[Federal Register: February 16, 2006 (Volume 71, Number 32)]
[Notices]
[Page 8307]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe06-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Manufacturing Subcommittee of the 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: 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
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).
Dated: February 9, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-2237 Filed 2-15-06; 8:45 am]
BILLING CODE 4160-01-S