[Federal Register Volume 64, Number 193 (Wednesday, October 6, 1999)]
[Notices]
[Page 54335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25970]


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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 20 and 21, 1999, 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Ave., 
Silver Spring, MD.
    Contact: Rhonda W. Stover, 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: On the morning of October 20, 1999, the committee will 
discuss the development of antimicrobial drugs for the treatment of 
catheter-related bloodstream infections.
    On the afternoon of October 20, 1999, the committee will discuss 
new drug applications (NDA's) 20-634 and 20-635, levofloxacin 
(LevaquinTM, The R.W. Johnson Pharmaceutical Research 
Institute) for the treatment of community-acquired pneumonia due to 
penicillin-resistant Streptococcal pneumoniae.
    On October 21, 1999, the committee will discuss NDA 21-085, 
moxifloxacin (AveloxTM, Bayer Corp. Pharmaceutical 
Division), for the treatment of community-acquired pneumonia, acute 
bacterial exacerbations of chronic bronchitis, skin and skin-structure 
infections, and acute sinusitis.
    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 13, 
1999. Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 9:30 a.m. and between approximately 1 p.m. and 
1:30 p.m. on October 20, 1999, and between approximately 8 a.m. and 
8:30 a.m. on October 21, 1999. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 13, 1999, 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 20, 1999, Anti-Infective Drugs Advisory Committee 
meeting. Because the agency believes there is some urgency to bring 
these issues to public discussion and qualified members of the Anti-
Infective Drugs Advisory Committee were available at this time, the 
Commissioner 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: September 29, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-25970 Filed 10-5-99; 8:45 am]
BILLING CODE 4160-01-F