[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5554 Enrolled Bill (ENR)]

        H.R.5554

                     One Hundred Fifteenth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

         Begun and held at the City of Washington on Wednesday,
           the third day of January, two thousand and eighteen


                                 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.

    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 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.).

                 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 2018''.
    (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, 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)--
                (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) 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) 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''.
    (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) 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 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. 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.
    SEC. 106. 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.--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.--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) Previous Sunset Provision.--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--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 2018''.
    (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, 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);
            ``(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.--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 drugs, subject 
        to subparagraphs (B) and (C). With respect to such adjustment--
                ``(i) 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) 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) 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:
        ``(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. 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. 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.--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.--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) 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.

                  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) 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) 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.
    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.--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'';
        (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) The Secretary shall, not later than September 30, 2019, issue 
guidance or regulations further clarifying the criteria specified in 
subparagraph (A)(ii).
    ``(C) 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) 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--
            ``(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) 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) 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--
            (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) 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 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. 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.--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.--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 
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) 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) 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 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.