[Federal Register Volume 66, Number 160 (Friday, August 17, 2001)]
[Notices]
[Pages 43264-43265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Anti-Infective 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: Anti-Infective 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 September 13, 2001, from 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact: Thomas H. Perez, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-6758, e-mail: [email protected], or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12530. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: The committee will hear presentations on the proposed 
approach for selection of delta in noninferiority (equivalence) 
clinical trials. The impact of this approach on studies of anti-
infective drug products will be considered, with a focus on acute 
exacerbation of chronic bronchitis and hospital-acquired pneumonia.
    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 September 4, 
2001. Oral presentations from the public will be scheduled between 
approximately 2 p.m. and 3 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before September 4, 2001, 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

[[Page 43265]]

an indication of the approximate time requested to make their 
presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 10, 2001.
Bonnie H. Malkin,
Acting Senior Associate Commissioner.
[FR Doc. 01-20801 Filed 8-16-01; 8:45 am]
BILLING CODE 4160-01-S