[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Notices]
[Page 73850-73851]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-117]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies 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: Cellular, Tissue and Gene Therapies 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 by teleconference on
February 5, 2008, from 12 noon to approximately 3:15 p.m. Eastern Time.
Location: National Institutes of Health, Building 29B, Conference
Room C, 9000 Rockville Pike, Bethesda, MD. This meeting will be held by
teleconference. The public is welcome to attend the meeting at the
specified location. A speakerphone will be provided at the specified
location for public participation in the meeting, on site. Important
information about transportation and directions to the NIH campus,
parking, and security procedures is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitor/index.htm.
Visitors must show two forms of
identification, one of which must be a government-issued photo
identification such as a Federal employee badge, driver's license,
passport, green card, etc. If you are planning to drive to and park on
the NIH campus, you must enter at the South Dr. entrance of the campus
which is located on Wisconsin Ave. (the Medical Center Metro entrance),
and allow extra time for vehicle inspection. Detailed information about
security procedures is located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitorsecurity.htm.
Because of the limited available parking, visitors
are encouraged to use public transportation.
Contact Person: Gail Dapolito or Danielle Cubbage, Center for
Biologics Evaluation and Research, 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 3014512389. 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
[[Page 73851]]
line/phone line to learn about possible modifications before coming to
the meeting.
Agenda: On February 5, 2008, the committee will meet in open
session to hear updates of research programs in the Division of
Therapeutic Proteins and the Division of Monoclonal Antibodies, Office
of Biotechnology Products, Center for Drug Evaluation and Research,
FDA.
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 will be
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 2008 and scroll down to the appropriate advisory committee
link.
Procedure: On February 5, 2008, from 12 noon to approximately 2:30
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 January 29, 2008. Oral presentations from the
public will be scheduled between approximately 1:30 p.m. and 2:30 p.m.
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 January 21, 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
person regarding their request to speak by January 22, 2008.
Closed Committee Deliberations: On February 5, 2008, from
approximately 2:30 p.m. to 3:15p.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
issues related to personnel progress and promotion.
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 Gail Dapolito 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 18, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-25124 Filed 12-27-07; 8:45 am]
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