[USC02] 21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 2: fees relating to drugs
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21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 2: fees relating to drugs
From Title 21—FOOD AND DRUGSCHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER VII—GENERAL AUTHORITYPart C—Fees

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 104(a) of Pub. L. 115–52, 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".

2007Pub. 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 2017 Amendment

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

Effective Date of 2012 Amendment

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

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

Effective and Termination Dates of 2007 Amendment

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of this title and amending this section and section 379h of this title) would cease to be effective Oct. 1, 2012, was repealed by Pub.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

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

Effective and Termination Dates of 2002 Amendment

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

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

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

Effective and Termination Dates of 1997 Amendment

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

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

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

Termination Date

Pub. L. 115–52, title I, §104(a), Aug. 18, 2017, 131 Stat. 1012, 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, 2022."

Pub. L. 112–144, title I, §105(a), July 9, 2012, 126 Stat. 1001, which provided that sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat. 1012.

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

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

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

Savings Provision

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

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

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

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

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

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

Accountability and Reports

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

"(a) Public Accountability.—

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

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

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

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

Congressional Findings Concerning Fees Relating to Drugs

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

Pub. L. 112–144, title I, §101(b), July 9, 2012, 126 Stat. 996, provided that: "The Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 379h and 379h–2 of this title and repealing 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—

"(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 review of human drug applications;

"(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] 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; 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;

"(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 review of human drug applications; and

"(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 2018, the Secretary shall assess and collect fees in accordance with this section as follows:

(1) Human drug application fee

(A) In general

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

(i) A fee established under subsection (c)(5) 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)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i).

(B) Payment

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

(C) Exception for previously filed application

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

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

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

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

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

(F) Exception for designated orphan drug

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

(G) Refund of fee if application withdrawn

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

(2) Prescription drug program fee

(A) In general

Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. 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 for certain prescription drug products

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

(i) 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.

(C) Limitation

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

(b) Fee revenue amounts

(1) In general

For each of the fiscal years 2018 through 2022, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

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

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

(C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2));

(D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3));

(E) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and

(F) additional dollar amounts for each fiscal year as follows:

(i) $20,077,793 for fiscal year 2018.

(ii) $21,317,472 for fiscal year 2019.

(iii) $16,953,329 for fiscal year 2020.

(iv) $5,426,896 for fiscal year 2021.

(v) $2,769,609 for fiscal year 2022.

(2) Types of fees

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

(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and

(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).

(3) Annual base revenue

For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

(A) for fiscal year 2018, $878,590,000; and

(B) for fiscal years 2019 through 2022, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(3) or (c)(4).

(c) Adjustments; annual fee setting

(1) Inflation adjustment

(A) In general

For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

(ii) the inflation adjustment percentage under subparagraph (B).

(B) Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years; and

(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-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.

(2) Capacity planning adjustment

(A) In general

For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.

(B) Interim methodology

(i) In general

Until the capacity planning methodology described in subparagraph (C) is effective, the adjustment under this paragraph for a fiscal year shall be based on the product of—

(I) the annual base revenue for such year, as adjusted for inflation under paragraph (1); and

(II) the adjustment percentage under clause (ii).

(ii) Adjustment percentage

The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the most recent year for which data are available, over the 3-year average ending in the previous year, for—

(I) the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary;

(II) the total number of active commercial investigational new drug applications; and

(III) the total number of formal meetings scheduled by the Secretary, and written responses issued by the Secretary in lieu of such formal meetings, as identified in section I.H of the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

(C) Capacity planning methodology

(i) Development; evaluation and report

The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment no later than the end of fiscal year 2020.

(ii) Establishment and implementation

After review of the report described in clause (i) and any public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

(I) replace the interim methodology under subparagraph (B);

(II) incorporate such approaches and attributes as the Secretary determines appropriate; and

(III) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.

(D) Limitation

Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year) and (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year).

(E) Publication in Federal Register

The Secretary shall publish in the Federal Register notice under paragraph (5) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

(3) Operating reserve adjustment

(A) Increase

For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.

(B) Decrease

If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.

(C) Notice of rationale

If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved.

(4) Additional direct cost adjustment

(A) In general

The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees—

(i) for fiscal year 2018, by $8,730,000; and

(ii) for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B).

(B) Amount

The amount determined under this subparagraph is—

(i) $8,730,000, multiplied by

(ii) the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2016.

(5) Annual fee setting

The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017—

(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

(B) publish such fee revenue and fees in the Federal Register.

(6) Limit

The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.

(d) Fee waiver or reduction

(1) In general

The Secretary shall grant to a person who is named as the applicant in a human drug application a waiver from or a reduction of one or more fees assessed to that person under subsection (a) where the Secretary finds that—

(A) such waiver or reduction is necessary to protect the public health,

(B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or

(C) 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) Rules relating to small businesses

(A) "Small business" defined

In paragraph (1)(C), the term "small business" means an entity that has fewer than 500 employees, including employees of affiliates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce.

(B) Waiver of application fee

The Secretary shall waive under paragraph (1)(C) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.

(e) Effect of failure to pay fees

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

(f) Limitations

(1) In general

Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 1997 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.

(2) Authority

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 human drug applications and prescription drug program fees at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.

(3) Limitation

Beginning on October 1, 2023, the authorities under section 379g(7)(C) of this title shall include only expenditures for leasing and necessary scientific equipment.

(g) Crediting and availability of fees

(1) In general

Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications.

(2) Collections and appropriation acts

(A) In general

The fees authorized by this section—

(i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and

(ii) shall be available 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 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c).

(h) Collection of unpaid fees

In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(i) Written requests for waivers, reductions, 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, employers, and advisory committees not engaged in the process of the review of human drug applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.

(k) Orphan drugs

(1) Exemption

A drug designated under section 360bb of this title for a rare disease or condition and approved under section 355 of this title or under section 262 of title 42 shall be exempt from prescription drug program fees under this section, if the drug meets all of the following conditions:

(A) The drug meets the public health requirements contained in this chapter as such requirements are applied to requests for waivers for prescription drug program fees.

(B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue 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; Pub. L. 115–52, title I, §102(a)(1), (b)–(h), title IX, §905(b)(1), Aug. 18, 2017, 131 Stat. 1007–1012, 1090.)

Termination of Section

For termination of section by section 104(a) of Pub. L. 115–52, see Termination Date note below.

References in Text

Section 357 of this title, referred to in subsec. (a)(2)(B)(iii), was repealed by Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

The Drug Price Competition and Patent Term Restoration Act of 1984, referred to in subsec. (a)(2)(B)(iv), is Pub. L. 98–417, Sept. 24, 1984, 98 Stat. 1585. For complete classification of this Act to the Code, see Short Title of 1984 Amendment note set out under section 301 of this title and Tables.

Section 101(b) of the Prescription Drug User Fee Amendments of 2017, referred to in subsec. (c)(2)(B)(ii)(III), is section 101(b) of Pub. L. 115–52, set out as a note under section 379g of this title.

Amendments

2017—Subsec. (a). Pub. L. 115–52, §102(a)(1)(A), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.

Subsec. (a)(1). Pub. L. 115–52, §102(a)(1)(B), (C), struck out "and supplement" before "fee" in heading and struck out "or a supplement" and "or supplement" wherever appearing in text.

Subsec. (a)(1)(A)(i). Pub. L. 115–52, §102(a)(1)(D)(i), substituted "(c)(5)" for "(c)(4)".

Subsec. (a)(1)(A)(ii). Pub. L. 115–52, §102(a)(1)(C), (D)(ii), substituted "A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval." for "A fee established under subsection (c)(4) for a human drug application for which clinical data with respect to safety or effectiveness are not required for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required."

Subsec. (a)(1)(C). Pub. L. 115–52, §102(a)(1)(E), struck out "or supplement" after "application" in heading.

Subsec. (a)(1)(F). Pub. L. 115–52, §102(a)(1)(F), struck out "or indication" after "drug" in heading and "A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section 360bb of this title as a drug for a rare disease or condition with regard to the indication proposed in such supplement." in text.

Subsec. (a)(2). Pub. L. 115–52, §102(a)(1)(G)–(I), redesignated par. (3) as (2), substituted "Prescription drug program fee" for "Prescription drug product fee" in heading, and struck out former par. (2) which related to prescription drug establishment fee.

Subsec. (a)(2)(A). Pub. L. 115–52, §102(a)(1)(J), substituted "Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year." for "Except as provided in subparagraph (B), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4)."

Subsec. (a)(2)(B). Pub. L. 115–52, §102(a)(1)(K), inserted "for certain prescription drug products" after "Exception" in heading and substituted "A prescription drug program fee shall not be assessed for a prescription drug product" for "A prescription drug product shall not be assessed a fee" in introductory provisions.

Subsec. (a)(2)(C). Pub. L. 115–52, §102(a)(1)(L), added subpar. (C).

Subsec. (a)(3). Pub. L. 115–52, §102(a)(1)(H), redesignated par. (3) as (2).

Subsec. (b). Pub. L. 115–52, §102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee revenue amounts for fiscal years 2013 through 2017.

Subsec. (c). Pub. L. 115–52, §102(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to adjustment of revenues for inflation and changes in workload, final year adjustment, setting of annual fee, and limit on total amount of fees charged.

Subsec. (d)(1)(C), (D). Pub. L. 115–52, §102(d)(1), redesignated subpar. (D) as (C) and struck out former subpar. (C) which read as follows: "the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of human drug applications for such person, or".

Subsec. (d)(3). Pub. L. 115–52, §102(d)(2), (3), redesignated par. (4) as (3) and struck out former par. (3). Text read as follows: "In making the finding in paragraph (1)(C), the Secretary may use standard costs."

Subsec. (d)(3)(A). Pub. L. 115–52, §102(d)(4)(A), substituted "paragraph (1)(C)" for "paragraph (1)(D)".

Subsec. (d)(3)(B). Pub. L. 115–52, §102(d)(4), substituted "paragraph (1)(C)" for "paragraph (1)(D)", struck out cl. (i) designation before "application fees", substituted a period for "; and" after "qualify as a small business", and struck out cl. (ii), which read as follows: "all supplement fees for all supplements to human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business."

Subsec. (d)(4). Pub. L. 115–52, §102(d)(3), redesignated par. (4) as (3).

Subsec. (e). Pub. L. 115–52, §102(e), substituted "all such fees" for "all fees".

Subsec. (f)(2). Pub. L. 115–52, §102(f), substituted "prescription drug program fees" for "supplements, prescription drug establishments, and prescription drug products".

Subsec. (f)(3). Pub. L. 115–52, §905(b)(1), added par. (3).

Subsec. (g)(3). Pub. L. 115–52, §102(g)(1), substituted "2018 through 2022" for "2013 through 2017" and struck out "and paragraph (4) of this subsection" after "subsection (c)".

Subsec. (g)(4). Pub. L. 115–52, §102(g)(2), struck out par. (4). Prior to amendment, text read as follows: "If the sum of the cumulative amount of fees collected under this section for the fiscal years 2013 through 2015 and the amount of fees estimated to be collected under this section for fiscal year 2016 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2013 through 2016, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017."

Subsec. (k)(1). Pub. L. 115–52, §102(h), substituted "prescription drug program fees" for "product and establishment fees" in two places.

2012—Subsec. (a). Pub. L. 112–144, §103(1)(A), substituted "fiscal year 2013" for "fiscal year 2008" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 112–144, §103(1)(B), substituted "(c)(4)" for "(c)(5)" in cls. (i) and (ii).

Subsec. (a)(2)(A). Pub. L. 112–144, §103(1)(C), substituted "(c)(4)" for "(c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section" for "payable on or before October 1 of each year" in concluding provisions.

Subsec. (a)(3)(A). Pub. L. 112–144, §103(1)(D)(i), substituted "subsection (c)(4)" for "subsection (c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section." for "payable on or before October 1 of each year."

Subsec. (a)(3)(B). Pub. L. 112–144, §103(1)(D)(ii), amended subpar. (B) generally. Prior to amendment, text read as follows: "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 355(b) or 355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984."

Subsec. (b)(1). Pub. L. 112–144, §103(2)(A)(i), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012" in introductory provisions.

Subsec. (b)(1)(A). Pub. L. 112–144, §103(2)(A)(ii), substituted "$693,099,000;" for "$392,783,000; and".

Subsec. (b)(1)(B), (C). Pub. L. 112–144, §103(2)(A)(iii), added subpars. (B) and (C) and struck out former subpar. (B) which read as follows: "an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3))."

Subsec. (b)(3), (4). Pub. L. 112–144, §103(2)(B), added par. (3) and struck out former pars. (3) and (4) which related to the modified workload adjustment factor for fiscal year 2007 and additional fee revenues for drug safety for fiscal years 2008 through 2012, respectively.

Subsec. (c). Pub. L. 112–144, §103(3), added subsec. (c) and struck out former subsec. (c) which related to inflation adjustment for fiscal year 2009 and subsequent fiscal years, workload adjustment for fiscal year 2009 and subsequent fiscal years, rent and rent-related cost adjustment for fiscal year 2010 and each subsequent fiscal year, final year adjustment for fiscal year 2012, annual fee setting for each fiscal year that began after Sept. 30, 2007, and the limit on the total amount of fees charged for a fiscal year.

Subsec. (g)(1). Pub. L. 112–144, §103(4)(A), substituted "Subject to paragraph (2)(C), fees authorized" for "Fees authorized".

Subsec. (g)(2)(A)(i). Pub. L. 112–144, §103(4)(B)(i), substituted "subject to subparagraph (C), shall be collected and available" for "shall be retained".

Subsec. (g)(2)(A)(ii). Pub. L. 112–144, §103(4)(B)(ii), substituted "shall be available" for "shall only be collected and available".

Subsec. (g)(2)(C). Pub. L. 112–144, §103(4)(B)(iii), added subpar. (C).

Subsec. (g)(3). Pub. L. 112–144, §103(4)(C), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012".

Subsec. (g)(4). Pub. L. 112–144, §103(4)(D), substituted "fiscal years 2013 through 2015" for "fiscal years 2008 through 2010", "fiscal year 2016" for "fiscal year 2011", "fiscal years 2013 through 2016" for "fiscal years 2008 through 2011", and "fiscal year 2017" for "fiscal year 2012".

2007—Subsec. (a). Pub. L. 110–85, §103(a)(1), substituted "2008" for "2003" in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)" in cls. (i) and (ii).

Subsec. (a)(1)(D). Pub. L. 110–85, §103(a)(2)(A), inserted "or withdrawn before filing" after "refused for filing" in heading and "or withdrawn without a waiver before filing" before period at end of text.

Subsec. (a)(1)(E) to (G). Pub. L. 110–85, §103(a)(2)(B), (C), added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively.

Subsec. (a)(2)(A). Pub. L. 110–85, §103(a)(3)(A), (g), substituted "subparagraphs (B) and (C)" for "subparagraph (B)" in introductory provisions and "(c)(5)" for "(c)(4)" in concluding provisions.

Subsec. (a)(2)(C). Pub. L. 110–85, §103(a)(3)(B), added subpar. (C).

Subsec. (a)(3)(A). Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)".

Subsec. (b). Pub. L. 110–85, §103(b), amended subsec. (b) generally, substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions relating to fee schedules for fiscal years 2003 to 2007.

Subsec. (c)(1). Pub. L. 110–85, §103(c)(1), amended par. (1) by substituting "For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)" for "The revenues established in subsection (b)" in introductory provisions, adding subpar. (C), and substituting "fiscal year 2008" for "fiscal year 2003" in concluding provisions.

Subsec. (c)(2). Pub. L. 110–85, §103(c)(2)(A), substituted "For fiscal year 2009 and subsequent fiscal years," for "Beginning with fiscal year 2004," in introductory provisions.

Subsec. (c)(2)(A). Pub. L. 110–85, §103(c)(2)(B), substituted "human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available." for "human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary." in first sentence.

Subsec. (c)(2)(B). Pub. L. 110–85, §103(c)(2)(C), inserted at end "Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities."

Subsec. (c)(2)(C). Pub. L. 110–85, §103(c)(2)(D), added subpar. (C).

Subsec. (c)(3). Pub. L. 110–85, §103(c)(3), added par. (3). Former par. (3) redesignated (4).

Subsec. (c)(4). Pub. L. 110–85, §103(c)(3)(A), (4), redesignated par. (3) as (4) and amended it generally. Prior to amendment, text read as follows: "For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) of this section if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made." Former par. (4) redesignated (5).

Subsec. (c)(5). Pub. L. 110–85, §103(c)(3)(A), (5), redesignated par. (4) as (5) and substituted "2007" for "2002". Former par. (5) redesignated (6).

Subsec. (c)(6). Pub. L. 110–85, §103(c)(3)(A), redesignated par. (5) as (6).

Subsec. (d)(1). Pub. L. 110–85, §103(d)(1), inserted "to a person who is named as the applicant in a human drug application" after "The Secretary shall grant" and "to that person" after "one or more fees assessed" in introductory provisions.

Subsec. (d)(2), (3). Pub. L. 110–85, §103(d)(2), (3), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

Subsec. (d)(4). Pub. L. 110–85, §103(d)(2), redesignated par. (3) as (4).

Subsec. (d)(4)(A). Pub. L. 110–85, §103(d)(4), inserted before period at end ", and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce".

Subsec. (g)(1). Pub. L. 110–85, §103(h)(1), substituted "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended." for "Fees collected for a fiscal year pursuant to subsection (a) of this section shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriation Acts until expended without fiscal year limitation."

Subsec. (g)(3). Pub. L. 110–85, §103(e)(1), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007.

Subsec. (g)(4). Pub. L. 110–85, §103(e)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year."

Subsec. (k). Pub. L. 110–85, §103(f), added subsec. (k).

2002—Subsec. (a). Pub. L. 107–188, §504(a)(1), substituted "fiscal year 2003" for "fiscal year 1998" in introductory provisions.

Subsec. (a)(1)(A)(i). Pub. L. 107–188, §504(a)(2)(A), substituted "under subsection (c)(4)" for "in subsection (b)".

Subsec. (a)(1)(A)(ii). Pub. L. 107–188, §504(a)(2), substituted "under subsection (c)(4)" for "in subsection (b)" and inserted "Such fee shall be half of the amount of the fee established under clause (i)." at end.

Subsec. (a)(1)(F), (G). Pub. L. 107–109 redesignated subpar. (G) as (F) and struck out heading and text of former subpar. (F). Text read as follows: "A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A)."

Subsec. (a)(2)(A). Pub. L. 107–188, §504(a)(3), in concluding provisions, substituted "under subsection (c)(4)" for "in subsection (b)" and "payable on or before October 1" for "payable on or before January 31".

Subsec. (a)(3)(A). Pub. L. 107–188, §504(a)(4)(A), amended heading and text of subpar. (A) generally. Prior to amendment, text read as follows: "Except as provided in subparagraph (B), each person—

"(i) who is named as the applicant in a human drug application for a prescription drug product which has been submitted for listing under section 360 of this title, and

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

shall pay for each such prescription drug product the annual fee established in subsection (b) of this section. Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable."

Subsec. (a)(3)(B). Pub. L. 107–188, §504(a)(4)(B), substituted "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 355(b)" for "The listing of a prescription drug product under section 360 of this title shall not require the person who listed such product to pay the fee prescribed by subparagraph (A) if such product is the same product as a product approved under an application filed under section 355(b)(2)".

Subsec. (b). Pub. L. 107–188, §504(b), amended heading and text of subsec. (b) generally, substituting "Fee revenue amounts" for "Fee amounts" in heading and substituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002.

Subsec. (c)(1). Pub. L. 107–188, §504(c)(1)(A), (D), substituted "revenues" for "fees and total fee revenues" in introductory provisions and "fiscal year 2003" for "fiscal year 1997" in concluding provisions.

Subsec. (c)(1)(A). Pub. L. 107–188, §504(c)(1)(B), struck out "during the preceding fiscal year" before "in the Consumer Price Index" and substituted "for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or" for ", or".

Subsec. (c)(1)(B). Pub. L. 107–188, §504(c)(1)(C), substituted "for the previous fiscal year" for "for such fiscal year".

Subsec. (c)(2) to (5). Pub. L. 107–188, §504(c)(2)–(4), added pars. (2) and (3), redesignated former pars. (2) and (3) as (4) and (5), respectively, and amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: "Subject to the amount appropriated for a fiscal year under subsection (g) of this section, the Secretary shall, within 60 days after the end of each fiscal year beginning after September 30, 1997, adjust the establishment and product fees described in subsection (b) of this section for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) of this section shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b) of this section."

Subsec. (d)(1)(C) to (E). Pub. L. 107–188, §504(d)(1), inserted "or" at end of subpar. (C), redesignated subpar. (E) as (D), and struck out former subpar. (D) which read as follows: "assessment of the fee for an application or a supplement filed under section 355(b)(1) of this title pertaining to a drug containing an active ingredient would be inequitable because an application for a product containing the same active ingredient filed by another person under section 355(b)(2) of this title could not be assessed fees under subsection (a)(1) of this section, or".

Subsec. (d)(3)(A), (B). Pub. L. 107–188, §504(d)(2), substituted "paragraph (1)(D)" for "paragraph (1)(E)".

Subsec. (f). Pub. L. 107–188, §504(e)(1), substituted "Limitations" for "Assessment of fees" in heading.

Subsec. (f)(1). Pub. L. 107–188, §504(e)(2), substituted "In general" for "Limitation" in heading and "Fees under subsection (a) shall be refunded for a fiscal year beginning" for "Fees may not be assessed under subsection (a) for a fiscal year beginning" in text.

Subsec. (g)(1). Pub. L. 107–188, §504(f)(1), which directed the amendment of par. (1) by striking "Fees collected for a fiscal year" and all that follows through "fiscal year limitation." and inserting "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.", was not executed because the phrase "fiscal year limitation." appeared in two places and because of the corrective amendment by Pub. L. 110–85, §103(h)(1), which is effective as if included in Pub. L. 107–188, §504. See 2007 Amendment note above and Effective Date of 2007 Amendment note below.

Subsec. (g)(2). Pub. L. 107–188, §504(f)(2), amended par. (2) by designating existing provisions as subpar. (A), inserting subpar. (A) heading, adding subpar. (B), redesignating former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), substituting "shall be retained in each fiscal year in an amount not to exceed the amount specified" for "shall be collected in each fiscal year in an amount equal to the amount specified" in cl. (i), and realigning margin of cl. (ii).

Subsec. (g)(3)(A) to (E). Pub. L. 107–188, §504(f)(3), added subpars. (A) to (E) and struck out former subpars. (A) to (E) which read as follows:

"(A) $106,800,000 for fiscal year 1998;

"(B) $109,200,000 for fiscal year 1999;

"(C) $109,200,000 for fiscal year 2000;

"(D) $114,000,000 for fiscal year 2001; and

"(E) $110,100,000 for fiscal year 2002,".

1997—Subsec. (a). Pub. L. 105–115, §103(a)(1), substituted "Beginning in fiscal year 1998" for "Beginning in fiscal year 1993" in introductory provisions.

Subsec. (a)(1)(B). Pub. L. 105–115, §103(a)(2)(A), amended heading and text of subpar. (B) generally. Prior to amendment, text read as follows:

"(i) First payment.—50 percent of the fee required by subparagraph (A) shall be due upon submission of the application or supplement.

"(ii) Final payment.—The remaining 50 percent of the fee required by subparagraph (A) shall be due upon—

"(I) the expiration of 30 days from the date the Secretary sends to the applicant a letter designated by the Secretary as an action letter described in section 379g(6)(B) of this title, or

"(II) the withdrawal of the application or supplement after it is filed unless the Secretary waives the fee or a portion of the fee because no substantial work was performed on such application or supplement after it was filed.

The designation under subclause (I) or the waiver under subclause (II) shall be solely in the discretion of the Secretary and shall not be reviewable."

Subsec. (a)(1)(D). Pub. L. 105–115, §103(a)(2)(B), substituted "refused" for "not accepted" in heading and "75 percent" for "50 percent", "subparagraph (B)" for "subparagraph (B)(i)", and "refused" for "not accepted" in text.

Subsec. (a)(1)(E) to (G). Pub. L. 105–115, §103(a)(2)(C), added subpars. (E) to (G).

Subsec. (a)(2). Pub. L. 105–115, §103(a)(3), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Each person that—

"(A) owns a prescription drug establishment, at which is manufactured at least 1 prescription drug product which is not the, or not the same as a, product approved under an application filed under section 355(b)(2) or 355(j) of this title, and

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

shall be subject to the annual fee established in subsection (b) of this section for each such establishment, payable on or before January 31 of each year."

Subsec. (a)(3)(A). Pub. L. 105–115, §103(a)(4)(A), substituted, in cl. (i), "has been submitted for listing" for "is listed" and, in closing provisions, "Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable." for "Such fee shall be payable at the time of the first such listing of such product in each calendar year. Such fee shall be paid only once each year for each listed prescription drug product irrespective of the number of times such product is listed under section 360 of this title."

Subsec. (a)(3)(B). Pub. L. 105–115, §103(a)(4)(B), substituted "355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984." for "355(j) of this title.".

Subsec. (b). Pub. L. 105–115, §103(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2).

Subsec. (c). Pub. L. 105–115, §103(c)(1), substituted "Adjustments" for "Increases and adjustments" in heading.

Subsec. (c)(1). Pub. L. 105–115, §103(c)(2), substituted "Inflation adjustment" for "Revenue increase" in heading, "The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary" for "The total fee revenues established by the schedule in subsection (b)(1) shall be increased by the Secretary" in introductory provisions, and "change" for "increase" after "total percentage" in subpars. (A) and (B), and inserted at end "The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 1997 under this subsection."

Subsec. (c)(2). Pub. L. 105–115, §103(c)(3), substituted "September 30, 1997, adjust the establishment and product fees described in subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b)." for "October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) for the following fiscal year to achieve the total fee revenues, as may be increased under paragraph (1). Such fees shall be adjusted under this paragraph to maintain the proportions established in such schedule."

Subsec. (c)(3). Pub. L. 105–115, §103(c)(4), substituted "this subsection" for "paragraph (2)".

Subsec. (d). Pub. L. 105–115, §103(d), struck out introductory provisions which read "The Secretary shall grant a waiver from or a reduction of 1 or more fees under subsection (a) of this section where the Secretary finds that—" and closing provisions which read "In making the finding in paragraph (3), the Secretary may use standard costs.", inserted designation, heading, and introductory provisions of par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, of par. (1), and added pars. (1)(E), (2), and (3).

Subsec. (f)(1). Pub. L. 105–115, §103(e), substituted "fiscal year 1997" for "fiscal year 1993" and "fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)" for "fiscal year 1992".

Subsec. (g)(1). Pub. L. 105–115, §103(f)(1), inserted at end "Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications."

Subsec. (g)(2)(A). Pub. L. 105–115, §103(f)(2)(A), substituted "Acts, or otherwise made available for obligation," for "Acts".

Subsec. (g)(2)(B). Pub. L. 105–115, §103(f)(2)(B), substituted "over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997" for "over such costs for fiscal year 1992".

Subsec. (g)(3), (4). Pub. L. 105–115, §103(f)(3), added pars. (3) and (4) and struck out heading and text of former par. (3). Text read as follows: "There are authorized to be appropriated for fees under this section—

"(A) $36,000,000 for fiscal year 1993,

"(B) $54,000,000 for fiscal year 1994,

"(C) $75,000,000 for fiscal year 1995,

"(D) $78,000,000 for fiscal year 1996, and

"(E) $84,000,000 for fiscal year 1997,

as adjusted to reflect increases in the total fee revenues made under subsection (c)(1) of this section."

Subsecs. (i), (j). Pub. L. 105–115, §103(g), added subsec. (i) and redesignated former subsec. (i) as (j).

Effective Date of 2017 Amendment

Amendment by section 102 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2012 Amendment

Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2012, see section 106 of Pub. L. 112–144, set out as a note under section 379g of this title.

Effective Date of 2007 Amendment

Pub. L. 110–85, title I, §103(h)(2), Sept. 27, 2007, 121 Stat. 832, provided that: "Paragraph (1) [amending this section] shall take effect as if included in section 504 of the Prescription Drug User Fee Amendments of 2002 (Public Law 107–188; 116 Stat. 687) [amending this section]."

Amendment by Pub. L. 110–85 effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Effective and Termination Dates of 2007 Amendment note under section 379g of this title.

Effective Date of 2002 Amendment

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

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective Oct. 1, 1997, see section 106 of Pub. L. 105–115, set out as an Effective and Termination Dates of 1997 Amendment note under section 379g of this title.

Termination Date

Section to terminate Oct. 1, 2022, see section 104(a) of Pub. L. 115–52, 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—

(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;

(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

Beginning with fiscal year 2018, 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—

(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 2017 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.

(3) Real time reporting

(A) In general

Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection.

(B) Data

The Secretary shall post the following data in accordance with subparagraph (A):

(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

(iii) The number of new drug applications and biological licensing applications approved.

(iv) The number of new drug applications and biological licensing applications filed.

(4) Rationale for PDUFA program changes

Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drugs, including identifying drivers of such changes; and

(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.

(5) Analysis

For each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:

(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—

(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;

(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.


(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.

(C) The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

(b) Fiscal report

Beginning with fiscal year 2018, 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 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) Corrective action report

Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

(1) Goals met

For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.

(2) Goals missed

For any of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and

(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

(d) Enhanced communication

(1) Communications with Congress

Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

(2) Participation in congressional hearing

Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.

(e) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration.

(f) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2022, 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;

(C) scientific and academic experts;

(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;

(C) provide for a period of 30 days for the public to provide written comments on such recommendations;

(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, 2022, 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; Pub. L. 115–52, title I, §103, title IX, §§903(a), 904(a), Aug. 18, 2017, 131 Stat. 1012, 1077, 1082.)

Termination of Section

For termination of section by section 104(b) of Pub. L. 115–52, see Effective and Termination Dates note below.

References in Text

Section 101(b) of the Prescription Drug User Fee Amendments of 2017, referred to in subsecs. (a) and (c), is section 101(b) of Pub. L. 115–52, which is set out as a note under section 379g of this title.

Amendments

2017—Subsec. (a)(1). Pub. L. 115–52, §103(a)(1), substituted "2018" for "2013".

Subsec. (a)(1)(A). Pub. L. 115–52, §103(1)(B), substituted "Prescription Drug User Fee Amendments of 2017" for "Prescription Drug User Fee Amendments of 2012".

Subsec. (a)(3), (4). Pub. L. 115–52, §903(a), added pars. (3) and (4).

Subsec. (a)(5). Pub. L. 115–52, §904(a)(1), added par. (5).

Subsec. (b). Pub. L. 115–52, §103(2), substituted "2018" for "2013".

Subsec. (c). Pub. L. 115–52, §904(a)(2)(B), added subsec. (c). Former subsec. (c) redesignated (e).

Subsec. (d). Pub. L. 115–52, §904(a)(2)(B), added subsec. (d). Former subsec. (d) redesignated (f).

Pub. L. 115–52, §103(3), substituted "2022" for "2017" in pars. (1) and (5).

Subsecs. (e), (f). Pub. L. 115–52, §904(a)(2)(A), redesignated subsecs. (c) and (d) as (e) and (f), respectively.

2012—Subsec. (a). Pub. L. 112–144, §104(1), amended subsec. (a) generally. Prior to amendment, text read as follows: "Beginning with fiscal year 2008, not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort."

Subsec. (b). Pub. L. 112–144, §104(2), substituted "2013" for "2008".

Subsec. (d)(1), (5). Pub. L. 112–144, §104(3), substituted "2017" for "2012".

Effective Date of 2017 Amendment

Amendment by section 103 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title.

Effective Date of 2012 Amendment

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 and Termination Dates

Pub. L. 115–52, title I, §104(b), Aug. 18, 2017, 131 Stat. 1012, 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, 2023."

Pub. L. 112–144, title I, §105(b), July 9, 2012, 126 Stat. 1001, which provided that section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title I, §104(c), Aug. 18, 2017, 131 Stat 1012.

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

Pub. L. 110–85, title I, §106(b), Sept. 27, 2007, 121 Stat. 842, which provided that the amendment made by section 105 of Pub. L. 110–85 (enacting this section) would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title I, §105(c)(1), July 9, 2012, 126 Stat. 1001.

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.