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U.S. Department of Health and Human Services

For Consumers

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Advisory Committee Meeting Notice - development of topical microbicides to reduce HIV transmission

6/12/2003

The Food and Drug Administration (FDA) will hold a meeting of its Antiviral Drugs Advisory Committee on on August 20, 2003, from 8 a.m. to 5 p.m. at the Holiday Inn, Versailles Ballroom, 8120 Wisconsin Avenue, Bethesda, MD, 20814.

The committee will discuss clinical trial design issues in the development of topical microbicides for the reduction of HIV transmission.

The meeting will be open to the public. No registration is necessary. If you need directions or accommodations, please contact the hotel directly at 301.652.2000

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to Tara P. Turner, Pharm.D (see contact information below) by August 13, 2003. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited depending on number of speakers.

Those desiring to make formal oral presentations should notify the contact person before August 13, 2003, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Tara Turner at least 7 days in advance of the meeting.

Contact Information: Tara P. Turner, Pharm.D., Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 301-827-7001, FAX 301.827.6776, e-mail: TurnerT@cder.fda.gov

Please call the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and enter code 12531 for up-to-date information about this meeting.

Richard Klein
Office of Special Health Issues
Food and Drug Administration