[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Notices]
[Page 51052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25107]


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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 October 16, 2001, from 
8:30 a.m. to 5 p.m.
    Location: Hilton Washington DC North, The Ballrooms, 620 Perry 
Pkwy., Gaithersburg, 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 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 October 9, 
2001. Oral presentations from the public will be scheduled on October 
16, 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 October 9, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the October 16, 2001, Anti-Infective Drugs Advisory Committee 
meeting. Because the agency believes there is some urgency to bring 
this issue to public discussion and qualified members of the Anti-
Infective 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: October 1, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-25107 Filed 10-2-01; 5:03 pm]
BILLING CODE 4160-01-S