[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6432 Enrolled Bill (ENR)]

        H.R.6432

                       One Hundred Tenth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

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


                                 An Act


 
 To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
    the animal drug user fee program, to establish a program of fees 
    relating to generic new animal drugs, to make certain technical 
corrections to the Food and Drug Administration Amendments Act of 2007, 
                         and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. TABLE OF CONTENTS.
    The table of contents of this Act is as follows:

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

                TITLE I--ANIMAL DRUG USER FEE AMENDMENTS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use animal drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Antimicrobial animal drug distribution reports.
Sec. 106. Savings clause.
Sec. 107. Effective date.
Sec. 108. Sunset dates.

                 TITLE II--ANIMAL GENERIC DRUG USER FEE

Sec. 201. Short title; findings.
Sec. 202. Fees relating to abbreviated applications for generic new 
          animal drugs.
Sec. 203. Accountability and reports.
Sec. 204. Sunset dates.

                TITLE III--TECHNICAL CORRECTIONS TO FDAAA

Sec. 301. Consideration of certain petitions.
Sec. 302. Registry and results data bank.
SEC. 2. REFERENCES IN ACT.
    Except as otherwise specified, amendments made by this Act to a 
section or other provision of law are amendments to such section or 
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.).

                TITLE I--ANIMAL DRUG USER FEE AMENDMENTS

    SEC. 101. SHORT TITLE; FINDING.
    (a) Short Title.--This title may be cited as the ``Animal Drug User 
Fee Amendments of 2008''.
    (b) Finding.--Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward expediting the 
animal drug development process and the review of new and supplemental 
animal drug applications and investigational animal drug submissions as 
set forth in the goals identified, for purposes of part 4 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the 
letters from the Secretary of Health and Human Services to the Chairman 
of the Committee on Energy and Commerce of the House of Representatives 
and the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate as set forth in the Congressional Record.
    SEC. 102. DEFINITIONS.
    Section 739 (21 U.S.C. 379j-11) is amended--
        (1) in paragraph (6), by striking ``, except for an approved 
    application for which all subject products have been removed from 
    listing under section 510'' and inserting ``that has not been 
    withdrawn by the applicant and for which approval has not been 
    withdrawn by the Secretary'';
        (2) in paragraph (8)(H), by striking ``but not such activities 
    after an animal drug has been approved'' and inserting ``but not 
    after such application has been approved'';
        (3) in paragraph (10), by striking ``year being 2003'' and 
    inserting ``month being October 2002'';
        (4) by redesignating paragraph (11) as paragraph (12); and
        (5) by inserting after paragraph (10) the following:
        ``(11) The term `person' includes an affiliate thereof.''.
    SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.
    (a) Types of Fees.--Section 740(a) (21 U.S.C. 379j-12(a)) is 
amended--
        (1) in paragraph (1)(A)(i), by inserting after ``for an animal 
    drug application'' the following: ``, except an animal drug 
    application subject to the criteria set forth in section 
    512(d)(4)''; and
        (2) by amending paragraph (1)(A)(ii) to read as follows:
                ``(ii) A fee established in subsection (b), in an 
            amount that is equal to 50 percent of the amount of the fee 
            under clause (i), for--

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

    (b) Fee Amounts.--
        (1) Total fee revenues for application and supplement fees.--
    Section 740(b)(1) (21 U.S.C. 379j-12(b)(1)) is amended--
            (A) by striking ``and supplemental animal drug application 
        fees'' and inserting ``and supplemental and other animal drug 
        application fees''; and
            (B) by striking ``$1,250,000'' and all that follows through 
        the period at the end and inserting ``$3,815,000 for fiscal 
        year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for 
        fiscal year 2011, $5,442,000 for fiscal year 2012, and 
        $6,061,000 for fiscal year 2013.''.
        (2) Total fee revenues for product fees.--Section 740(b)(2) (21 
    U.S.C. 379j-12(b)(2)) is amended by striking ``$1,250,000'' and all 
    that follows through the period at the end and inserting 
    ``$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, 
    $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, 
    and $6,061,000 for fiscal year 2013.''.
        (3) Total fee revenues for establishment fees.--Section 
    740(b)(3) (21 U.S.C. 379j-12(b)(3)) is amended by striking 
    ``$1,250,000'' and all that follows through the period at the end 
    and inserting ``$3,815,000 for fiscal year 2009, $4,320,000 for 
    fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for 
    fiscal year 2012, and $6,061,000 for fiscal year 2013.''.
        (4) Total fee revenues for sponsor fees.--Section 740(b)(4) (21 
    U.S.C. 379j-12(b)(4)) is amended by striking ``$1,250,000'' and all 
    that follows through the period at the end and inserting 
    ``$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, 
    $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, 
    and $6,061,000 for fiscal year 2013.''.
    (c) Adjustments to Fees.--Section 740(c) (21 U.S.C. 379j-12(c)) is 
amended--
        (1) by striking paragraph (1);
        (2) by redesignating paragraphs (2) through (5) as paragraphs 
    (1) through (4), respectively;
        (3) in paragraph (1), as so redesignated--
            (A) in the matter preceding subparagraph (A), by striking 
        ``After the fee revenues are adjusted for inflation in 
        accordance with paragraph (1), the fee revenues shall be 
        further adjusted each fiscal year after fiscal year 2004'' and 
        inserting ``The fee revenues shall be adjusted each fiscal year 
        after fiscal year 2009''; and
            (B) in subparagraph (B), by striking ``, as adjusted for 
        inflation under paragraph (1)''; and
        (4) in paragraph (2), as so redesignated--
            (A) by striking ``2008'' each place it appears and 
        inserting ``2013''; and
            (B) by striking ``2009'' and inserting ``2014''.
    (d) Authorization of Appropriations.--Subparagraphs (A) through (E) 
of section 740(g)(3) (21 U.S.C. 379j-12(g)(3)) are amended to read as 
follows:
            ``(A) $15,260,000 for fiscal year 2009;
            ``(B) $17,280,000 for fiscal year 2010;
            ``(C) $19,448,000 for fiscal year 2011;
            ``(D) $21,768,000 for fiscal year 2012; and
            ``(E) $24,244,000 for fiscal year 2013;''.
    (e) Offset.--Section 740(g)(4) (21 U.S.C. 379j-12(g)(4)) is amended 
to read as follows:
        ``(4) Offset.--If the sum of the cumulative amount of fees 
    collected under this section for fiscal years 2009 through 2011 and 
    the amount of fees estimated to be collected under this section for 
    fiscal year 2012 exceeds the cumulative amount appropriated under 
    paragraph (3) for the fiscal years 2009 through 2012, the excess 
    amount shall be credited to the appropriation account of the Food 
    and Drug Administration as provided in paragraph (1), and shall be 
    subtracted from the amount of fees that would otherwise be 
    authorized to be collected under this section pursuant to 
    appropriation Acts for fiscal year 2013.''.
    SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
    Part 4 of subchapter C of chapter VII (21 U.S.C. 379j-11 et seq.) 
is amended by inserting after section 740 the following:
``SEC. 740A. REAUTHORIZATION; REPORTING REQUIREMENTS.
    ``(a) Performance Report.--Beginning with fiscal year 2009, not 
later than 60 days after the end of each fiscal year during which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 101(b) of the Animal Drug User Fee Amendments of 
2008 toward expediting the animal drug development process and the 
review of the new and supplemental animal drug applications and 
investigational animal drug submissions during such fiscal year, the 
future plans of the Food and Drug Administration for meeting the goals, 
the review times for abbreviated new animal drug applications, and the 
administrative procedures adopted by the Food and Drug Administration 
to ensure that review times for abbreviated new animal drug 
applications are not increased from their current level due to 
activities under the user fee program.
    ``(b) Fiscal Report.--Beginning with fiscal year 2009, not later 
than 120 days after the end of each fiscal year during which fees are 
collected under this part, the Secretary shall prepare and submit to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report on the implementation of the authority for such fees 
during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected during such fiscal year for which 
the report is made.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Reauthorization.--
        ``(1) Consultation.--In developing recommendations to present 
    to the Congress with respect to the goals, and plans for meeting 
    the goals, for the process for the review of animal drug 
    applications for the first 5 fiscal years after fiscal year 2013, 
    and for the reauthorization of this part for such fiscal years, the 
    Secretary shall consult with--
            ``(A) the Committee on Energy and Commerce of the House of 
        Representatives;
            ``(B) the Committee on Health, Education, Labor, and 
        Pensions of the Senate;
            ``(C) scientific and academic experts;
            ``(D) veterinary professionals;
            ``(E) representatives of patient and consumer advocacy 
        groups; and
            ``(F) the regulated industry.
        ``(2) Prior public input.--Prior to beginning negotiations with 
    the regulated industry on the reauthorization of this part, the 
    Secretary shall--
            ``(A) publish a notice in the Federal Register requesting 
        public input on the reauthorization;
            ``(B) hold a public meeting at which the public may present 
        its views on the reauthorization, including specific 
        suggestions for changes to the goals referred to in subsection 
        (a);
            ``(C) provide a period of 30 days after the public meeting 
        to obtain written comments from the public suggesting changes 
        to this part; and
            ``(D) publish the comments on the Food and Drug 
        Administration's Internet Web site.
        ``(3) Periodic consultation.--Not less frequently than once 
    every 4 months during negotiations with the regulated industry, the 
    Secretary shall hold discussions with representatives of 
    veterinary, patient, and consumer advocacy groups to continue 
    discussions of their views on the reauthorization and their 
    suggestions for changes to this part as expressed under paragraph 
    (2).
        ``(4) Public review of recommendations.--After negotiations 
    with the regulated industry, the Secretary shall--
            ``(A) present the recommendations developed under paragraph 
        (1) to the Congressional committees specified in such 
        paragraph;
            ``(B) publish such recommendations in the Federal Register;
            ``(C) provide for a period of 30 days for the public to 
        provide written comments on such recommendations;
            ``(D) hold a meeting at which the public may present its 
        views on such recommendations; and
            ``(E) after consideration of such public views and 
        comments, revise such recommendations as necessary.
        ``(5) Transmittal of recommendations.--Not later than January 
    15, 2013, the Secretary shall transmit to the Congress the revised 
    recommendations under paragraph (4), a summary of the views and 
    comments received under such paragraph, and any changes made to the 
    recommendations in response to such views and comments.
        ``(6) Minutes of negotiation meetings.--
            ``(A) Public availability.--Before presenting the 
        recommendations developed under paragraphs (1) through (5) to 
        the Congress, the Secretary shall make publicly available, on 
        the Internet Web site of the Food and Drug Administration, 
        minutes of all negotiation meetings conducted under this 
        subsection between the Food and Drug Administration and the 
        regulated industry.
            ``(B) Content.--The minutes described under subparagraph 
        (A) shall summarize any substantive proposal made by any party 
        to the negotiations as well as significant controversies or 
        differences of opinion during the negotiations and their 
        resolution.''.
    SEC. 105. ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORTS.
    (a) Reports.--Section 512(l) (21 U.S.C. 360b(l)) is amended by 
adding at the end the following:
    ``(3)(A) In the case of each new animal drug described in paragraph 
(1) that contains an antimicrobial active ingredient, the sponsor of 
the drug shall submit an annual report to the Secretary on the amount 
of each antimicrobial active ingredient in the drug that is sold or 
distributed for use in food-producing animals, including information on 
any distributor-labeled product.
    ``(B) Each report under this paragraph shall specify the amount of 
each antimicrobial active ingredient--
        ``(i) by container size, strength, and dosage form;
        ``(ii) by quantities distributed domestically and quantities 
    exported; and
        ``(iii) by dosage form, including, for each such dosage form, a 
    listing of the target animals, indications, and production classes 
    that are specified on the approved label of the product.
    ``(C) Each report under this paragraph shall--
        ``(i) be submitted not later than March 31 each year;
        ``(ii) cover the period of the preceding calendar year; and
        ``(iii) include separate information for each month of such 
    calendar year.
    ``(D) The Secretary may share information reported under this 
paragraph with the Antimicrobial Resistance Task Force established 
under section 319E of the Public Health Service Act.
    ``(E) The Secretary shall make summaries of the information 
reported under this paragraph publicly available, except that--
        ``(i) the summary data shall be reported by antimicrobial 
    class, and no class with fewer than 3 distinct sponsors of approved 
    applications shall be independently reported; and
        ``(ii) the data shall be reported in a manner consistent with 
    protecting both national security and confidential business 
    information.''.
    (b) First Report.--For each new animal drug that is subject to the 
reporting requirement under section 512(l)(3) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a), and for which an 
approval of an application filed pursuant to section 512(b) or 571 of 
such Act is in effect on the date of the enactment of this title, the 
Secretary of Health and Human Services shall require the sponsor of the 
drug to submit the first report under such section 512(l)(3) for the 
drug not later than March 31, 2010.
    (c) Separate Report.--The reports required under section 512(l)(3) 
of the Federal Food, Drug, and Cosmetic Act, as added by subsection 
(a), shall be separate from periodic drug experience reports that are 
required under section 514.80(b)(4) of title 21, Code of Federal 
Regulations (as in effect on the date of the enactment of this title).
    SEC. 106. SAVINGS CLAUSE.
    Notwithstanding section 5 of the Animal Drug User Fee Act of 2003 
(21 U.S.C. 379j-11 note), and notwithstanding the amendments made by 
this title, part 4 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j-11 et seq.), as in effect on the 
day before the date of the enactment of this title, shall continue to 
be in effect with respect to animal drug applications and supplemental 
animal drug applications (as defined in such part as of such day) that 
on or after September 1, 2003, but before October 1, 2008, were 
accepted by the Food and Drug Administration for filing with respect to 
assessing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2009.
    SEC. 107. EFFECTIVE DATE.
    The amendments made by sections 102, 103, and 104 shall take effect 
on October 1, 2008, and fees under part 4 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act, as amended by this 
title, shall be assessed for all animal drug applications and 
supplemental animal drug applications received on or after such date, 
regardless of the date of the enactment of this title.
    SEC. 108. SUNSET DATES.
    (a) Authorization.--The amendments made by sections 102 and 103 
cease to be effective October 1, 2013.
    (b) Reporting Requirements.--The amendment made by section 104 
ceases to be effective January 31, 2014.

                 TITLE II--ANIMAL GENERIC DRUG USER FEE

    SEC. 201. SHORT TITLE; FINDINGS.
    (a) Short Title.--This title may be cited as the ``Animal Generic 
Drug User Fee Act of 2008''.
    (b) 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 title will be dedicated toward 
    expediting the generic new animal drug development process and the 
    review of abbreviated applications for generic new animal drugs, 
    supplemental abbreviated applications for generic new animal drugs, 
    and investigational submissions for generic new animal drugs as set 
    forth in the goals identified in the letters from the Secretary of 
    Health and Human Services to the Chairman of the Committee on 
    Energy and Commerce of the House of Representatives and the 
    Chairman of the Committee on Health, Education, Labor, and Pensions 
    of the Senate as set forth in the Congressional Record.
    SEC. 202. 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. 203. 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 202, 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 201(3) of the Animal Generic Drug User Fee Act of 
2008 toward expediting the generic new animal drug development process 
and the review of abbreviated applications for generic new animal 
drugs, supplemental abbreviated applications for generic new animal 
drugs, and investigational submissions for generic new animal drugs 
during such fiscal year.
    ``(b) Fiscal Report.--Beginning with fiscal year 2009, not later 
than 120 days after the end of each fiscal year during which fees are 
collected under this part, the Secretary shall prepare and submit to 
Committee on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Representatives a 
report on the implementation of the authority for such fees during such 
fiscal year and the use, by the Food and Drug Administration, of the 
fees collected during such fiscal year for which the report is made.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
Internet Web site of the Food and Drug Administration.
    ``(d) Reauthorization.--
        ``(1) Consultation.--In developing recommendations to present 
    to Congress with respect to the goals, and plans for meeting the 
    goals, for the process for the review of abbreviated applications 
    for generic new animal drugs for the first 5 fiscal years after 
    fiscal year 2013, and for the reauthorization of this part for such 
    fiscal years, the Secretary shall consult with--
            ``(A) the Committee on Energy and Commerce of the House of 
        Representatives;
            ``(B) the Committee on Health, Education, Labor, and 
        Pensions of the Senate;
            ``(C) scientific and academic experts;
            ``(D) veterinary professionals;
            ``(E) representatives of patient and consumer advocacy 
        groups; and
            ``(F) the regulated industry.
        ``(2) Prior public input.--Prior to beginning negotiations with 
    the regulated industry on the reauthorization of this part, the 
    Secretary shall--
            ``(A) publish a notice in the Federal Register requesting 
        public input on the reauthorization;
            ``(B) hold a public meeting at which the public may present 
        its views on the reauthorization, including specific 
        suggestions for changes to the goals referred to in subsection 
        (a);
            ``(C) provide a period of 30 days after the public meeting 
        to obtain written comments from the public suggesting changes 
        to this part; and
            ``(D) publish the comments on the Food and Drug 
        Administration's Internet Web site.
        ``(3) Periodic consultation.--Not less frequently than once 
    every 4 months during negotiations with the regulated industry, the 
    Secretary shall hold discussions with representatives of 
    veterinary, patient, and consumer advocacy groups to continue 
    discussions of their views on the reauthorization and their 
    suggestions for changes to this part as expressed under paragraph 
    (2).
        ``(4) Public review of recommendations.--After negotiations 
    with the regulated industry, the Secretary shall--
            ``(A) present the recommendations developed under paragraph 
        (1) to the congressional committees specified in such 
        paragraph;
            ``(B) publish such recommendations in the Federal Register;
            ``(C) provide for a period of 30 days for the public to 
        provide written comments on such recommendations;
            ``(D) hold a meeting at which the public may present its 
        views on such recommendations; and
            ``(E) after consideration of such public views and 
        comments, revise such recommendations as necessary.
        ``(5) Transmittal of recommendations.--Not later than January 
    15, 2013, the Secretary shall transmit to Congress the revised 
    recommendations under paragraph (4), a summary of the views and 
    comments received under such paragraph, and any changes made to the 
    recommendations in response to such views and comments.
        ``(6) Minutes of negotiation meetings.--
            ``(A) Public availability.--Before presenting the 
        recommendations developed under paragraphs (1) through (5) to 
        Congress, the Secretary shall make publicly available, on the 
        Internet Web site of the Food and Drug Administration, minutes 
        of all negotiation meetings conducted under this subsection 
        between the Food and Drug Administration and the regulated 
        industry.
            ``(B) Content.--The minutes described under subparagraph 
        (A) shall summarize any substantive proposal made by any party 
        to the negotiations as well as significant controversies or 
        differences of opinion during the negotiations and their 
        resolution.''.
    SEC. 204. SUNSET DATES.
    (a) Authorization.--The amendments made by section 202 shall cease 
to be effective October 1, 2013.
    (b) Reporting Requirements.--The amendment made by section 203 
shall cease to be effective January 31, 2014.

               TITLE III--TECHNICAL CORRECTIONS TO FDAAA

    SEC. 301. CONSIDERATION OF CERTAIN PETITIONS.
    Subparagraph (A) of section 505(q)(1) (21 U.S.C. 355(q)(1)) is 
amended by adding at the end the following:
        ``Consideration of the petition shall be separate and apart 
        from review and approval of any application.''.
    SEC. 302. REGISTRY AND RESULTS DATA BANK.
    Paragraph (3) of section 402(j) of the Public Health Service Act 
(42 U.S.C. 282(j)) is amended--
        (1) in the matter preceding clause (i) in subparagraph (C), by 
    striking ``the following elements'' and all that follows through 
    ``520(m) of such Act:'' and inserting ``for each applicable 
    clinical trial for a drug that is approved under section 505 of the 
    Federal Food, Drug, and Cosmetic Act or licensed under section 351 
    of this Act or a device that is cleared under section 510(k) of the 
    Federal Food, Drug, and Cosmetic Act or approved under section 515 
    or 520(m) of such Act, the following elements:''; and
        (2) in clauses (i) and (iii) of subparagraph (I), by striking 
    the term ``drugs described in subparagraph (C)'' each place such 
    term appears and inserting ``applicable clinical trials described 
    in subparagraph (C)''.

                               Speaker of the House of Representatives.

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