[Federal Register Volume 74, Number 180 (Friday, September 18, 2009)]
[Pages 47948-47949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22445]



Food and Drug Administration

[Docket No. FDA-2009-N-0431]

Preparation for International Conference on Hamonization: Public 

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice of public meeting.


SUMMARY:  The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Preparation for ICH meetings in St. Louis, 
Missouri'' to provide information and receive comments on the 
International Conference on Harmonization (ICH) as well as the upcoming 
meetings in St. Louis, MO. The topics to be discussed are the topics 
for discussion at the forthcoming ICH Steering Committee Meeting. The 
purpose of the public meeting is to solicit public input prior to the 
next Steering Committee and Expert Working Groups meetings in St. 
Louis, MO, October 24 to 29, 2009, at which discussion of the topics 
underway and the future of ICH will continue.
    Date and Time: The public meeting will be held on Wednesday, 
October 14, 2009, from 2:30 p.m. to 4:30 p.m.
    Location: The public meeting will be held at the Washington Room at 
the Hilton Rockville, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: Mary Morrison, 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: Mail or fax your 
registration information (including name, title, firm name, address, 
telephone and fax numbers), written material and requests to make oral 
presentations, to Mary Morrison (see Contact Person) by October 9, 
    If you need special accommodations due to a disability, please 
contact Mary Morrison (see Contact Person) at least 7 days in advance.

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.
    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 2:30 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 October 9, 2009, and submit a brief statement of the 
general nature of the evidence or arguments they wish to present, the 
names and addresses,

[[Page 47949]]

telephone number, fax, and e-mail of proposed participants, and an 
indication of the approximate time requested to make their 
    The agenda for the public meeting will be made available on the 
Internet at http://www.fda.gov/Drugs/NewsEvents/ucm181849.htm.
    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.

    Dated: September 11, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22445 Filed 9-17-09; 8:45 am]