[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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
