after the date of enactment of this Act. Any requests for waivers or refunds pertaining to a fee for a human drug application or supplement accepted for filing prior to October 1, 1997 or to a product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998, shall be evaluated according to the terms of the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under section 301 of this title] (as in effect on September 30, 1997) and part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] (as in effect on September 30, 1997). The term 'person' in such Acts shall continue to include an affiliate thereof."

¹ So in original. The word "of" probably should not appear. See sections 379j–42(c)(2)(D) and 379j–52(c)(3)(D) of this title.

§379h–1. Fees relating to advisory review of prescription-drug television advertising

(a) Types of direct-to-consumer television advertisement review fees

Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Advisory review fee

(A) In general

With respect to a proposed direct-to-consumer television advertisement (referred to in this section as a "DTC advertisement"), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as provided in subparagraph (B), be subject to a fee established under subsection (c)(3).

(B) Exception for required submissions

A DTC advertisement that is required to be submitted to the Secretary prior to initial public dissemination is not subject to a fee under subparagraph (A) unless the sponsor designates the submission as a submission for advisory review.

(C) Notice to Secretary of number of advertisements

Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of DTC advertisements the person intends to submit for advisory review in the next fiscal year. Notwithstanding the preceding sentence, for fiscal year 2008, the Secretary shall publish such a notice in the Federal Register not later than 30 days after September 27, 2007.

(D) Payment

(i) In general

The fee required by subparagraph (A) (referred to in this section as "an advisory review fee") shall be due not later than October 1 of the fiscal year in which the DTC advertisement involved is intended to be submitted for advisory review, subject to subparagraph (F)(i). Notwithstanding the preceding sentence, the advisory review fee for any DTC advertisement that is intended to be submitted for advisory review during fiscal year 2008 shall be due not later than 120 days after September 27, 2007, or an earlier date as specified by the Secretary.

(ii) Effect of submission

Notification of the Secretary under subparagraph (C) of the number of DTC advertisements a person intends to submit for advisory review is a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. Notwithstanding the preceding sentence, the commitment shall be a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions for fiscal year 2008 by the date specified in clause (i).

(iii) Notice regarding carryover submissions

In making a notification under subparagraph (C), the person involved shall in addition notify the Secretary if under subparagraph (F)(i) the person intends to submit a DTC advertisement for which the advisory review fee has already been paid. If the person does not so notify the Secretary, each DTC advertisement submitted by the person for advisory review in the fiscal year involved shall be subject to the advisory review fee.

(E) Modification of advisory review fee

(i) Late payment

If a person has submitted a notification under subparagraph (C) with respect to a fiscal year and has not paid all advisory review fees due under subparagraph (D) not later than November 1 of such fiscal year (or, in the case of such a notification submitted with respect to fiscal year 2008, not later than 150 days after September 27, 2007, or an earlier date specified by the Secretary), the fees shall be regarded as late and an increase in the amount of fees applies in accordance with this clause, notwithstanding any other provision of this section. For such person, all advisory review fees for such fiscal year shall be due and payable 20 days before any direct-to-consumer advertisement is submitted to the Secretary for advisory review, and each such fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

(ii) Exceeding identified number of submissions

If a person submits a number of DTC advertisements for advisory review in a fiscal year that exceeds the number identified by the person under subparagraph (C), an increase in the amount of fees applies under this clause for each submission in excess of such number, notwithstanding any other provision of this section. For each such DTC advertisement, the advisory review fee shall be due and payable 20 days before the advertisement is submitted to the Secretary, and the fee shall be equal to 150 percent of the fee that otherwise would have applied pursuant to subsection (c)(3).

(F) Limits

(i) Submissions

For each advisory review fee paid by a person for a fiscal year, the person is entitled to acceptance for advisory review by the Secretary of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.

(ii) No refunds

Except as provided by subsections (d)(4) and (f), fees paid under this section shall not be refunded.

(iii) No waivers, exemptions, or reductions

The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.

(iv) Right to advisory review not transferable

The right to an advisory review under this paragraph is not transferable, except to a successor in interest.

(2) Operating reserve fee

(A) In general

Each person that on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to fee ¹ established under subsection (d)(2) (referred to in this section as an "operating reserve fee") for the first fiscal year in which an advisory review fee is assessed to such person. The person is not subject to an operating reserve fee for any other fiscal year.

(B) Payment

Except as provided in subparagraph (C), the operating reserve fee shall be due no later than—

(i) October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1); or

(ii) for fiscal year 2008, 120 days after September 27, 2007, or an earlier date specified by the Secretary.

(C) Late notice of submission

If, in the first fiscal year of a person's participation in the program under this section, that person submits any DTC advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (a)(1)(C), that person shall pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(E)(ii). Fees required by this subparagraph shall be in addition to any fees required by subparagraph (A). Fees under this subparagraph shall be due 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.

(D) Late payment

(i) In general

Notwithstanding subparagraph (B), and subject to clause (ii), an operating reserve fee shall be regarded as late if the person required to pay the fee has not paid the complete operating reserve fee by—

(I) for fiscal year 2008, 150 days after September 27, 2007, or an earlier date specified by the Secretary; or

(II) in any subsequent year, November 1.

(ii) Complete payment

The complete operating reserve fee shall be due and payable 20 days before any DTC advertisement is submitted by such person to the Secretary for advisory review.

(iii) Amount

Notwithstanding any other provision of this section, an operating reserve fee that is regarded as late under this subparagraph shall be equal to 150 percent of the operating reserve fee that otherwise would have applied pursuant to subsection (d).

(b) Advisory review fee revenue amounts

Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsections (c) and (g)(4).

(c) Adjustments

(1) Inflation adjustment

Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of—

(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;

(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; or

(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 fiscal years of the previous 6 fiscal years.

The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.

(2) Workload adjustment

Beginning with fiscal year 2009, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of DTC advertisements for advisory review prior to initial dissemination. With respect to such adjustment:

(A) The adjustment shall be determined by the Secretary based upon the number of DTC advertisements identified pursuant to subsection (a)(1)(C) for the upcoming fiscal year, excluding allowable previously paid carry over submissions. The adjustment shall be determined by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)). The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.

(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.

(3) Annual fee setting for advisory review

(A) In general

Not later than August 1 of each fiscal year (or, with respect to fiscal year 2008, not later than 90 days after September 27, 2007), the Secretary shall establish for the next fiscal year the DTC advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under paragraphs (1) and (2), and the number of DTC advertisements identified pursuant to subsection (a)(1)(C), excluding allowable previously-paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of DTC advertisements so identified, excluding allowable previously-paid carry over submissions under subsection (a)(1)(F)(i).

(B) Fiscal year 2008 fee limit

Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.

(C) Annual fee limit

Notwithstanding subsection (b) and the adjustments pursuant to this subsection, the fee established under subparagraph (A) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.

(D) Limit

The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.

(d) Operating reserves

(1) In general

The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the program under this section in the event the fees collected in any subsequent fiscal year pursuant to subsection (a)(1) do not generate the fee revenue amount established for that fiscal year.

(2) Fee setting

The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of DTC advertisements identified by that person pursuant to subsection (a)(1)(C) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year, except that in no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the program under this section in fiscal year 2008.

(3) Use of operating reserve

The Secretary may use funds from the reserves only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsections (b) and (c) and the amount of fees actually collected for that fiscal year pursuant to subsection (a)(1), or to pay costs of ending the program under this section if it is terminated pursuant to subsection (f) or not reauthorized beyond fiscal year 2012.

(4) Refund of operating reserves

Within 120 days after the end of fiscal year 2012, or if the program under this section ends early pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the program under this section, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).

(e) Effect of failure to pay fees

Notwithstanding any other requirement, a submission for advisory review of a DTC advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.

(f) Effect of inadequate funding of program

(1) Initial funding

If on November 1, 2007, or 120 days after September 27, 2007, whichever is later, the Secretary has not received at least $11,250,000 in advisory review fees and operating reserve fees combined, the program under this section shall not commence and all collected fees shall be refunded.

(2) Later fiscal years

Beginning in fiscal year 2009, if, on November 1 of the fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years falls below $9,000,000, adjusted for inflation (as described in subsection (c)(1)), the program under this section shall terminate, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and finally, unused advisory review fees from the relevant fiscal year.

(g) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and

(ii) shall be available for obligation only if the amounts appropriated as budget authority for such fiscal year are sufficient to support a number of full-time equivalent review employees that is not fewer than the number of such employees supported in fiscal year 2007.

(B) Review employees

For purposes of subparagraph (A)(ii), the term "full-time equivalent review employees" means the total combined number of full-time equivalent employees in—

(i) the Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration; and

(ii) the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, Food and Drug Administration.

(3) Authorization of appropriations

For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted pursuant to subsection (c) and paragraph (4) of this subsection, plus amounts collected for the reserve fund under subsection (d).

(4) Offset

Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.

(h) Definitions

For purposes of this section:

(1) The term "advisory review" means reviewing and providing advisory comments on DTC advertisements regarding compliance of a proposed advertisement with the requirements of this chapter prior to its initial public dissemination.

(2) The term "advisory review fee" has the meaning indicated for such term in subsection (a)(1)(D).

(3) The term "carry over submission" means a submission for an advisory review for which a fee was paid in one fiscal year that is submitted for review in the following fiscal year.

(4) The term "direct-to-consumer television advertisement" means an advertisement for a prescription drug product (as defined in section 379g(3) of this title) intended to be displayed on any television channel for less than 3 minutes.

(5) The term "DTC advertisement" has the meaning indicated for such term in subsection (a)(1)(A).

(6) The term "operating reserve fee" has the meaning indicated for such term in subsection (a)(2)(A).

(7) The term "person" includes an individual, partnership, corporation, and association, and any affiliate thereof or successor in interest.

(8) The term "process for the advisory review of prescription drug advertising" means the activities necessary to review and provide advisory comments on DTC advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the program under this section that are not necessary for the advisory review of DTC advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.

(9) The term "resources allocated for the process for the advisory review of prescription drug advertising" means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for—

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;

(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and

(E) terminating the program under this section pursuant to subsection (f)(2) if that becomes necessary.

(10) The term "resubmission" means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary's comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.

(11) The term "submission for advisory review" means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.

(June 25, 1938, ch. 675, §736A, as added Pub. L. 110–85, title I, §104, Sept. 27, 2007, 121 Stat. 832.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

¹ So in original. Probably should be "the fee".

§379h–2. Reauthorization; reporting requirements

(a) Performance report

(1) In general

(A) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, including the status of the independent assessment described in such letters; and

(B) the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting the goals, including, for each review division—

(i) the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division;

(ii) the number of original priority new drug applications and biologics license applications filed per fiscal year for each review division;

(iii) the number of standard efficacy supplements filed per fiscal year for each review division;

(iv) the number of priority efficacy supplements filed per fiscal year for each review division;

(v) the number of applications filed for review under accelerated approval per fiscal year for each review division;

(vi) the number of applications filed for review as fast track products per fiscal year for each review division;

(vii) the number of applications filed for orphan-designated products per fiscal year for each review division;

(viii) the number of breakthrough designations for a fiscal year for each review division; and

(ix) the number of investigational new drug applications submitted per fiscal year, including for each review division.

Nothing in subparagraph (B) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.

(2) Inclusion

The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.

(3) Real time reporting

(A) In general

Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection.

(B) Data

The Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022.

(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022.

(iii) The number of new drug applications and biological licensing applications approved.

(iv) The number of new drug applications and biological licensing applications filed.

(v) For fiscal years 2023 and 2024, of the meeting requests from sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary, with both such numbers disaggregated by the relevant agency center.

(4) Rationale for PDUFA program changes

The Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 1001(b) of the Prescription Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379h of this title, and the number of full-time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drug applications, including identifying—

(i) drivers of such changes; and

(ii) changes in the average total cost per full-time equivalent in the prescription drug review program;

(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of human drug application.

(5) Analysis

For each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:

(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.

(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year.

(C) The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022.

(b) Fiscal report

(c) Corrective action report

For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(1) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.

(2) Goals missed

For any of the goals identified in the letters described in section 101(b) ¹ of the Prescription Drug User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and

(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

(d) Enhanced communication

(1) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(2) Participation in congressional hearing

Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart.

(e) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every month during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Updates to Congress

The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this subpart to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(5) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(7) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the public Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

(B) Content

The minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §736B, as added Pub. L. 110–85, title I, §105, Sept. 27, 2007, 121 Stat. 840; amended Pub. L. 112–144, title I, §104, July 9, 2012, 126 Stat. 1000; Pub. L. 115–52, title I, §103, title IX, §§903(a), 904(a), Aug. 18, 2017, 131 Stat. 1012, 1077, 1082; Pub. L. 117–180, div. F, title I, §1004, Sept. 30, 2022, 136 Stat. 2146; Pub. L. 117–328, div. FF, title III, §3626(a), Dec. 29, 2022, 136 Stat. 5883.)

Termination of Section

For termination of section by section 1005(b) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 1001(b) of the Prescription Drug User Fee Amendments of 2022, title I of div. F of Pub. L. 117–180, which is set out as a note under section 379g of this title. The Prescription Drug User Fee Amendments of 2022 does not contain a section 101(b).

Section 1001(b) of the Prescription Drug User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 1001(b) of title I of div. F of Pub. L. 117–180, which is set out as a note under section 379g of this title.

Amendments

2022—Pub. L. 117–180, §1004(2), substituted "Prescription Drug User Fee Amendments of 2022" for "Prescription Drug User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1). Pub. L. 117–328, §3626(a)(1)(A)(ii), inserted concluding provisions.

Pub. L. 117–180, §1004(1), substituted "Not" for "Beginning with fiscal year 2018, not" in introductory provisions.

Subsec. (a)(1)(B)(ix). Pub. L. 117–328, §3626(a)(1)(A)(i), added cl. (ix).

Subsec. (a)(3)(A). Pub. L. 117–180, §1004(3), substituted "Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart" for "Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter".

Subsec. (a)(3)(B)(v). Pub. L. 117–328, §3626(a)(1)(B), added cl. (v).

Subsec. (a)(4). Pub. L. 117–180, §1004(4), substituted "The" for "Beginning with fiscal year 2020, the" in introductory provisions.

Subsec. (a)(4)(A). Pub. L. 117–328, §3626(a)(1)(C)(i), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(4)(B). Pub. L. 117–328, §3626(a)(1)(C)(ii), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drugs, including identifying drivers of such changes; and".

Subsec. (a)(4)(D). Pub. L. 117–328, §3626(a)(1)(C)(iii), (iv), added subpar. (D).

Subsec. (b). Pub. L. 117–180, §1004(5), substituted "Not" for "Beginning with fiscal year 2018, not".

Subsec. (c). Pub. L. 117–180, §1004(6), substituted "For" for "Beginning with fiscal year 2018, for" in introductory provisions.

Subsec. (f)(1). Pub. L. 117–180, §1004(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.

Subsec. (f)(4). Pub. L. 117–328, §3626(a)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (f)(5). Pub. L. 117–328, §3626(a)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Pub. L. 117–180, §1004(7)(B), substituted "January 15, 2027" for "January 15, 2022".

Subsec. (f)(6), (7). Pub. L. 117–328, §3626(a)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (f)(7)(A). Pub. L. 117–328, §3626(a)(2)(C)(i), substituted "The" for "Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the" and inserted ", not later than 30 days after each such negotiation meeting" before period at end.

Subsec. (f)(7)(B). Pub. L. 117–328, §3626(a)(2)(C)(ii), inserted ", in sufficient detail," after "shall summarize".

2017—Subsec. (a)(1). Pub. L. 115–52, §103(a)(1), substituted "2018" for "2013".

Subsec. (a)(1)(A). Pub. L. 115–52, §103(1)(B), substituted "Prescription Drug User Fee Amendments of 2017" for "Prescription Drug User Fee Amendments of 2012".

Subsec. (a)(3), (4). Pub. L. 115–52, §903(a), added pars. (3) and (4).

Subsec. (a)(5). Pub. L. 115–52, §904(a)(1), added par. (5).

Subsec. (b). Pub. L. 115–52, §103(2), substituted "2018" for "2013".

Subsec. (c). Pub. L. 115–52, §904(a)(2)(B), added subsec. (c). Former subsec. (c) redesignated (e).

Subsec. (d). Pub. L. 115–52, §904(a)(2)(B), added subsec. (d). Former subsec. (d) redesignated (f).

Pub. L. 115–52, §103(3), substituted "2022" for "2017" in pars. (1) and (5).

Subsecs. (e), (f). Pub. L. 115–52, §904(a)(2)(A), redesignated subsecs. (c) and (d) as (e) and (f), respectively.

2012—Subsec. (a). Pub. L. 112–144, §104(1), amended subsec. (a) generally. Prior to amendment, text read as follows: "Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort."

Subsec. (b). Pub. L. 112–144, §104(2), substituted "2013" for "2008".

Subsec. (d)(1), (5). Pub. L. 112–144, §104(3), substituted "2017" for "2012".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Effective Date of 2017 Amendment

Amendment by section 103 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2012 Amendment

Effective and Termination Dates

Pub. L. 117–180, div. F, title I, §1005(b), Sept. 30, 2022, 136 Stat. 2147, provided that: "Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title I, §104(b), Aug. 18, 2017, 131 Stat. 1012, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147.

[Pub. L. 117–180, div. F, title I, §1005(c), Sept. 30, 2022, 136 Stat. 2147, provided that the repeal of section 104(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title I, §105(b), July 9, 2012, 126 Stat. 1001, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat 1012.

[Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012, provided that the repeal of section 105(b) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 110–85, title I, §106(b), Sept. 27, 2007, 121 Stat. 842, which provided that the amendment made by section 105 of Pub. L. 110–85 (enacting this section) would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title I, §105(c)(1), July 9, 2012, 126 Stat. 1001.

¹ See References in Text note below.

subpart 3—fees relating to devices

§379i. Definitions

For purposes of this subpart:

(1) The term "premarket application" means—

(A) an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or

(B) a product development protocol described in section 360e(f) of this title.

Such term does not include a supplement, a premarket report, or a premarket notification submission.

(2) The term "premarket report" means a report submitted under section 360e(c)(2) of this title.

(3) The term "premarket notification submission" means a report submitted under section 360(k) of this title.

(4)(A) The term "supplement", with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which—

(i) an application or report has been approved under section 360e(d) of this title, or an application has been approved under section 262 of title 42; or

(ii) a notice of completion has become effective under section 360e(f) of this title.

(B) The term "panel-track supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.

(C) The term "180-day supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.

(D) The term "real-time supplement" means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement.

(E) The term "efficacy supplement" means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.

(5) The term "30-day notice" means a notice under section 360e(d)(5) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.

(6) The term "request for classification information" means a request made under section 360c(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device.

(7) The term "annual fee", for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.

(8) The term "de novo classification request" means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device.

(9) The term "process for the review of device applications" means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests:

(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.

(B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval.

(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary's review of pending premarket applications, premarket reports, and supplements.

(D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, submissions, and de novo classification requests.

(E) Review of device applications subject to section 262 of title 42 for an investigational new drug application under section 355(i) of this title or for an investigational device exemption under section 360j(g) of this title and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title.

(F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests.

(G) The development of voluntary test methods, consensus standards, or mandatory performance standards under section 360d of this title in connection with the review of such applications, reports, supplements, submissions, or requests and related activities.

(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, submissions, or requests.

(I) Any activity undertaken under section 360c or 360e(i) of this title in connection with the initial classification or reclassification of a device or under section 360e(b) of this title in connection with any requirement for approval of a device.

(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.

(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, premarket notification submissions, or de novo classification requests.

(10) The term "costs of resources allocated for the process for the review of device applications" means the expenses in connection with the process for the review of device applications for—

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.

(11) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2021.

(12) The term "person" includes an affiliate thereof.

(13) The term "affiliate" means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(14) The term "establishment subject to a registration fee" means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.

(June 25, 1938, ch. 675, §737, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108–214, §2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577; Pub. L. 110–85, title II, §211, Sept. 27, 2007, 121 Stat. 843; Pub. L. 112–144, title II, §202, July 9, 2012, 126 Stat. 1002; Pub. L. 114–255, div. A, title III, §3051(c)(2), Dec. 13, 2016, 130 Stat. 1124; Pub. L. 115–52, title II, §202(a), Aug. 18, 2017, 131 Stat. 1013; Pub. L. 117–180, div. F, title II, §2002, Sept. 30, 2022, 136 Stat. 2148.)

Termination of Section

For termination of section by section 2007(a) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

Amendments

2022—Par. (9). Pub. L. 117–180, §2002(1)(A), substituted "premarket notification submissions, and de novo classification requests" for "and premarket notification submissions" in introductory provisions.

Par. (9)(D). Pub. L. 117–180, §2002(1)(B), substituted "submissions, and de novo classification requests" for "and submissions".

Par. (9)(F). Pub. L. 117–180, §2002(1)(C), substituted "premarket notification submissions, and de novo classification requests" for "and premarket notification submissions".

Par. (9)(G), (H). Pub. L. 117–180, §2002(1)(D), substituted "submissions, or requests" for "or submissions".

Par. (9)(K). Pub. L. 117–180, §2002(1)(E), substituted "premarket notification submissions, or de novo classification requests" for "or premarket notification submissions".

Par. (11). Pub. L. 117–180, §2002(2), substituted "2021" for "2016".

2017—Par. (8). Pub. L. 115–52, §202(a)(2), added par. (8). Former par. (8) redesignated (9).

Par. (9). Pub. L. 115–52, §202(a)(1), redesignated par. (8) as (9). Former par. (9) redesignated (10).

Par. (10). Pub. L. 115–52, §202(a)(1), (3), redesignated par. (9) as (10) and substituted "submissions, and de novo classification requests" for "and submissions" in subpar. (D). Former par. (10) redesignated (11).

Par. (11). Pub. L. 115–52, §202(a)(1), (4), redesignated par. (10) as (11) and substituted "2016" for "2011".

Pars. (12) to (14). Pub. L. 115–52, §202(a)(1), redesignated pars. (11) to (13) as (12) to (14), respectively.

2016—Par. (5). Pub. L. 114–255 substituted "360e(d)(5)" for "360e(d)(6)".

2012—Par. (9). Pub. L. 112–144, §202(1), struck out "incurred" after "expenses" in introductory provisions.

Par. (10). Pub. L. 112–144, §202(2), substituted "October 2011" for "October 2001".

Par. (13). Pub. L. 112–144, §202(3), substituted "is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device." for "is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:" and struck out subpars. (A) to (C) which related to manufacturer, single-use device reprocessor, and specification developer establishments.

2007—Pub. L. 110–85, §211(1), substituted "For purposes of this subpart" for "For purposes of this part" in introductory provisions.

Pars. (5) to (9). Pub. L. 110–85, §211(2), (3), added pars. (5) to (7) and redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively.

Par. (10). Pub. L. 110–85, §211(2), (4), redesignated par. (7) as (10) and substituted "October of the preceding fiscal year" for "April of the preceding fiscal year" and "October 2001" for "April 2002".

Par. (11). Pub. L. 110–85, §211(5), added par. (11).

Par. (12). Pub. L. 110–85, §211(2), redesignated par. (8) as (12).

Par. (13). Pub. L. 110–85, §211(6), added par. (13).

2004—Pub. L. 108–214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, §102(a), which enacted this section.

Par. (4)(B). Pub. L. 108–214, §2(a)(1)(A), substituted "and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness" for "and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness".

Par. (4)(D). Pub. L. 108–214, §2(a)(1)(B), struck out "manufacturing," after "software,".

Par. (5)(J). Pub. L. 108–214, §2(a)(1)(C), substituted "a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42." for "a premarket application under section 360e of this title or section 262 of title 42."

Par. (8). Pub. L. 108–214, §2(a)(1)(D), substituted "The term 'affiliate' means a business entity that has a relationship with a second business entity (whether domestic or international)" for "The term 'affiliate' means a business entity that has a relationship with a second business entity".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Effective Date of 2017 Amendment

Pub. L. 115–52, title II, §209, Aug. 18, 2017, 131 Stat. 1020, provided that: "The amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective Date of 2012 Amendment

Pub. L. 112–144, title II, §206, July 9, 2012, 126 Stat. 1007, provided that: "The amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] shall take effect on October 1, 2012, or the date of the enactment of this Act [July 9, 2012], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after October 1, 2012, regardless of the date of the enactment of this Act."

Effective and Termination Dates of 2007 Amendment

Pub. L. 110–85, title II, §216, Sept. 27, 2007, 121 Stat. 852, provided that: "The amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title] shall take effect on October 1, 2007, or the date of the enactment of this Act [Sept. 27, 2007], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all premarket applications, premarket reports, supplements, 30-day notices, and premarket notification submissions received on or after October 1, 2007, regardless of the date of the enactment of this Act."

Pub. L. 110–85, title II, §217, Sept. 27, 2007, 121 Stat. 852, which provided that the amendments by sections 211 to 217 of Pub. L. 110–85 (amending this section and section 379j of this title) would cease to be effective Oct. 1, 2012, and that section 379j–1 of this title would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title II, §207(b)(1), July 9, 2012, 126 Stat. 1007.

Effective and Termination Dates

Pub. L. 117–180, div. F, title II, §2007(a), Sept. 30, 2022, 136 Stat. 2154, provided that: "Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title II, §210(a), Aug. 18, 2017, 131 Stat. 1020, which provided that this section and section 379j of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154.

[Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154, provided that the repeal of section 210(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title II, §207(a), July 9, 2012, 126 Stat. 1007, which provided that sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) would cease to be effective Oct. 1, 2017, and that section 738A (21 U.S.C. 379j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title II, §210(c), Aug. 18, 2017, 131 Stat. 1020.

[Pub. L. 115–52, title II, §210(c), Aug. 18, 2017, 131 Stat. 1020, provided that the repeal of section 207(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 107–250, title I, §106, Oct. 26, 2002, 116 Stat. 1602, provided that: "The amendments made by this title [enacting this subpart] shall take effect on the date of the enactment of this Act [Oct. 26, 2002], except that fees shall be assessed for all premarket applications, premarket reports, supplements, and premarket notification submissions received on or after October 1, 2002, regardless of the date of enactment."

Pub. L. 107–250, title I, §107, Oct. 26, 2002, 116 Stat. 1602, which provided that the amendments made by title I of Pub. L. 107–250 (enacting this subpart) would cease to be effective Oct. 1, 2007, except that section 103 of Pub. L. 107–250, set out as a note below, would cease to be effective Jan. 31, 2008, was repealed by Pub. L. 112–144, title II, §207(c)(1), July 9, 2012, 126 Stat. 1007.

[Pub. L. 112–144, title II, §207(c), July 9, 2012, 126 Stat. 1007, provided that the repeal of section 107 of Pub. L. 107–250, formerly set out above, is effective Sept. 30, 2007.]

Savings Provisions

Pub. L. 117–180, div. F, title II, §2009, Sept. 30, 2022, 136 Stat. 2155, provided that: "Notwithstanding the amendments made by this title [amending this section and sections 379j and 379j–1 of this title and repealing provisions set out as notes under this section and section 379j–1 of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after October 1, 2017, but before October 1, 2022, were received by the Food and Drug Administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title II, §208, Aug. 18, 2017, 131 Stat. 1019, provided that: "Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Pub. L. 112–144, title II, §205, July 9, 2012, 126 Stat. 1007, provided that: "Notwithstanding the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [July 9, 2012], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (in effect as of such day) that on or after October 1, 2007, but before October 1, 2012, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013."

Pub. L. 110–85, title II, §214, Sept. 27, 2007, 121 Stat. 852, provided that: "Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) [formerly set out as an Effective and Termination Dates note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle [Sept. 27, 2007], shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008."

Congressional Findings Concerning Fees Relating to Devices

Pub. L. 117–180, div. F, title II, §2001(b), Sept. 30, 2022, 136 Stat. 2147, provided that: "Congress finds that the fees authorized under the amendments made by this title [amending this section and sections 379j and 379j–1 of this title and repealing provisions set out as notes under this section and section 379j–1 of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title II, §201(b), Aug. 18, 2017, 131 Stat. 1013, provided that: "The Congress finds that the fees authorized under the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title II, §201(b), July 9, 2012, 126 Stat. 1002, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 110–85, title II, §201(c), Sept. 27, 2007, 121 Stat. 842, provided that: "The Congress finds that the fees authorized under the amendments made by this title [enacting section 379j–1 of this title and amending this section and sections 333, 360, 360i, 360m, 374, and 379j of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 107–250, title I, §101, Oct. 26, 2002, 116 Stat. 1589, provided that: "The Congress finds that—

"(1) prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent disease;

"(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met; and

"(3) the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and section 379j of this title] will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record."

Annual Reports

Pub. L. 107–250, title I, §103, Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 109–43, §2(b), Aug. 1, 2005, 119 Stat. 441, provided that:

"(a) In General.—Beginning with fiscal year 2003, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report concerning—

"(1) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of Pub. L. 107–250 does not contain parts]; and

"(2) the implementation of the authority for such fees during such fiscal year, and the use, by the Food and Drug Administration, of the fees collected during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102 [enacting this subpart].

"(b) Additional Information.—For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include—

"(1) information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and

"(2) a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) [now (8)] of section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not less than such amounts for fiscal year 2002 multiplied by the adjustment factor, as defined in paragraph (7) [now (10)] of such section 737."

Study

Pub. L. 107–250, title I, §104(b), Oct. 26, 2002, 116 Stat. 1601, directed the Secretary of Health and Human Services to conduct a study for the purpose of making certain determinations regarding the medical device user-fee program established under the amendment made by section 102 of Pub. L. 107–250 and to submit a report to Congress by Jan. 10, 2007.

Consultation

Pub. L. 107–250, title I, §105, Oct. 26, 2002, 116 Stat. 1601, provided that:

"(a) In General.—In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of medical device applications for fiscal years after fiscal year 2007, and for the reauthorization of sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i, 379j], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.

"(b) Recommendations.—The Secretary shall publish in the Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations."

§379j. Authority to assess and use device fees

(a) Types of fees

(1) In general

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section.

(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device

(A) In general

Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2022, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:

(i) A premarket application.

(ii) For a premarket report, a fee equal to the fee that applies under clause (i).

(iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).

(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).

(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).

(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).

(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).

(viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i).

(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).

(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).

(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).

(B) Exceptions

(i) Humanitarian device exemption

An application under section 360j(m) of this title is not subject to any fee under subparagraph (A).

(ii) Further manufacturing use

No fee shall be required under subparagraph (A) for the submission of a premarket application under section 262 of title 42 for a product licensed for further manufacturing use only.

(iii) State or Federal Government sponsors

No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.

(iv) Premarket notifications by third parties

No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 360m of this title.

(v) Pediatric conditions of use

(I) In general

No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.

(II) Subsequent proposal of adult conditions of use

In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.

(C) Payment

The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.

(D) Refunds

(i) Application refused for filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.

(ii) Application withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.

(iii) Application withdrawn before first action

After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.

(iv) Modular applications withdrawn before first action

The Secretary shall refund 75 percent of the application fee paid for an application submitted under section 360e(c)(4) of this title that is withdrawn before a second portion is submitted and before a first action on the first portion.

(v) Later withdrawn modular applications

If an application submitted under section 360e(c)(4) of this title is withdrawn after a second or subsequent portion is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the portions submitted.

(vi) Sole discretion to refund

The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.

(3) Annual establishment registration fee

(A) In general

Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 360 of this title beginning with its registration for fiscal year 2008.

(B) Exception

(i) In general

No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act ¹ [25 U.S.C. 5301 et seq.]), unless a device manufactured by the establishment is to be distributed commercially.

(ii) Small businesses fee waiver

(I) Definition of small business

For purposes of this clause, the term "small business" means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(II) Waiver

The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined by the Secretary.

(III) Firms submitting tax returns to the United States Internal Revenue Service

The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates.

(IV) Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment's firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates.

(V) Request for waiver

An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable.

(C) Payment

The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—

(i) the initial or annual registration (as applicable) of the establishment under section 360 of this title; or

(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(b) Fee Amounts

(1) In general

Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2023 through 2027, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).

(2) Base fee amounts specified

For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:


Fee Type	Fiscal Year 2023	Fiscal Year 2024	Fiscal Year 2025	Fiscal Year 2026	Fiscal Year 2027
Premarket Application	$425,000	$435,000	$445,000	$455,000	$470,000
Establishment Registration	$6,250	$6,875	$7,100	$7,575	$8,465

(3) Total revenue amounts specified

For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

(A) $312,606,000 for fiscal year 2023.

(B) $335,750,000 for fiscal year 2024.

(D) $366,486,300 for fiscal year 2026.

(E) $418,343,000 for fiscal year 2027.

(c) Annual fee setting; adjustments

(1) In general

The Secretary shall, 60 days before the start of each fiscal year after September 30, 2022, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.

(2) Inflation adjustments

(A) Adjustment to total revenue amounts

For fiscal year 2023 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.

(B) Applicable inflation adjustment

The applicable inflation adjustment for fiscal year 2023 and each subsequent fiscal year is the product of—

(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and

(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2022.

(C) Base inflation adjustment

(i) In general

Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—

(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by 0.40.

(ii) Limitations

For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)—

(I) is less than 1, such adjustment shall be considered to be equal to 1; or

(II) is greater than 1.04, such adjustment shall be considered to be equal to 1.04.

(D) Adjustment to base fee amounts

For each of fiscal years 2023 through 2027, the Secretary shall—

(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and

(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).

(3) Volume-based adjustments to establishment registration base fees

For each of fiscal years 2023 through 2027, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be increased, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).

(4) Performance improvement adjustment

(A) In general

For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2) and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts, as applicable:

(i) For fiscal year 2025, the product of—

(I) the amount determined under subparagraph (B)(i)(I); and

(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

(ii) For fiscal year 2026, the product of—

(I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and

(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

(iii) For fiscal year 2027, the product of—

(I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and

(II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year.

(B) Amounts

(i) Presubmission amount

For purposes of subparagraph (A), with respect to the Presubmission Written Feedback goal, the amounts determined under this subparagraph are as follows:

(I) For fiscal year 2025, $15,396,600 if such goal for fiscal year 2023 is met.

(II) For fiscal year 2026:

(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.

(bb) $36,792,200 if such goal for fiscal year 2024 is met.

(III) For fiscal year 2027:

(aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met.

(bb) $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met.

(cc) $40,572,600 if such goal for fiscal year 2025 is met.

(ii) De novo classification request amount

For purposes of subparagraph (A), with respect to the De Novo Decision goal, the amounts determined under this subparagraph are as follows:

(I) For fiscal year 2026, $6,323,500 if such goal for fiscal year 2023 is met.

(II) For fiscal year 2027:

(aa) $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met.

(bb) $11,765,400 if such goal for fiscal year 2024 is met.

(iii) Premarket notification and premarket approval amount

For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal, the amounts determined under this subparagraph are as follows:

(I) For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met.

(II) For fiscal year 2027:

(aa) $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 are not met.

(bb) $3,906,000 if the 4 goals for fiscal year 2024 are met.

(C) Performance calculation

For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows:

(i) The performance of the Presubmission Written Feedback goal shall be based on data available as of—

(I) for fiscal year 2023, March 31, 2024;

(II) for fiscal year 2024, March 31, 2025; and

(III) for fiscal year 2025, March 31, 2026.

(ii) The performance of the De Novo Decision goal, 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal shall be based on data available as of—

(I) for fiscal year 2023, March 31, 2025; and

(II) for fiscal year 2024, March 31, 2026.

(D) Goals defined

For purposes of this paragraph, the terms "Presubmission Written Feedback goal", "De Novo Decision goal", "510(k) decision goal", "510(k) Shared Outcome Total Time to Decision goal", "PMA decision goal", and "PMA Shared Outcome Total Time to Decision goal" refer to the goals identified by the same names in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.

(5) Hiring adjustment

(A) In general

For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph (B) for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C).

(B) Thresholds

The thresholds specified in this subparagraph are as follows:

(i) For fiscal year 2025, the threshold is 123 hires for fiscal year 2023.

(ii) For fiscal year 2026, the threshold is 38 hires for fiscal year 2024.

(iii) For fiscal year 2027, the threshold is—

(I) 22 hires for fiscal year 2025 if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or

(II) 75 hires for fiscal year 2025 if such fees are so increased.

(C) Hiring adjustment amount

The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of—

(i) the number of hires by which the hiring goal specified in subparagraph (D) for the fiscal year before the prior fiscal year was not met;

(ii) $72,877; and

(iii) the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met.

(D) Hiring goals

The hiring goals for each of fiscal years 2023 through 2025 are as follows:

(i) For fiscal year 2023, 144 hires.

(ii) For fiscal year 2024, 42 hires.

(iii) For fiscal year 2025:

(I) 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i).

(II) 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i).

(E) Number of hires

For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary as set forth in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.

(6) Operating reserve adjustment

(A) In general

For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves.

(B) Designated amount

Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of—

(i) 13 weeks of operating reserves of carryover user fees; and

(ii) 1 month of operating reserves maintained pursuant to paragraph (8).

(C) Excluded amount

For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph (B) and shall not be subject to the decrease under subparagraph (A).

(7) Limit

(8) Supplement

(A) In general

The Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of the next fiscal year.

(B) Notice to Congress

Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.

(d) Small businesses; fee waiver and fee reduction regarding premarket approval fees

(1) In general

The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term "small business" means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).

(2) Rules relating to premarket approval fees

(A) Definition

For purposes of this paragraph, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(B) Evidence of qualification

(i) In general

An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate.

(ii) Firms submitting tax returns to the United States Internal Revenue Service

The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant's or affiliate's gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant's firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.

(C) Reduced fees

Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—

(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and

(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.

(D) Request for fee waiver or reduction

An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.

(e) Small businesses; fee reduction regarding premarket notification submissions

(1) In general

For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(viii) may be paid at a reduced rate in accordance with paragraph (2)(C).

(2) Rules relating to premarket notification submissions

(A) Definition

For purposes of this subsection, the term "small business" means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.

(B) Evidence of qualification

(i) In general

An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate.

(ii) Firms submitting tax returns to the United States Internal Revenue Service

(iii) Firms not submitting tax returns to the United States Internal Revenue Service

(C) Reduced fees

For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 25 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).

(D) Request for reduction

An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.

(f) Effect of failure to pay fees

(1) No acceptance of submissions

A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.

(2) No registration

Registration information submitted under section 360 of this title by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 360 of this title.

(g) Conditions

(1) Performance goals; termination of program

With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if—

(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $398,566,000 multiplied by the adjustment factor applicable to such fiscal year; or

(B) fees were not assessed under subsection (a) for the previous fiscal year.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(3) Limitation

Beginning on October 1, 2023, the authorities under section 379i(10)(C) of this title shall include only leasing and necessary scientific equipment.

(h) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(ii) shall be available—

(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.

(B) Compliance

(i) In general

(I) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(II)(aa) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and

(bb) such costs are not more than 5 percent below the level specified in such subparagraph.

(ii) More than 5 percent

To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.

(C) Provision for early payments

(3) Authorization of appropriations

(A) In general

For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under subparagraph (C).

(B) Revenue amount

For purposes of this paragraph, the revenue amount for each fiscal year is the sum of—

(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and

(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable.

(C) Amount of reductions

For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of—

(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and

(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.

(i) Collection of unpaid fees

(j) Written requests for refunds

To qualify for consideration for a refund under subsection (a)(2)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.

(k) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(June 25, 1938, ch. 675, §738, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108–214, §2(a)(2), (d)(2)(A), (B), (3)(A), Apr. 1, 2004, 118 Stat. 572, 576, 577; Pub. L. 109–43, §2(a), Aug. 1, 2005, 119 Stat. 439; Pub. L. 110–85, title II, §212, Sept. 27, 2007, 121 Stat. 844; Pub. L. 112–144, title II, §203(a)–(f), July 9, 2012, 126 Stat. 1002; Pub. L. 112–193, §2(b)(1), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title II, §203(a)–(f)(1), (2)(B)–(i), title IX, §905(b)(2), Aug. 18, 2017, 131 Stat. 1013–1016, 1090; Pub. L. 117–180, div. F, title II, §2003, Sept. 30, 2022, 136 Stat. 2148; Pub. L. 117–328, div. FF, title III, §§3309, 3625(d), (e)(1), Dec. 29, 2022, 136 Stat. 5836, 5882.)

Termination of Section

For termination of section by section 2007(a) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

The Indian Self Determination and Educational Assistance Act, referred to in subsec. (a)(3)(B)(i), probably means the Indian Self-Determination and Education Assistance Act, Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.

Section 2001(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (c)(4)(A), (C), (D), (5)(E), is section 2001(b) of title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title.

510(k), referred to in subsec. (c)(4)(B)(iii), (C)(ii), (D), means section 510(k) of the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, which is classified to section 360(k) of this title.

Amendments

2022—Subsec. (a)(1). Pub. L. 117–180, §2003(a)(1), substituted "fiscal year 2023" for "fiscal year 2018".

Subsec. (a)(2)(A). Pub. L. 117–180, §2003(a)(2)(A)(i), substituted "October 1, 2022" for "October 1, 2017" in introductory provisions.

Subsec. (a)(2)(A)(iii). Pub. L. 117–180, §2003(a)(2)(A)(ii), substituted "80 percent" for "75 percent".

Subsec. (a)(2)(A)(viii). Pub. L. 117–180, §2003(a)(2)(A)(iii), substituted "4.5 percent" for "3.4 percent".

Subsec. (a)(2)(B)(iii). Pub. L. 117–180, §2003(a)(2)(B), substituted "premarket notification submission, or de novo classification request" for "or premarket notification submission".

Subsec. (a)(2)(C). Pub. L. 117–180, §2003(a)(2)(C), substituted "periodic reporting concerning a class III device, or de novo classification request" for "or periodic reporting concerning a class III device".

Subsec. (a)(3)(B). Pub. L. 117–328, §3309(a), designated existing provisions as cl. (i), inserted heading, and added cl. (ii).

Subsec. (b)(1). Pub. L. 117–180, §2003(b)(1), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (b)(2). Pub. L. 117–180, §2003(b)(2), amended par. (2) generally. Prior to amendment, par. (2) specified base fee amounts for fiscal years 2018 to 2022.

Subsec. (b)(3). Pub. L. 117–180, §2003(b)(3), amended par. (3) generally. Prior to amendment, par. (3) specified total revenue amounts for fiscal years 2018 to 2022.

Subsec. (c)(1). Pub. L. 117–180, §2003(c)(1), substituted "2022" for "2017".

Subsec. (c)(2)(A). Pub. L. 117–180, §2003(c)(2)(A), substituted "2023" for "2018".

Subsec. (c)(2)(B). Pub. L. 117–180, §2003(c)(2)(B)(i), substituted "fiscal year 2023" for "fiscal year 2018" in introductory provisions.

Subsec. (c)(2)(B)(ii). Pub. L. 117–180, §2003(c)(2)(B)(ii), substituted "fiscal year 2022" for "fiscal year 2016".

Subsec. (c)(2)(C)(i)(II). Pub. L. 117–180, §2003(c)(2)(C), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2)(D). Pub. L. 117–180, §2003(c)(2)(D), substituted "fiscal years 2023 through 2027" for "fiscal years 2018 through 2022" in introductory provisions.

Subsec. (c)(3). Pub. L. 117–180, §2003(c)(3), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (c)(4) to (8). Pub. L. 117–180, §2003(c)(4), (5), added pars. (4) to (6) and redesignated former pars. (4) and (5) as (7) and (8), respectively.

Subsec. (d)(2)(B)(iii). Pub. L. 117–328, §3309(b), inserted ", if extant," after "national taxing authority".

Subsec. (e)(2)(B)(iii). Pub. L. 117–328, §3625(d)(1), inserted ", if extant," after "national taxing authority".

Subsec. (g)(1)(A). Pub. L. 117–180, §2003(d)(1), substituted "$398,566,000" for "$320,825,000".

Subsec. (g)(2). Pub. L. 117–180, §2003(d)(2), inserted "de novo classification requests," after "class III device,".

Subsec. (g)(3). Pub. L. 117–328, §3625(e)(1), which directed technical correction to directory language of Pub. L. 115–52, §905(b)(2), was executed by making technical correction to that section as if the amendment were retroactive to the effective date of the amendment by Pub. L. 115–52 to reflect the probable intent of Congress. See 2017 Amendment note below.

Pub. L. 117–328, §3625(d)(3), substituted "379i(10)(C) of this title" for "section 379i(9)(C) of this title".

Subsec. (h)(2)(A)(ii). Pub. L. 117–328, §3625(d)(2)(A), substituted "shall be available—" for "shall be available to defray", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023, to defray" before "increases in the costs", and added subcl. (II).

Subsec. (h)(2)(B)(i). Pub. L. 117–328, §3625(d)(2)(B), substituted "as described in subclause (I) or (II) of such subparagraph, as applicable" for "for the process for the review of device applications" in introductory provisions.

Subsec. (h)(3). Pub. L. 117–180, §2003(e), amended par. (3) generally. Prior to amendment, text read as follows: "For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c)."

2017—Subsec. (a)(1). Pub. L. 115–52, §203(a)(1), substituted "fiscal year 2018" for "fiscal year 2013".

Subsec. (a)(2)(A). Pub. L. 115–52, §203(f)(2)(B)(ii), substituted "(d) and (e)" for "(d), (e), and (f)" in introductory provisions.

Pub. L. 115–52, §203(a)(2)(A)(i), substituted "October 1, 2017" for "October 1, 2012" in introductory provisions.

Subsec. (a)(2)(A)(viii). Pub. L. 115–52, §203(a)(2)(A)(ii), substituted "3.4 percent" for "2 percent".

Subsec. (a)(2)(A)(xi). Pub. L. 115–52, §203(a)(2)(A)(iii), added cl. (xi).

Subsec. (a)(2)(B)(v)(I). Pub. L. 115–52, §203(a)(2)(B), substituted "premarket notification submission, or de novo classification request" for "or premarket notification submission".

Subsec. (a)(3)(A). Pub. L. 115–52, §203(f)(2)(B)(iii), struck out "and subsection (f)" after "subparagraph (B)".

Subsec. (b). Pub. L. 115–52, §203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2013 to 2017.

Subsec. (c)(1). Pub. L. 115–52, §203(c)(1), substituted "2017" for "2012".

Subsec. (c)(2)(A). Pub. L. 115–52, §203(c)(2)(A), substituted "2018" for "2014".

Subsec. (c)(2)(B). Pub. L. 115–52, §203(c)(2)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: "The applicable inflation adjustment for a fiscal year is—

"(i) for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and

"(ii) for fiscal year 2015 and each subsequent fiscal year, the product of—

"(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and

"(II) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014."

Subsec. (c)(2)(C). Pub. L. 115–52, §203(c)(2)(C), struck out "to total revenue amounts" after "adjustment" in heading.

Subsec. (c)(2)(D). Pub. L. 115–52, §203(c)(2)(D), amended subpar. (D) generally. Prior to amendment, text read as follows: "For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A)."

Subsec. (c)(3). Pub. L. 115–52, §203(c)(3), substituted "2018 through 2022" for "2014 through 2017" and "increased" for "further adjusted".

Subsec. (d)(1). Pub. L. 115–52, §203(d)(1), substituted "specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)" for "specified in clauses (i) through (v) and clauses (vii), (ix), and (x)".

Subsec. (d)(2)(C)(i). Pub. L. 115–52, §203(d)(2), substituted "supplement," for "supplement, or" and inserted ", or a de novo classification request" after "class III device".

Subsec. (e)(2)(C). Pub. L. 115–52, §203(e), substituted "25 percent" for "50 percent".

Subsec. (f). Pub. L. 115–52, §203(f)(1), (2)(B)(i), redesignated subsec. (g) as (f) and struck out former subsec. (f) which authorized the Secretary to grant waivers or reductions of fees under subsec. (a)(2) or (3) until Oct. 1, 2017.

Subsec. (f)(1). Pub. L. 115–52, §203(g), substituted "periodic reporting concerning a class III device, or de novo classification request" for "or periodic reporting concerning a class III device" and "all such fees" for "all fees".

Subsec. (g). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).

Subsec. (g)(1)(A). Pub. L. 115–52, §203(h), substituted "$320,825,000" for "$280,587,000".

Subsec. (h). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).

Subsec. (h)(3). Pub. L. 115–52, §203(i)(1), substituted "2018 through 2022" for "2013 through 2017" and "subsection (c)." for "subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4)."

Pub. L. 115–52, §905(b)(2), as amended by Pub. L. 117–328, §3625(e)(1), added par. (3), effective Aug. 18, 2017. Subsec. (h) subsequently redesignated (g) effective Oct. 1, 2017, by Pub. L. 115–52, §203(f)(2)(B)(i). See Amendment note above.

Subsec. (h)(4). Pub. L. 115–52, §203(i)(2), struck out par. (4). Text read as follows: "If the cumulative amount of fees collected during fiscal years 2013, 2014, and 2015, added to the amount estimated to be collected for fiscal year 2016, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2016, exceeds the cumulative amount appropriated pursuant to paragraph (3) for these four fiscal years, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017."

Subsecs. (i) to (l). Pub. L. 115–52, §203(f)(2)(B)(i), redesignated subsecs. (j) to (l) as (i) to (k), respectively. Former subsec. (i) redesignated (h).

2012—Subsec. (a)(1). Pub. L. 112–144, §203(a)(1), substituted "fiscal year 2013" for "fiscal year 2008".

Subsec. (a)(2)(A). Pub. L. 112–144, §203(a)(2)(A), substituted "subsections (d), (e), and (f)" for "subsections (d) and (e)", "October 1, 2012" for "October 1, 2002", and "subsection (c)" for "subsection (c)(1)" in introductory provisions.

Subsec. (a)(2)(A)(viii). Pub. L. 112–144, §203(a)(2)(B), substituted "2" for "1.84".

Subsec. (a)(3)(A). Pub. L. 112–144, §203(a)(3)(A), inserted "and subsection (f)" after "subparagraph (B)".

Subsec. (a)(3)(C). Pub. L. 112–144, §203(a)(3)(B), substituted "later of—" for "initial registration of the establishment or upon the annual registration under section 360 of this title." and added cls. (i) and (ii).

Subsec. (b). Pub. L. 112–144, §203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2008 to 2012.

Subsec. (c). Pub. L. 112–144, §203(c), inserted "; adjustments" after "setting" in heading, added pars. (1) to (3), redesignated former pars. (3) and (4) as (4) and (5), respectively, and struck out former pars. (1) and (2) which related to annual publication and adjustment of fees.

Subsecs. (f) to (h). Pub. L. 112–144, §203(d), added subsec. (f) and redesignated former subsecs. (f) and (g) as (g) and (h), respectively. Former subsec. (h) redesignated (i).

Subsec. (h)(1)(A). Pub. L. 112–144, §203(e), substituted "$280,587,000" for "$205,720,000".

Subsec. (i). Pub. L. 112–144, §203(d)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j).

Subsec. (i)(1). Pub. L. 112–144, §203(f)(1), substituted "Subject to paragraph (2)(C), fees authorized" for "Fees authorized".

Subsec. (i)(2)(A)(i). Pub. L. 112–144, §203(f)(2)(A)(i), substituted "subject to subparagraph (C), shall be collected and available" for "shall be retained".

Subsec. (i)(2)(A)(ii). Pub. L. 112–193 substituted "shall be available" for "shall only be available".

Pub. L. 112–144, §203(f)(2)(A)(ii), substituted "shall only be available" for "shall only be collected and available" and "fiscal year 2009" for "fiscal year 2002".

Subsec. (i)(2)(C). Pub. L. 112–144, §203(f)(2)(B), added subpar. (C).

Subsec. (i)(3). Pub. L. 112–144, §203(f)(3), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2008 to 2012.

Subsec. (i)(4). Pub. L. 112–144, §203(f)(4), substituted "fiscal years 2013, 2014, and 2015" for "fiscal years 2008, 2009, and 2010", "fiscal year 2016" for "fiscal year 2011", "June 30, 2016" for "June 30, 2011", "the cumulative amount appropriated pursuant to" for "the amount of fees specified in aggregate in", and "fiscal year 2017" for "fiscal year 2012" and struck out "aggregate amount in" before "excess shall be credited".

Subsecs. (j) to (l). Pub. L. 112–144, §203(d)(1), redesignated subsecs. (i) to (k) as (j) to (l), respectively.

2007—Subsec. (a)(1). Pub. L. 110–85, §212(a)(1)(A), substituted "Beginning in fiscal year 2008" for "Beginning on October 26, 2002".

Subsec. (a)(2). Pub. L. 110–85, §212(a)(1)(B), amended heading generally. Prior to amendment, heading read as follows: "Premarket application, premarket report, supplement, and submission fee".

Subsec. (a)(2)(A)(iii). Pub. L. 110–85, §212(a)(2)(A), substituted "a fee equal to 75 percent of the fee that applies" for "a fee equal to the fee that applies".

Subsec. (a)(2)(A)(iv). Pub. L. 110–85, §212(a)(2)(B), substituted "15 percent" for "21.5 percent".

Subsec. (a)(2)(A)(v). Pub. L. 110–85, §212(a)(2)(C), substituted "7 percent" for "7.2 percent".

Subsec. (a)(2)(A)(vi), (vii). Pub. L. 110–85, §212(a)(2)(D), (E), added cl. (vi) and redesignated former cl. (vi) as (vii). Former cl. (vii) redesignated (viii).

Subsec. (a)(2)(A)(viii). Pub. L. 110–85, §212(a)(2)(D), (F), redesignated cl. (vii) as (viii), substituted "1.84 percent" for "1.42 percent", and struck out ", subject to any adjustment under subsection (e)(2)(C)(ii) of this section" before period at end.

Subsec. (a)(2)(A)(ix), (x). Pub. L. 110–85, §212(a)(2)(G), added cls. (ix) and (x).

Subsec. (a)(2)(C). Pub. L. 110–85, §212(a)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: "The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and October 26, 2002, shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section 360e(c)(3) of this title shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003."

Subsec. (a)(2)(D)(iii). Pub. L. 110–85, §212(a)(4)(A), struck out at end "The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable."

Subsec. (a)(2)(D)(iv) to (vi). Pub. L. 110–85, §212(a)(4)(B), added cls. (iv) to (vi).

Subsec. (a)(3). Pub. L. 110–85, §212(a)(5), added par. (3).

Subsec. (b). Pub. L. 110–85, §212(b), amended subsec. (b) generally. Prior to amendment, text read as follows: "Except as provided in subsections (c), (d), (e), (g), and (h) of this section, the fees under subsection (a) of this section shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; and $29,785,000 in fiscal year 2005. If legislation is enacted after October 26, 2002, requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications."

Subsec. (c). Pub. L. 110–85, §212(c)(1)(A), made technical amendment to heading.

Subsec. (c)(1). Pub. L. 110–85, §212(c)(1)(B), struck out at end "The fees established for fiscal year 2006 shall be based on a premarket application fee of $259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600."

Subsec. (c)(2), (3). Pub. L. 110–85, §212(c)(2)(A), (B), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 110–85, §212(c)(2)(A), (C), redesignated par. (3) as (4) and substituted in subpar. (A) "The Secretary" for "For fiscal years 2006 and 2007, the Secretary" and "for the first month of the next fiscal year" for "for the first month of fiscal year 2008".

Subsec. (d)(1). Pub. L. 110–85, §212(d)(1), struck out ", partners, and parent firms" after "affiliates" and substituted "clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)" for "clauses (i) through (vi) of subsection (a)(2)(A) of this section".

Subsec. (d)(2)(A). Pub. L. 110–85, §212(d)(2)(A), struck out ", partners, and parent firms" before period at end.

Subsec. (d)(2)(B). Pub. L. 110–85, §212(d)(2)(B)(i), (ii), designated first sentence as cl. (i) and second to fourth sentences as cl. (ii) and inserted cl. headings.

Subsec. (d)(2)(B)(ii). Pub. L. 110–85, §212(d)(2)(B)(iii), (iv), struck out ", partners, and parent firms" after "its affiliates" and after "such affiliates" and substituted "If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates." for "If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively."

Subsec. (d)(2)(B)(iii). Pub. L. 110–85, §212(d)(2)(B)(v), added cl. (iii).

Subsec. (d)(2)(C). Pub. L. 110–85, §212(d)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: "Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) of this section may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement."

Subsec. (e)(1). Pub. L. 110–85, §212(e)(1), substituted "2008" for "2004" and "(a)(2)(A)(viii)" for "(a)(2)(A)(vii)".

Subsec. (e)(2)(A). Pub. L. 110–85, §212(e)(2)(A), struck out ", partners, and parent firms" before period at end.

Subsec. (e)(2)(B). Pub. L. 110–85, §212(e)(2)(B)(i), (ii), inserted cl. headings and designated first sentence as cl. (i) and second to fourth sentences as cl. (ii).

Subsec. (e)(2)(B)(ii). Pub. L. 110–85, §212(e)(2)(B)(iii), (iv), struck out ", partners, and parent firms" after "its affiliates" and after "such affiliates" and substituted "If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates." for "If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively."

Subsec. (e)(2)(B)(iii). Pub. L. 110–85, §212(e)(2)(B)(v), added cl. (iii).

Subsec. (e)(2)(C). Pub. L. 110–85, §212(e)(3), amended subpar. (C) generally. Prior to amendment, subpar. (C) contained provisions, for fiscal year 2004 and each subsequent fiscal year, authorizing in cl. (i) a reduced fee for a premarket notification submission, and directing in cl. (ii) the Secretary how to determine an adjustment per fee revenue amount.

Subsec. (f). Pub. L. 110–85, §212(f), amended subsec. (f) generally. Prior to amendment, text read as follows: "A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid."

Subsec. (g)(1). Pub. L. 110–85, §212(g)(1), added par. (1) and struck out former par. (1). Prior to amendment, par. (1) related to performance goals for fiscal years 2003 through 2005, with respect to the amount appropriated under the salaries and expenses account of the Food and Drug Administration, for devices and radiological products, and termination of the program after fiscal year 2005.

Subsec. (g)(2). Pub. L. 110–85, §212(g)(2), amended par. (2) generally. Prior to amendment, text read as follows: "If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of subparagraph (C) or (D) of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid."

Subsec. (h)(3). Pub. L. 110–85, §212(h)(1), amended par. (3) generally, substituting provisions authorizing appropriations for fiscal years 2008 to 2012 for provisions authorizing appropriations for fiscal years 2003 to 2007.

Subsec. (h)(4). Pub. L. 110–85, §212(h)(2), amended par. (4) generally. Prior to amendment, text read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

2005—Subsec. (a)(2)(A). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)".

Subsec. (b). Pub. L. 109–43, §2(a)(1), inserted "and" after "2004;" and substituted "2005" for "2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal year 2007".

Subsec. (c). Pub. L. 109–43, §2(a)(2)(A), substituted "Annual fee setting" for "Adjustments" in heading.

Subsec. (c)(1). Pub. L. 109–43, §2(a)(2)(B)–(D), redesignated par. (5) as (1), substituted "In general" for "Annual fee setting" in heading, "publish in the Federal Register fees under subsection (a) of this section. The fees" for "establish, for the next fiscal year, and publish in the Federal Register, fees under subsection (a) of this section, based on the revenue amounts established under subsection (b) of this section and the adjustment provided under this subsection and subsection (e)(2)(C)(ii) of this section, except that the fees", "2006" for "2003", and "$259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600." for "$154,000." in text, and struck out former par. (1) which required an annual inflation adjustment of the revenues established in subsec. (b).

Subsec. (c)(2). Pub. L. 109–43, §2(a)(2)(B), (C), redesignated par. (6) as (2) and struck out former par. (2) which required an annual adjustment of the fee revenues established in subsec. (b) to reflect changes in the workload of the Secretary for the process for the review of device applications.

Subsec. (c)(3). Pub. L. 109–43, §2(a)(2)(B), (E), added par. (3) and struck out former par. (3) which required an annual compensating adjustment of the fee revenues established in subsec. (b).

Subsec. (c)(4). Pub. L. 109–43, §2(a)(2)(B), struck out par. (4) which provided for a fiscal year 2007 adjustment of the fee revenues established in subsec. (b) to provide for operating reserves of carryover user fees.

Subsec. (c)(5), (6). Pub. L. 109–43, §2(a)(2)(C), redesignated pars. (5) and (6) as (1) and (2), respectively.

Subsec. (d)(1). Pub. L. 109–43, §2(a)(3)(A), inserted after first sentence "For the purposes of this paragraph, the term 'small business' means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms."

Subsec. (d)(2)(A). Pub. L. 109–43, §2(a)(3)(B), struck out cl. (i) designation and heading before "For purposes", substituted "paragraph," for "subsection," and "$100,000,000" for "$30,000,000", and struck out heading and text of clause (ii). Text read as follows: "The Secretary may adjust the $30,000,000 threshold established in clause (i) if the Secretary has evidence from actual experience that this threshold results in a reduction in revenues from premarket applications, premarket reports, and supplements that is 16 percent or more than would occur without small business exemptions and lower fee rates. To adjust this threshold, the Secretary shall publish a notice in the Federal Register setting out the rationale for the adjustment, and the new threshold."

Subsec. (d)(2)(C). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)".

Subsec. (e)(2)(A). Pub. L. 109–43, §2(a)(4), substituted "$100,000,000" for "$30,000,000".

Subsec. (e)(2)(C). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)" in cls. (i) and (ii).

Subsec. (g)(1)(B)(i). Pub. L. 109–43, §2(a)(5)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows: "For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is equal to or greater than the sum of—

"(I) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2003;

"(II) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2004; and

"(III) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2005."

Subsec. (g)(1)(B)(ii). Pub. L. 109–43, §2(a)(5)(A)(ii), added introductory provisions and struck out former introductory provisions which read as follows: "For fiscal year 2005, if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is less than the sum that applies under clause (i) for fiscal year 2005, the following applies:".

Subsec. (g)(1)(C). Pub. L. 109–43, §2(a)(5)(B)(i), substituted "2005 and" for "2003 through" and inserted "more than 1 percent" after "years, is".

Subsec. (g)(1)(C)(ii). Pub. L. 109–43, §2(a)(5)(B)(ii), substituted "amount that applies" for "sum that applies".

Subsec. (g)(1)(D)(i). Pub. L. 109–43, §2(a)(5)(C), inserted "more than 1 percent" after "year, is".

Subsec. (h)(3)(D), (E). Pub. L. 109–43, §2(a)(6), added subpar. (D) and struck out former subpars. (D) and (E) which read as follows:

"(D) $32,615,000 for fiscal year 2006; and

"(E) $35,000,000 for fiscal year 2007,".

2004—Pub. L. 108–214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, §102(a), which enacted this section.

Subsec. (a). Pub. L. 108–214, §2(d)(2)(A), designated introductory provisions of subsec. (a) as par. (1), inserted heading, substituted "this section." for "this section as follows:", and redesignated former par. (1) as (2).

Subsec. (a)(1)(A). Pub. L. 108–214, §2(a)(2)(A)(i), substituted, in introductory provisions, "subsections (d) and (e)" for "subsection (d)", in cl. (iv), "clause (i)" for "clause (i), subject to any adjustment under subsection (c)(3) of this section", and, in cl. (vii), "clause (i), subject to any adjustment under subsection (e)(2)(C)(ii)" for "clause (i), subject to any adjustment under subsection (c)(3) of this section and any adjustment under subsection (e)(2)(C)(ii)".

Subsec. (a)(1)(D)(i), (ii). Pub. L. 108–214, §2(a)(2)(A)(ii), substituted "application, report," for "application".

Subsec. (d)(1). Pub. L. 108–214, §2(d)(2)(B)(i), substituted "subsection (a)(2)(A)" for "subsection (a)(1)(A)" in last sentence.

Subsec. (d)(2)(B). Pub. L. 108–214, §2(a)(2)(B), substituted "firms, which show" for "firms. which show" in second sentence.

Subsec. (e)(1). Pub. L. 108–214, §2(a)(2)(C)(i), (d)(2)(B)(ii), substituted "For fiscal year 2004 and each subsequent fiscal year, where" for "Where" and "subsection (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)".

Subsec. (e)(2)(B). Pub. L. 108–214, §2(a)(2)(C)(ii)(I), substituted "firms, which show" for "firms. which show".

Subsec. (e)(2)(C). Pub. L. 108–214, §2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted "For fiscal year 2004 and each subsequent fiscal year, where" for "Where" in cl. (i), "subsection (a)(2)(A)(vii)" for "subsection (a)(1)(A)(vii)" in cls. (i) and (ii), and "subsection (a)(2)(A)(i)" for "subsection (a)(1)(A)(i)" in cl. (ii).

Subsec. (f). Pub. L. 108–214, §2(a)(2)(D), struck out "for filing" after "accepted".

Subsec. (h)(2)(B). Pub. L. 108–214, §2(a)(2)(E), designated existing provisions as cl. (i), inserted heading, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as items (aa) and (bb), respectively, of cl. (i)(II), and added cl. (ii).

Subsec. (j). Pub. L. 108–214, §2(d)(2)(B)(iv), substituted "subsection (a)(2)(D)" for "subsection (a)(1)(D)".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, §3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: "The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017]."

Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Effective Date of 2017 Amendment

Amendment by section 203 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in subsection (a)(2)(A) of this section received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2027, see section 2007(a) of Pub. L. 117–180, set out as a note under section 379i of this title.

Section effective Oct. 26, 2002, except for certain premarket fees, see section 106 of Pub. L. 107–250, set out as a note under section 379i of this title.

Fee Exemption for Certain Entities Submitting Premarket Reports

Pub. L. 107–250, title I, §102(b), Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 108–214, §2(d)(2)(C), (3)(B), Apr. 1, 2004, 118 Stat. 577, provided that: "A person submitting a premarket report to the Secretary of Health and Human Services is exempt from the fee under section 738(a)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j(a)(2)(A)(ii)] (as added by subsection (a) of this section) if—

"(1) the premarket report is the first such report submitted to the Secretary by the person; and

"(2) before October 1, 2002, the person submitted a premarket application to the Secretary for the same device as the device for which the person is submitting the premarket report."

¹ See References in Text note below.

§379j–1. Reauthorization; reporting requirements

(a) Reports

(1) Performance report

(A) In general

(i) General requirements

Beginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(ii) Additional information

Beginning with fiscal year 2023, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—

(I) the number of premarket applications filed under section 360e of this title per fiscal year for each review division;

(II) the number of reports submitted under section 360(k) of this title per fiscal year for each review division;

(III) the number of expedited development and priority review designations under section 360e–3 ¹ of this title per fiscal year;

(IV) the number of investigational device exemption applications submitted under section 360j(g) of this title per fiscal year, including for each review division; and

(V) the number of expedited development and priority review requests and designations under section 360e–3 of this title per fiscal year, including for each review division.

Nothing in this clause shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.

(iii) Real time reporting

(I) In general

Not later than 30 calendar days after the end of the second quarter of fiscal year 2023, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph.

(II) Data

The Secretary shall post the following data in accordance with subclause (I):

(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022; and

(bb) The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022.

(iv) Rationale for MDUFA program changes

Beginning with fiscal year 2023, the Secretary shall include in the annual report under paragraph (1)—

(I) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying—

(aa) drivers of such changes; and

(bb) changes in the average total cost per full-time equivalent in the medical device review program;

(III) for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

(IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of medical device application types.

(v) Analysis

For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:

(I) The difference between the aggregate number of premarket applications filed under section 360e of this title and aggregate reports submitted under section 360(k) of this title and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—

(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

(bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year.

(II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year.

(III) The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022.

(B) Publication

With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b).

(C) Updates

The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.

(2) Corrective action report

Beginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(A) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process.

(B) Goals missed

For each of the goals identified by the letters described in section 201(b) ¹ of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(i) a justification for such determination;

(ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under section 360e of this title or notifications submitted under section 360(k) of this title missed the review goal times but were approved during the first cycle review, as applicable;

(iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and

(iv) the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such ² fiscal year.

(3) Enhanced communication

(A) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(B) Participation in congressional hearing

(4) Fiscal report

For fiscal years 2023 through 2027, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

(5) Public availability

The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.

(b) Reauthorization

(1) Consultation

In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a)(1);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

(4) Updates to Congress

The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.

(5) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

Not later than January 15, 2027, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(7) Minutes of negotiation meetings

(A) Public availability

(B) Content

(June 25, 1938, ch. 675, §738A, as added Pub. L. 110–85, title II, §213, Sept. 27, 2007, 121 Stat. 850; amended Pub. L. 112–144, title II, §204, July 9, 2012, 126 Stat. 1006; Pub. L. 115–52, title II, §204, title IX, §§903(b), 904(b), Aug. 18, 2017, 131 Stat. 1016, 1078, 1083; Pub. L. 117–180, div. F, title II, §2004, Sept. 30, 2022, 136 Stat. 2153; Pub. L. 117–328, div. FF, title III, §3626(b), Dec. 29, 2022, 136 Stat. 5884.)

Termination of Section

For termination of section by section 2007(b) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 201(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A), (B), (2), probably should be a reference to section 2001(b) of the Medical Device User Fee Amendments of 2022, title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title. The Medical Device User Fee Amendments of 2022 does not contain a section 201(b).

Section 360e–3 of this title, referred to in subsec. (a)(1)(A)(ii)(III), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, §901(f)(2), Aug. 18, 2017, 131 Stat. 1077.

Section 2001(b) of the Medical Device User Fee Amendments of 2022, referred to in subsec. (a)(1)(A)(iv)(I), is section 2001(b) of title II of div. F of Pub. L. 117–180, which is set out as a note under section 379i of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–180, §2004(a)(1), (2), substituted "fiscal year 2023" for "fiscal year 2018" and "Medical Device User Fee Amendments of 2022" for "Medical Device User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1)(A)(ii). Pub. L. 117–328, §3626(b)(1)(A)(iii), inserted concluding provisions.

Subsec. (a)(1)(A)(ii)(IV), (V). Pub. L. 117–328, §3626(b)(1)(A), added subcls. (IV) and (V).

Subsec. (a)(1)(A)(iv). Pub. L. 117–180, §2004(a)(3)(B), substituted "fiscal year 2023" for "fiscal year 2020" in introductory provisions of cl. (iv) relating to rationale for MDUFA program changes.

Subsec. (a)(1)(A)(iv)(I). Pub. L. 117–328, §3626(b)(1)(B)(i), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(1)(A)(iv)(II). Pub. L. 117–328, §3626(b)(1)(B)(ii), amended subcl. (II) generally. Prior to amendment, subcl. (II) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and".

Subsec. (a)(1)(A)(iv)(IV). Pub. L. 117–328, §3626(b)(1)(B)(iii), (iv), added subcl. (IV).

Subsec. (a)(1)(A)(v). Pub. L. 117–180, §2004(a)(3)(A), redesignated cl. (iv) relating to analysis to be included in report as (v).

Subsec. (a)(4). Pub. L. 117–180, §2004(a)(4), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (b)(1). Pub. L. 117–180, §2004(b)(1), substituted "2027" for "2022" in introductory provisions.

Subsec. (b)(4). Pub. L. 117–328, §3626(b)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (b)(5). Pub. L. 117–328, §3626(b)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Pub. L. 117–180, §2004(b)(2), substituted "2027" for "2022".

Subsec. (b)(6), (7). Pub. L. 117–328, §3626(b)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (b)(7)(A). Pub. L. 117–328, §3626(b)(2)(C)(i), substituted "The" for "Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the" and inserted ", not later than 30 days after each such negotiation meeting" before period at end.

Subsec. (b)(7)(B). Pub. L. 117–328, §3626(b)(2)(C)(ii), inserted ", in sufficient detail," after "shall summarize".

2017—Subsec. (a)(1)(A). Pub. L. 115–52, §903(b), designated existing provisions as cl. (i), inserted heading, and added cls. (ii), (iii), and (iv) related to rationale for MDUFA program changes.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §204(a)(1)(A), substituted "2018" for "2013" and "the Medical Device User Fee Amendments of 2017" for "the Medical Device User Fee Amendments of 2012".

Subsec. (a)(1)(A)(iv). Pub. L. 115–52, §904(b)(1), added cl. (iv) relating to analysis to be included in report.

Subsec. (a)(1)(B). Pub. L. 115–52, §204(a)(1)(B), substituted "the Medical Device User Fee Amendments of 2017" for "the Medical Device User Fee Amendments Act of 2012".

Subsec. (a)(2), (3). Pub. L. 115–52, §904(b)(2)(B), added pars. (2) and (3). Former pars. (2) and (3) redesignated (4) and (5), respectively.

Subsec. (a)(4). Pub. L. 115–52, §904(b)(2)(A), redesignated par. (2) as (4).

Pub. L. 115–52, §204(a)(2), which directed amendment of par. (2), effective Oct. 1, 2017, by substituting "2018 through 2022" for "2013 through 2017", was executed by making the substitution in par. (4) to reflect the probable intent of Congress and the redesignation of par. (2) as (4), effective Aug. 18, 2017, by Pub. L. 115–52, §904(b)(2)(A). See Amendment note above.

Subsec. (a)(5). Pub. L. 115–52, §904(b)(2)(A), redesignated par. (3) as (5).

Subsec. (b)(1). Pub. L. 115–52, §204(b)(1), substituted "2022" for "2017" in introductory provisions.

Subsec. (b)(5). Pub. L. 115–52, §204(b)(2), substituted "2022" for "2017".

2012—Subsec. (a)(1). Pub. L. 112–144, §204(b)(1), added par. (1) and struck out former par. (1). Prior to amendment, text read as follows: "For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort."

Subsec. (a)(2). Pub. L. 112–144, §204(b)(2), substituted "2013 through 2017" for "2008 through 2012".

Subsec. (b)(1). Pub. L. 112–144, §204(a)(1), substituted "2017" for "2012".

Subsec. (b)(5). Pub. L. 112–144, §204(a)(2), substituted "2017" for "2012".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Effective Date of 2017 Amendment

Amendment by section 204 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2012, see section 206 of Pub. L. 112–144, set out as a note under section 379i of this title.

Effective and Termination Dates

Pub. L. 117–180, div. F, title II, §2007(b), Sept. 30, 2022, 136 Stat. 2154, provided that: "Section 738A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title II, §210(b), Aug. 18, 2017, 131 Stat. 1020, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154.

[Pub. L. 117–180, div. F, title II, §2007(c), Sept. 30, 2022, 136 Stat. 2154, provided that the repeal of section 210(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, see section 216 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379i of this title.

¹ See References in Text note below.

² So in original.

subpart 4—fees relating to animal drugs

Termination of Subpart

For termination of subpart by section 2307(a), (b) of Pub. L. 118–15, see Termination Date note set out under section 379j–11 of this title and Effective and Termination Dates note set out under section 379j–13 of this title.

§379j–11. Definitions

For purposes of this subpart:

(1)(A) The term "animal drug application" means—

(i) an application for approval of any new animal drug submitted under section 360b(b)(1) of this title; or

(ii) an application for conditional approval of a new animal drug submitted under section 360ccc of this title.

(B) Such term does not include either a new animal drug application submitted under section 360b(b)(2) of this title or a supplemental animal drug application.

(2) The term "supplemental animal drug application" means—

(A) a request to the Secretary to approve a change in an animal drug application which has been approved; or

(B) a request to the Secretary to approve a change to an application approved under section 360b(c)(2) of this title for which data with respect to safety or effectiveness are required.

(3) The term "animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the National Drug Code, and for which an animal drug application or a supplemental animal drug application has been approved.

(4) The term "animal drug establishment" means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form.

(5) The term "investigational animal drug submission" means—

(A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a new animal drug intended to be the subject of an animal drug application or a supplemental animal drug application; or

(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of an animal drug application or supplemental animal drug application in the event of their filing.

(6) The term "animal drug sponsor" means either an applicant named in an animal drug application that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary.

(7) The term "final dosage form" means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds.

(8) The term "process for the review of animal drug applications" means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions:

(A) The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(B) The issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and, where appropriate, the actions necessary to place such applications, supplements or submissions in condition for approval.

(C) The inspection of animal drug establishments and other facilities undertaken as part of the Secretary's review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(D) Monitoring of research conducted in connection with the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(E) The development of regulations and policy related to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(F) Development of standards for products subject to review.

(G) Meetings between the agency and the animal drug sponsor.

(H) Review of advertising and labeling prior to approval of an animal drug application or supplemental animal drug application, but not after such application has been approved.

(I) The activities necessary for implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to animal drug products subject to review, including implementation activities prior to and following product approval.

(9) The term "costs of resources allocated for the process for the review of animal drug applications" means the expenses in connection with the process for the review of animal drug applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific animal drug applications, supplemental animal drug applications, or investigational animal drug submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;

(B) management of information and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under section 379j–12 of this title and accounting for resources allocated for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions.

(10) The term "adjustment factor" applicable to a fiscal year refers to the formula set forth in section 379g(8) of this title with the base or comparator month being October 2002.

(11) The term "person" includes an affiliate thereof.

(12) The term "affiliate" refers to the definition set forth in section 379g(11) of this title.

(June 25, 1938, ch. 675, §739, as added Pub. L. 108–130, §3, Nov. 18, 2003, 117 Stat. 1361; amended Pub. L. 110–85, title I, §109, Sept. 27, 2007, 121 Stat. 842; Pub. L. 110–316, title I, §102, Aug. 14, 2008, 122 Stat. 3510; Pub. L. 113–14, title I, §102, June 13, 2013, 127 Stat. 452; Pub. L. 115–234, title I, §102, Aug. 14, 2018, 132 Stat. 2428; Pub. L. 118–15, div. B, title III, §2302, Sept. 30, 2023, 137 Stat. 86.)

Termination of Section

For termination of section by section 2307(a) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

Amendments

2023—Par. (3). Pub. L. 118–15, §2302(1), substituted "National Drug Code" for "national drug code".

Par. (8)(I). Pub. L. 118–15, §2302(2), amended subpar. (I) generally. Prior to amendment, subpar. (I) read as follows: "The activities necessary for implementation of the United States and European Union Good Manufacturing Practice Mutual Inspection Agreement with respect to animal drug products subject to review, including implementation activities prior to and following product approval."

2018—Par. (1). Pub. L. 115–234, §102(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The term 'animal drug application' means an application for approval of any new animal drug submitted under section 360b(b)(1) of this title. Such term does not include either a new animal drug application submitted under section 360b(b)(2) of this title or a supplemental animal drug application."

Par. (8)(I). Pub. L. 115–234, §102(2), added subpar. (I).

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section consisted of pars. (1) to (12) defining similar terms for this subpart.

2008—Par. (6). Pub. L. 110–316, §102(1), substituted "that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary" for ", except for an approved application for which all subject products have been removed from listing under section 360 of this title".

Par. (8)(H). Pub. L. 110–316, §102(2), substituted "but not after such application has been approved" for "but not such activities after an animal drug has been approved".

Par. (10). Pub. L. 110–316, §102(3), substituted "month being October 2002" for "year being 2003".

Pars. (11), (12). Pub. L. 110–316, §102(4), (5), added par. (11) and redesignated former par. (11) as (12).

2007—Pub. L. 110–85, §109(a), substituted "subpart" for "part" in introductory provisions.

Par. (11). Pub. L. 110–85, §109(b), substituted "379g(11)" for "379g(9)".

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Pub. L. 118–15, div. B, title III, §2306, Sept. 30, 2023, 137 Stat. 89, provided that: "The amendments made by this chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] shall take effect on October 1, 2023, or the date of the enactment of this Act [Sept. 30, 2023], whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amended by this chapter, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2023, regardless of the date of the enactment of this Act."

Effective Date of 2018 Amendment

Pub. L. 115–234, title I, §106, Aug. 14, 2018, 132 Stat. 2432, provided that: "The amendments made by this title [see section 101(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title] shall take effect on October 1, 2018, or the date of the enactment of this Act [Aug. 14, 2018], whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], as amended by this title, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2018, regardless of the date of the enactment of this Act."

Effective Date of 2013 Amendment

Pub. L. 113–14, title I, §106, June 13, 2013, 127 Stat. 464, provided that: "The amendments made by this title [amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under this section] shall take effect on October 1, 2013, or the date of enactment of this Act [June 13, 2013], whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], as amended by this title, shall be assessed for all animal drug applications and supplemental animal drug applications received on or after October 1, 2013, regardless of the date of the enactment of this Act."

Effective and Termination Dates of 2008 Amendment

Pub. L. 110–316, title I, §107, Aug. 14, 2008, 122 Stat. 3514, provided that: "The amendments made by sections 102, 103, and 104 [enacting section 379j–13 of this title and amending this section and section 379j–12 of this title] shall take effect on October 1, 2008, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], as amended by this title, shall be assessed for all animal drug applications and supplemental animal drug applications received on or after such date, regardless of the date of the enactment of this title [Aug. 14, 2008]."

Pub. L. 110–316, title I, §108, Aug. 14, 2008, 122 Stat. 3515, which provided that the amendments made by sections 102 and 103 of Pub. L. 110–316 (amending this section and section 379j–12 of this title) would cease to be effective Oct. 1, 2013, and that the amendment made by section 104 of Pub. L. 110–316 (enacting section 379j–13 of this title) would cease to be effective Jan. 31, 2014, was repealed by Pub. L. 113–14, title I, §107(c)(1), June 13, 2013, 127 Stat. 464.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

Termination Date

Pub. L. 118–15, div. B, title III, §2307(a), Sept. 30, 2023, 137 Stat. 89, provided that: "Sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. [sic] 21 U.S.C. 379j–11; 379j–12) shall cease to be effective October 1, 2028."

Pub. L. 108–130, §5, Nov. 18, 2003, 117 Stat. 1371, which provided that the amendments made by section 3 of Pub. L. 108–130 (enacting this subpart) would not be in effect after Oct. 1, 2008, and that section 4 of Pub. L. 108–130 (enacting provisions set out as a note below) would not be in effect after 120 days after Oct. 1, 2008, was repealed by Pub. L. 113–14, title I, §107(d), June 13, 2013, 127 Stat. 464, effective Nov. 18, 2003.

Savings Provisions

Pub. L. 118–15, div. B, title III, §2305, Sept. 30, 2023, 137 Stat. 89, provided that: "Notwithstanding the amendments made by this chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this chapter [Sept. 30, 2023], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024."

Pub. L. 115–234, title I, §105, Aug. 14, 2018, 132 Stat. 2431, provided that: "Notwithstanding the amendments made by this title [see section 101(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this title [Aug. 14, 2018], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019."

Pub. L. 113–14, title I, §105, June 13, 2013, 127 Stat. 463, provided that: "Notwithstanding the amendments made by this title [amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under this section], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of the enactment of this title [June 13, 2013], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2008, but before October 1, 2013, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2014."

Pub. L. 110–316, title I, §106, Aug. 14, 2008, 122 Stat. 3514, provided that: "Notwithstanding section 5 of the Animal Drug User Fee Act of 2003 [Pub. L. 108–130] ([former] 21 U.S.C. 379j–11 note), and notwithstanding the amendments made by this title [enacting section 379j–13 of this title and amending this section and sections 360b and 379j–12 of this title], part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of the enactment of this title [Aug. 14, 2008], shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after September 1, 2003, but before October 1, 2008, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2009."

Findings

Pub. L. 118–15, div. B, title III, §2301(b), Sept. 30, 2023, 137 Stat. 86, provided that: "Congress finds that the fees authorized by the amendments made in this chapter [chapter 1 (§§2301–2307) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and sections 379j–12 and 379j–13 of this title and repealing provisions set out as notes under sections 379j–12 and 379j–13 of this title] will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record."

Similar provisions were contained in the following prior acts:

Pub. L. 115–234, title I, §101(b), Aug. 14, 2018, 132 Stat. 2428.

Pub. L. 113–14, title I, §101(b), June 13, 2013, 127 Stat. 451.

Pub. L. 110–316, title I, §101(b), Aug. 14, 2008, 122 Stat. 3509.

Pub. L. 108–130, §2, Nov. 18, 2003, 117 Stat. 1361.

Accountability and Reports

Pub. L. 108–130, §4, Nov. 18, 2003, 117 Stat. 1370, provided that:

"(a) Public Accountability.—

"(1) Consultation.—In developing recommendations to Congress for the goals and plans for meeting the goals for the process for the review of animal drug applications for the fiscal years after fiscal year 2008, and for the reauthorization of sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (as added by section 3) [21 U.S.C. 379j–11, 379j–12], the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, veterinary professionals, representatives of consumer advocacy groups, and the regulated industry.

"(2) Recommendations.—The Secretary shall—

"(A) publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry;

"(B) present the recommendations to the Committees referred to in that paragraph;

"(C) hold a meeting at which the public may comment on the recommendations; and

"(D) provide for a period of 30 days for the public to provide written comments on the recommendations.

"(b) Performance Reports.—Beginning with fiscal year 2004, not later than 60 days after the end of each fiscal year during which fees are collected under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–11 et seq.], the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 2(3) of this Act [set out as a note above] toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year, the future plans of the Food and Drug Administration for meeting the goals, the review times for abbreviated new animal drug applications, and the administrative procedures adopted by the Food and Drug Administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program.

"(c) Fiscal Report.—Beginning with fiscal year 2004, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (b), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made."

§379j–12. Authority to assess and use animal drug fees

(a) Types of fees

Beginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Animal drug application and supplement fee

(A) In general

Each person that submits, on or after September 1, 2003, an animal drug application or a supplemental animal drug application shall be subject to a fee as follows:

(i) A fee established in subsection (c) for an animal drug application, except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title.

(ii) A fee established in subsection (c), in an amount that is equal to 50 percent of the amount of the fee under clause (i), for—

(I) a supplemental animal drug application for which safety or effectiveness data are required;

(II) an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title; and

(III) an application for conditional approval under section 360ccc of this title of a new animal drug for which an animal drug application submitted under section 360b(b)(1) of this title has been previously approved under section 360b(d)(1) of this title for another intended use.

(B) Payment

The fee required by subparagraph (A) shall be due upon submission of the animal drug application or supplemental animal drug application.

(C) Exceptions for previously filed application or supplement

(i) If an animal drug application or a supplemental animal drug application was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an animal drug application or a supplemental animal drug application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(ii) Beginning with fiscal year 2019, in the case of an animal drug application submitted by a person under section 360b(b)(1) of this title, where such person (or their licensor, assignor, or predecessor-in-interest) previously submitted an application for conditional approval under section 360ccc of this title for the same product and paid the applicable fee under subparagraph (A), the application under section 360b(b)(1) of this title shall not be subject to a fee under subparagraph (A) if submitted within the timeframe specified in section 360ccc(h) of this title.

(D) Refund of fee if application refused for filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any animal drug application or supplemental animal drug application which is refused for filing.

(E) Refund of fee if application withdrawn

If an animal drug application or a supplemental animal drug application is withdrawn after the application or supplement was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund the fee under this paragraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.

(2) Animal drug product fee

(A) In general

Each person—

(i) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section 360 of this title; and

(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,

shall pay for each such animal drug product the annual fee established in subsection (c).

(B) Payment; fee due date

Such fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

Such fee shall be paid only once for each animal drug product for a fiscal year in which the fee is payable.

(3) Animal drug establishment fee

(A) In general

Each person—

(i) who owns or operates, directly or through an affiliate, an animal drug establishment;

(ii) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section 360 of this title; and

(iii) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,

shall be assessed an annual establishment fee as established in subsection (c) for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures the animal drug product named in the application.

(B) Payment; fee due date

The annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph (2) unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year. The fee under this paragraph for a fiscal year shall be due upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

An establishment shall be assessed only one fee per fiscal year under this section.

(4) Animal drug sponsor fee

(A) In general

Each person—

(i) who meets the definition of an animal drug sponsor within a fiscal year; and

(ii) who, after September 1, 2003, had pending before the Secretary an animal drug application, a supplemental animal drug application, or an investigational animal drug submission,

shall be assessed an annual sponsor fee as established under subsection (c).

(B) Payment; fee due date

The fee under this paragraph for a fiscal year shall be due upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

Each animal drug sponsor shall pay only one such fee each fiscal year.

(b) Fee revenue amounts

(1) In general

Subject to subsections (c), (d), (f), and (g), for each of fiscal years 2024 through 2028, the fees required under subsection (a) shall be established to generate a total revenue amount of $33,500,000.

(2) Types of fees

Of the total revenue amount established for a fiscal year under paragraph (1)—

(A) 20 percent shall be derived from fees under subsection (a)(1) (relating to animal drug applications and supplements);

(B) 27 percent shall be derived from fees under subsection (a)(2) (relating to animal drug products);

(D) 27 percent shall be derived from fees under subsection (a)(4) (relating to animal drug sponsors).

(c) Annual fee setting; adjustments

(1) Annual fee setting

Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall—

(A) establish for that fiscal year animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue amounts and fees in the Federal Register.

(2) Inflation adjustment

(A) For fiscal year 2025 and subsequent fiscal years, the revenue amounts established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—

(i) one;

(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available; and

(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 years of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available.

(B) Compounded basis.—The adjustment made each fiscal year after fiscal year 2025 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.

(3) Workload adjustments

(A) In general

For fiscal year 2025 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications, subject to subparagraph (B). With respect to such adjustment—

(i) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;

(ii) such adjustment shall be made for each fiscal year that the adjustment determined by the Secretary is greater than 3 percent, except for the first fiscal year that the adjustment is greater than 3 percent; and

(iii) the Secretary shall publish in the Federal Register notice under paragraph (1) the amount of such adjustment and the supporting methodologies.

(B) Rule of application

Under no circumstances shall the workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).

(4) Operating reserve adjustment

(A) In general

For fiscal year 2025 and each subsequent fiscal year, after the fee revenue amount established under subsection (b) is adjusted in accordance with paragraphs (2) and (3), the Secretary shall—

(i) increase the fee revenue amount for such fiscal year, if necessary to provide an operating reserve of not less than 12 weeks; or

(ii) if the Secretary has an operating reserve in excess of the number of weeks specified in subparagraph (C) for that fiscal year, the Secretary shall decrease the fee revenue amount to provide not more than the number of weeks specified in subparagraph (C) for that fiscal year.

(B) Carryover user fees

For purposes of this paragraph, the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated.

(C) Number of weeks of operating reserves

The number of weeks of operating reserves specified in this subparagraph is—

(i) 22 weeks for fiscal year 2025;

(ii) 20 weeks for fiscal year 2026;

(iii) 18 weeks for fiscal year 2027; and

(iv) 16 weeks for fiscal year 2028.

(D) Publication

If an adjustment to the operating reserve is made under this paragraph, the Secretary shall publish in the Federal Register notice under paragraph (1) the rationale for the amount of the adjustment and the supporting methodologies.

(5) Limit

(d) Fee waiver or reduction; exemptions from fees

(1) Waiver or reduction

The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that—

(A) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances;

(B) the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of animal drug applications for such person;

(C) the animal drug application or supplemental animal drug application is intended solely to provide for use of the animal drug in—

(i) a Type B medicated feed (as defined in section 558.3(b)(3) of title 21, Code of Federal Regulations (or any successor regulation)) intended for use in the manufacture of Type C free-choice medicated feeds; or

(ii) a Type C free-choice medicated feed (as defined in section 558.3(b)(4) of title 21, Code of Federal Regulations (or any successor regulation));

(D) the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication; or

(E) the sponsor involved is a small business submitting its first animal drug application to the Secretary for review.

(2) Use of standard costs

In making the finding in paragraph (1)(B), the Secretary may use standard costs.

(3) Rules for small businesses

(A) Definition

In paragraph (1)(E), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates.

(B) Waiver of application fee

The Secretary shall waive under paragraph (1)(E) the application fee for the first animal drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent animal drug applications and supplemental animal drug applications for which safety or effectiveness data are required in the same manner as an entity that does not qualify as a small business.

(C) Certification

The Secretary shall require any person who applies for a waiver under paragraph (1)(E) to certify their qualification for the waiver. The Secretary shall periodically publish in the Federal Register a list of persons making such certifications.

(4) Exemption from fees

Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 379h, 379j, 379j–42, or 379j–52 of this title.

(e) Effect of failure to pay fees

An animal drug application or supplemental animal drug application submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational animal drug submission under section 379j–11(5)(B) of this title that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any animal drug application, supplemental animal drug application or investigational animal drug submission from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due.

(f) Assessment of fees

(1) Limitation

Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2003 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for animal drug applications, supplemental animal drug applications, investigational animal drug submissions, animal drug sponsors, animal drug establishments and animal drug products at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(g) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of animal drug applications.

(2) Collections and appropriation Acts

(A) In general

The fees authorized by this section—

(ii) shall be available to defray increases in the costs of the resources allocated for the process for the review of animal drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2003 multiplied by the adjustment factor.

(B) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications—

(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).

(C) Provision for early payments

(3) Authorization of appropriations

For each of the fiscal years 2024 through 2028, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount established under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).

(4) Excess collections

If the sum total of fees collected under this section for a fiscal year exceeds the amount of fees authorized to be appropriated for such year under paragraph (3), the excess collections shall be credited to the appropriations account of the Food and Drug Administration as provided in paragraph (1).

(h) Collection of unpaid fees

(i) Written requests for waivers, reductions, and refunds

To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.

(j) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of animal drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(k) Abbreviated new animal drug applications

The Secretary shall—

(1) to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications; and

(2) adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.

(June 25, 1938, ch. 675, §740, as added Pub. L. 108–130, §3, Nov. 18, 2003, 117 Stat. 1363; amended Pub. L. 110–316, title I, §103, Aug. 14, 2008, 122 Stat. 3510; Pub. L. 113–14, title I, §103, June 13, 2013, 127 Stat. 454; Pub. L. 115–52, title I, §102(a)(2), Aug. 18, 2017, 131 Stat. 1008; Pub. L. 115–234, title I, §103, title III, §304(b), Aug. 14, 2018, 132 Stat. 2428, 2438; Pub. L. 118–15, div. B, title III, §2303, Sept. 30, 2023, 137 Stat. 87.)

Termination of Section

For termination of section by section 2307(a) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

Amendments

2023—Subsec. (a)(1)(A)(ii)(III). Pub. L. 118–15, §2303(a), added subcl. (III).

Subsec. (b)(1). Pub. L. 118–15, §2303(b), amended par. (1) generally. Prior to amendment, text read as follows: "Subject to subsections (c), (d), (f), and (g)—

"(A) for fiscal year 2019, the fees required under subsection (a) shall be established to generate a total revenue amount of $30,331,240; and

"(B) for each of fiscal years 2020 through 2023, the fees required under subsection (a) shall be established to generate a total revenue amount of $29,931,240."

Subsec. (c)(1). Pub. L. 118–15, §2303(c)(1), amended par. (1) generally. Prior to amendment, text read as follows: "The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2003, for that fiscal year, animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection."

Subsec. (c)(2)(A). Pub. L. 118–15, §2303(c)(2)(A)(i), substituted "2025" for "2020" in introductory provisions.

Subsec. (c)(2)(A)(iii). Pub. L. 118–15, §2303(c)(2)(A)(ii), substituted "Arlington-Alexandria" for "Baltimore".

Subsec. (c)(2)(B). Pub. L. 118–15, §2303(c)(2)(B), substituted "2025" for "2020".

Subsec. (c)(3)(A). Pub. L. 118–15, §2303(c)(3)(A)(i), substituted "2025" for "2020" and "subparagraph (B)" for "subparagraphs (B) and (C)" in introductory provisions.

Subsec. (c)(3)(A)(ii), (iii). Pub. L. 118–15, §2303(c)(3)(A)(ii), (iii), added cls. (ii) and (iii) and struck out former cl. (ii) which read as follows: "the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies."

Subsec. (c)(3)(B), (C). Pub. L. 118–15, §2303(c)(3)(B), (C), redesignated subpar. (C) as (B) and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "For each of fiscal years 2021 through 2023, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase."

Subsec. (c)(4). Pub. L. 118–15, §2303(c)(4), amended par. (4) generally. Prior to amendment, text read as follows: "For fiscal year 2023, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of animal drug applications for the first 3 months of fiscal year 2024. If the Food and Drug Administration has carryover balances for the process for the review of animal drug applications in excess of 3 months of such operating reserves, then this adjustment will not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2023."

Subsec. (d)(4). Pub. L. 118–15, §2303(d), amended par. (4) generally. Prior to amendment, par. (4) related to exemptions from fees for certain labeling supplements to add number of approved application and for certain animal drug applications.

Subsec. (g)(3). Pub. L. 118–15, §2303(e)(1), (2)(A), substituted "2024 through 2028" for "2019 through 2023" and struck out "and paragraph (5)" after "under subsection (c)".

Subsec. (g)(5). Pub. L. 118–15, §2303(e)(2)(B), struck out par. (5) which related to recovery of collection shortfalls.

2018—Subsec. (a)(1)(C). Pub. L. 115–234, §304(b), substituted "Exceptions" for "Exception" in heading, designated existing provisions as cl. (i), and added cl. (ii).

Subsec. (b)(1)(A). Pub. L. 115–234, §103(a)(1)(A), substituted "2019" for "2014" and "$30,331,240" for "$23,600,000".

Subsec. (b)(1)(B). Pub. L. 115–234, §103(a)(1)(B), substituted "2020 through 2023" for "2015 through 2018" and "$29,931,240" for "$21,600,000".

Subsec. (b)(2). Pub. L. 115–234, §103(a)(2), substituted "established" for "determined" in introductory provisions.

Subsec. (c)(2). Pub. L. 115–234, §103(b)(1), substituted "(A) For fiscal year 2020" for "For fiscal year 2015", redesignated former subpars. (A) to (C) as cls. (i) to (iii), respectively, of subpar. (A), added subpar. (B), and struck out concluding provisions which read as follows: "The adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under this paragraph."

Subsec. (c)(3). Pub. L. 115–234, §103(b)(2), amended par. (3) generally. Prior to amendment, text read as follows: "For fiscal year 2015 and subsequent fiscal years, after the revenue amounts established in subsection (b) are adjusted for inflation in accordance with paragraph (2), the revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications. With respect to such adjustment—

"(A) such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;

"(B) the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies; and

"(C) under no circumstances shall such adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted for inflation under paragraph (2)."

Subsec. (c)(4). Pub. L. 115–234, §103(b)(3), substituted "2023" for "2018" in two places and "2024" for "2019".

Subsec. (d). Pub. L. 115–234, §103(c)(1), inserted "; exemptions from fees" after "reduction" in heading.

Subsec. (d)(1). Pub. L. 115–234, §103(c)(2), substituted "Waiver or reduction" for "In general" in heading.

Subsec. (d)(4). Pub. L. 115–234, §103(c)(3), added par. (4).

Subsec. (g)(3). Pub. L. 115–234, §103(d)(1), substituted "2019 through 2023" for "2014 through 2018", "established" for "determined", and "paragraph (5)" for "paragraph (4)".

Subsec. (g)(4), (5). Pub. L. 115–234, §103(d)(2), added pars. (4) and (5) and struck out former par. (4) which related to offset of overcollections and recovery of collection shortfalls for certain fiscal years.

2017—Subsec. (a)(3)(C). Pub. L. 115–52 amended subpar. (C) generally. Prior to amendment, text read as follows:

"(i) In general.—An establishment shall be assessed only one fee per fiscal year under this section, subject to clause (ii).

"(ii) Certain manufacturers.—If a single establishment manufactures both animal drug products and prescription drug products, as defined in section 379g(3) of this title, such establishment shall be assessed both the animal drug establishment fee and the prescription drug establishment fee, as set forth in section 379h(a)(2) of this title, within a single fiscal year."

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to authority to assess and use animal drug fees.

2008—Subsec. (a)(1)(A)(i). Pub. L. 110–316, §103(a)(1), inserted ", except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title" after "for an animal drug application".

Subsec. (a)(1)(A)(ii). Pub. L. 110–316, §103(a)(2), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: "A fee established in subsection (b) of this section for a supplemental animal drug application for which safety or effectiveness data are required, in an amount that is equal to 50 percent of the amount of the fee under clause (i)."

Subsec. (b)(1). Pub. L. 110–316, §103(b)(1), substituted "and supplemental and other animal drug application fees" for "and supplemental animal drug application fees" and "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (b)(2). Pub. L. 110–316, §103(b)(2), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (b)(3). Pub. L. 110–316, §103(b)(3), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (b)(4). Pub. L. 110–316, §103(b)(4), substituted "$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013." for "$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008."

Subsec. (c)(1). Pub. L. 110–316, §103(c)(1)–(3), redesignated par. (2) as (1), substituted "The fee revenues shall be adjusted each fiscal year after fiscal year 2009" for "After the fee revenues are adjusted for inflation in accordance with paragraph (1), the fee revenues shall be further adjusted each fiscal year after fiscal year 2004" in introductory provisions, struck out ", as adjusted for inflation under paragraph (1)" before period in subpar. (B), and struck out former par. (1) relating to inflation adjustment.

Subsec. (c)(2). Pub. L. 110–316, §103(c)(2), (4), redesignated par. (3) as (2) and substituted "2013" for "2008" in two places and "2014" for "2009". Former par. (2) redesignated (1).

Subsec. (c)(3) to (5). Pub. L. 110–316, §103(c)(2), redesignated pars. (4) and (5) as (3) and (4), respectively. Former par. (3) redesignated (2).

Subsec. (g)(3)(A) to (E). Pub. L. 110–316, §103(d), amended subpars. (A) to (E) generally. Prior to amendment, subpars. (A) to (E) read as follows:

"(A) $5,000,000 for fiscal year 2004;

"(B) $8,000,000 for fiscal year 2005;

"(C) $10,000,000 for fiscal year 2006;

"(D) $10,000,000 for fiscal year 2007; and

"(E) $10,000,000 for fiscal year 2008;".

Subsec. (g)(4). Pub. L. 110–316, §103(e), amended par. (4) generally. Prior to amendment, par. (4) read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriations Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Amendment by Pub. L. 118–15 effective Oct. 1, 2023, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amended, to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2023, see section 2306 of Pub. L. 118–15, set out as a note under section 379j–11 of this title.

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–234 effective Oct. 1, 2018, and fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.) to be assessed for animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2018, see section 106 of Pub. L. 115–234, set out as a note under section 379j–11 of this title.

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 2 of this part to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2013 Amendment

Amendment by Pub. L. 113–14 effective Oct. 1, 2013, see section 106 of Pub. L. 113–14, set out as a note under section 379j–11 of this title.

Effective Date of 2008 Amendment

Amendment by Pub. L. 110–316 effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of Pub. L. 110–316, set out as an Effective and Termination Dates of 2008 Amendment note under section 379j–11 of this title.

Termination Date

Section to cease to be effective Oct. 1, 2028, see section 2307(a) of Pub. L. 118–15, set out as a note under section 379j–11 of this title.

Pub. L. 115–234, title I, §107(a), Aug. 14, 2018, 132 Stat. 2432, which provided that section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) would cease to be effective Oct. 1, 2023, was repealed by Pub. L. 118–15, div. B, title III, §2307(c), Sept. 30, 2023, 137 Stat. 89, effective Oct. 1, 2023.

Pub. L. 113–14, title I, §107(a), June 13, 2013, 127 Stat. 464, which provided that section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) would cease to be effective Oct. 1, 2018, was repealed by Pub. L. 115–234, title I, §107(c), Aug. 14, 2018, 132 Stat. 2432, effective Oct. 1, 2018.

§379j–13. Reauthorization; reporting requirements

(a) Performance report

Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) ¹ of the Animal Drug User Fee Amendments of 2023 toward expediting the animal drug development process and the review of the new and supplemental animal drug applications and investigational animal drug submissions during such fiscal year, the future plans of the Food and Drug Administration for meeting the goals, the review times for abbreviated new animal drug applications, and the administrative procedures adopted by the Food and Drug Administration to ensure that review times for abbreviated new animal drug applications are not increased from their current level due to activities under the user fee program.

(b) Fiscal report

(c) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(d) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of animal drug applications for the first 5 fiscal years after fiscal year 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Health, Education, Labor, and Pensions of the Senate;

(B) the Committee on Energy and Commerce of the House of Representatives;

(D) veterinary professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every 4 months during negotiations with the regulated industry, the Secretary shall hold discussions with representatives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(5) Transmittal of recommendations

Not later than January 15, 2028, the Secretary shall transmit to Congress the revised recommendations under paragraph (4) ² a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6) Minutes of negotiation meetings

(A) Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to Congress, the Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry.

(B) Content

The minutes described under subparagraph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §740A, as added Pub. L. 110–316, title I, §104, Aug. 14, 2008, 122 Stat. 3511; amended Pub. L. 113–14, title I, §104, June 13, 2013, 127 Stat. 462; Pub. L. 115–234, title I, §104, Aug. 14, 2018, 132 Stat. 2431; Pub. L. 118–15, div. B, title III, §2304, Sept. 30, 2023, 137 Stat. 89.)

Termination of Section

For termination of section by section 2307(b) of Pub. L. 118–15, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 101(b) of the Animal Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2301(b) of the Animal Drug User Fee Amendments of 2023, chapter 1 of subtitle A of title III of div. B of Pub. L. 118–15, which is set out as a note under section 379j–11 of this title. The Animal Drug User Fee Amendments of 2023 does not contain a section 101(b).

Amendments

2023—Subsec. (a). Pub. L. 118–15, §2304(1), (2), substituted "2024" for "2019" and "2023" for "2018".

Subsec. (b). Pub. L. 118–15, §2304(2), substituted "2024" for "2019".

Subsec. (d)(1), (5). Pub. L. 118–15, §2304(3), substituted "2028" for "2023".

2018—Subsec. (a). Pub. L. 115–234, §104(1), (2), substituted "2019" for "2014" and "2018" for "2013".

Subsec. (b). Pub. L. 115–234, §104(2), substituted "2019" for "2014".

Subsec. (d)(1), (5). Pub. L. 115–234, §104(3), substituted "2023" for "2018".

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to reauthorization of this subpart and reporting requirements.

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Effective Date of 2018 Amendment

Effective Date of 2013 Amendment

Amendment by Pub. L. 113–14 effective Oct. 1, 2013, see section 106 of Pub. L. 113–14, set out as a note under section 379j–11 of this title.

Effective and Termination Dates

Pub. L. 118–15, div. B, title III, §2307(b), Sept. 30, 2023, 137 Stat. 89, provided that: "Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2029."

Pub. L. 115–234, title I, §107(b), Aug. 14, 2018, 132 Stat. 2432, which provided that section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) would cease to be effective Jan. 31, 2024, was repealed by Pub. L. 118–15, div. B, title III, §2307(c), Sept. 30, 2023, 137 Stat. 89, effective Oct. 1, 2023.

Pub. L. 113–14, title I, §107(b), June 13, 2013, 127 Stat. 464, which provided that section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) would cease to be effective Jan. 31, 2019, was repealed by Pub. L. 115–234, title I, §107(c), Aug. 14, 2018, 132 Stat. 2432, effective Oct. 1, 2018.

Section effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug applications and supplemental animal drug applications received on or after Oct. 1, 2008, see section 107 of Pub. L. 110–316, set out as an Effective and Termination Dates of 2008 Amendment note under section 379j–11 of this title.

¹ See References in Text note below.

² So in original. Probably should be followed by a comma.

subpart 5—fees relating to generic new animal drugs

Termination of Subpart

For termination of subpart by section 2316(a), (b) of Pub. L. 118–15, see Termination Date notes set out under sections 379j–21 and 379j–22 of this title.

§379j–21. Authority to assess and use generic new animal drug fees

(a) Types of fees

Beginning with respect to fiscal year 2009, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Abbreviated application fee

(A) In general

Each person that submits, on or after July 1, 2008, an abbreviated application for a generic new animal drug shall be subject to a fee as established in subsection (c) for such an application.

(B) Payment

The fee required by subparagraph (A) shall be due upon submission of the abbreviated application.

(C) Exceptions

(i) Previously filed application

If an abbreviated application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an abbreviated application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(ii) Certain abbreviated applications involving combination animal drugs

An abbreviated application which is subject to the criteria in section 360b(d)(4) of this title and submitted on or after October 1, 2013 shall be subject to a fee equal to 50 percent of the amount of the abbreviated application fee established in subsection (c).

(D) Refund of fee if application refused for filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any abbreviated application which is refused for filing.

(E) Refund of fee if application withdrawn

If an abbreviated application is withdrawn after the application was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.

(2) Generic new animal drug product fee

(A) In general

Each person—

(i) who is named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product which has been submitted for listing under section 360 of this title; and

(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application or supplemental abbreviated application,

shall pay for each such generic new animal drug product the annual fee established in subsection (c).

(B) Payment; fee due date

Such fee shall be payable for the fiscal year in which the generic new animal drug product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the generic new animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Limitation

Such fee shall be paid only once for each generic new animal drug product for a fiscal year in which the fee is payable.

(3) Generic new animal drug sponsor fee

(A) In general

Each person—

(i) who meets the definition of a generic new animal drug sponsor within a fiscal year; and

(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application, a supplemental abbreviated application, or an investigational submission,

shall be assessed an annual generic new animal drug sponsor fee as established under subsection (c).

(B) Payment; fee due date

Such fee shall be due each fiscal year upon the later of—

(i) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section; or

(ii) January 31 of each year.

(C) Amount of fee

Each generic new animal drug sponsor shall pay only 1 such fee each fiscal year, as follows:

(i) 100 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 6 approved abbreviated applications.

(ii) 75 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with more than 1 and fewer than 7 approved abbreviated applications.

(iii) 50 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c) for an applicant with 1 or fewer approved abbreviated applications.

(4) Generic investigational new animal drug file fee

(A) In general

(i) New file request

Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c).

(ii) New submission to established file

Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c).

(B) Payment

(i) New file request

The fee required by subparagraph (A)(i) shall be due upon submission of the request to establish the generic investigational new animal drug file.

(ii) New submission to established file

The fee required by subparagraph (A)(ii) shall be due upon the first submission to the generic investigational new animal drug file.

(C) Exceptions

(i) Terminating an existing generic investigational new animal drug file

If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.

(ii) Transferring an existing generic investigational new animal drug file

If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.

(b) Fee revenue amounts

(1) In general

(2) Types of fees

Of the total revenue amount established for a fiscal year under paragraph (1)—

(A) 20 percent shall be derived from fees under subsection (a)(1) (relating to abbreviated applications for a generic new animal drug) and fees under subsection (a)(4) (relating to generic investigational new animal drug files);

(B) 40 percent shall be derived from fees under subsection (a)(2) (relating to generic new animal drug products); and

(c) Annual fee setting; adjustments

(1) Annual fee setting

The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year—

(A) abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year;

(B) generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(C) a generic investigational new animal drug file fee of $50,000 for each request or submission described in subsection (a)(4)(A).

(2) Inflation adjustment

(A) In general

For fiscal year 2025 and subsequent fiscal years, the revenue amounts established under subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by multiplying such revenue amounts by an amount equal to the sum of—

(i) one;

(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available; and

(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 of the preceding 4 fiscal years for which data are available.

(B) Compounded basis

The adjustment made each fiscal year after fiscal year 2025 under this paragraph shall be applied on a compounded basis to the revenue amount calculated under this paragraph for the most recent previous fiscal year.

(3) Workload adjustments

(A) In general

For fiscal year 2025 and subsequent fiscal years, after the fee revenue amounts established under subsection (b) are adjusted for inflation in accordance with paragraph (2), the fee revenue amounts shall be further adjusted for each such fiscal year to reflect changes in the workload of the Secretary for the process for the review of abbreviated applications for generic new animal drugs, subject to subparagraphs (B) and (C). With respect to such adjustment—

(i) this adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests submitted to the Secretary;

(ii) if the workload adjustment calculated by the Secretary under clause (i) exceeds 25 percent, the Secretary shall use 25 percent for the adjustment; and

(iii) the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.

(B) Reduction of workload-based increase by amount of certain excess collections

For each of fiscal years 2026 through 2028, if application of the workload adjustment under subparagraph (A) increases the fee revenue amounts otherwise established for the fiscal year under subsection (b), as adjusted for inflation under paragraph (2), such fee revenue increase shall be reduced by the amount of any excess collections, as described in subsection (g)(4), for the second preceding fiscal year, up to the amount of such fee revenue increase.

(C) Rule of application

Under no circumstances shall workload adjustments under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established under subsection (b), as adjusted for inflation under paragraph (2).

(4) Final year adjustment

For fiscal year 2028, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of abbreviated applications for generic new animal drugs for the first 3 months of fiscal year 2029. If the Food and Drug Administration has carryover balances for the process for the review of abbreviated applications for generic new animal drugs in excess of 3 months of such operating reserves, then this adjustment shall not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2028.

(5) Limit

(d) Fee waiver or reduction

The Secretary shall grant a waiver from, or a reduction of, one or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.

(e) Effect of failure to pay fees

An abbreviated application for a generic new animal drug submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. An investigational submission for a generic new animal drug that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person have been paid. A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue review of any abbreviated application for a generic new animal drug, supplemental abbreviated application for a generic new animal drug, or investigational submission for a generic new animal drug from a person if such person has not submitted for payment all fees owed under this section by 30 days after the date upon which they are due.

(f) Assessment of fees

(1) Limitation

Fees may not be assessed under subsection (a) for a fiscal year beginning after fiscal year 2008 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 2003 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for abbreviated applications, generic new animal drug products, generic new animal drug sponsors, and generic investigational new animal drug files at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(g) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of abbreviated applications for generic new animal drugs.

(2) Collections and appropriation Acts

(A) In general

The fees authorized by this section—

(ii) shall be available to defray increases in the costs of the resources allocated for the process for the review of abbreviated applications for generic new animal drugs (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2008 multiplied by the adjustment factor.

(B) Compliance

(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii).

(C) Provision for early payments

(3) Authorization of appropriations

(4) Excess collections

(5) Recovery of collection shortfalls

The amount of fees otherwise authorized to be collected under this section shall be increased—

(A) for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3);

(B) for fiscal year 2027, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2025 falls below the amount of fees authorized for fiscal year 2025 under paragraph (3); and

(C) for fiscal year 2028, by the amount, if any, by which the amount collected under this section and appropriated for fiscal years 2026 and 2027 (including estimated collections for fiscal year 2027) falls below the amount of fees authorized for such fiscal years under paragraph (3).

(h) Collection of unpaid fees

(i) Written requests for waivers, reductions, and refunds

(j) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of abbreviated applications for generic new animal drugs, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(k) Definitions

In this section and section 379j–22 of this title:

(1) Abbreviated application for a generic new animal drug

The terms "abbreviated application for a generic new animal drug" and "abbreviated application" mean an abbreviated application for the approval of any generic new animal drug submitted under section 360b(b)(2) of this title. Such term does not include a supplemental abbreviated application for a generic new animal drug.

(2) Adjustment factor

The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by—

(A) for purposes of subsection (f)(1), such Index for October 2002; and

(B) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007.

(3) Costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs

The term "costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs" means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific abbreviated applications, supplemental abbreviated applications, or investigational submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under this section and accounting for resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(4) Final dosage form

The term "final dosage form" means, with respect to a generic new animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes generic new animal drug products intended for mixing in animal feeds.

(5) Generic new animal drug

The term "generic new animal drug" means a new animal drug that is the subject of an abbreviated application.

(6) Generic new animal drug product

The term "generic new animal drug product" means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an abbreviated application for a generic new animal drug or a supplemental abbreviated application has been approved.

(7) Generic new animal drug sponsor

The term "generic new animal drug sponsor" means either an applicant named in an abbreviated application for a generic new animal drug that has not been withdrawn by the applicant and for which approval has not been withdrawn by the Secretary, or a person who has submitted an investigational submission for a generic new animal drug that has not been terminated or otherwise rendered inactive by the Secretary.

(8) Generic investigational new animal drug meeting request

The term "generic investigational new animal drug meeting request" means a request submitted by a generic new animal drug sponsor to meet with the Secretary to discuss an investigational submission for a generic new animal drug.

(9) Investigational submission for a generic new animal drug

The terms "investigational submission for a generic new animal drug" and "investigational submission" mean—

(A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a generic new animal drug intended to be the subject of an abbreviated application or a supplemental abbreviated application; or

(B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of a generic new animal drug in the event of the filing of an abbreviated application or supplemental abbreviated application for such drug.

(10) Person

The term "person" includes an affiliate thereof (as such term is defined in section 379g(11) of this title).

(11) Process for the review of abbreviated applications for generic new animal drugs

The term "process for the review of abbreviated applications for generic new animal drugs" means the following activities of the Secretary with respect to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions:

(A) The activities necessary for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(B) The issuance of action letters which approve abbreviated applications or supplemental abbreviated applications or which set forth in detail the specific deficiencies in abbreviated applications, supplemental abbreviated applications, or investigational submissions and, where appropriate, the actions necessary to place such applications, supplemental applications, or submissions in condition for approval.

(C) The inspection of generic new animal drug establishments and other facilities undertaken as part of the Secretary's review of pending abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(D) Monitoring of research conducted in connection with the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(E) The development of regulations and policy related to the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

(F) Development of standards for products subject to review.

(G) Meetings between the agency and the generic new animal drug sponsor.

(H) Review of advertising and labeling prior to approval of an abbreviated application or supplemental abbreviated application, but not after such application has been approved.

(I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.

(12) Request to establish a generic investigational new animal drug file

The term "request to establish a generic investigational new animal drug file" means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.

(13) Supplemental abbreviated application for generic new animal drug

The terms "supplemental abbreviated application for a generic new animal drug" and "supplemental abbreviated application" mean a request to the Secretary to approve a change in an approved abbreviated application.

(June 25, 1938, ch. 675, §741, as added Pub. L. 110–316, title II, §202(b), Aug. 14, 2008, 122 Stat. 3515; amended Pub. L. 113–14, title II, §202, June 13, 2013, 127 Stat. 465; Pub. L. 115–234, title II, §202, Aug. 14, 2018, 132 Stat. 2432; Pub. L. 118–15, div. B, title III, §2312, Sept. 30, 2023, 137 Stat. 90.)

Termination of Section

For termination of section by section 2316(a) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

Prior Provisions

A prior section 741 of act June 25, 1938, was renumbered section 745 and is classified to section 379k of this title.

Amendments

2023—Subsec. (a)(4). Pub. L. 118–15, §2312(a), added par. (4).

Subsec. (b)(1). Pub. L. 118–15, §2312(b)(1), substituted "2024 through 2028" for "2019 through 2023" and "$25,000,000" for "$18,336,340".

Subsec. (b)(2)(A). Pub. L. 118–15, §2312(b)(2)(A), substituted "20 percent" for "25 percent" and inserted before semicolon at end "and fees under subsection (a)(4) (relating to generic investigational new animal drug files)".

Subsec. (b)(2)(B), (C). Pub. L. 118–15, §2312(b)(2)(B), (C), substituted "40 percent" for "37.5 percent".

Subsec. (c)(1). Pub. L. 118–15, §2312(c)(1), amended par. (1) generally. Prior to amendment, text read as follows: "The Secretary shall establish, 60 days before the start of each fiscal year beginning after September 30, 2008, for that fiscal year, abbreviated application fees, generic new animal drug sponsor fees, and generic new animal drug product fees, based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection."

Subsec. (c)(2)(A). Pub. L. 118–15, §2312(c)(2)(A), substituted "2025" for "2020" in introductory provisions.

Subsec. (c)(2)(A)(iii). Pub. L. 118–15, §2312(c)(2)(A)(ii), substituted "Arlington-Alexandria" for "Baltimore".

Subsec. (c)(2)(B). Pub. L. 118–15, §2312(c)(2)(B), substituted "2025" for "2020".

Subsec. (c)(3)(A). Pub. L. 118–15, §2312(c)(3)(A)(i), substituted "2025" for "2020" in introductory provisions.

Subsec. (c)(3)(A)(i). Pub. L. 118–15, §2312(c)(3)(A)(ii)(I), substituted "investigational generic new animal drug protocol submissions, requests to establish a generic investigational new animal drug file, and generic investigational new animal drug meeting requests" for "and investigational generic new animal drug protocol submissions".

Subsec. (c)(3)(A)(ii), (iii). Pub. L. 118–15, §2312(c)(3)(A)(ii)(II)–(iv), added cl. (ii) and redesignated former cl. (ii) as (iii).

Subsec. (c)(3)(B). Pub. L. 118–15, §2312(c)(3)(B), substituted "2026 through 2028" for "2021 through 2023".

Subsec. (c)(4). Pub. L. 118–15, §2312(c)(4), substituted "2028" for "2023" in two places and "2029" for "2024".

Subsec. (d). Pub. L. 118–15, §2312(d), amended subsec. (d) generally. Prior to amendment, subsec. (d) related to fee waiver or reduction and exemption from fees.

Subsec. (e). Pub. L. 118–15, §2312(e), substituted "A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue" for "The Secretary may discontinue".

Subsec. (f)(2). Pub. L. 118–15, §2312(f), substituted "products, generic new animal drug sponsors, and generic investigational new animal drug files at any time" for "sponsors, and generic new animal drug products at any time".

Subsec. (g)(3). Pub. L. 118–15, §2312(g)(1), substituted "2024 through 2028" for "2019 through 2023".

Subsec. (g)(4). Pub. L. 118–15, §2312(g)(2), struck out par. (4) relating to offset. Text read as follows: "If the sum of the cumulative amount of fees collected under this section for the fiscal years 2014 through 2016 and the amount of fees estimated to be collected under this section for fiscal year 2017 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2014 through 2017, the excess amount shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2018."

Subsec. (g)(5). Pub. L. 118–15, §2312(g)(3), added par. (5).

Subsec. (k)(8) to (11). Pub. L. 118–15, §2312(h)(1), (2), added par. (8) and redesignated former pars. (8) to (10) as (9) to (11), respectively. Former par. (11) redesignated (13).

Subsec. (k)(11)(I). Pub. L. 118–15, §2312(h)(3), added subpar. (I).

Subsec. (k)(12), (13). Pub. L. 118–15, §2312(h)(1), (4), added par. (12) and redesignated par. (11) as (13).

2018—Subsec. (b). Pub. L. 115–234, §202(a), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts for fiscal years 2014 to 2018.

Subsec. (c)(2). Pub. L. 115–234, §202(b)(1)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Pub. L. 115–234, §202(b)(1)(A), (2), redesignated par. (2) as (3) and amended it generally. Prior to amendment, text read as follows: "The fee revenues shall be adjusted each fiscal year after fiscal year 2014 to reflect changes in review workload. With respect to such adjustment:

"(A) This adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investigational generic new animal drug protocol submissions submitted to the Secretary. The Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies.

"(B) Under no circumstances shall this workload adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b)."

Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 115–234, §202(b)(1)(A), (3), redesignated par. (3) as (4) and substituted "2023" for "2018" in two places and "2024" for "2019". Former par. (4) redesignated (5).

Subsec. (c)(5). Pub. L. 115–234, §202(b)(1)(A), redesignated par. (4) as (5).

Subsec. (d). Pub. L. 115–234, §202(c), amended subsec. (d) generally. Prior to amendment, text read as follows: "The Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection (a) where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication."

Subsec. (g)(3), (4). Pub. L. 115–234, §202(d), added par. (3) and par. (4) relating to excess collections and struck out former par. (3) which related to authorization of appropriations for fiscal years 2014 to 2018.

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to authority to assess and use generic new animal drug fees.

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Pub. L. 118–15, div. B, title III, §2315, Sept. 30, 2023, 137 Stat. 94, provided that: "The amendments made by this chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title] shall take effect on October 1, 2023, or the date of the enactment of this Act [Sept. 30, 2023], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended by this chapter, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2023, regardless of the date of enactment of this Act."

Effective Date of 2018 Amendment

Pub. L. 115–234, title II, §205, Aug. 14, 2018, 132 Stat. 2435, provided that: "The amendments made by this title [see section 201(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title] shall take effect on October 1, 2018, or the date of the enactment of this Act [Aug. 14, 2018], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as amended by this title, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2018, regardless of the date of enactment of this Act."

Effective Date of 2013 Amendment

Pub. L. 113–14, title II, §205, June 13, 2013, 127 Stat. 474, provided that: "The amendments made by this title [amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title] shall take effect on October 1, 2013, or the date of enactment of this Act [June 13, 2013], whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as amended by this title, shall be assessed for all abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2013, regardless of the date of enactment of this Act."

Termination Date

Pub. L. 118–15, div. B, title III, §2316(a), Sept. 30, 2023, 137 Stat. 94, provided that: "Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall cease to be effective October 1, 2028."

Pub. L. 115–234, title II, §206(a), Aug. 14, 2018, 132 Stat. 2435, which provided that section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) would cease to be effective Oct. 1, 2023, was repealed by Pub. L. 118–15, div. B, title III, §2316(c), Sept. 30, 2023, 137 Stat. 94, effective Oct. 1, 2023.

Pub. L. 113–14, title II, §206(a), June 13, 2013, 127 Stat. 474, which provided that section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) would cease to be effective Oct. 1, 2018, was repealed by Pub. L. 115–234, title II, §206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.

Pub. L. 110–316, title II, §204(a), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendments made by section 202 of Pub. L. 110–316 (enacting this section and amending sections 379k, 379l, and 379o of this title) would cease to be effective Oct. 1, 2013, was repealed by Pub. L. 113–14, title II, §206(c)(1), June 13, 2013, 127 Stat. 474.

Savings Provisions

Pub. L. 118–15, div. B, title III, §2314, Sept. 30, 2023, 137 Stat. 94, provided that: "Notwithstanding the amendments made by this chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this chapter [Sept. 30, 2023], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024."

Pub. L. 115–234, title II, §204, Aug. 14, 2018, 132 Stat. 2435, provided that: "Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115–234, set out as a Short Title of 2018 Amendment note under section 301 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this title [Aug. 14, 2018], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2013, but before October 1, 2018, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2019."

Pub. L. 113–14, title II, §204, June 13, 2013, 127 Stat. 474, provided that: "Notwithstanding the amendments made by this title [amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title], part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–21 et seq.], as in effect on the day before the date of enactment of this title [June 13, 2013], shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2008, but before October 1, 2013, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2014."

Findings

Pub. L. 118–15, div. B, title III, §2311(b), Sept. 30, 2023, 137 Stat. 90, provided that: "Congress finds that the fees authorized by the amendments made in this chapter [chapter 2 (§§2311–2316) of subtitle A of title III of div. B of Pub. L. 118–15, amending this section and section 379j–22 of this title and repealing provisions set out as notes under this section and section 379j–22 of this title] will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record."

Similar provisions were contained in the following prior acts:

Pub. L. 115–234, title II, §201(b), Aug. 14, 2018, 132 Stat. 2432.

Pub. L. 113–14, title II, §201(b), June 13, 2013, 127 Stat. 464.

Pub. L. 110–316, title II, §201(b), Aug. 14, 2008, 122 Stat. 3515.

§379j–22. Reauthorization; reporting requirements

(a) Performance reports

Beginning with fiscal year 2024, not later than 120 days after the end of each fiscal year during which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) ¹ of the Animal Generic Drug User Fee Amendments of 2023 toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs during such fiscal year.

(b) Fiscal report

(c) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(d) Reauthorization

(1) Consultation

In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of abbreviated applications for generic new animal drugs for the first 5 fiscal years after fiscal year 2028, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) veterinary professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

(4) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(5) Transmittal of recommendations

Not later than January 15, 2028, the Secretary shall transmit to Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(6) Minutes of negotiation meetings

(A) Public availability

(B) Content

(June 25, 1938, ch. 675, §742, as added Pub. L. 110–316, title II, §203, Aug. 14, 2008, 122 Stat. 3522; amended Pub. L. 113–14, title II, §203, June 13, 2013, 127 Stat. 472; Pub. L. 115–234, title II, §203, Aug. 14, 2018, 132 Stat. 2435; Pub. L. 118–15, div. B, title III, §2313, Sept. 30, 2023, 137 Stat. 93.)

Termination of Section

For termination of section by section 2316(b) of Pub. L. 118–15, see Termination Date note below.

Editorial Notes

References in Text

Section 201(b) of the Animal Generic Drug User Fee Amendments of 2023, referred to in subsec. (a), probably should be a reference to section 2311(b) of the Animal Generic Drug User Fee Amendments of 2023, chapter 2 of subtitle A of title III of div. B of Pub. L. 118–15, which is set out as a note under section 379j–21 of this title. The Animal Generic Drug User Fee Amendments of 2023 does not contain a section 201(b).

Prior Provisions

A prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to section 379l of this title.

Amendments

2023—Subsec. (a). Pub. L. 118–15, §2313(1), (2), substituted "2024" for "2019" and "2023" for "2018".

Subsec. (b). Pub. L. 118–15, §2313(2), substituted "2024" for "2019".

Subsec. (d)(1), (5). Pub. L. 118–15, §2313(3), substituted "2028" for "2023".

2018—Subsec. (a). Pub. L. 115–234, §203(1), (3), substituted "2019" for "2014" and "2018" for "2013".

Subsec. (b). Pub. L. 115–234, §203(2), (3), substituted "2019" for "2014" and "to the Committee on Health, Education, Labor and Pensions" for "to Committee on Health, Education, Labor, and Pensions".

Subsec. (d)(1), (5). Pub. L. 115–234, §203(4), substituted "2023" for "2018".

2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to reauthorization of this subpart and reporting requirements.

Statutory Notes and Related Subsidiaries

Effective Date of 2023 Amendment

Amendment by Pub. L. 118–15 effective Oct. 1, 2023, and fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended, to be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after Oct. 1, 2023, see section 2315 of Pub. L. 118–15, set out as a note under section 379j–21 of this title.

Effective Date of 2018 Amendment

Amendment by Pub. L. 115–234 effective on Oct. 1, 2018, and fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended, to be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after Oct. 1, 2018, see section 205 of Pub. L. 115–234, set out as a note under section 379j–21 of this title.

Effective Date of 2013 Amendment

Amendment by Pub. L. 113–14 effective Oct. 1, 2013, see section 205 of Pub. L. 113–14, set out as a note under section 379j–21 of this title.

Termination Date

Pub. L. 118–15, div. B, title III, §2316(b), Sept. 30, 2023, 137 Stat. 94, provided that: "Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2029."

Pub. L. 115–234, title II, §206(b), Aug. 14, 2018, 132 Stat. 2435, which provided that section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) would cease to be effective Jan. 31, 2024, was repealed by Pub. L. 118–15, div. B, title III, §2316(c), Sept. 30, 2023, 137 Stat. 94, effective Oct. 1, 2023.

Pub. L. 113–14, title II, §206(b), June 13, 2013, 127 Stat. 474, which provided that section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) would cease to be effective Jan. 31, 2019, was repealed by Pub. L. 115–234, title II, §206(c), Aug. 14, 2018, 132 Stat. 2435, effective Oct. 1, 2018.

Pub. L. 110–316, title II, §204(b), Aug. 14, 2008, 122 Stat. 3524, which provided that the amendment made by section 203 of Pub. L. 110–316 (enacting this section) would cease to be effective Jan. 31, 2014, was repealed by Pub. L. 113–14, title II, §206(c)(1), June 13, 2013, 127 Stat. 474.

¹ See References in Text note below.

subpart 6—fees related to food

§379j–31. Authority to collect and use fees

(a) In general

(1) Purpose and authority

For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from—

(A) the responsible party for each domestic facility (as defined in section 350d(b) ¹ of this title) and the United States agent for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;

(B) the responsible party for a domestic facility (as defined in section 350d(b) ¹ of this title) and an importer who does not comply with a recall order under section 350l of this title or under section 350a(f) of this title in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year;

(C) each importer participating in the voluntary qualified importer program under section 384b of this title in such year, to cover the administrative costs of such program for such year; and

(D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.

(2) Definitions

For purposes of this section—

(A) the term "reinspection" means—

(i) with respect to domestic facilities (as defined in section 350d(b) ¹ of this title), 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary's satisfaction; and

(ii) with respect to importers, 1 or more examinations conducted under section 381 of this title subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary's satisfaction;

(B) the term "reinspection-related costs" means all expenses, including administrative expenses, incurred in connection with—

(i) arranging, conducting, and evaluating the results of reinspections; and

(ii) assessing and collecting reinspection fees under this section; and

(b) Establishment of fees

(1) In general

Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.

(2) Fee methodology

(A) Fees

Fees amounts established for collection—

(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year;

(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year;

(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; and

(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary's estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year.

(B) Other considerations

(i) Voluntary qualified importer program

In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 384b(c) of this title informing the Secretary of the intent of such importer to participate in the program under section 384b of this title in such fiscal year.

(II) ² Recoupment

In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after January 4, 2011, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under section 384b of this title.

(ii) Crediting of fees

In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.

(iii) Published guidelines

Not later than 180 days after January 4, 2011, the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines. The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking.

(3) Use of fees

The Secretary shall make all of the fees collected pursuant to clause ³ (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively.

(c) Limitations

(1) In general

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless the amount of the total appropriations for food safety activities at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under paragraph (3).

(2) Authority

If—

(A) the Secretary does not assess fees under subsection (a) for a portion of a fiscal year because paragraph (1) applies; and

(B) at a later date in such fiscal year, such paragraph (1) ceases to apply,

the Secretary may assess and collect such fees under subsection (a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(3) Adjustment factor

(A) In general

The adjustment factor described in paragraph (1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative.

(B) Compounded basis

The adjustment under subparagraph (A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009.

(4) Limitation on amount of certain fees

(A) In general

Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected—

(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; and

(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined.

(B) Exception

If a domestic facility (as defined in section 350d(b) ¹ of this title) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer.

(d) Crediting and availability of fees

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.

(e) Collection of fees

(1) In general

The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected.

(2) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31.

(f) Annual report to Congress

Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.

(g) Authorization of appropriations

For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.

(June 25, 1938, ch. 675, §743, as added Pub. L. 111–353, title I, §107(a), Jan. 4, 2011, 124 Stat. 3906.)

Editorial Notes

References in Text

Section 350d(b) of this title, referred to in subsecs. (a)(1)(A), (B), (2)(A)(i) and (c)(4)(B), was redesignated section 350d(c) by Pub. L. 111–353, title I, §102(b)(1)(B), Jan. 4, 2011, 124 Stat. 3887.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

¹ See References in Text note below.

² So in original. No subcl. (I) has been enacted.

³ So in original. Probably should be "clauses".

subpart 7—fees relating to generic drugs

§379j–41. Definitions

For purposes of this subpart:

(1) The term "abbreviated new drug application"—

(A) means an application submitted under section 355(j) of this title, an abbreviated application submitted under section 357 of this title (as in effect on the day before November 21, 1997), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and

(B) does not include an application—

(i) for a positron emission tomography drug; or

(ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.

(2) The term "active pharmaceutical ingredient" means—

(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—

(i) to be used as a component of a drug; and

(ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or

(B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A).

(3) The term "adjustment factor" means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011.

(4) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(5) The term "contract manufacturing organization facility" means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.

(6)(A) The term "facility"—

(i) means a business or other entity—

(I) under one management, either direct or indirect; and

(II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and

(ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing.

(B) For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are—

(i) closely related to the same business enterprise;

(ii) under the supervision of the same local management; and

(iii) capable of being inspected by the Food and Drug Administration during a single inspection.

(C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.

(7) The term "finished dosage form" means—

(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;

(B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or

(C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B).

(8) The term "generic drug submission" means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application.

(9) The term "human generic drug activities" means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:

(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions.

(B) The issuance of—

(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or

(ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval.

(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or

(ii) document that no deficiencies need to be addressed.

(D) Inspections related to generic drugs.

(E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files.

(F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:

(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports.

(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).

(G) Regulatory science activities related to generic drugs.

(10) The term "positron emission tomography drug" has the meaning given to the term "compounded positron emission tomography drug" in section 321(ii) of this title, except that paragraph (1)(B) of such section shall not apply.

(11) The term "prior approval supplement" means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.

(12) The term "resources allocated for human generic drug activities" means the expenses for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers and employees and to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs.

(13) The term "Type II active pharmaceutical ingredient drug master file" means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.

(June 25, 1938, ch. 675, §744A, as added Pub. L. 112–144, title III, §302, July 9, 2012, 126 Stat. 1008; amended Pub. L. 115–52, title III, §302, Aug. 18, 2017, 131 Stat. 1020.)

Termination of Section

For termination of section by section 3004(a) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 357 of this title, referred to in par. (1)(A), was repealed by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in par. (1)(A), is Pub. L. 98–417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.

Amendments

2017—Par. (1)(B). Pub. L. 115–52, §302(1), substituted "application—" for "application for a positron emission tomography drug." and added cls. (i) and (ii).

Pars. (5) to (13). Pub. L. 115–52, §302(2), (3), added par. (5) and redesignated former pars. (5) to (12) as (6) to (13), respectively.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title III, §3005, Sept. 30, 2022, 136 Stat. 2159, provided that: "The amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.) shall be assessed for all abbreviated new drug applications received on or after October 1, 2022, regardless of the date of the enactment of this Act."

Effective Date of 2017 Amendment

Pub. L. 115–52, title III, §306, Aug. 18, 2017, 131 Stat. 1027, provided that: "The amendments made by this title [see section 301(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–41 et seq.] shall be assessed for all abbreviated new drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective and Termination Dates

Pub. L. 117–180, div. F, title III, §3004(a), Sept. 30, 2022, 136 Stat. 2159, provided that: "Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title III, §305(a), Aug. 18, 2017, 131 Stat. 1027, which provided that this section and section 379j–42 of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159.

[Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159, provided that the repeal of section 305(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title III, §304(a), July 9, 2012, 126 Stat. 1024, which provided that this section and section 379j–42 of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027.

[Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027, provided that the repeal of section 304(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 112–144, title III, §305, July 9, 2012, 126 Stat. 1024, provided that: "The amendments made by this title [enacting this section and sections 379d–4, 379j–42, and 379j–43 of this title and amending sections 352 and 379d–3 of this title] shall take effect on October 1, 2012, or the date of the enactment of this title [July 9, 2012], whichever is later, except that fees under section 302 [enacting this section and sections 379j–42 and 379j–43 of this title] shall be assessed for all human generic drug submissions and Type II active pharmaceutical drug master files received on or after October 1, 2012, regardless of the date of enactment of this title."

Savings Clause

Pub. L. 117–180, div. F, title III, §3006, Sept. 30, 2022, 136 Stat. 2159, provided that: "Notwithstanding the amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title], part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title III, §307, Aug. 18, 2017, 131 Stat. 1027, provided that: "Notwithstanding the amendments made by this title [amending this section and sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title], part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–41 et seq.], as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Congressional Findings Concerning Fees Relating to Human Generic Drugs

Pub. L. 117–180, div. F, title III, §3001(b), Sept. 30, 2022, 136 Stat. 2155, provided that: "Congress finds that the fees authorized by the amendments made by this title [amending sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title] will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title III, §301(b), Aug. 18, 2017, 131 Stat. 1020, provided that: "The Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 379j–42 and 379j–43 of this title and repealing provisions set out as notes under this section and section 379j–43 of this title] will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–41 et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title III, §301(b), July 9, 2012, 126 Stat. 1008, provided that: "The Congress finds that the fees authorized by the amendments made in this title [enacting this section and sections 379d–4, 379j–42, and 379j–43 of this title and amending sections 352 and 379d–3 of this title] will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

§379j–42. Authority to assess and use human generic drug fees

(a) Types of fees

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) One-time backlog fee for abbreviated new drug applications pending on October 1, 2012

(A) In general

Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B).

(B) Method of fee amount calculation

The amount of each one-time backlog fee shall be calculated by dividing $50,000,000 by the total number of abbreviated new drug applications pending on October 1, 2012, that have not received a tentative approval as of that date.

(C) Notice

Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fee required by subparagraph (A).

(D) Fee due date

The fee required by subparagraph (A) shall be due no later than 30 calendar days after the date of the publication of the notice specified in subparagraph (C).

(E) Sunset

This paragraph shall cease to be effective October 1, 2022.

(2) Drug master file fee

(A) In general

Each person that owns a Type II active pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee.

(B) One-time payment

If a person has paid a drug master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to pay a subsequent drug master file fee when that Type II active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions.

(C) Notice

Not later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year.

(D) Availability for reference

(i) In general

Subject to subsection (g)(2)(C), for a generic drug submission to reference a Type II active pharmaceutical ingredient drug master file, the drug master file must be deemed available for reference by the Secretary.

(ii) Conditions

A drug master file shall be deemed available for reference by the Secretary if—

(I) the person that owns a Type II active pharmaceutical ingredient drug master file has paid the fee required under subparagraph (A) within 20 calendar days after the applicable due date under subparagraph (E); and

(II) the drug master file has not failed an initial completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary.

(iii) List

The Secretary shall make publicly available on the Internet Web site of the Food and Drug Administration a list of the drug master file numbers that correspond to drug master files that have successfully undergone an initial completeness assessment, in accordance with criteria to be published by the Secretary, and are available for reference.

(E) Fee due date

(i) In general

Subject to clause (ii), a drug master file fee shall be due on the earlier of—

(I) the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file; or

(II) the date on which the drug master file holder requests the initial completeness assessment.

(ii) Limitation

No fee shall be due under subparagraph (A) for a fiscal year until the later of—

(I) 30 calendar days after publication of the notice provided for in subparagraph (C); or

(II) 30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(3) Abbreviated new drug application filing fee

(A) In general

Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d).

(B) Notice

Not later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(C) Fee due date

The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.

(D) Refund of fee if abbreviated new drug application is not considered to have been received, is withdrawn prior to being received, or is no longer received

(i) Applications not considered to have been received and applications withdrawn prior to being received

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 355(j)(5)(A) of this title for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 355(j)(5)(A) of this title.

(ii) Applications no longer received

The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under section 355(j)(5)(A) of this title and subsequently determines that an exclusivity period for a listed drug should have prevented the Secretary from receiving such application, such that the abbreviated new drug application is no longer received within the meaning of section 355(j)(5)(A) of this title.

(E) Fee for an application the Secretary considers not to have been received, or that has been withdrawn

An abbreviated new drug application that was submitted on or after October 1, 2012, and that the Secretary considers not to have been received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission following the applicant's withdrawal of the application, be subject to a full fee under subparagraph (A).

(F) Additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file

An applicant that submits a generic drug submission on or after October 1, 2017, shall pay a fee, in the amount determined under subsection (d)(2), in addition to the fee required under subparagraph (A), if—

(i) such submission contains information concerning the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical drug master file; and

(ii) a fee in the amount equal to the drug master file fee established in paragraph (2) has not been previously paid with respect to such information.

(4) Generic drug facility fee and active pharmaceutical ingredient facility fee

(A) In general

Facilities identified in at least one generic drug submission that is approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees as follows:

(i) Generic drug facility

Each person that owns a facility which is identified in at least one generic drug submission that is approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility.

(ii) Active pharmaceutical ingredient facility

Each person that owns a facility which is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such generic drug submission, shall be assessed an annual fee for each such facility.

(iii) Facilities producing both active pharmaceutical ingredients and finished dosage forms

Each person that owns a facility identified in at least one generic drug submission that is approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject only to the fee attributable to the manufacture of the finished dosage forms for that facility.

(B) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C) Notice

Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D) Fee due date

For each of fiscal years 2023 through 2027, the fees under subparagraph (A) for such fiscal year shall be due on the later of—

(i) the first business day on or after October 1 of each such year; or

(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.

(5) Generic drug applicant program fee

(A) In general

A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).

(B) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C) Notice

Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D) Fee due date

For each of fiscal years 2023 through 2027, the fees under subparagraph (A) for such fiscal year shall be due on the later of—

(i) the first business day on or after October 1 of each such fiscal year; or

(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.

(6) Date of submission

For purposes of this chapter, a generic drug submission or Type II pharmaceutical master file is deemed to be "submitted" to the Food and Drug Administration—

(A) if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office that will review that submission is not otherwise open for business shall be deemed to be submitted on the next day when that office is open for business; or

(B) if it is submitted in physical media form, on the day it arrives at the appropriate designated document room of the Food and Drug Administration.

(b) Fee revenue amounts

(1) In general

(A) Fiscal year 2023

For fiscal year 2023, fees under subsection (a) shall be established to generate a total estimated revenue amount under such subsection of $582,500,000.

(B) Fiscal years 2024 through 2027

(i) In general

For each of the fiscal years 2024 through 2027, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause (ii), as adjusted pursuant to subsection (c).

(ii) Base revenue amount

The base revenue amount for a fiscal year referred to in clause (i) is equal to the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3).

(2) Types of fees

In establishing fees under paragraph (1) to generate the revenue amounts specified in such paragraph for a fiscal year, such fees shall be derived from the fees under paragraphs (2) through (5) of subsection (a) as follows:

(A) Five percent shall be derived from fees under subsection (a)(2) (relating to drug master files).

(B) Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications).

(C) Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to twenty-four percent of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.

(D) Six percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States, including its territories and possessions.

(E)(i) Thirty-six percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows:

(I) If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.

(II) If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.

(III) If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.

(ii) For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.

(c) Adjustments

(1) Inflation adjustment

For fiscal year 2024 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied by an amount equal to the sum of—

(A) one;

(B) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years multiplied by the proportion of personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years; and

(C) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years.

(2) Capacity planning adjustment

(A) In general

Beginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities.

(B) Capacity planning methodology

The Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

(i) be derived from the methodology and recommendations made in the report titled "Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations" announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and

(ii) incorporate approaches and attributes determined appropriate by the Secretary, including approaches and attributes made in such report, except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022.

(C) Limitations

(i) In general

Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph (1) (the dollar amount of the inflation adjustment for the fiscal year).

(ii) Additional limitation

An adjustment under this paragraph shall not exceed 3 percent of the sum described in clause (i) for the fiscal year, except that such limitation shall be 4 percent if—

(I) for purposes of a fiscal year 2024 adjustment, the Secretary determines that during the period from April 1, 2021, through March 31, 2023—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022);

(II) for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the period from April 1, 2022, through March 31, 2024—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined);

(III) for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the period from April 1, 2023, through March 31, 2025—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and

(IV) for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the period from April 1, 2024, through March 31, 2026—

(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or

(bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined).

(D) Publication in Federal Register

The Secretary shall publish in the Federal Register notice referred to in subsection (a) the fee revenue and fees resulting from the adjustment and the methodology under this paragraph.

(3) Operating reserve adjustment

(A) In general

For fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section for such fiscal year if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B) with respect to that fiscal year.

(B) Number of weeks

The number of weeks specified in this subparagraph is—

(i) 8 weeks for fiscal year 2024;

(ii) 9 weeks for fiscal year 2025; and

(iii) 10 weeks for each of fiscal year 2026 and 2027.

(C) Decrease

If the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves.

(D) Rationale for adjustment

If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under subsection (a) publishing the fee revenue and fees for the fiscal year involved.

(d) Annual fee setting

(1) Fiscal years 2023 through 2027

Not later than 60 days before the first day of each of fiscal years 2023 through 2027, the Secretary shall establish the fees described in paragraphs (2) through (5) of subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).

(2) Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file

In establishing the fee under paragraph (1), the amount of the fee under subsection (a)(3)(F) shall be determined by multiplying—

(A) the sum of—

(i) the total number of such active pharmaceutical ingredients in such submission; and

(ii) for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and

(B) the amount equal to the drug master file fee established in subsection (a)(2) for such submission.

(e) Limitations

(1) In general

The total amount of fees charged, as adjusted under subsection (c), for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for human generic drug activities.

(2) Leasing and necessary equipment

Beginning on October 1, 2023, the authorities under section 379j–41(12)(C) of this title shall include only leasing and necessary scientific equipment.

(f) Identification of facilities

(1) Required submission of facility identification

Each person that owns a facility described in subsection (a)(4)(A) or a site or organization required to be identified by paragraph (3) shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.

(2) Information required to be submitted

At a minimum, the submission required by paragraph (1) shall include for each such facility—

(A) identification of a facility identified in an approved or pending generic drug submission;

(B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both;

(D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs;

(E) whether the facility manufactures drugs that are not generic drugs; and

(F) whether the facility is a contract manufacturing organization facility.

(3) Certain sites and organizations

(A) In general

Any person that owns or operates a site or organization described in subparagraph (B) shall submit to the Secretary information concerning the ownership, name, and address of the site or organization.

(B) Sites and organizations

A site or organization is described in this subparagraph if it is identified in a generic drug submission and is—

(i) a site in which a bioanalytical study is conducted;

(ii) a clinical research organization;

(iii) a contract analytical testing site; or

(iv) a contract repackager site.

(C) Notice

The Secretary may, by notice published in the Federal Register, specify the means and format for submission of the information under subparagraph (A) and may specify, as necessary for purposes of this section, any additional information to be submitted.

(D) Inspection authority

The Secretary's inspection authority under section 374(a)(1) of this title shall extend to all such sites and organizations.

(g) Effect of failure to pay fees

(1) Generic drug backlog fee

Failure to pay the fee under subsection (a)(1) shall result in the Secretary placing the person that owns the abbreviated new drug application subject to that fee on a publicly available arrears list, such that no new abbreviated new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, will be received within the meaning of section 355(j)(5)(A) of this title until such outstanding fee is paid. This paragraph shall cease to be effective on October 1, 2022.

(2) Drug master file fee

(A) Failure to pay the fee under subsection (a)(2) within 20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active pharmaceutical ingredient drug master file not being deemed available for reference.

(B)(i) Any generic drug submission submitted on or after October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient drug master file that has not been deemed available for reference shall not be received within the meaning of section 355(j)(5)(A) of this title unless the condition specified in clause (ii) is met.

(ii) The condition specified in this clause is that the fee established under subsection (a)(2) has been paid within 20 calendar days of the Secretary providing the notification to the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the drug master file fee as specified in subparagraph (C).

(C)(i) If an abbreviated new drug application or supplement to an abbreviated new drug application references a Type II active pharmaceutical ingredient drug master file for which a fee under subsection (a)(2)(A) has not been paid by the applicable date under subsection (a)(2)(E), the Secretary shall notify the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the applicable fee.

(ii) If such fee is not paid within 20 calendar days of the Secretary providing the notification, the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 355(j)(5)(A) of this title.

(3) Abbreviated new drug application fee

Failure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or the prior approval supplement to an abbreviated new drug application not being received within the meaning of section 355(j)(5)(A) of this title until such outstanding fee is paid.

(4) Generic drug facility fee and active pharmaceutical ingredient facility fee

(A) In general

Failure to pay the fee under subsection (a)(4) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:

(i) The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, will be received within the meaning of section 355(j)(5)(A) of this title.

(ii) Any new generic drug submission submitted on or after October 1, 2012, that references such a facility shall not be received, within the meaning of section 355(j)(5)(A) of this title if the outstanding facility fee is not paid within 20 calendar days of the Secretary providing the notification to the sponsor of the failure of the owner of the facility to pay the facility fee under subsection (a)(4)(C).

(iii) All drugs or active pharmaceutical ingredients manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(aa) of this title.

(B) Application of penalties

The penalties under this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility.

(C) Nonreceival for nonpayment

(i) Notice

If an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee.

(ii) Nonreceival

If the facility fee is not paid within 20 calendar days of the Secretary providing the notification under clause (i), the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 355(j)(5)(A) of this title.

(5) Generic drug applicant program fee

(A) In general

A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following:

(i) The Secretary shall place the person on a publicly available arrears list.

(ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 355(j)(5)(A) of this title.

(iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 352(aa) of this title.

(B) Application of penalties

The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.

(h) Limitations

(1) In general

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor (as defined in section 379j–41 of this title) applicable to the fiscal year involved.

(2) Authority

If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(i) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, subject to paragraph (2). Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for human generic drug activities.

(2) Collections and appropriation Acts

(A) In general

The fees authorized by this section—

(ii) shall be available—

(I) for fiscal year 2023, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in section 379j–41(3) of this title applicable to such fiscal year; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in section 379j–41(3) of this title applicable to the fiscal year involved.

(B) Compliance

(C) Provision for early payments

(3) Authorization of appropriations

For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equivalent to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted under subsection (c), if applicable, or as otherwise affected under paragraph (2) of this subsection.

(j) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(k) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(l) Positron emission tomography drugs

(1) Exemption from fees

Submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs shall not be required to pay a facility fee as established in subsection (a)(4).

(2) Identification requirement

Facilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f).

(m) Disputes concerning fees

To qualify for the return of a fee claimed to have been paid in error under this section, a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.

(n) Substantially complete applications

An abbreviated new drug application that is not considered to be received within the meaning of section 355(j)(5)(A) of this title because of failure to pay an applicable fee under this provision within the time period specified in subsection (g) shall be deemed not to have been "substantially complete" on the date of its submission within the meaning of section 355(j)(5)(B)(iv)(II)(cc) of this title. An abbreviated new drug application that is not substantially complete on the date of its submission solely because of failure to pay an applicable fee under the preceding sentence shall be deemed substantially complete and received within the meaning of section 355(j)(5)(A) of this title as of the date such applicable fee is received.

(o) Information on abbreviated new drug applications owned by applicants and their affiliates

(1) In general

By April 1 of each year, each person that owns an abbreviated new drug application, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Secretary a list of—

(A) all approved abbreviated new drug applications owned by such person; and

(B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate.

(2) Format and method

The Secretary shall specify in guidance the format and method for submission of lists under this subsection.

(June 25, 1938, ch. 675, §744B, as added Pub. L. 112–144, title III, §302, July 9, 2012, 126 Stat. 1011; amended Pub. L. 112–193, §2(b)(2), (3), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title III, §303, title IX, §905(b)(3), Aug. 18, 2017, 131 Stat. 1021, 1090; Pub. L. 117–180, div. F, title III, §3002, Sept. 30, 2022, 136 Stat. 2155; Pub. L. 117–328, div. FF, title III, §3625(c), Dec. 29, 2022, 136 Stat. 5881.)

Termination of Section

For termination of section by section 3004(a) of Pub. L. 117–180, see Effective and Termination Dates note below.

Editorial Notes

References in Text

Section 3001(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsec. (c)(2)(B)(ii), (C)(ii)(I)(bb), is section 3001(b) of title III of div. F of Pub. L. 117–180, which is set out as a note under section 379j–41 of this title.

Amendments

2022—Subsec. (a). Pub. L. 117–180, §3002(a)(1), substituted "2023" for "2018" in introductory provisions.

Subsec. (a)(2)(C). Pub. L. 117–180, §3002(a)(2), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (a)(3)(B). Pub. L. 117–180, §3002(a)(3), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (a)(4)(D). Pub. L. 117–180, §3002(a)(4), substituted "2023 through 2027" for "2018 through 2022" in introductory provisions.

Subsec. (a)(5)(D). Pub. L. 117–180, §3002(a)(5), substituted "2023 through 2027" for "2018 through 2022" in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 117–180, §3002(b)(1)(A), substituted "2023" for "2018" in heading and "2023" for "2018" and "$582,500,000" for "$493,600,000" in text.

Subsec. (b)(1)(B). Pub. L. 117–180, §3002(b)(1)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: "For each of the fiscal years 2019 through 2022, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to $493,600,000, as adjusted pursuant to subsection (c)."

Subsec. (b)(2)(C). Pub. L. 117–180, §3002(b)(2)(A), substituted "twenty-four percent" for "one-third the amount".

Subsec. (b)(2)(D). Pub. L. 117–180, §3002(b)(2)(B), substituted "Six percent" for "Seven percent".

Subsec. (b)(2)(E)(i). Pub. L. 117–180, §3002(b)(2)(C), substituted "Thirty-six percent" for "Thirty-five percent".

Subsec. (c)(1). Pub. L. 117–180, §3002(c)(1)(A), in introductory provisions, substituted "2024" for "2019" and "to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied" for "to equal the product of the total revenues established in such notice for the prior fiscal year multiplied".

Subsec. (c)(1)(C). Pub. L. 117–180, §3002(c)(1)(B), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2), (3). Pub. L. 117–180, §3002(c)(2), added pars. (2) and (3) and struck out former par. (2) which provided for increases in fees in fiscal year 2022 if needed to provide for not more than 3 months of operating reserves for the first 3 months of fiscal year 2023.

Subsec. (d)(1). Pub. L. 117–180, §3002(d), substituted "2023 through 2027" for "2018 through 2022" in heading and "later than 60 days before the first day of each of fiscal years 2023 through 2027" for "more than 60 days before the first day of each of fiscal years 2018 through 2022" in text.

Subsec. (e)(2). Pub. L. 117–328, §3625(c)(1), substituted "379j–41(12)(C) of this title" for "379j–41(11)(C) of this title".

Subsec. (g)(3). Pub. L. 117–180, §3002(e), struck out "and prior approval supplement fee" after "application fee" in heading.

Subsec. (i)(2)(A)(ii). Pub. L. 117–328, §3625(c)(2)(A), substituted "available—" for "available for a fiscal year beginning after fiscal year 2012", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023," before "to defray the costs", substituted "such fiscal year; and" for "the fiscal year involved.", and added subcl. (II).

Subsec. (i)(2)(B). Pub. L. 117–328, §3625(c)(2)(B), substituted "as described in subclause (I) or (II) of such subparagraph, as applicable," for "for human generic activities".

Subsec. (i)(3). Pub. L. 117–180, §3002(f), substituted "fiscal years 2023 through 2027" for "fiscal years 2018 through 2022".

2017—Subsec. (a). Pub. L. 115–52, §303(a)(1), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.

Subsec. (a)(1)(E). Pub. L. 115–52, §303(a)(2), added subpar. (E).

Subsec. (a)(2)(C). Pub. L. 115–52, §303(a)(3)(A), amended subpar. (C) generally. Prior to amendment, subpar. (C) related to publication of notice for fiscal years 2013 to 2017.

Subsec. (a)(2)(E)(i). Pub. L. 115–52, §303(a)(3)(B)(i), substituted "on the earlier of—" for "no later than", inserted subcl. (I) designation before "the date", substituted "; or" for period at end, and added subcl. (II).

Subsec. (a)(2)(E)(ii)(I). Pub. L. 115–52, §303(a)(3)(B)(ii), substituted "notice provided for in subparagraph (C)" for "notice provided for in clause (i) or (ii) of subparagraph (C), as applicable".

Subsec. (a)(3). Pub. L. 115–52, §303(a)(4)(A), struck out "and prior approval supplement" after "application" in heading.

Subsec. (a)(3)(A). Pub. L. 115–52, §303(a)(4)(B), struck out "or a prior approval supplement to an abbreviated new drug application" after "application".

Subsec. (a)(3)(B), (C). Pub. L. 115–52, §303(a)(4)(C), amended subpars. (B) and (C) generally. Prior to amendment, subpars. (B) and (C) related to notice for fiscal years 2013 to 2017 and fee due dates, respectively.

Subsec. (a)(3)(D). Pub. L. 115–52, §303(a)(4)(D), inserted in heading ", is withdrawn prior to being received, or is no longer received" after "received" and in text substituted cls. (i) and (ii) for "The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application or prior approval supplement to an abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 355(j)(5)(A) of this title for a cause other than failure to pay fees."

Subsec. (a)(3)(E). Pub. L. 115–52, §303(a)(4)(E), struck out "or prior approval supplement" after "new drug application".

Subsec. (a)(3)(F). Pub. L. 115–52, §303(a)(4)(F), substituted "2017" for "2012" and "subsection (d)(2)" for "subsection (d)(3)" in introductory provisions.

Subsec. (a)(4)(A). Pub. L. 115–52, §303(a)(5)(A)(i), substituted "in at least one generic drug submission that is" for ", or intended to be identified, in at least one generic drug submission that is pending or" in introductory provisions.

Subsec. (a)(4)(A)(i). Pub. L. 115–52, §303(a)(5)(A)(ii), substituted "in at least one generic drug submission that is" for "or intended to be identified in at least one generic drug submission that is pending or".

Subsec. (a)(4)(A)(ii). Pub. L. 115–52, §303(a)(5)(A)(iii), substituted "is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such" for "produces, or which is pending review to produce, one or more active pharmaceutical ingredients identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II active pharmaceutical ingredient drug master file referenced in such a".

Subsec. (a)(4)(A)(iii). Pub. L. 115–52, §303(a)(5)(A)(i), (iv), substituted "in at least one generic drug submission that is" for ", or intended to be identified, in at least one generic drug submission that is pending or" and "only to the fee attributable to the manufacture of the finished dosage forms" for "to fees under both such clauses".

Subsec. (a)(4)(C), (D). Pub. L. 115–52, §303(a)(5)(B), amended subpars. (C) and (D) generally. Prior to amendment, subpars. (C) and (D) related to notice and fee due date for fiscal years 2013 to 2017, respectively.

Subsec. (a)(5), (6). Pub. L. 115–52, §303(a)(6), (7), added par. (5) and redesignated former par. (5) as (6).

Subsec. (b)(1)(A). Pub. L. 115–52, §303(b)(1)(A), substituted "2018" for "2013" in heading and "2018" for "2013" and "$493,600,000" for "$299,000,000" in text and struck out at end "Of that amount—

"(i) $50,000,000 shall be generated by the one-time backlog fee for generic drug applications pending on October 1, 2012, established in subsection (a)(1); and

"(ii) $249,000,000 shall be generated by the fees under paragraphs (2) through (4) of subsection (a)."

Subsec. (b)(1)(B). Pub. L. 115–52, §303(b)(1)(B), substituted "2019 through 2022" for "2014 through 2017" in heading and "2019 through 2022" for "2014 through 2017", "paragraphs (2) through (5)" for "paragraphs (2) through (4)", and "$493,600,000" for "$299,000,000" in text.

Subsec. (b)(2). Pub. L. 115–52, §303(b)(2)(A), substituted "such paragraph for a fiscal year" for "paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017" and "through (5)" for "through (4)" in introductory provisions.

Subsec. (b)(2)(A). Pub. L. 115–52, §303(b)(2)(B), substituted "Five percent" for "Six percent".

Subsec. (b)(2)(B), (C). Pub. L. 115–52, §303(b)(2)(C), amended subpars. (B) and (C) generally. Prior to amendment, subpars. (B) and (C) read as follows:

"(B) Twenty-four percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications and supplements). The amount of a fee for a prior approval supplement shall be half the amount of the fee for an abbreviated new drug application.

"(C) Fifty-six percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States, including its territories and possessions, and those located outside of the United States and its territories and possessions."

Subsec. (b)(2)(D). Pub. L. 115–52, §303(b)(2)(D), substituted "Seven percent" for "Fourteen percent", "$15,000" for "not less than $15,000 and not more than $30,000", and "possessions." for "possessions, as determined by the Secretary on the basis of data concerning the difference in cost between inspections of facilities located in the United States and its territories and possessions and those located outside of the United States and its territories and possessions."

Subsec. (b)(2)(E). Pub. L. 115–52, §303(b)(2)(E), added subpar. (E).

Subsec. (c)(1). Pub. L. 115–52, §303(c)(1), substituted "2019" for "2014" and inserted "to equal the product of the total revenues established in such notice for the prior fiscal year multiplied" after "a fiscal year," in introductory provisions and struck out concluding provisions which read as follows: "The adjustment made each fiscal year under this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this subsection."

Subsec. (c)(2). Pub. L. 115–52, §303(c)(2), substituted "2022" for "2017" in two places, substituted "the first 3 months of fiscal year 2023" for "the first 3 months of fiscal year 2018", and struck out "Such fees may only be used in fiscal year 2018." before "If such an adjustment".

Subsec. (d)(1). Pub. L. 115–52, §303(d)(1), added par. (1) and struck out former par. (1) which related to setting fees for fiscal year 2013.

Subsec. (d)(2), (3). Pub. L. 115–52, §303(d), redesignated par. (3) as (2), substituted "fee under paragraph (1)" for "fees under paragraphs (1) and (2)" in introductory provisions, and struck out former par. (2) which related to setting fees for fiscal years 2014 through 2017.

Subsec. (e). Pub. L. 115–52, §905(b)(3), substituted "Limitations" for "Limit" in heading, designated existing provisions as par. (1) and inserted heading, and added par. (2).

Subsec. (f)(1). Pub. L. 115–52, §303(e)(3), substituted "paragraph (3)" for "paragraph (4)" and "Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year." for "Such information shall—

"(A) for fiscal year 2013, be submitted not later than 60 days after the publication of the notice under paragraph (1); and

"(B) for each subsequent fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous year."

Pub. L. 115–52, §303(e)(1), (2), redesignated par. (2) as (1) and struck out former par. (1). Prior to amendment, text of par. (1) read as follows: "Not later than October 1, 2012, the Secretary shall publish in the Federal Register a notice requiring each person that owns a facility described in subsection (a)(4)(A), or a site or organization required to be identified by paragraph (4), to submit to the Secretary information on the identity of each such facility, site, or organization. The notice required by this paragraph shall specify the type of information to be submitted and the means and format for submission of such information."

Subsec. (f)(2). Pub. L. 115–52, §303(e)(4)(A), (B), substituted "Information required to be submitted" for "Contents of notice" in heading and "paragraph (1)" for "paragraph (2)" in introductory provisions.

Pub. L. 115–52, §303(e)(2), redesignated par. (3) as (2). Former par. (2) redesignated (1).

Subsec. (f)(2)(A). Pub. L. 115–52, §303(e)(4)(C), struck out "or intended to be identified" after "facility identified".

Subsec. (f)(2)(F). Pub. L. 115–52, §303(e)(4)(D)–(F), added subpar. (F).

Subsec. (f)(3), (4). Pub. L. 115–52, §303(e)(2), redesignated par. (4) as (3). Former par. (3) redesignated (2).

Subsec. (g)(1). Pub. L. 115–52, §303(f)(1), inserted at end "This paragraph shall cease to be effective on October 1, 2022."

Subsec. (g)(2)(C)(ii). Pub. L. 115–52, §303(f)(2), substituted "of section 355(j)(5)(A)" for "of 355(j)(5)(A)".

Subsec. (g)(5). Pub. L. 115–52, §303(f)(3), added par. (5).

Subsec. (h)(2). Pub. L. 115–52, §303(g), struck out "for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities" after "in the rate,".

Subsec. (i)(2)(A)(i). Pub. L. 115–52, §303(h)(1)(A), substituted "subparagraph (C)" for "subparagraphs (C) and (D)".

Subsec. (i)(2)(C). Pub. L. 115–52, §303(h)(1)(B), (D), redesignated subpar. (D) as (C) and struck out former subpar. (C). Prior to amendment, text of subpar. (C) read as follows: "Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain available until expended."

Subsec (i)(2)(D). Pub. L. 115–52, §303(h)(1)(D), redesignated subpar. (D) as (C).

Pub. L. 115–52, §303(h)(1)(C), struck out "in subsequent years" after "payments" in heading and "(after fiscal year 2013)" after "fiscal year" in text.

Subsec. (i)(3). Pub. L. 115–52, §303(h)(2), substituted "fiscal years 2018 through 2022" for "fiscal years 2013 through 2017".

Subsec. (o). Pub. L. 115–52, §303(i), added subsec. (o).

2012—Subsec. (a). Pub. L. 112–193, §2(b)(2), inserted "for such year" after "obligation of fees" wherever appearing.

Subsec. (i)(2)(C). Pub. L. 112–193, §2(b)(3), inserted comma after "September 30, 2013" and struck out comma after "for fiscal year 2013".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2022, see section 3005 of Pub. L. 117–180, set out as a note under section 379j–41 of this title.

Effective Date of 2017 Amendment

Amendment by section 303 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2017, see section 306 of Pub. L. 115–52, set out as a note under section 379j–41 of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2027, see section 3004(a) of Pub. L. 117–180, set out as a note under section 379j–41 of this title.

Section effective Oct. 1, 2012, with fees under this section and section 379j–41 of this title to be assessed for all human generic drug submissions and Type II active pharmaceutical drug master files received on or after Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as a note under section 379j–41 of this title.

Fees Authorized for Fiscal Year 2013

Pub. L. 112–193, §2(c), Oct. 5, 2012, 126 Stat. 1443, provided that:

"(1) Notwithstanding section 744B(a)(2)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)(2)(E)(ii)), the fee authorized under section 744B(a)(2) of such Act for fiscal year 2013 shall be due 30 calendar days after publication of the notice provided for in section 744B(a)(2)(C)(i) of such Act.

"(2) Notwithstanding section 744B(a)(3)(C)(ii) of such Act, the fee authorized under section 744B(a)(3) of such Act for fiscal year 2013 shall be due on the later of—

"(A) the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies; or

"(B) 30 calendar days after publication of the notice referred to in section 744B(a)(3)(B)(i) of such Act.

"(3) Notwithstanding section 744B(a)(4)(D)(i) of such Act, the fee authorized under section 744B(a)(4) of such Act for fiscal year 2013 shall be due not later than 45 days after the publication of the notice under section 744B(a)(4)(C)(i) of such Act."

§379j–43. Reauthorization; reporting requirements

(a) Performance report

(1) General requirements

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(2) Real time reporting

(A) In general

Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.

(B) Data

The Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022.

(ii) The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022.

(3) Rationale for GDUFA program changes

The Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j–42 of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including—

(i) identifying drivers of such changes; and

(ii) changes in the total average cost per full-time equivalent in the generic drug review program;

(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application.

(4) Analysis

For each fiscal year, the Secretary shall include in the report an analysis of the following:

(A) The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year.

(B) Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year.

(C) The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022.

(b) Fiscal report

(c) Corrective action report

(1) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the abbreviated new drug application review process.

(2) Goals missed

For each of the goals identified by the letters described in section 301(b) ¹ of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

(B) with respect to performance enhancement goals that were not achieved, a detailed description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such ² fiscal year.

(d) Enhanced communication

(1) Communications with Congress

(2) Participation in congressional hearing

(e) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for human generic drug activities for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the generic drug industry.

(2) Prior public input

Prior to beginning negotiations with the generic drug industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a);

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and

(D) publish the comments on the Food and Drug Administration's Internet Web site.

(3) Periodic consultation

Not less frequently than once every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2).

(4) Updates to Congress

(5) Public review of recommendations

After negotiations with the generic drug industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

(7) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the generic drug industry, not later than 30 days after each such negotiation meeting.

(B) Content

(June 25, 1938, ch. 675, §744C, as added Pub. L. 112–144, title III, §303, July 9, 2012, 126 Stat. 1022; amended Pub. L. 115–52, title III, §304, title IX, §§903(c), 904(c), Aug. 18, 2017, 131 Stat. 1027, 1080, 1085; Pub. L. 117–180, div. F, title III, §3003, Sept. 30, 2022, 136 Stat. 2158; Pub. L. 117–328, div. FF, title III, §3626(c), Dec. 29, 2022, 136 Stat. 5885.)

Termination of Section

For termination of section by section 3004(b) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 301(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 3001(b) of the Generic Drug User Fee Amendments of 2022, title III of div. F of Pub. L. 117–180, which is set out as a note under section 379j–41 of this title. The Generic Drug User Fee Amendments of 2022 does not contain a section 301(b).

Section 3001(b) of the Generic Drug User Fee Amendments of 2022, referred to in subsec. (a)(3)(A), is section 3001(b) of title III of div. F of Pub. L. 117–180, which is set out as a note under section 379j–41 of this title.

Amendments

2022—Pub. L. 117–180, §3003(2), substituted "Generic Drug User Fee Amendments of 2022" for "Generic Drug User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1). Pub. L. 117–180, §3003(1), substituted "Not later" for "Beginning with fiscal year 2018, not later".

Subsec. (a)(2). Pub. L. 117–180, §3003(3), substituted "Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart" for "Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter".

Subsec. (a)(3). Pub. L. 117–180, §3003(4), substituted "The Secretary" for "Beginning with fiscal year 2020, the Secretary" in introductory provisions.

Subsec. (a)(3)(A). Pub. L. 117–328, §3626(c)(1)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(3)(B). Pub. L. 117–328, §3626(c)(1)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including identifying drivers of such changes; and".

Subsec. (a)(3)(D). Pub. L. 117–328, §3626(c)(1)(C), (D), added subpar. (D).

Subsec. (b). Pub. L. 117–180, §3003(5), substituted "Not later" for "Beginning with fiscal year 2018, not later".

Subsec. (c). Pub. L. 117–180, §3003(6), substituted "For each" for "Beginning with fiscal year 2018, for each" in introductory provisions.

Subsec. (f)(1). Pub. L. 117–180, §3003(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.

Subsec. (f)(4). Pub. L. 117–328, §3626(c)(2)(B), added par. (4). Former par. (4) redesignated (5).

Subsec. (f)(5). Pub. L. 117–328, §3626(c)(2)(A), redesignated par. (4) as (5). Former par. (5) redesignated (6).

Pub. L. 117–180, §3003(7)(B), substituted "January 15, 2027" for "January 15, 2022".

Subsec. (f)(6), (7). Pub. L. 117–328, §3626(c)(2)(A), redesignated pars. (5) and (6) as (6) and (7), respectively.

Subsec. (f)(7)(A). Pub. L. 117–328, §3626(c)(2)(C)(i), substituted "The" for "Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, the" and inserted ", not later than 30 days after each such negotiation meeting" before period at end.

Subsec. (f)(7)(B). Pub. L. 117–328, §3626(c)(2)(C)(ii), inserted ", in sufficient detail," after "shall summarize".

2017—Subsec. (a). Pub. L. 115–52, §903(c), designated existing provisions as par. (1), inserted heading, and added pars. (2) and (3).

Pub. L. 115–52, §304(1), substituted "2018" for "2013" and "Generic Drug User Fee Amendments of 2017" for "Generic Drug User Fee Amendments of 2012".

Subsec. (a)(4). Pub. L. 115–52, §904(c)(1), added par. (4).

Subsec. (b). Pub. L. 115–52, §304(2), substituted "2018" for "2013".

Subsecs. (c) to (e). Pub. L. 115–52, §904(c)(2), added subsecs. (c) and (d) and redesignated former subsec. (c) as (e). Former subsec. (d) redesignated (f).

Subsec. (f). Pub. L. 115–52, §904(c)(2)(A), redesignated subsec. (d) as (f).

Pub. L. 115–52, §304(3), which directed amendment of subsec. (d), effective Oct. 1, 2017, by substituting "2022" for "2017" wherever appearing, was executed by making the substitution in subsec. (f) to reflect the probable intent of Congress and the redesignation of subsec. (d) as (f), effective Aug. 18, 2017, by Pub. L. 115–52, §904(c)(2). See Amendment note above.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Effective Date of 2017 Amendment

Amendment by section 304 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all abbreviated new drug applications received on or after Oct. 1, 2017, see section 306 of Pub. L. 115–52, set out as a note under section 379j–41 of this title.

Effective and Termination Dates

Pub. L. 117–180, div. F, title III, §3004(b), Sept. 30, 2022, 136 Stat. 2159, provided that: "Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title III, §305(b), Aug. 18, 2017, 131 Stat. 1027, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159.

[Pub. L. 117–180, div. F, title III, §3004(c), Sept. 30, 2022, 136 Stat. 2159, provided that the repeal of section 305(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title III, §304(b), July 9, 2012, 126 Stat. 1024, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027.

[Pub. L. 115–52, title III, §305(c)(1), Aug. 18, 2017, 131 Stat. 1027, provided that the repeal of section 304(b) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Section effective Oct. 1, 2012, see section 305 of Pub. L. 112–144, set out as a note under section 379j–41 of this title.

¹ See References in Text note below.

² So in original.

subpart 8—fees relating to biosimilar biological products

§379j–51. Definitions

For purposes of this subpart:

(1) The term "adjustment factor" applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by such Index for September 2011.

(2) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(3) The term "biosimilar biological product" means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.

(4)(A) Subject to subparagraph (B), the term "biosimilar biological product application" means an application for licensure of a biological product under section 262(k) of title 42.

(B) Such term does not include—

(i) a supplement to such an application;

(ii) an application filed under section 262(k) of title 42 that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date;

(iii) an application filed under section 262(k) of title 42 with respect to—

(I) whole blood or a blood component for transfusion;

(II) an in vitro diagnostic biological product; or

(III) a biological product for further manufacturing use only; or

(iv) an application for licensure under section 262(k) of title 42 that is submitted by a State or Federal Government entity for a product that is not distributed commercially.

(5) The term "biosimilar biological product development meeting" means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.

(6) The term "biosimilar biological product development program" means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development.

(7)(A) The term "biosimilar biological product establishment" means a foreign or domestic place of business—

(i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and

(ii) at which one or more biosimilar biological products are manufactured in final dosage form.

(B) For purposes of subparagraph (A)(ii), the term "manufactured" does not include packaging.

(8) The term "biosimilar initial advisory meeting"—

(A) means a meeting, if requested, that is limited to—

(i) a general discussion regarding whether licensure under section 262(k) of title 42 may be feasible for a particular product; and

(ii) if so, general advice on the expected content of the development program; and

(B) does not include any meeting that involves substantive review of summary data or full study reports.

(9) The term "costs of resources allocated for the process for the review of biosimilar biological product applications" means the expenses in connection with the process for the review of biosimilar biological product applications for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under section 379j–52 of this title and accounting for resources allocated for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.

(10) The term "final dosage form" means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).

(11) The term "financial hold"—

(A) means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of section 379j–52(a)(1) of this title; and

(B) does not mean that any of the bases for a "clinical hold" under section 355(i)(3) of this title have been determined by the Secretary to exist concerning the investigation.

(12) The term "person" includes an affiliate of such person.

(13) The term "process for the review of biosimilar biological product applications" means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:

(A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.

(B) Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the actions necessary to place such applications in condition for approval.

(C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary's review of pending biosimilar biological product applications and supplements.

(D) Activities necessary for the release of lots of biosimilar biological products under section 262(k) of title 42.

(E) Monitoring of research conducted in connection with the review of biosimilar biological product applications.

(F) Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:

(i) Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.

(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.

(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.

(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).

(14) The term "supplement" means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 262(k)(4) of title 42.

(June 25, 1938, ch. 675, §744G, as added Pub. L. 112–144, title IV, §402, July 9, 2012, 126 Stat. 1026; amended Pub. L. 115–52, title IV, §402, Aug. 18, 2017, 131 Stat. 1028; Pub. L. 117–180, div. F, title IV, §4002, Sept. 30, 2022, 136 Stat. 2160.)

Termination of Section

For termination of section by section 4005(a) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

Amendments

2022—Par. (1). Pub. L. 117–180, §4002(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The term 'adjustment factor' applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011."

Par. (4)(B)(iii)(II) to (IV). Pub. L. 117–180, §4002(b), redesignated subcls. (III) and (IV) as (II) and (III), respectively, and struck out former subcl. (II) which read as follows: "an allergenic extract product;".

2017—Par. (1). Pub. L. 115–52, §402(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The term 'adjustment factor' applicable to a fiscal year that is the Consumer Price Index for all urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) of the preceding fiscal year divided by such Index for September 2011."

Par. (3). Pub. L. 115–52, §402(b), substituted "means a specific strength of a biological product in final dosage form" for "means a product".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–180, div. F, title IV, §4006, Sept. 30, 2022, 136 Stat. 2166, provided that: "The amendments made by this title [see section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under section 301 of this title] shall take effect on October 1, 2022, or the date of the enactment of this Act [Sept. 30, 2022], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.) shall be assessed for all biosimilar biological product applications received on or after October 1, 2022, regardless of the date of the enactment of this Act."

Effective Date of 2017 Amendment

Pub. L. 115–52, title IV, §406, Aug. 18, 2017, 131 Stat. 1035, provided that: "The amendments made by this title [see section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on October 1, 2017, or the date of the enactment of this Act [Aug. 18, 2017], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51 et seq.] shall be assessed for all biosimilar biological product applications received on or after October 1, 2017, regardless of the date of the enactment of this Act."

Effective and Termination Dates

Pub. L. 117–180, div. F, title IV, §4005(a), Sept. 30, 2022, 136 Stat. 2166, provided that: "Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51, 379j–52) shall cease to be effective October 1, 2027."

Pub. L. 115–52, title IV, §405(a), Aug. 18, 2017, 131 Stat. 1035, which provided that this section and section 379j–52 of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166.

[Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166, provided that the repeal of section 405(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title IV, §404(a), July 9, 2012, 126 Stat. 1038, which provided that this section and section 379j–52 of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title IV, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035.

[Pub. L. 115–52, title III, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Pub. L. 112–144, title IV, §405, July 9, 2012, 126 Stat. 1039, provided that:

"(a) In General.—Except as provided under subsection (b), the amendments made by this title [enacting this section and sections 379j–52 and 379j–53 of this title and amending sections 379d–4 and 379g of this title] shall take effect on the later of—

"(1) October 1, 2012; or

"(2) the date of the enactment of this title [July 9, 2012].

"(b) Exception.—Fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as added by this title, shall be assessed for all biosimilar biological product applications received on or after October 1, 2012, regardless of the date of the enactment of this title."

Savings

Pub. L. 117–180, div. F, title IV, §4007, Sept. 30, 2022, 136 Stat. 2167, provided that: "Notwithstanding the amendments made by this title [see section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under section 301 of this title], part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), as in effect on the day before the date of the enactment of this title [Sept. 30, 2022], shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2017, but before October 1, 2022, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023."

Pub. L. 115–52, title IV, §407, Aug. 18, 2017, 131 Stat. 1035, provided that: "Notwithstanding the amendments made by this title [see section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51 et seq.], as in effect on the day before the date of the enactment of this title [Aug. 18, 2017], shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018."

Congressional Findings Concerning Fees Relating to Biosimilar Biological Products

Pub. L. 117–180, div. F, title IV, §4001(b), Sept. 30, 2022, 136 Stat. 2160, provided that: "Congress finds that the fees authorized by the amendments made by this title [see section 4001(a) of Pub. L. 117–180, set out as a Short Title of 2022 Amendment note under section 301 of this title] will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 115–52, title IV, §401(b), Aug. 18, 2017, 131 Stat. 1028, provided that: "The Congress finds that the fees authorized by the amendments made in this title [see section 401(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51 et seq.], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

Pub. L. 112–144, title IV, §401(b), July 9, 2012, 126 Stat. 1026, provided that: "The Congress finds that the fees authorized by the amendments made in this title [enacting this section and sections 379j–52 and 379j–53 of this title and amending sections 379d–4 and 379g of this title] will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

§379j–52. Authority to assess and use biosimilar biological product fees

(a) Types of fees

Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Biosimilar biological product development program fees

(A) Initial biosimilar biological product development fee

(i) In general

Each person that submits to the Secretary a meeting request described under clause (ii) or a clinical protocol for an investigational new drug protocol described under clause (iii) shall pay for the product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established under subsection (c)(5).

(ii) Meeting request

The meeting request described in this clause is a request for a biosimilar biological product development meeting for a product.

(iii) Clinical protocol for IND

A clinical protocol for an investigational new drug protocol described in this clause is a clinical protocol consistent with the provisions of section 355(i) of this title, including any regulations promulgated under section 355(i) of this title, (referred to in this section as "investigational new drug application") describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for a product.

(iv) Due date

The initial biosimilar biological product development fee shall be due by the earlier of the following:

(I) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.

(II) The date of submission of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application.

(v) Transition rule

Each person that has submitted an investigational new drug application prior to July 9, 2012, shall pay the initial biosimilar biological product development fee by the earlier of the following:

(I) Not later than 60 days after July 9, 2012, if the Secretary determines that the investigational new drug application describes an investigation that is intended to support a biosimilar biological product application.

(II) Not later than 7 days after the Secretary grants a request for a biosimilar biological product development meeting.

(B) Annual biosimilar biological product development fee

(i) In general

A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal year following the fiscal year in which the initial biosimilar biological product development fee was paid, an annual fee established under subsection (c)(5) for the biosimilar biological product development program (referred to in this section as "annual biosimilar biological product development fee"), except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee.

(ii) Due date

The annual biosimilar biological product development fee for each fiscal year will be due on the later of—

(I) the first business day on or after October 1 of each such year; or

(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(iii) Exception

The annual biosimilar biological product development fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—

(I) submitted a marketing application for the biological product that was accepted for filing;

(II) discontinued participation in the biosimilar biological product development program for the product under subparagraph (C); or

(III) been administratively removed from the biosimilar biological product development program for the product under subparagraph (E)(v).

(iv) Refund

If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is subsequently accepted for filing, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.

(C) Discontinuation of fee obligation

A person may discontinue participation in the biosimilar biological product development program for a product, effective October 1 of a fiscal year, by, not later than August 1 of the preceding fiscal year—

(i) if no investigational new drug application concerning the product has been submitted, submitting to the Secretary a written declaration that the person has no present intention of further developing the product as a biosimilar biological product; or

(ii) if an investigational new drug application concerning the product has been submitted, withdrawing the investigational new drug application in accordance with part 312 of title 21, Code of Federal Regulations (or any successor regulations).

(D) Reactivation fee

(i) In general

A person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C), or who has been administratively removed from such program for a product under subparagraph (E)(v), shall, if the person seeks to resume participation in such program, pay all annual biosimilar biological product development fees previously assessed for such product and still owed and a fee (referred to in this section as "reactivation fee") by the earlier of the following:

(I) Not later than 7 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued or the date of administrative removal, as applicable).

(II) Upon the date of submission (after the date on which such participation was discontinued or the date of administrative removal, as applicable) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.

(ii) Application of annual fee

A person that pays a reactivation fee for a product shall pay for such product, beginning in the next fiscal year, the annual biosimilar biological product development fee under subparagraph (B), except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee.

(E) Effect of failure to pay fees

(i) No biosimilar biological product development meetings

If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), the Secretary shall not provide a biosimilar biological product development meeting relating to the product for which fees are owed.

(ii) No receipt of investigational new drug applications

Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under section 355(i)(2) of this title if—

(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

(II) the sponsor has failed to pay an initial or annual biosimilar biological product development fee for the product as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D).

(iii) Financial hold

Notwithstanding section 355(i)(2) of this title, except in extraordinary circumstances, the Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if—

(I) the Secretary determines that the investigation is intended to support a biosimilar biological product application; and

(iv) No acceptance of biosimilar biological product applications or supplements

If a person has failed to pay an initial or annual biosimilar biological product development fee as required under subparagraph (A) or (B), or a reactivation fee as required under subparagraph (D), any biosimilar biological product application or supplement submitted by that person shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.

(v) Administrative removal from the biosimilar biological product development program

If a person has failed to pay an annual biosimilar biological product development fee for a product as required under subparagraph (B) for a period of 2 consecutive fiscal years, the Secretary may administratively remove such person from the biosimilar biological product development program for the product. At least 30 days prior to administratively removing a person from the biosimilar biological product development program for a product under this clause, the Secretary shall provide written notice to such person of the intended administrative removal.

(F) Limits regarding fees

(i) Refunds

Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).

(ii) No waivers, exemptions, or reductions

The Secretary shall not grant a waiver, exemption, or reduction of any initial or annual biosimilar biological product development fee due or payable under subparagraph (A) or (B), or any reactivation fee due or payable under subparagraph (D).

(2) Biosimilar biological product application fee

(A) In general

Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:

(i) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.

(ii) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).

(B) Rule of applicability; treatment of certain previously paid fees

Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall—

(i) be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and

(ii) be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).

(C) Payment due date

Any fee required by subparagraph (A) shall be due upon submission of the application for which such fee applies.

(D) Exception for previously filed application

If a biosimilar biological product application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a biosimilar biological product application for the same product by the same person (or the person's licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).

(E) Refund of application fee if application refused for filing or withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under this paragraph for any application which is refused for filing or withdrawn without a waiver before filing.

(F) Fees for applications previously refused for filing or withdrawn before filing

A biosimilar biological product application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived under subsection (d).

(3) Biosimilar biological product program fee

(A) In general

Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that—

(i) is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year;

(ii) may be dispensed only under prescription pursuant to section 353(b) of this title; and

(iii) as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.

(B) Due date

The biosimilar biological product program fee for a fiscal year shall be due on the later of—

(i) the first business day on or after October 1 of each such year; or

(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

(C) One fee per product per year

The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.

(D) Limitation

A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.

(E) Movement to discontinued list

(i) Date of inclusion

If a written request to place a product on the list referenced in subparagraph (A) of discontinued biosimilar biological products is submitted to the Secretary on behalf of an applicant, and the request identifies the date the product is, or will be, withdrawn from sale, then for purposes of assessing the biosimilar biological product program fee, the Secretary shall consider such product to have been included on such list on the later of—

(I) the date such request was received; or

(II) if the product will be withdrawn from sale on a future date, such future date when the product is withdrawn from sale.

(ii) Treatment as withdrawn from sale

For purposes of clause (i), a product shall be considered withdrawn from sale once the applicant has ceased its own distribution of the product, whether or not the applicant has ordered recall of all previously distributed lots of the product, except that a routine, temporary interruption in supply shall not render a product withdrawn from sale.

(iii) Special rule for products removed from discontinued list

If a biosimilar biological product that is identified in a biosimilar biological product application approved as of October 1 of a fiscal year appears, as of October 1 of such fiscal year, on the list referenced in subparagraph (A) of discontinued biosimilar biological products, and on any subsequent day during such fiscal year the biosimilar biological product does not appear on such list, except as provided in subparagraph (D), each person who is named as the applicant in a biosimilar biological product application with respect to such product shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for such biosimilar biological product. Notwithstanding subparagraph (B), such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for each fiscal year.

(b) Fee revenue amounts

(1) In general

For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—

(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(D) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(3));

(E) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(4));

(F) for fiscal year 2023 an additional amount of $4,428,886; and

(G) for fiscal year 2024 an additional amount of $320,569.

(2) Allocation of revenue amount among fees

(A) Allocation

The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—

(i) initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);

(ii) biosimilar biological product application fees under subsection (a)(2); and

(iii) biosimilar biological product program fees under subsection (a)(3).

(B) Biosimilar biological product development fees

The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.

(C) Reactivation fee

The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.

(3) Annual base revenue

For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2023, $43,376,922; and

(B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(4).

(c) Adjustments; annual fee setting

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

(ii) the inflation adjustment percentage under subparagraph (B).

(B) Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years; and

(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years.

(2) Strategic hiring and retention adjustment

For each fiscal year, after the annual base revenue under subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), the Secretary shall further increase the fee revenue and fees by $150,000.

(3) Capacity planning adjustment

(A) In general

For each fiscal year, the Secretary shall, in addition to the adjustments under paragraphs (1) and (2), further adjust the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.

(B) Methodology

For purposes of this paragraph, the Secretary shall employ the capacity planning methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled "Biosimilar User Fee Rates for Fiscal Year 2021" published in the Federal Register on August 4, 2020 (85 Fed. Reg. 47220). The workload categories used in applying such methodology in forecasting shall include only the activities described in that notice and, as feasible, additional activities that are directly related to the direct review of biosimilar biological product applications and supplements, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved biosimilar biological products. Subject to the exceptions in the preceding sentence, the Secretary shall not include as workload categories in applying such methodology in forecasting any non-core review activities, including those activities that the Secretary referenced for potential future use in such notice but did not utilize in setting fees for fiscal year 2021.

(C) Limitations

(D) Publication in Federal Register

The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

(4) Operating reserve adjustment

(A) Increase

For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for at least 10 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.

(B) Decrease

(i) Fiscal year 2023

For fiscal year 2023, if the Secretary has carryover balances for such process in excess of 33 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 33 weeks of such operating reserves.

(ii) Fiscal year 2024

For fiscal year 2024, if the Secretary has carryover balances for such process in excess of 27 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 27 weeks of such operating reserves.

(iii) Fiscal year 2025 and subsequent fiscal years

For fiscal year 2025 and subsequent fiscal years, if the Secretary has carryover balances for such process in excess of 21 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 21 weeks of such operating reserves.

(C) Federal Register notice

If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.

(5) Annual fee setting

For fiscal year 2023 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—

(A) establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue and fees in the Federal Register.

(6) Limit

The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.

(d) Application fee waiver for small business

(1) Waiver of application fee

The Secretary shall grant to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business.

(2) Considerations

In determining whether to grant a waiver of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.

(3) Small business defined

In this subsection, the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in section 379g of this title) or a biosimilar biological product application (as defined in section 379j–51(4) of this title) and introduced or delivered for introduction into interstate commerce.

(e) Effect of failure to pay fees

A biosimilar biological product application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.

(f) Crediting and availability of fees

(1) In general

Subject to paragraph (2), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of biosimilar biological product applications.

(2) Collections and appropriation Acts

(A) In general

Subject to subparagraphs (C) and (D), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year.

(B) Use of fees and limitations

(i) In general

The fees authorized by this section shall be available—

(I) for fiscal year 2023, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $20,000,000, multiplied by the adjustment factor applicable to such fiscal year; and

(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the process for the review of biosimilar biological product applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with the process for the review of biosimilar biological product applications, is no less than $20,000,000, multiplied by the adjustment factor applicable to the fiscal year involved.

(ii) Leasing and necessary equipment

Beginning on October 1, 2023, the authorities under section 379j–51(9)(C) of this title shall include only leasing and necessary scientific equipment.

(C) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable, are not more than 15 percent below the level specified in such subparagraph.

(D) Provision for early payments

(3) Authorization of appropriations

For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.

(g) Collection of unpaid fees

(h) Written requests for waivers and returns; disputes concerning fees

To qualify for consideration for a waiver under subsection (d), or for the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall submit to the Secretary a written request justifying such waiver or return and, except as otherwise specified in this section, such written request shall be submitted to the Secretary not later than 180 days after such fee is due. A request submitted under this paragraph shall include any legal authorities under which the request is made.

(i) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the review of biosimilar biological product applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(June 25, 1938, ch. 675, §744H, as added Pub. L. 112–144, title IV, §402, July 9, 2012, 126 Stat. 1029; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(V), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115–52, title IV, §403, title IX, §905(b)(4), Aug. 18, 2017, 131 Stat. 1028, 1090; Pub. L. 116–136, div. A, title III, §3856(b)(1), Mar. 27, 2020, 134 Stat. 458; Pub. L. 117–180, div. F, title IV, §4003, Sept. 30, 2022, 136 Stat. 2160; Pub. L. 117–328, div. FF, title III, §3625(b), Dec. 29, 2022, 136 Stat. 5880.)

Termination of Section

For termination of section by section 4005(a) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

Amendments

2022—Subsec. (a). Pub. L. 117–180, §4003(a)(1), substituted "fiscal year 2023" for "fiscal year 2018" in introductory provisions.

Subsec. (a)(1)(A)(iv)(I), (v)(II). Pub. L. 117–180, §4003(a)(2), substituted "7 days" for "5 days".

Subsec. (a)(1)(B)(i). Pub. L. 117–180, §4003(a)(3)(A), inserted before period at end ", except that, in the case that such product (including, where applicable, ownership of the relevant investigational new drug application) is transferred to a licensee, assignee, or successor of such person, and written notice of such transfer is provided to the Secretary, such licensee, assignee, or successor shall pay the annual biosimilar biological product development fee".

Subsec. (a)(1)(B)(iii)(III). Pub. L. 117–180, §4003(a)(3)(B), added subcl. (III).

Subsec. (a)(1)(B)(iv). Pub. L. 117–180, §4003(a)(3)(C), substituted "is subsequently accepted for filing" for "is accepted for filing on or after October 1 of such fiscal year".

Subsec. (a)(1)(D). Pub. L. 117–180, §4003(a)(4), amended subpar. (D) generally. Prior to amendment, subpar. (D) related to payment of a reactivation fee for resuming participation in the biosimilar biological product development program and application of annual biosimilar biological product development fee for a person paying a reactivation fee.

Subsec. (a)(1)(E)(v). Pub. L. 117–180, §4003(a)(5), added cl. (v).

Subsec. (a)(2)(D). Pub. L. 117–180, §4003(a)(6), inserted "prior to approval" after "or was withdrawn".

Subsec. (a)(3)(A)(ii), (iii). Pub. L. 117–180, §4003(a)(7)(A), added cl. (ii) and redesignated former cl. (ii) as (iii).

Subsec. (a)(3)(E). Pub. L. 117–180, §4003(a)(7)(B), added subpar. (E).

Subsec. (a)(4). Pub. L. 117–180, §4003(a)(8), struck out par. (4) which related to the annual fee for each biosimilar biological product in a biosimilar biological product application.

Subsec. (b)(1). Pub. L. 117–180, §4003(b)(2), (3), redesignated par. (2) as (1) and amended it generally. Prior to amendment, par. related to fee revenue amounts for fiscal years 2019 through 2022. Former par. (1) struck out.

Pub. L. 117–180, §4003(b)(1), struck out par. (1) which related to fee revenue amounts for fiscal year 2018.

Subsec. (b)(2). Pub. L. 117–180, §4003(b)(2), (4)(A), redesignated par. (3) as (2) and struck out "; limitations on fee amounts" after "among fees" in heading. Former par. (2) redesignated (1).

Subsec. (b)(2)(B) to (D). Pub. L. 117–180, §4003(b)(4)(B), (C), redesignated subpars. (C) and (D) as (B) and (C), respectively, and struck out former subpar. (B). Prior to amendment, text of subpar. (B) read as follows: "Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection (a) for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018."

Subsec. (b)(3), (4). Pub. L. 117–180, §4003(b)(2), (5), redesignated par. (4) as (3) and amended it generally. Prior to amendment, text read as follows: "For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3)." Former par. (3) redesignated (2).

Subsec. (c)(1)(A). Pub. L. 117–180, §4003(c)(1)(A)(i), substituted "subsection (b)(1)(B)" for "subsection (b)(2)(B)" in introductory provisions.

Subsec. (c)(1)(A)(i). Pub. L. 117–180, §4003(c)(1)(A)(ii), substituted "subsection (b)(1)(A)" for "subsection (b)".

Subsec. (c)(1)(B)(ii). Pub. L. 117–180, §4003(c)(1)(B), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV".

Subsec. (c)(2) to (4). Pub. L. 117–180, §4003(c)(2), added pars. (2) to (4) and struck out former pars. (2) to (4) which related to application and methodology of capacity planning adjustment, operating reserve adjustment, and fiscal year 2018 adjustment, respectively.

Subsec. (c)(5). Pub. L. 117–180, §4003(c)(3), substituted "2023" for "2018" in introductory provisions.

Subsec. (f)(2)(B)(i). Pub. L. 117–328, §3625(b)(1), substituted "available—" for "available for a fiscal year beginning after fiscal year 2012", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023," before "to defray the costs", substituted "such fiscal year; and" for "the fiscal year involved.", and added subcl. (II).

Subsec. (f)(2)(C). Pub. L. 117–328, §3625(b)(2), substituted "subparagraph (B)(i) in any fiscal year if the costs allocated as described in subclause (I) or (II) of such subparagraph, as applicable," for "subparagraph (B) in any fiscal year if the costs described in such subparagraph".

Subsec. (f)(3). Pub. L. 117–180, §4003(d), substituted "2023 through 2027" for "2018 through 2022".

Subsec. (h). Pub. L. 117–180, §4003(e), amended subsec. (h) generally. Prior to amendment, text read as follows: "To qualify for consideration for a waiver under subsection (d), or for a refund of any fee collected in accordance with subsection (a)(2)(A), a person shall submit to the Secretary a written request for such waiver or refund not later than 180 days after such fee is due."

2020—Subsec. (f)(2)(B). Pub. L. 116–136, §3856(b)(1), amended Pub. L. 115–52, §905(b)(4). See 2017 Amendment note below.

2017—Subsec. (a). Pub. L. 115–52, §403(a)(1), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.

Subsec. (a)(1). Pub. L. 115–52, §403(a)(2), substituted "Biosimilar biological product" for "Biosimilar" in heading.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §403(a)(3), substituted "(c)(5)" for "(b)(1)(A)".

Subsec. (a)(1)(B)(i). Pub. L. 115–52, §403(a)(4), substituted "(c)(5) for the biosimilar biological product development program" for "(b)(1)(B) for biosimilar biological product development".

Subsec. (a)(1)(B)(ii). Pub. L. 115–52, §403(a)(5), substituted "annual biosimilar biological product development fee" for "annual biosimilar biological product development program fee" in introductory provisions.

Subsec. (a)(1)(B)(iii). Pub. L. 115–52, §403(a)(6), substituted "annual biosimilar biological product development fee" for "annual biosimilar development program fee".

Subsec. (a)(1)(B)(iv). Pub. L. 115–52, §403(a)(7), added cl. (iv).

Subsec. (a)(1)(C). Pub. L. 115–52, §403(a)(8), substituted "for a product, effective October 1 of a fiscal year, by," for "for a product effective October 1 of a fiscal year by," in introductory provisions.

Subsec. (a)(1)(D)(i). Pub. L. 115–52, §403(a)(9)(A), inserted ", if the person seeks to resume participation in such program," before "pay a fee" in introductory provisions.

Subsec. (a)(1)(D)(i)(I). Pub. L. 115–52, §403(a)(9)(B), inserted "by such person" after "grants a request".

Subsec. (a)(1)(D)(i)(II). Pub. L. 115–52, §403(a)(9)(C), inserted "by such person" after "discontinued)".

Subsec. (a)(1)(E). Pub. L. 115–52, §403(a)(10), struck out "biosimilar development program" after "pay" in heading.

Subsec. (a)(1)(F). Pub. L. 115–52, §403(a)(11)(A), struck out "biosimilar development program" after "regarding" in heading.

Subsec. (a)(1)(F)(i). Pub. L. 115–52, §403(a)(11)(B), amended cl. (i) generally. Prior to amendment, text read as follows: "The Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D)."

Subsec. (a)(2). Pub. L. 115–52, §403(a)(12)(A), struck out "and supplement" after "application" in heading.

Subsec. (a)(2)(A), (B). Pub. L. 115–52, §403(a)(12)(B), amended subpars. (A) and (B) generally. Prior to amendment, subpars. (A) and (B) related to the fee for a biosimilar biological product application or a supplement submitted on or after Oct. 1, 2012, and to a reduction in certain fees, respectively.

Subsec. (a)(2)(C). Pub. L. 115–52, §403(a)(12)(D), struck out "or supplement" after "application".

Subsec. (a)(2)(D). Pub. L. 115–52, §403(a)(12)(C)–(E), in heading, struck out "or supplement" after "application" and in text, substituted "application was submitted" for "application or supplement was submitted", "application, was accepted" for "application or supplement, was accepted", and "application for the same product" for "application or a supplement for the same product".

Subsec. (a)(2)(E). Pub. L. 115–52, §403(a)(12)(D), struck out "or supplement" after "application".

Subsec. (a)(2)(F). Pub. L. 115–52, §403(c)(2), substituted "subsection (d)" for "subsection (c)".

Pub. L. 115–52, §403(a)(12)(D), struck out "or supplement" after "application".

Subsec. (a)(3). Pub. L. 115–52, §403(a)(13), amended par. (3) generally. Prior to amendment, par. (3) consisted of subpars. (A) to (E) which related to biosimilar biological product establishment fee, assessment, due date, assessment and division of fee for a biosimilar biological product establishment that manufactures for multiple applicants, and exception for new products, respectively.

Subsec. (a)(4)(A). Pub. L. 115–52, §403(c)(3), substituted "subsection (c)(5)" for "subsection (b)(1)(F)".

Subsec. (b). Pub. L. 115–52, §403(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) consisted of pars. (1) and (2) which related to fee amounts and limit to total amount of fees, respectively.

Subsec. (c). Pub. L. 115–52, §403(c)(4), added subsec. (c). Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 115–52, §403(c)(1), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (e).

Subsec. (d)(1). Pub. L. 115–52, §403(d), substituted "affiliate shall pay" for "affiliate shall pay—" and "not a small business." for "not a small business; and", struck out subpar. (A) designation before "application fees for all", and struck out subpar. (B) which read as follows: "all supplement fees for all supplements to biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business."

Subsec. (e). Pub. L. 115–52, §403(e), substituted "all such fees" for "all fees".

Pub. L. 115–52, §403(c)(1), redesignated subsec. (d) as (e). Former subsec. (e) redesignated (f).

Subsec. (f). Pub. L. 115–52, §403(c)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).

Subsec. (f)(2)(B). Pub. L. 115–52, §905(b)(4), as amended by Pub. L. 116–136, §3856(b)(1), substituted "limitations" for "limitation" in heading, designated existing provisions as cl. (i) and inserted heading, and added cl. (ii).

Subsec. (f)(2)(C). Pub. L. 115–52, §403(f)(1)(A), added subpar. (C) and struck out former subpar. (C). Prior to amendment, text read as follows: "Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain available until expended."

Subsec. (f)(2)(D). Pub. L. 115–52, §403(f)(1)(B), struck out "in subsequent years" after "payments" in heading and "(after fiscal year 2013)" after "fiscal year" in text.

Subsec. (f)(3). Pub. L. 115–52, §403(f)(2), substituted "2018 through 2022" for "2013 through 2017".

Subsec. (g). Pub. L. 115–52, §403(c)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h).

Subsec. (h). Pub. L. 115–52, §403(c)(2), substituted "subsection (d)" for "subsection (c)".

Pub. L. 115–52, §403(c)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i).

Subsec. (i). Pub. L. 115–52, §403(c)(1), redesignated subsec. (h) as (i).

2016—Subsec. (a)(1)(A)(v). Pub. L. 114–255, §3101(a)(2)(V)(i), which directed technical amendment in paragraph (1)(A)(v) to reference in original act which appears in text as reference to July 9, 2012, was executed by making the amendment in introductory provisions and in subcl. (I), to reflect the probable intent of Congress.

Subsec. (a)(2)(B). Pub. L. 114–255, §3101(a)(2)(V)(ii), substituted "Biosimilar User Fee Act of 2012" for "Biosimilars User Fee Act of 2012".

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2022, see section 4006 of Pub. L. 117–180, set out as a note under section 379j–51 of this title.

Effective Date of 2020 Amendment

Pub. L. 116–136, div. A, title III, §3856(b)(2), Mar. 27, 2020, 134 Stat. 458, provided that: "The amendment made by paragraph (1) [amending Pub. L. 115–52 which amended this section] shall take effect as of the enactment of the FDA Reauthorization Act of 2017 (Public Law 115–52)."

Effective Date of 2017 Amendment

Amendment by section 403 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2017, see section 406 of Pub. L. 115–52, set out as a note under section 379j–51 of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2027, see section 4005(a) of Pub. L. 117–180, set out as a note under section 379j–51 of this title.

Section effective Oct. 1, 2012, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.

§379j–53. Reauthorization; reporting requirements

(a) Performance report

(1) General requirements

Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort.

(2) Additional information

The report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—

(A) information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort;

(B) the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and

(C) the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals ² letters issued by the agency for such applications.

(3) Real time reporting

(A) In general

Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.

(B) Data

The Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022.

(ii) The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022.

(4) Rationale for BSUFA program changes

Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 4001(b) of the Biosimilar User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j–52 of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying—

(i) drivers of such changes; and

(ii) changes in the average total cost per full-time equivalent in the biosimilar biological product review program;

(D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application.

(5) Analysis

For each fiscal year, the Secretary shall include in the report an analysis of the following:

(A) The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year.

(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance enhancement goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year.

(C) The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022.

(b) Fiscal report

(c) Corrective action report

For each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(1) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the biosimilar biological product application review process.

(2) Goals missed

For each of the goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(A) a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

(d) Enhanced communication

(1) Communications with Congress

(2) Participation in congressional hearing

(e) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for the process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Prior public input

Prior to beginning negotiations with the regulated industry on the reauthorization of this subpart, the Secretary shall—

(A) publish a notice in the Federal Register requesting public input on the reauthorization;

(B) hold a public meeting at which the public may present its views on the reauthorization;

(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and

(D) publish the comments on the Food and Drug Administration's website.

(3) Periodic consultation

(4) Updates to Congress

(5) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(6) Transmittal of recommendations

Not later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(7) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the public website of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

(B) Content

(June 25, 1938, ch. 675, §744I, as added Pub. L. 112–144, title IV, §403, July 9, 2012, 126 Stat. 1037; amended Pub. L. 115–52, title IV, §404, title IX, §§903(d), 904(d), Aug. 18, 2017, 131 Stat. 1035, 1081, 1087; Pub. L. 117–180, div. F, title IV, §4004, Sept. 30, 2022, 136 Stat. 2166; Pub. L. 117–328, div. FF, title III, §3626(d), Dec. 29, 2022, 136 Stat. 5886.)

Termination of Section

For termination of section by section 4005(b) of Pub. L. 117–180, see Effective and Termination Dates note set out below.

Editorial Notes

References in Text

Section 401(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsecs. (a) and (c), probably should be a reference to section 4001(b) of the Biosimilar User Fee Amendments of 2022, title IV of div. F of Pub. L. 117–180, which is set out as a note under section 379j–51 of this title. The Biosimilar User Fee Amendments of 2022 does not contain a section 401(b).

Section 4001(b) of the Biosimilar User Fee Amendments of 2022, referred to in subsec. (a)(4)(A), is section 4001(b) of title IV of div. F of Pub. L. 117–180, which is set out as a note under section 379j–51 of this title.

Codification

Amendments made by section 904(d)(2) of Pub. L. 115–52, effective Aug. 18, 2017, were executed after the amendments made by section 404(3)–(5) of Pub. L. 115–52, effective Oct. 1, 2017, to reflect the probable intent of Congress and the directory language of section 904(d)(2) of Pub. L. 115–52, which expressly amended this section "as amended by section 404" of Pub. L. 115–52. See 2017 Amendment notes below.

Amendments

2022—Pub. L. 117–180, §4004(2), substituted "Biosimilar User Fee Amendments of 2022" for "Biosimilar User Fee Amendments of 2017" wherever appearing.

Subsec. (a)(1). Pub. L. 117–180, §4004(1), substituted "Not" for "Beginning with fiscal year 2018, not".

Subsec. (a)(2). Pub. L. 117–180, §4004(3), substituted "The" for "Beginning with fiscal year 2018, the" in introductory provisions.

Subsec. (a)(3)(A). Pub. L. 117–180, §4004(4), substituted "Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart" for "Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter".

Subsec. (a)(4)(A). Pub. L. 117–328, §3626(d)(1)(A), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2022 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;".

Subsec. (a)(4)(B). Pub. L. 117–328, §3626(d)(1)(B), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: "data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying drivers of such changes; and".

Subsec. (a)(4)(D). Pub. L. 117–328, §3626(d)(1)(C), (D), added subpar. (D).

Subsec. (b). Pub. L. 117–180, §4004(5), substituted "Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart" for "Not later than 120 days after the end of fiscal year 2018 and each subsequent fiscal year for which fees are collected under this subpart".

Subsec. (c). Pub. L. 117–180, §4004(6), substituted "For" for "Beginning with fiscal year 2018, and for" in introductory provisions.

Subsec. (f)(1). Pub. L. 117–180, §4004(7)(A), substituted "fiscal year 2027" for "fiscal year 2022" in introductory provisions.

Subsec. (f)(2). Pub. L. 117–328, §3626(d)(2)(B), added par. (2). Former par. (2) redesignated (5).

Subsec. (f)(3). Pub. L. 117–328, §3626(d)(2)(B), added par. (3). Former par. (3) redesignated (6).

Pub. L. 117–180, §4004(7)(B), substituted "January 15, 2027" for "January 15, 2022".

Subsec. (f)(4) to (7). Pub. L. 117–328, §3626(d)(2), added pars. (4) and (7) and redesignated formers pars. (2) and (3) as (5) and (6), respectively.

2017—Subsec. (a). Pub. L. 115–52, §903(d), designated existing provisions as par. (1), inserted heading, and added pars. (2) to (4).

Pub. L. 115–52, §404(1), substituted "2018" for "2013" and "Biosimilar User Fee Amendments of 2017" for "Biosimilar User Fee Act of 2012".

Subsec. (a)(5). Pub. L. 115–52, §904(d)(1), added par. (5).

Subsec. (b). Pub. L. 115–52, §404(2), substituted "2018" for "2013".

Subsec. (c). Pub. L. 115–52, §904(d)(2), added subsec. (c). Former subsec. (c) redesignated (e).

Subsecs. (d), (e). Pub. L. 115–52, §904(d)(2), added subsec. (d) and redesignated subsec. (c) as (e). Former subsec. (d), as redesignated by section 404(4) of Pub. L. 115–52, redesignated (f). See Amendment notes below.

Pub. L. 115–52, §404(3)–(5), redesignated subsec. (e) as (d), substituted "2022" for "2017" in pars. (1) and (3), and struck out former subsec. (d) which related to a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications.

Subsec. (f). Pub. L. 115–52, §904(d)(2), redesignated subsec. (d) as (f).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Effective Date of 2017 Amendment

Amendment by section 404 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2017, see section 406 of Pub. L. 115–52, set out as a note under section 379j–51 of this title.

Effective and Termination Dates

Pub. L. 117–180, div. F, title IV, §4005(b), Sept. 30, 2022, 136 Stat. 2166, provided that: "Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) shall cease to be effective January 31, 2028."

Pub. L. 115–52, title IV, §405(b), Aug. 18, 2017, 131 Stat. 1035, which provided that this section would cease to be effective Jan. 31, 2023, was repealed by Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166.

[Pub. L. 117–180, div. F, title IV, §4005(c), Sept. 30, 2022, 136 Stat. 2166, provided that the repeal of section 405(b) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]

Pub. L. 112–144, title IV, §404(b), July 9, 2012, 126 Stat. 1038, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title IV, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035.

[Pub. L. 115–52, title III, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(b) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]

Section effective Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.

¹ See References in Text note below.

² So in original.

subpart 9—fees relating to outsourcing facilities

§379j–61. Definitions

In this subpart:

(1) The term "affiliate" has the meaning given such term in section 379g(11) of this title.

(2) The term "gross annual sales" means the total worldwide gross annual sales, in United States dollars, for an outsourcing facility, including the sales of all the affiliates of the outsourcing facility.

(3) The term "outsourcing facility" has the meaning given to such term in section 353b(d)(4) of this title.

(4) The term "reinspection" means, with respect to an outsourcing facility, 1 or more inspections conducted under section 374 of this title subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this chapter, specifically to determine whether compliance has been achieved to the Secretary's satisfaction.

(June 25, 1938, ch. 675, §744J, as added Pub. L. 113–54, title I, §102(b), Nov. 27, 2013, 127 Stat. 593.)

§379j–62. Authority to assess and use outsourcing facility fees

(a) Establishment and reinspection fees

(1) In general

For fiscal year 2015 and each subsequent fiscal year, the Secretary shall, in accordance with this subsection, assess and collect—

(A) an annual establishment fee from each outsourcing facility; and

(B) a reinspection fee from each outsourcing facility subject to a reinspection in such fiscal year.

(2) Multiple reinspections

An outsourcing facility subject to multiple reinspections in a fiscal year shall be subject to a reinspection fee for each reinspection.

(b) Establishment and reinspection fee setting

The Secretary shall—

(1) establish the amount of the establishment fee and reinspection fee to be collected under this section for each fiscal year based on the methodology described in subsection (c); and

(2) publish such fee amounts in a Federal Register notice not later than 60 calendar days before the start of each such year.

(c) Amount of establishment fee and reinspection fee

(1) In general

For each outsourcing facility in a fiscal year—

(A) except as provided in paragraph (4), the amount of the annual establishment fee under subsection (b) shall be equal to the sum of—

(i) $15,000, multiplied by the inflation adjustment factor described in paragraph (2); plus

(ii) the small business adjustment factor described in paragraph (3); and

(B) the amount of any reinspection fee (if applicable) under subsection (b) shall be equal to $15,000, multiplied by the inflation adjustment factor described in paragraph (2).

(2) Inflation adjustment factor

(A) In general

For fiscal year 2015 and subsequent fiscal years, the fee amounts established in paragraph (1) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of—

(i) 1;

(ii) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years; plus

(iii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the Food and Drug Administration for the first 3 years of the preceding 4 fiscal years.

(B) Compounded basis

The adjustment made each fiscal year under subparagraph (A) shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under subparagraph (A).

(3) Small business adjustment factor

The small business adjustment factor described in this paragraph shall be an amount established by the Secretary for each fiscal year based on the Secretary's estimate of—

(A) the number of small businesses that will pay a reduced establishment fee for such fiscal year; and

(B) the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the Secretary would have collected if no entity qualified for the small business exception in paragraph (4).

(4) Exception for small businesses

(A) In general

In the case of an outsourcing facility with gross annual sales of $1,000,000 or less in the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which the fees under this section are assessed, the amount of the establishment fee under subsection (b) for a fiscal year shall be equal to \1/3\ of the amount calculated under paragraph (1)(A)(i) for such fiscal year.

(B) Application

To qualify for the exception under this paragraph, a small business shall submit to the Secretary a written request for such exception, in a format specified by the Secretary in guidance, certifying its gross annual sales for the 12 months ending April 1 of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed. Any such application shall be submitted to the Secretary not later than April 30 of such immediately preceding fiscal year.

(5) Crediting of fees

In establishing the small business adjustment factor under paragraph (3) for a fiscal year, the Secretary shall—

(A) provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of the small business adjustment factor for such previous fiscal year; and

(B) consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.

(d) Use of fees

The Secretary shall make all of the fees collected pursuant to subparagraphs (A) and (B) of subsection (a)(1) available solely to pay for the costs of oversight of outsourcing facilities.

(e) Supplement not supplant

Funds received by the Secretary pursuant to this section shall be used to supplement and not supplant any other Federal funds available to carry out the activities described in this section.

(f) Crediting and availability of fees

Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the costs of oversight of outsourcing facilities.

(g) Collection of fees

(1) Establishment fee

An outsourcing facility shall remit the establishment fee due under this section in a fiscal year when submitting a registration pursuant to section 353b(b) of this title for such fiscal year.

(2) Reinspection fee

The Secretary shall specify in the Federal Register notice described in subsection (b)(2) the manner in which reinspection fees assessed under this section shall be collected and the timeline for payment of such fees. Such a fee shall be collected after the Secretary has conducted a reinspection of the outsourcing facility involved.

(3) Effect of failure to pay fees

(A) Registration

An outsourcing facility shall not be considered registered under section 353b(b) of this title in a fiscal year until the date that the outsourcing facility remits the establishment fee under this subsection for such fiscal year.

(B) Misbranding

All drugs manufactured, prepared, propagated, compounded, or processed by an outsourcing facility for which any establishment fee or reinspection fee has not been paid, as required by this section, shall be deemed misbranded under section 352 of this title until the fees owed for such outsourcing facility under this section have been paid.

(4) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under this section within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31.

(h) Annual report to Congress

Not later than 120 calendar days after each fiscal year in which fees are assessed and collected under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for such year, a summary description of entities paying the fees, a description of the hiring and placement of new staff, a description of the use of fee resources to support inspecting outsourcing facilities, and the number of inspections and reinspections of such facilities performed each year.

(i) Authorization of appropriations

For fiscal year 2014 and each subsequent fiscal year, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.

(June 25, 1938, ch. 675, §744K, as added Pub. L. 113–54, title I, §102(b), Nov. 27, 2013, 127 Stat. 594.)

subpart 10—fees relating to over-the-counter drugs

§379j–71. Definitions

In this subpart:

(1) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(2) The term "contract manufacturing organization facility" means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

(3) The term "costs of resources allocated for OTC monograph drug activities" means the expenses in connection with OTC monograph drug activities for—

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under section 379j–72 of this title and accounting for resources allocated for OTC monograph drug activities.

(4) The term "FDA establishment identifier" is the unique number automatically generated by Food and Drug Administration's Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).

(5) The term "OTC monograph drug" means a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title.

(6) The term "OTC monograph drug activities" means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:

(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—

(i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs;

(ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;

(iii) all OTC monograph drug development and review activities, including intra-agency collaboration;

(iv) regulation and policy development activities related to OTC monograph drugs;

(v) development of product standards for products subject to review and evaluation;

(vi) meetings referred to in section 355h(i) of this title;

(vii) review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and

(viii) regulatory science activities related to OTC monograph drugs.

(B) Inspections related to OTC monograph drugs.

(D) Safety activities with respect to OTC monograph drugs, including—

(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;

(ii) developing and using improved adverse event data-collection systems, including information technology systems; and

(iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.

(E) Other activities necessary for implementation of section 355h of this title.

(7) The term "OTC monograph order request" means a request for an order submitted under section 355h(b)(5) of this title.

(8) The term "Tier 1 OTC monograph order request" means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request.

(9)(A) The term "Tier 2 OTC monograph order request" means, subject to subparagraph (B), an OTC monograph order request for—

(i) the reordering of existing information in the drug facts label of an OTC monograph drug;

(ii) the addition of information to the other information section of the drug facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations);

(iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to section 355h(c)(3)(A) of this title;

(iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;

(v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or

(vi) addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).

(B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 355h of this title.

(10)(A) The term "OTC monograph drug facility" means a foreign or domestic business or other entity that—

(i) is—

(I) under one management, either direct or indirect; and

(II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;

(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and

(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.

(B) For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—

(i) closely related to the same business enterprise;

(ii) under the supervision of the same local management; and

(iii) under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection.

(C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.

(11) The term "OTC monograph drug meeting" means any meeting regarding the content of a proposed OTC monograph order request.

(12) The term "person" includes an affiliate of a person.

(13) The terms "requestor" and "sponsor" have the meanings given such terms in section 355h of this title.

(June 25, 1938, ch. 675, §744L, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 459.)

Statutory Notes and Related Subsidiaries

Finding

Pub. L. 116–136, div. A, title III, §3861, Mar. 27, 2020, 134 Stat. 458, provided that: "The Congress finds that the fees authorized by the amendments made in this part [part II of subtitle F of title III of div. A of Pub. L. 116–136, enacting this subpart] will be dedicated to OTC monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

§379j–72. Authority to assess and use OTC monograph fees

(a) Types of fees

Beginning with fiscal year 2021, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Facility fee

(A) In general

Each person that owns a facility identified as an OTC monograph drug facility on December 31 of the fiscal year or at any time during the preceding 12-month period shall be assessed an annual fee for each such facility as determined under subsection (c).

(B) Exceptions

(i) Facilities that cease activities

A fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—

(I) has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and

(II) has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 360 of this title.

(ii) Contract manufacturing organizations

The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.

(C) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (c).

(D) Due date

(i) For first program year

For fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—

(I) the first business day of July of 2020; or

(II) 45 calendar days after publication of the Federal Register notice provided for under subsection (c)(4)(A).

(ii) Subsequent fiscal years

For each fiscal year after fiscal year 2021, the facility fees required under subparagraph (A) shall be due on the later of—

(I) the first business day of June of such year; or

(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.

(2) OTC monograph order request fee

(A) In general

Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—

(i) for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and

(ii) for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).

(B) Due date

The OTC monograph order request fees required under subparagraph (A) shall be due on the date of submission of the OTC monograph order request.

(C) Exception for certain safety changes

A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—

(i) a contraindication, warning, or precaution;

(ii) a statement about risk associated with misuse or abuse; or

(iii) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.

(D) Refund of fee if order request is recategorized as a Tier 2 OTC monograph order request

If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.

(E) Refund of fee if order request refused for filing or withdrawn before filing

The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any order request which is refused for filing or was withdrawn before being accepted or refused for filing.

(F) Fees for order requests previously refused for filing or withdrawn before filing

An OTC monograph order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest.

(G) Refund of fee if order request withdrawn

If an order request is withdrawn after the order request was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.

(3) Refunds

(A) In general

Other than refunds provided pursuant to any of subparagraphs (D) through (G) of paragraph (2), the Secretary shall not refund any fee paid under paragraph (1) except as provided in subparagraph (B).

(B) Disputes concerning fees

To qualify for the return of a fee claimed to have been paid in error under paragraph (1) or (2), a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.

(4) Notice

Within the timeframe specified in subsection (c), the Secretary shall publish in the Federal Register the amount of the fees under paragraph (1) for such fiscal year.

(b) Fee revenue amounts

(1) Fiscal year 2021

For fiscal year 2021, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—

(A) the annual base revenue for fiscal year 2021 (as determined under paragraph (3));

(B) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2)); and

(2) Subsequent fiscal years

For each of the fiscal years 2022 through 2025, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—

(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(C) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));

(D) additional direct cost adjustments (as determined under subsection (c)(3)); and

(E) additional dollar amounts for each fiscal year as follows:

(i) $7,000,000 for fiscal year 2022.

(ii) $6,000,000 for fiscal year 2023.

(iii) $7,000,000 for fiscal year 2024.

(iv) $3,000,000 for fiscal year 2025.

(3) Annual base revenue

For purposes of paragraphs (1)(A) and (2)(A), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2021, $8,000,000; and

(B) for fiscal years 2022 through 2025, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made under subsection (c)(2) or (c)(3).

(c) Adjustments; annual fee setting

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(2); and

(ii) the inflation adjustment percentage under subparagraph (C).

(B) OTC monograph order request fees

For purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—

(i) the applicable fee under subsection (a)(2) for the preceding fiscal year; and

(ii) the inflation adjustment percentage under subparagraph (C).

(C) Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to—

(i) for each of fiscal years 2022 and 2023, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and

(ii) for each of fiscal years 2024 and 2025, the sum of—

(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and

(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.

(2) Operating reserve adjustment

(A) In general

For fiscal year 2021 and subsequent fiscal years, for purposes of subsections (b)(1)(B) and (b)(2)(C), the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for OTC monograph drug activities for not more than the number of weeks specified in subparagraph (B).

(B) Number of weeks

The number of weeks specified in this subparagraph is—

(i) 3 weeks for fiscal year 2021;

(ii) 7 weeks for fiscal year 2022;

(iii) 10 weeks for fiscal year 2023;

(iv) 10 weeks for fiscal year 2024; and

(v) 10 weeks for fiscal year 2025.

(C) Decrease

If the Secretary has carryover balances for such process in excess of 10 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 10 weeks of such operating reserves.

(D) Rationale for adjustment

If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (4) establishing fee revenue and fees for the fiscal year involved.

(3) Additional direct cost adjustment

The Secretary shall, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees for purposes of subsection (b)(2)(D) by an amount equal to—

(A) $14,000,000 for fiscal year 2021;

(B) $7,000,000 for fiscal year 2022;

(D) $3,000,000 for fiscal year 2024; and

(E) $3,000,000 for fiscal year 2025.

(4) Annual fee setting

(A) Fiscal year 2021

The Secretary shall, not later than the second Monday in May of 2020—

(i) establish OTC monograph drug facility fees for fiscal year 2021 under subsection (a), based on the revenue amount for such year under subsection (b) and the adjustments provided under this subsection; and

(ii) publish fee revenue, facility fees, and OTC monograph order requests in the Federal Register.

(B) Subsequent fiscal years

The Secretary shall, for each fiscal year that begins after September 30, 2021, not later than the second Monday in March that precedes such fiscal year—

(i) establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—

(I) OTC monograph drug facility fees under subsection (a)(1); and

(II) OTC monograph order request fees under subsection (a)(2); and

(ii) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.

(d) Identification of facilities

Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—

(1) be submitted as part of the requirements for drug establishment registration set forth in section 360 of this title; and

(2) include for each such facility, at a minimum, identification of the facility's business operation as that of an OTC monograph drug facility.

(e) Effect of failure to pay fees

(1) OTC monograph drug facility fee

(A) In general

Failure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:

(i) The Secretary shall place the facility on a publicly available arrears list.

(ii) All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(ff) of this title.

(B) Application of penalties

The penalties under this paragraph shall apply until the fee established by subsection (a)(1) is paid.

(2) Order requests

An OTC monograph order request submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person under this section have been paid.

(3) Meetings

A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.

(f) Crediting and availability of fees

(1) In general

(2) Collections and appropriation Acts

(A) In general

Subject to subparagraph (C), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year.

(B) Use of fees and limitation

The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for OTC monograph drug activities (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved under subsection (c)(1).

(C) Compliance

The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs funded by appropriations and allocated for OTC monograph drug activities are not more than 15 percent below the level specified in such subparagraph.

(D) Provision for early payments in subsequent years

Payment of fees authorized under this section for a fiscal year (after fiscal year 2021), prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3) Authorization of appropriations

For each of the fiscal years 2021 through 2025, there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section.

(g) Collection of unpaid fees

(h) Construction

This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in OTC monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(June 25, 1938, ch. 675, §744M, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 461.)

§379j–73. Reauthorization; reporting requirements

(a) Performance report

Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 3861(b) ¹ of the CARES Act during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.

(b) Fiscal report

Not later than 120 calendar days after the end of fiscal year 2021 and each subsequent fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the internet website of the Food and Drug Administration.

(d) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2025, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(3) Transmittal of recommendations

Not later than January 15, 2025, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(June 25, 1938, ch. 675, §744N, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 468.)

Editorial Notes

References in Text

Section 3861(b) of the CARES Act, referred to in subsec. (a), probably means section 3861 of Pub. L. 116–136, div. A, title III, Mar. 27, 2020, 134 Stat. 458, which is set out as a note under section 379j–71 of this title. Section 3861 of Pub. L. 116–136 does not contain subsecs.

¹ See References in Text note below.

Part D—Information and Education

§379k. Information system

The Secretary shall establish and maintain an information system to track the status and progress of each application or submission (including a petition, notification, or other similar form of request) submitted to the Food and Drug Administration requesting agency action.

(June 25, 1938, ch. 675, §745, formerly §741, as added Pub. L. 105–115, title IV, §407(a), Nov. 21, 1997, 111 Stat. 2370; renumbered §745, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Report on Status of System

Pub. L. 105–115, title IV, §407(b), Nov. 21, 1997, 111 Stat. 2370, provided that not later than 1 year after Nov. 21, 1997, Secretary of Health and Human Services was to submit report to Congress on status of system to be established under this section, including projected costs of system and concerns about confidentiality.

§379k–1. Electronic format for submissions

(a) Drugs and biologics

(1) In general

Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of section 355 of this title or subsection (a) or (k) of section 262 of title 42 shall be submitted in such electronic format as specified by the Secretary in such guidance.

(2) Guidance contents

In the guidance under paragraph (1), the Secretary may—

(A) provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and

(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.

(3) Exception

This subsection shall not apply to submissions described in section 360bbb of this title.

(b) Devices

(1) In general

Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 of this title or section 262 of title 42, and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions.

(2) Guidance contents

In the guidance under paragraph (1), the Secretary may—

(A) provide standards for the electronic copy required under such paragraph; and

(B) set forth criteria for waivers of and exemptions from the requirements of this subsection.

(3) Presubmissions and submissions solely in electronic format

(A) In general

Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.

(B) Draft guidance

The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—

(i) any further standards for the submission by electronic format required under subparagraph (A);

(ii) a timetable for the establishment by the Secretary of such further standards; and

(iii) criteria for waivers of and exemptions from the requirements of this subsection.

(C) Final guidance

The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.

(June 25, 1938, ch. 675, §745A, as added Pub. L. 112–144, title XI, §1136, July 9, 2012, 126 Stat. 1123; amended Pub. L. 115–52, title II, §207, Aug. 18, 2017, 131 Stat. 1019.)

Editorial Notes

Amendments

2017—Subsec. (b)(3). Pub. L. 115–52 added par. (3).

Statutory Notes and Related Subsidiaries

Effective Date of 2017 Amendment

Amendment by title II of Pub. L. 115–52, effective Oct. 1, 2017, except that fees under subpart 3 of part C of this subchapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

§379l. Education

(a) In general

The Secretary shall conduct training and education programs for the employees of the Food and Drug Administration relating to the regulatory responsibilities and policies established by this chapter, including programs for—

(1) scientific training;

(2) training to improve the skill of officers and employees authorized to conduct inspections under section 374 of this title;

(3) training to achieve product specialization in such inspections; and

(4) training in administrative process and procedure and integrity issues.

(b) Intramural fellowships and other training programs

The Secretary, acting through the Commissioner, may, through fellowships and other training programs, conduct and support intramural research training for predoctoral and postdoctoral scientists and physicians. Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services.

(June 25, 1938, ch. 675, §746, formerly §742, as added Pub. L. 105–115, title IV, §408(a), Nov. 21, 1997, 111 Stat. 2371; amended Pub. L. 110–85, title VI, §601(c), Sept. 27, 2007, 121 Stat. 897; renumbered §746, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

Editorial Notes

Prior Provisions

A prior section 746 of act June 25, 1938, was renumbered section 749 and is classified to section 379o of this title.

Amendments

2007—Subsec. (b). Pub. L. 110–85 inserted at end "Any such fellowships and training programs under this section or under section 379dd(d)(2)(A)(ix) of this title may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services."

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part E—Environmental Impact Review

§379o. Environmental impact

Notwithstanding any other provision of law, an environmental impact statement prepared in accordance with the regulations published in part 25 of title 21, Code of Federal Regulations (as in effect on August 31, 1997) in connection with an action carried out under (or a recommendation or report relating to) this chapter, shall be considered to meet the requirements for a detailed statement under section 4332(2)(C) of title 42.

(June 25, 1938, ch. 675, §749, formerly §746, as added Pub. L. 105–115, title IV, §411, Nov. 21, 1997, 111 Stat. 2373; renumbered §749, Pub. L. 110–316, title II, §202(a), Aug. 14, 2008, 122 Stat. 3515.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part F—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics

§379r. National uniformity for nonprescription drugs

(a) In general

Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political subdivision of a State may establish or continue in effect any requirement—

(1) that relates to the regulation of a drug that is not subject to the requirements of section 353(b)(1) or 353(f)(1)(A) of this title; and

(2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

(b) Exemption

(1) In general

Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement that—

(A) protects an important public interest that would otherwise be unprotected, including the health and safety of children;

(B) would not cause any drug to be in violation of any applicable requirement or prohibition under Federal law; and

(2) Timely action

The Secretary shall make a decision on the exemption of a State or political subdivision requirement under paragraph (1) not later than 120 days after receiving the application of the State or political subdivision under paragraph (1).

(c) Scope

(1) In general

This section shall not apply to—

(A) any State or political subdivision requirement that relates to the practice of pharmacy; or

(B) any State or political subdivision requirement that a drug be dispensed only upon the prescription of a practitioner licensed by law to administer such drug.

(2) Safety or effectiveness

For purposes of subsection (a), a requirement that relates to the regulation of a drug shall be deemed to include any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug.

(d) Exceptions

(1) In general

In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 355 of this title or section 357 of this title (as in effect on the day before November 21, 1997) or a final order under section 355h of this title by the Secretary establishing conditions under which the drug is generally recognized as safe and effective, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with—

(A) a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or

(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997.

(2) State initiatives

This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

(e) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(f) State enforcement authority

Nothing in this section shall prevent a State or political subdivision thereof from enforcing, under any relevant civil or other enforcement authority, a requirement that is identical to a requirement of this chapter.

(June 25, 1938, ch. 675, §751, as added Pub. L. 105–115, title IV, §412(a), Nov. 21, 1997, 111 Stat. 2373; amended Pub. L. 116–136, div. A, title III, §3851(c), Mar. 27, 2020, 134 Stat. 454.)

Editorial Notes

References in Text

The Poison Prevention Packaging Act of 1970, referred to in subsec. (a)(2), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

Amendments

2020—Subsec. (d)(1). Pub. L. 116–136, §3851(c)(1), in introductory provisions, substituted "final order under section 355h of this title" for "final regulation promulgated" and struck out "and not misbranded" after "safe and effective".

Subsec. (d)(1)(A). Pub. L. 116–136, §3851(c)(2), substituted "regulation or order in effect" for "regulation in effect".

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

§379s. Preemption for labeling or packaging of cosmetics

(a) In general

Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

(b) Exemption

(1) protects an important public interest that would otherwise be unprotected;

(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and

(3) would not unduly burden interstate commerce.

(c) Scope

For purposes of subsection (a), a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relating to public information or any other form of public communication.

(d) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(e) State initiative

This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

(June 25, 1938, ch. 675, §752, as added Pub. L. 105–115, title IV, §412(d), Nov. 21, 1997, 111 Stat. 2376.)

Editorial Notes

References in Text

The Poison Prevention Packaging Act of 1970, referred to in subsec. (a), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat. 1670, which is classified principally to chapter 39A (§1471 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1471 of Title 15 and Tables.

The Fair Packaging and Labeling Act, referred to in subsec. (a), is Pub. L. 89–755, Nov. 3, 1966, 80 Stat. 1296, which is classified generally to chapter 39 (§1451 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 1451 of Title 15 and Tables.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part G—Safety Reports

§379v. Safety report disclaimers

With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a product (including a product that is a food, drug, device, dietary supplement, or cosmetic) under this chapter (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.

(June 25, 1938, ch. 675, §756, as added Pub. L. 105–115, title IV, §420, Nov. 21, 1997, 111 Stat. 2379.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Part H—Serious Adverse Event Reports

§379aa. Serious adverse event reporting for nonprescription drugs

(a) Definitions

In this section:

(1) Adverse event

The term "adverse event" means any health-related event associated with the use of a nonprescription drug that is adverse, including—

(A) an event occurring from an overdose of the drug, whether accidental or intentional;

(B) an event occurring from abuse of the drug;

(D) any failure of expected pharmacological action of the drug.

(2) Nonprescription drug

The term "nonprescription drug" means a drug that is—

(A) not subject to section 353(b) of this title; and

(B) not subject to approval in an application submitted under section 355 of this title.

(3) Serious adverse event

The term "serious adverse event" is an adverse event that—

(A) results in—

(i) death;

(ii) a life-threatening experience;

(iii) inpatient hospitalization;

(iv) a persistent or significant disability or incapacity; or

(v) a congenital anomaly or birth defect; or

(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(4) Serious adverse event report

The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).

(b) Reporting requirement

(1) In general

The manufacturer, packer, or distributor whose name (pursuant to section 352(b)(1) of this title) appears on the label of a nonprescription drug marketed in the United States (referred to in this section as the "responsible person") shall submit to the Secretary any report received of a serious adverse event associated with such drug when used in the United States, accompanied by a copy of the label on or within the retail package of such drug.

(2) Retailer

A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the nonprescription drug to submit the required reports for such drugs to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such drug that are reported to the retailer through the address or telephone number described in section 352(x) of this title.

(c) Submission of reports

(1) Timing of reports

The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received through the address or phone number described in section 352(x) of this title.

(2) New medical information

The responsible person shall submit to the Secretary any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after the new information is received by the responsible person.

(3) Consolidation of reports

The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.

(4) Exemption

The Secretary, after providing notice and an opportunity for comment from interested parties, may establish an exemption to the requirements under paragraphs (1) and (2) if the Secretary determines that such exemption would have no adverse effect on public health.

(d) Contents of reports

Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for nonprescription drugs, and may be accompanied by additional information.

(e) Maintenance and inspection of records

(1) Maintenance

The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.

(2) Records inspection

(A) In general

The responsible person shall permit an authorized person to have access to records required to be maintained under this section, during an inspection pursuant to section 374 of this title.

(B) Authorized person

For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services who has—

(i) appropriate credentials, as determined by the Secretary; and

(ii) been duly designated by the Secretary to have access to the records required under this section.

(f) Protected information

A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be—

(1) a safety report under section 379v of this title and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event; and

(2) a record about an individual under section 552a of title 5 (commonly referred to as the "Privacy Act of 1974") and a medical or similar file the disclosure of which would constitute a violation of section 552 of such title 5 (commonly referred to as the "Freedom of Information Act"), and shall not be publicly disclosed unless all personally identifiable information is redacted.

(g) Rule of construction

The submission of any adverse event report in compliance with this section shall not be construed as an admission that the nonprescription drug involved caused or contributed to the adverse event.

(h) Preemption

(1) In general

No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for nonprescription drugs, that is different from, in addition to, or otherwise not identical to, this section.

(2) Effect of section

(A) In general

Nothing in this section shall affect the authority of the Secretary to provide adverse event reports and information to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, under a memorandum of understanding between the Secretary and such State, territory, or political subdivision.

(B) Personally-identifiable information

Notwithstanding any other provision of law, personally-identifiable information in adverse event reports provided by the Secretary to any health, food, or drug officer or employee of any State, territory, or political subdivision of a State or territory, shall not—

(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

(C) Use of safety reports

Nothing in this section shall permit a State, territory, or political subdivision of a State or territory, to use any safety report received from the Secretary in a manner inconsistent with subsection (g) or section 379v of this title.

(i) Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary.

(June 25, 1938, ch. 675, §760, as added Pub. L. 109–462, §2(a), Dec. 22, 2006, 120 Stat. 3469.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109–462, set out as an Effective Date of 2006 Amendment note under section 352 of this title.

Modifications

Pub. L. 109–462, §2(b), Dec. 22, 2006, 120 Stat. 3472, provided that: "The Secretary of Health and Human Services may modify requirements under the amendments made by this section [enacting this section and amending sections 331 and 352 of this title] in accordance with section 553 of title 5, United States Code, to maintain consistency with international harmonization efforts over time."

Guidance

Pub. L. 109–462, §2(e)(3), Dec. 22, 2006, 120 Stat. 3472, provided that: "Not later than 270 days after the date of enactment of this Act [Dec. 22, 2006], the Secretary of Health and Human Services shall issue guidance on the minimum data elements that should be included in a serious adverse event report described under the amendments made by this Act [see Short Title of 2006 Amendment note set out under section 301 of this title]."

Pub. L. 109–462, §3(d)(3), Dec. 22, 2006, 120 Stat. 3475, enacted provisions substantially identical to those enacted by Pub. L. 109–462, §2(e)(3), set out above.

§379aa–1. Serious adverse event reporting for dietary supplements

(a) Definitions

In this section:

(1) Adverse event

The term "adverse event" means any health-related event associated with the use of a dietary supplement that is adverse.

(2) Serious adverse event

The term "serious adverse event" is an adverse event that—

(A) results in—

(i) death;

(ii) a life-threatening experience;

(iii) inpatient hospitalization;

(iv) a persistent or significant disability or incapacity; or

(v) a congenital anomaly or birth defect; or

(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).

(3) Serious adverse event report

The term "serious adverse event report" means a report that is required to be submitted to the Secretary under subsection (b).

(b) Reporting requirement

(1) In general

The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 343(e)(1) of this title) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the "responsible person") shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.

(2) Retailer

A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number described in section 343(y) of this title.

(c) Submission of reports

(1) Timing of reports

(2) New medical information

(3) Consolidation of reports

The Secretary shall develop systems to ensure that duplicate reports of, and new medical information related to, a serious adverse event shall be consolidated into a single report.

(4) Exemption

(d) Contents of reports

Each serious adverse event report under this section shall be submitted to the Secretary using the MedWatch form, which may be modified by the Secretary for dietary supplements, and may be accompanied by additional information.

(e) Maintenance and inspection of records

(1) Maintenance

The responsible person shall maintain records related to each report of an adverse event received by the responsible person for a period of 6 years.

(2) Records inspection

(A) In general

The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 374 of this title.

(B) Authorized person

For purposes of this paragraph, the term "authorized person" means an officer or employee of the Department of Health and Human Services, who has—

(i) appropriate credentials, as determined by the Secretary; and

(ii) been duly designated by the Secretary to have access to the records required under this section.

(f) Protected information

(g) Rule of construction

The submission of any adverse event report in compliance with this section shall not be construed as an admission that the dietary supplement involved caused or contributed to the adverse event.

(h) Preemption

(1) In general

No State or local government shall establish or continue in effect any law, regulation, order, or other requirement, related to a mandatory system for adverse event reports for dietary supplements, that is different from, in addition to, or otherwise not identical to, this section.

(2) Effect of section

(A) In general

(B) Personally-identifiable information

(i) be made publicly available pursuant to any State or other law requiring disclosure of information or records; or

(ii) otherwise be disclosed or distributed to any party without the written consent of the Secretary and the person submitting such information to the Secretary.

(C) Use of safety reports

(i) Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary.

(June 25, 1938, ch. 675, §761, as added Pub. L. 109–462, §3(a), Dec. 22, 2006, 120 Stat. 3472.)

Statutory Notes and Related Subsidiaries

Effective Date

Section effective 1 year after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109–462, set out as an Effective Date of 2006 Amendment note under section 343 of this title.

Part I—Reagan-Udall Foundation for the Food and Drug Administration

§379dd. Establishment and functions of the Foundation

(a) In general

A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this part as the "Foundation") shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e).¹ The Foundation shall not be an agency or instrumentality of the United States Government.

(b) Purpose of Foundation

The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

(c) Duties of the Foundation

The Foundation shall—

(1) taking into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics, and including the incorporation of more sensitive and predictive tools and devices to measure safety;

(2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1);

(3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural research and development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;

(4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements with, scientists and entities, which may include the Food and Drug Administration, university consortia, public-private partnerships, institutions of higher education, entities described in section 501(c)(3) of title 26 (and exempt from tax under section 501(a) of such title), and industry, to efficiently and effectively advance the goals and priorities established under paragraph (2);

(5) recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to further the goals and priorities established under paragraph (2);

(6) release and publish information and data and, to the extent practicable, license, distribute, and release material, reagents, and techniques to maximize, promote, and coordinate the availability of such material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organizations, and academic and industrial researchers to further the goals and priorities established under paragraph (2);

(7) ensure that—

(A) action is taken as necessary to obtain patents for inventions developed by the Foundation or with funds from the Foundation;

(B) action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; and

(C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation to further the goals and priorities established under paragraph (2);

(8) provide objective clinical and scientific information to the Food and Drug Administration and, upon request, to other Federal agencies to assist in agency determinations of how to ensure that regulatory policy accommodates scientific advances and meets the agency's public health mission;

(9) conduct annual assessments of the unmet needs identified in paragraph (1); and

(10) carry out such other activities consistent with the purposes of the Foundation as the Board determines appropriate.

(d) Board of Directors

(1) Establishment

(A) In general

The Foundation shall have a Board of Directors (referred to in this part as the "Board"), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members.

(B) Ex officio members

The ex officio members of the Board shall be the following individuals or their designees:

(i) The Commissioner.

(ii) The Director of the National Institutes of Health.

(iii) The Director of the Centers for Disease Control and Prevention.

(iv) The Director of the Agency for Healthcare Research and Quality.

(C) Appointed members

(i) In general

The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such appointed members—

(I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries;

(II) 3 shall be representatives of academic research organizations;

(III) 2 shall be representatives of patient or consumer advocacy organizations;

(IV) 1 shall be a representative of health care providers; and

(V) 4 shall be at-large members with expertise or experience relevant to the purpose of the Foundation.

(ii) Additional members

The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries.

(iii) Requirements

(I) Expertise

The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.

(II) Federal employees

No employee of the Federal Government shall be appointed as a member of the Board under this subparagraph or under paragraph (3)(B). For purposes of this section, the term "employee of the Federal Government" does not include a special Government employee, as that term is defined in section 202(a) of title 18.

(D) Initial meeting

(i) In general

Not later than 30 days after September 27, 2007, the Secretary shall convene a meeting of the ex officio members of the Board to—

(I) incorporate the Foundation; and

(II) appoint the members of the Board in accordance with subparagraph (C).

(ii) Service of ex officio members

Upon the appointment of the members of the Board under clause (i)(II)—

(I) the terms of service of the Director of the Centers for Disease Control and Prevention and of the Director of the Agency for Healthcare Research and Quality as ex officio members of the Board shall terminate; and

(II) the Commissioner and the Director of the National Institutes of Health shall continue to serve as ex officio members of the Board, but shall be nonvoting members.

(iii) Chair

The ex officio members of the Board under subparagraph (B) shall designate an appointed member of the Board to serve as the Chair of the Board.

(2) Duties of Board

The Board shall—

(A) establish bylaws for the Foundation that—

(i) are published in the Federal Register and available for public comment;

(ii) establish policies for the selection of the officers, employees, agents, and contractors of the Foundation;

(iii) establish policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation, including appropriate limits on the ability of donors to designate, by stipulation or restriction, the use or recipient of donated funds;

(iv) establish policies that would subject all employees, fellows, and trainees of the Foundation to the conflict of interest standards under section 208 of title 18;

(v) establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions developed by the Foundation or with Foundation funds to carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging cost-based fees for published material produced by the Foundation;

(vi) specify principles for the review of proposals and awarding of grants and contracts that include peer review and that are consistent with those of the Foundation for the National Institutes of Health, to the extent determined practicable and appropriate by the Board;

(vii) specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agreement from the Foundation;

(viii) establish policies for the execution of memoranda of understanding and cooperative agreements between the Foundation and other entities, including the Food and Drug Administration;

(ix) establish policies for funding training fellowships, whether at the Foundation, academic or scientific institutions, or the Food and Drug Administration, for scientists, doctors, and other professionals who are not employees of regulated industry, to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic research into clinical and regulatory practice;

(x) specify a process for annual Board review of the operations of the Foundation; and

(xi) establish specific duties of the Executive Director;

(B) prioritize and provide overall direction to the activities of the Foundation;

(D) carry out any other necessary activities regarding the functioning of the Foundation.

(3) Terms and vacancies

(A) Term

The term of office of each member of the Board appointed under paragraph (1)(C)(i), and the term of office of any member of the Board whose position is established pursuant to paragraph (1)(C)(ii), shall be 4 years, except that—

(i) the terms of offices for the members of the Board initially appointed under paragraph (1)(C)(i) shall expire on a staggered basis as determined by the ex officio members; and

(ii) the terms of office for the persons initially appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered basis, as determined by the individuals who, as of the date of the amendment establishing such positions, are members of the Board.

(B) Vacancy

Any vacancy in the membership of the Board—

(i) shall not affect the power of the remaining members to execute the duties of the Board; and

(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.

(C) Partial term

If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.

(D) Serving past term

A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed.

(4) Compensation

Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board.

(e) Incorporation

The ex officio members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.

(f) Nonprofit status

In carrying out subsection (b), the Board shall establish such policies and bylaws under subsection (d), and the Executive Director shall carry out such activities under subsection (g), as may be necessary to ensure that the Foundation maintains status as an organization that—

(1) is described in subsection (c)(3) of section 501 of title 26; and

(2) is, under subsection (a) of such section, exempt from taxation.

(g) Executive Director

(1) In general

The Board shall appoint an Executive Director who shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.

(2) Compensation

The compensation of the Executive Director shall be fixed by the Board.

(h) Administrative powers

In carrying out this part, the Board, acting through the Executive Director, may—

(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;

(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary, and define their duties;

(3) prescribe the manner in which—

(A) real or personal property of the Foundation is acquired, held, and transferred;

(B) general operations of the Foundation are to be conducted; and

(4) with the consent of the applicable executive department or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section;

(5) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;

(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation under subsection (i);

(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board considers appropriate to conduct the activities of the Foundation;

(8) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this part;

(9) take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees;

(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;

(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the Foundation; and

(12) exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this part.

(i) Acceptance of funds from other sources

The Executive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or bequests of real or personal property made to the Foundation, including from private entities, for the purposes of carrying out the duties of the Foundation.

(j) Service of Federal employees

Federal Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its functions, so long as such employees do not direct or control Foundation activities.

(k) Detail of Government employees; fellowships

(1) Detail from Federal agencies

Federal Government employees may be detailed from Federal agencies with or without reimbursement to those agencies to the Foundation at any time, and such detail shall be without interruption or loss of civil service status or privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards applicable to the employees of the agency from which such employee is detailed and those of the Foundation.

(2) Voluntary service; acceptance of Federal employees

(A) Foundation

The Executive Director of the Foundation may accept the services of employees detailed from Federal agencies with or without reimbursement to those agencies.

(B) Food and Drug Administration

The Commissioner may accept the uncompensated services of Foundation fellows or trainees. Such services shall be considered to be undertaking an activity under contract with the Secretary as described in section 379 of this title.

(l) Annual reports

(1) Reports to Foundation

Any recipient of a grant, contract, fellowship, memorandum of understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a report on an annual basis for the duration of such grant, contract, fellowship, memorandum of understanding, or cooperative agreement, that describes the activities carried out under such grant, contract, fellowship, memorandum of understanding, or cooperative agreement.

(2) Report to Congress and the FDA

Beginning with fiscal year 2009, the Executive Director shall submit to Congress and the Commissioner an annual report that—

(A) describes the activities of the Foundation and the progress of the Foundation in furthering the goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated product development;

(B) provides a specific accounting of the source and use of all funds used by the Foundation to carry out such activities; and

(C) provides information on how the results of Foundation activities could be incorporated into the regulatory and product review activities of the Food and Drug Administration.

(m) Separation of funds

The Executive Director shall ensure that the funds received from the Treasury are managed as individual programmatic funds under subsection (i), according to best accounting practices.

(n) Funding

From amounts appropriated to the Food and Drug Administration for each fiscal year, the Commissioner shall transfer not less than $1,250,000 and not more than $5,000,000, to the Foundation to carry out subsections (a), (b), and (d) through (m).

(June 25, 1938, ch. 675, §770, as added Pub. L. 110–85, title VI, §601(a), Sept. 27, 2007, 121 Stat. 890; amended Pub. L. 114–255, div. A, title III, §3076, Dec. 13, 2016, 130 Stat. 1139; Pub. L. 117–101, §2(a), Mar. 15, 2022, 136 Stat. 47.)

Editorial Notes

Amendments

2022—Subsec. (n). Pub. L. 117–101 substituted "$1,250,000 and not more than $5,000,000" for "$500,000 and not more than $1,250,000".

2016—Subsec. (d)(1)(C)(ii). Pub. L. 114–255, §3076(a)(1)(B), added cl. (ii). Former cl. (ii) redesignated (iii).

Subsec. (d)(1)(C)(iii). Pub. L. 114–255, §3076(a)(1)(A), redesignated cl. (ii) as (iii).

Subsec. (d)(1)(C)(iii)(I). Pub. L. 114–255, §3076(a)(1)(C), substituted "The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure" for "The ex officio members shall ensure".

Subsec. (d)(1)(C)(iii)(II). Pub. L. 114–255, §3076(a)(2), inserted at end "For purposes of this section, the term 'employee of the Federal Government' does not include a special Government employee, as that term is defined in section 202(a) of title 18."

Subsec. (d)(3)(A). Pub. L. 114–255, §3076(a)(3), amended subpar. (A) generally. Prior to amendment, text read as follows: "The term of office of each member of the Board appointed under paragraph (1)(C) shall be 4 years, except that the terms of offices for the initial appointed members of the Board shall expire on a staggered basis as determined by the ex officio members."

Subsec. (g)(2). Pub. L. 114–255, §3076(b), struck out before period at end "but shall not be greater than the compensation of the Commissioner".

Subsec. (m). Pub. L. 114–255, §3076(c), substituted "are managed as individual programmatic funds under subsection (i), according to best accounting practices" for "are held in separate accounts from funds received from entities under subsection (i)".

¹ So in original. Probably should be "subsection (g)."

§379dd–1. Location of Foundation

The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.

(June 25, 1938, ch. 675, §771, as added Pub. L. 110–85, title VI, §601(b), Sept. 27, 2007, 121 Stat. 897.)

§379dd–2. Activities of the Food and Drug Administration

(a) In general

The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under section 379dd(l)(2) of this title.

(b) Report to Congress

Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report summarizing the incorporation of the information provided by the Foundation in the report described under section 379dd(l)(2) of this title and by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product review activities of the Food and Drug Administration.

(c) Extramural grants

The provisions of this part and section 360bbb–5 of this title shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the Food and Drug Administration and any other entity entered into before, on, or after September 27, 2007.

(June 25, 1938, ch. 675, §772, as added Pub. L. 110–85, title VI, §601(b), Sept. 27, 2007, 121 Stat. 897.)