[House Report 113-188]
[From the U.S. Government Publishing Office]


113th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    113-188

======================================================================



 
 AMENDING THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO REAUTHORIZE USER 
               FEE PROGRAMS RELATING TO NEW ANIMAL DRUGS

                                _______
                                

 August 2, 2013.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

         Mr. Upton, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 1407]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1407) to amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize user fee programs relating to new 
animal drugs, having considered the same, report favorably 
thereon with amendments and recommend that the bill as amended 
do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................    17
Background and Need for Legislation..............................    17
Hearings.........................................................    18
Committee Consideration..........................................    18
Committee Votes..................................................    19
Committee Oversight Findings.....................................    19
Statement of General Performance Goals and Objectives............    19
New Budget Authority, Entitlement Authority, and Tax Expenditures    19
Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......    19
Committee Cost Estimate..........................................    19
Congressional Budget Office Estimate.............................    19
Federal Mandates Statement.......................................    24
Duplication of Federal Programs..................................    24
Disclosure of Directed Rule Makings..............................    24
Advisory Committee Statement.....................................    24
Applicability to Legislative Branch..............................    24
Section-by-Section Analysis of the Legislation...................    24
Changes in Existing Law Made by the Bill, as Reported............    25

    The amendments are as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. TABLE OF CONTENTS.

Sec. 1. Table of Contents.

                TITLE I--ANIMAL DRUG USER FEE AMENDMENTS

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--ANIMAL GENERIC DRUG USER FEE AMENDMENTS

Sec. 201. Short title; finding.
Sec. 202. Authority to assess and use generic new animal drug fees.
Sec. 203. Reauthorization; reporting requirements.
Sec. 204. Savings clause.
Sec. 205. Effective date.
Sec. 206. Sunset dates.

                TITLE I--ANIMAL DRUG USER FEE AMENDMENTS

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 described 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 
                                described 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 Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate 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 Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate 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 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. 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 title, 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 title.

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.--Public Law 110-316 (122 Stat. 
        2509) 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--ANIMAL GENERIC DRUG USER FEE AMENDMENTS

SECTION 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 for an animal drug 
                        described 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 
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 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 title, 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 title.

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.--Public Law 110-316 (122 Stat. 
        3509) is amended in the table of contents in section 1, by 
        striking the item relating to section 204.

    Amend the title to read:
    A bill to amend the Federal Food, Drug, and Cosmetic Act to 
reauthorize user fee programs relating to new animal drugs and generic 
new animal drugs.

                          Purpose and Summary

    H.R. 1407, the ``Animal Drug User Fee Amendments of 2013,'' 
was introduced on April 9, 2013, by Rep. John Shimkus (R-IL) 
and subsequently referred to the Committee on Energy and 
Commerce Subcommittee on Health.
    This legislation would amend the Federal Food, Drug, and 
Cosmetic Act to reauthorize user fee programs relating to new 
and generic animal drugs.

                  Background and Need for Legislation

    Title I of H.R. 1407 would reauthorize the Animal Drug User 
Fee Act. In 2003, Congress first enacted the Animal Drug User 
Fee Act (ADUFA) to help improve the Food and Drug 
Administration's (FDA) review of new animal drugs. The program 
was modeled after the Prescription Drug User Fee Program for 
human drugs and authorized for five years (ADUFA I).\1\ Under 
the user fee authority of ADUFA I, FDA collected funds to help 
expedite the new animal drug approval process, reduce the 
application backlog, and improve communications with drug 
sponsors. In 2008, because of the success of the program, 
Congress reauthorized ADUFA for an additional five years (ADUFA 
II). Unless Congress reauthorizes these user fees, FDA cannot 
collect them after September 30, 2013.
---------------------------------------------------------------------------
    \1\Department of Health and Human Services, Food and Drug 
Administration, Fiscal Year 2005. http://www.fda.gov/aboutfda/
reportsmanualsforms/reports/budgetreports/2005fda budgetsummary/
ucm112985.htm
---------------------------------------------------------------------------
    Following the process prescribed by statute, FDA and 
industry negotiated a proposed agreement (agreement) regarding 
the size and scope of the user fees for Fiscal Years (FY) 2014 
to 2018. In February 2013, FDA sent its final legislative 
recommendations on the agreement to the Committee on Energy and 
Commerce. Under the agreement, industry would pay approximately 
$23,600,000 in FY 2014 ($21,600,000 plus $2,000,000 for one-
time information technology funding), and similar amounts in 
the remaining four years based on inflation adjusters. The fee 
would be paid through application fees (20 percent), product 
fees (27 percent), sponsor fees (27 percent), and establishment 
fees (26 percent).\2\
---------------------------------------------------------------------------
    \2\Proposed ADUFA III Provisions of the Federal Food, Drug, and 
Cosmetic Act. Page 6-7.
---------------------------------------------------------------------------
    Title II of H.R. 1407 would reauthorize the Animal Generic 
Drug User Fee Act (AGDUFA). The language of this title is 
identical to H.R. 1408, which was introduced by Rep. Gardner 
(R-CO) on April 9, 2013. H.R 1408 was also the subject of the 
legislative hearing on April 9.
    In 2008, Congress authorized the AGDUFA program for five 
years in order to improve the review of abbreviated new animal 
drug applications (AGDUFA I). AGDUFA I enabled the agency to 
eliminate its application backlog and reduce review times. FDA 
cannot collect these user fees after September 30, 2013, unless 
they are reauthorized by Congress.
    Similar to ADUFA, FDA and industry negotiated an agreement 
regarding the size and scope of AGDUFA for FY 2014 to 2018, and 
FDA sent its final legislative recommendations on the AGDUFA 
agreement to the Committee in February 2013. Under the proposed 
AGDUFA agreement, the industry would pay $7,328,00 in FY 2014 
($6,478,000 plus $850,000 for one-time information technology 
funding), $6,944,00 in FY 2015, $7,429,000 in FY 2016, 
$7,936,000 in FY 2017, and $8,467,000 in FY 2018. These fees 
would be paid through application fees (25 percent), product 
fees (37.5 percent), and sponsor fees (37.5 percent).\3\
---------------------------------------------------------------------------
    \3\Proposed ADUFA III Provisions of the Federal Food, Drug, and 
Cosmetic Act. Page 6-7.
---------------------------------------------------------------------------

                                Hearings

    The Subcommittee on Health held a hearing on the 
reauthorization of Animal Drug User Fee Program and the Animal 
Generic Drug User Fee Program on April 9, 2013. The 
Subcommittee received testimony from: Dr. Bernadette Dunham, 
Director, Center for Veterinary Medicine, Food and Drug 
Administration; Dr. Richard A. Carnevale, Vice President, 
Regulatory, Scientific and International Affairs, Animal Health 
Institute; Dr. Mike Apley, Professor and Section Head, 
Production Medicine and Clinical Pharmacology, College of 
Veterinary Medicine, Kansas State University; and Dr. Lance B. 
Price, Professor, Department of Occupational and Environmental 
Health, George Washington University.

                        Committee Consideration

    On May 8, 2013, the Subcommittee on Health met in open 
markup session and approved H.R. 1407, Animal Drug User Fee 
Amendments Act of 2013, for full Committee consideration, as 
amended, by a voice vote.
    On May 15, 2013, the full Committee met in open markup 
session and approved H.R. 1407 by voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 1407 reported. A motion by Mr. Upton to order H.R. 1407 
reported to the House, as amended, was agreed to by a voice 
vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee made findings that are 
reflected in this report.

         Statement of General Performance Goals and Objectives

    H.R. 1407, Animal Drug User Fee Amendments Act of 2013, 
would reauthorize the Animal Drug User Fee Act and the Animal 
Drug User Fee Act through September 30, 2018.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
1407, Animal Drug User Fee Amendments Act of 2013, would result 
in no new or increased budget authority, entitlement authority, 
or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI 
of the Rules of the House of Representatives, the Committee 
finds that H.R. 1407, Animal Drug User Fee Amendments Act of 
2013, contains no earmarks, limited tax benefits, or limited 
tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                      Washington, DC, May 24, 2013.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1407, the Animal 
Drug User Fee Amendments of 2013.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 1407--Animal Drug User Fee Amendments of 2013

    Summary: H.R. 1407 would authorize the collection and 
spending of fees by the Food and Drug Administration (FDA) for 
certain activities to expedite the development and marketing 
approval of drugs for use in animals. Fees would supplement 
appropriated funds to cover FDA's costs associated with 
reviewing certain applications and investigational submissions 
for brand and generic animal drugs. Such fees could be 
collected and made available for obligation only to the extent 
and in the amounts provided in advance in appropriation acts. 
The legislation would extend through fiscal year 2018, and make 
several technical changes to, FDA's existing fee programs for 
brand and generic animal drugs, which expire at the end of 
fiscal year 2013.
    CBO estimates that implementing H.R. 1407 would reduce 
discretionary outlays, on net, by $7 million over the 2014-2018 
period, assuming appropriation actions consistent with the 
bill.
    Pay-as-you-go procedures do not apply to this legislation 
because it would not affect direct spending or revenues.
    H.R. 1407 contains no intergovernmental mandates as defined 
in the Unfunded Mandates Reform Act (UMRA). The bill would 
impose private-sector mandates, as defined in UMRA, because it 
would require manufacturers of drugs for use in animals to pay 
specified fees to FDA. CBO estimates that the direct cost of 
complying with these requirements would not exceed the annual 
threshold established by UMRA for private-sector mandates ($150 
million in 2013, adjusted annually for inflation).
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 1407 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                 By fiscal year, in millions of dollars--
                                                         -------------------------------------------------------
                                                            2014     2015     2016     2017     2018   2014-2018
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Title I: Fees Relating to Animal Drugs:
    Collections from Fees:
        Estimated Authorization Level...................      -24      -22      -22      -23      -23      -114
        Estimated Outlays...............................      -24      -22      -22      -23      -23      -114
    Spending of Fees:
        Estimated Authorization Level...................       24       22       22       23       23       114
        Estimated Outlays...............................       19       21       22       23       23       109
            Subtotal, Estimated Authorization Level.....        0        0        0        0        0         0
            Subtotal, Estimated Outlays.................       -5       -1        *        *        *        -6

Title II: Fees Relating to Generic Animal Drugs:
    Collections from Fees
        Estimated Authorization Level...................       -7       -7       -7       -8       -8       -38
        Estimated Outlays...............................       -7       -7       -7       -8       -8       -38
    Spending of Fees
        Estimated Authorization Level...................        7        7        7        8        8        38
        Estimated Outlays...............................        6        7        7        8        8        36
            Subtotal, Estimated Authorization Level.....        0        0        0        0        0         0
            Subtotal, Estimated Outlays.................       -1        *        *        *        *        -2

Administrative Expenses:
    Estimated Authorization Level.......................        *        *        *        *        *         1
    Estimated Outlays...................................        *        *        *        *        *         1
Net Effect on Spending by the Food and Drug
 Administration:
    Estimated Authorization Level.......................        *        *        *        *        *         1
    Estimated Outlays...................................       -6       -1        *        *        *       -7
----------------------------------------------------------------------------------------------------------------
Note: Components may not sum to totals because of rounding; * = between -$500,000 and $500,000.

    Basis of estimate: For this estimate, CBO assumes that H.R. 
1407 will be enacted near the start of fiscal year 2014, that 
the full amounts authorized will be collected and appropriated 
for each year, and that outlays will follow historical patterns 
for the fee programs. Assuming appropriation actions that 
trigger the collection of fees and are consistent with other 
provisions of the bill, CBO estimates that implementing H.R. 
1407 would reduce discretionary outlays, on net, by $7 million 
over the 2014-2018 period, mostly because the spending of 
authorized fees lags slightly behind their collection.

Conditions for assessment and use of fees

    H.R. 1407 would authorize the collection and spending of 
fees by FDA for certain activities to expedite the development 
and marketing approval of drugs for use in animals for fiscal 
years 2014 through 2018. Under current law, FDA administers two 
separate fee programs involving animal drugs: One program 
covers brand-name animal drugs and the other program covers 
generic drugs for use in animals. Both fee programs will expire 
at the end of fiscal year 2013.
    Fees authorized by the bill could be collected and made 
available for obligation by FDA only to the extent and in the 
amounts provided in advance in appropriation acts. The 
legislation would also retain the existing statutory 
limitations that fees cannot be assessed in a given year unless 
appropriations for salaries and expenses of FDA (excluding the 
amount of user fees appropriated for such fiscal year) satisfy 
a maintenance-of-effort requirement. Fees could be assessed 
only if the amount appropriated in that year equals or exceeds 
the amount appropriated for 2003 increased by an adjustment 
factor that reflects the percentage increase in the consumer 
price index for all urban consumers.
    In addition, for each of the programs, fees could be 
collected and spent in a given year only if the cost of 
resources allocated to reviewing brand and generic animal drug 
applications (excluding fees) exceeds the amount that is 3 
percent below the level allocated for such activities in a base 
year inflated by an adjustment factor. This estimate assumes 
that such conditions would be met.

Title I: Fees relating to animal drugs

    H.R. 1407 would authorize FDA to assess and spend certain 
fees from manufacturers of brand-name drugs for use in animals 
to help defray FDA's costs of expediting the regulatory review 
process for such drugs through fiscal year 2018. For fiscal 
year 2012, FDA collected about $21 million in fees associated 
with brand-name animal drugs.
    Similar to the existing fee structure, four categories of 
fees would be authorized by title I of the bill: (1) animal 
drug application and supplement fees, (2) animal drug product 
fees, (3) animal drug establishment fees, and (4) animal drug 
sponsor fees. H.R. 1407 would authorize the appropriation of 
specific aggregate amounts of collections for each fiscal year 
2014 through 2018, subject to further adjustments defined by 
the legislation. Collections would be adjusted each year by an 
inflation factor to reflect changes in FDA's operating costs. 
Collections could also be modified based on certain workload 
estimates, when applicable. (No such adjustments for workload 
have occurred over the last four years of the existing program, 
and we expect that they would not occur in the future.) For 
fiscal year 2018, the bill would authorize the collection of 
operating reserves for the beginning of fiscal year 2019, 
unless carryover balances for the fee program exceed three 
months of such reserves. CBO expects that the final-year 
adjustment for operating reserves would not be made. We 
estimate aggregate collections from fees for the brand animal 
drug program authorized by H.R. 1407 would total $114 million 
over the 2014-2018 period.
    CBO estimates that authorizing the fee program for brand 
animal drugs through 2018 would reduce discretionary outlays, 
on net, by $6 million over the 2014-2018 period, assuming 
appropriation actions consistent with the bill. The estimated 
authorization levels for collections and spending offset each 
other exactly from 2014 through 2018. However, spending of 
authorized fees lags somewhat behind their collection, thereby 
generating savings over the period.

Title II: Fees relating to generic animal drugs

    H.R. 1407 would extend FDA's authority to assess and spend 
fees from manufacturers of certain generic new drugs for use in 
animals that would help cover the costs of regulatory 
activities to expedite the development and approval for 
marketing such drugs through fiscal year 2018. (The term 
``generic new drug'' refers to drugs that must gain marketing 
approval by FDA because they are not generally recognized as 
safe and effective for use in animals and are approved under an 
abbreviated review process.) Collections associated with FDA's 
fee program for generic animal drugs totaled about $7 million 
for fiscal year 2012.
    Three categories of fees would be authorized by title II of 
the bill: (1) fees for abbreviated applications, (2) fees on 
generic new drug products for animals, and (3) fees on sponsors 
of generic new drugs for animals. The bill would authorize the 
appropriation of specific aggregate amounts of collections for 
each fiscal year 2014 through 2018. Collections could be 
further adjusted each year based on certain workload estimates, 
when applicable. (No such adjustments for workload have 
occurred over the last four years of the existing program, and 
we expect that they would not occur in the future.) For fiscal 
year 2018, the bill would authorize additional adjustments to 
collections under specific circumstances, including the 
assessment of up to three months of operating reserves for the 
beginning of fiscal year 2019, unless carryover balances for 
the fee program exceed three months of such reserves. CBO 
expects that the final-year adjustment for operating reserves 
would not be made. We estimate aggregate collections from fees 
for generic new animal drugs authorized by the bill would total 
$38 million over the 2014-2018 period.
    CBO estimates that authorizing the fee program for generic 
new animal drugs over the 2014-2018 period would reduce 
discretionary outlays, on net, by $2 million over that period, 
assuming appropriation actions consistent with the bill. 
Because FDA would have the authority to spend collections, the 
estimated negative budget authority resulting from collections 
would exactly offset the budget authority for spending in each 
fiscal year. However, spending of fees would lag behind the 
collections and thus generate net discretionary savings over 
the 2014-2018 period.

Other administrative expenses

    Funding for certain administrative activities associated 
with the fee programs authorized by H.R. 1407 would not be 
fully covered by fees. The bill would require that FDA report 
annually to the Congress on its performance under the fee 
programs and on the fiscal status of the programs. The 
legislation would also require that FDA consult with the 
Congressional committees of jurisdiction and outside experts, 
including industry and consumer groups, and publish its 
recommendations concerning reauthorization of the fee programs. 
CBO estimates that such administrative activities associated 
with implementing H.R. 1407 that are not covered by fees would 
cost less than $500,000 annually.
    Pay-as-You-Go considerations: None.
    Estimated impact on state, local, and tribal governments: 
H.R. 1407 contains no intergovernmental mandates as defined in 
UMRA and would impose no costs on state, local, or tribal 
governments.
    Estimated impact on the private sector: The imposition of 
application, product, establishment, and sponsor fees that 
private entities would pay to FDA would be considered a 
private-sector mandate as defined in UMRA. CBO estimates that 
the fees collected over the 2014-2018 period would total $153 
million. Those amounts would not exceed the annual threshold 
specified in UMRA ($150 million in 2013, adjusted annually for 
inflation) in any of the five years that the mandate would be 
effective.
    Previous CBO estimate: On March 20, 2013, CBO transmitted a 
cost estimate for S. 622, the Animal Drug and Animal Generic 
Drug User Fee Reauthorization Act of 2013, as reported by the 
Senate Committee on Health, Education, Labor, and Pensions on 
March 20, 2013. The text of the two pieces of legislation is 
nearly identical, and the CBO cost estimates are the same.
    Estimate prepared by: Federal Costs: Julia Christensen; 
Impact on State, Local, and Tribal Governments: Lisa Ramirez-
Branum; Impact on the Private Sector: Alexia Diorio.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 1407 establishes or reauthorizes a 
program of the Federal Government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 1407 
specifically directs to be completed zero specific rule makings 
within the meaning of 5 U.S.C. 551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


                TITLE I--ANIMAL DRUG USER FEE AMENDMENTS

    Section 101. Short Title; Finding: This section provides 
the short title and finding.
    Section 102. Definitions: This section defines the terms 
``animal drug application,'' ``supplemental animal drug 
application,'' ``animal drug product,'' ``animal drug 
establishment,'' ``investigational animal drug submission,'' 
``animal drug sponsor,'' ``final dosage form,'' ``process for 
the review of animal drug applications,'' ``costs of resources 
allocated for the process for the review of animal drug 
applications,'' ``adjustment factor,'' ``person,'' and 
``affiliate.''
    Section 103. Authority to Assess and Use Animal Drug Fees: 
This section establishes the fees due under this title of the 
bill.
    Section 104. Reauthorization; Reporting Requirements: This 
section requires FDA to submit a performance report and 
financial report within 120 days after the end of each FY. Both 
of these reports will be available on the FDA website. The 
section also establishes the process for the reauthorization of 
the user fee.
    Section 105. Savings Clause: Animal drug applications and 
supplemental animal drug applications submitted and accepted 
for filing by the FDA on or after October 1, 2008, but before 
October 1, 2013, and which are still pending as of the AGDUFA 
II enactment are subject to AGDUFA I fees.
    Section 106. Effective Date: This section establishes the 
effective date as the later of October 1, 2013, or the date of 
enactment.
    Section 107. Sunset Dates: This section provides that the 
title will cease to be effective on October 1, 2018.

                 TITLE II--ANIMAL GENERIC DRUG USER FEE

    Section 201. Short Title; Finding: This section provides 
the short title and finding.
    Section 202. Authority to Assess and Use Generic New Animal 
Drug Fees: This section establishes the animal generic drug 
fees under the bill.
    Section 203. Reauthorization; Reporting Requirements: This 
section requires the Secretary to submit a financial report and 
performance report within 120 days after the end of each fiscal 
year. Both of these reports will be available on the FDA's 
website. The section also establishes the process for the 
reauthorization of the fee.
    Section 204. Savings Clause: Applications submitted and 
accepted for filing on or after October 1, 2008, but before 
October 1, 2013, and which are still pending as of the AGDUFA 
II enactment, are subject to AGDUFA I fees.
    Section 205. Effective Date: This section establishes the 
effective date as the later of October 1, 2013, or the date of 
enactment.
    Section 206. Sunset Dates: This section provides that the 
title will cease to be effective on October 1, 2018.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *



CHAPTER VII--GENERAL AUTHORITY

           *       *       *       *       *       *       *



Subchapter C--Fees

           *       *       *       *       *       *       *



                 PART 4--FEES RELATING TO ANIMAL DRUGS

[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 incurred 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. 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 
                        (b) for an animal drug application, 
                        except an animal drug application 
                        subject to the criteria set forth in 
                        section 512(d)(4); and
                          [(ii) A fee established in subsection 
                        (b), 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.--Each person--
                  [(A) 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
                  [(B) 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 (b). 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 payable on or before January 31 
        of each year. 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.--Each person--
                  [(A) who owns or operates, directly or 
                through an affiliate, an animal drug 
                establishment, and
                  [(B) 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
                  [(C) who, after September 1, 2003, had 
                pending before the Secretary an animal drug 
                application or supplemental animal drug 
                application,
        shall be assessed an annual fee established in 
        subsection (b) 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. 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 shall be paid on or 
        before January 31 of each year. The establishment shall 
        be assessed only one fee per fiscal year under this 
        section: Provided, however, That where 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.--Each person--
                  [(A) who meets the definition of an animal 
                drug sponsor within a fiscal year; and
                  [(B) 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 fee established under 
        subsection (b). The fee shall be paid on or before 
        January 31 of each year. Each animal drug sponsor shall 
        pay only one such fee each fiscal year.
  [(b) Fee Amounts.--Except as provided in subsection (a)(1) 
and 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 and 
        supplement fees.--The total fee revenues to be 
        collected in animal drug application fees under 
        subsection (a)(1)(A)(i) and supplemental and other 
        animal drug application fees under subsection 
        (a)(1)(A)(ii) shall be $3,815,000 for fiscal year 2009, 
        $4,320,000 for fiscal year 2010, $4,862,000 for fiscal 
        year 2011, $5,442,000 for fiscal year 2012, and 
        $6,061,000 for fiscal year 2013.
          [(2) Total fee revenues for product fees.--The total 
        fee revenues to be collected in product fees under 
        subsection (a)(2) shall be $3,815,000 for fiscal year 
        2009, $4,320,000 for fiscal year 2010, $4,862,000 for 
        fiscal year 2011, $5,442,000 for fiscal year 2012, and 
        $6,061,000 for fiscal year 2013.
          [(3) Total fee revenues for establishment fees.--The 
        total fee revenues to be collected in establishment 
        fees under subsection (a)(3) shall be $3,815,000 for 
        fiscal year 2009, $4,320,000 for fiscal year 2010, 
        $4,862,000 for fiscal year 2011, $5,442,000 for fiscal 
        year 2012, and $6,061,000 for fiscal year 2013.
          [(4) Total fee revenues for sponsor fees.--The total 
        fee revenues to be collected in sponsor fees under 
        subsection (a)(4) shall be $3,815,000 for fiscal year 
        2009, $4,320,000 for fiscal year 2010, $4,862,000 for 
        fiscal year 2011, $5,442,000 for fiscal year 2012, and 
        $6,061,000 for fiscal year 2013.
  [(c) Adjustments.--
          [(1) Workload adjustment.--The fee revenues shall be 
        adjusted each fiscal year after fiscal year 2009 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 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. 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).
          [(2) Final year adjustment.--For fiscal year 2013, 
        the Secretary may further increase the fees 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 
        2014. 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 2013.
          [(3) 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.
          [(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 
        animal drug applications.
  [(d) Fee Waiver or Reduction.--
          [(1) In general.--The Secretary shall grant a waiver 
        from or a reduction of 1 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.--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) shall be retained 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 only be collected and 
                        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).
          [(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this 
        section--
                  [(A) $15,260,000 for fiscal year 2009;
                  [(B) $17,280,000 for fiscal year 2010;
                  [(C) $19,448,000 for fiscal year 2011;
                  [(D) $21,768,000 for fiscal year 2012; and
                  [(E) $24,244,000 for fiscal year 2013;
        as adjusted to reflect adjustments in the total fee 
        revenues made under this section and changes in the 
        total amounts collected by animal drug application 
        fees, supplemental animal drug application fees, animal 
        drug sponsor fees, animal drug establishment fees, and 
        animal drug product fees.
          [(4) Offset.--If the sum of the cumulative amount of 
        fees collected under this section for fiscal years 2009 
        through 2011 and the amount of fees estimated to be 
        collected under this section for fiscal year 2012 
        exceeds the cumulative amount appropriated under 
        paragraph (3) for the fiscal years 2009 through 2012, 
        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 
        2013.
  [(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. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.

  [(a) Performance Report.--Beginning with fiscal year 2009, 
not later than 60 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 Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate 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 2008 
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 2009, 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 Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate 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 2013, 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, 2013, the Secretary shall transmit to the 
        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 the 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. 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. 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 
                        described 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 described 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. 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 Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate 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 Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate 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 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.

           PART 5--FEES RELATING TO GENERIC NEW ANIMAL DRUGS

[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 (b) for such an application.
                  [(B) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the abbreviated application.
                  [(C) Exception for 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).
                  [(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.--Each 
        person--
                  [(A) 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
                  [(B) 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 (b). 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 payable on or before January 31 of 
        each year. 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 fee established 
                under subsection (b). The fee shall be paid on 
                or before January 31 of each year.
                  [(B) 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)(3) 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)(3) 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)(3) for an applicant with 
                        1 or fewer approved abbreviated 
                        applications.
  [(b) Fee Amounts.--Except as provided in subsection (a)(1) 
and 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 
        $1,449,000 for fiscal year 2009, $1,532,000 for fiscal 
        year 2010, $1,619,000 for fiscal year 2011, $1,712,000 
        for fiscal year 2012, and $1,809,000 for fiscal year 
        2013.
          [(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 
        $1,691,000 for fiscal year 2009, $1,787,000 for fiscal 
        year 2010, $1,889,000 for fiscal year 2011, $1,997,000 
        for fiscal year 2012, and $2,111,000 for fiscal year 
        2013.
          [(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 
        $1,691,000 for fiscal year 2009, $1,787,000 for fiscal 
        year 2010, $1,889,000 for fiscal year 2011, $1,997,000 
        for fiscal year 2012, and $2,111,000 for fiscal year 
        2013.
  [(c) Adjustments.--
          [(1) Workload adjustment.--The fee revenues shall be 
        adjusted each fiscal year after fiscal year 2009 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).
          [(2) Final year adjustment.--For fiscal year 2013, 
        the Secretary may further increase the fees 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 2014. 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 2013.
          [(3) 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.
          [(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.--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) shall be retained 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 only be collected and 
                        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).
          [(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this 
        section--
                  [(A) $4,831,000 for fiscal year 2009;
                  [(B) $5,106,000 for fiscal year 2010;
                  [(C) $5,397,000 for fiscal year 2011;
                  [(D) $5,706,000 for fiscal year 2012; and
                  [(E) $6,031,000 for fiscal year 2013;
        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 
        2009 through 2011 and the amount of fees estimated to 
        be collected under this section for fiscal year 2012 
        exceeds the cumulative amount appropriated under 
        paragraph (3) for the fiscal years 2009 through 2012, 
        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 
        2013.
  [(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 incurred 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. 742. REAUTHORIZATION; REPORTING REQUIREMENTS.

  [(a) Performance Reports.--Beginning with fiscal year 2009, 
not later than 60 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(3) of the Animal Generic Drug User Fee Act of 2008 
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 2009, 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 2013, 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, 2013, 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. 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 for an animal 
                        drug described 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. 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 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 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.

           *       *       *       *       *       *       *


                           PUBLIC LAW 110-316



           *       *       *       *       *       *       *
SECTION 1. TABLE OF CONTENTS

  The table of contents of this Act is as follows:

Sec. 1. Table of contents.
Sec. 2. References in Act.

                TITLE I--ANIMAL DRUG USER FEE AMENDMENTS

Sec. 101. Short title; finding.
     * * * * * * *
[Sec. 108. Sunset dates.]
     * * * * * * *
[Sec. 204. Sunset dates.]

           *       *       *       *       *       *       *


                TITLE I--ANIMAL DRUG USER FEE AMENDMENTS

SEC. 101. SHORT TITLE; FINDING

  (a) Short Title.--This title may be cited as the ``Animal 
Drug User Fee Amendments of 2008''.

           *       *       *       *       *       *       *


[SEC. 108. SUNSET DATES.

  [(a) Authorization.--The amendments made by sections 102 and 
103 cease to be effective October 1, 2013.
  [(b) Reporting Requirements.--The amendment made by section 
104 ceases to be effective January 31, 2014.]

           *       *       *       *       *       *       *


                 TITLE II--ANIMAL GENERIC DRUG USER FEE

SEC. 201. SHORT TITLE; FINDINGS

  (a) Short Title.--This title may be cited as the ``Animal 
Generic Drug User Fee Act of 2008''.

           *       *       *       *       *       *       *


[SEC. 204. SUNSET DATES

  [(a) Authorization.--The amendments made by section 202 shall 
cease to be effective October 1, 2013.
  [(b) Reporting Requirements.--The amendment made by section 
203 shall cease to be effective January 31, 2014.]

           *       *       *       *       *       *       *


           SECTION 5 OF THE ANIMAL DRUG USER FEE ACT OF 2003



           *       *       *       *       *       *       *
[SEC. 5. SUNSET.

  [The amendments made by section 3 shall not be in effect 
after October 1, 2008, and section 4 shall not be in effect 
after 120 days after such date.]

                                  
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