[Federal Register Volume 62, Number 161 (Wednesday, August 20, 1997)]
[Notices]
[Page 44282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22090]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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). The meeting will
be open to the public.
Name of Committee: Anesthetic and Life Support 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 September 17, 1997, 8
a.m. to 5 p.m.
Location: Gaithersburg Hilton, Grand Ballroom, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Karen M. Templeton-Somers or Robin M. Spencer,
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 12529. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will hear presentations and discuss data
submitted regarding new drug application (NDA) 20-747,
ActiqTM (oral transmucosal fentanyl citrate, drug matrix on
a handle), Anesta Corp., for the management of chronic pain,
particularly breakthrough pain, in patients who are already receiving
and are tolerant to opioid therapy.
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 September 4,
1997. Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m. and 3 p.m. and 3:30 p.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
September 4, 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: August 14, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-22090 Filed 8-19-97; 8:45 am]
BILLING CODE 4160-01-F
