[Federal Register: October 1, 2004 (Volume 69, Number 190)]
[Notices]
[Page 58928-58929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc04-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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 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
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.
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://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]
BILLING CODE 4160-01-S