[Federal Register: September 27, 2005 (Volume 70, Number 186)]
[Page 56472]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 
    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]