[House Report 110-805]
[From the U.S. Government Publishing Office]



110th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     110-805

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



 
                ANIMAL GENERIC DRUG USER FEE ACT OF 2008

                                _______
                                

 July 30, 2008.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

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

                              R E P O R T

                        [To accompany H.R. 6433]

      [Including cost estimate of the Congressional Budget Office]

      The Committee on Energy and Commerce, to whom was 
referred the bill (H.R. 6433) to amend the Federal Food, Drug, 
and Cosmetic Act to establish a program of fees relating to 
generic new animal drugs, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     8
Background and Need for Legislation..............................     8
Hearings.........................................................     9
Committee Consideration..........................................     9
Committee Votes..................................................     9
Committee Oversight Findings.....................................    10
Statement of General Performance Goals and Objectives............    10
New Budget Authority, Entitlement Authority, and Tax Expenditures    10
Earmarks and Tax and Tariff Benefits.............................    10
Committee Cost Estimate..........................................    10
Congressional Budget Office Estimate.............................    10
Federal Mandates Statement.......................................    13
Advisory Committee Statement.....................................    13
Constitutional Authority Statement...............................    13
Applicability to Legislative Branch..............................    13
Section-by-Section Analysis of the Legislation...................    13
Changes in Existing Law Made by the Bill, as Reported............    15

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE; REFERENCES.

  (a) Short Title.--This Act may be cited as the ``Animal Generic Drug 
User Fee Act of 2008''.
  (b) References in Act.--Except as otherwise specified, amendments 
made by this Act to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 2. FINDINGS.

  Congress finds as follows:
          (1) Prompt approval of abbreviated applications for safe and 
        effective generic new animal drugs will reduce animal 
        healthcare costs and promote the well-being of animal health 
        and the public health.
          (2) Animal health and the public health will be served by 
        making additional funds available for the purpose of augmenting 
        the resources of the Food and Drug Administration that are 
        devoted to the process for the review of abbreviated 
        applications for the approval of generic new animal drugs.
          (3) The fees authorized by this Act 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. 3. FEES RELATING TO ABBREVIATED APPLICATIONS FOR GENERIC NEW 
                    ANIMAL DRUGS.

  (a) Redesignation.--Chapter VII (21 U.S.C. 371 et seq.) is amended by 
redesignating sections 741, 742, and 746 as sections 745, 746, and 749, 
respectively.
  (b) Authority To Assess and Use Generic New Animal Drug Fees.--
Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379f et seq.) is amended by adding at the end the following:

          ``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. 4. ACCOUNTABILITY AND REPORTS.

  Part 5 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379f et seq.), as added by section 3, is 
amended by inserting after section 741 the following:

``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 2(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. 5. SUNSET DATES.

  (a) Authorization.--The amendments made by section 3 shall cease to 
be effective October 1, 2013.
  (b) Reporting Requirements.--The amendment made by section 4 shall 
cease to be effective January 31, 2014.

                          Purpose and Summary

    The purpose of H.R. 6433, the Animal Generic Drug User Fee 
Act of 2008, is to establish a program of fees for the review 
of generic animal drug submissions and to improve the 
timeliness and predictability of the process for generic animal 
drug submissions.

                  Background and Need for Legislation 

    H.R. 6433 would establish a program of fees relating to 
generic new animal drugs. Using the Animal Drug User Fee Act of 
2003 (ADUFA) as a model, the Animal Generic Drug User Fee Act 
of 2008 (AGDUFA) would provide funding for increased review of 
generic animal drug submissions, for training and development 
of staff members, and for refining business processes and 
developing policies to allow more efficient review of generic 
animal drug submissions.
    In Congressional testimony in June 2008, the Food and Drug 
Administration (FDA) reported that in fiscal year 2007, the 
average review time for generic animal drug submissions was 570 
days and that there was a backlog of 446 of these submissions, 
almost double the number in fiscal year (FY) 2000. Section 
512(c)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA) 
requires FDA to review and act on these submissions within 180 
days of submission.
    In order to alleviate this backlog, a user fee for generic 
animal drug submissions is proposed, along with relevant 
performance goals. Under the AGDUFA user-fee proposal, FDA 
would agree to meet review performance goals to improve the 
timeliness and predictability of the animal generic drug review 
process. These performance goals are intended to achieve 
progressive yearly improvements, shortening the time for FDA to 
review and act on submissions with each fiscal year. By the 
fifth and final year of the proposed user fees, FDA would agree 
to review and act on 90 percent of the sentinel submission 
types within specified timeframes. Currently, FDA's review of 
generic animal drug submissions is funded entirely through 
appropriations.
    The AGDUFA proposal has many similarities to the proposal 
for ADUFA II (H.R. 6432, the Animal Drug User Fee Amendments of 
2008), such as comparable fee triggers, fee-setting 
requirements, workload adjustments, and reporting requirements. 
The major differences are that AGDUFA does not allow FDA to 
collect establishment fees, and FDA may only waive or reduce 
fees if the drug is intended for a minor use or minor species 
indication. Also, similar to the ADUFA II proposal, the AGDUFA 
proposal has fixed annual increases instead of the inflation 
adjuster used for the original ADUFA.
    AGDUFA authorizes the collection of fees for FY 2009 to 
2013 in the following amounts: $4,831,000 for FY 2009; 
$5,106,000 for FY 2010; $5,397,000 for FY 2011; $5,706,000 for 
FY 2012; and $6,031,000 for FY 2013. Fees are included for 
abbreviated applications, generic new animal drug products, and 
generic new animal drug sponsors.

                                Hearings

    On June 5, 2008, the Subcommittee on Health held a hearing 
on ``Committee Prints on Administration Legislative Proposals 
on the Animal Drug User Fee Act Amendments of 2008 and the 
Animal Generic Drug User Fee Act of 2008.'' The Subcommittee 
received testimony from Bernadette Dunham, D.V.M., Ph.D., 
Director, Center for Veterinary Medicine, Food and Drug 
Administration. Dr. Dunham was accompanied by Steven Vaughn, 
D.V.M., Director, Office of New Animal Drug Evaluation, and 
David Wardrop, Jr., Director, Office of Management. The 
Subcommittee also received testimony from Richard A. Carnevale, 
V.M.D., Vice President of Regulatory, Scientific, and 
International Affairs, Animal Health Institute; Ms. Stephanie 
Batliner, Chairperson, Generic Animal Drug Alliance, Director, 
Pre-Market Regulatory Affairs, IVX Animal Health, Inc.; and Mr. 
Robert Martin, Executive Director, Pew Commission on Industrial 
Farm Animal Production.

                        Committee Consideration 

    On Wednesday, July 9, 2008, the Subcommittee on Health met 
in open markup session and favorably forwarded H.R. 6433 to the 
full Committee for consideration, by a voice vote. On 
Wednesday, July 16, 2008, the full Committee met in open markup 
session and ordered H.R. 6433 favorably reported to the House, 
amended, by a 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. No 
record votes were taken on amendments or in connection with 
ordering H.R. 6433 reported to the House. A motion by Mr. 
Dingell to order H.R. 6433 favorably reported to the House, 
amended, was agreed to by a voice vote.

                     Committee Oversight Findings 

    Regarding clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the oversight findings of the 
Committee regarding H.R. 6433 are reflected in this report.

         Statement of General Performance Goals and Objectives

    The objectives of H.R. 6433 are to improve the timeliness 
and predictability of the review process for generic animal 
drug submissions and to improve the timeliness and 
predictability of the process for generic animal drug 
submissions.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee finds 
that H.R. 6433 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Earmarks and Tax and Tariff Benefits

    Regarding compliance with clause 9 of rule XXI of the Rules 
of the House of Representatives, H.R. 6433 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate on H.R. 
6433 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 on 
H.R. 6433 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, July 28, 2008.
Hon. John D. Dingell,
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. 6433, the Animal 
Generic Drug User Fee Act of 2008.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Julia 
Christensen.
            Sincerely,
                                         Robert A. Sunshine
                                   (For Peter R. Orszag, Director).
    Enclosure.

H.R. 6433 Animal Generic Drug User Fee Act of 2008

    Summary: H.R. 6433 would amend the Federal Food, Drug, and 
Cosmetic Act to authorize the Food and Drug Administration 
(FDA) to collect fees to cover the cost for certain activities 
to expedite the development and marketing of generic new drugs 
for use in animals. Fees would supplement appropriated funds to 
cover FDA's cost associated with reviewing certain marketing 
applications and investigational submissions for such drugs. 
Those fees could be collected and made available for obligation 
only to the extent and in the amounts provided in advance in 
appropriation acts.
    CBO estimates that implementing H.R. 6433 would reduce 
discretionary outlays, on net, by $1 million over the 2009-2013 
period, assuming the necessary authorities are provided in 
appropriation acts. Enacting the bill would not affect direct 
spending or revenues.
    H.R. 6433 contains no intergovernmental mandates as defined 
in the Unfunded Mandates Reform Act (UMRA).
    The bill's requirement that sponsors of generic new drugs 
for use in animals to pay certain fees to FDA would be a 
private-sector mandate as defined in UMRA. However, CBO 
estimates that the direct cost of complying with this 
requirement would not exceed the annual thresholds established 
by UMRA for private-sector mandates ($136 million in 2008, 
adjusted annually for inflation).
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 6433 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                    By fiscal year, in millions of dollars--
                                                              --------------------------------------------------
                                                                2009    2010    2011    2012    2013   2009-2013
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Food and Drug Administration (FDA):
    Collection of User Fees:
        Estimated Authorization Level........................      -5      -5      -5      -6      -8       -29
        Estimated Outlays....................................      -5      -5      -5      -6      -8       -29
    Spending of User Fees:
        Estimated Authorization Level........................       5       5       5       6       8        29
        Estimated Outlays....................................       3       6       6       6       6        27
    Administrative Expenses:
        Estimated Authorization Level........................       *       *       *       *       *         1
        Estimated Outlays....................................       *       *       *       *       *         1
        Net Effect on Spending by FDA:
            Estimated Authorization Level....................       *       *       *       *       *         1
            Estimated Outlays................................      -2       1       *       *      -1       -1
----------------------------------------------------------------------------------------------------------------
Note: * = less than $500,000. Components may not sum to totals because of rounding.

    Basis of estimate: For this estimate, CBO assumes that H.R. 
6433 will be enacted near the start of fiscal year 2009, that 
the full amounts authorized will be collected and appropriated 
for each year, and that outlays will follow historical patterns 
for similar activities. Assuming appropriation action 
consistent with the bill, CBO estimates that implementing H.R. 
6433 would reduce discretionary outlays, on net, by $1 million 
over the 2009-2013 period, primarily because the spending of 
authorized fees slightly lags behind their collection.

User fees for generic new drugs for use in animals

    H.R. 6433 would establish a new user fee program to help 
defray FDA's costs of expediting and improving the regulatory 
review process for generic new drugs for use in animals. It 
would require FDA to assess and collect application and other 
user fees from manufacturers of generic new drugs for use in 
animals to expedite the development of such drugs and the 
review of new and supplemental abbreviated applications and 
investigational submissions for such products.
    The bill would create three categories of user fees: (1) 
abbreviated application fees, (2) fees on generic new drug 
products for animals, and (3) fees on sponsors of generic new 
drugs for animals. The aggregate amounts of such fees are 
specified for each of fiscal years 2009 through 2013. Each 
year, the amounts to be collected could be adjusted further for 
workload estimates, when applicable. For fiscal year 2013, the 
bill also would authorize the assessment and collection of up 
to three months of operating reserves for the first three 
months of fiscal year 2014.
    Fees authorized by H.R. 6433 could be collected and made 
available for obligation only to the extent and in the amounts 
provided in advance in appropriation acts. In total, we 
estimate that aggregate collections from fees authorized by the 
bill would amount to $29 million over the 2009-2013 period, 
assuming the necessary appropriation action.
    Under the bill, user fees could not 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) in that year satisfy a maintenance-of-effort requirement. 
The user fees could be assessed if the amount appropriated 
exceeded 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, fees 
could be collected and made available to defray increases in 
the cost of resources allocated to reviewing abbreviated 
applications for generic new drugs for use in animals only to 
the extent that the percentage increase in those costs 
(excluding fees) exceeds the costs for fiscal year 2003 
adjusted by the adjustment factor. This estimate assumes that 
such conditions would be met.
    Before accounting for costs associated with additional 
administrative activities not covered by the user fees, CBO 
estimates that establishing the user fee program would reduce 
discretionary outlays, on net, by $2 million over the 2009-2013 
period, assuming appropriation action consistent with the bill. 
The estimated authorization levels for collections and spending 
offset each other exactly from 2009 through 2013; however, 
spending of authorized fees lags somewhat behind their 
collection, thereby generating net savings over the period. In 
addition, the amounts available for obligation and spending for 
fiscal year 2013 would not include special reserve funds 
collected in that year. That difference would result in savings 
of almost $2 million for fiscal year 2013, CBO estimates.

Other administrative expenses

    Funding for certain administrative activities associated 
with the new user fee program would not be fully covered by 
fees. The bill would require that FDA report annually to the 
Congress on its performance under the user fee program and on 
the fiscal status of the program. H.R. 6433 would 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 user fee program on a specified schedule. CBO estimates 
that the administrative activities associated with implementing 
the user fee program that are not covered by the user fees 
would cost less than $500,000 annually.
    Estimated impact on state, local, and tribal governments: 
H.R. 6433 contains no intergovernmental mandates as defined in 
UMRA.
    Estimated impact on the private sector: H.R. 6433 would 
establish a user fee program at FDA for sponsors of generic 
drugs intended for use in animals. The imposition of 
application, product, 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 2009-2013 period would total $29 million. Those amounts 
would not exceed the annual threshold specified in UMRA ($136 
million in 2008, adjusted annually for inflation) in any of the 
five years that the mandates would be effective.
    Estimate prepared by: Federal Costs: Julia Christensen; 
Impact on State, Local, and Tribal Governments: Lisa Ramirez-
Branum; Impact on the Private Sector: Paul Jacobs.
    Estimate approved by: Keith J. Fontenot; Deputy Assistant 
Director for Health and Human Resources, Budget Analysis 
Division.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates regarding H.R. 6433 prepared by the Director of the 
Congressional Budget Office pursuant to section 423 of the 
Unfunded Mandates Reform Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act would be created by H.R. 
6433.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for H.R. 6433 is provided in Article 
I, section 8, clause 3, which grants Congress the power to 
regulate commerce with foreign nations, among the several 
States, and with the Indian Tribes.

                  Applicability to Legislative Branch

    The Committee finds that H.R. 6433 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 of 1995.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    This section establishes the short title of the legislation 
as the ``Animal Generic Drug User Fee Act of 2008''.

Section 2. Findings

    This section presents findings of Congress that making 
additional funds available through user fees for the review of 
abbreviated applications for generic new animal drugs would 
serve animal and public health by facilitating prompt review of 
safe and effective animal drugs.
    These congressional findings also state that user fees 
authorized under the legislation will be used to expedite the 
process for generic drug development and for reviewing 
abbreviated applications for generic new animal drugs.

Section 3. Fees relating to abbreviated applications for generic new 
        animal drugs

    This section would amend the Federal Food, Drug, and 
Cosmetic Act (FFDCA) to add authority for the FDA to collect 
user fees for abbreviated applications, including: applicable 
definitions for the various types of abbreviated applications 
and submissions, as well as other terms to be used in the user-
fee program; provision for abbreviated application, product, 
and sponsor fees; the total fee revenues to be collected for 
each fee type for fiscal years 2009 through 2013 with 
adjustments (used as the basis for determining fee amounts); 
provision for fee waivers or reductions and collection of 
unpaid fees; the annual user-fee trigger requires, exclusive of 
user-fee appropriations, that FDA salaries and expenses 
appropriations for such fiscal year equal or exceed such 
appropriations for fiscal year 2003 multiplied by the 
applicable adjustment factor; provisions governing the 
crediting and availability of fees; and authorization of 
appropriations for fees for each of fiscal years 2009 through 
2013.

Section 4. Accountability and reports

    This section states that the Secretary of Health and Human 
Services (HHS) shall consult with the Committee on Energy and 
Commerce and the Committee on Health, Education, Labor, and 
Pensions (HELP), scientific and academic experts, veterinary 
professionals, representatives of patient and consumer advocacy 
groups, and the regulated industry in developing 
recommendations to present to Congress regarding goals for 
abbreviated applications for generic new animal drugs after 
fiscal year 2013 and for reauthorizing the user fee program.
    This section requires the Secretary of HHS to submit a 
performance report and fiscal report to the Committee on Energy 
and Commerce and the Committee on HELP each fiscal year. The 
performance report will discuss the progress of FDA in 
achieving the goals of the user-fee program as identified in a 
letter from the Secretary of HHS to Congress. The fiscal report 
will also discuss the implementation of the authority to 
collect user fees and FDA's use of such fees during that year. 
These reports shall be made publicly available through FDA's 
Web site.
    The Secretary is further directed to develop the 
reauthorization proposal for AGDUFA in consultation with its 
stakeholders, including representatives from consumer advocacy 
and patient groups, veterinary professionals, and the regulated 
industry.

Section 5. Sunset

    This section states that authority for user fees will 
expire October 1, 2013, and that the reporting provisions will 
expire 120 days after that date.

         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 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 2(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.

                Subchapter D--Information and Education

SEC. [741.] 745. INFORMATION SYSTEM.

  The Secretary shall establish and maintain an information 
system to track the status and progress of each application or 
submission (including a petition, notification, or other 
similar form of request) submitted to the Food and Drug 
Administration requesting agency action.

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SEC. [742.] 746. EDUCATION.

  (a) * * *

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               Subchapter E--Environmental Impact Review

SEC. [746.] 749. ENVIRONMENTAL IMPACT.

  Notwithstanding any other provision of law, an environmental 
impact statement prepared in accordance with the regulations 
published in part 25 of title 21, Code of Federal Regulations 
(as in effect on August 31, 1997) in connection with an action 
carried out under (or a recommendation or report relating to) 
this Act, shall be considered to meet the requirements for a 
detailed statement under section 102(2)(C) of the National 
Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)).

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