[Federal Register: March 16, 2007 (Volume 72, Number 51)]
[Page 12621]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 12621]]



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.


    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(3) receive an update and discuss revisions to the FDA draft guidance 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 
    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 
    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]