[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Page 8716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4027]


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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 regulatory issues.
    Date and Time: The meeting will be held on March 24, 2000, 8:30 
a.m. to 5:30 p.m.
    Location: Marriott Washingtonian Center, Grand Ballroom, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: Kimberly L. Topper, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001 or [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 discuss new drug applications (NDA) 21-
130, ZyvoxL (linezolid) tablets, NDA 21-131 ZyvoxL for injection 
(linezolid injection), and NDA 21-132 ZyvoxL Oral Suspension (linezolid 
oral suspension), Pharmacia & Upjohn Co., for treatment of community-
acquired pneumonia, hospital-acquired pneumonia, complicated and 
uncomplicated skin and skin structure infections, and Vancomycin-
resistant Enterococcus faecalis and faecium infections, including cases 
with concurrent bacteremia.
    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 March 3, 2000. 
Oral presentations from the public will be scheduled 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 March 3, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 14, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-4027 Filed 2-18-00; 8:45 am]
BILLING CODE 4160-01-F