[Federal Register: June 9, 2003 (Volume 68, Number 110)]
[Notices]
[Page 34395-34396]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn03-55]
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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 June 19, 2003, from 8
a.m. to 4:30 p.m. and on June 20, 2003, from 8:30 a.m. to 3 p.m.
Location: Hilton Gaithersburg, Grand Ballrooms A, B, C, and D, 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 20852-1448, 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 June 19, 2003, the committee will hear updates on the
following tentative topics: Medical Device User Fee and Modernization
Act, secure e-mail and electronic submissions, white particulate matter
in blood bags, safety reporting requirements for human drug and
biological products, and bovine spongiform encephalopathy in Canada.
The committee will further hear informational presentations on severe
acute respiratory syndrome and West
[[Page 34396]]
Nile virus. On June 20, 2003, the committee will hear presentations,
discuss, and provide recommendations on the topic of recovered plasma.
In the afternoon, the committee will hear an informational presentation
on the current thinking and indications for use on vaccinia immune
globulin intravenous. The background material for this meeting will be
posted 1 working day before the meeting under ``Blood Products Advisory
Committee'' on the Dockets Management Branch Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
.
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, 2003.
Oral presentations from the public will be scheduled between
approximately 10:45 a.m. and 11:30 a.m. and 2:30 p.m. and 3:30 p.m. on
June 19, 2003, and between approximately 9:30 a.m. and 10:30 a.m. and 2
p.m. and 2:30 p.m. on June 20, 2003. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before June 13, 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.
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
at 301-827-3514 or Pearline K. Muckelvene at 301-827-1281 at least 7
days in advance of the meeting. Persons attending FDA advisory
committee meetings are advised that the agency is not responsible for
providing access to electrical outlets.
FDA regrets that it was unable to publish this notice 15 days prior
to the Blood Products Advisory Committee meeting. Because the agency
believes there is some urgency to bring these issues to public
discussion and qualified members of the Blood Products Advisory
Committee were available at this time, the Commissioner of Food and
Drugs concluded that it was in the public interest to hold this meeting
even if there was not sufficient time for the customary 15-day public
notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 2, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-14450 Filed 6-4-03; 4:10 pm]
BILLING CODE 4160-01-S