[Federal Register Volume 69, Number 9 (Wednesday, January 14, 2004)]
[Notices]
[Page 2146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-812]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Animal Drug User Fee Act of 2003; Interim Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing interim 
procedures relating to the Animal Drug User Fee Act (ADUFA) of 2003, 
which was signed by the President on November 18, 2003. This act amends 
the Federal Food, Drug, and Cosmetic Act, and authorizes FDA to collect 
four types of user fees: Application fees, establishment fees, product 
fees, and sponsor fees. Before FDA can begin collecting these fees, 
enabling appropriations must be enacted. Until further notice, such 
fees should not be submitted to FDA. However, sponsors should continue 
to submit new animal drug applications as in the past until additional 
direction is provided. Certain types of applications submitted on or 
after September 1, 2003, will be subject to fees, but an invoice for 
those fees will not be issued until after enabling appropriations are 
enacted. FDA will publish another Federal Register notice specifying 
fee amounts and procedures for submitting payments.

ADDRESSES: Visit the FDA Web site that provides further information on 
ADUFA at: http://www.fda.gov/oc/adufa.

FOR FURTHER INFORMATION CONTACT: Robert Miller, Center for Veterinary 
Medicine (HFV-10), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 301-827-5436; e-mail: [email protected]. For 
general questions, you may also contact the Center for Veterinary 
Medicine at: mailto:[email protected].

SUPPLEMENTARY INFORMATION: ADUFA authorizes FDA to collect fees for: 
(1) Certain types of animal drug applications and supplemental animal 
drug applications submitted on or after September 1, 2003, (2) certain 
animal drug products, (3) certain establishments where such products 
are manufactured in final dosage form, and (4) certain sponsors of 
animal drug applications or investigational animal drug submissions. 
However, FDA may not begin to collect these fees until enabling 
appropriations are enacted. After the enactment of enabling 
appropriations, FDA will publish a Federal Register notice with 
detailed payment procedures.
    For FY 2004 through FY 2008, ADUFA establishes overall fee revenue 
amounts for application fees, establishment fees, product fees, and 
sponsor fees. Revenue amounts established for years after FY 2004 are 
subject to annual adjustments for inflation and workload. Fees for 
applications, establishments, products, and sponsors are to be 
established each year by FDA so that revenues will approximate the 
levels established in the statute, after those amounts have been first 
adjusted for inflation and workload. FDA will publish a Federal 
Register notice with the FY 2004 fee rates and detailed payment 
instructions.
    In an effort to better ensure broad awareness of interim procedures 
relating to ADUFA, FDA has established a Web site that provides further 
information at http://www.fda.gov/oc/adufa.

    Dated: January 7, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-812 Filed 1-13-04; 8:45 am]
BILLING CODE 4160-01-S