[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50110-50112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21594]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3636]


United States Food and Drug Administration and Health Canada 
Joint Public Consultation on the 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 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 ``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 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 Charlotte, NC, scheduled for November 11 through 15, 
2018. The topics to be discussed are the topics for discussion at the 
forthcoming ICH Assembly Meeting in Charlotte, NC.

DATES: The public meeting will be held on October 17, 2018, from 9 a.m. 
to 12 p.m., Eastern Time. Submit either electronic or written comments 
on this

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public meeting by October 31, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

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 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 31, 2018. 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-2018-N-3636 for ``U.S. Food and Drug Administration and Health 
Canada Joint Public Consultation on the International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use; Public Meeting and Webcast; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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, 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: William Lewallen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 301-
796-3810, [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 establish ICH as 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. Expanded involvement is also anticipated from 
global regulated pharmaceutical industry parties, joining as ICH 
observers and industry members. The reforms build on a 25-year track 
record of successful delivery of harmonized guidelines for global 
pharmaceutical development and regulation.
    ICH guidelines are developed following a five-step process. In Step 
1, experts from the different ICH regions work together to prepare a 
consensus draft of the Step 1 Technical Document. The Step 1 Technical 
Document is submitted to the ICH Assembly to request endorsement under 
Step 2a of the process. Step 2b is a ``Regulators only'' step in which 
the ICH regulatory members review the Step 2a Final Technical Document 
and take any actions, which might include revisions that they deem 
necessary, to develop the draft ``Guideline.'' Step 3 of the process 
begins with the public consultation process conducted by each of the 
ICH regulatory members in their respective regions, and this step 
concludes with completion and acceptance of any revisions that need to 
be made to the Step 2b draft guideline in response to public comments. 
Adoption of the new guideline occurs in Step 4. Following adoption, the 
harmonized guideline moves to Step 5, the final step of the process, 
when it is implemented by each of the regulatory members in their 
respective regions. The ICH process has achieved significant 
harmonization of

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the technical requirements for the approval of pharmaceuticals for 
human use in the ICH regions since 1990. More information on the 
current ICH process and structure can be found at the following 
website: http://www.ich.org.

II. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online by October 12, 2018. To register to attend the 
public meeting either in person or via webcast, please visit the 
following website: https://www.eventbrite.ca/e/health-canada-us-fda-ich-consultation-tickets-47713713000. Please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by October 12, 2018, 11:59 p.m. Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, the number of participants from each organization may be 
limited. The agenda for the public meeting will be made available on 
the internet at https://www.fda.gov/Drugs/NewsEvents/ucm612657.htm 
approximately 2 weeks in advance of the meeting.
    If you need special accommodations due to a disability, please 
contact William Lewallen (see FOR FURTHER INFORMATION CONTACT) no later 
than October 12, 2018.
    Requests for Oral Presentations: If you wish to make a presentation 
during the public comment session, please contact William Lewallen (see 
FOR FURTHER INFORMATION CONTACT) no later than October 12, 2018. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and request time for a 
joint presentation. All requests to make presentations must be received 
by the close of registration on October 12, 2018. If selected for 
presentation, any presentation materials must be emailed to William 
Lewallen (see FOR FURTHER INFORMATION CONTACT) no later than October 
12, 2018. No commercial or promotional material will be permitted to be 
presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. To register to attend via webcast, please visit the 
following website: https://www.eventbrite.ca/e/health-canada-us-fda-ich-consultation-tickets-47713713000. FDA has verified the website 
addresses in this document, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

    Dated: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21594 Filed 10-3-18; 8:45 am]
 BILLING CODE 4164-01-P