[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Pages 11803-11804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05955]



[[Page 11803]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0444]


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 Amsterdam, Netherlands, scheduled for June 2 
through 6, 2019. 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 Amsterdam.

DATES: The public meeting will be held on April 29, 2019, from 10 a.m. 
to 1 p.m. Submit either electronic or written comments on this public 
meeting by May 20, 2019. 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, the Great Room 
(Rm. 1503), 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 May 20, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time on May 20, 2019. 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-2019-N-0444 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: William Lewallen, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6304, Silver 
Spring, MD 20993-0002, 301-796-3810, [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 11804]]

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 it as a true global 
initiative and to expand 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 built on a 25-year track record and have allowed ICH to 
continue its successful delivery of harmonized guidelines for global 
pharmaceutical development and their regulation.

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. 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: https://www.ich.org.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting 
must register online by April 22, 2019. To register for the public 
meeting, please visit the following website: https://ich_regional_consultation_2019.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 22, 2019, 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/ucm624770.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 April 15, 2019.
    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 April 15, 2019. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their presentations and request time for a 
joint presentation. If selected for presentation, any presentation 
materials must be emailed to William Lewallen (see FOR FURTHER 
INFORMATION CONTACT) no later than April 24, 2019. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public meeting. Signup 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 through the following link: https://collaboration.fda.gov/ich2019. To register to attend via webcast, 
please visit the following website: https://ich_regional_consultation_2019.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: March 21, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05955 Filed 3-27-19; 8:45 am]
BILLING CODE 4164-01-P