[Federal Register: March 4, 2003 (Volume 68, Number 42)]
[Page 10253-10254]
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.

[[Page 10254]]

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 March 13, 2003, from 8 
a.m. to 6 p.m., and March 14, 2003, from 8:30 a.m. to 4 p.m.
    Location: Hilton DC North--Gaithersburg, Grand Ballrooms A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD.
    Contact: 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. 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. Persons attending FDA's advisory 
committee meetings are advised that the agency is not responsible for 
providing access to electrical outlets.
    Agenda: On March 13, 2003, the following committee updates are 
tentatively scheduled: FDA consolidation, Medical Device User Fee and 
Modernization Act, Clinical Laboratory Improvement Amendments waiver 
for human immunodeficiency, type 1 human immunodeficiency virus-1 (HIV-
1) rapid tests, and the Trans Net pilot program. The committee will 
hear presentations, discuss, and provide recommendations on the topic 
of West Nile Virus testing. On March 14, 2003, the following committee 
updates are tentatively scheduled: Limitations on validation of 
anticoagulant and additive solutions to permit freezing and irradiation 
of red cells, and particulates in blood bags. The committee will hear 
presentations, discuss, and provide recommendations on the topic of 
extensions of the dating period for pooled platelets.
    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 March 7, 2003. 
Oral presentations from the public will be scheduled between 
approximately 9:15 a.m. and 9:45 a.m.; and 3 p.m. and 4:30 p.m. on 
March 13, 2003, and between approximately 9 a.m. and 9:30 a.m.; and 
10:50 a.m. and noon on March 14, 2003. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 7, 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 regrets that was unable to publish this notice 15 days prior to 
the March 13 and 14, 2003, 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: February 26, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4974 Filed 3-3-03; 8:45 am]