[Federal Register: February 16, 2006 (Volume 71, Number 32)]
[Page 8307]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Manufacturing Subcommittee of the 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: Manufacturing Subcommittee of the 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 April 18 and 19, 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 T. 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: 301-827-6778, e-mail: PHANM@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.
    Agenda: On April 18, 2006, the subcommittee will: (1) Receive topic 
updates for ongoing activities pertaining to the International 
Conference on Harmonisation (ICH) Q8, Q9, Q10, and future ICH quality 
topics; and (2) discuss and provide comments on modernized Current Good 
Manufacturing Practice (CGMP) approaches to process validation that 
encourage continuous improvement over the product life-cycle. On April 
19, 2006, the subcommittee will: (1) Discuss and provide comments on 
the agency's new approaches to Chemistry, Manufacturing, and Control 
(CMC) guidance development, as illustrated by the comparability 
protocol guidance; (2) discuss and provide comments on the CMC Pilot 
Program; and (3) receive an update on the Cooperative Research and 
Development Agreement (CRADA) with Conformia Software, Inc., to obtain 
information on factors influencing pharmaceutical development. 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.
 (Click on the year 2006 and scroll down to 

the Advisory Committee for Pharmaceutical Science meetings.)
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person by April 11, 
2006. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 1:30 p.m. on April 18, 2006, and between 
approximately 11:30 a.m. and 12 noon on April 19, 2006. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before April 11, 
2006, 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 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).

    Dated: February 9, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-2237 Filed 2-15-06; 8:45 am]