[Federal Register: October 18, 2002 (Volume 67, Number 202)]
[Page 64399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.
    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 Ave., 
Bethesda, MD.
    Contact Person: Tara P. Turner, 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 
125061/0, peginterferon alfa-2a copackaged with ribavirin, new drug 
application 21-511, Hoffmann-La Roche, Inc., 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 (see 
Contact Person) 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).

    Dated: October 10, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-26615 Filed 10-17-02; 8:45 am]