[Congressional Record (Bound Edition), Volume 149 (2003), Part 17]
[House]
[Pages 23825-23830]
[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 bill 
(H.R. 1260) to amend the Federal Food, Drug, and Cosmetic Act to 
establish a program of fees relating to animal drugs.
  The Clerk read as follows:

                               H.R. 1260

       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 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. 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 23826]]



     ``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 subparagraph (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 subparagraph 
     (c)(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 23827]]

       ``(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, 
     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 23828]]

       (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 (a), 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. Pursuant to the rule, the gentleman from 
Michigan (Mr. Upton) and the gentleman from Ohio (Mr. Brown) each will 
control 20 minutes.
  The Chair recognizes the gentleman from Michigan (Mr. Upton).
  Mr. UPTON. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, as the lead sponsor of the Animal Drug User Fee Act of 
2003, I am very pleased that we are taking up this bill on the House 
floor today. 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 FDA's Center for Veterinary Medicine the 
resources and incentives needed to significantly improve the animal 
drug review process.
  This bill was unanimously approved by the Committee on Energy and 
Commerce and is supported by a broad coalition of veterinary and 
producer groups, including the American Veterinary Medical Association 
and the American Farm Bureau, to name just two of the coalition 
members.
  We would not be here on the floor today were it not for the strong 
bipartisan support that this legislation received in our committee. I 
would like to especially acknowledge my original cosponsor and author 
of the bill, the gentlewoman from Colorado (Ms. DeGette), committee 
chairman and ranking member, the gentleman from Louisiana (Mr. Tauzin) 
and the gentleman from Michigan (Mr. Dingell), our Subcommittee on 
Health Chair, the gentleman from Florida (Mr. Bilirakis), and the 
ranking member, the gentleman from Ohio (Mr. Brown), who is here today, 
as well as the Members on both sides of the aisle who have cosponsored 
this legislation.
  I am grateful, too, for the hard work of our committee staff, Brent 
Delmonte, Patrick Ronan, and John Ford and for the assistance we have 
received from the FDA and the Animal Health Alliance, particularly my 
staff, Jane Williams.
  This legislation is sorely needed. Despite a statutory review time of 
180 days, the average new animal drug application review currently 
takes about a year and a half and it may drag on for even longer. The 
slowdown in review time is jeopardizing the supply of new, safe and 
effective animal drugs needed to keep our pets, flocks and herds 
healthy and help provide American consumers with a safe and wholesome 
food supply.
  Under this proposal, H.R. 1260, 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.
  I encourage my colleagues to vote for this much-needed bipartisan 
bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may 
consume.
  I rise in support of the Animal Drug User Fee Act. I thank the 
gentleman from Michigan (Mr. Upton), also the gentleman from Florida 
(Mr. Bilirakis), the gentleman from Louisiana (Mr. Tauzin), and the 
gentleman from Michigan (Mr. Dingell) for their excellent work on this 
bill, especially the work that the gentlewoman from Colorado (Ms. 
DeGette) did as the author of this legislation.
  H.R. 1260, Mr. Speaker, builds on a successful program for fee-funded 
expedited review of new human drug applications authorized in 1992 by 
something called the Prescription Drug User Fee Act, known as PDUFA, 
the congressional acronym that we are wont to do around here.

                              {time}  1200

  We also reauthorized PDUFA some years ago. Congress has done a 
generally good job in speeding the approval process through the 
Prescription Drug User Fee Act. We have done not quite as good a job on 
expediting the approval of generic drugs, something that we need to 
work with the FDA to accelerate. It takes oftentimes as long as 18 
months for a generic drug, something that costs consumers money by the 
slowness of the approval process.
  I think this legislation on animal drugs is almost as important as 
those other two in terms of what it does with pets, what it does with 
zoos, and especially what it does with cattle and poultry. We have 
found, Mr. Speaker, in terms of an issue of antibiotic resistance where 
we have drugs that are on the market to cure animals, and sometimes 
those drugs have lost their effectiveness, as they have in the human 
population, and it is important that this legislation, H.R. 1260, the 
gentleman from Michigan's (Mr. Upton) bill, get through Congress 
because it does, in fact, help to put more drugs on the market, more 
antibiotics in some indications to deal with the problems of antibiotic 
resistance.
  We have had debates on the House floor that the gentleman from 
Florida (Mr. Bilirakis) has been part of on this whole issue of 
antibiotic resistance. We have seen the use of nontherapeutic drugs 
given for prophylactic purposes to cattle and poultry, given for growth 
treatments for cattle and poultry where there has been some residue 
from those drugs in the human population that have caused problems with 
antibiotic resistance, both in the animals and, after human 
consumption, in human beings. And it is especially important in light 
of the fact that we really have not fixed that problem. We still use 
far too many drugs for nontherapeutic purposes for cattle and poultry. 
It is important that this legislation passes because I think H.R. 1260 
will help us deal with that.
  I again ask for support for this legislation. It matters for our 
pets. It matters for zoos. It matters for production of cattle and 
poultry, and it ultimately matters in human health. I ask my colleagues 
to support H.R. 1260.
  Mr. Speaker, I reserve the balance of my time.
  Mr. UPTON. Mr. Speaker, I yield 3 minutes to the gentleman from 
Florida (Mr. Stearns), my friend and an important supporter of this 
legislation, a member of the Committee on Energy and Commerce.
  Mr. STEARNS. Mr. Speaker, I thank my distinguished colleague, who is

[[Page 23829]]

chairman of the Telecommunications and the Internet Subcommittee and 
has been very active in this, for yielding me this time.
  I obviously rise in support of H.R. 1260, the Animal Drug User Fee 
Act. By funding more FDA drug reviewers, Mr. Speaker, this act will 
help accelerate approval of important veterinarian drugs, resulting in 
the comfort and treatment of countless companions, pets, zoo animals 
and livestock.
  This is very important. I am proud of the major veterinary school in 
my congressional district. The College of Veterinary Medicine in the 
University of Florida, Florida's only veterinary college, offers 
comprehensive service to the public through a fourfold mission: 
teaching, research, extension to the community, and patient care. And I 
am proud, Mr. Speaker, to be wearing a University of Florida tie in 
honor of their efforts and their leadership this morning. In fact, at 
this school, no creature is too small, too large, too pesky, or too 
dangerous for these fine veterinarians to treat, such as the endangered 
Florida panthers or even some exotic tropical birds. They have a 
Performance Animal Physiology Clinic, a Pharmacology and Disease 
Division, which, in fact, studies humane treatment of equine and 
greyhound species, athletes among pets. All of these animals, all of 
them, will benefit from innovative pharmaceuticals that are brought to 
the market in a more expedited manner.
  In addition, one of the Nation's foremost thoroughbred horse 
industries is located in my hometown of Ocala, Florida. We are actually 
known as the horse capital of the world. We have 460 horse farms 
located in Ocala and in Marion County. The Florida Thoroughbred 
Breeders' and Owners' Association, Florida Thoroughbred Charities, and 
other equine-related concerns all serve a tremendously important part 
of our economy and this Nation's entertainment.
  Do they demand the best medicines available in the world, available 
as quickly as possible for their pets and their assets? Absolutely. 
This bill will help, and that is why I am pleased to support this, and 
I thank the gentleman from Michigan (Mr. Upton) for his very energetic 
work on behalf of this, and, of course, for my vet school and horse-
owning friends in Florida's 6th Congressional District.
  Mr. BROWN of Ohio. Mr. Speaker, I yield 4 minutes to the gentlewoman 
from Colorado (Ms. DeGette), author of the bill.
  Ms. DeGETTE. Mr. Speaker, I would like to add my thanks to the 
gentleman from Michigan (Mr. Upton) for taking the lead on this 
important piece of legislation and also for his diligence in making 
sure that it was brought to the floor today and the leadership on both 
sides of the aisle of the House subcommittee of the Committee on Energy 
and Commerce. It is always a pleasure to write and pass a bill with 
full bipartisan support.
  The bill will improve the public's health, the efficiency of FDA's 
drug approval process, and perhaps most importantly to some, the health 
of the family pet and of our livestock in this country. In our society, 
pets have become even more important to Americans, and just like with 
humans, pharmaceuticals have helped improve the quality of our pets 
lives. My sister has a 16-year-old dog that is on insulin and several 
antiinflammatory drugs for arthritis just like senior citizens in this 
country, and her pet's health has been helped by these drugs, and 
thereby her family's situation has been improved, and they are happy to 
have their pet.
  Unfortunately, up until now, drugs have not been able to be approved 
with speed like they are for humans, and the Animal Drug User Fee Act 
is closely modeled after the Prescription Drug User Fee Act, which was 
enacted 10 years ago. The purpose of this legislation is twofold: to 
increase resources available to the FDA so that it may speed up the 
approval process for pharmaceuticals, and also to maintain monitoring 
of the safety and efficacy of all pharmaceuticals. Decreasing delays of 
the approval process is a necessary step to keeping up with medical 
innovation, and this applies to drug for animals as well as for humans. 
The monitoring is an essential function that safeguards the public's 
health.
  Ensuring the safety and efficacy of pharmaceuticals is of paramount 
importance. I am well aware of some of the issues with PDUFA, some of 
which were discussed by the gentleman from Ohio (Mr. Brown), but I feel 
strongly that we must increase the FDA's work capacity. This bill has 
been carefully crafted on both sides of the aisle to avoid the problems 
of the past, and as my colleagues have heard, it was unanimously passed 
by the Committee on Energy and Commerce.
  This bill, ADUFA, requires the Center for Veterinary Medicine at the 
FDA to meet performance standards in exchange for a 5-year infusion of 
funds.
  By collecting fees from animal drug manufacturers, the FDA will be 
able to decrease the review time of new drug applications. These 
delays, which have been considerable in the past, prevent 
pharmaceuticals from entering the market. I am very pleased that the 
FDA has also worked very closely with us on the bill and is willing to 
implement the new program.
  Increasing access to animal drugs not only helps lengthen and improve 
the lives of the family pet, but it will also, and perhaps more 
importantly, have a wide-ranging impact on our Nation's food supply and 
will improve prevention of food-borne disease epidemics. For example, 
for more than 40 years, antibiotics have played a critical role in 
keeping our Nation's food animals healthy. Without such treatments, 
illness would be transmitted to humans, and the livestock market would 
be more susceptible to devastation. Therefore, we must continue to 
develop new treatments and quickly bring them to market, but we cannot 
do that without the speedy approval of the FDA.
  I am particularly concerned about the food and medicine supply of 
this country. This commitment to safety that we are showing today 
through this legislation starts with the FDA's examination and approval 
of new pharmaceuticals and continues as these legal drugs are 
manufactured and distributed throughout the Nation. Commitment to 
safety must always be a part of the system.
  The benefits of this bill are substantial, and, therefore, I am very 
pleased to cosponsor the bill. Vote yes on H.R. 1260, the Animal Drug 
User Fee Act.
  Mr. GOODLATTE. Mr. Speaker, animal medicines are used to assist 
livestock producers raising and maintaining healthy, high quality stock 
and ultimately, in delivering safe and wholesome food to American 
dinner tables. They are also used to keep pets healthy, which 
contributes to the quality of life for millions of companion animal 
owners.
  The Food and Drug Administration's Center for Veterinary Medicine 
(CVM) is currently experiencing unprecedented delays in its review of 
new product submissions. The delays are severe and problematic for the 
submission sponsors, for CVM, and for veterinarians, livestock and 
poultry producers, and pet owners in need of new and innovative 
products to combat animal disease--at a time when animal disease around 
the world is capturing headlines. The deadlock at the Center also has a 
chilling effect on the animal health industry's investment in important 
research and development, threatening the pipeline of products that 
will be important to livestock and poultry producers in managing their 
production in the future. The lack of these tools imperils not only 
animal health but also has implications for the food supply and food 
safety.
  In 1966 Congress, with industry support, enacted the Animal Drug 
Availability Act to streamline drug review and approval procedures. 
Contrary to Congressional intent and despite additional resources, it 
is now more difficult than ever to get new products approved. 
Unfortunately, this situation is detrimental to veterinarians, to 
livestock and poultry producers, to food producers and to the public. 
As a result, it is important for Congress and the Administration to 
take action to ensure that the CVM can better manage its resources and 
personnel and make institutional changes to fulfill its mandated 
mission and responsibilities.
  Modeled after the successful Prescription Drug User Fee Act, the 
Animal Drug User Fee Act will increase efficiencies in review times for 
new animal pharmaceuticals by providing CVM with additional resources 
to allow for improved communication between FDA and product sponsors 
and more expeditious FDA actions on applications.

[[Page 23830]]

  Mr. Speaker, I congratulate Congressman Upton for his leadership and 
that of the full Committee on Energy and Commerce for bringing this 
important legislation to the floor today and urge all Members to 
support it.
  Mr. BROWN of Ohio. Mr. Speaker, I yield back the balance of my time.
  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 bill, H.R. 1260.
  The question was taken; and (two-thirds having voted in favor 
thereof) the rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

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