[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]
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