[Federal Register: October 17, 2003 (Volume 68, Number 201)]
[Page 59796]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0470]

Preparation for the International Conference on Harmonisation 
Meetings and ICH 6 Conference in Osaka, 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 and ICH 6 Conference in 
Osaka, Japan, November 9-15, 2003'' to provide information and receive 
comments on the International Conference on Harmonisation (ICH) as well 
as the upcoming meetings in Osaka, 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 and ICH 
6 Public Conference in Osaka, Japan, November 2003, at which discussion 
of the topics underway and the future of ICH will continue.
    Date and Time: The meeting will be held on November 3, 2003, from 1 
p.m. to 4 p.m.
    Location: The meeting will be held at 5600 Fishers Lane, 3d floor, 
Twinbrook Conference Room, Rockville, MD 20857.
    Contact Person: Christelle Anquez, Office of the Commissioner, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20817, 301-827-0037, FAX: 301-480-0716, e-mail: canquez@oc.fda.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 24, 2003. If you need 
special accommodations due to a disability, please contact Christelle 
Anquez 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 International Conference on 
Harmonisation 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 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 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 (FDA has verified the Web site address, 
but is not responsible for subsequent changes to the Web site after 
this document publishes in the Federal Register).
    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 
3:15 p.m. and 4 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 24, 2003, 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.
    The agenda for the public meeting will be made available on October 
17, 2003, via the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/calendar/meeting/ich2003/nov3meeting.htm
    Information on the ICH 6 Public Conference in Osaka, Japan on 
November 12-15, 2003, can be obtained via the internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ich.org/ich6tris.html
 (FDA has verified the Web site address, but 
is not responsible for any subsequent changes to the Web site after 
this document publishes in the Federal Register).

    Dated: October 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26283 Filed 10-16-03; 8:45 am]