Union Calendar No. 80
118th CONGRESS 1st Session |
[Report No. 118–104]
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.
March 7, 2023
Mr. Pence (for himself and Ms. Schrier) introduced the following bill; which was referred to the Committee on Energy and Commerce
June 9, 2023
Additional sponsor: Ms. Lee of Nevada
June 9, 2023
Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on March 7, 2023]
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Animal Drug and Animal Generic Drug User Fee Amendments of 2023”.
The table of contents for this Act is the following:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Savings clause.
Sec. 106. Effective date.
Sec. 107. Sunset dates.
Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.
Sec. 301. Reporting requirements.
Sec. 302. Definition of major species.
Sec. 303. Antimicrobial resistance.
(b) Finding.—Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the animal drug development process and the review of new and supplemental animal drug applications and investigational animal drug submissions as set forth in the goals identified for purposes of part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate as set forth in the Congressional Record.
Section 739 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11) is amended—
(2) by amending paragraph (8)(I) to read as follows:
“(I) The activities necessary for implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to animal drug products subject to review, including implementation activities prior to and following product approval.”.
(a) In general.—Section 740(a)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(a)(1)(A)(ii)) is amended—
(b) Fee revenue amounts.—Section 740(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(b)(1)) is amended to read as follows:
(c) Annual fee setting; adjustments.—
(1) ANNUAL FEE SETTING.—Section 740(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(1)) is amended to read as follows:
“(1) ANNUAL FEE SETTING.—Not later than 60 days before the start of each fiscal year beginning after September 30, 2023, the Secretary shall—
“(A) establish for that fiscal year animal drug application fees, supplemental animal drug application fees, animal drug sponsor fees, animal drug establishment fees, and animal drug product fees based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
(2) INFLATION ADJUSTMENT.—Section 740(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(2)) is amended—
(3) WORKLOAD ADJUSTMENTS.—Section 740(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(3)) is amended—
(A) in subparagraph (A)—
(4) FINAL YEAR ADJUSTMENT.—Section 740(c)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(c)(4)) is amended to read as follows:
“(4) OPERATING RESERVE ADJUSTMENT.—
“(A) IN GENERAL.—For fiscal year 2025 and each subsequent fiscal year, after the fee revenue amount established under subsection (b) is adjusted in accordance with paragraphs (2) and (3), the Secretary shall—
“(B) CARRYOVER USER FEES.—For purposes of this paragraph, the operating reserve of carryover user fees for the process for the review of animal drug applications does not include carryover user fees that have not been appropriated.
(d) Exemption from fees.—Section 740(d)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(d)(4)) is amended to read as follows:
“(4) EXEMPTION FROM FEES.—Fees under paragraphs (2), (3), and (4) of subsection (a) shall not apply with respect to any person who is the named applicant or sponsor of an animal drug application, supplemental animal drug application, or investigational animal drug submission if such application or submission involves the intentional genomic alteration of an animal that is intended to produce a drug, device, or biological product subject to fees under section 736, 738, 744B, or 744H.”.
(e) Crediting and availability of fees.—
(1) AUTHORIZATION OF APPROPRIATIONS.—Section 740(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(g)(3)) is amended by striking “2019 through 2023” and inserting “2024 through 2028”.
(2) COLLECTION SHORTFALLS.—Section 740(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(g)) is amended—
Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) is amended—
Notwithstanding the amendments made by this title, part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as in effect on the day before the date of enactment of this title, shall continue to be in effect with respect to animal drug applications and supplemental animal drug applications (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024.
The amendments made by this title shall take effect on October 1, 2023, or the date of the enactment of this Act, whichever is later, except that fees under part 4 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as amended by this title, shall be assessed for animal drug applications and supplemental animal drug applications received on or after October 1, 2023, regardless of the date of the enactment of this Act.
(a) Authorization.—Sections 739 and 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 U.S.C. 379j–11; 379j–12) shall cease to be effective October 1, 2028.
(b) Reporting requirements.—Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13) shall cease to be effective January 31, 2029.
(c) Previous sunset provision.—Effective October 1, 2023, subsections (a) and (b) of section 107 of the Animal Drug User Fee Amendments of 2018 (Public Law 115–234) are repealed.
(b) Finding.—Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified for purposes of part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor and Pensions of the Senate as set forth in the Congressional Record.
(a) Generic Investigational New Animal Drug File Fee.—Section 741(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(a)) is amended by adding at the end the following:
“(4) GENERIC INVESTIGATIONAL NEW ANIMAL DRUG FILE FEE.—
“(A) IN GENERAL.—
“(i) NEW FILE REQUEST.—Each person that submits a request to establish a generic investigational new animal drug file on or after October 1, 2023, shall be assessed a fee as established under subsection (c).
“(ii) NEW SUBMISSION TO ESTABLISHED FILE.—Each person that makes a submission to a generic investigational new animal drug file on or after October 1, 2023, where such file was established prior to October 1, 2023, shall be assessed a fee for the first submission on or after October 1, 2023, as established under subsection (c).
“(B) PAYMENT.—
“(C) EXCEPTIONS.—
“(i) TERMINATING AN EXISTING GENERIC INVESTIGATIONAL NEW ANIMAL DRUG FILE.—If a person makes a submission to the generic investigational new animal drug file to terminate that file, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.
“(ii) TRANSFERRING AN EXISTING GENERIC INVESTIGATIONAL NEW ANIMAL DRUG FILE.—If a person makes a submission to the generic investigational new animal drug file to transfer that file to a different generic new animal drug sponsor, the person shall not be subject to a fee under subparagraph (A)(ii) for that submission.”.
(b) Fee revenue amounts.—Section 741(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(b)) is amended—
(c) Annual fee setting; adjustments.—
(1) ANNUAL FEE SETTING.— Section 741(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(1)) is amended to read as follows:
“(1) ANNUAL FEE SETTING.—The Secretary shall establish, not later than 60 days before the start of each fiscal year beginning after September 30, 2023, for that fiscal year—
“(A) abbreviated application fees that are based on the revenue amounts established under subsection (b), the adjustments provided under this subsection, and the amount of fees anticipated to be collected under subsection (a)(4) during that fiscal year;
(2) INFLATION ADJUSTMENT.—Section 741(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(2)) is amended—
(3) WORKLOAD ADJUSTMENT.—Section 741(c)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(3)) is amended—
(A) in subparagraph (A)—
(ii) in clause (i)—
(4) FINAL YEAR ADJUSTMENT.—Section 741(c)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(c)(4)) is amended—
(d) Fee waiver or reduction; exemption from fees.—Subsection (d) of section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) is amended to read as follows:
(e) Effect of failure to pay fees.—Section 741(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(e)) is amended by striking “The Secretary may discontinue” and inserting “A request to establish a generic investigational new animal drug file that is submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for action by the Secretary until all fees owed by such person have been paid. The Secretary may discontinue”.
(f) Assessment of fees.—Section 741(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(f)(2)) is amended by striking “sponsors, and generic new animal drug products at any time” and inserting “products, generic new animal drug sponsors, and generic investigational new animal drug files at any time”.
(g) Crediting and availability of fees.—Section 741(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(g)) is amended—
(2) by striking the second paragraph (4) (relating to Offset), as added by section 202 of the Animal Generic Drug User Fee Amendments of 2013 (Public Law 113–14); and
(3) by adding at the end the following:
“(5) RECOVERY OF COLLECTION SHORTFALLS.—The amount of fees otherwise authorized to be collected under this section shall be increased—
“(A) for fiscal year 2026, by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2024 falls below the amount of fees authorized for fiscal year 2024 under paragraph (3);
(h) Definitions.—Section 741(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(k)) is amended—
(1) by redesignating paragraphs (8), (9), (10), and (11) as paragraphs (9), (10), (11), and (13), respectively;
(3) in paragraph (11) (as so redesignated), by adding at the end the following:
“(I) The activities necessary for exploration and implementation of the United States and European Union Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections, and the United States and United Kingdom Mutual Recognition Agreement Sectoral Annex for Pharmaceutical Good Manufacturing Practices, and other mutual recognition agreements, with respect to generic new animal drug products subject to review, including implementation activities prior to and following product approval.”; and
(4) by inserting after paragraph (11) (as so redesignated) the following:
“(12) REQUEST TO ESTABLISH A GENERIC INVESTIGATIONAL NEW ANIMAL DRUG FILE.—The term ‘request to establish a generic investigational new animal drug file’ means the submission to the Secretary of a request to establish a generic investigational new animal drug file to contain investigational submissions for a generic new animal drug.”.
Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) is amended—
Notwithstanding the amendments made by this title, part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as in effect on the day before the date of enactment of this title, shall continue to be in effect with respect to abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug (as defined in such part as of such day) that on or after October 1, 2018, but before October 1, 2023, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2024.
The amendments made by this title shall take effect on October 1, 2023, or the date of the enactment of this Act, whichever is later, except that fees under part 5 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as amended by this title, shall be assessed for abbreviated applications for a generic new animal drug and supplemental abbreviated applications for a generic new animal drug received on or after October 1, 2023, regardless of the date of enactment of this Act.
(a) Authorization.—Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall cease to be effective October 1, 2028.
(b) Reporting requirements.—Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–22) shall cease to be effective January 31, 2029.
(c) Previous sunset provision.—Effective October 1, 2023, subsections (a) and (b) of section 206 of the Animal Generic Drug User Fee Amendments of 2018 (Public Law 115–234) are repealed.
Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–13), as amended by section 104, is further amended—
(1) in subsection (a)—
(B) by adding at the end the following:
“(2) CONTENTS.—The report under paragraph (1) shall include the following:
“(A) Data, analysis and discussion of the changes in the number of individuals hired and funded by fees collected pursuant to section 740, and data, analysis, and discussion of the number of full-time equivalents in the animal drug review program, including a breakdown by funding from fees collected pursuant to section 740 versus budget authority, and by each division within the Center for Veterinary Medicine, 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 animal drug applications, including identifying—
“(C) Data, analysis, and discussion of changes in the average full-time equivalent hours required to complete review of each type of animal drug application.
“(D) For fiscal years 2024 and 2025, of the meeting requests from animal drug sponsors for which the Secretary has determined that a face-to-face meeting is appropriate, the number of face-to-face meetings requested by sponsors to be conducted in person (in such manner as the Secretary shall prescribe on the website of the Food and Drug Administration), and the number of such in-person meetings granted by the Secretary.”; and
(2) in subsection (d)—
(C) by inserting after paragraph (5) the following:
“(6) UPDATES TO CONGRESS.—The Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives.”; and
Section 201(nn) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(nn)) is amended by inserting “, or remove species from,” after “add species to”.
(a) Report on Antimicrobial Stewardship.—Not later than December 31, 2023, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall 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 describing—
(1) activities conducted by the Center for Veterinary Medicine of the Food and Drug Administration (referred to in this section as “the Center”) during the period of fiscal years 2019 through 2023 to support antimicrobial stewardship in veterinary settings, including ongoing activities and the targeted completion date of such activities; and
(b) Annual progress reports.—Not later than 120 days after the end of each fiscal year during which fees are collected under section 740, the Secretary shall 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 that includes—
(1) a description of activities conducted by the Center in the prior fiscal year to support antimicrobial stewardship in veterinary settings, including progress made toward goals and activities specified in subsection (a)(2);
(2) in the case of an incomplete activity described in subsection (a)(2)(B) for which the target completion date has passed—
Union Calendar No. 80 | |||||
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[Report No. 118–104] | |||||
A BILL | |||||
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user fee programs relating to new animal drugs and generic new animal drugs. | |||||
June 9, 2023 | |||||
Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed |