[Federal Register Volume 65, Number 124 (Tuesday, June 27, 2000)]
[Notices]
[Page 39623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16123]


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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 July 28, 2000, 8:30 a.m. 
to 5:30 p.m.
    Location: Parklawn Bldg., conference rooms G and H, 5600 Fishers 
Lane, and CDER Advisory Committee conference room 1066, 5630 Fishers 
Lane, Rockville, MD.
    Contact Person: 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 discuss supplemental new drug 
applications (NDA's) 19-537/S038, 19-847/S024, 19-857/S027, 19-858/
S021, 20-780/S008 for Cipro (ciprofloxacin), Bayer Corp. 
Pharmaceutical Division, for post-exposure prophylaxis of clinical 
disease from inhaled Bacillus anthracis.
    Registration: Persons interested in attending the meeting are 
required to register by July 14, 2000. You may register by submitting 
your name, affiliation, telephone and fax number, and e-mail address to 
Thomas Perez, FAX 301-827-6801, or e-mail: [email protected]. 
Registration confirmation will be sent by e-mail or facsimile on July 
21, 2000.
    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 July 19, 2000. 
Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 19, 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: June 19, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-16123 Filed 6-26-00; 8:45 am]
BILLING CODE 4160-01-F