[Federal Register Volume 75, Number 70 (Tuesday, April 13, 2010)]
[Notices]
[Page 18848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8379]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Preparation for International Conference on Harmonisation
Steering Committee and Expert Working Group Meetings in Tallinn,
Estonia; Regional 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 Steering Committee and Expert
Working Group Meetings in Tallinn, Estonia'' to provide information and
receive comments on the International Conference on Harmonisation (ICH)
as well as the upcoming meetings in Tallinn, Estonia. 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 Group
meetings in Tallinn, Estonia, June 5 through 10, 2010, at which
discussion of the topics underway and the future of ICH will continue.
Date and Time: The meeting will be held on Wednesday, May 5, 2010,
from 2:30 p.m. to 4:30 p.m.
Location: The meeting will be held at the Washington Theater at the
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: All participants must register with Jennifer
Haggerty, Office of the Commissioner, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, by e-mail:
[email protected] or FAX: 301-827-0003.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), written material and requests to make oral presentations,
to the contact person by April 30, 2010.
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 4 p.m. and 4:30
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 April 30, 2010, and submit a brief statement of the general
nature of the evidence or arguments they wish 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 via the
Internet at: http://www.fda.gov/Drugs/NewsEvents/ucm204924.htm.
If you need special accommodations due to a disability, please
contact Jennifer Haggerty at least 7 days in advance.
Transcripts: Please be advised that as soon as a transcript is
available, it can be obtained in either hardcopy or on CD-ROM, after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (HFI-35), Office of
Management Programs, Food and Drug Administration, 5600 Fishers Lane,
rm. 6-30, Rockville, MD 20857.
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 Manufactures
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.
Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8379 Filed 4-12-10; 8:45 am]
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