[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17500-17501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8679]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0178]


Preparation for International Conference on Harmonisation 
Meetings in Yokohama, Japan; 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 meetings in Yokohama, Japan'' to 
provide information and receive comments on the International 
Conference on Harmonisation (ICH) as well as the upcoming meetings in 
Yokohama, 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 Groups meetings in Yokohama, 
Japan, scheduled for June 6 through 11, 2009, at which discussion of 
the topics underway and the future of ICH will continue, as well as 
provide comprehensive updates of the various ICH topics.
    Date and Time: The meeting will be held on May 6, 2009, from 2:30 
p.m. to 5 p.m.
    Location: The meeting will be held in the Washington Room at the 
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 
Rockville Pike, Rockville, MD 20852. For security reasons, all 
attendees are asked to arrive no later than 2:15 p.m.
    Contact Person: All participants must register with Tammie Jo Bell, 
Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, e-mail: [email protected], or 
FAX: 301-827-0003.
    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 presentation, 
to the contact person by April 29, 2009.
    If you need special accommodations due to a disability, please 
contact Tammie Jo Bell (see Contact Person) at least 7 days in advance.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. It may be viewed at the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD. A transcript will also be available 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 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 Association; 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 (IFPMA). The 
ICH Steering Committee includes

[[Page 17501]]

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. Time allotted 
for oral presentations may be limited to 10 minutes. Those desiring to 
make oral presentations should notify the contact person by April 29, 
2009, 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 e-mail 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/cder/meeting/ICH_20090506.htm.

    Dated: April 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8679 Filed 4-14-09; 8:45 am]
BILLING CODE 4160-01-S