[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Page 20690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8816]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Preparation for International Conference on Harmonization
Steering Committee and Expert Working Group Meetings in Cincinnati, OH;
Regional Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Preparation for ICH Steering Committee and Expert
Working Group Meetings in Cincinnati, Ohio'' to provide information and
receive comments on the International Conference on Harmonization (ICH)
as well as the upcoming meetings in Cincinnati, OH. The topics to be
discussed are the topics for discussion at the forthcoming ICH Steering
Committee Meeting. The purpose of the meeting is to solicit public
input prior to the next Steering Committee and Expert Working Group
meetings in Cincinnati, OH, scheduled on June 11 through 17, 2011, at
which discussion of the topics underway and the future of ICH will
continue.
Date and Time: The public meeting will be held on May 19, 2011,
from 2 p.m. to 4 p.m.
Location: The public meeting will be held at the Washington Theater
room at the Hilton Washington DC/Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person: All participants must register with Kimberly
Franklin, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, e-mail:
[email protected], or FAX: 301-595-7937.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone, and
fax number), written material, and requests to make oral presentations
to the contact person (see Contact Person) by May 16, 2011.
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 3:30 p.m. and 4
p.m. Time allotted for oral presentations may be limited to 10 minutes.
Those desiring to make oral presentations should notify the contact
person (see Contact Person) by May 16, 2011, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses, telephone number, fax, and email
of proposed participants, and an indication of the approximate time
requested to make their presentation.
If you need special accommodations due to a disability, please
contact Kimberly Franklin (see Contact Person) at least 7 days in
advance.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information, 12420 Parklawn
Dr., Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: The 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.
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, 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 Manufactures
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 (IFPMA). The
ICH Steering Committee includes representatives from each of the ICH
sponsors and Health Canada, the European Free Trade Area and the World
Health Organization. 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 at the following
Web site: http://www.ich.org. (FDA has verified the Web site addresses
in this document, but FDA is not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.)
The agenda for the public meeting will be made available on the
Internet at http://www.fda.gov/Drugs/NewsEvents/ucm248489.htm.
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8816 Filed 4-12-11; 8:45 am]
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