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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 622 Enrolled Bill (ENR)]

        S.622

                     One Hundred Thirteenth Congress

                                 of the

                        United States of America

                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Thursday,
           the third day of January, two thousand and thirteen

                                 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 Reauthorization Act of 2013''.
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
    (a) Table of Contents.--The table of contents of 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.

    (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 2013''.
    (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 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-11) is amended to read as follows:
    ``SEC. 739. DEFINITIONS.
    ``For purposes of this part:
        ``(1) The term `animal drug application' means an application 
    for approval of any new animal drug submitted under section 
    512(b)(1). Such term does not include either a new animal drug 
    application submitted under section 512(b)(2) or a supplemental 
    animal drug application.
        ``(2) The term `supplemental animal drug application' means--
            ``(A) a request to the Secretary to approve a change in an 
        animal drug application which has been approved; or
            ``(B) a request to the Secretary to approve a change to an 
        application approved under section 512(c)(2) for which data 
        with respect to safety or effectiveness are required.
        ``(3) The term `animal drug product' means each specific 
    strength or potency of a particular active ingredient or 
    ingredients in final dosage form marketed by a particular 
    manufacturer or distributor, which is uniquely identified by the 
    labeler code and product code portions of the national drug code, 
    and for which an animal drug application or a supplemental animal 
    drug application has been approved.
        ``(4) The term `animal drug establishment' means a foreign or 
    domestic place of business which is at one general physical 
    location consisting of one or more buildings all of which are 
    within 5 miles of each other, at which one or more animal drug 
    products are manufactured in final dosage form.
        ``(5) The term `investigational animal drug submission' means--
            ``(A) the filing of a claim for an investigational 
        exemption under section 512(j) for a new animal drug intended 
        to be the subject of an animal drug application or a 
        supplemental animal drug application; or
            ``(B) the submission of information for the purpose of 
        enabling the Secretary to evaluate the safety or effectiveness 
        of an animal drug application or supplemental animal drug 
        application in the event of their filing.
        ``(6) The term `animal drug sponsor' means either an applicant 
    named in an animal drug application that has not been withdrawn by 
    the applicant and for which approval has not been withdrawn by the 
    Secretary, or a person who has submitted an investigational animal 
    drug submission that has not been terminated or otherwise rendered 
    inactive by the Secretary.
        ``(7) The term `final dosage form' means, with respect to an 
    animal drug product, a finished dosage form which is approved for 
    administration to an animal without substantial further 
    manufacturing. Such term includes animal drug products intended for 
    mixing in animal feeds.
        ``(8) The term `process for the review of animal drug 
    applications' means the following activities of the Secretary with 
    respect to the review of animal drug applications, supplemental 
    animal drug applications, and investigational animal drug 
    submissions:
            ``(A) The activities necessary for the review of animal 
        drug applications, supplemental animal drug applications, and 
        investigational animal drug submissions.
            ``(B) The issuance of action letters which approve animal 
        drug applications or supplemental animal drug applications or 
        which set forth in detail the specific deficiencies in animal 
        drug applications, supplemental animal drug applications, or 
        investigational animal drug submissions and, where appropriate, 
        the actions necessary to place such applications, supplements 
        or submissions in condition for approval.
            ``(C) The inspection of animal drug establishments and 
        other facilities undertaken as part of the Secretary's review 
        of pending animal drug applications, supplemental animal drug 
        applications, and investigational animal drug submissions.
            ``(D) Monitoring of research conducted in connection with 
        the review of animal drug applications, supplemental animal 
        drug applications, and investigational animal drug submissions.
            ``(E) The development of regulations and policy related to 
        the review of animal drug applications, supplemental animal 
        drug applications, and investigational animal drug submissions.
            ``(F) Development of standards for products subject to 
        review.
            ``(G) Meetings between the agency and the animal drug 
        sponsor.
            ``(H) Review of advertising and labeling prior to approval 
        of an animal drug application or supplemental animal drug 
        application, but not after such application has been approved.
        ``(9) The term `costs of resources allocated for the process 
    for the review of animal drug applications' means the expenses in 
    connection with the process for the review of animal drug 
    applications for--
            ``(A) officers and employees of the Food and Drug 
        Administration, contractors of the Food and Drug 
        Administration, advisory committees consulted with respect to 
        the review of specific animal drug applications, supplemental 
        animal drug applications, or investigational animal drug 
        submissions, and costs related to such officers, employees, 
        committees, and contractors, including costs for travel, 
        education, and recruitment and other personnel activities;
            ``(B) management of information and the acquisition, 
        maintenance, and repair of computer resources;
            ``(C) leasing, maintenance, renovation, and repair of 
        facilities and acquisition, maintenance, and repair of 
        fixtures, furniture, scientific equipment, and other necessary 
        materials and supplies; and
            ``(D) collecting fees under section 740 and accounting for 
        resources allocated for the review of animal drug applications, 
        supplemental animal drug applications, and investigational 
        animal drug submissions.
        ``(10) The term `adjustment factor' applicable to a fiscal year 
    refers to the formula set forth in section 735(8) with the base or 
    comparator month being October 2002.
        ``(11) The term `person' includes an affiliate thereof.
        ``(12) The term `affiliate' refers to the definition set forth 
    in section 735(11).''.
    SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
    Section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-12) is amended to read as follows:
    ``SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
    ``(a) Types of Fees.--Beginning in fiscal year 2004, the Secretary 
shall assess and collect fees in accordance with this section as 
follows:
        ``(1) Animal drug application and supplement fee.--
            ``(A) In general.--Each person that submits, on or after 
        September 1, 2003, an animal drug application or a supplemental 
        animal drug application shall be subject to a fee as follows:
                ``(i) A fee established in subsection (c) for an animal 
            drug application, except an animal drug application subject 
            to the criteria set forth in section 512(d)(4).
                ``(ii) A fee established in subsection (c), in an 
            amount that is equal to 50 percent of the amount of the fee 
            under clause (i), for--

                    ``(I) a supplemental animal drug application for 
                which safety or effectiveness data are required; and
                    ``(II) an animal drug application subject to the 
                criteria set forth in section 512(d)(4).

            ``(B) Payment.--The fee required by subparagraph (A) shall 
        be due upon submission of the animal drug application or 
        supplemental animal drug application.
            ``(C) Exception for previously filed application or 
        supplement.--If an animal drug application or a supplemental 
        animal drug application was submitted by a person that paid the 
        fee for such application or supplement, was accepted for 
        filing, and was not approved or was withdrawn (without a waiver 
        or refund), the submission of an animal drug application or a 
        supplemental animal drug application for the same product by 
        the same person (or the person's licensee, assignee, or 
        successor) shall not be subject to a fee under subparagraph 
        (A).
            ``(D) Refund of fee if application refused for filing.--The 
        Secretary shall refund 75 percent of the fee paid under 
        subparagraph (B) for any animal drug application or 
        supplemental animal drug application which is refused for 
        filing.
            ``(E) Refund of fee if application withdrawn.--If an animal 
        drug application or a supplemental animal drug application is 
        withdrawn after the application or supplement was filed, the 
        Secretary may refund the fee or portion of the fee paid under 
        subparagraph (B) if no substantial work was performed on the 
        application or supplement after the application or supplement 
        was filed. The Secretary shall have the sole discretion to 
        refund the fee under this paragraph. A determination by the 
        Secretary concerning a refund under this paragraph shall not be 
        reviewable.
        ``(2) Animal drug product fee.--
            ``(A) In general.--Each person--
                ``(i) who is named as the applicant in an animal drug 
            application or supplemental animal drug application for an 
            animal drug product which has been submitted for listing 
            under section 510; and
                ``(ii) who, after September 1, 2003, had pending before 
            the Secretary an animal drug application or supplemental 
            animal drug application,
        shall pay for each such animal drug product the annual fee 
        established in subsection (c).
            ``(B) Payment; fee due date.--Such fee shall be payable for 
        the fiscal year in which the animal drug product is first 
        submitted for listing under section 510, or is submitted for 
        relisting under section 510 if the animal drug product has been 
        withdrawn from listing and relisted. After such fee is paid for 
        that fiscal year, such fee shall be due each subsequent fiscal 
        year that the product remains listed, upon the later of--
                ``(i) the first business day after the date of 
            enactment of an appropriations Act providing for the 
            collection and obligation of fees for such fiscal year 
            under this section; or
                ``(ii) January 31 of each year.
            ``(C) Limitation.--Such fee shall be paid only once for 
        each animal drug product for a fiscal year in which the fee is 
        payable.
        ``(3) Animal drug establishment fee.--
            ``(A) In general.--Each person--
                ``(i) who owns or operates, directly or through an 
            affiliate, an animal drug establishment;
                ``(ii) who is named as the applicant in an animal drug 
            application or supplemental animal drug application for an 
            animal drug product which has been submitted for listing 
            under section 510; and
                ``(iii) who, after September 1, 2003, had pending 
            before the Secretary an animal drug application or 
            supplemental animal drug application,
        shall be assessed an annual establishment fee as established in 
        subsection (c) for each animal drug establishment listed in its 
        approved animal drug application as an establishment that 
        manufactures the animal drug product named in the application.
            ``(B) Payment; fee due date.--The annual establishment fee 
        shall be assessed in each fiscal year in which the animal drug 
        product named in the application is assessed a fee under 
        paragraph (2) unless the animal drug establishment listed in 
        the application does not engage in the manufacture of the 
        animal drug product during the fiscal year. The fee under this 
        paragraph for a fiscal year shall be due upon the later of--
                ``(i) the first business day after the date of 
            enactment of an appropriations Act providing for the 
            collection and obligation of fees for such fiscal year 
            under this section; or
                ``(ii) January 31 of each year.
            ``(C) Limitation.--
                ``(i) In general.--An establishment shall be assessed 
            only one fee per fiscal year under this section, subject to 
            clause (ii).
                ``(ii) Certain manufacturers.--If a single 
            establishment manufactures both animal drug products and 
            prescription drug products, as defined in section 735(3), 
            such establishment shall be assessed both the animal drug 
            establishment fee and the prescription drug establishment 
            fee, as set forth in section 736(a)(2), within a single 
            fiscal year.
        ``(4) Animal drug sponsor fee.--
            ``(A) In general.--Each person--
                ``(i) who meets the definition of an animal drug 
            sponsor within a fiscal year; and
                ``(ii) who, after September 1, 2003, had pending before 
            the Secretary an animal drug application, a supplemental 
            animal drug application, or an investigational animal drug 
            submission,
        shall be assessed an annual sponsor fee as established under 
        subsection (c).
            ``(B) Payment; fee due date.--The fee under this paragraph 
        for a fiscal year shall be due upon the later of--
                ``(i) the first business day after the date of 
            enactment of an appropriations Act providing for the 
            collection and obligation of fees for such fiscal year 
            under this section; or
                ``(ii) January 31 of each year.
            ``(C) Limitation.--Each animal drug sponsor shall pay only 
        one such fee each fiscal year.
    ``(b) Fee Revenue Amounts.--
        ``(1) In general.--Subject to subsections (c), (d), (f), and 
    (g)--
            ``(A) for fiscal year 2014, the fees required under 
        subsection (a) shall be established to generate a total revenue 
        amount of $23,600,000; and
            ``(B) for each of fiscal years 2015 through 2018, the fees 
        required under subsection (a) shall be established to generate 
        a total revenue amount of $21,600,000.
        ``(2) Types of fees.--Of the total revenue amount determined 
    for a fiscal year under paragraph (1)--
            ``(A) 20 percent shall be derived from fees under 
        subsection (a)(1) (relating to animal drug applications and 
        supplements);
            ``(B) 27 percent shall be derived from fees under 
        subsection (a)(2) (relating to animal drug products);
            ``(C) 26 percent shall be derived from fees under 
        subsection (a)(3) (relating to animal drug establishments); and
            ``(D) 27 percent shall be derived from fees under 
        subsection (a)(4) (relating to animal drug sponsors).
    ``(c) Annual Fee Setting; Adjustments.--
        ``(1) Annual fee setting.--The Secretary shall establish, 60 
    days before the start of each fiscal year beginning after September 
    30, 2003, for that fiscal year, animal drug application fees, 
    supplemental animal drug application fees, animal drug sponsor 
    fees, animal drug establishment fees, and animal drug product fees 
    based on the revenue amounts established under subsection (b) and 
    the adjustments provided under this subsection.
        ``(2) Inflation adjustment.--For fiscal year 2015 and 
    subsequent fiscal years, the revenue amounts established in 
    subsection (b) shall be adjusted by the Secretary by notice, 
    published in the Federal Register, for a fiscal year, by an amount 
    equal to the sum of--
            ``(A) one;
            ``(B) 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 
        years of the preceding 4 fiscal years for which data are 
        available; and
            ``(C) 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 years 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 years of the preceding 4 
        fiscal years for which data are available.
    The adjustment made each fiscal year under this paragraph shall be 
    added on a compounded basis to the sum of all adjustments made each 
    fiscal year after fiscal year 2014 under this paragraph.
        ``(3) Workload adjustment.--For fiscal year 2015 and subsequent 
    fiscal years, after the revenue amounts established in subsection 
    (b) are adjusted for inflation in accordance with paragraph (2), 
    the 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. With respect to such 
    adjustment--
            ``(A) 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;
            ``(B) the Secretary shall publish in the Federal Register 
        the fees resulting from such adjustment and the supporting 
        methodologies; and
            ``(C) under no circumstances shall such adjustment 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 for inflation under paragraph (2).
        ``(4) Final year adjustment.--For fiscal year 2018, the 
    Secretary may, in addition to other adjustments under this 
    subsection, further increase the fees under this section, if such 
    an adjustment is necessary, to provide for up to 3 months of 
    operating reserves of carryover user fees for the process for the 
    review of animal drug applications for the first 3 months of fiscal 
    year 2019. If the Food and Drug Administration has carryover 
    balances for the process for the review of animal drug applications 
    in excess of 3 months of such operating reserves, then this 
    adjustment will not be made. If this adjustment is necessary, then 
    the rationale for the amount of the increase shall be contained in 
    the annual notice setting fees for fiscal year 2018.
        ``(5) Limit.--The total amount of fees charged, as adjusted 
    under this subsection, for a fiscal year may not exceed the total 
    costs for such fiscal year for the resources allocated for the 
    process for the review of animal drug applications.
    ``(d) Fee Waiver or Reduction.--
        ``(1) In general.--The Secretary shall grant a waiver from or a 
    reduction of one or more fees assessed under subsection (a) where 
    the Secretary finds that--
            ``(A) the assessment of the fee would present a significant 
        barrier to innovation because of limited resources available to 
        such person or other circumstances;
            ``(B) the fees to be paid by such person will exceed the 
        anticipated present and future costs incurred by the Secretary 
        in conducting the process for the review of animal drug 
        applications for such person;
            ``(C) the animal drug application or supplemental animal 
        drug application is intended solely to provide for use of the 
        animal drug in--
                ``(i) a Type B medicated feed (as defined in section 
            558.3(b)(3) of title 21, Code of Federal Regulations (or 
            any successor regulation)) intended for use in the 
            manufacture of Type C free-choice medicated feeds; or
                ``(ii) a Type C free-choice medicated feed (as defined 
            in section 558.3(b)(4) of title 21, Code of Federal 
            Regulations (or any successor regulation));
            ``(D) the animal drug application or supplemental animal 
        drug application is intended solely to provide for a minor use 
        or minor species indication; or
            ``(E) the sponsor involved is a small business submitting 
        its first animal drug application to the Secretary for review.
        ``(2) Use of standard costs.--In making the finding in 
    paragraph (1)(B), the Secretary may use standard costs.
        ``(3) Rules for small businesses.--
            ``(A) Definition.--In paragraph (1)(E), the term `small 
        business' means an entity that has fewer than 500 employees, 
        including employees of affiliates.
            ``(B) Waiver of application fee.--The Secretary shall waive 
        under paragraph (1)(E) the application fee for the first animal 
        drug application that a small business or its affiliate submits 
        to the Secretary for review. After a small business or its 
        affiliate is granted such a waiver, the small business or its 
        affiliate shall pay application fees for all subsequent animal 
        drug applications and supplemental animal drug applications for 
        which safety or effectiveness data are required in the same 
        manner as an entity that does not qualify as a small business.
            ``(C) Certification.--The Secretary shall require any 
        person who applies for a waiver under paragraph (1)(E) to 
        certify their qualification for the waiver. The Secretary shall 
        periodically publish in the Federal Register a list of persons 
        making such certifications.
    ``(e) Effect of Failure To Pay Fees.--An animal drug application or 
supplemental animal drug application submitted by a person subject to 
fees under subsection (a) shall be considered incomplete and shall not 
be accepted for filing by the Secretary until all fees owed by such 
person have been paid. An investigational animal drug submission under 
section 739(5)(B) that is submitted by a person subject to fees under 
subsection (a) shall be considered incomplete and shall not be accepted 
for review by the Secretary until all fees owed by such person have 
been paid. The Secretary may discontinue review of any animal drug 
application, supplemental animal drug application or investigational 
animal drug submission from a person if such person has not submitted 
for payment all fees owed under this section by 30 days after the date 
upon which they are due.
    ``(f) Assessment of Fees.--
        ``(1) Limitation.--Fees may not be assessed under subsection 
    (a) for a fiscal year beginning after fiscal year 2003 unless 
    appropriations for salaries and expenses of the Food and Drug 
    Administration for such fiscal year (excluding the amount of fees 
    appropriated for such fiscal year) are equal to or greater than the 
    amount of appropriations for the salaries and expenses of the Food 
    and Drug Administration for the fiscal year 2003 (excluding the 
    amount of fees appropriated for such fiscal year) multiplied by the 
    adjustment factor applicable to the fiscal year involved.
        ``(2) Authority.--If the Secretary does not assess fees under 
    subsection (a) during any portion of a fiscal year because of 
    paragraph (1) and if at a later date in such fiscal year the 
    Secretary may assess such fees, the Secretary may assess and 
    collect such fees, without any modification in the rate, for animal 
    drug applications, supplemental animal drug applications, 
    investigational animal drug submissions, animal drug sponsors, 
    animal drug establishments and animal drug products at any time in 
    such fiscal year notwithstanding the provisions of subsection (a) 
    relating to the date fees are to be paid.
    ``(g) Crediting and Availability of Fees.--
        ``(1) In general.--Subject to paragraph (2)(C), fees authorized 
    under subsection (a) shall be collected and available for 
    obligation only to the extent and in the amount provided in advance 
    in appropriations Acts. Such fees are authorized to be appropriated 
    to remain available until expended. Such sums as may be necessary 
    may be transferred from the Food and Drug Administration salaries 
    and expenses appropriation account without fiscal year limitation 
    to such appropriation account for salary and expenses with such 
    fiscal year limitation. The sums transferred shall be available 
    solely for the process for the review of animal drug applications.
        ``(2) Collections and appropriation acts.--
            ``(A) In general.--The fees authorized by this section--
                ``(i) subject to subparagraph (C), shall be collected 
            and available in each fiscal year in an amount not to 
            exceed the amount specified in appropriation Acts, or 
            otherwise made available for obligation for such fiscal 
            year, and
                ``(ii) shall be available to defray increases in the 
            costs of the resources allocated for the process for the 
            review of animal drug applications (including increases in 
            such costs for an additional number of full-time equivalent 
            positions in the Department of Health and Human Services to 
            be engaged in such process) over such costs, excluding 
            costs paid from fees collected under this section, for 
            fiscal year 2003 multiplied by the adjustment factor.
            ``(B) Compliance.--The Secretary shall be considered to 
        have met the requirements of subparagraph (A)(ii) in any fiscal 
        year if the costs funded by appropriations and allocated for 
        the process for the review of animal drug applications--
                ``(i) are not more than 3 percent below the level 
            specified in subparagraph (A)(ii); or
                ``(ii)(I) are more than 3 percent below the level 
            specified in subparagraph (A)(ii), and fees assessed for 
            the fiscal year following the subsequent fiscal year are 
            decreased by the amount in excess of 3 percent by which 
            such costs fell below the level specified in subparagraph 
            (A)(ii); and
                ``(II) such costs are not more than 5 percent below the 
            level specified in subparagraph (A)(ii).
            ``(C) Provision for early payments.--Payment of fees 
        authorized under this section for a fiscal year, prior to the 
        due date for such fees, may be accepted by the Secretary in 
        accordance with authority provided in advance in a prior year 
        appropriations Act.
        ``(3) Authorization of appropriations.--For each of the fiscal 
    years 2014 through 2018, there is authorized to be appropriated for 
    fees under this section an amount equal to the total revenue amount 
    determined under subsection (b) for the fiscal year, as adjusted or 
    otherwise affected under subsection (c) and paragraph (4).
        ``(4) Offset of overcollections; recovery of collection 
    shortfalls.--
            ``(A) Offset of overcollections.--If the sum of the 
        cumulative amount of fees collected under this section for 
        fiscal years 2014 through 2016 and the amount of fees estimated 
        to be collected under this section for fiscal year 2017 
        (including any increased fee collections attributable to 
        subparagraph (B)), exceeds the cumulative amount appropriated 
        pursuant to paragraph (3) for the fiscal years 2014 through 
        2017, the excess amount shall be credited to the appropriation 
        account of the Food and Drug Administration as provided in 
        paragraph (1), and shall be subtracted from the amount of fees 
        that would otherwise be authorized to be collected under this 
        section pursuant to appropriation Acts for fiscal year 2018.
            ``(B) Recovery of collection shortfalls.--
                ``(i) Fiscal year 2016.--For fiscal year 2016, 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 2014 falls below the amount of 
            fees authorized for fiscal year 2014 under paragraph (3).
                ``(ii) Fiscal year 2017.--For fiscal year 2017, 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 2015 falls below the amount of 
            fees authorized for fiscal year 2015 under paragraph (3).
                ``(iii) Fiscal year 2018.--For fiscal year 2018, the 
            amount of fees otherwise authorized to be collected under 
            this section (including any reduction in the authorized 
            amount under subparagraph (A)), shall be increased by the 
            cumulative amount, if any, by which the amount collected 
            under this section and appropriated for fiscal years 2016 
            and 2017 (including estimated collections for fiscal year 
            2017) falls below the cumulative amount of fees authorized 
            under paragraph (3) for fiscal years 2016 and 2017.
    ``(h) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund of any fee collected in accordance with subsection 
(a), a person shall submit to the Secretary a written request for such 
waiver, reduction, or refund not later than 180 days after such fee is 
due.
    ``(j) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in the process of the review of animal drug 
applications, be reduced to offset the number of officers, employees, 
and advisory committees so engaged.
    ``(k) Abbreviated New Animal Drug Applications.--The Secretary 
shall--
        ``(1) to the extent practicable, segregate the review of 
    abbreviated new animal drug applications from the process for the 
    review of animal drug applications; and
        ``(2) adopt other administrative procedures to ensure that 
    review times of abbreviated new animal drug applications do not 
    increase from their current level due to activities under the user 
    fee program.''.
    SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
    Section 740A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-13) is amended to read as follows:
``SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
    ``(a) Performance Report.--Beginning with fiscal year 2014, not 
later than 120 days after the end of each fiscal year during which fees 
are collected under this part, the Secretary shall prepare and 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 concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 101(b) of the Animal Drug User Fee Amendments of 
2013 toward expediting the animal drug development process and the 
review of the new and supplemental animal drug applications and 
investigational animal drug submissions during such fiscal year, the 
future plans of the Food and Drug Administration for meeting the goals, 
the review times for abbreviated new animal drug applications, and the 
administrative procedures adopted by the Food and Drug Administration 
to ensure that review times for abbreviated new animal drug 
applications are not increased from their current level due to 
activities under the user fee program.
    ``(b) Fiscal Report.--Beginning with fiscal year 2014, not later 
than 120 days after the end of each fiscal year during which fees are 
collected under this part, the Secretary shall prepare and 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 on the implementation of the authority for 
such fees during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected during such fiscal year for which 
the report is made.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Reauthorization.--
        ``(1) Consultation.--In developing recommendations to present 
    to the Congress with respect to the goals, and plans for meeting 
    the goals, for the process for the review of animal drug 
    applications for the first 5 fiscal years after fiscal year 2018, 
    and for the reauthorization of this part for such fiscal years, the 
    Secretary shall consult with--
            ``(A) the Committee on Health, Education, Labor, and 
        Pensions of the Senate;
            ``(B) the Committee on Energy and Commerce of the House of 
        Representatives;
            ``(C) scientific and academic experts;
            ``(D) veterinary professionals;
            ``(E) representatives of patient and consumer advocacy 
        groups; and
            ``(F) the regulated industry.
        ``(2) Prior public input.--Prior to beginning negotiations with 
    the regulated industry on the reauthorization of this part, the 
    Secretary shall--
            ``(A) publish a notice in the Federal Register requesting 
        public input on the reauthorization;
            ``(B) hold a public meeting at which the public may present 
        its views on the reauthorization, including specific 
        suggestions for changes to the goals referred to in subsection 
        (a);
            ``(C) provide a period of 30 days after the public meeting 
        to obtain written comments from the public suggesting changes 
        to this part; and
            ``(D) publish the comments on the Food and Drug 
        Administration's Internet Web site.
        ``(3) Periodic consultation.--Not less frequently than once 
    every 4 months during negotiations with the regulated industry, the 
    Secretary shall hold discussions with representatives of 
    veterinary, patient, and consumer advocacy groups to continue 
    discussions of their views on the reauthorization and their 
    suggestions for changes to this part as expressed under paragraph 
    (2).
        ``(4) Public review of recommendations.--After negotiations 
    with the regulated industry, the Secretary shall--
            ``(A) present the recommendations developed under paragraph 
        (1) to the Congressional committees specified in such 
        paragraph;
            ``(B) publish such recommendations in the Federal Register;
            ``(C) provide for a period of 30 days for the public to 
        provide written comments on such recommendations;
            ``(D) hold a meeting at which the public may present its 
        views on such recommendations; and
            ``(E) after consideration of such public views and 
        comments, revise such recommendations as necessary.
        ``(5) Transmittal of recommendations.--Not later than January 
    15, 2018, the Secretary shall transmit to Congress the revised 
    recommendations under paragraph (4) a summary of the views and 
    comments received under such paragraph, and any changes made to the 
    recommendations in response to such views and comments.
        ``(6) Minutes of negotiation meetings.--
            ``(A) Public availability.--Before presenting the 
        recommendations developed under paragraphs (1) through (5) to 
        Congress, the Secretary shall make publicly available, on the 
        Internet Web site of the Food and Drug Administration, minutes 
        of all negotiation meetings conducted under this subsection 
        between the Food and Drug Administration and the regulated 
        industry.
            ``(B) Content.--The minutes described under subparagraph 
        (A) shall summarize any substantive proposal made by any party 
        to the negotiations as well as significant controversies or 
        differences of opinion during the negotiations and their 
        resolution.''.
    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 
the 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, 2008, but before October 1, 2013, 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 2014.
    SEC. 106. EFFECTIVE DATE.
    The amendments made by this title shall take effect on October 1, 
2013, or the date of 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 all animal drug applications and supplemental animal drug 
applications received on or after October 1, 2013, 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, 
2018.
    (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, 2019.
    (c) Previous Sunset Provision.--
        (1) In general.--Section 108 of the Animal Drug User Fee 
    Amendments of 2008 (Public Law 110-316) is repealed.
        (2) Conforming amendment.--The Animal Drug User Fee Amendments 
    of 2008 (Public Law 110-316) is amended in the table of contents in 
    section 1, by striking the item relating to section 108.
    (d) Technical Clarification.--Effective November 18, 2003, section 
5 of the Animal Drug User Fee Act of 2003 (Public Law 108-130) is 
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 2013''.
    (b) Finding.--The fees authorized by 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 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.
    Section 741 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-21) is amended to read as follows:
    ``SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW ANIMAL DRUG 
      FEES.
    ``(a) Types of Fees.--Beginning with respect to fiscal year 2009, 
the Secretary shall assess and collect fees in accordance with this 
section as follows:
        ``(1) Abbreviated application fee.--
            ``(A) In general.--Each person that submits, on or after 
        July 1, 2008, an abbreviated application for a generic new 
        animal drug shall be subject to a fee as established in 
        subsection (c) for such an application.
            ``(B) Payment.--The fee required by subparagraph (A) shall 
        be due upon submission of the abbreviated application.
            ``(C) Exceptions.--
                ``(i) Previously filed application.--If an abbreviated 
            application was submitted by a person that paid the fee for 
            such application, was accepted for filing, and was not 
            approved or was withdrawn (without a waiver or refund), the 
            submission of an abbreviated application for the same 
            product by the same person (or the person's licensee, 
            assignee, or successor) shall not be subject to a fee under 
            subparagraph (A).
                ``(ii) Certain abbreviated applications involving 
            combination animal drugs.--An abbreviated application which 
            is subject to the criteria in section 512(d)(4) and 
            submitted on or after October 1, 2013 shall be subject to a 
            fee equal to 50 percent of the amount of the abbreviated 
            application fee established in subsection (c).
            ``(D) Refund of fee if application refused for filing.--The 
        Secretary shall refund 75 percent of the fee paid under 
        subparagraph (B) for any abbreviated application which is 
        refused for filing.
            ``(E) Refund of fee if application withdrawn.--If an 
        abbreviated application is withdrawn after the application was 
        filed, the Secretary may refund the fee or portion of the fee 
        paid under subparagraph (B) if no substantial work was 
        performed on the application after the application was filed. 
        The Secretary shall have the sole discretion to refund the fee 
        under this subparagraph. A determination by the Secretary 
        concerning a refund under this subparagraph shall not be 
        reviewable.
        ``(2) Generic new animal drug product fee.--
            ``(A) In general.--Each person--
                ``(i) who is named as the applicant in an abbreviated 
            application or supplemental abbreviated application for a 
            generic new animal drug product which has been submitted 
            for listing under section 510; and
                ``(ii) who, after September 1, 2008, had pending before 
            the Secretary an abbreviated application or supplemental 
            abbreviated application,
        shall pay for each such generic new animal drug product the 
        annual fee established in subsection (c).
            ``(B) Payment; fee due date.--Such fee shall be payable for 
        the fiscal year in which the generic new animal drug product is 
        first submitted for listing under section 510, or is submitted 
        for relisting under section 510 if the generic new animal drug 
        product has been withdrawn from listing and relisted. After 
        such fee is paid for that fiscal year, such fee shall be due 
        each subsequent fiscal year that the product remains listed, 
        upon the later of--
                ``(i) the first business day after the date of 
            enactment of an appropriations Act providing for the 
            collection and obligation of fees for such fiscal year 
            under this section; or
                ``(ii) January 31 of each year.
            ``(C) Limitation.--Such fee shall be paid only once for 
        each generic new animal drug product for a fiscal year in which 
        the fee is payable.
        ``(3) Generic new animal drug sponsor fee.--
            ``(A) In general.--Each person--
                ``(i) who meets the definition of a generic new animal 
            drug sponsor within a fiscal year; and
                ``(ii) who, after September 1, 2008, had pending before 
            the Secretary an abbreviated application, a supplemental 
            abbreviated application, or an investigational submission,
        shall be assessed an annual generic new animal drug sponsor fee 
        as established under subsection (c).
            ``(B) Payment; fee due date.--Such fee shall be due each 
        fiscal year upon the later of--
                ``(i) the first business day after the date of 
            enactment of an appropriations Act providing for the 
            collection and obligation of fees for such fiscal year 
            under this section; or
                ``(ii) January 31 of each year.
            ``(C) Amount of fee.--Each generic new animal drug sponsor 
        shall pay only 1 such fee each fiscal year, as follows:
                ``(i) 100 percent of the amount of the generic new 
            animal drug sponsor fee published for that fiscal year 
            under subsection (c) for an applicant with more than 6 
            approved abbreviated applications.
                ``(ii) 75 percent of the amount of the generic new 
            animal drug sponsor fee published for that fiscal year 
            under subsection (c) for an applicant with more than 1 and 
            fewer than 7 approved abbreviated applications.
                ``(iii) 50 percent of the amount of the generic new 
            animal drug sponsor fee published for that fiscal year 
            under subsection (c) for an applicant with 1 or fewer 
            approved abbreviated applications.
    ``(b) Fee Amounts.--Subject to subsections (c), (d), (f), and (g), 
the fees required under subsection (a) shall be established to generate 
fee revenue amounts as follows:
        ``(1) Total fee revenues for application fees.--The total fee 
    revenues to be collected in abbreviated application fees under 
    subsection (a)(1) shall be $1,832,000 for fiscal year 2014, 
    $1,736,000 for fiscal year 2015, $1,857,000 for fiscal year 2016, 
    $1,984,000 for fiscal year 2017, and $2,117,000 for fiscal year 
    2018.
        ``(2) Total fee revenues for product fees.--The total fee 
    revenues to be collected in generic new animal drug product fees 
    under subsection (a)(2) shall be $2,748,000 for fiscal year 2014, 
    $2,604,000 for fiscal year 2015, $2,786,000 for fiscal year 2016, 
    $2,976,000 for fiscal year 2017, and $3,175,000 for fiscal year 
    2018.
        ``(3) Total fee revenues for sponsor fees.--The total fee 
    revenues to be collected in generic new animal drug sponsor fees 
    under subsection (a)(3) shall be $2,748,000 for fiscal year 2014, 
    $2,604,000 for fiscal year 2015, $2,786,000 for fiscal year 2016, 
    $2,976,000 for fiscal year 2017, and $3,175,000 for fiscal year 
    2018.
    ``(c) Annual Fee Setting; Adjustments.--
        ``(1) Annual fee setting.--The Secretary shall establish, 60 
    days before the start of each fiscal year beginning after September 
    30, 2008, for that fiscal year, abbreviated application fees, 
    generic new animal drug sponsor fees, and generic new animal drug 
    product fees, based on the revenue amounts established under 
    subsection (b) and the adjustments provided under this subsection.
        ``(2) Workload adjustment.--The fee revenues shall be adjusted 
    each fiscal year after fiscal year 2014 to reflect changes in 
    review workload. With respect to such adjustment:
            ``(A) 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. The Secretary 
        shall publish in the Federal Register the fees resulting from 
        this adjustment and the supporting methodologies.
            ``(B) Under no circumstances shall this workload adjustment 
        result in fee revenues for a fiscal year that are less than the 
        fee revenues for that fiscal year established in subsection 
        (b).
        ``(3) Final year adjustment.--For fiscal year 2018, the 
    Secretary may, in addition to other adjustments under this 
    subsection, further increase the fees under this section, if such 
    an adjustment is necessary, to provide for up to 3 months of 
    operating reserves of carryover user fees for the process for the 
    review of abbreviated applications for generic new animal drugs for 
    the first 3 months of fiscal year 2019. If the Food and Drug 
    Administration has carryover balances for the process for the 
    review of abbreviated applications for generic new animal drugs in 
    excess of 3 months of such operating reserves, then this adjustment 
    shall not be made. If this adjustment is necessary, then the 
    rationale for the amount of the increase shall be contained in the 
    annual notice setting fees for fiscal year 2018.
        ``(4) Limit.--The total amount of fees charged, as adjusted 
    under this subsection, for a fiscal year may not exceed the total 
    costs for such fiscal year for the resources allocated for the 
    process for the review of abbreviated applications for generic new 
    animal drugs.
    ``(d) Fee Waiver or Reduction.--The Secretary shall grant a waiver 
from or a reduction of 1 or more fees assessed under subsection (a) 
where the Secretary finds that the generic new animal drug is intended 
solely to provide for a minor use or minor species indication.
    ``(e) Effect of Failure To Pay Fees.--An abbreviated application 
for a generic new animal drug submitted by a person subject to fees 
under subsection (a) shall be considered incomplete and shall not be 
accepted for filing by the Secretary until all fees owed by such person 
have been paid. An investigational submission for a generic new animal 
drug that is submitted by a person subject to fees under subsection (a) 
shall be considered incomplete and shall not be accepted for review by 
the Secretary until all fees owed by such person have been paid. The 
Secretary may discontinue review of any abbreviated application for a 
generic new animal drug, supplemental abbreviated application for a 
generic new animal drug, or investigational submission for a generic 
new animal drug from a person if such person has not submitted for 
payment all fees owed under this section by 30 days after the date upon 
which they are due.
    ``(f) Assessment of Fees.--
        ``(1) Limitation.--Fees may not be assessed under subsection 
    (a) for a fiscal year beginning after fiscal year 2008 unless 
    appropriations for salaries and expenses of the Food and Drug 
    Administration for such fiscal year (excluding the amount of fees 
    appropriated for such fiscal year) are equal to or greater than the 
    amount of appropriations for the salaries and expenses of the Food 
    and Drug Administration for the fiscal year 2003 (excluding the 
    amount of fees appropriated for such fiscal year) multiplied by the 
    adjustment factor applicable to the fiscal year involved.
        ``(2) Authority.--If the Secretary does not assess fees under 
    subsection (a) during any portion of a fiscal year because of 
    paragraph (1) and if at a later date in such fiscal year the 
    Secretary may assess such fees, the Secretary may assess and 
    collect such fees, without any modification in the rate, for 
    abbreviated applications, generic new animal drug sponsors, and 
    generic new animal drug products at any time in such fiscal year 
    notwithstanding the provisions of subsection (a) relating to the 
    date fees are to be paid.
    ``(g) Crediting and Availability of Fees.--
        ``(1) In general.--Subject to paragraph (2)(C), fees authorized 
    under subsection (a) shall be collected and available for 
    obligation only to the extent and in the amount provided in advance 
    in appropriations Acts. Such fees are authorized to be appropriated 
    to remain available until expended. Such sums as may be necessary 
    may be transferred from the Food and Drug Administration salaries 
    and expenses appropriation account without fiscal year limitation 
    to such appropriation account for salary and expenses with such 
    fiscal year limitation. The sums transferred shall be available 
    solely for the process for the review of abbreviated applications 
    for generic new animal drugs.
        ``(2) Collections and appropriation acts.--
            ``(A) In general.--The fees authorized by this section--
                ``(i) subject to subparagraph (C), shall be collected 
            and available in each fiscal year in an amount not to 
            exceed the amount specified in appropriation Acts, or 
            otherwise made available for obligation for such fiscal 
            year; and
                ``(ii) shall be available to defray increases in the 
            costs of the resources allocated for the process for the 
            review of abbreviated applications for generic new animal 
            drugs (including increases in such costs for an additional 
            number of full-time equivalent positions in the Department 
            of Health and Human Services to be engaged in such process) 
            over such costs, excluding costs paid from fees collected 
            under this section, for fiscal year 2008 multiplied by the 
            adjustment factor.
            ``(B) Compliance.--The Secretary shall be considered to 
        have met the requirements of subparagraph (A)(ii) in any fiscal 
        year if the costs funded by appropriations and allocated for 
        the process for the review of abbreviated applications for 
        generic new animal drugs--
                ``(i) are not more than 3 percent below the level 
            specified in subparagraph (A)(ii); or
                ``(ii)(I) are more than 3 percent below the level 
            specified in subparagraph (A)(ii), and fees assessed for 
            the fiscal year following the subsequent fiscal year are 
            decreased by the amount in excess of 3 percent by which 
            such costs fell below the level specified in subparagraph 
            (A)(ii); and
                ``(II) such costs are not more than 5 percent below the 
            level specified in subparagraph (A)(ii).
            ``(C) Provision for early payments.--Payment of fees 
        authorized under this section for a fiscal year, prior to the 
        due date for such fees, may be accepted by the Secretary in 
        accordance with authority provided in advance in a prior year 
        appropriations Act.
        ``(3) Authorization of appropriations.--There are authorized to 
    be appropriated for fees under this section--
            ``(A) $7,328,000 for fiscal year 2014;
            ``(B) $6,944,000 for fiscal year 2015;
            ``(C) $7,429,000 for fiscal year 2016;
            ``(D) $7,936,000 for fiscal year 2017; and
            ``(E) $8,467,000 for fiscal year 2018;
    as adjusted to reflect adjustments in the total fee revenues made 
    under this section and changes in the total amounts collected by 
    abbreviated application fees, generic new animal drug sponsor fees, 
    and generic new animal drug product fees.
        ``(4) Offset.--If the sum of the cumulative amount of fees 
    collected under this section for the fiscal years 2014 through 2016 
    and the amount of fees estimated to be collected under this section 
    for fiscal year 2017 exceeds the cumulative amount appropriated 
    under paragraph (3) for the fiscal years 2014 through 2017, the 
    excess amount shall be credited to the appropriation account of the 
    Food and Drug Administration as provided in paragraph (1), and 
    shall be subtracted from the amount of fees that would otherwise be 
    authorized to be collected under this section pursuant to 
    appropriation Acts for fiscal year 2018.
    ``(h) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 days after it is due, such fee shall be treated as a claim of the 
United States Government subject to subchapter II of chapter 37 of 
title 31, United States Code.
    ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund of any fee collected in accordance with subsection 
(a), a person shall submit to the Secretary a written request for such 
waiver, reduction, or refund not later than 180 days after such fee is 
due.
    ``(j) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employees, and advisory 
committees not engaged in the process of the review of abbreviated 
applications for generic new animal drugs, be reduced to offset the 
number of officers, employees, and advisory committees so engaged.
    ``(k) Definitions.--In this section and section 742:
        ``(1) Abbreviated application for a generic new animal drug.--
    The terms `abbreviated application for a generic new animal drug' 
    and `abbreviated application' mean an abbreviated application for 
    the approval of any generic new animal drug submitted under section 
    512(b)(2). Such term does not include a supplemental abbreviated 
    application for a generic new animal drug.
        ``(2) Adjustment factor.--The term `adjustment factor' 
    applicable to a fiscal year is the Consumer Price Index for all 
    urban consumers (all items; United States city average) for October 
    of the preceding fiscal year divided by--
            ``(A) for purposes of subsection (f)(1), such Index for 
        October 2002; and
            ``(B) for purposes of subsection (g)(2)(A)(ii), such Index 
        for October 2007.
        ``(3) Costs of resources allocated for the process for the 
    review of abbreviated applications for generic new animal drugs.--
    The term `costs of resources allocated for the process for the 
    review of abbreviated applications for generic new animal drugs' 
    means the expenses in connection with the process for the review of 
    abbreviated applications for generic new animal drugs for--
            ``(A) officers and employees of the Food and Drug 
        Administration, contractors of the Food and Drug 
        Administration, advisory committees consulted with respect to 
        the review of specific abbreviated applications, supplemental 
        abbreviated applications, or investigational submissions, and 
        costs related to such officers, employees, committees, and 
        contractors, including costs for travel, education, and 
        recruitment and other personnel activities;
            ``(B) management of information, and the acquisition, 
        maintenance, and repair of computer resources;
            ``(C) leasing, maintenance, renovation, and repair of 
        facilities and acquisition, maintenance, and repair of 
        fixtures, furniture, scientific equipment, and other necessary 
        materials and supplies; and
            ``(D) collecting fees under this section and accounting for 
        resources allocated for the review of abbreviated applications, 
        supplemental abbreviated applications, and investigational 
        submissions.
        ``(4) Final dosage form.--The term `final dosage form' means, 
    with respect to a generic new animal drug product, a finished 
    dosage form which is approved for administration to an animal 
    without substantial further manufacturing. Such term includes 
    generic new animal drug products intended for mixing in animal 
    feeds.
        ``(5) Generic new animal drug.--The term `generic new animal 
    drug' means a new animal drug that is the subject of an abbreviated 
    application.
        ``(6) Generic new animal drug product.--The term `generic new 
    animal drug product' means each specific strength or potency of a 
    particular active ingredient or ingredients in final dosage form 
    marketed by a particular manufacturer or distributor, which is 
    uniquely identified by the labeler code and product code portions 
    of the national drug code, and for which an abbreviated application 
    for a generic new animal drug or a supplemental abbreviated 
    application has been approved.
        ``(7) Generic new animal drug sponsor.--The term `generic new 
    animal drug sponsor' means either an applicant named in an 
    abbreviated application for a generic new animal drug that has not 
    been withdrawn by the applicant and for which approval has not been 
    withdrawn by the Secretary, or a person who has submitted an 
    investigational submission for a generic new animal drug that has 
    not been terminated or otherwise rendered inactive by the 
    Secretary.
        ``(8) Investigational submission for a generic new animal 
    drug.--The terms `investigational submission for a generic new 
    animal drug' and `investigational submission' mean--
            ``(A) the filing of a claim for an investigational 
        exemption under section 512(j) for a generic new animal drug 
        intended to be the subject of an abbreviated application or a 
        supplemental abbreviated application; or
            ``(B) the submission of information for the purpose of 
        enabling the Secretary to evaluate the safety or effectiveness 
        of a generic new animal drug in the event of the filing of an 
        abbreviated application or supplemental abbreviated application 
        for such drug.
        ``(9) Person.--The term `person' includes an affiliate thereof 
    (as such term is defined in section 735(11)).
        ``(10) Process for the review of abbreviated applications for 
    generic new animal drugs.--The term `process for the review of 
    abbreviated applications for generic new animal drugs' means the 
    following activities of the Secretary with respect to the review of 
    abbreviated applications, supplemental abbreviated applications, 
    and investigational submissions:
            ``(A) The activities necessary for the review of 
        abbreviated applications, supplemental abbreviated 
        applications, and investigational submissions.
            ``(B) The issuance of action letters which approve 
        abbreviated applications or supplemental abbreviated 
        applications or which set forth in detail the specific 
        deficiencies in abbreviated applications, supplemental 
        abbreviated applications, or investigational submissions and, 
        where appropriate, the actions necessary to place such 
        applications, supplemental applications, or submissions in 
        condition for approval.
            ``(C) The inspection of generic new animal drug 
        establishments and other facilities undertaken as part of the 
        Secretary's review of pending abbreviated applications, 
        supplemental abbreviated applications, and investigational 
        submissions.
            ``(D) Monitoring of research conducted in connection with 
        the review of abbreviated applications, supplemental 
        abbreviated applications, and investigational submissions.
            ``(E) The development of regulations and policy related to 
        the review of abbreviated applications, supplemental 
        abbreviated applications, and investigational submissions.
            ``(F) Development of standards for products subject to 
        review.
            ``(G) Meetings between the agency and the generic new 
        animal drug sponsor.
            ``(H) Review of advertising and labeling prior to approval 
        of an abbreviated application or supplemental abbreviated 
        application, but not after such application has been approved.
        ``(11) Supplemental abbreviated application for generic new 
    animal drug.--The terms `supplemental abbreviated application for a 
    generic new animal drug' and `supplemental abbreviated application' 
    mean a request to the Secretary to approve a change in an approved 
    abbreviated application.''.
    SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS.
    Section 742 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j-22) is amended to read as follows:
    ``SEC. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.
    ``(a) Performance Reports.--Beginning with fiscal year 2014, not 
later than 120 days after the end of each fiscal year during which fees 
are collected under this part, the Secretary shall prepare and 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 concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 201(b) of the Animal Generic Drug User Fee 
Amendments of 2013 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 during such fiscal year.
    ``(b) Fiscal Report.--Beginning with fiscal year 2014, not later 
than 120 days after the end of each fiscal year during which fees are 
collected under this part, the Secretary shall prepare and submit to 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, of the 
fees collected during such fiscal year for which the report is made.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Reauthorization.--
        ``(1) Consultation.--In developing recommendations to present 
    to Congress with respect to the goals, and plans for meeting the 
    goals, for the process for the review of abbreviated applications 
    for generic new animal drugs for the first 5 fiscal years after 
    fiscal year 2018, and for the reauthorization of this part for such 
    fiscal years, the Secretary shall consult with--
            ``(A) the Committee on Energy and Commerce of the House of 
        Representatives;
            ``(B) the Committee on Health, Education, Labor, and 
        Pensions of the Senate;
            ``(C) scientific and academic experts;
            ``(D) veterinary professionals;
            ``(E) representatives of patient and consumer advocacy 
        groups; and
            ``(F) the regulated industry.
        ``(2) Prior public input.--Prior to beginning negotiations with 
    the regulated industry on the reauthorization of this part, the 
    Secretary shall--
            ``(A) publish a notice in the Federal Register requesting 
        public input on the reauthorization;
            ``(B) hold a public meeting at which the public may present 
        its views on the reauthorization, including specific 
        suggestions for changes to the goals referred to in subsection 
        (a);
            ``(C) provide a period of 30 days after the public meeting 
        to obtain written comments from the public suggesting changes 
        to this part; and
            ``(D) publish the comments on the Food and Drug 
        Administration's Internet Web site.
        ``(3) Periodic consultation.--Not less frequently than once 
    every 4 months during negotiations with the regulated industry, the 
    Secretary shall hold discussions with representatives of 
    veterinary, patient, and consumer advocacy groups to continue 
    discussions of their views on the reauthorization and their 
    suggestions for changes to this part as expressed under paragraph 
    (2).
        ``(4) Public review of recommendations.--After negotiations 
    with the regulated industry, the Secretary shall--
            ``(A) present the recommendations developed under paragraph 
        (1) to the congressional committees specified in such 
        paragraph;
            ``(B) publish such recommendations in the Federal Register;
            ``(C) provide for a period of 30 days for the public to 
        provide written comments on such recommendations;
            ``(D) hold a meeting at which the public may present its 
        views on such recommendations; and
            ``(E) after consideration of such public views and 
        comments, revise such recommendations as necessary.
        ``(5) Transmittal of recommendations.--Not later than January 
    15, 2018, the Secretary shall transmit to Congress the revised 
    recommendations under paragraph (4), a summary of the views and 
    comments received under such paragraph, and any changes made to the 
    recommendations in response to such views and comments.
        ``(6) Minutes of negotiation meetings.--
            ``(A) Public availability.--Before presenting the 
        recommendations developed under paragraphs (1) through (5) to 
        Congress, the Secretary shall make publicly available, on the 
        Internet Web site of the Food and Drug Administration, minutes 
        of all negotiation meetings conducted under this subsection 
        between the Food and Drug Administration and the regulated 
        industry.
            ``(B) Content.--The minutes described under subparagraph 
        (A) shall summarize any substantive proposal made by any party 
        to the negotiations as well as significant controversies or 
        differences of opinion during the negotiations and their 
        resolution.''.
    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, 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, 2008, but before October 1, 
2013, 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 2014.
    SEC. 205. EFFECTIVE DATE.
    The amendments made by this title shall take effect on October 1, 
2013, or the date of 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 all abbreviated applications for a generic new animal drug 
and supplemental abbreviated applications for a generic new animal drug 
received on or after October 1, 2013, 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, 
2018.
    (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, 2019.
    (c) Previous Sunset Provision.--
        (1) In general.--Section 204 of the Animal Generic Drug User 
    Fee Act of 2008 (Public Law 110-316) is repealed.
        (2) Conforming amendment.--The Animal Generic Drug User Fee Act 
    of 2008 (Public Law 110-316) is amended in the table of contents in 
    section 1, by striking the item relating to section 204.

                               Speaker of the House of Representatives.

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