[Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
[Notices]
[Pages 44700-44701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22556]



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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: General Hospital and Personal Use Devices Panel 
of the Medical Devices 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 15, 1997, 10 
a.m. to 5:30 p.m., and September 16, 1997, 8 a.m. to 12 m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Martha T. O'Lone, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12520. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On September 15 and 16, 1997, the committee will discuss 
and make recommendations on the draft guidance entitled ``Testing for 
Skin Sensitization to Chemicals in Latex Products.'' Single copies of 
this draft guidance are available to the public from the Division of 
Small Manufacturers Assistance, 1350 Piccard Dr., Rockville, MD 20851, 
1-800-638-2041, or on the Internet using the World Wide Web (WWW) 
(http://www.fda.gov/cdrh/draftgui.html).
    Procedure: On September 15, 1997, from 10:30 a.m. to 5:30 p.m., and 
September 16, 1997, from 8 a.m. to 12 m., the meeting is 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 August 9, 1997. Oral 
presentations from the public will be scheduled between approximately 
11 a.m. and 12 m. on September 15, 1997. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact

[[Page 44701]]

person before August 9, 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.
    Closed committee deliberations: On September 15, 1997, from 10 a.m. 
to 10:30 a.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)). FDA staff will present trade secret and/or confidential 
information regarding pending and future submissions.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the September 15 and 16, 1997, General Hospital and Personal Use 
Devices Panel of the Medical Devices Advisory Committee meeting. 
Because the agency believes there is some urgency to bring this issue 
to public discussion and qualified members of the General Hospital and 
Personal Use Devices Panel of the Medical Devices Advisory Committee 
were available at this time, the Commissioner concluded that it was in 
the public interest to hold this meeting even if there was not 
sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 19, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-22556 Filed 8-20-97; 2:10 pm]
BILLING CODE 4160-01-F