[Federal Register: October 17, 2003 (Volume 68, Number 201)]
[Notices]
[Page 59796]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc03-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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://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://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://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]
BILLING CODE 4160-01-S