[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Page 17558]
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 April 26, 2007, from 2 
p.m. to 6 p.m. and on April 27, 2007, from 8 a.m. to 3:30 p.m.
    Location: Hilton Hotel, Washington, DC North/Gaithersburg, 620 
Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike (HFM-71), Rockville, MD 20852, 301-
827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), code 3014519516. Please call 
the Information Line for up-to-date information on this meeting.
    Agenda: On April 26, 2007, the committee will hear an update on a 
summary of August 30 and 31, 2006, meeting of the Department of Health 
and Human Services Advisory Committee on Blood Safety and Availability. 
The committee will then discuss issues related to implementation of 
blood donor screening for infection with Trypanosoma cruzi and issues 
related to transmissibility of Trypanosoma cruzi in donors of human 
cells, tissue, and cellular and tissue-based products. On April 27, 
2007, the committee will hear updates on summary of December 15, 2006, 
meeting of the Transmissible Spongiform Encephelopathies Advisory 
Committee, FDA's risk communication on plasma-derived Factor VIII and 
Factor XI, and summary of September 25 and 26, 2006, FDA Workshop on 
Molecular Methods in Immunohematology. The committee will then discuss 
transfusion related acute lung injury, and discuss issues related to 
implementation of blood donor screening for infection with West Nile 
    FDA intends to make background material available to the public no 
later than 1 business day before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available 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, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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 on or before 
April 18, 2007. Oral presentations from the public will be scheduled 
between approximately 4:30 p.m. and 5 p.m. on April 26, 2007, and 
between approximately 10:45 a.m. and 11:15 a.m. on April 27, 2007. 
Those desiring to make formal oral presentations should notify the 
contact person 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 on or before April 10, 2007. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by April 11, 2007.
    Persons attending FDA's 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 Donald W. Jehn or 
Pearline K. Muckelvene 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: April 3, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-6594 Filed 4-6-07; 8:45 am]