[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