21 USC CHAPTER 9, SUBCHAPTER VII, Part C: Fees

From Title 21—FOOD AND DRUGSCHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER VII—GENERAL AUTHORITY

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) of this section. 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.)

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, an allergenic extract product, or 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) The term "prescription drug product" means a specific strength or potency of a drug in final dosage form—

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

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

(C) 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).

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, 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.

(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.

(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.)

Termination of Section

For termination of section by section 105(a) of Pub. L. 112–144, see Termination Date note below.

Amendments

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).

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. 112–144, title I, §105(a), July 9, 2012, 126 Stat. 1001, 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, 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. 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. 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 sections 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)."

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 2013, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Human drug application and supplement fee

(A) In general

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

(i) A fee established under subsection (c)(4) of this section 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)(4) of this section for a human drug application for which clinical data with respect to safety or effectiveness are not required or a supplement for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required. 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 or supplement.

(C) Exception for previously filed application or supplement

If a human drug application or supplement 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), the submission of a human drug application or a supplement 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 or supplement 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 or supplement 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 or indication

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. 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.

(G) Refund of fee if application withdrawn

If an application or supplement is withdrawn after the application or supplement was filed, the Secretary may refund the fee or a portion of the fee 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 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.

(2) Prescription drug establishment fee

(A) In general

Except as provided in subparagraphs (B) and (C), each person that—

(i) is named as the applicant in a human drug application; and

(ii) after September 1, 1992, had pending before the Secretary a human drug application or supplement,

shall be assessed an annual fee established under subsection (c)(4) of this section for each prescription drug establishment listed in its approved human drug application as an establishment that manufactures the prescription drug product named in the application. The annual establishment fee shall be assessed in each fiscal year in which the prescription drug product named in the application is assessed a fee under paragraph (3) unless the prescription drug establishment listed in the application does not engage in the manufacture of the prescription drug product during the fiscal year. The establishment 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. Each such establishment shall be assessed only one fee per establishment, notwithstanding the number of prescription drug products manufactured at the establishment. In the event an establishment is listed in a human drug application by more than one applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the applicants whose prescription drug products are manufactured by the establishment during the fiscal year and assessed product fees under paragraph (3).

(B) Exception

If, during the fiscal year, an applicant initiates or causes to be initiated the manufacture of a prescription drug product at an establishment listed in its human drug application—

(i) that did not manufacture the product in the previous fiscal year; and

(ii) for which the full establishment fee has been assessed in the fiscal year at a time before manufacture of the prescription drug product was begun;

the applicant will not be assessed a share of the establishment fee for the fiscal year in which the manufacture of the product began.

(C) Special rules for positron emission tomography drugs

(i) In general

Except as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a positron emission tomography drug shall be subject under subparagraph (A) to one-sixth of an annual establishment fee with respect to each such establishment identified in the application as producing positron emission tomography drugs under the approved application.

(ii) Exception from annual establishment fee

Each person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that—

(I) the person is a not-for-profit medical center that has only 1 establishment for the production of positron emission tomography drugs; and

(II) at least 95 percent of the total number of doses of each positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center.

(iii) Definition

For purposes of this subparagraph, 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.

(3) Prescription drug product fee

(A) In general

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) of this section. 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.

(B) Exception

A prescription drug product shall not be assessed a fee 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.

(b) Fee revenue amounts

(1) In general

For each of the fiscal years 2013 through 2017, 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) $693,099,000;

(B) the dollar amount equal to the inflation adjustment for fiscal year 2013 (as determined under paragraph (3)(A)); and

(2) Types of fees

Of the total revenue amount determined for a fiscal year under paragraph (1)—

(A) one-third shall be derived from fees under subsection (a)(1) (relating to human drug applications and supplements);

(B) one-third shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments); and

(3) Fiscal year 2013 inflation and workload adjustments

For purposes of paragraph (1), the dollar amount of the inflation and workload adjustments for fiscal year 2013 shall be determined as follows:

(A) Inflation adjustment

The inflation adjustment for fiscal year 2013 shall be the sum of—

(i) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(B); and

(ii) $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(C).

(B) Workload adjustment

Subject to subparagraph (C), the workload adjustment for fiscal 2013 shall be—

(i) $652,709,000 plus the amount of the inflation adjustment calculated under subparagraph (A); multiplied by

(ii) the amount (if any) by which a percentage workload adjustment for fiscal year 2013, as determined using the methodology described in subsection (c)(2)(A), would exceed the percentage workload adjustment (as so determined) for fiscal year 2012, if both such adjustment percentages were calculated using the 5-year base period consisting of fiscal years 2003 through 2007.

(C) Limitation

Under no circumstances shall the adjustment under subparagraph (B) result in fee revenues for fiscal year 2013 that are less than the sum of the amount under paragraph (1)(A) and the amount under paragraph (1)(B).

(c) Adjustments

(1) Inflation adjustment

For fiscal year 2014 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 by the 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 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

(C) 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 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.

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 2013 under this paragraph.

(2) Workload adjustment

For fiscal year 2014 and subsequent fiscal years, 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 for the process for the review of human drug applications. With respect to such adjustment:

(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of 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. 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 sum of the amount under subsection (b)(1)(A) and the amount under subsection (b)(1)(B), as adjusted for inflation under paragraph (1).

(C) The Secretary shall contract with an independent accounting or consulting firm to periodically review the adequacy of the adjustment and publish the results of those reviews. The first review shall be conducted and published by the end of fiscal year 2013 (to examine the performance of the adjustment since fiscal year 2009), and the second review shall be conducted and published by the end of fiscal year 2015 (to examine the continued performance of the adjustment). The reports shall evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity and present options to discontinue, retain, or modify any elements of the adjustment. The reports shall be published for public comment. After review of the reports and receipt of public comments, the Secretary shall, if warranted, adopt appropriate changes to the methodology. If the Secretary adopts changes to the methodology based on the first report, the changes shall be effective for the first fiscal year for which fees are set after the Secretary adopts such changes and each subsequent fiscal year.

(3) Final year adjustment

For fiscal year 2017, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for the process for the review of human drug applications for the first 3 months of fiscal year 2018. 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 2017. If the Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjustment under this paragraph shall not be made.

(4) Annual fee setting

The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2012, establish, for the next fiscal year, application, product, and establishment fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection.

(5) 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) of this section 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,

(C) 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

(D) the applicant involved is a small business submitting its first human drug application to the Secretary for review.

(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) Use of standard costs

In making the finding in paragraph (1)(C), the Secretary may use standard costs.

(4) Rules relating to small businesses

(A) "Small business" defined

In paragraph (1)(D), 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)(D) 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—

(i) 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; and

(ii) 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.

(e) Effect of failure to pay fees

A human drug application or supplement submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid.

(f) Limitations

(1) In general

Fees under subsection (a) of this section 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

If the Secretary does not assess fees under subsection (a) of this section 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 human drug applications and supplements, prescription drug establishments, and prescription drug products 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.

(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 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.

(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 human drug applications—

(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 2013 through 2017, 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) and paragraph (4) of this subsection.

(4) Offset

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.

(h) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) of this section 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, and refunds

To qualify for consideration for a waiver or reduction under subsection (d) of this section, or for a refund of any fee collected in accordance with subsection (a) of this section, 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, 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 product and establishment 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 product and establishment 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 during the previous year.

(2) Evidence of qualification

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.

(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.)

Termination of Section

For termination of section by section 105(a) of Pub. L. 112–144, see Termination Date note below.

References in Text

Section 357 of this title, referred to in subsec. (a)(3)(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)(3)(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.

Amendments

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) of this section shall be refunded for a fiscal year beginning" for "Fees may not be assessed under subsection (a) of this section 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) of this section shall be adjusted by the Secretary" for "The total fee revenues established by the schedule in subsection (b)(1) of this section 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) 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." for "October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) of this section 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).

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 to terminate Oct. 1, 2017, see section 105(a) of Pub. L. 112–144, 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."

§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.)

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) of the Prescription Drug User Fee Amendments of 2012 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; and

(viii) the number of breakthrough designations for a fiscal year for each review division.

(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.

(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 human drug applications for the first 5 fiscal years after fiscal year 2017, 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) 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, 2017, 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.

(6) Minutes of negotiation meetings

(A) Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to the Congress, 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.

(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, §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.)

Termination of Section

For termination of section by section 105(b) of Pub. L. 112–144, see Effective and Termination Dates note below.

References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2012, referred to in subsec. (a)(1)(A), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title.

Amendments

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".

Effective Date of 2012 Amendment

Effective and Termination Dates

Pub. L. 112–144, title I, §105(b), July 9, 2012, 126 Stat. 1001, 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, 2018."

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.

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)(6) 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 "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, and premarket notification submissions:

(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, and submissions.

(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, and premarket notification submissions.

(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, or submissions and related activities.

(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, or submissions.

(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, or premarket notification submissions.

(9) 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, and submissions.

(10) 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 2011.

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

(12) 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.

(13) 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.)

Termination of Section

For termination of section by section 207(a) of Pub. L. 112–144, see Effective and Termination Dates note below.

Amendments

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".

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. 112–144, title II, §207(a), July 9, 2012, 126 Stat. 1007, provided that: "Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i [379i]; 739j [379j]) shall cease to be effective October 1, 2017. Section 738A (21 U.S.C. 739j–1 [379j–1]) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2018."

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 Provision

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."

Findings

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 [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. 107–250, 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 2013, 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), (e), and (f) of this section, each person who submits any of the following, on or after October 1, 2012, shall be subject to a fee established under subsection (c) of this section 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 75 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 2 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).

(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, or premarket notification submission 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, or premarket notification submission 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, or periodic reporting concerning a class III device. 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) and subsection (f), 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

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. 450 et seq.]), unless a device manufactured by the establishment is to be distributed commercially.

(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), (f), and (i), for each of fiscal years 2013 through 2017, 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 2013	Fiscal Year 2014	Fiscal Year 2015	Fiscal Year 2016	Fiscal Year 2017
Premarket Application	$248,000	$252,960	$258,019	$263,180	$268,443
Establishment Registration	$2,575	$3,200	$3,750	$3,872	$3,872

(3) Total revenue amounts specified

For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

(A) $97,722,301 for fiscal year 2013.

(B) $112,580,497 for fiscal year 2014.

(D) $129,339,949 for fiscal year 2016.

(E) $130,184,348 for fiscal year 2017.

(c) Annual fee setting; adjustments

(1) In general

The Secretary shall, 60 days before the start of each fiscal year after September 30, 2012, 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 2014 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 to total revenue amounts

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.

(C) Base inflation adjustment to total revenue amounts

(i) In general

Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus—

(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 0.60; 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 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 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).

(3) Volume-based adjustments to establishment registration base fees

For each of fiscal years 2014 through 2017, 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 further adjusted, 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) Limit

(5) 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) of this section 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 (v) and clauses (vii), (ix), and (x) 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 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, or periodic reporting concerning a class III device; 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) of this section. 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) of this section 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 50 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) of this section. The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.

(f) Fee waiver or reduction

(1) In general

The Secretary may, at the Secretary's sole discretion, grant a waiver or reduction of fees under subsection (a)(2) or (a)(3) if the Secretary finds that such waiver or reduction is in the interest of public health.

(2) Limitation

The sum of all fee waivers or reductions granted by the Secretary in any fiscal year under paragraph (1) shall not exceed 2 percent of the total fee revenue amounts established for such year under subsection (c).

(3) Duration

The authority provided by this subsection terminates October 1, 2017.

(g) 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, or periodic reporting concerning a class III device 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 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.

(h) 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 $280,587,000 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, 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.

(i) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) of this section 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 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.

(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) Authorizations of appropriations

For each of the fiscal years 2013 through 2017, 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) and, for fiscal year 2017 only, as further adjusted under paragraph (4).

(4) Offset

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.

(j) Collection of unpaid fees

(k) Written requests for refunds

To qualify for consideration for a refund under subsection (a)(2)(D) of this section, a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.

(l) 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.)

Termination of Section

For termination of section by section 207(a) of Pub. L. 112–144, see Effective and Termination Dates note below.

References in Text

The Indian Self Determination and Educational Assistance Act, referred to in subsec. (a)(3)(B), 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 subchapter II (§450 et seq.) of chapter 14 of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 450 of Title 25 and Tables.

Amendments

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)".

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, 2017, see section 207(a) of Pub. L. 112–144, 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

Beginning with fiscal year 2013, 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) of the Medical Device User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(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) of the Medical Device User Fee Amendments Act of 2012, 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) Fiscal report

For fiscal years 2013 through 2017, 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.

(3) 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 2017, 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) 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, 2017, 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, §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.)

Termination of Section

For termination of section by section 207(a) of Pub. L. 112–144, see Effective and Termination Dates note below.

References in Text

Section 201(b) of the Medical Device User Fee Amendments of 2012, referred to in subsec. (a)(1)(A), (B), is section 201(b) of Pub. L. 112–144, which is set out as a note under section 379i of this title.

Amendments

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".

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

Section ceases to be effective Jan. 31, 2018, see section 207(a) of Pub. L. 112–144, set out as a note under section 379i of this title.

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.

subpart 4—fees relating to animal drugs

Termination of Subpart

For termination of subpart by section 5 of Pub. L. 108–130, see Termination Date note set out under section 379j–11 of this title.

For savings provisions, see section 106 of Pub. L. 110–316, set out as a note under section 379j–11 of this title.

§379j–11. Definitions

For purposes of this subpart:

(1) 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.

(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.

(9) The term "costs of resources allocated for the process for the review of animal drug applications" means the expenses incurred 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.)

Amendment of Section

For termination of amendment by section 108(a) of Pub. L. 110–316, see Effective and Termination Dates of 2008 Amendment note below.

Termination of Section

For termination of section by section 5 of Pub. L. 108–130, see Termination Date note below.

For savings provisions, see section 106 of Pub. L. 110–316, set out as a note below.

Amendments

2008—Par. (6). Pub. L. 110–316, §§102(1), 108(a), temporarily 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". See Effective and Termination Dates of 2008 Amendment note below.

Par. (8)(H). Pub. L. 110–316, §§102(2), 108(a), temporarily substituted "but not after such application has been approved" for "but not such activities after an animal drug has been approved". See Effective and Termination Dates of 2008 Amendment note below.

Par. (10). Pub. L. 110–316, §§102(3), 108(a), temporarily substituted "month being October 2002" for "year being 2003". See Effective and Termination Dates of 2008 Amendment note below.

Pars. (11), (12). Pub. L. 110–316, §§102(4), (5), 108(a), temporarily added par. (11) and redesignated former par. (11) as (12). See Effective and Termination Dates of 2008 Amendment note below.

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)".

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, provided that:

"(a) Authorization.—The amendments made by sections 102 and 103 [amending this section and section 379j–12 of this title] cease to be effective October 1, 2013.

"(b) Reporting Requirements.—The amendment made by section 104 [enacting section 379j–13 of this title] ceases to be effective January 31, 2014."

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. 108–130, §5, Nov. 18, 2003, 117 Stat. 1371, provided that: "The amendments made by section 3 [enacting this subpart] shall not be in effect after October 1, 2008, and section 4 [enacting provisions set out as a note below] shall not be in effect after 120 days after such date."

Savings Provisions

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] (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. 110–316, title I, §101(b), Aug. 14, 2008, 122 Stat. 3509, provided that: "Congress finds that the fees authorized by the amendments made in this title [enacting section 379j–13 of this title and amending this section and sections 360b and 379j–12 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."

Pub. L. 108–130, §2, Nov. 18, 2003, 117 Stat. 1361, provided that: "Congress finds as follows:

"(1) Prompt approval of safe and effective new animal drugs is critical to the improvement of animal health and the public health.

"(2) Animal health and 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 review of new animal drug applications.

"(3) The fees authorized by this Act [enacting this subpart and provisions set out as notes under this section and section 301 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 [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."

Accountability and Reports

Pub. L. 108–130, §4, Nov. 18, 2003, 117 Stat. 1370, which required the Secretary of Health and Human Services, after certain consultations, to develop recommendations relating to the review of animal drug applications after fiscal year 2008, to submit to congressional committees a report each fiscal year concerning the progress of the Food and Drug Administration in achieving certain goals toward expediting the animal drug development process and the review of the animal drug applications and investigational animal drug submissions, and to submit a report for each fiscal year to congressional committees on the implementation of the authority for the fees collected under this subpart during the fiscal year and the use, by the Food and Drug Administration, of the fees collected, ceased to be effective 120 days after Oct. 1, 2008. See Termination Date note above.

§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 (b) of this section for an animal drug application, except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title; and

(ii) A fee established in subsection (b), 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; and

(II) an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title.

(B) Payment

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

(C) Exception for previously filed application or supplement

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).

(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

Each person—

(A) 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

(B) 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 (b) of this section. 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 payable on or before January 31 of each year. 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

Each person—

(A) who owns or operates, directly or through an affiliate, an animal drug establishment, and

(B) 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

(C) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,

shall be assessed an annual fee established in subsection (b) of this section 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. 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 shall be paid on or before January 31 of each year. The establishment shall be assessed only one fee per fiscal year under this section: Provided, however, that where 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.

(4) Animal drug sponsor fee

Each person—

(A) who meets the definition of an animal drug sponsor within a fiscal year; and

(B) 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 fee established under subsection (b) of this section. The fee shall be paid on or before January 31 of each year. Each animal drug sponsor shall pay only one such fee each fiscal year.

(b) Fee amounts

Except as provided in subsection (a)(1) of this section and subsections (c), (d), (f), and (g) of this section, the fees required under subsection (a) of this section shall be established to generate fee revenue amounts as follows:

(1) Total fee revenues for application and supplement fees

The total fee revenues to be collected in animal drug application fees under subsection (a)(1)(A)(i) of this section and supplemental and other animal drug application fees under subsection (a)(1)(A)(ii) of this section shall be $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.

(2) Total fee revenues for product fees

The total fee revenues to be collected in product fees under subsection (a)(2) of this section shall be $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.

(3) Total fee revenues for establishment fees

The total fee revenues to be collected in establishment fees under subsection (a)(3) of this section shall be $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.

(4) Total fee revenues for sponsor fees

The total fee revenues to be collected in sponsor fees under subsection (a)(4) of this section shall be $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.

(c) Adjustments

(1) Workload adjustment

The fee revenues shall be adjusted each fiscal year after fiscal year 2009 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 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. 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) of this section.

(2) Final year adjustment

For fiscal year 2013, the Secretary may further increase the fees 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 2014. 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 2013.

(3) Annual fee setting

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) of this section and the adjustments provided under this subsection.

(4) Limit

(d) Fee waiver or reduction

(1) In general

The Secretary shall grant a waiver from or a reduction of 1 or more fees assessed under subsection (a) of this section 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.

(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) of this section 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) of this section 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) of this section 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) of this section 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) of this section relating to the date fees are to be paid.

(g) Crediting and availability of fees

(1) In general

Fees authorized under subsection (a) of 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 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—

(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 only be collected and 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

(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).

(3) Authorization of appropriations

There are authorized to be appropriated for fees under this section—

(A) $15,260,000 for fiscal year 2009;

(B) $17,280,000 for fiscal year 2010;

(D) $21,768,000 for fiscal year 2012; and

(E) $24,244,000 for fiscal year 2013;

as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees.

(4) Offset

If the sum of the cumulative amount of fees collected under this section for fiscal years 2009 through 2011 and the amount of fees estimated to be collected under this section for fiscal year 2012 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2009 through 2012, 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 2013.

(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 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.)

Amendment of Section

For termination of amendment by section 108(a) of Pub. L. 110–316, see Effective and Termination Dates of 2008 Amendment note below.

Termination of Section

For termination of section by section 5 of Pub. L. 108–130, see Termination Date note below.

For savings provisions, see section 106 of Pub. L. 110–316, set out as a note under section 379j–11 of this title.

Amendments

2008—Subsec. (a)(1)(A)(i). Pub. L. 110–316, §§103(a)(1), 108(a), temporarily 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". See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (a)(1)(A)(ii). Pub. L. 110–316, §§103(a)(2), 108(a), temporarily 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)." See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (b)(1). Pub. L. 110–316, §§103(b)(1), 108(a), temporarily 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." See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (b)(2). Pub. L. 110–316, §§103(b)(2), 108(a), temporarily 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." See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (b)(3). Pub. L. 110–316, §§103(b)(3), 108(a), temporarily 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." See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (b)(4). Pub. L. 110–316, §§103(b)(4), 108(a), temporarily 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." See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (c)(1). Pub. L. 110–316, §§103(c)(1)–(3), 108(a), temporarily 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. See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (c)(2). Pub. L. 110–316, §§103(c)(2), (4), 108(a), temporarily redesignated par. (3) as (2) and substituted "2013" for "2008" in two places and "2014" for "2009". Former par. (2) redesignated (1). See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (c)(3) to (5). Pub. L. 110–316, §§103(c)(2), 108(a), temporarily redesignated pars. (4) and (5) as (3) and (4), respectively. Former par. (3) redesignated (2). See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (g)(3)(A) to (E). Pub. L. 110–316, §§103(d), 108(a), temporarily 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;".

See Effective and Termination Dates of 2008 Amendment note below.

Subsec. (g)(4). Pub. L. 110–316, §§103(e), 108(a), temporarily 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." See Effective and Termination Dates of 2008 Amendment note below.

Effective and Termination Dates 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, and ceases to be effective Oct. 1, 2013, see sections 107 and 108(a) of Pub. L. 110–316, set out as notes under section 379j–11 of this title.

Termination Date

Section not effective after Oct. 1, 2008, see section 5 of Pub. L. 108–130, set out as a note under section 379j–11 of this title.

§379j–13. Reauthorization; reporting requirements

(a) Performance report

Beginning with fiscal year 2009, not later than 60 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 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(b) of the Animal Drug User Fee Amendments of 2008 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

Beginning with fiscal year 2009, 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 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.

(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 2013, 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

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, 2013, 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.

(6) Minutes of negotiation meetings

(A) Public availability

Before presenting the recommendations developed under paragraphs (1) through (5) to the 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

(June 25, 1938, ch. 675, §740A, as added Pub. L. 110–316, title I, §104, Aug. 14, 2008, 122 Stat. 3511.)

Termination of Section

For termination of section by section 108(b) of Pub. L. 110–316, see Effective and Termination Dates note below.

References in Text

Section 101(b) of the Animal Drug User Fee Amendments of 2008, referred to in subsec. (a), is section 101(b) of Pub. L. 110–316, which is set out as a note under section 379j–11 of this title.

Effective and Termination Dates

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, and ceases to be effective Jan. 31, 2014, see sections 107 and 108(b) of Pub. L. 110–316, set out as Effective and Termination Dates of 2008 Amendment notes under section 379j–11 of this title.

subpart 5—fees relating to generic new animal drugs

Termination of Subpart

For termination of subpart by section 204 of Pub. L. 110–316, 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 (b) for such an application.

(B) Payment

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

(C) Exception for 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).

(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

Each person—

(A) 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

(B) 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 (b). 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 payable on or before January 31 of each year. 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 fee established under subsection (b). The fee shall be paid on or before January 31 of each year.

(B) 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)(3) 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)(3) 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)(3) for an applicant with 1 or fewer approved abbreviated applications.

(b) Fee amounts

Except as provided in subsection (a)(1) and subsections (c), (d), (f), and (g), the fees required under subsection (a) shall be established to generate fee revenue amounts as follows:

(1) Total fee revenues for application fees

The total fee revenues to be collected in abbreviated application fees under subsection (a)(1) shall be $1,449,000 for fiscal year 2009, $1,532,000 for fiscal year 2010, $1,619,000 for fiscal year 2011, $1,712,000 for fiscal year 2012, and $1,809,000 for fiscal year 2013.

(2) Total fee revenues for product fees

The total fee revenues to be collected in generic new animal drug product fees under subsection (a)(2) shall be $1,691,000 for fiscal year 2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal year 2011, $1,997,000 for fiscal year 2012, and $2,111,000 for fiscal year 2013.

(3) Total fee revenues for sponsor fees

The total fee revenues to be collected in generic new animal drug sponsor fees under subsection (a)(3) shall be $1,691,000 for fiscal year 2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal year 2011, $1,997,000 for fiscal year 2012, and $2,111,000 for fiscal year 2013.

(c) Adjustments

(1) Workload adjustment

The fee revenues shall be adjusted each fiscal year after fiscal year 2009 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).

(2) Final year adjustment

For fiscal year 2013, the Secretary may further increase the fees 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 2014. 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 2013.

(3) Annual fee setting

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.

(4) Limit

(d) Fee waiver or reduction

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.

(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. 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 sponsors, and generic new 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

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—

(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 only be collected and 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).

(3) Authorization of appropriations

There are authorized to be appropriated for fees under this section—

(A) $4,831,000 for fiscal year 2009;

(B) $5,106,000 for fiscal year 2010;

(D) $5,706,000 for fiscal year 2012; and

(E) $6,031,000 for fiscal year 2013;

as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by abbreviated application fees, generic new animal drug sponsor fees, and generic new animal drug product fees.

(4) Offset

If the sum of the cumulative amount of fees collected under this section for the fiscal years 2009 through 2011 and the amount of fees estimated to be collected under this section for fiscal year 2012 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2009 through 2012, 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 2013.

(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, 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 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 incurred 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) 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.

(9) Person

The term "person" includes an affiliate thereof (as such term is defined in section 379g(11) of this title).

(10) 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.

(11) 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.)

Termination of Section

For termination of section by section 204(a) of Pub. L. 110–316, see Termination Date note below.

Prior Provisions

A prior section 741 of act June 25, 1938, was renumbered section 745 and is classified to section 379k of this title.

Termination Date

Pub. L. 110–316, title II, §204(a), Aug. 14, 2008, 122 Stat. 3524, provided that: "The amendments made by section 202 [enacting this section and amending sections 379k, 379l, and 379o of this title] shall cease to be effective October 1, 2013."

Findings

Pub. L. 110–316, title II, §201(b), Aug. 14, 2008, 122 Stat. 3515, provided that: "Congress finds as follows:

"(1) Prompt approval of abbreviated applications for safe and effective generic new animal drugs will reduce animal healthcare costs and promote the well-being of animal health and the public health.

"(3) The fees authorized by this title [see Short Title of 2008 Amendment note set out under section 301 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 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."

§379j–22. Reauthorization; reporting requirements

(a) Performance reports

Beginning with fiscal year 2009, not later than 60 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(3) ¹ of the Animal Generic Drug User Fee Act of 2008 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

Beginning with fiscal year 2009, 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 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.

(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 2013, 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, 2013, 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

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

(June 25, 1938, ch. 675, §742, as added Pub. L. 110–316, title II, §203, Aug. 14, 2008, 122 Stat. 3522.)

Termination of Section

For termination of section by section 204(b) of Pub. L. 110–316, see Termination Date note below.

References in Text

Section 201(3) of the Animal Generic Drug User Fee Act of 2008, referred to in subsec. (a), probably means section 201(b)(3) of Pub. L. 110–316, which is set out as a note under section 379j–21 of this title.

Prior Provisions

A prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to section 379l of this title.

Termination Date

Pub. L. 110–316, title II, §204(b), Aug. 14, 2008, 122 Stat. 3524, provided that: "The amendment made by section 203 [enacting this section] shall cease to be effective January 31, 2014."

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) 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) 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) 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) ¹ 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 ² (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) 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.)

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 So in original. No subcl. (I) has been enacted.

² 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 for a positron emission tomography drug.

(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)(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.

(6) 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).

(7) 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.

(8) 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.

(9) 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.

(10) 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.

(11) 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.

(12) 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.)

Termination of Section

For termination of section by section 304(a) of Pub. L. 112–144, see Effective and Termination Dates note set out below.

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.

Effective and Termination Dates

Pub. L. 112–144, title III, §304(a), July 9, 2012, 126 Stat. 1024, provided that: "Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–41, 379j–42], as added by section 302 of this Act, shall cease to be effective October 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."

Finding

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 2013, 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).

(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

(i) Fiscal year 2013

Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the drug master file fee for fiscal year 2013.

(ii) Fiscal year 2014 through 2017

Not later than 60 days before the start of each of fiscal years 2014 through 2017, 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 no later than the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file.

(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 clause (i) or (ii) of subparagraph (C), as applicable; 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 and prior approval supplement filing fee

(A) In general

Each applicant that submits, on or after October 1, 2012, an abbreviated new drug application or a prior approval supplement to an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d).

(B) Notice

(i) Fiscal year 2013

Not later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fees under subparagraph (A) for fiscal year 2013.

(ii) Fiscal years 2014 through 2017

Not later than 60 days before the start of each of fiscal years 2014 through 2017, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(C) Fee due date

(i) In general

Except as provided in clause (ii), 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.

(ii) Special rule for 2013

For fiscal year 2013, such fees shall be due on the later of—

(I) the date on which the fee is due under clause (i);

(II) 30 calendar days after publication of the notice referred to in subparagraph (B)(i); or

(III) if an appropriations Act is not enacted providing for the collection and obligation of fees for such year under this section by the date of submission of the application or prior approval supplement for which the fees under subparagraphs (A) and (F) apply, 30 calendar days after the date that such an appropriations Act is enacted.

(D) Refund of fee if abbreviated new drug application is not considered to have been received

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.

(E) Fee for an application the Secretary considers not to have been received, or that has been withdrawn

An abbreviated new drug application or prior approval supplement 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, 2012, shall pay a fee, in the amount determined under subsection (d)(3), 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, or intended to be identified, in at least one generic drug submission that is pending or 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 or intended to be identified in at least one generic drug submission that is pending or 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 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 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, or intended to be identified, in at least one generic drug submission that is pending or 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 to fees under both such clauses for that facility.

(B) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C) Notice

(i) Fiscal year 2013

For fiscal year 2013, the Secretary shall publish in the Federal Register a notice announcing the amount of the fees provided for in subparagraph (A) within the timeframe specified in subsection (d)(1)(B).

(ii) Fiscal years 2014 through 2017

Within the timeframe specified in subsection (d)(2), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D) Fee due date

(i) Fiscal year 2013

For fiscal year 2013, the fees under subparagraph (A) shall be due on the later of—

(I) not later than 45 days after the publication of the notice under subparagraph (B); or

(II) if an appropriations Act is not enacted providing for the collection and obligation of fees for such year under this section by the date of the publication of such notice, 30 days after the date that such an appropriations Act is enacted.

(ii) Fiscal years 2014 through 2017

For each of fiscal years 2014 through 2017, 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) 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 2013

For fiscal year 2013, fees under subsection (a) shall be established to generate a total estimated revenue amount under such subsection of $299,000,000. 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).

(B) Fiscal years 2014 through 2017

For each of the fiscal years 2014 through 2017, fees under paragraphs (2) through (4) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to $299,000,000, as adjusted pursuant to subsection (c).

(2) Types of fees

In establishing fees under paragraph (1) to generate the revenue amounts specified in paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017, such fees shall be derived from the fees under paragraphs (2) through (4) of subsection (a) as follows:

(A) Six percent shall be derived from fees under subsection (a)(2) (relating to drug master files).

(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.

(D) Fourteen 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 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, including 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 and its territories and possessions and those located outside of the United States and its territories and possessions.

(c) Adjustments

(1) Inflation adjustment

(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-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 human generic drug activities for the first 3 years of the preceding 4 fiscal years.

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.

(2) Final year adjustment

For fiscal year 2017, the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for human generic drug activities for the first 3 months of fiscal year 2018. Such fees may only be used in fiscal year 2018. 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 2017. If the Secretary has carryover balances for such activities in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made.

(d) Annual fee setting

(1) Fiscal year 2013

For fiscal year 2013—

(A) the Secretary shall establish, by October 31, 2012, the one-time generic drug backlog fee for generic drug applications pending on October 1, 2012, the drug master file fee, the abbreviated new drug application fee, and the prior approval supplement fee under subsection (a), based on the revenue amounts established under subsection (b); and

(B) the Secretary shall establish, not later than 45 days after the date to comply with the requirement for identification of facilities in subsection (f)(2), the generic drug facility fee and active pharmaceutical ingredient facility fee under subsection (a) based on the revenue amounts established under subsection (b).

(2) Fiscal years 2014 through 2017

Not more than 60 days before the first day of each of fiscal years 2014 through 2017, the Secretary shall establish the drug master file fee, the abbreviated new drug application fee, the prior approval supplement fee, the generic drug facility fee, and the active pharmaceutical ingredient facility fee under subsection (a) for such fiscal year, based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).

(3) Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file

In establishing the fees under paragraphs (1) and (2), 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) Limit

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.

(f) Identification of facilities

(1) Publication of notice; deadline for compliance

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.

(2) 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 (4) shall submit to the Secretary the information required under this subsection each year. 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.

(3) Contents of notice

At a minimum, the submission required by paragraph (2) shall include for each such facility—

(A) identification of a facility identified or intended to be 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; and

(E) whether the facility manufactures drugs that are not generic drugs.

(4) 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.

(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 355(j)(5)(A) of this title.

(3) Abbreviated new drug application fee and prior approval supplement 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.

(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, 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 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—

(i) subject to subparagraphs (C) and (D), 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 for a fiscal year beginning after fiscal year 2012 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 the fiscal year involved.

(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 human generic activities are not more than 10 percent below the level specified in such subparagraph.

(C) Fee collection during first program year

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.

(D) Provision for early payments in subsequent years

Payment of fees authorized under this section for a fiscal year (after fiscal year 2013), 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 2013 through 2017, 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.

(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.)

Termination of Section

For termination of section by section 304(a) of Pub. L. 112–144, see Effective and Termination Dates note below.

Amendments

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".

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2017, see section 304(a) of Pub. L. 112–144, 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

Beginning with fiscal year 2013, 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) of the Generic Drug User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(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 human generic drug activities for the first 5 fiscal years after fiscal year 2017, 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) 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.

(5) Transmittal of recommendations

(6) Minutes of negotiation meetings

(A) Public availability

(B) Content

(June 25, 1938, ch. 675, §744C, as added Pub. L. 112–144, title III, §303, July 9, 2012, 126 Stat. 1022.)

Termination of Section

For termination of section by section 304(b) of Pub. L. 112–144, see Effective and Termination Dates note set out below.

References in Text

Section 301(b) of the Generic Drug User Fee Amendments of 2012, referred to in subsec. (a), is section 301(b) of Pub. L. 112–144, which is set out as a note under section 379j–41 of this title.

Effective and Termination Dates

Pub. L. 112–144, title III, §304(b), July 9, 2012, 126 Stat. 1024, provided that: "Section 744C of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–43], as added by section 303 of this Act, shall cease to be effective January 31, 2018."

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.

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 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.

(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 product 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 allergenic extract product;

(III) an in vitro diagnostic biological product; or

(IV) 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.)

Termination of Section

For termination of section by section 404(a) of Pub. L. 112–144, see Effective and Termination Dates note set out below.

Effective and Termination Dates

Pub. L. 112–144, title IV, §404(a), July 9, 2012, 126 Stat. 1038, provided that: "Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51, 379j–52], as added by section 402 of this Act, shall cease to be effective October 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."

Finding

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 2013, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Biosimilar 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 (b)(1)(A).

(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 5 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 5 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 (b)(1)(B) for biosimilar biological product development (referred to in this section as "annual biosimilar biological product development fee").

(ii) Due date

The annual biosimilar biological product development program 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 development program 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; or

(II) discontinued participation in the biosimilar biological product development program for the product under subparagraph (C).

(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) shall pay a fee (referred to in this section as "reactivation fee") by the earlier of the following:

(I) Not later than 5 days after the Secretary grants a request for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued).

(II) Upon the date of submission (after the date on which such participation was discontinued) 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).

(E) Effect of failure to pay biosimilar development program 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.

(F) Limits regarding biosimilar development program fees

(i) No refunds

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 and supplement fee

(A) In general

Each person that submits, on or after October 1, 2012, a biosimilar biological product application or a supplement shall be subject to the following fees:

(i) A fee for a biosimilar biological product application that is equal to—

(I) the amount of the fee established under subsection (b)(1)(D) 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; minus

(II) the cumulative amount of fees paid, if any, under subparagraphs (A), (B), and (D) of paragraph (1) for the product that is the subject of the application.

(ii) A fee for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required, that is equal to—

(I) half of the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product application; minus

(II) the cumulative amount of fees paid, if any, under subparagraphs (A), (B), and (D) of paragraph (1) for that product.

(iii) A fee for a supplement for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required, that is equal to half of the amount of the fee established under subsection (b)(1)(D) for a biosimilar biological product application.

(B) Reduction in fees

Notwithstanding section 404 of the Biosimilars ¹ User Fee Act of 2012, 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 be entitled to the reduction of any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted, by the cumulative amount of fees paid under subparagraphs (A), (B), and (D) of paragraph (1) for that product.

(C) Payment due date

Any fee required by subparagraph (A) shall be due upon submission of the application or supplement for which such fee applies.

(D) Exception for previously filed application or supplement

If a biosimilar biological product application or supplement 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), the submission of a biosimilar biological product application or a supplement 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 or supplement 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 or supplement 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 (c).

(3) Biosimilar biological product establishment fee

(A) In general

Except as provided in subparagraph (E), each person that is named as the applicant in a biosimilar biological product application shall be assessed an annual fee established under subsection (b)(1)(E) for each biosimilar biological product establishment that is listed in the approved biosimilar biological product application as an establishment that manufactures the biosimilar biological product named in such application.

(B) Assessment in fiscal years

The establishment fee shall be assessed in each fiscal year for which the biosimilar biological product named in the application is assessed a fee under paragraph (4) unless the biosimilar biological product establishment listed in the application does not engage in the manufacture of the biosimilar biological product during such fiscal year.

(C) Due date

The establishment fee for a fiscal year shall be due on the later of—

(i) the first business day on or after October 1 of such fiscal year; or

(ii) 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.

(D) Application to establishment

(i) Each biosimilar biological product establishment shall be assessed only one fee per biosimilar biological product establishment, notwithstanding the number of biosimilar biological products manufactured at the establishment, subject to clause (ii).

(ii) In the event an establishment is listed in a biosimilar biological product application by more than one applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the applicants whose biosimilar biological products are manufactured by the establishment during the fiscal year and assessed biosimilar biological product fees under paragraph (4).

(E) Exception for new products

If, during the fiscal year, an applicant initiates or causes to be initiated the manufacture of a biosimilar biological product at an establishment listed in its biosimilar biological product application—

(i) that did not manufacture the biosimilar biological product in the previous fiscal year; and

(ii) for which the full biosimilar biological product establishment fee has been assessed in the fiscal year at a time before manufacture of the biosimilar biological product was begun,

the applicant shall not be assessed a share of the biosimilar biological product establishment fee for the fiscal year in which the manufacture of the product began.

(4) Biosimilar biological product fee

(A) In general

Each person who is named as the applicant in a biosimilar biological product application shall pay for each such biosimilar biological product the annual fee established under subsection (b)(1)(F).

(B) Due date

The biosimilar biological product 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 fee shall be paid only once for each product for each fiscal year.

(b) Fee setting and amounts

(1) In general

Subject to paragraph (2), the Secretary shall, 60 days before the start of each fiscal year that begins after September 30, 2012, establish, for the next fiscal year, the fees under subsection (a). Except as provided in subsection (c), such fees shall be in the following amounts:

(A) Initial biosimilar biological product development fee

The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to 10 percent of the amount established under section 379h(c)(4) of this title for a human drug application described in section 379h(a)(1)(A)(i) of this title for that fiscal year.

(B) Annual biosimilar biological product development fee

The annual biosimilar biological product development fee under subsection (a)(1)(B) for a fiscal year shall be equal to 10 percent of the amount established under section 379h(c)(4) of this title for a human drug application described in section 379h(a)(1)(A)(i) of this title for that fiscal year.

(C) Reactivation fee

The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to 20 percent of the amount of the fee established under section 379h(c)(4) of this title for a human drug application described in section 379h(a)(1)(A)(i) of this title for that fiscal year.

(D) Biosimilar biological product application fee

The biosimilar biological product application fee under subsection (a)(2) for a fiscal year shall be equal to the amount established under section 379h(c)(4) of this title for a human drug application described in section 379h(a)(1)(A)(i) of this title for that fiscal year.

(E) Biosimilar biological product establishment fee

The biosimilar biological product establishment fee under subsection (a)(3) for a fiscal year shall be equal to the amount established under section 379h(c)(4) of this title for a prescription drug establishment for that fiscal year.

(F) Biosimilar biological product fee

The biosimilar biological product fee under subsection (a)(4) for a fiscal year shall be equal to the amount established under section 379h(c)(4) of this title for a prescription drug product for that fiscal year.

(2) Limit

The total amount of fees charged for a fiscal year under this section may not exceed the total amount for such fiscal year of the costs of resources allocated for the process for the review of biosimilar biological product applications.

(c) 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—

(A) 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; and

(B) 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.

(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.

(d) 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 fees owed by such person have been paid.

(e) 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 limitation

The fees authorized by this section shall be available for a fiscal year beginning after fiscal year 2012 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 the fiscal year involved.

(C) Fee collection during first program year

(D) Provision for early payments in subsequent years

(3) Authorization of appropriations

For each of fiscal years 2013 through 2017, 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.

(f) Collection of unpaid fees

(g) Written requests for waivers and refunds

To qualify for consideration for a waiver under subsection (c), 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.

(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 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.)

Termination of Section

For termination of section by section 404(a) of Pub. L. 112–144, see Effective and Termination Dates note below.

References in Text

July 9, 2012, referred to in subsec. (a)(1)(A)(v), was in the original "the date of the enactment of the Biosimilars User Fee Act of 2012", which was translated as meaning the date of enactment of the Biosimilar User Fee Act of 2012, title IV of Pub. L. 112–144, to reflect the probable intent of Congress.

Section 404 of the Biosimilar User Fee Act of 2012, referred to in subsec. (a)(2)(B), is section 404 of title IV of Pub. L. 112–144, July 9, 2012, 126 Stat. 1038. Section 404(a) is set out as a note under section 379j–51 of this title, and section 404(b) is set out as a note under section 379j–53 of this title.

Effective and Termination Dates

Section ceases to be effective Oct. 1, 2017, see section 404(a) of Pub. L. 112–144, 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.

¹ So in original. Probably should be "Biosimilar".

§379j–53. Reauthorization; reporting requirements

(a) Performance report

Beginning with fiscal year 2013, 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) of the Biosimilar User Fee Act of 2012 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.

(b) Fiscal report

Not later than 120 days after the end of fiscal year 2013 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 Web site of the Food and Drug Administration.

(d) Study

(1) In general

The Secretary shall contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications.

(2) Interim results

Not later than June 1, 2015, the Secretary shall publish, for public comment, interim results of the study described under paragraph (1).

(3) Final results

Not later than September 30, 2016, the Secretary shall publish, for public comment, the final results of the study described under paragraph (1).

(e) 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 2017, 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, 2017, 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, §744I, as added Pub. L. 112–144, title IV, §403, July 9, 2012, 126 Stat. 1037.)

Termination of Section

For termination of section by section 404(b) of Pub. L. 112–144, see Effective and Termination Dates note set out below.

References in Text

Section 401(b) of the Biosimilar User Fee Act of 2012, referred to in subsec. (a), is section 401(b) of Pub. L. 112–144, which is set out as a note under section 379j–51 of this title.

Effective and Termination Dates

Pub. L. 112–144, title IV, §404(b), July 9, 2012, 126 Stat. 1038, provided that: "Section 744I of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–53], as added by section 403 of this Act, shall cease to be effective January 31, 2018."

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.