Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013
PL 113-14 (S.622), enacted 06/13/2013

[113th Congress Public Law 14]
[From the U.S. Government Publishing Office]



[[Page 127 STAT. 451]]

Public Law 113-14
113th Congress

                                 An Act


 
 To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
    fee programs relating to new animal drugs and generic new animal 
               drugs. <<NOTE: June 13, 2013 -  [S. 622]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Animal Drug and 
Animal Generic Drug User Fee Reauthorization Act of 2013. 21 USC 301 
note.>> 
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 <<NOTE: Animal Drug User Fee Amendments of 2013.>>  I--FEES 
RELATING TO ANIMAL DRUGS
SEC. 101. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Animal Drug User Fee Amendments of 2013''.

    (b) <<NOTE: 21 USC 379j-11 note.>>  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

[[Page 127 STAT. 452]]

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.

[[Page 127 STAT. 453]]

            ``(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;

[[Page 127 STAT. 454]]

                    ``(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) <<NOTE: Effective date.>>  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.

[[Page 127 STAT. 455]]

                    ``(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) <<NOTE: Deadline.>>  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

[[Page 127 STAT. 456]]

                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) <<NOTE: Deadline.>>  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);

[[Page 127 STAT. 457]]

                    ``(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) <<NOTE: Notice. Federal Register, publication.>>  
        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) <<NOTE: Determination.>>  such adjustment 
                shall be determined by the Secretary based on a weighted 
                average of the change in the total number of animal drug 
                applications, supplemental animal drug applications for 
                which data with respect to safety or effectiveness are 
                required, manufacturing supplemental animal drug 
                applications, investigational animal drug study 
                submissions, and investigational animal drug protocol 
                submissions submitted to the Secretary;

[[Page 127 STAT. 458]]

                    ``(B) <<NOTE: Federal Register, publication.>>  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. <<NOTE: Notice.>>  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.--

[[Page 127 STAT. 459]]

                    ``(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) <<NOTE: Federal Register, 
                publication. Lists.>>  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. <<NOTE: Deadline.>>  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

[[Page 127 STAT. 460]]

        obligation only to the extent and in the amount provided in 
        advance in appropriations Acts. <<NOTE: Appropriation 
        authorization.>>  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

[[Page 127 STAT. 461]]

                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) <<NOTE: Deadline.>>  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) <<NOTE: Deadline.>>  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

[[Page 127 STAT. 462]]

            ``(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. <<NOTE: Effective dates.>>  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) <<NOTE: Web posting.>>  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) <<NOTE: Recommenda- tions.>>  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.

[[Page 127 STAT. 463]]

            ``(2) Prior public input.--Prior to beginning negotiations 
        with the regulated industry on the reauthorization of this part, 
        the Secretary shall--
                    ``(A) <<NOTE: Notice. Federal Register, 
                publication.>>  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) <<NOTE: Time period.>>  provide a period of 30 
                days after the public meeting to obtain written comments 
                from the public suggesting changes to this part; and
                    ``(D) <<NOTE: Web posting.>>  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) <<NOTE: Federal Register, publication.>>  
                publish such recommendations in the Federal Register;
                    ``(C) <<NOTE: Time period.>>  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) <<NOTE: Web posting.>>  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. <<NOTE: Extension. Time period. 21 USC 379j-11 note.>>  
                        SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 4 of 
subchapter C of chapter VII of the Federal Food, Drug, and

[[Page 127 STAT. 464]]

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. <<NOTE: 21 USC 379j-11 note.>>  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) <<NOTE: 21 USC 379j-12 note.>>  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) <<NOTE: 21 USC 379j-13 note.>>  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) <<NOTE: Repeal.>>  In general.--Section 108 of the 
        Animal Drug User Fee Amendments of 2008 (Public Law 110-
        316) <<NOTE: 21 USC 379j-11 note.>>  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) <<NOTE: Repeal.>>  Technical Clarification.--Effective November 
18, 2003, section 5 of the Animal Drug User Fee Act of 2003 (Public Law 
108-130) <<NOTE: 21 USC 379j-11 note.>>  is repealed.

 TITLE <<NOTE: Animal Generic Drug User Fee Amendments of 2013.>>  II--
FEES RELATING TO GENERIC ANIMAL DRUGS
SEC. 201. SHORT TITLE; FINDING.

    (a) <<NOTE: 21 USC 301 note.>>  Short Title.--This title may be 
cited as the ``Animal Generic Drug User Fee Amendments of 2013''.

    (b) <<NOTE: 21 USC 379j-21 note.>>  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.

[[Page 127 STAT. 465]]

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) <<NOTE: Effective date.>>  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,

[[Page 127 STAT. 466]]

                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,

[[Page 127 STAT. 467]]

        $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) <<NOTE: Determination.>>  This adjustment 
                shall be determined by the Secretary based on a weighted 
                average of the change in the total number of abbreviated 
                applications for generic new animal drugs, manufacturing 
                supplemental abbreviated applications for generic new 
                animal drugs, investigational generic new animal drug 
                study submissions, and investigational generic new 
                animal drug protocol submissions submitted to the 
                Secretary. <<NOTE: Federal Register, publication.>>  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. <<NOTE: Notice.>>  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

[[Page 127 STAT. 468]]

        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. <<NOTE: Deadline.>>  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. <<NOTE: Appropriation 
        authorization.>>  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.--

[[Page 127 STAT. 469]]

                    ``(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.

[[Page 127 STAT. 470]]

    ``(h) <<NOTE: Deadline.>>  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) <<NOTE: Deadline.>>  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

[[Page 127 STAT. 471]]

                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

[[Page 127 STAT. 472]]

                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. <<NOTE: Effective dates.>>  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.

[[Page 127 STAT. 473]]

    ``(c) <<NOTE: Web posting.>>  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) <<NOTE: Recommenda- tions.>>  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) <<NOTE: Notice. Federal Register, 
                publication.>>  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) <<NOTE: Time period.>>  provide a period of 30 
                days after the public meeting to obtain written comments 
                from the public suggesting changes to this part; and
                    ``(D) <<NOTE: Web posting.>>  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) <<NOTE: Federal Register, publication.>>  
                publish such recommendations in the Federal Register;
                    ``(C) <<NOTE: Time period.>>  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

[[Page 127 STAT. 474]]

        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) <<NOTE: Web posting.>>  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. <<NOTE: Extension. Time period. 21 USC 379j-21 note.>>  
                        SAVINGS CLAUSE.

    Notwithstanding the amendments made by this title, part 5 of 
subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
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. <<NOTE: 21 USC 379j-21 note.>>  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) <<NOTE: 21 USC 379j-21 note.>>  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) <<NOTE: 21 USC 379j-22 note.>>  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) <<NOTE: Repeal.>>  In general.--Section 204 of the 
        Animal Generic Drug User Fee Act of 2008 (Public Law 110-
        316) <<NOTE: 21 USC 379j-21 note, 379j-22 note.>>  is repealed.
            (2) Conforming amendment.--The Animal Generic Drug User Fee 
        Act of 2008 (Public Law 110-316) is amended in

[[Page 127 STAT. 475]]

        the table of contents in section 1, by striking the item 
        relating to section 204.

    Approved June 13, 2013.

LEGISLATIVE HISTORY--S. 622:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 159 (2013):
            May 8, considered and passed Senate.
            June 3, considered and passed House.

                                  <all>