[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Notices]
[Pages 9001-9003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04256]


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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 the International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use; Public Meeting; 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 Agency) is announcing 
a regional public meeting entitled ``U.S. Food and Drug Administration 
and Health Canada Joint Regional Consultation on the International 
Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use (ICH).'' The purpose of the public meeting is to provide 
information and solicit public input on the current activities of the 
ICH, as well as the upcoming ICH Assembly Meeting and the Expert 
Working Group Meetings in Kobe, Japan, scheduled for June 4 through 7, 
2018. The topics to be addressed at the public meeting are the current 
ICH guideline topics under development that will be discussed at the 
forthcoming ICH Assembly Meeting in Kobe.

DATES: The public meeting will be held on Friday, April 6, 2018, from 
10 a.m. to 1 p.m. Submit either electronic or written comments on this 
public meeting by April 30, 2018. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (Great 
Room), Silver Spring, MD 20993-0002. The meeting will also be broadcast 
on the web, allowing participants to join in person OR via the web. For 
those who will attend in person, the 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. For 
those who register to attend the public meeting remotely via the 
webcast, a link to access the webcast will be emailed 1 week in advance 
of the meeting.
    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 April 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 30, 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 in the sections below (see ``Written/Paper Submissions'' and 
``Instructions'').

[[Page 9002]]

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-2016-N-1112 for ``U.S. Food and Drug Administration and Health 
Canada Joint Regional Consultation on the International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use; Public Meeting; 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 https://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: Amanda Roache, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 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 requirements for safety and effectiveness. One of the goals 
of harmonization is to identify and then reduce regional differences in 
technical regulatory requirements for pharmaceutical products while 
preserving a consistently high standard for drug efficacy, safety, and 
quality. 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 join 
counterparts from Europe, Japan, the United States, Canada, and 
Switzerland as ICH observers and 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 their 
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 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/home.html. (FDA has verified 
the website addresses, as of the date this document publishes in the 
Federal Register, but websites are subject to change over time.)

II. Topics for Discussion at the Public Meeting

    The topics for discussion at this public meeting include the 
current guidelines under development under the ICH. These guidelines 
include the following:
    Topics Currently Under Regional Public Consultation (Step 3 of ICH 
Process):

 S11 Nonclinical Safety Testing in Support of Development of 
Pediatric Medicines
 Q12 Technical and Regulatory Considerations for Pharmaceutical 
Product Lifecycle Management
 E9(R1) Addendum: Statistical Principles for Clinical Trials

    Selected Topics Recently Finalized (Step 4 of ICH Process):

 E17 General Principles on Planning/Designing Multi-Regional 
Clinical Trials

    Electronic Standards and MedDRA (Medical Dictionary for Regulatory 
Activities):

 M2 Electronic Standards for the Transfer of Regulatory 
Information
 M8 Electronic Common Technical Document (eCTD)
 E2B Clinical Safety Data Management: Data Elements for 
Transmission of Individual Case Safety Reports
 M1 MedDRA Terminology

    Additional Ongoing Topics:


[[Page 9003]]


 E19 Optimization of Safety Data Collection
 E8(R1) Revision on General Considerations for Clinical Trials
 E11A Pediatric Extrapolation
 E14/S7B Discussion Group on Clinical and Nonclinical 
Evaluation of QT/QTc Interval Prolongation
 M9 Biopharmaceutics Classification System-Based Biowaivers
 M10 Bioanalytical Method Validation
 S1(R1) Revision on Rodent Carcinogenicity Studies for Human 
Pharmaceuticals
 S5(R3) Revision on Detection of Toxicity to Reproduction for 
Human Pharmaceuticals
 Q3C(R7) Impurities: Guideline for Residual Solvents
 Q3D(R1) Guideline on Elemental Impurities

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online by April 3, 2018. To register for the public 
meeting, please visit the following website: https://ich_regional_consultation_2018.eventbrite.com. 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 April 3, 2018, midnight Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. If time 
and space permit, onsite registration on the day of the public meeting 
will be provided beginning at 9:30 a.m.
    The agenda for the public meeting will be made available on the 
internet at https://www.fda.gov/Drugs/NewsEvents/ucm592065.htm 
approximately 2 weeks in advance of the meeting.
    If you need special accommodations due to a disability, please 
contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later 
than March 23, 2018.
    Requests for Oral Presentations: If you wish to make a presentation 
during the public comment session, please contact Amanda Roache (see 
FOR FURTHER INFORMATION CONTACT) no later than March 23, 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 April 3, 2018. If selected for 
presentation, any presentation materials must be emailed to Amanda 
Roache (see FOR FURTHER INFORMATION CONTACT) no later than April 3, 
2018. No commercial or promotional material will be permitted to be 
presented or distributed at the public meeting. Sign-up for making a 
public comment will also be available between 9 a.m. and 10 a.m. on the 
day of the 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://ich_regional_consultation_2018.eventbrite.com. If you have never 
attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a 
quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. 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: February 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04256 Filed 3-1-18; 8:45 am]
 BILLING CODE 4164-01-P