[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 313 Reported in Senate (RS)]






                                                       Calendar No. 104
108th CONGRESS
  1st Session
                                 S. 313

                          [Report No. 108-51]

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 5, 2003

 Mr. Ensign (for himself, Mr. Harkin, Mr. Gregg, Mr. Kennedy, and Mr. 
Lugar) introduced the following bill; which was read twice and referred 
       to the Committee on Health, Education, Labor, and Pensions

                              May 21, 2003

                 Reported by Mr. Gregg, with amendments
  [Omit the part struck through and insert the part printed in italic]

_______________________________________________________________________

                                 A BILL


 
   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 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 3 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:

       <DELETED>``PART 3--FEES RELATING TO ANIMAL DRUGS</DELETED>

                ``PART 4--FEES RELATING TO ANIMAL DRUGS

<DELETED>``SEC. 738. DEFINITIONS.</DELETED>

<DELETED>    ``For purposes of this subchapter:</DELETED>

``SEC. 739. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

    (a) 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 739 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).

<DELETED>``SEC. 739. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 
              FEES.</DELETED>

    ``<DELETED>(a)</DELETED> (b) 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 
                        <DELETED>(b)</DELETED> (c) for an animal drug 
                        application; and
                            ``(ii) A fee established in subsection 
                        <DELETED>(b)</DELETED> (c) 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 <DELETED>(b)</DELETED> (c). 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 
        <DELETED>(b)</DELETED> (c) 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 
        <DELETED>(b)</DELETED> (c). 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.
    ``<DELETED>(b)</DELETED> (c) Fee Amounts.--Except as provided in 
subsection <DELETED>(a)(1)</DELETED> (b)(1) and subsections 
<DELETED>(c), (d), (f), and (g),</DELETED> (d), (e), (g), and (h), the 
fees required under subsection <DELETED>(a)</DELETED> (b) 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 <DELETED>(a)(1)(A)(i)</DELETED> 
        (b)(1)(A)(i) and supplemental animal drug application fees 
        under subsection <DELETED>(a)(1)(A)(ii)</DELETED> (b)(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 and 2007.
            ``(2) Total fee revenues for product fees.--The total fee 
        revenues to be collected in product fees under subsection 
        <DELETED>(a)(2)</DELETED> (b)(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 and 2007.
            ``(3) Total fee revenues for establishment fees.--The total 
        fee revenues to be collected in establishment fees under 
        subsection <DELETED>(a)(3)</DELETED> (b)(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 and 2007.
            ``(4) Total fee revenues for sponsor fees.--The total fee 
        revenues to be collected in sponsor fees under subsection 
        <DELETED>(a)(4)</DELETED> (b)(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 and 2007.
    ``<DELETED>(c)</DELETED> (d) Adjustments.--
            ``(1) Inflation adjustment.--The fees and total fee 
        revenues established in subsection <DELETED>(b)</DELETED> (c) 
        shall be adjusted by the Secretary by notice, published in the 
        Federal Register, for a fiscal year according to the formula 
        set forth in section 736(c)(1).
            ``(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 <DELETED>(b),</DELETED> 
                (c), as adjusted for inflation under subparagraph 
                <DELETED>(c)(1)</DELETED> (d)(1).
            ``(3) Final year adjustment.--For fiscal year 2007, 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 2008. 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 2007.
            ``(4) Annual fee setting.--The Secretary shall establish, 
        60 days before the start of each fiscal year that begins 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 <DELETED>(b)</DELETED> (c) 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.
    ``<DELETED>(d)</DELETED> (e) 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 
        <DELETED>(a)</DELETED> (b) 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)(D), 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)(D) 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)(D) to certify their qualification for the waiver. 
                The Secretary shall periodically publish in the Federal 
                Register a list of persons making such certifications.
    ``<DELETED>(e)</DELETED> (f) Effect of Failure To Pay Fees.--An 
animal drug application or supplemental animal drug application 
submitted by a person subject to fees under subsection <DELETED>(a)</DELETED> 
(b) 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 738(5)(B) that is 
submitted by a person subject to fees under subsection <DELETED>(a)</DELETED> 
(b) 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.
    ``<DELETED>(f)</DELETED> (g) 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 <DELETED>(a)</DELETED> (b) 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.
    ``<DELETED>(g)</DELETED> (h) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection 
        <DELETED>(a)</DELETED> (b) 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; and
                    ``(D) $10,000,000 for fiscal year 2007;
        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.
    ``<DELETED>(h)</DELETED> (i) Collection of Unpaid Fees.--In any 
case where the Secretary does not receive payment of a fee assessed 
under subsection <DELETED>(a)</DELETED> (b) 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.
    ``<DELETED>(i)</DELETED> (j) Written Requests for Waivers, 
Reductions, and Refunds.--To qualify for consideration for a waiver or 
reduction under subsection <DELETED>(d),</DELETED> (e), or for a refund 
of any fee collected in accordance with subsection <DELETED>(a),</DELETED> 
(b), 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.
    ``<DELETED>(j)</DELETED> (k) 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.
    ``<DELETED>(k)</DELETED> (l) Administrative Procedure.--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 2007, and for the 
        reauthorization of section 738 and 739 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 3 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, 2007 and section 4 shall not be in effect after 120 days 
after such date.




                                                       Calendar No. 104

108th CONGRESS

  1st Session

                                 S. 313

                          [Report No. 108-51]

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                                 A BILL

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

_______________________________________________________________________

                              May 21, 2003

                        Reported with amendments