    [United States Statutes at Large, Volume 132, 115th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    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. <>

    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.).

    [[Page 2428]]

    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)--

    [[Page 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) <>  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''.

    [[Page 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) <>  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

    [[Page 2431]]

    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.

    [[Page 2432]]

    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);

    [[Page 2433]]

    ``(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

    [[Page 2434]]

    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:

    [[Page 2435]]

    ``(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.

    [[Page 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) <>  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'';

    [[Page 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) <>  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--

    [[Page 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) <>  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--

    [[Page 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) <>  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 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. <>  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

    [[Page 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) <>  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

    [[Page 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):
    ---------------------------------------------------------------------------

    CONGRESSIONAL RECORD, Vol. 164 (2018):
    July 16, considered and passed House.
    July 31, considered and passed Senate.