|
|
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)
|
|
|
|
|
|