[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]
 BILLING CODE 4164-01-P