[Federal Register Volume 65, Number 124 (Tuesday, June 27, 2000)]
[Notices]
[Pages 39623-39624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16196]


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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.

[[Page 39624]]


ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed 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 July 25, 2000, 8:30 a.m. 
to 5 p.m. and on July 26, 2000, 8:30 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Nancy Chamberlin or Beverly O'Neil, 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, or by e-mail: 
[email protected], 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 July 25, 2000, the committee will discuss scientific 
data characterizing relationships of pharmacokinetic parameters and 
virologic response to approved antiretroviral drugs used in the 
treatment of human immunodeficiency virus (HIV) infection. The primary 
objectives for the committee deliberations are to explore the use of 
pharmacokinetic data to improve the evaluation of new formulations, 
alternative dosing regimens, and choice of dosing in the setting of 
drug-drug interactions for approved antiretroviral drugs. Additionally, 
other issues to be discussed include: the relationship between 
pharmacokinetic parameters and drug toxicity, and safety requirements 
and pediatric considerations for alternative dosing regimens.
    Procedure: On July 25, 2000, from 8:30 a.m. to 5 p.m., the meeting 
is open to the public. 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 11, 2000. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 2 p.m. on July 25, 2000. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before July 11, 
2000, 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.
    Closed Committee Deliberations: On July 26, 2000, from 8:30 a.m. to 
5 p.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
Pending investigational new drug applications and drug development 
plans will be presented, and recent action on selected new drug 
applications will be discussed. This portion of the meeting will be 
closed to permit discussion of this information.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 19, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-16196 Filed 6-26-00; 8:45 am]
BILLING CODE 4160-01-F