[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6432 Engrossed in House (EH)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
110th CONGRESS
  2d Session
                                H. R. 6432

_______________________________________________________________________

                                 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)''.

            Passed the House of Representatives July 30, 2008.

            Attest:

                                                                 Clerk.
110th CONGRESS

  2d Session

                               H. R. 6432

_______________________________________________________________________

                                 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.