[Federal Register: March 16, 2007 (Volume 72, Number 51)]
[Notices]
[Page 12621]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr07-69]
[[Page 12621]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology (formerly called Advisory Committee for Pharmaceutical
Science); 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: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology (formerly called Advisory Committee for
Pharmaceutical Science).
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 and 2, 2007, from
8:30 a.m. to 5 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Victoria Ferretti-Aceto, Center for Drug Evaluation
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD
20857, 301-827-7001, FAX: 301-827-6776, e-mail:
Victoria.FerrettiAceto@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC
area), code 3014512539.Please call the Information Line for up to date
information on this meeting.
Agenda: On May 1, 2007, the committee will do the following: (1)
Receive and discuss updates from the October 18 and 19, 2006, Clinical
Pharmacology Subcommittee Meeting and the April 30, 2007, Manufacturing
Subcommittee Meeting; (2) receive an update, discuss and make comments
on current strategies and directions for the Critical Path Initiative;
(3) receive an update and discuss revisions to the FDA draft guidance
for industry entitled ``Comparability Protocols -- Chemistry,
Manufacturing, and Controls Information;'' (4) discuss current thinking
on risk-based approaches to managing post-approval activity. On May 2,
2007, the committee will do the following: (1) Receive an update from
the Office of Generic Drugs (OGD) on the bioequivalence of highly
variable drugs, (2) receive an update on and discuss general strategies
within the OGD pertaining to the bioequivalence of narrow therapeutic
index drug products, and (3) discuss and provide comments on the topic
of alcohol-induced dose dumping.
FDA intends to make background material available to the public no
later than 1 business day 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://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 2007 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
April 17, 2007. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. each day. 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 9, 2007. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonable 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 10, 2007.
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 Victoria Ferretti-
Aceto at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 8, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-4797 Filed 3-15-07; 8:45 am]
BILLING CODE 4160-01-S