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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Public Meeting April 24, 2007: Animal Drug User Fee Act (ADUFA)

March 13, 2007

CVM will convene a public meeting on the Animal Drug User Fee Act (ADUFA) on April 24, 2007 to seek public comments relative to the program’s overall performance and reauthorization as directed by Congress. The meeting will begin at 9 a.m. at the Food and Drug Administration, 7519 Standish Pl., third floor, rm. A, Rockville, MD.

In the language authorizing the Animal Drug User Fee Act, Congress directed the Secretary of Health and Human Services (the Secretary) to consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor and Pensions of the Senate, appropriate scientific and academic experts, veterinary professionals, representatives of consumer advocacy groups, and the regulated industry in developing recommendations to Congress for the reauthorization of ADUFA and for the goals and plans for meeting the goals associated with the process for review of animal drug applications. As directed by Congress, FDA is holding a public meeting to gather information on what we should consider to include in the reauthorization of ADUFA and hear stakeholder views on this subject.

We are offering the following two general questions for consideration, and we are interested in responses to these questions and any other pertinent information stakeholders would like to share:

  1. What is your assessment of the overall performance of the ADUFA program thus
  2. What suggestions or changes would you make relative to the reauthorization of ADUFA?

We have published a number of reports that may help inform the public about the ADUFA program. Key documents such as ADUFA-related guidance, legislation, performance reports, and financial reports can be found at http://www.fda.gov/cvm/adufa.htm.

In general, the meeting format will include presentations by FDA followed by the Open Public Comment period. Registered speakers for the Open Public Comments will be grouped and invited to speak in the order of their affiliation and time of registration (scientific and academic experts/veterinary professionals, representatives of consumer advocacy groups, and the regulated industry). The FDA presentations are planned from 9:00 a.m. until 10:30 a.m. The Open Public Comment portion of the meeting for registered speakers is planned to begin at 10:30 a.m. We will try to accommodate all persons who wish to make a presentation. The time allotted for presentations may depend on the number of persons who wish to speak. An opportunity for public comments from meeting attendees will commence following the registered presentations, if time permits.

Registration is strongly encouraged due to building security requirements and limited meeting space. The REGISTRATION FORM should be submitted no later than one day in advance of the meeting, or April 23, 2007.

Photo identification is required to clear building security. Public parking is adjacent to the building. Registration requests to make an oral presentation at the meeting must be submitted by April 17, 2007, to Aleta Sindelar, Office of the Director (HFV-3), Center for Veterinary Medicine (CVM), FDA, 7519 Standish Place, Rockville, MD 20855, Telephone number 240-276-9004, FAX: 240-276-9020, e-mail: aleta.sindelar@fda.hhs.gov

Written comments should be submitted to the Division of Dockets Management (HFA-305), identified with the docket number 2007N-0069, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Electronic comments may be submitted to the docket at the following site: http://www.fda.gov/dockets/ecomments. Submit a single copy of electronic comments or two paper copies of any written comments (individuals may submit one paper copy). The docket will remain open for written comments through May 24, 2007, 30 days following the meeting. Comments may be reviewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

If you require special accommodations due to a disability, please contact Aleta Sindelar at least 7 days in advance of the meeting.

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Additional Information

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Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855