[Federal Register Volume 66, Number 250 (Monday, December 31, 2001)]
[Notices]
[Page 67535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-32123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0580]


Preparation for ICH Meetings in Brussels, Belgium, Including 
Progress on Implementation of the Common Technical Document; Notice of 
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 
(CTD)'' 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 public meeting is to 
solicit public input prior to the next Steering Committee and Expert 
Working Group meetings in Brussels, Belgium, February 4 through 7, 
2002, at which discussion of the implementation of the CTD and the 
future of ICH will continue.
    Date and Time: The public meeting will be held on January 17, 2002, 
from 10:30 a.m. to 2 p.m.
    Location: The public meeting will be held in the Center for Drug 
Evaluation and Research, Advisory Committee Conference Room, at 5630 
Fishers Lane, rm. 1066, Rockville, MD 20857.
    Contact: Kimberly Topper, Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 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 January 10, 2002.
    If you need special accommodations due to a disability, please 
contact Kimberly Topper (address above) 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 ICH 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. 
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, 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 meeting 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 January 10, 2002, 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 January 
10, 2002, under Docket Number 01N-0580 at the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-32123 Filed 12-26-01; 3:36 pm]
BILLING CODE 4160-01-S