[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Notices]
[Pages 55908-55909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19017]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0363]
Preparation for International Conference on Harmonization
Meetings in Chicago, Illinois; 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 Chicago, Illinois''
to provide information and receive comments on the International
Conference on Harmonization (ICH) as well as the upcoming meetings in
Chicago, IL. 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 Chicago, IL, November 7 through
10, 2005, at which discussion of the topics underway and the future of
ICH will continue.
Date and Time: The meeting will be held on October 20, 2005, from
1:30 p.m. to 4 p.m.
Location: The meeting will be held at 5600 Fishers Lane, 3rd Fl.,
Maryland Conference Room, Rockville, MD 20857. For security reasons,
all attendees are asked to arrive no later than 1:25 p.m., as you will
be escorted from the front entrance of 5600 Fishers Lane to the
Maryland Conference Room.
Contact: Sema Hashemi, Office of the Commissioner (HFG-1), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3050, FAX: 301-480-0716, e-mail: [email protected].
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax
[[Page 55909]]
number), written material and requests to make oral presentations, to
the contact person by October 14, 2005. If you need special
accommodations due to a disability, please contact Sema Hashemi at
least 7 days in advance.
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 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. 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
3:30 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 14, 2005, 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
7, 2005, via the Internet at http://www.fda.gov/cder/meeting/ICH/ICH_fall2005.htm.
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.
Dated: September 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19017 Filed 9-22-05; 8:45 am]
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