[Federal Register: July 25, 2002 (Volume 67, Number 143)]
[Page 48664-48665]
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 August 6 and 7, 2002, 
from 8 a.m. to 5 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: On August 6, 2002, the committee will discuss new drug 
application (NDA) 21–449, adefovir dipivoxil tablets, Gilead 
Sciences, Inc., proposed for treatment of chronic hepatitis B infection 
(HBV). On August 7, 2002, the committee will discuss clinical trial 
design issues in the development of products for the treatment of 
chronic hepatitis B infection.
    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 July 30, 2002. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. each day. Time allotted

[[Page 48665]]

for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before July 30, 
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 
    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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the August 6 and 7, 2002, Antiviral Drugs Advisory Committee 
meeting. Because the agency believes there is some urgency to bring 
these issues to public discussion and qualified members of the 
Antiviral Drugs Advisory Committee were available at this time, the 
Commissioner of Food and Drugs concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 18, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 0218772 Filed 7–24–02; 8:45 am]