[Federal Register: April 26, 2004 (Volume 69, Number 80)]
[Page 22539-22540]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0176]

Preparation for the International Conference on Harmonization 
Meetings in Washington, DC; 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 Washington, DC'' to 
provide information and receive comments on the International 
Conference on Harmonization (ICH) as well as the upcoming meetings in 
Washington, DC. 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 Experts Working Groups meetings in Washington, 
DC, June 7-10, 2004, at which discussion of the topics underway and the 
future of ICH will continue.
    Date and Time: The meeting will be held on May 17, 2004, from 1:30 
to 4:30 p.m.
    Location: The meeting will be held at 5600 Fishers Lane, 3d floor, 
Potomac Conference Room, Rockville, MD 20857. For security reasons, all 
attendees are asked to arrive no later than 1:30 p.m., as you will be 
escorted from the front entrance of 5600 Fishers Lane to the Potomac 
Conference Room.
    Contact Person: Sema Hashemi, Office of the Commissioner, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov.
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
fax number), and written material and requests to make oral 
presentations, to the contact person by May 7, 2004.
    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-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.
    If you need special accommodations due to a disability, please 
contact Sema Hashemi 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 the 
following three regions: The European Union,

[[Page 22540]]

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 (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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 3:45 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 May 7, 2004, 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 on May 3, 
2004, via the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/ICH_05172004.htm

    Dated: April 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9323 Filed 4-23-04; 8:45 am]