[Federal Register Volume 62, Number 96 (Monday, May 19, 1997)]
[Notices]
[Page 27261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13020]


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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: Blood Products 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 June 19, 1997, 9 a.m. to 
2:30 p.m., and June 20, 1997, 8:30 a.m. to 1:30 p.m.
    Location: Quality Suites Hotel, Potomac Ballrooms I, II, and III, 
Three Research Ct., Rockville, MD.
    Contact Person: Linda A. Smallwood, Center for Biologics Evaluation 
and Research (HFM-350), Food and Drug Administration, 1401 Rockville 
Pike, Rockville, MD 20852-1448, 301-827-3514, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12388. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On June 19, 1997, the committee will sit as a Medical 
Device Panel to review agency recommendations for the following 
reclassification changes under 21 CFR part 860, subpart C: (1) 
Inclusion of automated infectious disease test systems used for donor 
screening, and (2) reclassification of class I medical devices used in 
collection and processing of blood. On June 20, 1997, the committee 
will hear discussion and provide recommendations regarding inadvertent 
contamination of plasma used for fractionation.
    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 June 13, 1997. 
Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal 
presentations should notify the contact person before June 13, 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 required to 
make their presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 13, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-13020 Filed 5-16-97; 8:45 am]
BILLING CODE 4160-01-F