[Congressional Record Volume 169, Number 122 (Monday, July 17, 2023)]
[House]
[Pages H3620-H3624]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ANIMAL DRUG AND ANIMAL GENERIC DRUG USER FEE AMENDMENTS OF 2023
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 1418) to amend the Federal Food, Drug, and Cosmetic Act to
reauthorize user fee programs relating to new animal drugs and generic
new animal drugs, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 1418
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Animal Drug and Animal
Generic Drug User Fee Amendments of 2023''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is the following:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO ANIMAL DRUGS
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.
TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS
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.
TITLE III--SUPPORTING ANIMAL AND HUMAN HEALTH
Sec. 301. Reporting requirements.
Sec. 302. Definition of major species.
Sec. 303. Antimicrobial resistance.
TITLE I--FEES RELATING TO ANIMAL DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal
Drug User Fee Amendments of 2023''.
(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.
SEC. 102. DEFINITIONS.
Section 739 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-11) is amended--
(1) in paragraph (3), by striking ``national drug code''
and inserting ``National Drug Code''; and
(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.''.
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(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--
(1) in subclause (I), by striking ``and'' at the end;
(2) in subclause (II), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(III) an application for conditional approval under
section 571 of a new animal drug for which an animal drug
application submitted under section 512(b)(1) has been
previously approved under section 512(d)(1) for another
intended use.''.
(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:
``(1) In general.--Subject to subsections (c), (d), (f),
and (g), for each of fiscal years 2024 through 2028, the fees
required under subsection (a) shall be established to
generate a total revenue amount of $33,500,000.''.
(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
``(B) publish such fee revenue amounts and fees in the
Federal Register.''.
[[Page H3621]]
(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--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by striking
``2020'' and inserting ``2025''; and
(ii) in clause (iii), by striking ``Baltimore'' and
inserting ``Arlington-Alexandria''; and
(B) in subparagraph (B), by striking ``2020'' and inserting
``2025''.
(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)--
(i) in the matter preceding clause (i)--
(I) by striking ``2020'' and inserting ``2025''; and
(II) by striking ``subparagraphs (B) and (C)'' and
inserting ``subparagraph (B)'';
(ii) in clause (i) by striking ``and'' at the end; and
(iii) by striking clause (ii) and inserting the following:
``(ii) such adjustment shall be made for each fiscal year
that the adjustment determined by the Secretary is greater
than 3 percent, except for the first fiscal year that the
adjustment is greater than 3 percent; and
``(iii) the Secretary shall publish in the Federal Register
notice under paragraph (1) the amount of such adjustment and
the supporting methodologies.'';
(B) by striking subparagraph (B); and
(C) by redesignating subparagraph (C) as subparagraph (B).
(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--
``(i) increase the fee revenue amount for such fiscal year,
if necessary to provide an operating reserve of not less than
12 weeks; or
``(ii) if the Secretary has an operating reserve in excess
of the number of weeks specified in subparagraph (C) for that
fiscal year, the Secretary shall decrease the fee revenue
amount to provide not more than the number of weeks specified
in subparagraph (C) for that fiscal year.
``(B) Carryover user fees.--For purposes of this paragraph,
the operating reserve of carryover user fees for the process
for the review of animal drug applications does not include
carryover user fees that have not been appropriated.
``(C) Number of weeks of operating reserves.--The number of
weeks of operating reserves specified in this subparagraph
is--
``(i) 22 weeks for fiscal year 2025;
``(ii) 20 weeks for fiscal year 2026;
``(iii) 18 weeks for fiscal year 2027; and
``(iv) 16 weeks for fiscal year 2028.
``(D) Publication.--If an adjustment to the operating
reserve is made under this paragraph, the Secretary shall
publish in the Federal Register notice under paragraph (1)
the rationale for the amount of the adjustment and the
supporting methodologies.''.
(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--
(A) in paragraph (3), by striking ``and paragraph (5)'';
and
(B) by striking paragraph (5).
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 740A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-13) is amended--
(1) in subsection (a), by striking ``2018'' and inserting
``2023'';
(2) by striking ``2019'' each place it appears in
subsections (a) and (b) and inserting ``2024''; and
(3) in subsection (d)--
(A) in paragraph (1), by striking ``2023'' and inserting
``2028''; and
(B) in paragraph (5), by striking ``2023'' and inserting
``2028''.
SEC. 105. SAVINGS CLAUSE.
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.
SEC. 106. EFFECTIVE DATE.
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.
SEC. 107. SUNSET DATES.
(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.
TITLE II--FEES RELATING TO GENERIC ANIMAL DRUGS
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal
Generic Drug User Fee Amendments of 2023''.
(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.
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG
FEES.
(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.--
``(i) New file request.--The fee required by subparagraph
(A)(i) shall be due upon submission of the request to
establish the generic investigational new animal drug file.
``(ii) New submission to established file.--The fee
required by subparagraph (A)(ii) shall be due upon the first
submission to the generic investigational new animal drug
file.
``(C) Exceptions.--
``(i) Terminating an existing generic investigational new
animal drug file.--If a person makes a submission to the
generic investigational new animal drug file to terminate
that file, the person shall not be subject to a fee under
subparagraph (A)(ii) for that submission.
``(ii) Transferring an existing generic investigational new
animal drug file.--If a person makes a submission to the
generic investigational new animal drug file to transfer that
file to a different generic new animal drug sponsor, the
person shall not be subject to a fee under subparagraph
(A)(ii) for that submission.''.
(b) Fee Revenue Amounts.--Section 741(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(b)) is
amended--
(1) in paragraph (1)--
(A) by striking ``2019 through 2023'' and inserting ``2024
through 2028''; and
(B) by striking ``$18,336,340'' and inserting
``$25,000,000''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) by striking ``25 percent'' and inserting ``20
percent''; and
(ii) by inserting before the semicolon at the end the
following: ``and fees under subsection (a)(4) (relating to
generic investigational new animal drug files)'';
(B) in subparagraph (B), by striking ``37.5 percent'' and
inserting ``40 percent''; and
(C) in subparagraph (C), by striking ``37.5 percent'' and
inserting ``40 percent''.
(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;
``(B) generic new animal drug sponsor fees, and generic new
animal drug product fees, based on the revenue amounts
established under subsection (b) and the adjustments provided
under this subsection; and
[[Page H3622]]
``(C) a generic investigational new animal drug file fee of
$50,000 for each request or submission described in
subsection (a)(4)(A).''.
(2) Inflation adjustment.--Section 741(c)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21(c)(2)) is
amended--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by striking
``2020'' and inserting ``2025''; and
(ii) in clause (iii), by striking ``Baltimore'' and
inserting ``Arlington-Alexandria''; and
(B) in subparagraph (B), by striking ``2020'' and inserting
``2025''.
(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)--
(i) in the matter preceding clause (i), by striking
``2020'' and inserting ``2025'';
(ii) in clause (i)--
(I) by striking ``and investigational generic new animal
drug protocol submissions'' and inserting ``investigational
generic new animal drug protocol submissions, requests to
establish a generic investigational new animal drug file, and
generic investigational new animal drug meeting requests'';
and
(II) by striking ``; and'' and inserting a semicolon;
(iii) by redesignating clause (ii) as clause (iii); and
(iv) by inserting after clause (i) the following:
``(ii) if the workload adjustment calculated by the
Secretary under clause (i) exceeds 25 percent, the Secretary
shall use 25 percent for the adjustment; and''; and
(B) in subparagraph (B), by striking ``2021 through 2023''
and inserting ``2026 through 2028''.
(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--
(A) by striking ``2023'' each place it appears and
inserting ``2028''; and
(B) by striking ``2024'' and inserting ``2029''.
(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:
``(d) Fee Waiver or Reduction.--The Secretary shall grant a
waiver from, or a reduction of, one or more fees assessed
under subsection (a) where the Secretary finds that the
generic new animal drug is intended solely to provide for a
minor use or minor species indication.''.
(e) Effect of Failure to Pay Fees.--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--
(1) in paragraph (3), by striking ``2019 through 2023'' and
inserting ``2024 through 2028'';
(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);
``(B) for fiscal year 2027, by the amount, if any, by which
the amount collected under this section and appropriated for
fiscal year 2025 falls below the amount of fees authorized
for fiscal year 2025 under paragraph (3); and
``(C) for fiscal year 2028, by the amount, if any, by which
the amount collected under this section and appropriated for
fiscal years 2026 and 2027 (including estimated collections
for fiscal year 2027) falls below the amount of fees
authorized for such fiscal years under paragraph (3).''.
(h) 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;
(2) by inserting after paragraph (7) the following:
``(8) Generic investigational new animal drug meeting
request.--The term `generic investigational new animal drug
meeting request' means a request submitted by a generic new
animal drug sponsor to meet with the Secretary to discuss an
investigational submission for a generic new animal drug.'';
(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.''.
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 742 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-22) is amended--
(1) in subsection (a), by striking ``2018'' and inserting
``2023'';
(2) by striking ``2019'' each place it appears in
subsections (a) and (b) and inserting ``2024''; and
(3) in subsection (d), by striking ``2023'' each place it
appears and inserting ``2028''.
SEC. 204. SAVINGS CLAUSE.
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.
SEC. 205. EFFECTIVE DATE.
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.
SEC. 206. SUNSET DATES.
(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.
TITLE III--SUPPORTING ANIMAL AND HUMAN HEALTH
SEC. 301. REPORTING REQUIREMENTS.
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)--
(A) by striking ``Beginning with'' and inserting the
following:
``(1) In general.--Beginning with''; and
(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--
``(i) the drivers of such changes; and
``(ii) changes in the total cost per full-time equivalent
in the animal drug review program.
``(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)--
(A) in paragraph (5), by inserting a comma after
``paragraph (4)'';
(B) by redesignating paragraph (6) as paragraph (7);
(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
(D) in paragraph (7) (as so redesignated)--
(i) in subparagraph (A)--
(I) by striking ``Before presenting the recommendations
developed under paragraphs (1) through (5) to Congress, the
Secretary'' and inserting ``The Secretary''; and
[[Page H3623]]
(II) by inserting before the period at the end the
following: ``, not later than 30 days after each such
negotiation meeting''; and
(ii) in subparagraph (B), by inserting ``, in sufficient
detail,'' after ``shall summarize''.
SEC. 302. DEFINITION OF MAJOR SPECIES.
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''.
SEC. 303. ANTIMICROBIAL RESISTANCE.
(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
(2) with respect to antimicrobial stewardship in veterinary
settings--
(A) the goals of the Center regarding supporting
antimicrobial stewardship in veterinary settings;
(B) activities the Center plans to execute during the
period of fiscal years 2024 through 2028 to support such
goals, including targeted completion dates for such
activities; and
(C) metrics the Center plans to use to evaluate progress
toward its goals regarding supporting antimicrobial
stewardship in veterinary settings.
(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--
(A) an explanation for why such target completion date was
not met; and
(B) if applicable, the updated expected completion date for
such activity;
(3) a description of emerging challenges related to
antimicrobial stewardship in veterinary settings that impact
Center activities; and
(4) a description of activities undertaken to incentivize
the development of new drugs for the treatment, prevention,
or control of bacterial diseases in animals.
The SPEAKER pro tempore (Mr. Van Drew). Pursuant to the rule, the
gentleman from Florida (Mr. Bilirakis) and the gentlewoman from
Washington (Ms. Schrier) each will control 20 minutes.
The Chair recognizes the gentleman from Florida.
General Leave
Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material in the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Florida?
There was no objection.
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in support of H.R. 1418, the Animal Drug
and Animal Generic Drug User Fee Amendments of 2023, sponsored by my
good friend, Mr. Pence, and, of course, Ms. Schrier on the Democrat
side and their members on the Energy and Commerce Committee.
Our committee has worked hard on this legislation for many months,
holding a legislative hearing in March and two markups this spring
before advancing it out of full committee last month by a vote of 49-0.
At each step, our members worked in a bipartisan fashion to consider
ways to make improvements to this legislation and keep any
controversial policies from getting in the way of passing this bill
before its September deadline. Great work.
Overall, the ADUFA amendments of 2023 will reauthorize the two user
fee programs established to support the development and review of
animal drugs and generics.
These drugs keep our animals healthy, from our household pets to our
farm animals, and they ensure that our food supply is safe for humans
too. That is how important this bill is.
The bill before us also includes provisions to support the review
process in getting new drugs to the market faster and adds new
reporting requirements to improve transparency and accountability
within the FDA's Center for Veterinary Medicine.
It also takes steps to support utilizing the conditional approval
pathway for animal drugs, which will bring more drugs to the market for
small animal populations with unmet clinical needs.
There are even more program enhancements contained in these
agreements, addressing foreign inspections, fiscal responsibility, and
the need for more innovation.
If this legislation is not signed into law before September 30, Mr.
Speaker, the review and approval of the medicines that farmers and pet
owners rely on will dramatically slow down. We can't let that happen.
Drugmakers will also face regulatory uncertainty in getting their
therapies to the market, impacting access to new cures and treatments.
They are relying on Congress to do its job, and we will, which is why I
strongly urge support of this legislation and encourage my colleagues
to vote ``yes.''
I reserve the balance of my time, Mr. Speaker.
Ms. SCHRIER. Mr. Speaker, I yield myself such time as I may consume.
I first thank Chair Rogers, Ranking Member Pallone, Representative
Bilirakis, and, of course, Representative Pence, who sponsored this
bill together with me, for their leadership and hard work on this
bipartisan bill. I am a proud sponsor.
The Animal Drug User Fee Agreement is important for the safety of
both animal and human health. This bill will accelerate the development
of new medications for animals with a predictable and streamlined
review process.
It will hold the FDA accountable for performance goals that will
improve wait times for inspections and provide regulatory certainty for
innovators and pet and animal owners alike.
It will ensure that our Nation's food supply is safe by making sure
the medicines that are administered to food-producing animals are safe.
{time} 1645
I want to underscore that this bill is a win for everyone, but it is
especially good for farmers.
In my district, farmers, ranchers, and dairymen rely on these FDA-
approved medications to keep their livestock healthy. For them, keeping
animals healthy is not just about their affection and responsibility
for these animals. It is critical for food production, food safety, and
their very economic survival.
Having timely access to affordable, effective medications is a key
part of our domestic food chain, and that is really the heart of our
rural economies.
I am happy to go to bat for our rural areas and our agricultural
communities with this legislation. I encourage my colleagues to vote
``yes'' on this important bill, Mr. Speaker, and I reserve the balance
of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to
the gentleman from Indiana (Mr. Pence), the sponsor of the bill along
with Ms. Schrier.
Mr. PENCE. Mr. Speaker, I am proud to champion the fifth
reauthorization of the Animal Drug User Fee Act with Congresswoman
Schrier.
This important legislation is critical to ensuring safe and effective
drugs for our Nation's livestock industry and farm animals for the next
5 years. It provides resources for the review of new and generic animal
drugs, accelerates the development of animal therapeutics, and promotes
a more predictable and streamlined review process.
It is important we hold the FDA accountable to performance goals that
will enhance inspection times and provide regulatory certainty for both
innovators and pet owners alike.
Farmers, ranchers, and rural communities across southern Indiana rely
on veterinary medicines and therapeutics produced by animal drug
manufacturers. Innovators in the Hoosier State, like Elanco Animal
Health, are leading the charge to keep American farm animals safe and
healthy. We need innovation in veterinary medicine to secure the best
care for our Nation's veterinary patients.
This legislation would preserve the security of America's food supply
by making certain the medications administered to food-producing
animals are safe for animal and human health.
Mr. Speaker, I urge support for final passage of this legislation.
[[Page H3624]]
Ms. SCHRIER. Mr. Speaker, I yield myself the balance of my time to
close.
I thank Mr. Bilirakis and Members on the other side of the aisle for
working together on this bipartisan bill. I encourage my colleagues to
vote ``yes'' on this bill to make sure we can speed novel medications
to animals in this country.
Mr. Speaker, I yield back the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, this is a great bill. It is a necessary
bill for our farmers but also our animal owners. I used to be the chair
of the Humane Bond Caucus, and we absolutely love our animals. Mr.
Pence and Ms. Schrier are doing an excellent job on this particular
bill, and I urge unanimous passage.
Mr. Speaker, I yield back the balance of my time.
Ms. JACKSON LEE. Mr. Speaker, I rise in support of H.R. 1418, the
``Animal Drug and Animal Generic Drug User Fee Amendments of 2023'', or
ADUFA and AGDUFA, which will enable the U.S. to lead the world in
innovation and drug development for animal pharmaceuticals.
The Animal Drug and Animal Generic Drug User Fee Amendment or AGDUFA
was designed to enhance the performance of the generic new animal drug
review process and enable the FDA to more efficiently ensure that
generic new animal drug products are safe and effective.
AGDUFA was originally signed into law in 2008 and reauthorized in
2013 and 2018.
This bill reauthorizes the FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, generic new
animal drug products and from certain sponsors of abbreviated
applications for generic new animal drugs and investigational
submissions for generic new animal drugs.
Specifically, this bill ensures that the Center for Veterinary
Medicine can continue to meet the needs of the animal drug industry as
it evolves.
This bipartisan bill will lead to increased transparency, additional
pathways for animal drug approvals, and reduced review times for
pioneer and generic drug applications while maintaining high standards
for safety and efficacy.
Veterinarians have far fewer FDA-approved animal drugs compared to
the number of FDA-approved human drugs.
My district in Houston is home to hundreds of veterinarians working
hard to improve the health of animals.
In fact, Houston ranks fourth among metro areas for dog ownership and
was named the ``Dog Capital of the World'' in a 2022 study conducted by
Protect Our Paws.
Protect Our Paws found that Houston had the highest dog-toperson
ratio in the world with 52.1 dogs per 100 humans.
More broadly, with Texas being No. 4 in pet ownership and over 58
percent of households owning at least one pet, we have thousands ot
pets and animals to protect.
I have a vested interest in moving these reauthorizations forward
because they are critical to animal and human health and well-being.
FDA continues to make progress to mitigate the growth of
antimicrobial resistance in food-producing animals, including ending
over-the-counter access to medically important antibiotics which are
used in both humans and animals, but more needs to be done.
I remain fully committed to moving the Animal Drug and Animal Generic
Drug User Fee Amendments of 2023 through a swift reauthorization before
the programs expire on September 30th.
I urge all my colleagues to join me in voting in favor of H.R. 1418,
the Animal Drug and Animal Generic Drug User Fee Amendments of 2023.''
Ms. JACKSON LEE. Mr. Speaker, I rise today in support of H.R. 813,
the Global Investment in American Jobs Act of 2023.
This bill will direct the Secretary of Commerce to conduct an
interagency review of and report to Congress on ways to increase the
global competitiveness of the United States in attracting foreign
direct investment.
The report will look at the economic impact of foreign direct
investments in the United States, focusing on manufacturing, services,
trade, and jobs in the United States.
This will allow Congress to better understand trends and challenges
in global cross-border investments, as well as collaborate with other
trusted partner countries.
Specifically, this bill will attract foreign direct investment from
responsible private-sector entities, which is directly linked to the
long-term economic prosperity, global competitiveness, and security of
the United States.
It will promote polices to ensure that United States remains the
global leader in developing and deploying cutting-edge technologies,
such as self-driving vehicle technology and artificial intelligence.
As digital information becomes increasingly important to the United
States economy and the development of new technologies and services
that will be crucial to the country's competitiveness in the 21st
century global economy, barriers including data localization and
infringement of intellectual property rights must be further addressed.
This study will focus on the economic impact of foreign direct
investment, challenges associated with foreign direct investment by
state-owned enterprises, and the influence of protectionist policies
enacted by other countries on the advanced technology economy.
Further, this bill will allow us to reduce our supply-chain
dependence on China.
For the success of our larger economy, national security, and global
relationships, it is vital that we pass H.R. 813.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Florida (Mr. Bilirakis) that the House suspend the rules
and pass the bill, H.R. 1418, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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