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






                                                 Union Calendar No. 520
110th CONGRESS
  2d Session
                                H. R. 6432

                          [Report No. 110-804]

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
       the animal drug user fee program, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              July 8, 2008

Mr. Pallone (for himself, Mr. Dingell, Mr. Barton of Texas, Mr. Deal of 
   Georgia, and Mr. Towns) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

                             July 30, 2008

                    Additional sponsor: Ms. DeGette

                             July 30, 2008

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on July 8, 
                                 2008]

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
       the animal drug user fee program, 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. SHORT TITLE; REFERENCES; FINDING.

    (a) Short Title.--This Act may be cited as the ``Animal Drug User 
Fee Amendments of 2008''.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this Act to a section or other provision of law are amendments 
to such section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).
    (c) Finding.--Congress finds that the fees authorized by the 
amendments made in this Act 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. 2. 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. 3. 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. 4. 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 1(c) 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. 5. 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 Act, 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 Act).

SEC. 6. DESTRUCTION OF COUNTERFEIT ANIMAL DRUGS OFFERED FOR IMPORT.

    Section 801(a) (21 U.S.C. 381(a)) is amended--
            (1) in the third sentence, by inserting ``or (4) such 
        article is a counterfeit drug intended for use for animals 
        other than man,'' before ``then such article shall be refused 
        admission''; and
            (2) by striking ``Clause (2) of the third sentence of this 
        paragraph'' and inserting ``Notwithstanding the preceding 
        sentence, the Secretary of the Treasury shall cause the 
        destruction of any such article refused admission if (1) the 
        article is a drug intended for use for animals other than man, 
        the article appears to be adulterated, misbranded, or in 
        violation of section 505, and the article has a value less than 
        $2,000 or such amount as the Secretary of Health and Human 
        Services may determine by regulation; or (2) the article 
        appears to be a counterfeit drug intended for use for animals 
        other than man. Clause (2) of the third sentence of this 
        subsection''.

SEC. 7. 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 Act, 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 Act, 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. 8. EFFECTIVE DATE.

    The amendments made by sections 2, 3, and 4 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 Act, 
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 Act.

SEC. 9. SUNSET DATES.

    (a) Authorization.--The amendments made by sections 2 and 3 cease 
to be effective October 1, 2013.
    (b) Reporting Requirements.--The amendment made by section 4 ceases 
to be effective January 31, 2014.
                                                 Union Calendar No. 520

110th CONGRESS

  2d Session

                               H. R. 6432

                          [Report No. 110-804]

_______________________________________________________________________

                                 A BILL

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
       the animal drug user fee program, and for other purposes.

_______________________________________________________________________

                             July 30, 2008

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed