April 27, 2004
FDA Establishes FY2004 Rates and Payment Procedures for Animal Drug Product, Establishment, and Sponsors Fees
The Food and Drug Administration (FDA) is announcing the rates for product, establishment, and sponsor fees for fiscal year (FY) 2004 and payment procedures for those fees. The Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Animal Drug User Fee Act of 2003, authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. A separate notice was published establishing fee rates and payment procedures for animal drug application fees for FY 2004 on February 18, 2004 (http://www.fda.gov/OHRMS/DOCKETS/98fr/04-3410.pdf).
For FY 2004, the product fee rate is $1,750, the establishment fee rate is $23,950, and the sponsor fee rate is $15,450. FDA will issue invoices for FY 2004 product, establishment and sponsor fees on or about May 1, 2004. Those invoices will be due and payable within 30 days of the date of the invoice. Complete payment instructions will be included with each invoice. FDA will issue additional invoices after October 1, 2004, for any products, establishments and sponsors that become subject to these fees after April 1, 2004, and these invoices will likewise include complete payment instructions.
The animal drug product fee (also referred to as the product fee) must be paid annually by the person named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product submitted for listing under section 510 of the Act (http://www.fda.gov/opacom/laws/fdcact/fdcact5a.htm,) and who had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003.
The animal drug establishment fee (also referred to as the establishment fee) must be paid annually by the person who: (1) owns or operates, directly or through an affiliate, an animal drug establishment; (2) is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product submitted for listing under section 510 of the Act; (3) had an animal drug application or supplemental animal drug application pending at FDA after September 1, 2003; and (4) whose establishment engaged in the manufacture of the animal drug product during the fiscal year. An establishment subject to animal drug establishment fees is assessed only one such fee per fiscal year.
The animal drug sponsor fee (also referred to as the sponsor fee) must be paid annually by each person who: (1) is named as the applicant in an animal drug application, except for an approved application for which all subject products have been removed from listing under section 510 of the Act or has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive; and (2) had an animal drug application, supplemental animal drug application, or investigational animal drug submission pending at FDA after September 1, 2003. An animal drug sponsor is subject to only one such fee each fiscal year.
Additional information about these fees is included in the April 27, 2004, Federal Register (http://www.fda.gov/OHRMS/DOCKETS/98fr/04-9565.htm ), the FDA Home Page at: http://www.fda.gov/oc/adufa/, and from Mr. Robert Miller, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7529 Standish Place, Rockville, MD 20855, 301-827-5436.
The fee rates for FY 2004 are summarized below.
Animal Drug User Fee Category
Fee Rate for FY 2004
Animal Drug Application Fees
Animal Drug Application
Supplemental Animal Drug Application for which Safety or
Effectiveness Data are Required$61,000
$30,500Animal Drug Product Fee $1,750 Animal Drug Establishment Fee $23,950 Animal Drug Sponsor Fee $15,450
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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