[Federal Register Volume 62, Number 168 (Friday, August 29, 1997)]
[Notices]
[Pages 45822-45823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23020]


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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). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Immunology 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 19, 1997, 9:30 
a.m. to 5 p.m.
    Location: Parklawn Bldg., conference rooms D and E, 5600 Fishers 
Lane, Rockville, MD.
    Contact Person: Peter E. Maxim, Center for Devices and Radiological 
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 301-594-1293, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12516. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will hear presentations from FDA staff 
regarding new review initiatives pertinent to types of submissions 
generally reviewed by the committee. FDA will also present a first year 
summary of activities associated with the down classification of tumor 
markers used for monitoring cancer patients. FDA seeks to obtain 
committee input on the data requirements for class II submissions of 
tumor markers with the intent of modifying the guidance document that 
serves as a special control for these class II products. Single copies 
of the guidance document entitled ``Guidance For Submission Of Tumor 
Marker Premarket Notifications'' can be obtained by contacting the 
Division of Small Manufacturers Assistance, 1350 Piccard Dr., 
Rockville, MD 20851, 1-800-638-2041 or 301-443-6597, or on the Internet 
using the World Wide Web (WWW) (http://www.fda.gov/cdrh/draftgui.html).
    Procedure: On September 19, 1997, from 10 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

[[Page 45823]]

before the committee. Written submissions may be made to the contact 
person by September 5, 1997. Oral presentations from the public will be 
scheduled between approximately 12:30 p.m. and 1:30 p.m. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before September 5, 
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 19, 1997, from 9:30 
a.m. to 10 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 to the committee confidential 
information regarding pending or future submissions.
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 22, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-23020 Filed 8-28-97; 8:45 am]
BILLING CODE 4160-01-F