[Federal Register: October 1, 2004 (Volume 69, Number 190)]
[Page 58928-58929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Preparation for the International Conference on Harmonization 
Meetings in Yokohama, Japan: Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.


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 Harmonization (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 Experts Working Groups meetings in Yokohama, 
Japan on November 15 through 18, 2004, at which discussion of the 
topics underway and the future of ICH will continue.
    Date and Time: The meeting will be held on October 19, 2004, from 
1:30 to 3 p.m.
    Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, 
Chesapeake Conference Room, Rockville, MD. For security reasons, all 
attendees are asked to arrive no later than 1:15 p.m., as you will be 
escorted from the front entrance of 5600 Fishers Lane to the Chesapeake 
Conference Room.
    Contact Person: Sema Hashemi, Office of the Commissioner, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3050, FAX 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov.
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
fax number), and written material and requests to make oral 
presentations, to the contact person by October 15, 2004.
    If you need special accommodations due to a disability, please 
contact Sema Hashemi at least 7 days in advance.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.

SUPPLEMENTARY INFORMATION: The ICH of Technical Requirements for the 
Registration of Pharmaceuticals for Human Use 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 
    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 Associations; the Japanese Ministry of 
Health, Labor, and Welfare; the Japanese Pharmaceutical Manufacturers 
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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ich.org.

    Interested persons may present data, information, or views orally 
or in writing, on issues pending at the public meeting. Oral 
presentations from the public will be scheduled between approximately 
2:30 and 3 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 October 15, 2004, and submit a brief statement of the 
general nature of the evidence or arguments they which to present, the 
names and addresses, phone number, fax, and e-mail of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.

[[Page 58929]]

    The agenda for the public meeting will be made available on October 
8, 2004, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/ICH_10192004.htm

    Dated: September 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22053 Filed 9-30-04; 8:45 am]