Blood Products Advisory Committee; Notice of Meeting, 74725 [E8-29105]
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Federal Register / Vol. 73, No. 237 / Tuesday, December 9, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Blood Products Advisory Committee;
Notice of Meeting
pwalker on PROD1PC71 with NOTICES
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 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Administration Draft Guidance for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
VerDate Aug<31>2005
17:00 Dec 08, 2008
Jkt 217001
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 https://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
https://www.fda.gov/oc/advisory/
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
74725
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30-Day
Proposed Information Collection:
Indian Health Service Health
Promotion/Disease Prevention Grantee
Survey
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 which requires
30 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
project was previously published in the
Federal Register (73 FR 23254) on
August 25, 2008 and allowed 60 days
for public comment. No public
comment was received in response to
the notice. The purpose of this notice is
to allow 30 days for public comment to
be submitted directly to OMB.
Proposed Collection: Title: 0917–
NEW, ‘‘Indian Health Service Health
Promotion/Disease Prevention Grantee
Survey.’’
Type of Information Collection
Request: This is a one-time survey to
fulfill an OMB request for an
independent external evaluation
collection, 0917–NEW, ‘‘Indian Health
Service Health Promotional Disease
Prevention (HP/DP) Grantee Survey.’’
Form Number(s): None.
Need and Use of Information
Collection: The IHS goal is to raise the
health status of the American Indian
and Alaska Native (AI/AN) people to the
highest possible level by providing
comprehensive health care and
preventive health services. HP/DP is one
of the three IHS Director’s initiatives to
reduce health disparities among AI/AN
populations through a coordinated and
systematic approach to enhance health
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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 https://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 https://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
