[Federal Register: September 27, 2005 (Volume 70, Number 186)]
[Notices]
[Page 56472]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se05-66]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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.
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 October 25 and 26, 2005,
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: Igor Cerny, 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, e-mail: cerny@cder.fda.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. The background material will become available no later
than the day before the meeting and will be posted on FDA's Web site 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 under the heading
``Advisory Committee for Pharmaceutical Science (ACPS).'' (Click on the
year 2005 and scroll down to ACPS meetings.)
Agenda: On October 25, 2005, the committee will do the following:
(1) Receive an update on current activities of the Parametric Tolerance
Interval Test Workgroup; (2) receive and discuss presentations from the
Pharmaceutical Research and Manufacturing Association, the Generic
Pharmaceutical Association, and the U.S. Pharmacopeia pertaining to
their perspectives on the general topic of Quality-By-Design (QBD) and
drug release or dissolution specification setting; and (3) discuss and
provide comments on the updated tactical plan under development for the
establishment of drug release or dissolution specifications. On October
26, 2005, the committee will do the following: (1) Discuss and provide
comments on the general QBD topics of question-based review and
alcohol-induced dose dumping and (2) receive and discuss an update on
the establishment of a workgroup for the review and assessment of
Office of Pharmaceutical Science research programs. Following those
items, an awareness topic will be introduced concerning the need to
enhance the pharmaceutical education system in the United States.
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 by October 17,
2005. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 noon on October 25, 2005, and between
approximately 1 p.m. and 2 p.m. on October 26, 2005. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 17, 2005,
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.
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 Igor Cerny 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: September 19, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-19193 Filed 9-26-05; 8:45 am]
BILLING CODE 4160-01-S