[Federal Register Volume 72, Number 64 (Wednesday, April 4, 2007)]
[Notices]
[Pages 16370-16371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1633]


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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: [email protected], 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