Document ID: FDA-2008-N-0038-0091
Agency: fda
Document Type: Notice
Title: Blood Products Advisory Committee; Notice of Meeting
Posted Date: 2008-12-09T05:00Z

[Federal Register: December 9, 2008 (Volume 73, Number 237)]
[Notices]               
[Page 74725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de08-58]                         

[[Page 74725]]

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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 January 9, 2009, from 8 
a.m. to 6 p.m.
    Location: Hilton Hotel, Washington, D.C./Rockville Executive 
Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: William Freas or Pearline K. Muckelvene, Center for 
Biologics Evaluation and Research (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 January 9, 2009, the Committee will 
discuss CSL Behring's Biologics License Application for plasma-derived 
fibrinogen concentrate for treatment of bleeding in congenital 
fibrinogen deficiency. In the afternoon, the Committee will hear an 
update on the ``Food and Drug Administration Draft Guidance for 
Industry on Regulation of Genetically Engineered Animals Containing 
Heritable Recombinant Deoxynucleic Acid Constructs.'' Following this 
update, the Committee will discuss GTC Biotherapeutics' Biologics 
License Application for recombinant Antithrombin III derived from 
genetically engineered goats for treatment of patients with hereditary 
Antithrombin III deficiency to prevent thrombosis during high risk 
situations like surgery and obstetrical procedures.
    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 2009 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 
December 30, 2008. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11 a.m. and between approximately 
4 p.m. and 5 p.m. on January 9, 2009. 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 December 19, 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 December 
22, 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 William Freas 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: December 1, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-29105 Filed 12-8-08; 8:45 am]

BILLING CODE 4160-01-S