[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4955 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 4955

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 18, 2002

Mr. Ganske (for himself, Mr. Norwood, Mr. Whitfield, Mr. Pickering, and 
Mr. Bilirakis) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 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 2002''.

SEC. 2. FINDINGS.

    The 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 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:

``PART 3--FEES RELATING TO ANIMAL DRUGS

``SEC. 738. 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 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, and 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 2002.
            ``(11) The term `affiliate' refers to the definition set 
        forth in section 735(9).

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

    ``(a) Types of Fees.--Beginning in fiscal year 2003, 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, 2002, 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.
                    ``(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, 2002, 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;
                    ``(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, 2002, 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, 2002, 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 determined and assessed as follows:
            ``(1) Application and supplement fees.--
                    ``(A) The animal drug application fee under 
                subsection (a)(1)(A)(i) shall be $35,750 in fiscal year 
                2003, $57,150 in fiscal year 2004, and $71,500 in 
                fiscal years 2005, 2006, and 2007.
                    ``(B) The supplemental animal drug application fee 
                under subsection (a)(1)(A)(ii) shall be $17,850 in 
                fiscal year 2003, $28,575 in fiscal year 2004, and 
                $35,700 in fiscal years 2005, 2006, and 2007.
            ``(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 2003, $2,000,000 in 
        fiscal year 2004, and $2,500,000 in fiscal years 2005, 2006, 
        and 2007.
            ``(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 2003, 
        $2,000,000 in fiscal year 2004, and $2,500,000 in fiscal years 
        2005, 2006, and 2007.
            ``(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 2003, $2,000,000 in 
        fiscal year 2004, and $2,500,000 in fiscal years 2005, 2006, 
        and 2007.
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--The fees and total fee 
        revenues established in subsection (b) 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 paragraph (1), the 
        fee revenues shall be further adjusted each fiscal year after 
        fiscal year 2003 to reflect changes in review workload. With 
        respect to such adjustment:
                    ``(A) The 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 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 three 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 three 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 adjustment.--Subject to the amount 
        appropriated for a fiscal year under subsection (g), the 
        Secretary shall, within 60 days after the end of each fiscal 
        year beginning after September 30, 2002, adjust the fees 
        established by the schedule in subsection (b) for the fiscal 
        year in which the adjustment occurs so that the revenues 
collected from each of the categories of fees described in paragraphs 
(1), (2), (3), and (4) of subsection (b) shall be set to be equal to 25 
percent of the total fees appropriated under subsection (g).
            ``(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 one 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) such waiver or reduction is necessary to 
                promote the availability of animal drug products for 
                minor uses or for use in minor species; or
                    ``(D) 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.
    ``(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 (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 
        2002 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 2002 (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 2002 multiplied 
                        by the adjustment factor.
                    ``(B) Compliance with requirement.--The Food and 
                Drug Administration will be considered to have met the 
                requirements of subparagraph (A)(ii) in any fiscal year 
                if--
                            ``(i) the costs funded by appropriations 
                        and allocated for the process for the review of 
                        animal drug applications are not more than 3 
                        percent below the level specified in (B)(i); or
                            ``(ii) the costs funded by appropriations 
                        and allocated for the process for the review of 
                        animal drug applications are more than 3 
                        percent below the level specified in (B)(i), 
                        and fees assessed for a subsequent fiscal year 
                        are decreased by the  amount in excess of 3 
percent by which the costs funded by appropriations and allocated for 
the process for the review of animal drug applications fell below the 
level specified in (B)(i), provided that the costs funded by 
appropriations and allocated for the process for the review of animal 
drug applications are not more than 5 percent below the level specified 
in (B)(i).
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section--
                    ``(A) $5,000,000 for fiscal year 2003;
                    ``(B) $8,000,000 for fiscal year 2004;
                    ``(C) $10,000,000 for fiscal year 2005;
                    ``(D) $10,000,000 for fiscal year 2006; and
                    ``(E) $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.
    ``(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.''.

SEC. 4. ANNUAL REPORTS.

    (a) Performance Report.--Beginning with fiscal year 2003, not later 
than 60 days after the end of each fiscal year during which fees are 
collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act, the Secretary of Health and Human 
Services 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 and the future plans of 
the Food and Drug Administration for meeting the goals.
    (b) Fiscal Report.--Beginning with fiscal year 2003, 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 of 
Health and Human Services 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.
                                 <all>