[Federal Register Volume 64, Number 141 (Friday, July 23, 1999)]
[Notices]
[Pages 40016-40017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18768]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


General Hospital and Personal Use Devices Panel of the Medical 
Devices 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's regulatory issues.
    Date and Time: The meeting will be held on August 2, 1999, 8 a.m. 
to 5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, 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: The committee will discuss possible revisions to the 1995 
draft guidance entitled ``Supplementary Guidance on the Content of 
Premarket Notification [510(k)] Submissions for Medical Devices With 
Sharps Injury Prevention Features.'' The committee will also discuss 
the development of guidance for needle-free devices such as jet 
injectors intended for the delivery of drugs and biologics and the need 
for and content of educational programs to encourage the safe and 
effective use of these devices. Single copies of the 1995 draft 
guidance are available to the public by calling 1-800-899-0381 or 301-
827-0111, and requesting Facts-on-Demand document number 934, or on the 
Internet using the World Wide Web (WWW) ``http://www.fda.gov/cdrh/ode/
doc934.pdf''.
    Procedure: On August 2, 1999, from 8:30 a.m. to 5 p.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 
July 23, 1999. Oral presentations from the public will be scheduled 
between approximately 11 a.m. and 12 m. and between approximately 3:45 
p.m. and 4:15 p.m. Time allotted for each presentation may be limited. 
Those individuals desiring to make formal oral presentations should 
notify the contact person by July 23, 1999, and submit a brief 
statement of the general nature of the evidence or

[[Page 40017]]

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 August 2, 1999, from 8 a.m. to 
8:30 a.m., the meeting will be closed to permit FDA to present to the 
committee trade secret and/or confidential commercial information (5 
U.S.C. 552b(c)(4)) regarding pending issues and applications.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the August 2, 1999, General Hospital and Personal Use Devices Panel 
of the Medical Devices Advisory Committee meeting. Because the agency 
believes there is some urgency to bring these issues 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: July 16, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-18768 Filed 7-22-99; 8:45 am]
BILLING CODE 4160-01-F