[Federal Register: November 21, 2003 (Volume 68, Number 225)]
[Page 65718-65719]
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 December 11, 2003, from 
8 a.m. to 6:30 p.m.; and on December 12, 2003, from 8 a.m. to 3 p.m.
    Location: Hilton DC North--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, 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

[[Page 65719]]

for up-to-date information on this meeting.
    Agenda: On December 11, 2003, the committee will hear presentations 
and discuss and provide recommendations on these topics: The American 
Association for Blood Banks (AABB) abbreviated donor questionnaire; and 
blood donor deferral for exposure to Leishmaniasis. In the afternoon, 
the committee will hear an update on the West Nile Virus (WNV) epidemic 
and donor testing in 2003 including updates on WNV testing under 
investigational new drug applications and plans for 2004. On December 
12, 2003, the committee will hear updates on these topics: The Medical 
Device User Fee and Modernization Act of 2002 (MDUFMA), the use of 
secure e-mail, a summary of the factor VIII inhibitor workshop, 
platelet testing and evaluation guidance, and freezing and storage 
temperatures for source plasma (-25 [deg]C and -30 [deg]C). The 
committee will also hear presentations and discuss and provide 
recommendations on the review of plasma collection nomograms.
    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 November 21, 
2003. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m., 2 p.m. and 2:30 p.m., and 5:30 
p.m. and 5:45 p.m. on December 11, 2003; and between approximately 9:30 
a.m. and 10:15 a.m., and 12 noon and 12:30 p.m. on December 12, 2003. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
November 21, 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 advisory committee meetings are advised that 
the agency is not responsible for providing access to electrical 
    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: November 14, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-29075 Filed 11-20-03; 8:45 am]