[Federal Register Volume 73, Number 237 (Tuesday, December 9, 2008)]
[Notices]
[Page 74725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29105]
[[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update on the ``Food and Drug Administration Draft Guidance for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