[Federal Register Volume 75, Number 70 (Tuesday, April 13, 2010)]
[Page 18848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8379]



Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Preparation for International Conference on Harmonisation 
Steering Committee and Expert Working Group Meetings in Tallinn, 
Estonia; Regional 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 Steering Committee and Expert 
Working Group Meetings in Tallinn, Estonia'' to provide information and 
receive comments on the International Conference on Harmonisation (ICH) 
as well as the upcoming meetings in Tallinn, Estonia. 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 Group 
meetings in Tallinn, Estonia, June 5 through 10, 2010, at which 
discussion of the topics underway and the future of ICH will continue.
    Date and Time: The meeting will be held on Wednesday, May 5, 2010, 
from 2:30 p.m. to 4:30 p.m.
    Location: The meeting will be held at the Washington Theater at the 
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 
Rockville Pike, Rockville, MD 20852.
    Contact Person: All participants must register with Jennifer 
Haggerty, 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: 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 30, 2010.
    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 4 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 April 30, 2010, and submit a brief statement of the general 
nature of the evidence or arguments they wish 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 
    The agenda for the public meeting will be made available via the 
Internet at: http://www.fda.gov/Drugs/NewsEvents/ucm204924.htm.
    If you need special accommodations due to a disability, please 
contact Jennifer Haggerty at least 7 days in advance.
    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.

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.

    Dated: April 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8379 Filed 4-12-10; 8:45 am]