Document ID: FDA-2008-N-0484-0001
Agency: fda
Document Type: Notice
Title: Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting
Posted Date: 2008-09-16T04:00Z

[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]                         

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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.

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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 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]

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