Document ID: FDA-2008-N-0038-0019
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee; Notice of Meeting
Posted Date: 2008-03-26T04:00Z

[Federal Register: March 26, 2008 (Volume 73, Number 59)]
[Notices]               
[Page 16023-16024]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr08-80]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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). At least one 
portion of the meeting will be closed 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 May 1, 2008, from 8:30 
a.m. to 5:30 p.m. and on May 2, 2008, from 8:30 a.m. to 4 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), 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 the morning of May 1, 2008, the committee will hear 
updates on the following: (1) Summaries of August 22-23, 2007, and 
January 9-10, 2008, meetings of the Department of Health and Human 
Services Advisory Committee on Blood Safety and Availability; (2) 2007 
West Nile Virus Epidemiology and the use of nucleic acid tests to 
reduce the risk of transmission of West Nile Virus in Whole Blood and 
blood components for transfusion and Human Cells, Tissues, and Cellular 
and Tissue-based products (HCT/Ps); (3) implementation of blood donor 
screening for infection with Trypanosoma cruzi and the use of 
serological tests to reduce the risk of transmission of T. cruzi 
infection in Whole Blood and blood components for transfusion and HCT/
Ps; (4) FDA's proposal to lower the minimum recommended lot release 
titer for measles antibodies in Immune Globulin Intravenous (Human) and 
Immune Globulin Subcutaneous (Human); (5) Gambro/Fenwal Post Approval 
Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) Post 
Marketing Study--7 Day Platelets; (6) Experience with 7 Day Platelets 
Versus 5 Day Platelets; and (7) FDA Perspective on the PASSPORT Study. 
These updates will be followed by informational presentations on FDA's 
Center for Biologics Evaluation and Research Safety Teams related to 
blood and tissue. In the afternoon, the committee will discuss the 
Biomedical Excellence for Safer Transfusion Committee Report on red 
blood cell recovery standards. On the morning of May 2, 2008, the 
committee will discuss Lev Pharmaceutical's plasma-derived C1 esterase 
inhibitor (CINRYZE). Then, in the afternoon the committee will review 
the research programs in the Laboratory of Hepatitis and Related 
Emerging Agents, Division of Emerging and Transfusion Transmitted 
Diseases, Office of Blood Research and Review, CBER Site Visit of 
November 8, 2007.
    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: The entire day of May 1, 2008, and on May 2, 2008, from 
8:30 a.m. to 3:15 p.m., the meeting is open to the public. 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 23, 2008. Oral presentations 
from the public will be scheduled between approximately 11:50 a.m. and 
12:20 p.m. and between approximately 4:20 p.m. and 4:50 p.m. on May 1, 
2008, and between approximately 10:40 a.m. and 11:10 a.m. and 2:40 p.m. 
and 3 p.m. on May 2, 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 April 15, 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 April 16, 
2008.
    Closed Committee Deliberations: On May 2, 2008, between 3:15 p.m. 
and 4 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of 
intramural research programs and make recommendations regarding 
personnel staffing decisions.
    Persons attending FDA's advisory committee meetings are advised 
that the

[[Page 16024]]

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: March 20, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-6208 Filed 3-25-08; 8:45 am]

BILLING CODE 4160-01-S