[Federal Register: August 8, 2002 (Volume 67, Number 153)]
[Notices]
[Page 51589-51590]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au02-68]
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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: Topperk@cder.fda.gov.
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