[Federal Register: September 16, 2008 (Volume 73, Number 180)]
[Notices]
[Page 53428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se08-53]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0484]
Preparation for International Conference on Harmonization
Meetings in Brussels, Belgium; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
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 Harmonization (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, November 10 to 13, 2008, at which discussion of the topics
underway and the future of ICH will continue.
Date and Time: The meeting will be held on Tuesday, October 21,
2008, from 3 p.m. to 5:30 p.m.
Location: The meeting will be held at 5600 Fishers Lane, 3rd floor,
Conference Rooms D and E, Rockville, MD 20857. For security reasons,
all attendees are asked to arrive no later than 2:45 p.m., as you will
be escorted from the front entrance of 5600 Fishers Lane to Conference
Rooms D and E.
Contact Person: All participants must register with Tammie Jo Bell,
Office of the Commissioner, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, by email: tammie.bell@fda.hhs.gov 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 presentation,
to the contact person by October 14, 2008.
If you need special accommodations due to a disability, please
contact Tammie Jo Bell 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-66, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
Background: 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: September 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21573 Filed 9-15-08; 8:45 am]
BILLING CODE 4160-01-S