[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]
BILLING CODE 4160-01-S