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U.S. Department of Health and Human Services

For Industry

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ADUFA: A Program of Fees

PowerPoint Version

Slide 1

ADUFA: A Program of Fees

Comments by A. Robert Miller
Associate Director, CVM Office Of Management
Rockville, Maryland
April 24, 2007

ADUFA: A Program of Fees Slide 1

Slide 2

ADUFA: A Program of Fees

ADUFA FINANCIAL FEATURES:

  • Revenue collections over a five-year period increasing from $5 million to $10 million
  • Plus - fee adjustment to account for inflation and increased workload based on specific parameters
  • However - If we collect more than we are supposed to, that amount is subtracted in subsequent fiscal year
  • A stable revenue stream through four fee types, each generating the same level of income in a given fiscal year
ADUFA: A Program of Fees Slide 2

Slide 3

ADUFA: A Program of Fees

ADUFA Provides for Collection of Four Fees:

  1. Applications and Supplements
  2. annual fees for Products,
  3. annual fees for Establishments, and
  4. annual fees for Sponsors
ADUFA: A Program of Fees Slide 3

Slide 4

ADUFA: A Program of Fees

ADUFA FINANCIAL IMPLEMENTATION ACCOMPLISHMENTS:

  • E-Govt. initiative to tie the appropriate fee to the application the Sponsor is submitting.
  • Guidance for Industry #170 - Animal Drug User Fees and Fee Waivers and Reductions
  • Guidance for Industry #173- Animal Drug Sponsor Fees
  • Guidance for Industry #183 - Fees Exceed Costs Waiver/Reduction
ADUFA: A Program of Fees Slide 4

Slide 5

ADUFA: A Program of Fees
History ADUFA Collections ($000)

ADUFA: A Program of Fees Slide 5

Slide 6

Financial Reports to Congress for ADUFA

ADUFA: A Program of Fees Slide 6