[Federal Register: August 20, 2003 (Volume 68, Number 161)]
[Notices]
[Page 50155]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au03-66]
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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 18, 2003, from
8 a.m. to 6 p.m.
Location: Gaithersburg Hilton Hotel, 620 Perry Pkwy., Gaithersburg,
MD.
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 18, 2003, the following committee updates are
tentatively scheduled: (1) Announcement of appointment of the new
Director, Division of Hematology, Office of Blood Research and Review,
Center for Biologics Evaluation and Research; (2) summary of Public
Health Service Advisory Committee on Blood Safety and Availability; (3)
summary of National Heart, Lung and Blood Institute workshop on
pathogen reduction and blood component safety; (4) approval of human
immune deficiency virus, type 1 (HIV-1) group ``O'' sensitive assays;
(5) revised guidance on Severe Acute Respiratory Syndrome; (6) updated
donor travel survey; and (7) labeling and storage: Blood and blood
components (proposed regulation). In the morning, the committee will
also hear informational presentations on: (1) An overview of
counterterrorism exercise; and (2) the current status of West Nile
Virus safety. In the afternoon, the committee will hear presentations,
discuss and provide recommendations on the topic of supplemental
testing for HIV-1 and hepatitis C virus.
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 September 8,
2003. Oral presentations from the public will be scheduled between
approximately 10 a.m. and 10:15 a.m., 11:30 a.m. and 12:30 p.m., and
4:15 p.m. and 4:45 p.m. on September 18, 2003. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 8,
2003, 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 13, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-21229 Filed 8-19-03; 8:45 am]
BILLING CODE 4160-01-S