[115th Congress Public Law 234]
[From the U.S. Government Publishing Office]
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[[Page 132 STAT. 2427]]
Public Law 115-234
115th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user
fee programs relating to new animal drugs and generic new animal
drugs. <<NOTE: Aug. 14, 2018 - [H.R. 5554]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Animal Drug and
Animal Generic Drug User Fee Amendments of 2018. 21 USC 301 note.>>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Animal Drug and Animal Generic Drug
User Fee Amendments of 2018''.
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title.
Sec. 2. Table of contents; references in Act.
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--MISCELLANEOUS PROVISIONS
Sec. 301. Electronic submissions.
Sec. 302. Index of legally marketed unapproved new animal drugs for
minor species.
Sec. 303. Misbranded drugs and devices.
Sec. 304. Conditional approval of new animal drugs.
Sec. 305. Guidance addressing investigation designs.
Sec. 306. Food additives intended for use in animal food.
(b) References in Act.--Except as otherwise specified, amendments
made by this Act to a section or other provision of law are amendments
to such section or other provision of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
[[Page 132 STAT. 2428]]
TITLE I-- <<NOTE: Animal Drug User Fee Amendments of 2018.>> FEES
RELATING TO ANIMAL DRUGS
SEC. 101. <<NOTE: 21 USC 301 note.>> SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Animal Drug User
Fee Amendments of 2018''.
(b) Finding.-- <<NOTE: 21 USC 379j-11 note.>> 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, 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 (21 U.S.C. 379j-11) is amended--
(1) by amending paragraph (1) to read as follows:
``(1)(A) The term `animal drug application' means--
``(i) an application for approval of any new animal
drug submitted under section 512(b)(1); or
``(ii) an application for conditional approval of a
new animal drug submitted under section 571.
``(B) Such term does not include either a new animal drug
application submitted under section 512(b)(2) or a supplemental
animal drug application.''; and
(2) in paragraph (8), by adding at the end the following:
``(I) The activities necessary for implementation of
the United States and European Union Good Manufacturing
Practice Mutual Inspection Agreement with respect to
animal drug products subject to review, including
implementation activities prior to and following product
approval.''.
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
(a) Fee Revenue Amounts.--Section 740(b) (21 U.S.C. 379j-12(b)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2014'' and inserting
``2019''; and
(ii) by striking ``$23,600,000'' and inserting
``$30,331,240''; and
(B) in subparagraph (B)--
(i) by striking ``2015 through 2018'' and
inserting ``2020 through 2023''; and
(ii) by striking ``$21,600,000'' and inserting
``$29,931,240''; and
(2) in paragraph (2), in the matter preceding subparagraph
(A), by striking ``determined'' and inserting ``established''.
(b) Annual Fee Setting; Adjustments.--
(1) Inflation adjustment.--Section 740(c)(2) (21 U.S.C.
379j-12(c)(2)) is amended--
(A) in the matter preceding subparagraph (A)--
[[Page 132 STAT. 2429]]
(i) by striking ``For fiscal year 2015'' and
inserting ``(A) For fiscal year 2020''; and
(ii) by inserting ``multiplying such revenue
amounts by'' before ``an amount'';
(B) by redesignating subparagraphs (A), (B), and (C)
as clauses (i), (ii), and (iii), respectively;
(C) by striking the flush text at the end; and
(D) by adding at the end the following new
subparagraph:
``(B) Compounded basis.--The adjustment made each fiscal
year after fiscal year 2020 under this paragraph shall be
applied on a compounded basis to the revenue amount calculated
under this paragraph for the most recent previous fiscal
year.''.
(2) Workload adjustments.--Paragraph (3) of section 740(c)
(21 U.S.C. 379j-12(c)) is amended to read as follows:
``(3) Workload adjustments.--
``(A) In general.--For fiscal year 2020 and
subsequent fiscal years, after the fee revenue amounts
established under subsection (b) are adjusted for
inflation in accordance with paragraph (2), the fee
revenue amounts shall be further adjusted for such
fiscal year to reflect changes in the workload of the
Secretary for the process for the review of animal drug
applications, subject to subparagraphs (B) and (C). With
respect to such adjustment--
``(i) <<NOTE: Determination.>> such
adjustment shall be determined by the Secretary
based on a weighted average of the change in the
total number of animal drug applications,
supplemental animal drug applications for which
data with respect to safety or effectiveness are
required, manufacturing supplemental animal drug
applications, investigational animal drug study
submissions, and investigational animal drug
protocol submissions submitted to the Secretary;
and
``(ii) <<NOTE: Federal Register,
publication.>> the Secretary shall publish in the
Federal Register the fees resulting from such
adjustment and the supporting methodologies.
``(B) Reduction of workload-based increase by amount
of certain excess collections.--For each of fiscal years
2021 through 2023, if application of the workload
adjustment under subparagraph (A) increases the fee
revenue amounts otherwise established for the fiscal
year under subsection (b), as adjusted for inflation
under paragraph (2), such fee revenue increase shall be
reduced by the amount of any excess collections, as
described in subsection (g)(4), for the second preceding
fiscal year, up to the amount of such fee revenue
increase.
``(C) Rule of application.--Under no circumstances
shall the workload adjustments under this paragraph
result in fee revenues for a fiscal year that are less
than the fee revenues for that fiscal year established
under subsection (b), as adjusted for inflation under
paragraph (2).''.
(3) Final year adjustment.--Section 740(c)(4) (21 U.S.C.
379j-12(c)(4)) is amended--
(A) by striking ``2018'' each place it appears and
inserting ``2023''; and
(B) by striking ``2019'' and inserting ``2024''.
[[Page 132 STAT. 2430]]
(c) Exemptions From Fees.--Section 740(d) (21 U.S.C. 379j-12(d)) is
amended--
(1) in the subsection heading, by inserting ``; Exemptions
From Fees'' after ``Reduction'';
(2) by striking the heading of paragraph (1) and inserting
``Waiver or reduction''; and
(3) by adding at the end the following:
``(4) Exemptions from fees.--
``(A) Certain labeling supplements to add number of
approved application.--Fees under this section shall not
apply with respect to any person who--
``(i) <<NOTE: Deadline.>> not later than
September 30, 2023, submits a supplemental animal
drug application relating to a new animal drug
application approved under section 512, solely to
add the new animal drug application number to the
labeling of the drug in the manner specified in
section 502(w)(3); and
``(ii) otherwise would be subject to fees
under this section solely on the basis of such
supplemental application.
``(B) Certain animal drug applications.--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.''.
(d) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 740(g)(3) (21
U.S.C. 379j-12(g)(3)) is amended--
(A) by striking ``2014 through 2018'' and inserting
``2019 through 2023'';
(B) by striking ``determined'' and inserting
``established''; and
(C) by striking ``paragraph (4)'' and inserting
``paragraph (5)''.
(2) Excess collections.--Section 740(g) (21 U.S.C. 379j-
12(g)) is amended by striking paragraph (4) and inserting the
following:
``(4) Excess collections.--If the sum total of fees
collected under this section for a fiscal year exceeds the
amount of fees authorized to be appropriated for such year under
paragraph (3), the excess collections shall be credited to the
appropriations account of the Food and Drug Administration as
provided in paragraph (1).
``(5) Recovery of collection shortfalls.--
``(A) In general.--Subject to subparagraph (B)--
``(i) for fiscal year 2021, the amount of fees
otherwise authorized to be collected under this
section shall be increased by the amount, if any,
by which the amount collected under this section
and appropriated for fiscal year 2019 falls below
the amount of fees authorized for fiscal year 2019
under paragraph (3);
``(ii) for fiscal year 2022, the amount of
fees otherwise authorized to be collected under
this section shall
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be increased by the amount, if any, by which the
amount collected under this section and
appropriated for fiscal year 2020 falls below the
amount of fees authorized for fiscal year 2020
under paragraph (3); and
``(iii) for fiscal year 2023, the amount of
fees otherwise authorized to be collected under
this section shall be increased by the cumulative
amount, if any, by which the amount collected
under this section and appropriated for fiscal
years 2021 and 2022 (including estimated
collections for fiscal year 2022) falls below the
cumulative amount of fees authorized for such
fiscal years under paragraph (3).
``(B) Reduction of shortfall-based fee increase by
prior year excess collections.--
``(i) In general.--Subject to clause (ii), the
Secretary shall, in such manner as the Secretary
determines appropriate, reduce any fee increase
otherwise applicable for a fiscal year under
subparagraph (A) by the amount of any excess
collections under this section for preceding
fiscal years (after fiscal year 2018).
``(ii) Workload-based fee accounting.--In
applying clause (i), the Secretary shall account
for the reduction of workload-based fee revenue
increases by excess collections under subsection
(c)(3)(B), in such manner as needed to provide
that no portion of any excess collections
described in clause (i) is applied for purposes of
reducing fee increases under both such subsection
(c)(3)(B) and this paragraph.
``(C) Rule of application.--Under no circumstances
shall adjustments under this paragraph result in fee
revenues for a fiscal year that are less than the fee
revenues for that fiscal year established in subsection
(b), as adjusted or otherwise affected under subsection
(c).''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 740A (21 U.S.C. 379j-13) is amended--
(1) in subsection (a), by striking ``2013'' and inserting
``2018'';
(2) by striking ``2014'' each place it appears in
subsections (a) and (b) and inserting ``2019''; and
(3) in subsection (d), by striking ``2018'' each place it
appears and inserting ``2023''.
SEC. <<NOTE: Time period. 21 USC 379j-11 note.>> 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, 2013,
but before October 1, 2018, were accepted by the Food and Drug
Administration for filing with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal year 2019.
[[Page 132 STAT. 2432]]
SEC. 106. <<NOTE: 21 USC 379j-11 note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2018, 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, as amended by this title, shall be
assessed for animal drug applications and supplemental animal drug
applications received on or after October 1, 2018, regardless of the
date of the enactment of this Act.
SEC. 107. SUNSET DATES.
(a) Authorization.-- <<NOTE: 21 USC 379j-12 note.>> Section 740 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12) shall cease
to be effective October 1, 2023.
(b) Reporting Requirements.-- <<NOTE: 21 USC 379j-13 note.>> Section
740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13)
shall cease to be effective January 31, 2024.
(c) <<NOTE: Repeals. 21 USC 379j-12 note.>> Previous Sunset
Provision.-- <<NOTE: Animal Generic Drug User Fee Amendments of
2018.>> Effective October 1, 2018, subsections (a) and (b) of section
107 of the Animal Drug User Fee Amendments of 2013 (Public Law 113-14)
are repealed.
TITLE II-- <<NOTE: Animal Generic Drug User Fee Amendments of
2018.>> FEES RELATING TO GENERIC ANIMAL DRUGS
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.-- <<NOTE: 21 USC 301 note.>> This title may be
cited as the ``Animal Generic Drug User Fee Amendments of 2018''.
(b) Finding.-- <<NOTE: 21 USC 379j-21 note.>> 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,
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) Fee Revenue Amounts.--Subsection (b) of section 741 (21 U.S.C.
379j-21) is amended to read as follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--Subject to subsections (c), (d), (f), and
(g), for each of fiscal years 2019 through 2023, the fees
required under subsection (a) shall be established to generate a
total revenue amount of $18,336,340.
``(2) Types of fees.--Of the total revenue amount
established for a fiscal year under paragraph (1)--
``(A) 25 percent shall be derived from fees under
subsection (a)(1) (relating to abbreviated applications
for a generic new animal drug);
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``(B) 37.5 percent shall be derived from fees under
subsection (a)(2) (relating to generic new animal drug
products); and
``(C) 37.5 percent shall be derived from fees under
subsection (a)(3) (relating to generic new animal drug
sponsors).''.
(b) Annual Fee Setting; Adjustments.--
(1) Inflation adjustment.--Section 741(c) (21 U.S.C. 379j-
21(c)) is amended--
(A) by redesignating paragraphs (2) through (4) as
paragraphs (3) through (5), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) Inflation adjustment.--
``(A) In general.-- <<NOTE: Notice. Federal
Register, publication.>> For fiscal year 2020 and
subsequent fiscal years, the revenue amounts established
under subsection (b) shall be adjusted by the Secretary
by notice, published in the Federal Register, for a
fiscal year, by multiplying such revenue amounts by an
amount equal to the sum of--
``(i) one;
``(ii) the average annual percent change in
the cost, per full-time equivalent position of the
Food and Drug Administration, of all personnel
compensation and benefits paid with respect to
such positions for the first 3 of the preceding 4
fiscal years for which data are available,
multiplied by the average proportion of personnel
compensation and benefits costs to total Food and
Drug Administration costs for the first 3 of the
preceding 4 fiscal years for which data are
available; and
``(iii) the average annual percent change that
occurred in the Consumer Price Index for urban
consumers (Washington-Baltimore, DC-MD-VA-WV; not
seasonally adjusted; all items less food and
energy; annual index) for the first 3 of the
preceding 4 years for which data are available
multiplied by the average proportion of all costs
other than personnel compensation and benefits
costs to total Food and Drug Administration costs
for the first 3 of the preceding 4 fiscal years
for which data are available.
``(B) Compounded basis.--The adjustment made each
fiscal year after fiscal year 2020 under this paragraph
shall be applied on a compounded basis to the revenue
amount calculated under this paragraph for the most
recent previous fiscal year.''.
(2) Workload adjustments.--Paragraph (3) of section 741(c)
(21 U.S.C. 379j-21(c)), as redesignated, is amended to read as
follows:
``(3) Workload adjustments.--
``(A) In general.--For fiscal year 2020 and
subsequent fiscal years, after the fee revenue amounts
established under subsection (b) are adjusted for
inflation in accordance with paragraph (2), the fee
revenue amounts shall be further adjusted for each such
fiscal year to reflect changes in the workload of the
Secretary for the process for the review of abbreviated
applications for generic new animal
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drugs, subject to subparagraphs (B) and (C). With
respect to such adjustment--
``(i) <<NOTE: Determination.>> this
adjustment shall be determined by the Secretary
based on a weighted average of the change in the
total number of abbreviated applications for
generic new animal drugs, manufacturing
supplemental abbreviated applications for generic
new animal drugs, investigational generic new
animal drug study submissions, and investigational
generic new animal drug protocol submissions
submitted to the Secretary; and
``(ii) <<NOTE: Federal Register,
publication.>> the Secretary shall publish in the
Federal Register the fees resulting from this
adjustment and the supporting methodologies.
``(B) Reduction of workload-based increase by amount
of certain excess collections.--For each of fiscal years
2021 through 2023, if application of the workload
adjustment under subparagraph (A) increases the fee
revenue amounts otherwise established for the fiscal
year under subsection (b), as adjusted for inflation
under paragraph (2), such fee revenue increase shall be
reduced by the amount of any excess collections, as
described in subsection (g)(4), for the second preceding
fiscal year, up to the amount of such fee revenue
increase.
``(C) Rule of application.--Under no circumstances
shall workload adjustments under this paragraph result
in fee revenues for a fiscal year that are less than the
fee revenues for that fiscal year established under
subsection (b), as adjusted for inflation under
paragraph (2).''.
(3) Final year adjustment.--Paragraph (4) of section 741(c)
(21 U.S.C. 379j-21(c)), as redesignated, is amended by--
(A) striking ``2018'' each place it appears and
inserting ``2023''; and
(B) striking ``2019'' and inserting ``2024''.
(c) Fee Waiver or Reduction; Exemption From Fees.--Subsection (d) of
section 741 (21 U.S.C. 379j-21) is amended to read as follows:
``(d) Fee Waiver or Reduction; Exemption From Fees.--
``(1) 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.
``(2) Exemption from fees.--Fees under this section shall
not apply with respect to any person who--
``(A) <<NOTE: Deadline.>> not later than September
30, 2023, submits a supplemental abbreviated application
for a generic new animal drug approved under section
512, solely to add the application number to the
labeling of the drug in the manner specified in section
502(w)(3); and
``(B) otherwise would be subject to fees under this
section solely on the basis of such supplemental
abbreviated application.''.
(d) Crediting and Availability of Fees.--Section 741(g) (21 U.S.C.
379j-21) is amended by striking paragraph (3) and inserting the
following paragraphs:
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``(3) Authorization of appropriations.--For each of the
fiscal years 2019 through 2023, there is authorized to be
appropriated for fees under this section an amount equal to the
total revenue amount established under subsection (b) for the
fiscal year, as adjusted or otherwise affected under subsection
(c).
``(4) Excess collections.--If the sum total of fees
collected under this section for a fiscal year exceeds the
amount of fees authorized to be appropriated for such year under
paragraph (3), the excess collections shall be credited to the
appropriations account of the Food and Drug Administration as
provided in paragraph (1).''.
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 742 (21 U.S.C. 379j-22) is amended--
(1) in subsection (a), by striking ``2013'' and inserting
``2018'';
(2) in subsection (b), by striking ``Committee on Health,
Education, Labor, and Pensions'' and inserting ``the Committee
on Health, Education, Labor and Pensions'';
(3) by striking ``2014'' each place it appears in
subsections (a) and (b) and inserting ``2019''; and
(4) in subsection (d), by striking ``2018'' each place it
appears and inserting ``2023''.
SEC. 204. <<NOTE: Time period. 21 USC 379j-21 note.>> 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, 2013, but before
October 1, 2018, were accepted by the Food and Drug Administration for
filing with respect to assessing and collecting any fee required by such
part for a fiscal year prior to fiscal year 2019.
SEC. 205. <<NOTE: 21 USC 379j-21 note.>> EFFECTIVE DATE.
The amendments made by this title shall take effect on October 1,
2018, 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, as amended by this title, shall be
assessed for abbreviated applications for a generic new animal drug and
supplemental abbreviated applications for a generic new animal drug
received on or after October 1, 2018, regardless of the date of
enactment of this Act.
SEC. 206. SUNSET DATES.
(a) Authorization.-- <<NOTE: 21 USC 379j-21 note.>> Section 741 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-21) shall cease
to be effective October 1, 2023.
(b) Reporting Requirements.-- <<NOTE: 21 USC 379j-22 note.>> Section
742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-22)
shall cease to be effective January 31, 2024.
(c) <<NOTE: Repeals. 21 USC 379j-21 note.>> Previous Sunset
Provision.--Effective October 1, 2018, subsections (a) and (b) of
section 206 of the Animal Generic Drug User Fee Amendments of 2013
(Public Law 113-14) are repealed.
[[Page 132 STAT. 2436]]
TITLE III--MISCELLANEOUS PROVISIONS
SEC. 301. ELECTRONIC SUBMISSIONS.
(a) New Animal Drug Applications and Abbreviated Applications for a
Generic New Animal Drug.--Section 512(b) (21 U.S.C. 360b(b)) is amended
by adding at the end the following:
``(4) <<NOTE: Effective date.>> Beginning on October 1, 2018, all
applications or submissions pursuant to this subsection shall be
submitted by electronic means in such format as the Secretary may
require.''.
(b) Conditional Approval of New Animal Drugs for Minor Use and Minor
Species.--Section 571(a) (21 U.S.C. 360ccc(a)) is amended by adding at
the end the following:
``(4) <<NOTE: Effective date.>> Beginning on October 1, 2018, all
applications or submissions pursuant to this subsection shall be
submitted by electronic means in such format as the Secretary may
require.''.
SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS
FOR MINOR SPECIES.
<<NOTE: Effective date. 21 USC 360ccc-1 note.>> Effective on October
1, 2018, section 572(h) (21 U.S.C. 360ccc-1(h)) is amended--
(1) by amending paragraph (1) to read as follows:
``(1) `LEGAL STATUS--In order to be legally marketed, a new
animal drug intended for a minor species must be Approved,
Conditionally Approved, or Indexed by the Food and Drug
Administration. THIS PRODUCT IS INDEXED--MIF #' (followed by the
applicable minor species index file number and a period) `Extra-
label use is prohibited.';''; and
(2) in paragraph (2), by striking ``other animals'' and
inserting ``food-producing animals''.
SEC. 303. MISBRANDED DRUGS AND DEVICES.
(a) In General.--Section 502(w) (21 U.S.C. 352(w)) is amended--
(1) in subparagraph (1), by striking ``; or'' and inserting
``;'';
(2) in subparagraph (2), by striking the period and
inserting ``; or''; and
(3) by adding at the end the following:
``(3) for which an application has been approved under
section 512 and the labeling of such drug does not include the
application number in the format: `Approved by FDA under (A)NADA
# xxx-xxx', except that this subparagraph shall not apply to
representative labeling required under section 514.1(b)(3)(v)(b)
of title 21, Code of Federal Regulations (or any successor
regulation) for animal feed bearing or containing a new animal
drug.''.
(b) Applicability.-- <<NOTE: Effective date. 21 USC 352
note.>> Section 502(w)(3) of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (a), shall apply beginning on September 30, 2023.
SEC. 304. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS.
(a) In General.--Section 571 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360ccc) is amended--
(1) in the section heading, by striking ``species'' and
inserting ``species and certain new animal drugs'';
[[Page 132 STAT. 2437]]
(2) in subsection (a)--
(A) by amending paragraph (1) to read as follows:
``(1)(A) Except as provided in paragraph (3), any person may file
with the Secretary an application for conditional approval of--
``(i) a new animal drug intended for a minor use or a minor
species; or
``(ii) a new animal drug not intended for a minor use or
minor species--
``(I) that is intended to treat a serious or life-
threatening disease or condition or addresses an unmet
animal or human health need; and
``(II) for which the Secretary determines that a
demonstration of effectiveness would require a complex
or particularly difficult study or studies.
``(B) <<NOTE: Deadline. Guidance. Regulations.>> The Secretary
shall, not later than September 30, 2019, issue guidance or regulations
further clarifying the criteria specified in subparagraph (A)(ii).
``(C) <<NOTE: Compliance.>> An application under this paragraph
shall comply in all respects with the provisions of section 512 except
for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e),
(h), and (n) of such section unless otherwise stated in this section,
and any additional provisions of this section.
``(D) New animal drugs for which conditional approval is sought
under this section are subject to the same safety standards that would
be applied to new animal drugs under section 512(d) (including, for
antimicrobial new animal drugs, with respect to antimicrobial
resistance).''; and
(B) in paragraph (3)--
(i) in subparagraph (B), by striking ``, or''
and inserting ``; or'';
(ii) by redesignating subparagraphs (A), (B),
and (C) as clauses (i), (ii), and (iii),
respectively;
(iii) by striking ``A person may not file''
and inserting ``(A) A person may not file''; and
(iv) by adding at the end the following new
subparagraph:
``(B) A person may not file an application under paragraph
(1)(A)(ii) if the application seeks conditional approval of a new animal
drug that contains an antimicrobial active ingredient.'';
(3) in subsection (f)--
(A) in paragraph (1), in the matter preceding
subparagraph (A), by inserting ``for the conditionally
approved use'' after ``shall''; and
(B) in paragraph (2)--
(i) <<NOTE: Regulations. Guidance. Determination.>>
by striking ``An intended use'' and inserting
``The Secretary shall, through regulation or
guidance, determine under what conditions an
intended use''; and
(ii) by striking ``shall not'' and inserting
``may''; and
(4) by adding at the end the following new subsection:
``(k) Sunset.--
``(1) The Secretary's authority to grant conditional
approval of new animal drugs not intended for a minor use or
minor species pursuant to subsection (a)(1)(A)(ii) terminates on
October 1, 2028.
``(2) The Secretary--
[[Page 132 STAT. 2438]]
``(A) may not accept any new applications for such
conditional approval pursuant to subsection
(a)(1)(A)(ii) on or after such date; and
``(B) may continue all activities under this section
with respect to drugs that were conditionally approved
pursuant to (a)(1)(A)(ii) prior to such date.
``(3) <<NOTE: Deadline.>> The Secretary may, until October
1, 2032, accept applications for approval under 512 of drugs
conditionally approved pursuant to (a)(1)(A)(ii).''.
(b) Exception From Fees in Case of Certain Previously Submitted
Applications for Conditional Approval.--Section 740(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-12(a)(1)(C)) is
amended--
(1) in the caption by striking ``Exception'' and inserting
``Exceptions'';
(2) by striking ``If an animal drug'' and inserting the
following:
``(i) If an animal drug''; and
(3) by inserting after clause (i), as so designated, the
following new clause:
``(ii) <<NOTE: Effective date.>> Beginning
with fiscal year 2019, in the case of an animal
drug application submitted by a person under
section 512(b)(1), where such person (or their
licensor, assignor, or predecessor-in-interest)
previously submitted an application for
conditional approval under section 571 for the
same product and paid the applicable fee under
subparagraph (A), the application under section
512(b)(1) shall not be subject to a fee under
subparagraph (A) if submitted within the timeframe
specified in section 571(h).''.
(c) Report on Incorporating Veterinary Oversight.--Not later than
September 30, 2019, the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall submit a report to the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor and Pensions of the Senate
identifying how the Food and Drug Administration will incorporate
veterinary oversight for all approved medically important antimicrobial
drugs administered to animals that are not yet subject to veterinary
oversight. Such report shall address requirements related to revisions
of labeling to reflect that medically important antimicrobial drugs
administered to animals shall be subject to veterinary oversight.
(d) GAO Study of Conditional Approval Programs.--
(1) Study.--The Comptroller General of the United States
(referred to in this section as the ``Comptroller General'')
shall conduct a study on the effectiveness and overall impact of
the conditional approval pathway under section 571 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc).
(2) Issuance of report.--Not later than January 1, 2026, the
Comptroller General shall submit to the Committee on Health,
Education, Labor and Pensions of the Senate and the Committee on
Energy and Commerce of the House of Representatives a report
containing the results of the study under paragraph (1).
(3) Contents of reports.--The report submitted under
paragraph (2) shall address--
[[Page 132 STAT. 2439]]
(A) for each drug for which a conditional approval
has been awarded since October 1, 2018--
(i) whether the drug was granted conditional
approval pursuant to clause (i) or (ii) of section
571(a)(1)(A) of the Federal Food, Drug, and
Cosmetic Act, as amended by subsection (a);
(ii) whether the drug was dual labeled during
its conditional approval;
(iii) the indications for which the drug was
granted conditional approval under section 571 of
such Act (21 U.S.C. 360ccc) and whether the drug
was approved or not approved under section 512 of
such Act (21 U.S.C. 360b);
(iv) the number of years the drug was so
conditionally approved and a description of the
complexity of the investigation to demonstrate the
drug's effectiveness;
(v) whether, and to what extent, the
conditional approval pathway under such section
571 (21 U.S.C. 360ccc) impacted the sponsor's
decision to develop the drug or seek approval of
the drug under section 512 of such Act (21 U.S.C.
360b);
(vi) whether, and to what extent, conditional
approval pursuant to clause (ii) of section
571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A))
addressed a serious or life-threatening condition;
and
(vii) whether, and to what extent, conditional
approval pursuant to clause (ii) of section
571(a)(1)(A) of such Act (21 U.S.C. 360b(a)(1)(A))
addressed an unmet animal or human health need,
and whether before such conditional approval there
were available therapies for the disease or
condition involved;
(B) <<NOTE: Analysis.>> an analysis of the
conditional approval program under section 571 of such
Act (21 U.S.C. 360ccc), including--
(i) the resources used by the Food and Drug
Administration in reviewing applications for
conditional approval of drugs pursuant to such
program and renewal of such conditional approval,
including the effects of the program on the Food
and Drug Administration's review of animal drugs
for which conditional approval is not used;
(ii) whether any improvements to the program
under section 512 of such Act (21 U.S.C. 360b) are
necessary to incentivize the development of animal
drugs that would likely not otherwise be
developed, or developed in as timely a manner, to
address--
(I) serious or life-threatening
conditions; and
(II) an unmet animal or human health
need; and
(iii) whether the conditional approval pathway
has resulted in a greater number of animal drugs
approved under section 512 of such Act (21 U.S.C.
360b) for serious or life-threatening conditions
or unmet animal or human health needs than would
have otherwise come to market under the practices
and commitments of the Center for Veterinary
Medicine of the Food
[[Page 132 STAT. 2440]]
and Drug Administration as such practices and
commitments existed as of the day before the date
of enactment of this Act; and
(C) how the Center for Veterinary Medicine of the
Food and Drug Administration has utilized complex
adaptive or other novel investigation designs, data from
foreign countries, real-world evidence (including
ongoing surveillance activities, observational studies,
and registry data), biomarkers, or surrogate endpoints--
(i) to support the approval of products under
section 512 of such Act (21 U.S.C. 360b),
including how many such products have been
approved since October 1, 2018; and
(ii) to support the approval of products under
section 512 of such Act (21 U.S.C. 360b) that
received conditional approval under section 571 of
such Act (21 U.S.C. 360ccc), including how many
such products have been approved since October 1,
2018.
SEC. 305. <<NOTE: 21 USC 360b note.>> GUIDANCE ADDRESSING
INVESTIGATION DESIGNS.
(a) In General.--For purposes of assisting sponsors in incorporating
complex adaptive and other novel investigation designs, data from
foreign countries, real world evidence (including ongoing surveillance
activities, observational studies, and registry data), biomarkers, and
surrogate endpoints (referred to in this section as ``elements of
investigations'') into proposed clinical investigation protocols and
applications for new animal drugs under sections 512 and 571 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b; 360ccc), the
Secretary of Health and Human Services (referred to in this section as
the ``Secretary'') shall issue guidance addressing the use of such
elements of investigations in the development and regulatory review of
such new animal drugs.
(b) Contents.--The guidance under subsection (a) shall address how
the Secretary will evaluate the elements of investigations proposed or
submitted pursuant to section 512(b)(1)(A) of the Federal Food, Drug,
and Cosmetic Act or to meet the commitment under section 571(a)(2)(F) of
such Act, and how sponsors of such applications may obtain feedback from
the Secretary on technical issues related to such investigations prior
to the submission of an application to the Secretary.
(c) Meeting.-- <<NOTE: Consultation. Deadline.>> Prior to issuing
the guidance under subsection (a), the Secretary shall consult with
stakeholders, including representatives of regulated industry, consumer
groups, academia, veterinarians, and food producers, through a public
meeting to be held not later than 1 year after the date of enactment of
this Act.
(d) Timing.-- <<NOTE: Deadlines.>> The Secretary shall issue a draft
guidance under subsection (a) not later than 1 year after the date of
the public meeting under subsection (c), and shall finalize such
guidance not later than 1 year after the date on which the public
comment period on such draft guidance ends.
SEC. 306. FOOD ADDITIVES INTENDED FOR USE IN ANIMAL FOOD.
(a) Food Additive Petitions for Animal Food.--Section 409 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amended by
adding at the end the following:
``(k) Food Additives Intended for Use in Animal Food.--(1) In taking
action on a petition under subsection (c) for, or for
[[Page 132 STAT. 2441]]
recognition of, a food additive intended for use in animal food, the
Secretary shall review reports of investigations conducted in foreign
countries, provided by the petitioner.
``(2) <<NOTE: Deadline. Web posting.>> Not later than 12 months
after the date of enactment of the Animal Drug and Animal Generic Drug
Use Fee Amendments of 2018, the Secretary shall post on the internet
website of the Food and Drug Administration--
``(A) the number of petitions for food additives intended
for use in animal food filed under subsection (b) that are
pending;
``(B) how long each such petition submitted under subsection
(b) has been pending, including such petitions the Secretary has
extended under subsection (c)(2); and
``(C) the number of study protocols that have been pending
review for over 50 days, and the number that have received an
extension.
``(3) In the case of a food additive petition intended for use in
animal food, the Secretary shall provide information to the petitioner
on the required contents of such petition. If the Secretary requires
additional studies beyond what the petitioner proposed, the Secretary
shall provide the scientific rationale for such requirement.''.
(b) Ensuring the Safety of Pet Food.--Section 1002(a) of the Food
and Drug Administration Amendments Act of 2007 (21 U.S.C. 2102(a)) is
amended--
(1) by striking paragraph (1); and
(2) by redesignating paragraphs (2) and (3) as paragraphs
(1) and (2), respectively.
(c) <<NOTE: Deadlines. 21 USC 348 note.>> Guidance on Pre-Petition
Consultation Process for Animal Food Additives.--
(1) In general.--Not later than 18 months after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this subsection as the ``Secretary'')
shall publish draft guidance relating to the voluntary pre-
petition consultation process for food additives intended for
use in animal food.
(2) Contents.--The guidance under paragraph (1) shall
include--
(A) the recommended format to submit to the Food and
Drug Administration existing data, including any
applicable foreign data, for assessment prior to
submission of a food additive petition for animal food
under section 409(b) of the Federal Food, Drug, and
Cosmetic Act;
(B) the manner and the number of days by which the
Food and Drug Administration intends to review and
respond to such existing data, including with respect to
providing a scientific rationale for any additional data
request;
(C) circumstances under which the submission of
study protocols is recommended prior to submission of a
food additive petition under such section 409(b);
(D) the manner in which the Secretary intends to
inform the person submitting a study protocol for a food
additive if the review of such study protocol will take
longer than 50 days; and
(E) best practices for communication between the
Food and Drug Administration and industry on the
development
[[Page 132 STAT. 2442]]
of pre-petition submissions of study protocols and
existing data for food additives.
(3) Final guidance.--The guidance under paragraph (1) shall
be finalized, withdrawn, or reissued not later than 1 year after
the close of the comment period on the draft guidance.
Approved August 14, 2018.
LEGISLATIVE HISTORY--H.R. 5554 (S. 2434):
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CONGRESSIONAL RECORD, Vol. 164 (2018):
July 16, considered and passed House.
July 31, considered and passed Senate.
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