Document ID: FDA-2008-N-0038-0056
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee; Notice of Meeting
Posted Date: 2008-07-29T04:00Z

[Federal Register: July 29, 2008 (Volume 73, Number 146)]
[Notices]               
[Page 43941-43942]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy08-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
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 September 10, 2008, from 
8 a.m. to 5:45 p.m. and on September 11, 2008, from 8 a.m. to 3 p.m.
    Location: Hilton Hotel, Washington, DC/Rockville Executive Meeting 
Center, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center 
for Biologics Evaluation and Research (CBER) (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, 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. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On the morning of September 10, 2008, the Committee will 
hear an update on the May 29 to 30, 2008, meeting of the Department of 
Health and Human Services Advisory Committee on Blood Safety and 
Availability. Following this update, the Committee will discuss 
strategies to enhance bacterial safety of 7 day platelets for 
transfusion. In the afternoon, the Committee will discuss iron status 
in blood donors. On September 11, 2008, the Committee will hear updates 
on the following topics: (1)

[[Page 43942]]

April 29 to 30, 2008, workshop on hemoglobin based oxygen carriers; (2) 
July 10 to 11, 2008, blood establishment computer software conference; 
(3) the development of an automated Biologics License Application 
submission system; and (4) Draft Guidance for Industry: Re-
qualification Method for Re-entry of Blood Donors Deferred Because of 
Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-
HBc). Following these updates, the Committee will discuss options for 
blood donor screening and re-entry for malaria. FDA intends to make 
background material available to the public no later than 2 business 
days 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://
www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and 
scroll down to the appropriate advisory committee link.
    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 
September 2, 2008. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:30 a.m. and between 
approximately 4 p.m. and 4:30 p.m. on September 10, 2008, and between 
approximately 9:15 a.m. and 9:45 a.m. and between approximately 1:30 
p.m. and 2 p.m. on September 11, 2008. 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 August 22, 2008. 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 August 
25, 2008.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    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.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17359 Filed 7-28-08; 8:45 am]

BILLING CODE 4160-01-S