[Federal Register Volume 63, Number 122 (Thursday, June 25, 1998)]
[Notices]
[Page 34655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16934]


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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 29, 30, and 31, 
1998, 8 a.m. to 5 p.m.
    Location: Gaithersburg Hilton, Grand Ballroom, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Ermona B. McGoodwin, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, 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 documents on ``Guidance to 
Industry'' being developed by the Office of Drug Evaluation IV's 
Division of Anti-Infective Drug Products and the Division of Special 
Pathogens and Immunologic Drug Products. Copies of these draft guidance 
documents can be obtained from the Center for Drug Evaluation and 
Research (HFD-210), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4573, or requested by FAX at 301-827-4577. 
Electronic versions of these guidance documents will be available via 
Internet using the World Wide Web (www). To access the documents on the 
www, connect to CDER Home Page at http://www.fda.gov/cder/guidance.htm.
    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 22, 1998. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 1:30 p.m. on July 29, 30, and 31, 1998. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before July 
22, 1998, 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 18, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-16934 Filed 6-24-98; 8:45 am]
BILLING CODE 4160-01-F