Pub.L. 108-131 To authorize the Secretary of the Interior to acquire the property in Cecil County, Maryland, known as Garrett Island for inclusion in the Blackwater National Wildlife Refuge. <> ...

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[[Page 117 STAT. 1361]]

Public Law 108-130
108th Congress

                                 An Act


 
To amend the Federal Food, Drug, and Cosmetic Act to establish a program 
 of fees relating to animal drugs. <<NOTE: Nov. 18, 2003 -  [S. 313]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Animal Drug User Fee Act of 
2003.>>  assembled,

SECTION 1. SHORT TITLE. <<NOTE: 21 USC 301 note.>> 

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

SEC. 2. FINDINGS. <<NOTE: 21 USC 379j-11 note.>> 

    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. <<NOTE: 21 USC 379j-11.>> 

    ``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

[[Page 117 STAT. 1362]]

        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

[[Page 117 STAT. 1363]]

                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. <<NOTE: 21 USC 
            379j-12.>> 

    ``(a) Types of Fees.--Beginning in fiscal year 2004, the Secretary 
shall assess and collect fees in accordance with this section as 
follows:

[[Page 117 STAT. 1364]]

            ``(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. <<NOTE: Deadline.>> After such fee is 
        paid for that fiscal year, such fee shall be payable on or 
        before January

[[Page 117 STAT. 1365]]

        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. <<NOTE: Deadline.>> 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). <<NOTE: Deadline.>> 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) 

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