[Federal Register: September 7, 2001 (Volume 66, Number 174)]
[Notices]
[Page 46801-46802]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se01-63]
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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: Topper@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 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