[Federal Register: June 9, 2003 (Volume 68, Number 110)]
[Page 34395-34396]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Blood Products 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'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 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]