[Congressional Record (Bound Edition), Volume 154 (2008), Part 12]
[House]
[Pages 17282-17289]
[From the U.S. Government Publishing Office, www.gpo.gov]




                ANIMAL DRUG USER FEE AMENDMENTS OF 2008

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 6432) to amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the animal drug user fee program, and for other 
purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 6432

       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

[[Page 17283]]

       (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--

[[Page 17284]]

       ``(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.

[[Page 17285]]

       ``(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

[[Page 17286]]

     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

[[Page 17287]]

     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)''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Georgia (Mr. Deal) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days to revise and extend their remarks and 
include extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Prior to 2003, the FDA's review of animal drug submissions was taking 
over a year and a half to be completed. This obviously led to serious 
concerns that new and innovative pharmaceutical products were not 
making their way onto the marketplace in order to treat our Nation's 
pets, as well as food animals that help sustain the Nation's food 
supply.
  Accordingly, in 2003, Congress enacted the Animal Drug User Fee Act 
(ADUFA) which was modeled after the successful user fee programs for 
the review of human drug and medical device submissions. Like the user 
fee programs that preceded it, ADUFA authorized the FDA to collect fees 
to help ensure that the agency had the resources it needed to provide a 
timely review of animal drug applications.
  The legislation before us today would reauthorize the ADUFA program 
for another 5 years. Under this legislation, the amount of fees 
collected for the review of animal drug submissions would increase from 
$15 million to $24 million over 5 years, for a total of $98 million. 
Revenues would be derived from a mix of application, product, 
establishment and sponsor fees.
  The legislation would also improve the uniform collection and 
reporting of data to FDA on the sales about animal drugs that contain 
an antibiotic ingredient.
  During the debate on reauthorization of ADUFA, we heard many concerns 
about the use of antibiotics in animal populations for non-therapeutic 
purposes and the threat that these practices pose to human health. This 
bill includes language that would enhance FDA's current data collection 
by creating a new antimicrobial animal drug use data report for all 
food-producing animals. The report puts critical information in one 
place for FDA; otherwise, the agency would have to search through 
warehouses of multiple paper reports.
  In addition to the reauthorization of ADUFA, this legislation would 
establish a new animal generic drug user fee. According to FDA, the 
average review time of an animal generic drug submission was 570 days 
in Fiscal Year 2007, in spite of a 180-day statutory requirement. At 
the end of last year there was a recorded backlog of 446 submissions 
waiting for review and agency action.
  Accordingly, the bill before us would provide for the collection of 
user fees increasing annually from $4.8 million to $6 million over 5 
years, for a total of $27 million. And these additional revenues are 
designed to help speed up the review process. By Year 5 of the 
authorization period, most reviews of generic animal drug submissions 
should occur in 270 days or less, a substantial improvement over the 
time it is now taking FDA to conduct such reviews.
  Mr. Speaker, I am also pleased that the generic drug industry and FDA 
have been able to work out this agreement. If enacted, AGDUFA will 
speed lower cost animal drugs to the marketplace and bring significant 
savings to ranchers, farmers and pet owners. While that is an important 
and noteworthy goal, I also think it is equally, if not more important, 
to ensure for the timely review of generic human drug applications.
  There is a provision in this bill that would improve the speed in 
which FDA reviews generic drug applications, and that provision makes a 
technical correction to the Food and Drug Administration Amendments Act 
of 2007 as it relates to the application process for obtaining FDA 
approval of certain new generic drugs.
  Citizen petitions can be submitted to FDA to raise issues about drugs 
that are being considered in the application process. At the time of 
negotiations on the Food and Drug Administration Amendments Act of 
2007, an agreed-upon sentence was inadvertently dropped from our final 
version of that bill. The sentence makes clear that consideration of a 
citizen petition regarding a drug is to be separate and apart from 
review and approval of any application for the drug. The language 
included in the bill we are considering today restores that sentence.
  There is another correction to the FDA Amendments Act that is 
included in the bill before us. This change concerns the types of 
information to be included in the clinical trials data bank established 
under that law. More specifically, the issue is adverse event 
information on drugs and on medical devices.
  Adverse event information was clearly intended to be included in the 
data bank for both drugs and devices. Express specific requirements to 
that effect were included in multiple drafts of the legislation. In 
negotiations, however, it was agreed that rather than the bill itself 
including express specific requirements regarding adverse event 
information, the FDA would issue regulations that would set the 
specific requirements. In drafting the ``regulations'' approach, the 
reference to medical devices was inadvertently dropped, and that was a 
simple mistake. So the bill before us today corrects that mistake.
  In closing, I want to thank my Republican colleagues for working for 
us in a bipartisan fashion to move this bill forward. Mr. Deal, Mr. 
Barton and of course Mr. Dingell all worked together, so this is, in 
fact, a bipartisan bill, and a very important bill as well.
  Mr. Speaker, I reserve the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, today the House is set to pass legislation reauthorizing 
the Animal Drug User Fee Act, also known as ADUFA. This legislation 
represents a compromise between the parties, the administration, and 
the industry.
  Development of animal drugs can take years and cost millions of 
dollars.

[[Page 17288]]

A predictable review process is important to make sure that these 
products are approved in a timely way. Since the passage of ADUFA in 
2003, the review times for new animal drugs went from 295 days in 
Fiscal Year 2004 to 180 days in Fiscal Year 2008.
  We need to reauthorize this program before we leave for the August 
recess. If we fail to do so, the FDA may have to begin issuing 
reduction in force notices to its employees. The bill before us today 
will provide financial stability for the program and improve the health 
information infrastructure for drug review. It will also provide more 
user revenue for the program.
  Along with ADUFA, for the first time, Congress is set to pass 
legislation which would create the Animal Generic Drug User Fee Act, or 
AGDUFA. AGDUFA will allow the FDA to collect user fees, thereby 
improving the times necessary for generic drug approval. This will not 
only bring generics to the market more quickly, but will also lower 
costs for consumers. If AGDUFA is authorized, approval times could be 
reduced from 700 days in Fiscal Year 2009, to around 270 days in Fiscal 
Year 2013.
  Mr. Speaker, I look forward to the passage of both of these pieces of 
legislation in the bill that is before us today.
  I would reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I am pleased to yield 3 minutes to the 
gentleman from California (Mr. Waxman) who, I must add, has been such 
an outstanding spokesman on FDA issues over the years, and particularly 
promoting generic drugs. I yield to the gentleman 3 minutes.
  Mr. WAXMAN. Mr. Speaker, I thank the chairman of our subcommittee for 
yielding to me.
  This bill that we are considering now, the Animal Drug User Fee Act, 
or ADUFA, will enhance and improve FDA's ability to promptly review new 
medicines for animals, and that is very important that we all support 
this.
  This reauthorization has also given us an opportunity to look at 
providing FDA with new tools to address a related public health crisis, 
the problem of antibiotic resistance caused by the industrial farming 
practice of using human antibiotics for non-therapeutic uses in food 
producing animals.
  We now have an overwhelming body of evidence showing that the overuse 
of antibiotics in industrial farm production is threatening to destroy 
the effectiveness of some of our most important antibiotics for human 
use. Many of the world's most prestigious experts, the Institute of 
Medicine, the Pew Commission, World Health Organization and Government 
Accountability Office have warned about the dangers to global public 
health of such widespread overuse. These drugs are breeding resistant 
microorganisms that can and do get transferred to humans. They also 
leach into the environment and show up in our drinking water. The 
experts have told us that the more antibiotics we consume, the more 
resistance develops.
  The ADUFA bill we are considering includes a provision to increase 
the availability and accessibility of data on the amount of animal 
antibiotics being distributed. This data will help us to determine how 
resistant bugs are developing and inform research on ways to stop those 
bugs from threatening human health.
  This is an important step forward, and I appreciate the cooperation 
of Chairman Dingell and Chairman Pallone in helping us to get this 
done.
  But let me be clear: This is only just the beginning. We, in 
Congress, need to do much more to address the problem of antibiotic 
resistance. It is imperative that we look at ways to curtail the 
practice of using the same antibiotics that are so vitally important 
for preventing and curing human disease for non-therapeutic uses in 
food-producing animals.
  I look forward to continuing to work with our colleagues on this 
important issue.
  Mr. DEAL of Georgia. Mr. Speaker, I would yield at this time such 
time as he may consume to the gentleman from Indiana (Mr. Buyer).
  Mr. BUYER. Mr. Speaker, I need to discuss an amendment that was 
adopted at the committee that is not in this bill today. We, as a 
country, are facing a tremendous challenge, and that is, with the 
advent of the Internet, it is very easy for people to get on the 
Internet; they go to a Web site and they believe that they can order 
drugs and that the drugs that they order on the Web site can be the 
very same drugs that they get down at the CVS or the Walgreens or the 
local community pharmacy.
  Every time the FDA does an inspection at our international mail 
facilities, they discover anywhere from 67 to 90 percent of the drugs 
that are coming in from the orders of these mail sites, are either 
adulterated, misbranded or counterfeit drugs.
  Now, let's just do the math. Every day, 20 to 30,000 packages, 
pharmaceutical packages enter each of our 12 international mail 
facilities every day. The FDA only screens less than 1 percent.
  Now, let's think about this. Just take 30 days, for a month, times 
400,000 packages, you get 12 million, times 12 months, that is 144 
million pharmaceutical packages.
  Now, do the math with regard to the number that are either 
misbranded, adulterated or counterfeit. Now, let's just do really 
simple math, and just say, okay, we will give a little flexibility in 
there. That is 100 million pharmaceutical packages that are either 
adulterated, misbranded or counterfeit. We have a very, very serious 
problem. Now, that is with regard to the human consumption.
  Now, you are saying, Steve, what does that have to do with the Animal 
Drug Fee User Act here today?
  Well, what I had hoped to do is, it is only a matter of time before 
the bad actors of the world enter this economic space, meaning, if they 
can scam the American people with regard to human consumption, you know 
what? It is really going to be easier for them to do this in the animal 
drug business because you are never going to know why that animal died.

                              {time}  1545

  We have a tremendous challenge. The FDA feels that they do not have 
the authority to destroy these misbranded, adulterated, or counterfeit 
drugs. So what's happening? You go to an international mail facility. 
When Customs finds one of those packages, they'll destroy it, but if 
that package then gets referred to the FDA, FDA feels that they do not 
have the legal authority to destroy that package.
  Now when they feel they don't have the legal ability to destroy, they 
have adopted a ``return-to-sender'' policy.
  Now let's think about this. The bad actors of the world, the 
counterfeiters and the criminal syndicates, are very sophisticated as 
to how they move these counterfeit packages from country to country to 
gain access into our marketplace. Then when we discover that package, 
the FDA, through their policy now, returns it to the counterfeiter. 
Think about that. Our own FDA that is there to protect us then becomes 
the enabler of the counterfeiter. So the counterfeiter takes the 
person's money and we return the merchandise that's counterfeit to the 
counterfeiter.
  Now that is stupid. That's about as idiotic as I have ever seen.
  So what did I attempt to do? Well, we're working on a food and drug 
safety bill in the committee, and I appreciate the gentlemen's work on 
both sides of the aisle. It's on human consumption. So what I had hoped 
to do here was say, Well, let's stop these bad actors and the criminal 
syndicates and the counterfeiters from entering into animal drugs. 
Chairman John Dingell agrees with that provision, and it was going to 
be in here.
  The Democrat leadership said, ``No. We can't have that in this 
bill.'' Now that's a curious and puzzling thing. But what I will say 
is, and my agreement with Chairman Dingell is that this is an issue as 
a country in matters of food and drug safety that we, as Republicans 
and Democrats, must come together to protect the American people and to 
go after these bad actors around the world, the criminal syndicates who 
are preying upon America's most vulnerable populations. We have to 
enjoin

[[Page 17289]]

together to do this. And that's my pledge to work with Chairman Dingell 
and Joe Barton and other members of the committee, and I salute Mr. 
Matheson, for us to do this so not only do we bring protections on the 
animal side to go after the bad actors, we put protections in place on 
the human side. And we can do that not only in stopping the bad actors 
but also including electronic pedigree, and I will work with you to do 
just that.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  I just wanted to say that I understand the gentleman's concerns who 
just spoke, Mr. Buyer, the gentleman from Indiana, and I, too, am very 
concerned about counterfeit drugs entering the U.S. marketplace. I 
think the FDA should have the authority to seize and destroy 
counterfeit drugs. And as the gentleman knows, we are working with him 
to address this issue in a larger bill that will empower the FDA to 
protect the consumers from dangerous products, including counterfeit 
drugs. So I hope that we can continue to work with the gentleman on 
this matter.
  Mr. BUYER. Will the gentleman yield?
  Mr. PALLONE. I yield to the gentleman from Indiana.
  Mr. BUYER. In my conversations with the chairman, not only last night 
but also this morning, I will work with the gentleman to make sure that 
we can have this in the drug safety bill not only on humans but will 
also protect animals, so we will give the authority to the FDA to 
destroy. I will work with the gentleman.
  But we also brought up in the conversation--I understand that a 
little pain could have been created here today. I want to work with the 
majority. In other words, they weren't forced to go through the Rules 
Committee and then we have a big fight on the floor. I agreed with the 
chairman. We withdraw the amendment.
  But I want to work also--please work with Mr. Matheson and I on the 
electronic pedigree. It builds off of Chairman Dingell's paper pedigree 
so we can sophisticate America's systems for American people here as we 
also then fight the counterfeiters who are trying to gain access into 
our market. And I'll work with the chairman to do that.
  Mr. PALLONE. Mr. Speaker, I certainly heard what my colleague from 
Indiana said, and I'm certainly willing to work with him on what he's 
suggesting.
  I reserve the balance of my time.
  Mr. DEAL of Georgia. Mr. Speaker, I would also compliment Mr. Buyer 
for his sincere efforts on the issue of counterfeiting and look forward 
to working with him to address that issue both for humans and for 
animals in future legislation.
  But because of the importance of this particular legislation and the 
need to reauthorize it in the time frame that is before us, I would 
urge the adoption of this legislation.
  Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 6432. Today we 
consider important public health legislation that, in the best 
tradition of the Committee on Energy and Commerce, has strong 
bipartisan support as well as backing from industry, consumer, and 
stakeholder groups.
  I note that this bill has three titles--each representing different 
bills considered by the Committee on Energy and Commerce. The first 
title is the ``Animal Drug User Fee Amendments of 2008''. This title 
reauthorizes a successful user fee program that has allowed the Food 
and Drug Administration (FDA) to safely and efficiently review animal 
drugs. This part of the bill improves the existing program by 
increasing fee revenues, providing greater transparency, and setting 
specific timeframes by which data must be submitted to the FDA.
  This title of the bill also contains provisions related to the issue 
of antimicrobial resistance. The Committee worked closely with Members 
from both sides of the aisle, as well as industry and consumer groups, 
to ensure that the FDA has the necessary information to examine safety 
concerns related to the use of antibiotics in food-producing animals. I 
commend Representatives Matheson, Waxman, Pallone, Deal, and Barton for 
reaching agreement on this important public health concern.
  The next title is the ``Animal Generic Drug User Fee Act of 2008'' 
(AGDUFA). This program is similar in design to the ADUFA program, but 
with a specific focus on expediting the review of applications for new 
generic animal drugs.
  A key component of both ADUFA and AGDUFA is additional resources for 
FDA to protect the public health. The lack of resources for the FDA has 
been a major focus of the Committee. I intend to address this issue 
more broadly in legislation being drafted with Representatives Barton, 
Deal, Pallone, Shimkus, Stupak, and others, that will significantly 
improve and enhance our food and drug safety system.
  The third and final title makes two technical corrections to public 
law 110-85, the Food and Drug Administration Amendments Act of 2007. 
The first correction addresses an implementation problem related to the 
clinical trials results and registry database, which was expanded in 
that public law. The second correction clarifies that the FDA should 
review and approve generic drug applications separate and apart from 
citizen petitions pertaining to that application.
  I encourage all of my colleagues to join me in support of this bill, 
and I thank the Members of the Committee on Energy and Commerce for 
working together to reach agreement on legislation critical to 
protecting the public health.
  Mr. MARKEY. Mr. Speaker, I rise in strong support of inclusion in 
this legislation of a technical fix to an important provision in the 
Federal Drug Administration Amendments, FDAAA, that I authored with 
Congressman Waxman.
  When the FDAAA was signed into law last September, it included a 
drafting error that had the effect of exempting medical devices from 
the requirement in the FDAAA that adverse events occurring during 
clinical trials must be reported to the registry and results data bank 
created by the bill.
  There is bipartisan agreement that this exemption resulted from a 
clerical error, not a deliberate change of policy. The data bank 
created by the bill is intended to provide patients with comprehensive 
information about clinical trials that are being conducted so they can 
consider enrolling in a trial and also learn about the benefits and 
problems associated with the drugs and medical devices that are being 
tested.
  The drafting error has the effect of only requiring drug companies to 
report medical problems that surface during clinical trials, exempting 
device companies.
  Everyone agrees that it was not the intent of Congress to exempt 
devices from reporting adverse events in their clinical trials. Both 
drug companies and device manufacturers were required to report to the 
database according to the agreement reached by Members on both sides of 
the aisle.
  I am pleased that this legislation fixes this clerical error.
  Mr. DEAL of Georgia. I would yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, again, I want to thank my colleagues on 
both sides of the aisle for their support of this legislation and urge 
that it be adopted.
  I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 6432, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  The title was amended so as to read: ``A bill 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.''.
  A motion to reconsider was laid on the table.

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