[Federal Register Volume 63, Number 22 (Tuesday, February 3, 1998)]
[Notices]
[Page 5562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2577]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed 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 February 19, 1998, 8 
a.m. to 5 p.m., and on February 20, 1998, 8:30 a.m. to 2 p.m.
    Location: Gaithersburg Hilton, Ballroom, 620 Perry Pkwy., 
Gaithersburg, 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 February 19, 1998, the committee will discuss new drug 
applications (NDA's) 50-747 and 50-748 quinupristin/dalfopristin 
(Synercid, Rhone-Poulenc Rorer Pharmaceuticals, Inc.) for use 
in the treatment of vancomycin-resistant Enterococcus faecium (VREF) 
infections, complicated skin and skin structure infections, community-
acquired pneumonia, and hospital-acquired (nosocomial) pneumonia. On 
February 20, 1998, the committee will meet in closed session to permit 
discussion and review of trade secret and/or confidential information.
    Procedure: On February 19, 1998, from 8 a.m. to 5 p.m. the meeting 
will be open to the public. 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 
February 13, 1998. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 p.m. on February 19, 1998. 
Time allotted for each presentation may be limited. Those desiring to 
make formal presentations should notify the contact person before 
February 13, 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.
    Closed Committee Deliberations: On February 20, 1998, from 8:30 
a.m. to 2 p.m. the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information. (5 U.S.C. 
552b(c)(4)). The investigational new drug (IND) and Phase I and II drug 
products in process will be presented.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 27, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-2577 Filed 2-2-98; 8:45 am]
BILLING CODE 4160-01-F