[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
