
[Federal Register Volume 77, Number 48 (Monday, March 12, 2012)]
[Notices]
[Pages 14528-14529]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Preparation for International Conference on Harmonization 
Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; 
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 Fukuoka, Japan'' to provide information and 
receive comments on the International Conference on Harmonization (ICH) 
as well as the upcoming meetings in Fukuoka, Japan. 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 Fukuoka, Japan, scheduled on June 2 through 7, 2012, at 
which discussion of the topics underway and the future of ICH will 
continue.

DATES:  Date and Time: The public meeting will be held on May 14, 2012, 
from 2 p.m. to 4 p.m.
    Location: The public meeting will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31, Conference Center, the 
Great Room (rm. 1503), Silver Spring, MD 20993. Information regarding 
visitor parking and transportation may be accessed at: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm; under the heading ``Public 
Meetings at the White Oak Campus.'' Please note that visitors to the 
White Oak Campus must enter through Building 1.
    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, FAX: 301-595-
7937, email: Kimberly.Franklin@fda.hhs.gov.
    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 9, 2012.
    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 9, 2012, 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 (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., 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

[[Page 14529]]

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 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 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/ucm291624.htm.

    Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5857 Filed 3-9-12; 8:45 am]
BILLING CODE 4160-01-P


