[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22614-22615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08880]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Public Meeting on the International Council for Harmonisation of 
Technical Requirements for Pharmaceuticals for Human Use

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 Agency) is announcing 
a regional public meeting entitled ``U.S. Food and Drug Administration 
and Health Canada Joint Public Consultation on International Council 
for Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH).'' The meeting will take place on the FDA campus and 
also be broadcast on the Internet. The goal of this meeting is to 
provide information and receive comments on the ICH, as well as 
information related to the upcoming ICH meetings in Lisbon, Portugal, 
in June 2016. The topics to be discussed in the regional public meeting 
are the topics for discussion at the forthcoming ICH Assembly Meeting. 
The purpose of this regional public meeting is to solicit public input 
prior to the next Assembly and Expert Working Group meetings in Lisbon, 
Portugal, scheduled for June 11 through 16, 2016, at which the 
discussion of the topics underway and ICH reforms will continue to 
progress.

DATES: The public meeting will be held on May 6, 2016, from 9 a.m. to 
12 p.m., EST. Registration to attend the Webcast and requests for oral 
presentations must be received by May 4, 2016. Interested persons may 
submit either electronic or written comments to the public docket (see 
ADDRESSES) by June 6, 2016.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center (Rm. 1503A), 
Silver Spring, MD 20993-0002. 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: 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 ``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 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, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301-796-
4548, [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

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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. Additionally, the 
reforms strengthen ICH as the leading platform for global 
pharmaceutical regulatory harmonization, and brings together in a 
transparent manner all key regulatory authorities and industry 
stakeholders.
    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 Management 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; the World Health Organization; and International 
Federation of Pharmaceutical Manufacturers and Associations (as 
Observers). 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. Webcast Attendance and Participation

A. Registration

    If you wish to attend this meeting, visit http://ichpublicconsult2016.eventbrite.com. Please register by May 4, 2016. If 
you are unable to attend the meeting in person, you can register to 
view a live Webcast on the meeting. You will be asked to indicate in 
your registration if you plan to attend in person or via the Webcast. 
Your registration must also contain your complete contact information, 
including name, title, affiliation, address, email address, and phone 
number. 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. Onsite 
registration on the day of the meeting will be based on space 
availability. If you need special accommodations because of a 
disability, please contact Amanda Roache (see FOR FURTHER INFORMATION 
CONTACT) at least 7 days before the Webcast.

B. Requests for Oral Presentations

    Interested persons may present data, information, or views orally 
or in writing on issues pending at the public Webcast. Public oral 
presentations will be scheduled between approximately 11:30 a.m. and 12 
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 29, 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 
Webcast will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm488618.htm.

    Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08880 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P