[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64164-64166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1112]


Health Canada and United States Food and Drug Administration 
Joint Public Consultation on International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use; Public 
Meeting and Webcast

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and Webcast; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a regional public meeting (which will also be Webcast) entitled 
``Health Canada and U.S. Food and Drug Administration Joint Public 
Consultation on International Council for Harmonisation of Technical

[[Page 64165]]

Requirements for Pharmaceuticals for Human Use (ICH).'' The goal of 
this meeting is to provide information and receive comments on the 
current activities of ICH, as well as the upcoming ICH meetings in 
Osaka, Japan, in November 2016. The topics to be discussed are the 
topics for discussion at the forthcoming ICH Assembly Meeting in Osaka. 
The purpose of this public meeting is to solicit public input prior to 
the next ICH Assembly meeting and the Expert Working Group meetings in 
Osaka, Japan, scheduled for November 6 through November 11, 2015.

DATES: The public meeting will be held on October 24, 2016, from 1 p.m. 
to 3 p.m., EST. Registration to attend the meeting and requests for 
oral presentations must be received by October 21, 2016; see the 
SUPPLEMENTARY INFORMATION section for information on how to register 
for the meeting. Interested persons may submit either electronic or 
written comments to the public docket (see ADDRESSES) by October 19, 
2016.

ADDRESSES: The meeting will be held at Sir Frederick G. Banting 
Research Centre, 251 Sir Frederick Banting Driveway, Ottawa, ON K1Y 
0M1, Canada. It will also be broadcast on the Web allowing participants 
to join in person or via the Web.
    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 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-2016-N-1112 for ``Health Canada and U.S. Food and Drug 
Administration Joint Public Consultation on International Council on 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use; Public Meeting.'' 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. 1176, 
Silver Spring, MD 20993, 301-796-4548, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The ICH, formerly known as the International Conference on 
Harmonisation 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 2015 the ICH was 
reformed to make the ICH a true global initiative that expands beyond 
the previous ICH members. More involvement from regulators around the 
world is expected, as they will join their counterparts from Europe, 
Japan, the United States, Canada, and Switzerland as ICH regulatory 
members. The reforms build on a 25-year track record of successful 
delivery of harmonized guidelines for global pharmaceutical 
development, and their regulation. 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. The ICH process has achieved 
significant harmonization of

[[Page 64166]]

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 meeting, please register at the following 
Web site: https://healthcanada-usfda_ich_consultation.eventbrite.ca. 
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 Oral Presentations

    Interested persons may present data, information, or views orally 
or in writing on issues pending at the public Webinar. Public oral 
presentations will be scheduled between approximately 2:30 p.m. and 3 
p.m. Time allotted for oral presentations may be limited to 5 minutes. 
Those desiring to make oral presentations should notify Amanda Roache 
(see FOR FURTHER INFORMATION CONTACT) by October 19, 2016, 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 
Webinar will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm516166.htm.

    Dated: September 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22471 Filed 9-16-16; 8:45 am]
BILLING CODE 4164-01-P