[Federal Register Volume 67, Number 153 (Thursday, August 8, 2002)]
[Notices]
[Pages 51589-51590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. 02N-0332


Preparation for the International Conference on Harmonization 
Meetings in Washington, DC, Including Progress on Implementation of the 
Common Technical Document; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Preparation for ICH Meetings in Washington, DC, 
Including Progress on Implementation of the Common Technical Document'' 
to solicit information and receive comments on the International 
Conference on Harmonisation (ICH) as well as the upcoming meetings in 
Washington, DC. The purpose of the meeting is to solicit public input 
prior to the next Steering Committee and Expert Working Group meetings 
in Washington, DC, September 9 to 12, 2002, at which discussion of the 
Common Technical Document and the future of ICH will continue.
    Date and Time: The public meeting will be held on September 5, 
2002, from 10:30 a.m. to 2 p.m.
    Location: The public meeting will be held at 5630 Fishers Lane, rm. 
1066, Rockville, MD 20852.
    Contact: Kimberly 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, e-mail: [email protected].
    Registration and Request for Oral Presentation: 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 August 29, 2002.
    If you need special accommodations due to a disability, please 
contact Kimberly Topper at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The International Conference on 
Harmonisation of Technical Requirements for the Registration of 
Pharmaceuticals for Human Use 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,

[[Page 51590]]

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. 
The ICH was organized to provide an opportunity for harmonization 
initiatives to be developed with input from both regulatory and 
industry representatives. The 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 Canadian Therapeutics Programme, and the European Free 
Trade Area. 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://www.ifpma.org/ich1.html
    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 
11:30 a.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 August 29, 2002, 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 August 
29, 2002, under Docket No. 02N-0332, at the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    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.

    Dated: August 1, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-20009 Filed 8-7-02; 8:45 am]
BILLING CODE 4160-01-S