[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67764-67766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27953]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3921]
Health Canada and United States Food and Drug Administration
Joint Public Consultation on International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for Human
Use; Public Webinar; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public webinar; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a regional public webinar entitled ``Health Canada and U.S. Food and
Drug Administration Joint Public Consultation on International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH).'' The goal of this webinar is
to provide information and receive comments on the ICH, as well as the
upcoming ICH meetings in Jacksonville, FL, in December 2015. The topics
to be discussed are the topics for discussion at the forthcoming ICH
Management Steering Meeting. The purpose of the webinar is to solicit
public input prior to the next Steering Committee and Expert Working
Group meetings in Jacksonville, FL, scheduled for December 5 to 10,
2015, at which the discussion of the topics underway and ICH reforms
will continue.
DATES: The public webinar will be held on November 12, 2015, from 1
p.m. to 4 p.m., Eastern Standard Time. Registration to attend the
webinar and requests for online presentations must be received by
November 6, 2015. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the webinar. Interested persons may
submit either electronic or written comments to the public docket (see
ADDRESSES) by December 12, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your
[[Page 67765]]
comment will be made public, you are solely responsible for ensuring
that your comment does not include any confidential information that
you or a third party may not wish to be posted, such as medical
information, your or anyone else's Social Security number, or
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-3921 for ``Health Canada and U.S. Food and Drug
Administration Joint Public Consultation on International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use; Public Webinar.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amanda Roache, Food and Drug
Administration, Center for Drug Evaluation and Research, Office of
Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1128,
Silver Spring, MD 20993, 301-796-4548, 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. 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 as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.)
II. Webinar Attendance and Participation
A. Registration
If you wish to attend the webinar, submit a request in writing via
email to sc.gc.ca">HPFB_ICH_DGPSA@hc-sc.gc.ca by November 6, 2015. Registrations
may be limited, so early registration is recommended. Registration is
free and will be on a first-come, first-served basis. However, the
number of participants from each organization may be limited based on
space limitations. Registrants will receive confirmation once they have
been accepted. If you need special accommodations because of a
disability, please contact Amanda Roache (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the webinar.
B. Requests for Online Presentations
Interested persons may present data, information, or views orally
or in writing on issues pending at the public webinar. Online
presentations made by the public will be scheduled between
approximately 3:30 p.m. and 4 p.m. Time allotted for online
presentations may be limited to 5 minutes. Those desiring to make
online presentations should notify Amanda Roache (see FOR FURTHER
INFORMATION CONTACT) by November 6, 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
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indication of the approximate time requested to make their
presentation. The agenda for the public webinar will be made available
on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm466461.htm.
III. Transcripts
Please be advised that as soon as a webinar transcript is
available, FDA will post it at http://www.fda.gov/Drugs/NewsEvents/ucm466461.htm.
Dated: October 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27953 Filed 11-2-15; 8:45 am]
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