[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Notices]
[Page 54118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27530]
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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 November 19 and 20,
1997, 8 a.m. to 5:30 p.m.; and November 21, 1997, 8 a.m. to 2 p.m.
Location: Holiday Inn, Versailles Ballrooms III and IV, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Ermona B. McGoodwin or Danyiel A. D'Antonio, Center
for Drug Evaluation and Research (HFD-21), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,
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 November 19, 1997, the committee will discuss issues
relating to the development of fluoroquinolones for use in pediatric
patients. On the morning of November 20, 1997, the committee will
discuss new drug application (NDA) 50-585/S046, ceftriaxone sodium
(Rocephin sterile vials, Roche Laboratories) for single dose
intramuscular treatment of acute otitis media. On the afternoon of
November 20, 1997, the committee will discuss NDA 20-799, ofloxacin
otic (Floxin, Daiichi Pharmaceuticals) for treatment of
otitis externa, chronic suppurative otitis media with perforated
tympanic membrane, and acute otitis media in pediatric patients with
tympanostomy tubes. On November 21, 1997, the committee will discuss
NDA 50-753, tobramycin solution for inhalation (TOBI,
PathoGenesis Corp.) for the management of cystic fibrosis patients.
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 November 12,
1997. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on November 19 and 20, and between
approximately 11 a.m. and 12 m. on November 21. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 12,
1997, 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: October 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-27530 Filed 10-16-97; 8:45 am]
BILLING CODE 4160-01-F
