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Animal Drug User Fee Act of 2003 (ADUFA)

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.

Fees

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

  • The Animal Drug User Fee Cover Sheet - is required for your Animal Drug Application Submission. By completing this cover sheet, you will be assigned a unique Payment Identification Number that distinguishes your fee payment and submission.

Guidance Documents

  • Guidance for Industry #183 -Guidance for Industry- Animal Drug User Fees: Fees Exceed Costs Waiver/Reduction, March 9, 2007 | html | | pdf | | FR Notice |

  • Guidance for Industry #173 - Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA), February 7, 2005 | pdf | | doc | Appendix | pdf | | doc |

  • Guidance for Industry #170 - Animal Drug User Fees and Fee Waivers and Reductions, Final Guidance, March 15, 2004 | pdf | | doc | | html |

Meetings

CVM Updates

Federal Register Notices

  • MEETINGS - Docket No. FDA-2008-N-0082, CVM 20089. Animal Drug User Fee Act; Public Meeting; Request for Comments. Pages 9571-9575 [FR Doc. E8–3267] February 21, 2008 [TXT] [PDF] [PRE-PUB] Meeting on March 11, 2008 Comments due April 14, 2008

  • OC 2007185. Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2008. Pages 42415-42419 [FR Doc. 07-3782 ] August 2, 2007 | htm | | pdf | | Pre-Pub |

  • Docket No. 2007N-0069,CVM 200717.  Animal Drug User Fee Act; Public Meeting.  Pages 11369-11370 [FR Doc. E7-04452] March 13, 2007 | htm | | pdf | | Pre-Pub | Meeting on April 24, 2007 Comments due May 24, 2007

  • Docket No. 2006D-0301 Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs Waiver/Reduction; Availability.  Pages  10767-10768 [FR Doc. E7-04322]  [TXT] [PDF]

  • OC 2006170. Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2007. Pages 43776-43780 [FR Doc. E6-12396] August 2, 2006 | htm | | pdf | | Pre-Pub |

  • Docket No. 2005N-0488, CVM 200615. Animal Drug User Fee Act; Public Meeting; Cancellation. Pages 8860-8861 [FR Doc. 06-1571 ] February 21, 2006 | htm | | pdf | | pre-pub |

  • MEETING CANCELLED - Meetings - Docket No. 2005N-0488, CVM 200587. Animal Drug User Fee Act; Public Meeting. Pages 76851-76852 [FR Doc. E5-07876] December 28, 2005, Meeting on February 24, 2006 Comments on meeting by March 26, 2006

  • CVM 200547.  Establishment of Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2006.  Pages  44101-44104 [FR Doc. 05-15158] August 1, 2005 | htm | | pdf |

  • CVM 2004124.  Guidance for Industry: Animal Drug Sponsor Fees Under the Animal Drug User Fee Act; Availability.  Pages  6696-6697 February 8, 2005  [FR Doc. 05-02417] | htm | | pdf | Comments by February 8, 2006

  • 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  | htm | | pdf |

  • OC 2004100.  Establishment of Animal Drug User Fee Rates and Payment Procedures for Product, Establishment, and Sponsor Fees for Fiscal Year 2004.  Pages  22846-22849 [FR Doc. 04-09565]  April 27, 2004 | htm | | 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 |

  • CVM 2003137.  Animal Drug User Fee Act of 2003; Interim Procedures.  Page  2146
    [FR Doc. 04-00812] | htm | | pdf |

The Law

FDA News Releases

ADUFA Implementation Letter

  • Important Information: Passage of the Animal Drug User Fee Act of 2003 | pdf | | htm |

Performance Goals

  • Animal Drug User Fee Act Performance Goals and Procedures | pdf | | htm |

Reports

  • FY 2006 ADUFA Financial Report required by the Animal Drug User Fee Act of 2003 | htm | | pdf |

  • FY 2006 Performance Report to the Congress for the Animal Drug User Fee Act  | htm | | pdf |

  • FY 2005 ADUFA Financial Report required by the Animal Drug User Fee Act of 2003 | htm | | pdf |

  • FY 2005 Performance Report to the Congress for the Animal Drug User Fee Act | htm | | pdf |

  • FY 2004 ADUFA Financial Report required by the Animal Drug User Fee Act of 2003 | htm | | pdf |

  • FY 2004 Performance Report to the Congress for the Animal Drug User Fee Act | pdf | | doc

Presidential Signing Statement

  • Statement on Signing the Animal Drug User Fee Act of 2003 - November 18, 2003 | pdf |

Other User Fee Info:

Contact Information:

For general questions regarding ADUFA, please send your inquiries to cvmadufa@fda.gov


Web Page Updated by hd - April 28, 2008, 10:50 AM ET




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