[Federal Register Volume 66, Number 174 (Friday, September 7, 2001)]
[Notices]
[Pages 46801-46802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0370]


Preparation for ICH Meetings in Brussels, Belgium, Including 
Progress on Implementing 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 is announcing a public 
meeting entitled ``Preparation for ICH Meetings in Brussels, Belgium, 
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 
Brussels, Belgium. The purpose of the meeting is to solicit public 
input prior to the next Steering Committee and Expert Working Group 
meetings in Brussels, Belgium, October 22 to 25, 2001, at which 
discussion of the Common Technical Document and other topics related to 
the upcoming meeting in Brussels, Belgium will take place.
    Date and Time: The public meeting will be held on October 5, 2001, 
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

[[Page 46802]]

(HFD-21), Food and Drug Administration, 5630 Fishers Lane, Rockville, 
MD 20857, 301-827-7001, FAX 301-827-6801, e-mail: [email protected].
    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 September 28, 2001.
    If you need special accommodations due to a disability, please 
contact Kimberly Topper (address above) 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, 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 
12:30 and 2 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 September 28, 2001, 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 presentation.
    The agenda for the public meeting will be made available on 
September 28, 2001, under Docket No. 01N-0370, at the Docket 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 30, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-22471 Filed 9-6-01; 8:45 am]
BILLING CODE 4160-01-S