[Federal Register Volume 84, Number 202 (Friday, October 18, 2019)]
[Notices]
[Pages 55971-55972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22760]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0444]
Health Canada and United States Food and Drug Administration
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 ``Health Canada and U.S. Food and
Drug Administration 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 Singapore scheduled for November 16 through
November 20, 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 Singapore.
DATES: The public meeting will be held on Monday, November 4, 2019,
from 1 p.m. to 4 p.m. Submit either electronic or written comments on
this public meeting by Friday, November 8, 2019. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public meeting will be held at Sir Frederick G. Banting
Research Centre, 251 Sir Frederick Banting Dr., Ottawa, ON K1Y 0M1,
Canada. The meeting 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 November 8, 2019. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time on November 8, 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 in the sections below (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 ``Health Canada and U.S. Food and Drug
Administration 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.
[[Page 55972]]
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:
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. (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.)
The topics for discussion at this public meeting include the
current guidelines under development under the ICH.
II. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online by October 28, 2019. To register for the public
meeting, please visit the following website: https://www.eventbrite.ca/e/health-canada-us-fda-joint-consultation-on-ich-tickets-63004743885.
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 28, 2019, midnight Eastern Time. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
The agenda for the public meeting will be made available on the
internet at: http://wcms-internet.fda.gov/drugs/news-events-human-drugs/health-canada-and-united-states-food-and-drug-administration-joint-regional-consultation 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 21, 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 October 28, 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 October 28, 2019. No commercial or
promotional material will be permitted to be presented or distributed
at the public meeting.
Streaming Webcast of the Public Meeting: To register to attend via
webcast, please visit the following website: https://www.eventbrite.ca/e/health-canada-us-fda-joint-consultation-on-ich-tickets-63004743885.
Dated: October 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22760 Filed 10-17-19; 8:45 am]
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