[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Page 32620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15638]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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: Dermatologic and Ophthalmic 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 July 14 and 15, 1997,
8:30 a.m. to 5:30 p.m..
Location: Holiday Inn, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Tracy K. Riley or Angie Whitacre, 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 12534. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On July 14, 1997, the committee will discuss biologic
licensing application (BLA) 96-1408, Regranex (becaplermin
[PDGF-BB], Chiron Corp., in a carboxymethyl cellulose gel), OMJ
Pharmaceuticals, Inc., for treatment of chronic diabetic foot ulcers.
On July 15, 1997, the committee will participate in a general
scientific discussion regarding the development of a possible future
guidance document for chronic cutaneous ulcers. This is one segment of
an overall effort by the agency to provide guidance on wound healing
products, including a future discussion of products for treatment of
burns. The agency encourages investigators, academicians, members of
the pharmaceutical industry, consumer groups, and others with
information relevant to the topics to respond to the contact person.
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 July 3, 1997.
Oral presentations from the public will be scheduled between
approximately 8:30 a.m. and 9 a.m., on July 14, 1997; between
approximately 8:30 a.m. and 9 a.m., and between approximately 1 p.m.
and 1:30 p.m., on July 15, 1997. Time allotted for each presentation
may be limited. Those desiring to make formal presentations should
notify the contact person before July 3, 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: June 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-15638 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F
