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Animal Drug User Fee Act of 2003

The Act

The Animal Drug User Fee Act of 2003 (ADUFA), amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and authorizes FDA to collect fees for certain applications and establishments, products and sponsors of those applications in support of the review of animal drugs. These additional resources will support FDA's responsibilities under the Act to ensure that new animal drug products are safe and effective for animals as well as human consumers with respect to animals intended for food consumption.

This program is similar to the very successful program for human drugs that have been in place for over ten years. Like the Prescription Drug User Fee Act, and the recently enacted Medical Device User Fee and Modernization Act, this legislation will help FDA expedite and improve its review of applications for new animal drugs so that safe and effective new products will be available more quickly.

Complete Text of the Law

Performance Goals

Background Information

ADUFA Implementation Letter
HTML
PDF

Interim Procedures (Federal Register Jan. 14, 2004) (PDF 34 KB)

Press Release (November 19, 2003)

Statement by Dr. Mark McClellan (November 7, 2003)

CVM ADUFA Web Page

Fees

Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005 (Federal Register Aug. 2, 2004) (PDF 64 KB)

Establishment of Animal Drug User Fee Rates and Payment Procedures for Product, Establishment, and Sponsor Fees for Fiscal Year 2004 (Federal Register April 27, 2004) (PDF 22 KB)

Animal Drug User Fee Rates for Applications for Fiscal Year 2004 and Payment Procedures (Federal Register Feb. 18, 2004) (PDF 49.7 KB)

Forms

User Fee Cover Sheet

Guidance

Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions (PDF 96.5 KB)

What's New:

Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005 (Federal Register Aug. 2, 2004) (PDF 64 KB)

Contacts:

Email general questions to cvmadufa@fda.gov

Other User Fee Information:

Documents in Portable Document Format (PDF) retain their original format. To view or print these documents, you must use the Adobe Acrobat Reader, which is free and available directly from Adobe's Website with full installation instructions.

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