[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 313 Enrolled Bill (ENR)]

        S.313

                       One Hundred Eighth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Tuesday,
           the seventh day of January, two thousand and three


                                 An Act


 
To amend the Federal Food, Drug, and Cosmetic Act to establish a program 
                    of fees relating to animal drugs.

    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).

``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.--
        ``(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;
            (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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.