[Federal Register: August 17, 2006 (Volume 71, Number 159)]
[Notices]               
[Page 47501]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au06-55]                         

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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.

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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.
    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 5 and 6, 2006, 
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: Mimi Phan, 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: 301-827-6801, e-mail: mimi.phan@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. 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.'' (Click on the year 2006 and scroll down to the above named 
committee meeting.)
    Agenda: On October 5, 2006, the committee will: (1) Receive an 
update on the International Conference on Harmonization Quality Topics 
(Q8, Q9, Q10, Q4B, QOS) and discuss the impact on current regulatory 
direction, and (2) receive and discuss a series of presentations from 
the different offices within the Office of Pharmaceutical Science on 
progress being made on quality-by-design (QBD) initiatives, followed by 
presentations from the pharmaceutical industry trade associations (The 
Generic Pharmaceutical Association [GPhA] and The Pharmaceutical 
Research and Manufacturers of America [PhRMA]) on their QBD 
perspectives and issues. On October 6, 2006, the committee will: (1) 
Receive an awareness presentation on risk management for complex 
pharmaceuticals, (2) receive presentations and discuss bioequivalence 
issues pertaining to highly variable drugs, (3) discuss current 
thinking on issues and definitions pertaining to nanotechnology, (4) 
discuss implementation of definitions for topical dosage forms, and (5) 
receive an update and discuss current strategies and direction for the 
Critical Path Initiative.
    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 
September 21, 2006. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. each day. Time 
allotted for each presentation may be limited. 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 September 21, 2006.
    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 Mimi Phan 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).

    August 8, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-13506 Filed 8-16-06; 8:45 am]

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