[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57803-57804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23642]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0490]
Preparation for International Conference on Harmonisation
Steering Committee and Expert Working Group Meetings in Fukuoka, Japan;
Regional Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Preparation for ICH Steering Committee and Expert
Working Group Meetings in Fukuoka, Japan'' to provide information and
receive comments on the International Conference on Harmonisation (ICH)
as well as the upcoming meetings in Fukuoka, Japan. The topics to be
discussed are the topics for discussion at the forthcoming ICH Steering
Committee Meeting. The purpose of the meeting is to solicit public
input prior to the next Steering Committee and Expert Working Group
meetings in Fukuoka, Japan, November 6 through 11, 2010, at which
discussion of the topics underway and the future of ICH will continue.
Date and Time: The public meeting will be held on October 13, 2010,
from 2:30 p.m. to 4:30 p.m.
Location: The public meeting will be held at the Washington Theater
at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center,
1750 Rockville Pike, Rockville, MD 20852.
Contact Person: All participants must register with Jennifer
Haggerty, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, email:
[email protected], or FAX: 301-595-7937.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), written material, and requests to make oral presentations
to Jennifer Haggerty (see Contact Person) by 5 p.m. e.s.t. on October
11, 2010.
If you need special accommodations due to a disability, please
contact Jennifer Haggerty (see Contact Person) at least 7 days in
advance.
Transcripts: Please be advised that as soon as a transcript is
available, it can be obtained in either hardcopy or on CD-ROM, after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (HFI-35), Office of
Management Programs, Food and Drug Administration, 5600 Fishers Lane,
rm. 6-30, Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: The ICH was established in 1990 as a joint
regulatory/industry project to improve, through harmonization, the
efficiency of the process for developing and registering new medicinal
products in Europe, Japan, and the United States without compromising
the regulatory obligations of safety and effectiveness.
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for medical product development among regulatory agencies.
ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. ICH is concerned with
[[Page 57804]]
harmonization among three regions: The European Union, Japan, and the
United States. The six ICH sponsors are the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labor and Welfare; the Japanese
Pharmaceutical Manufactures Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations. The ICH Steering Committee includes
representatives from each of the ICH sponsors and Health Canada, the
European Free Trade Area and the World Health Organization. The ICH
process has achieved significant harmonization of the technical
requirements for the approval of pharmaceuticals for human use in the
three ICH regions.
The current ICH process and structure can be found at the following
Web site: http://www.ich.org.
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 4 p.m. and 4:30
p.m. Time allotted for oral presentations may be limited to 10 minutes.
Those desiring to make oral presentations should notify the contact
person by 5 p.m. e.s.t. on October 11, 2010, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses, telephone number, fax, and email
of proposed participants, and an indication of the approximate time
requested to make their presentation.
The agenda for the public meeting will be made available on the
Internet at: http://www.fda.gov/Drugs/NewsEvents/ucm225322.htm.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23642 Filed 9-21-10; 8:45 am]
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