[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Notices]
[Pages 13458-13459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04839]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

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 or the Agency) is 
announcing a regional public meeting entitled ``U.S. Food and Drug 
Administration and Health Canada Joint Regional Consultation on 
International Council for Harmonisation of Technical 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 Montreal. The topics to be 
covered in the public meeting are the topics for discussion at the 
forthcoming ICH Assembly Meeting in Montreal. The purpose of this 
public meeting is also to solicit public input prior to the ICH 
Assembly meeting and the Expert Working Group meetings in Montreal, 
Canada, scheduled for May 28 through June 1, 2017.

DATES: The public meeting will be held on April 24, 2017, from 11 a.m. 
to 2 p.m., Eastern Time. Submit either electronic or written comments 
on this public meeting by May 12, 2017. Late, untimely filed comments 
will not be considered. Electronic comments must be submitted on or 
before May 12, 2017. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
May 12, 2017. Comments received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date. See the SUPPLEMENTARY INFORMATION section for registration 
date and information. Registration to attend the meeting and requests 
for oral presentations must be received by April 19, 2017; see the 
SUPPLEMENTARY INFORMATION section for information on how to register 
for the meeting.

ADDRESSES: The public meeting will be held at 10903 New Hampshire Ave., 
Bldg. 31, Rm. 1503 Section A, Silver Spring, MD 20993. It will also be 
broadcast on the Web allowing participants to join in person OR via the 
Web. 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.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 the U.S. Food and Drug Administration and Health 
Canada Joint Public Consultation on International Council on 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use; Public Meeting. Received comments, those filed in a timely manner 
(see DATES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://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

[[Page 13459]]

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 https://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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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, USA, 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 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://ich_regional_consultation.eventbrite.com. 
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 
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 1:30 p.m. and 2 
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 April 19, 2017, 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/ucm536015.htm.

    Dated: March 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04839 Filed 3-10-17; 8:45 am]
 BILLING CODE 4164-01-P