[Federal Register Volume 66, Number 79 (Tuesday, April 24, 2001)]
[Notices]
[Pages 20664-20665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10068]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0167]


Preparation for ICH Meetings in Tokyo, Japan, Including Progress 
on the Common Technical Document and Possibilities for New Topics; 
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 (FDA) is announcing a public 
meeting entitled ``Preparation for ICH Meetings in Tokyo, Japan, 
Including Progress on the Common Technical Document and Possibilities 
for New Topics,'' to solicit information and receive comments on the 
future of the International Conference on Harmonisation (ICH) as well 
as the upcoming meetings in Tokyo, Japan. The topic to be discussed is 
the

[[Page 20665]]

Common Technical Document (CTD) and possibilities for new topics. The 
purpose of the meeting is to solicit public input prior to the next 
Steering Committee and Expert Working Group meetings in Tokyo, Japan, 
May 21 to 24, 2001, at which discussion of the CTD and possible new 
topics will be continued.
    Date and Time: The public meeting will be held on May 8, 2001, 
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, 
Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20852, 
301-827-7001, FAX 301-827-6801, or email: [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 May 1, 2001.
    If you need special accommodations due to a disability, please 
contact Kimberly Topper at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

I. Background

    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. 
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 Center for Drug Evaluation and Research and the Center 
for 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.

II. Issues To Be Discussed at the Public Meeting

    The issues to be discussed include the following: (1) ICH overview 
and procedures, (2) CTD, and (3) possibilities for new topics (e.g., 
biotech and postmarketing surveillance).
    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 
10:30 a.m. 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 May 1, 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 available on May 2, 2001, 
at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, under 
Docket Number 01N-0167.
    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: April 18, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-10068 Filed 4-23-01; 8:45 am]
BILLING CODE 4160-01-S