[Federal Register Volume 66, Number 164 (Thursday, August 23, 2001)]
[Notices]
[Page 44356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21284]


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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 12, 2001, from 
8:30 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 at [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 consider the safety and efficacy of 
Activated Protein C (human, recombinant, human kidney cells, new 
biologic license application (BLA) 125029), Eli Lilly & Co. for the 
treatment of severe sepsis.
    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 on September 
12, 2001, 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 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 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 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-21284 Filed 8-22-01; 8:45 am]
BILLING CODE 4160-01-S