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Table of Contents The Law |
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Animal Drug User Fee Act of 2003 (ADUFA)
The Animal Drug User Fee Act of 2003 (ADUFA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and authorizes FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs. These additional resources will support FDA’s responsibilities under the FFDCA to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption. This program is similar to the very successful program for human drugs that has 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. FDA is working to prepare for the implementation of the user fee program. A significant part of the preparations include determining the fee levels for fiscal year 2004. That work is underway. The ADUFA provides for four fees: 1) a sponsor fee, 2) an establishment fee, 3) a product fee and 4) an application fee. The bill also provides for specific waivers and exemptions from fees. FDA is working to prepare guidance for the industry regarding the fees, billings and submission of fees, as well as waivers and exemptions. The total amount of money that would be collected if the bills are enacted would be $5 million in fiscal year 2004, $8 million in fiscal year 2005, and $10 million in each fiscal year 2006 through 2008. About 25% of the total amount to be collected will be received through each fee type. So, in fiscal year 2004, we expect to receive $1, 250,000 from sponsor fees and the same amount from establishment fees, product fees and application fees. Accordingly, the fees that will be assessed will be substantially lower than those collected through the Prescription Drug User Fee Act. The animal health industry is a $4 billion industry. The user fees will be used to achieve shorter, more predictable review times by increasing the review staff at CVM and building better management systems. As a result, we anticipate substantial savings to the industry in regulatory review and developmental expenses. The Agency animal drug pre-market review program strives to provide an adequate supply of safe and effective drugs to meet the therapeutic and production needs of animal owners. By doing so. the public health is protected by providing safe and effective animal drugs with labeled directions for safe use. FDA is committed to making this operation as effective as possible. With the advent of user fees, FDA is looking forward to a new opportunity to make substantial improvements in the animal drug review processes. CVM Update - FDA Announces FY 2005 Animal Drug User Fee Rates, August 2, 2004 CVM UPDATE - FDA Announces Animal Drug User Fee Rates for FY04, February 18, 2004 Federal Register Notice - CVM 20049. Establishment of Animal Drug User Fee Rates for Applications for Fiscal Year 2004 and Payment Procedures. Pages 7646-7649 February 18, 2004 [FR Doc. 04-03410] | htm | | pdf | Forms Guidance Documents Guidance for Industry #170 - Animal Drug User Fees and Fee Waivers and Reductions, Final Guidance, March 15, 2004 | pdf | | doc | Draft Guidance Available on Sponsor Fees Under ADUFA, September 28, 2004 FDA Announces FY 2005 Animal Drug User Fee Rates, August 2, 2004 FDA Announces Animal Drug User Fee Rates for FY04, February 18, 2004 CVM 200450. Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act; Availability. Pages 57941-57942 [FR Doc. 04-21677] | htm | | pdf | Comments due October 28, 2004 CVM 200461. Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2005. Pages 46147-46151 [FR Doc. 04-17441] August 2, 2004 [TXT] [PDF] CVM 20049. Establishment of Animal Drug User Fee Rates
for Applications for Fiscal Year 2004 and Payment Procedures.
Pages 7646-7649 February 18, 2004 [FR Doc. 04-03410] |htm| |pdf
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Presidential Signing Statement
For general questions regarding ADUFA, please
send your inquiries to cvmadufa@fda.gov
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