[Federal Register: July 25, 2002 (Volume 67, Number 143)]
[&thnsp;Notices]
[Page 48664-48665]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy02-76]
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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.
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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
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.
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. 02–18772 Filed 7–24–02; 8:45 am]
BILLING CODE 4160–01–S