[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19668-19669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1082]


Preparation for International Conference on Harmonization 
Steering Committee and Expert Working Group Meetings in Fukuoka, Japan; 
Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
regional 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 6 through 11, 2015, at which the discussion of the 
topics underway and ICH reforms will continue.

DATES: The public meeting will be held on May 15, 2015, from 1 p.m. to 
4 p.m. Registration to attend the meeting and requests for oral 
presentations must be received by May 11, 2015. See the SUPPLEMENTARY 
INFORMATION section for information on how to register for the meeting.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, Great Room 
(Rm. 1503 A), Silver Spring, MD 20993. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit either electronic or written comments by June 14, 2015. 
Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. All comments should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Tracy Porter, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1173, Silver Spring, MD 20993, 301-796-
7789, FAX: 301-847-8443, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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.

[[Page 19669]]

    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. Members of the ICH Steering Committee include 
the European Union; the European Federation of Pharmaceutical 
Industries Associations; the Japanese Ministry of Health, Labor, and 
Welfare; the Japanese Pharmaceutical Manufacturers Association; FDA; 
the Pharmaceutical Research and Manufacturers of America; Health 
Canada; Swissmedic; and the World Health Organization (as an Observer). 
The ICH process has achieved significant harmonization of the technical 
requirements for the approval of pharmaceuticals for human use in the 
ICH regions over the past two decades.
    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.)

II. Meeting Attendance and Participation

A. Registration

    If you wish to attend the meeting, visit https://www.eventbrite.com/e/international-conference-on-harmonization-regional-public-meeting-tickets-16183519342. Please register for the 
meeting by May 11, 2015. Seating may be limited, so early registration 
is recommended. Registration is free and will be on a first-come, 
first-served basis. However, FDA may limit the number of participants 
from each organization based on space limitations. Registrants will 
receive confirmation once they have been accepted. Onsite registration 
on the day of the meetings will be based on space availability.
    If you need special accommodations because of a disability, please 
contact Tracy Porter (see FOR FURTHER INFORMATION CONTACT) at least 7 
days before the meeting.

B. Requests for Oral Presentations

    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 5 minutes. 
Those desiring to make oral presentations should notify Tracy Porter 
(see FOR FURTHER INFORMATION CONTACT) by May 11, 2015, 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.
    The agenda for the public meeting will be made available on the 
Internet at http://www.fda.gov/Drugs/NewsEvents/ucm439475.htm.

III. Comments

    Interested persons may submit either electronic or written comments 
to the public docket (see ADDRESSES) by June 14, 2015. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

IV. Transcripts

    Please be advised that as soon as a meeting transcript is 
available, FDA will post it at http://www.fda.gov/Drugs/NewsEvents/ucm439475.htm.

    Dated: April 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08359 Filed 4-10-15; 8:45 am]
 BILLING CODE 4164-01-P