[Federal Register: July 20, 2007 (Volume 72, Number 139)]
[Page 39814-39815]
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 August 16, 2007, from 8 
a.m. to 5 p.m.
    Location: Doubletree Hotel and Executive Meeting Center, 8120 
Wisconsin Ave., Bethesda, MD 20814.
    Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center 
for Biologics Evaluation and Research, 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. 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 August 16, 2007, the Committee will hear updates on the 
following topics: (1) Summary of the May 10 through 11, 2007, and the 
August 6 through 7, 2007, meetings of the Department of Health and 
Human Services Advisory Committee on Blood Safety and Availability; (2) 
summary of the April 25 through 26, 2007, FDA Workshop on Immune 
Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, 
Potency and Testing; and (3) summary of the August 15, 2007, FDA 
Workshop on Licensure of Apheresis Blood Products. The Committee will 
then hear informational presentations relating to World Health 
Organization (WHO) biological standards on the following topics: (1) 
Summary of the January 29 through 30, 2007, WHO meeting with WHO 
collaborating centers for biological standards and standardization to 
support the development of WHO biological reference preparations for 
high risk blood safety-related in vitro diagnostics; (2) potency and 
safety standards for plasma derivatives; and (3) joint FDA/WHO minimum 
potency standards for certain blood grouping reagents. The Committee 
will hear the response of the Office of Blood Research and Review to 
their office level site visit of July 22, 2005. In the afternoon the 
Committee will discuss measles antibody levels in U.S. Immune Globulin 
    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://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 
August 8, 2007. Oral presentations from the public will be

[[Page 39815]]

scheduled between approximately 11:15 a.m. and 11:45 p.m. and between 
approximately 3:30 p.m. and 4 p.m. on August 16, 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 July 31, 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 August 1, 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: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-14088 Filed 7-19-07; 8:45 am]