[Federal Register: April 4, 2007 (Volume 72, Number 64)]
[Notices]
[Page 16370-16371]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap07-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Preparation for International Conference on Harmonisation
Meetings in Brussels, Belgium; 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 Brussels, Belgium''
to provide information and receive comments on the International
Conference on Harmonisation (ICH) as well as the upcoming meetings in
Brussels, Belgium. 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 Brussels,
Belgium May 5-10, 2007, at which discussion of the topics underway and
the future of ICH will continue.
Date and Time: The meeting will be held on Friday April 6, 2007,
from 3:30 p.m. to 5 p.m.
Location: The meeting will be held at 5600 Fishers Lane, third
floor, Conference Room G, Rockville, MD 20857. For security reasons,
all attendees are asked to arrive no later than 3:20 p.m., as you will
be escorted from the front entrance of 5600 Fishers Lane to Conference
Room G.
Contact Person: Michelle Limoli, Office of the Commissioner (HFG-
1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-0908, e-mail: michelle.limoli@fda.hhs.gov, 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 5, 2007.
If you need special accommodations due to a disability, please
contact Michelle Limoli as soon as possible.
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
[[Page 16371]]
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
4:30 p.m. and 5 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 5, 2007, 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 via the
Internet at http://www.fda.gov/cder/meeting/ICH_20060508.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. 6-30, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
Dated: March 28, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1633 Filed 3-29-07; 3:56 pm]
BILLING CODE 4160-01-S