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Anitviral Advisory Committee to consider application for peginterferon alfa-2a + ribavirin for treatment of Hepatitis C

10/11/2002

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Antiviral Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. No registration is required.

Name of Committee: Antiviral Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on November 14, 2002, from 8:30 a.m. to 4 p.m.

Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Avenue, Bethesda, MD.*

Contact Person: 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, e-mail: TurnerT@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12531. Please call the Information Line for up-to-date information on this meeting.

Agenda: The committee will discuss biologics license application (BLA) 125061/0, peginterferon alfa-2a co-packaged with ribavirin, new drug application (NDA) 21-511, Hoffmann-La Roche, Incorporated, proposed as combination therapy for the treatment of chronic hepatitis C.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by November 6, 2002. 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. Those desiring to make formal oral presentations should notify the contact person before November 6, 2002, 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.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

*The hotel is located near the Washington Metro Red Line, Bethesda Station.
For hotel accommodations or directions, you can contact the Holiday Inn directly at (301) 652-2000

Richard Klein
Office of Special Health Issues
Food and Drug Administration