
[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46508-46509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5017]


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 entitled ``Health Canada and U.S. Food and 
Drug Administration Joint Public Consultation on International Council 
for Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH).'' The purpose of this public meeting is to provide 
information and solicit public input on the current activities of ICH 
as well as the upcoming ICH Assembly Meeting and the Expert Working 
Group Meetings in Geneva, Switzerland, scheduled for November 11 
through 16, 2017. The topics to be discussed are the topics for 
discussion at the forthcoming ICH Assembly Meeting in Geneva.

DATES: The public meeting will be held on October 19, 2017, from 9 a.m. 
to 12 noon Eastern Time. Submit either electronic or written comments 
on this public meeting by October 26, 2017. See the SUPPLEMENTARY 
INFORMATION section for registration date and information. Registration 
to attend the meeting and requests for oral presentations must be 
received by October 16, 2017; see the SUPPLEMENTARY INFORMATION section 
for information on how to register for the meeting.

ADDRESSES: The public meeting will be held at the Sir Frederick G. 
Banting Research Centre, 251 Sir Frederick Banting Dr., 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: Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before October 26, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 27, 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.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-5017 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

[[Page 46509]]

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 Dockets Management Staff 
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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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, October 12, 2017, 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 Dockets Management Staff, 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: 
Amanda.Roache@fda.hhs.gov.

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 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. 
For those attending online, a link will be provided upon registration. 
In person 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 11:30 a.m. and 12 
noon. 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 12, 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 https://www.fda.gov/Drugs/NewsEvents/ucm574251.htm.

    Dated: September 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21437 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P


