[Congressional Record (Bound Edition), Volume 149 (2003), Part 19]
[House]
[Pages 27047-27051]
[From the U.S. Government Publishing Office, www.gpo.gov]




                    ANIMAL DRUG USER FEE ACT OF 2003

  Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the 
Senate bill (S. 313) to amend the Federal Food, Drug, and Cosmetic Act 
to establish a program of fees relating to animal drugs, as amended.
  The Clerk read as follows:

                                 S. 313

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Animal Drug User Fee Act of 
     2003''.

     SEC. 2. FINDINGS.

       Congress finds as follows:
       (1) Prompt approval of safe and effective new animal drugs 
     is critical to the improvement 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 review of new animal drug 
     applications.
       (3) The fees authorized by 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. 3. FEES RELATING TO ANIMAL DRUGS.

       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:

                ``PART 4--FEES RELATING TO ANIMAL DRUGS

     ``SEC. 739. DEFINITIONS.

       ``For purposes of this subchapter:
       ``(1) The term `animal drug application' means an 
     application for approval of any new animal drug submitted 
     under section 512(b)(1). Such term does not include either a 
     new animal drug application submitted under section 512(b)(2) 
     or a supplemental animal drug application.
       ``(2) The term `supplemental animal drug application' 
     means--
       ``(A) a request to the Secretary to approve a change in an 
     animal drug application which has been approved; or
       ``(B) a request to the Secretary to approve a change to an 
     application approved under section 512(c)(2) for which data 
     with respect to safety or effectiveness are required.
       ``(3) The term `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 animal drug application or a 
     supplemental animal drug application has been approved.
       ``(4) The term `animal drug establishment' means a foreign 
     or domestic place of business which is at one general 
     physical location consisting of one or more buildings all of 
     which are within 5 miles of each other, at which one or more 
     animal drug products are manufactured in final dosage form.
       ``(5) The term `investigational animal drug submission' 
     means--
       ``(A) the filing of a claim for an investigational 
     exemption under section 512(j) for a new animal drug intended 
     to be the subject of an animal drug application or a 
     supplemental animal drug application, or
       ``(B) the submission of information for the purpose of 
     enabling the Secretary to evaluate the safety or 
     effectiveness of an animal drug application or supplemental 
     animal drug application in the event of their filing.
       ``(6) The term `animal drug sponsor' means either an 
     applicant named in an animal drug application, except for an 
     approved application for which all subject products have been 
     removed from listing under section 510, or a person who has 
     submitted an investigational animal drug submission that has 
     not been terminated or otherwise rendered inactive by the 
     Secretary.
       ``(7) The term `final dosage form' means, with respect to 
     an animal drug product, a finished dosage form which is 
     approved for administration to an animal without substantial 
     further manufacturing. Such term includes animal drug 
     products intended for mixing in animal feeds.
       ``(8) The term `process for the review of animal drug 
     applications' means the following activities of the Secretary 
     with respect to the review of animal drug applications, 
     supplemental animal drug applications, and investigational 
     animal drug submissions:
       ``(A) The activities necessary for the review of animal 
     drug applications, supplemental animal drug applications, and 
     investigational animal drug submissions.
       ``(B) The issuance of action letters which approve animal 
     drug applications or supplemental animal drug applications or 
     which set forth in detail the specific deficiencies in animal 
     drug applications, supplemental animal drug applications, or 
     investigational animal drug submissions and, where 
     appropriate, the actions necessary to place such 
     applications, supplements or submissions in condition for 
     approval.
       ``(C) The inspection of animal drug establishments and 
     other facilities undertaken as part of the Secretary's review 
     of pending animal drug applications, supplemental animal drug 
     applications, and investigational animal drug submissions.
       ``(D) Monitoring of research conducted in connection with 
     the review of animal drug applications, supplemental animal 
     drug applications, and investigational animal drug 
     submissions.
       ``(E) The development of regulations and policy related to 
     the review of animal drug applications, supplemental animal 
     drug applications, and investigational animal drug 
     submissions.
       ``(F) Development of standards for products subject to 
     review.
       ``(G) Meetings between the agency and the animal drug 
     sponsor.
       ``(H) Review of advertising and labeling prior to approval 
     of an animal drug application or supplemental animal drug 
     application, but not such activities after an animal drug has 
     been approved.
       ``(9) The term `costs of resources allocated for the 
     process for the review of animal drug applications' means the 
     expenses incurred in connection with the process for the 
     review of animal drug applications 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 animal drug applications, supplemental 
     animal drug applications, or investigational animal drug 
     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 section 740 and accounting for 
     resources allocated for the review of animal drug 
     applications, supplemental animal drug applications, and 
     investigational animal drug submissions.
       ``(10) The term `adjustment factor' applicable to a fiscal 
     year refers to the formula set forth in section 735(8) with 
     the base or comparator year being 2003.
       ``(11) The term `affiliate' refers to the definition set 
     forth in section 735(9).

[[Page 27048]]



     ``SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2004, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) Animal drug application and supplement fee.--
       ``(A) In general.--Each person that submits, on or after 
     September 1, 2003, an animal drug application or a 
     supplemental animal drug application shall be subject to a 
     fee as follows:
       ``(i) A fee established in subsection (b) for an animal 
     drug application; and
       ``(ii) A fee established in subsection (b) for a 
     supplemental animal drug application for which safety or 
     effectiveness data are required, in an amount that is equal 
     to 50 percent of the amount of the fee under clause (i).
       ``(B) Payment.--The fee required by subparagraph (A) shall 
     be due upon submission of the animal drug application or 
     supplemental animal drug application.
       ``(C) Exception for previously filed application or 
     supplement.--If an animal drug application or a supplemental 
     animal drug application was submitted by a person that paid 
     the fee for such application or supplement, was accepted for 
     filing, and was not approved or was withdrawn (without a 
     waiver or refund), the submission of an animal drug 
     application or a supplemental animal drug 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 animal drug application or 
     supplemental animal drug application which is refused for 
     filing.
       ``(E) Refund of fee if application withdrawn.--If an animal 
     drug application or a supplemental animal drug application is 
     withdrawn after the application or supplement 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 or supplement after the application or supplement 
     was filed. The Secretary shall have the sole discretion to 
     refund the fee under this paragraph. A determination by the 
     Secretary concerning a refund under this paragraph shall not 
     be reviewable.
       ``(2) Animal drug product fee.--Each person--
       ``(A) who is named as the applicant in an animal drug 
     application or supplemental animal drug application for an 
     animal drug product which has been submitted for listing 
     under section 510, and
       ``(B) who, after September 1, 2003, had pending before the 
     Secretary an animal drug application or supplemental animal 
     drug application;

     shall pay for each such animal drug product the annual fee 
     established in subsection (b). Such fee shall be payable for 
     the fiscal year in which the animal drug product is first 
     submitted for listing under section 510, or is submitted for 
     relisting under section 510 if the 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 animal drug product for a fiscal year in which 
     the fee is payable.
       ``(3) Animal drug establishment fee.--Each person--
       ``(A) who owns or operates, directly or through an 
     affiliate, an animal drug establishment, and
       ``(B) who is named as the applicant in an animal drug 
     application or supplemental animal drug application for an 
     animal drug product which has been submitted for listing 
     under section 510, and
       ``(C) who, after September 1, 2003, had pending before the 
     Secretary an animal drug application or supplemental animal 
     drug application,

     shall be assessed an annual fee established in subsection (b) 
     for each animal drug establishment listed in its approved 
     animal drug application as an establishment that manufactures 
     the animal drug product named in the application. The annual 
     establishment fee shall be assessed in each fiscal year in 
     which the animal drug product named in the application is 
     assessed a fee under paragraph (2) unless the animal drug 
     establishment listed in the application does not engage in 
     the manufacture of the animal drug product during the fiscal 
     year. The fee shall be paid on or before January 31 of each 
     year. The establishment shall be assessed only one fee per 
     fiscal year under this section, provided, however, that where 
     a single establishment manufactures both animal drug products 
     and prescription drug products, as defined in section 735(3), 
     such establishment shall be assessed both the animal drug 
     establishment fee and the prescription drug establishment 
     fee, as set forth in section 736(a)(2), within a single 
     fiscal year.
       ``(4) Animal drug sponsor fee.--Each person--
       ``(A) who meets the definition of an animal drug sponsor 
     within a fiscal year; and
       ``(B) who, after September 1, 2003, had pending before the 
     Secretary an animal drug application, a supplemental animal 
     drug application, or an investigational animal drug 
     submission,

     shall be assessed an annual fee established under subsection 
     (b). The fee shall be paid on or before January 31 of each 
     year. Each animal drug sponsor shall pay only one such fee 
     each fiscal year.
       ``(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 and supplement 
     fees.--The total fee revenues to be collected in animal drug 
     application fees under subsection (a)(1)(A)(i) and 
     supplemental animal drug application fees under subsection 
     (a)(1)(A)(ii) shall be $1,250,000 in fiscal year 2004, 
     $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal 
     years 2006, 2007, and 2008.
       ``(2) Total fee revenues for product fees.--The total fee 
     revenues to be collected in product fees under subsection 
     (a)(2) shall be $1,250,000 in fiscal year 2004, $2,000,000 in 
     fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, 
     and 2008.
       ``(3) Total fee revenues for establishment fees.--The total 
     fee revenues to be collected in establishment fees under 
     subsection (a)(3) shall be $1,250,000 in fiscal year 2004, 
     $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal 
     years 2006, 2007, and 2008.
       ``(4) Total fee revenues for sponsor fees.--The total fee 
     revenues to be collected in sponsor fees under subsection 
     (a)(4) shall be $1,250,000 in fiscal year 2004, $2,000,000 in 
     fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, 
     and 2008.
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--The revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year to 
     reflect the greater of--
       ``(A) the total percentage change that occurred in the 
     Consumer Price Index for all urban consumers (all items; 
     United States city average) for the 12-month period ending 
     June 30 preceding the fiscal year for which fees are being 
     established; or
       ``(B) the total percentage change for the previous fiscal 
     year in basic pay under the General Schedule in accordance 
     with section 5332 of title 5, United States Code, as adjusted 
     by any locality-based comparability payment pursuant to 
     section 5304 of such title for Federal employees stationed in 
     the District of Columbia.

     The adjustment made each fiscal year by this subsection will 
     be added on a compounded basis to the sum of all adjustments 
     made each fiscal year after fiscal year 2004 under this 
     subsection.
       ``(2) Workload adjustment.--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 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 animal drug applications, supplemental animal drug 
     applications for which data with respect to safety or 
     effectiveness are required, manufacturing supplemental animal 
     drug applications, investigational animal drug study 
     submissions, and investigational 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), as adjusted for inflation under paragraph 
     (1).
       ``(3) Final year adjustment.--For fiscal year 2008, 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 animal drug applications for the 
     first 3 months of fiscal year 2009. If the Food and Drug 
     Administration has carryover balances for the process for the 
     review of animal drug applications in excess of 3 months of 
     such operating reserves, then this adjustment will 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 2008.
       ``(4) Annual fee setting.--The Secretary shall establish, 
     60 days before the start of each fiscal year beginning after 
     September 30, 2003, for that fiscal year, animal drug 
     application fees, supplemental animal drug application fees, 
     animal drug sponsor fees, animal drug establishment fees, and 
     animal drug product fees based on the revenue amounts 
     established under subsection (b) and the adjustments provided 
     under this subsection.
       ``(5) 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 animal drug applications.
       ``(d) Fee Waiver or Reduction.--

[[Page 27049]]

       ``(1) In general.--The Secretary shall grant a waiver from 
     or a reduction of 1 or more fees assessed under subsection 
     (a) where the Secretary finds that--
       ``(A) the assessment of the fee would present a significant 
     barrier to innovation because of limited resources available 
     to such person or other circumstances,
       ``(B) the fees to be paid by such person will exceed the 
     anticipated present and future costs incurred by the 
     Secretary in conducting the process for the review of animal 
     drug applications for such person,
       ``(C) the animal drug application or supplemental animal 
     drug application is intended solely to provide for use of the 
     animal drug in--
       ``(i) a Type B medicated feed (as defined in section 
     558.3(b)(3) of title 21, Code of Federal Regulations (or any 
     successor regulation)) intended for use in the manufacture of 
     Type C free-choice medicated feeds, or
       ``(ii) a Type C free-choice medicated feed (as defined in 
     section 558.3(b)(4) of title 21, Code of Federal Regulations 
     (or any successor regulation)),
       ``(D) the animal drug application or supplemental animal 
     drug application is intended solely to provide for a minor 
     use or minor species indication, or
       ``(E) the sponsor involved is a small business submitting 
     its first animal drug application to the Secretary for 
     review.
       ``(2) Use of standard costs.--In making the finding in 
     paragraph (1)(B), the Secretary may use standard costs.
       ``(3) Rules for small businesses.--
       ``(A) Definition.--In paragraph (1)(E), the term `small 
     business' means an entity that has fewer than 500 employees, 
     including employees of affiliates.
       ``(B) Waiver of application fee.--The Secretary shall waive 
     under paragraph (1)(E) the application fee for the first 
     animal drug application that a small business or its 
     affiliate submits to the Secretary for review. After a small 
     business or its affiliate is granted such a waiver, the small 
     business or its affiliate shall pay application fees for all 
     subsequent animal drug applications and supplemental animal 
     drug applications for which safety or effectiveness data are 
     required in the same manner as an entity that does not 
     qualify as a small business.
       ``(C) Certification.--The Secretary shall require any 
     person who applies for a waiver under paragraph (1)(E) to 
     certify their qualification for the waiver. The Secretary 
     shall periodically publish in the Federal Register a list of 
     persons making such certifications.
       ``(e) Effect of Failure To Pay Fees.--An animal drug 
     application or supplemental animal drug application 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 animal drug submission under section 
     739(5)(B) 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 animal drug application, supplemental animal 
     drug application or investigational animal drug submission 
     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 
     2003 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 animal drug applications, supplemental animal 
     drug applications, investigational animal drug submissions, 
     animal drug sponsors, animal drug establishments and 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 animal drug applications.
       ``(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 animal drug applications (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 2003 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 animal drug 
     applications--
       ``(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) $5,000,000 for fiscal year 2004;
       ``(B) $8,000,000 for fiscal year 2005;
       ``(C) $10,000,000 for fiscal year 2006;
       ``(D) $10,000,000 for fiscal year 2007; and
       ``(E) $10,000,000 for fiscal year 2008;

     as adjusted to reflect adjustments in the total fee revenues 
     made under this section and changes in the total amounts 
     collected by animal drug application fees, supplemental 
     animal drug application fees, animal drug sponsor fees, 
     animal drug establishment fees, and animal drug product fees.
       ``(4) Offset.--Any amount of fees collected for a fiscal 
     year under this section that exceeds the amount of fees 
     specified in appropriations Acts for such fiscal year 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 a subsequent fiscal year.
       ``(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 animal drug applications, be reduced to 
     offset the number of officers, employees, and advisory 
     committees so engaged.
       ``(k) Abbreviated New Animal Drug Applications.--The 
     Secretary shall--
       ``(1) to the extent practicable, segregate the review of 
     abbreviated new animal drug applications from the process for 
     the review of animal drug applications, and
       ``(2) adopt other administrative procedures to ensure that 
     review times of abbreviated new animal drug applications do 
     not increase from their current level due to activities under 
     the user fee program.''.

     SEC. 4. ACCOUNTABILITY AND REPORTS.

       (a) Public Accountability.--
       (1) Consultation.--In developing recommendations to 
     Congress for the goals and plans for meeting the goals for 
     the process for the review of animal drug applications for 
     the fiscal years after fiscal year 2008, and for the 
     reauthorization of sections 739 and 740 of the Federal Food, 
     Drug, and Cosmetic Act (as added by section 3), the Secretary 
     of Health and Human Services (referred to in this section as 
     the ``Secretary'') shall consult with the Committee on Energy 
     and Commerce of the House of Representatives, the Committee 
     on Health, Education, Labor, and Pensions of the Senate, 
     appropriate scientific and academic experts, veterinary 
     professionals, representatives of consumer advocacy groups, 
     and the regulated industry.
       (2) Recommendations.--The Secretary shall--
       (A) publish in the Federal Register recommendations under 
     paragraph (1), after negotiations with the regulated 
     industry;
       (B) present the recommendations to the Committees referred 
     to in that paragraph;

[[Page 27050]]

       (C) hold a meeting at which the public may comment on the 
     recommendations; and
       (D) provide for a period of 30 days for the public to 
     provide written comments on the recommendations.
       (b) Performance Reports.--Beginning with fiscal year 2004, 
     not later than 60 days after the end of each fiscal year 
     during which fees are collected under part 4 of subchapter C 
     of chapter VII of the Federal Food, Drug, and Cosmetic Act, 
     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 2(3) of this Act 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.
       (c) Fiscal Report.--Beginning with fiscal year 2004, not 
     later than 120 days after the end of each fiscal year during 
     which fees are collected under the part described in 
     subsection (b), 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.

     SEC. 5. SUNSET.

       The amendments made by section 3 shall not be in effect 
     after October 1, 2008, and section 4 shall not be in effect 
     after 120 days after such date.

  The SPEAKER pro tempore (Mr. Boozman). Pursuant to the rule, the 
gentleman from Michigan (Mr. Upton) and the gentlewoman from California 
(Ms. Eshoo) each will control 20 minutes.
  The Chair recognizes the gentleman from Michigan (Mr. Upton).


                             General Leave

  Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days within which to revise and extend their remarks 
and to insert extraneous material on the Senate bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, as the lead sponsor of the House-passed version of the 
Animal Drug User Fee Act of 2003, it is my pleasure today to manage S. 
313, the Senate version of the same legislation on the floor.
  What we are doing today is taking up the Senate-passed version of the 
Animal Drug User Fee Act and inserting the updated House language from 
H.R. 1260, which was approved by this body by voice last month. We are 
doing so because we determined that it was the best way to expedite the 
final passage of this much-needed legislation giving the FDA the 
authority to begin collecting the user fees this fiscal year needed to 
substantially beef up the new animal drug development and review 
process.
  I would like to take the opportunity again to acknowledge and thank 
the gentlewoman from Colorado (Ms. DeGette), my original cosponsor; the 
gentleman from Louisiana (Mr. Tauzin), our committee chairman; the 
gentleman from Michigan (Mr. Dingell), ranking member; the gentleman 
from Florida (Mr. Bilirakis), Health Subcommittee chairman; and the 
gentleman from Ohio (Mr. Brown), ranking member; and the Members on 
both sides of the aisle who have cosponsored the bill. I am grateful 
too for the hard work of our committee staff, Brent Delmonte, Pat 
Ronan, John Ford, and for the assistance that we have received from the 
FDA and the Animal Health Alliance. And also Jane Williams, my health 
care expert, deserves special merit as well.
  Closely modeled after the very successful Prescription Drug User Fee 
Act of 1992 for human drugs, the Animal Drug User Fee Act is designed 
to give the Food and Drug Administration's Center for Veterinary 
Medicine the right resources and incentives needed to significantly 
improve the animal drug review process. The bill is supported by a 
broad coalition of veterinary and producer groups, including the 
American Veterinary Medical Association and the American Farm Bureau.
  The legislation is sorely needed. Despite a statutory review time of 
180 days, the average new animal drug application review currently 
takes about 1\1/2\ years and sometimes may drag on for even several 
years. This slowdown in review time is jeopardizing the supply of the 
new, safe, and effective animal drugs needed to keep our pets, flocks, 
and herds healthy and to provide American consumers with a safe and 
wholesome food supply.
  Under this proposal, the additional revenues generated from fees paid 
by the pioneer animal drug industry would be dedicated for use in 
expediting the testing and review of new animal drugs in accordance 
with the performance goals that have been mutually agreed upon by the 
FDA and the animal drug industry.
  As FDA Commissioner Mark McClellan has noted, a faster, more 
predictable review process is expected to spur more spending on 
research and development by the industry, promoting animal health by 
increasing the availability and diversity of new, safe, and effective 
products.
  Mr. Speaker, I encourage my colleagues to vote for this much-needed 
bipartisan bill.
  Mr. Speaker, I reserve the balance of my time.
  Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
  I am pleased that we are bringing the Animal Drug User Fee Act to the 
floor today. This is a bipartisan bill that enjoys strong support from 
a number of veterinary and farm organizations, as well as from a 
significant number of Members of Congress.
  The Food and Drug Administration is a seriously underfunded agency. 
This has always been a source of concern to me given the critical 
mission that the FDA has of protecting our food supply, our drug 
supply, and protecting consumers. Over the last few years, Congress has 
taken a number of steps to rectify the funding shortfall. Last year we 
renewed the Prescription Drug User Fee Act for the second time. We also 
passed new legislation, the Medical Device User Fee and Modernization 
Act, which created a user fee program for medical devices that will 
help speed new technology to the patients who need them.
  The Animal Drug User Fee Act is the next in this slate of bills that 
are aimed at boosting FDA's resources. This bill will provide the FDA's 
Center for Veterinary Medicine with an additional $48 million over the 
next 5 years. The money will be directed and solely directed to hiring 
new staff and acquiring the additional resources needed to approve the 
applications for animal drugs in a speedier manner while still 
maintaining FDA's gold standard of safety and efficacy.
  This bill will touch everyone's life in multiple ways, even though 
they may not think so, whether it is through lifesaving medications for 
pets or better, less toxic medications for farm animals. It is in 
everyone's best interest to have an FDA that is equipped to review 
these new drug applications in a safe and in a timely manner.
  I want to thank the gentlewoman from Colorado (Ms. DeGette), who 
cannot be here. She is the one who really should be standing here 
rather than myself, and the gentleman from New York (Mr. Towns) for all 
of their hard work they put in on this bill with the gentleman from 
Michigan (Mr. Upton), its sponsor. It is to their credit that it will 
be law. I also want to thank the gentleman from Michigan (Mr. Dingell), 
our distinguished ranking member, and certainly his staff, John Ford, 
whom over and over and over again does superb work and tireless work in 
this specific case to help bring this bill through the committee and to 
the floor of the House. So to the gentleman from Michigan (Mr. Upton), 
our chairman, I salute him. This is a great day for him on the floor 
because both the E-911 Implementation Act of 2003 and certainly

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this bill, the Animal Drug User Fee Act of 2003, are very important 
ones that push the edges of the envelope out and really help to protect 
consumers and the people of our country. So I salute him.
  Mr. Speaker, I have no further requests for time, and I yield back 
the balance of my time.
  Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume.
  I want to thank the gentlewoman from California (Ms. Eshoo), a very 
able replacement for the gentlewoman from Colorado (Ms. DeGette), who I 
too regret she is not here. This has been a bipartisan effort from get-
go.
  Mr. TAUZIN. Mr. Speaker, I am proud to rise in favor of S. 313, the 
Animal Drug User Fee Act (``ADUFA''), sponsored in the House by my good 
friend from Michigan, Mr. Upton.
  This legislation, modeled after the successful Prescription Drug User 
Fee Act (PDUFA), is designed to decrease the review time of new animal 
drugs at the Center for Veterinary Medicine (CVM) of the Food and Drug 
Administration (FDA). This legislation is essential to the health of 
pets and livestock, as well as food safety. CVM is currently 
experiencing sizable delays in its review of drug applications. These 
delays are problematic for CVM, drug sponsors, pet owners, 
veterinarians, and livestock producers.
  Simply put, the CVM needs an infusion of funds to address review 
shortcomings. The slowdown of the approval process threatens to reduce 
the tools available to livestock and poultry producers to produce 
vibrant stock and to combat animal disease. The slowdown of the 
approval process also threatens the health and well being of family 
pets and zoo animals. Further, delays at CVM have a chilling effect on 
the animal health industry's investment in important research and 
development, threatening the pipeline of new products.
  In conclusion, this is a very modest program, but one that is 
desperately needed. The pace of animal drug reviews has slowed in 
recent years and the FDA needs the proper resources to hire more 
reviewers. Please join me in supporting S. 313, The Animal Drug User 
Fee Act of 2003.
  Mr. GREEN of Texas. Mr. Speaker, I rise today in support of S. 313, 
the Animal Drug User Fee Act. This legislation is modeled after the 
successful Prescription Drug User Fee Act, which ensures that consumers 
have timely access to lifesaving drugs. ADUFA would establish the same 
expedited process to ensure that pets and livestock also have access to 
groundbreaking pharmaceuticals.
  Despite a current requirement that limits the review time of a new 
animal drug application to 180 days, the review process takes an 
average of 1.5 years to complete, with some applications taking several 
years. Eighty-eight percent of original new animal drug applications 
are overdue, the longest day being 717 days.
  Mr. Speaker, we wouldn't stand for that kind of delay for people, and 
I don't think that Man's Best Friend, or the livestock that feeds all 
Americans, should have to either. I support this legislation, and am 
happy to see it on our agenda.
  However, I would point out that this House has not yet acted on 
legislation which would authorize the FDA to require pharmaceuticals 
manufacturers to test their products on children. For too long, doctors 
have been guessing about how best to treat our children. Kids are being 
used as guinea pigs because pharmaceutical companies haven't done the 
testing necessary to ensure that their products are safe and effective 
for kids. Many of us have been fighting for several years to ``codify 
the rule,'' and I am anxious to work on legislation that would do that. 
As important as animals are, nothing is more important than the health 
and safety of our children.
  It is high time for us to put the interests of our children first. I 
urge the leadership of the House of Representatives to take up 
legislation which would ensure that the FDA has the authority it needs 
to require prescription drug manufacturers to test their products for 
children.
  Mr. UPTON. Mr. Speaker, I have no further requests for time, and I 
yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Michigan (Mr. Upton) that the House suspend the rules 
and pass the Senate bill, S. 313, as amended.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the Senate bill, as amended, was 
passed.
  A motion to reconsider was laid on the table.

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