[Federal Register: August 27, 2002 (Volume 67, Number 166)]
[Notices]
[Page 55024]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au02-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood Products 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's regulatory issues.
Date and Time: The meeting will be held on September 12, 2002, from
8 a.m. to 5:30 p.m.
Location: Hilton Silver Spring Hotel, Maryland Ballroom, 8727
Colesville Rd., Silver Spring, MD 20910.
Contact Person: Linda A. Smallwood, Center for Biologics Evaluation
and Research (HFM-302), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301-827-3514, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 19516. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On September 12, 2002, the following committee updates are
tentatively scheduled: (1) Consideration of the Clinical Laboratory
Improvement Act (CLIA) waivers for rapid human immunodeficiency virus
(HIV) tests; (2) implementation of HIV, type 1/hepatitis C virus
nucleic acid testing algorithm; (3) summary of Public Health Service
Advisory Committee on Blood Safety and Availability meeting held on
September 5, 2002; (4) summary of the workshop on pathogen inactivation
held on August 7 and 8, 2002; and (5) blood establishment registration-
-electronic submissions. In the morning, the committee will hear
discussion and provide recommendations on the topic of self-
administration of the uniform donor history questionnaire: first time
donors. In the afternoon, the committee will hear an informational
presentation on testing for Chagas disease, and a presentation on
window period for HIV cases and current estimates of residual risk.
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 August 30,
2002. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 11:30 a.m., and 3:45 p.m. and 4:30 p.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
August 30, 2002, 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.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Linda A. Smallwood
or Pearline K. Muckelvene at 301-827-1281 at least 7 days in advance of
the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 20, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-21734 Filed 8-26-02; 8:45 am]
BILLING CODE 4160-01-S