[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<Register> 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<Register>, 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<Register>, 
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