[Federal Register: June 3, 2003 (Volume 68, Number 106)]
[Page 33163-33164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0207]

Preparation for ICH Meetings in Brussels, Belgium, and ICH 6 
Conference in Osaka, Japan: Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration is announcing a public 
meeting entitled ``Preparation for ICH Meetings in Brussels, Belgium, 
July 15-18, 2003, and ICH 6 Conference in Osaka, Japan, November 12-15, 
2003'' to solicit information and receive comments on the International 
Conference on Harmonisation (ICH) as well as the upcoming Meetings in 
Brussels, Belgium. The topic to be discussed is the Common Technical 
Document, GMPs Initiative and Update on other 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 Brussels, Belgium, July 2003, at 
which discussion of the topics underway and the future of ICH will 
continue and also to inform the public about the ICH 6 Public 
Conference in Osaka, Japan in November 2003.
    Date and Time: The public meeting will be held on June 24, 2003, 
from 10 a.m. to 1 p.m.
    Location: The public meeting will be held at 5630 Fishers Lane, rm. 
1066, Rockville, MD 20857.
    Contact Person: Kimberly L. Topper, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, FAX 301-827-6801, email: 
Topperk@cder.fda.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 June 9, 2003.
    If you need special accommodations due to a disability, please 

[[Page 33164]]

Kimberly Topper 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-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.

SUPPLEMENTARY INFORMATION: The International Conference on 
Harmonisation of Technical Requirements for the Registration of 
Pharmaceuticals for Human Use (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, 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 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 on the Internet 
at 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 
12:15 p.m. and 1 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 June 9, 2003, 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 June 9, 
2003, via the internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/calendar/meeting/ich2003
    Information on the ICH 6 Public Conference in Osaka, Japan on 
November 12-15, 2003, can be obtained via the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.ich.org/ich6bis.html

    Dated: May 28, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13830 Filed 6-2-03; 8:45 am]