[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13659-13660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04754]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0256]
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 Vancouver, Canada, scheduled for May 23
through 27, 2020. 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 Vancouver.
DATES: The public meeting will be held on Friday, April 3, 2020, from
10 a.m. to 1 p.m. Submit either electronic or written comments on this
public meeting by Thursday, April 30, 2020. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public meeting will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the
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 May 20, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on Thursday, April 30, 2020. 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-2020-N-0256 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
[[Page 13660]]
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.govinfo.gov/content/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 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 2, 2020. To register for the public
meeting, please visit the following website: https://ich_regional_consultation_2020.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 in person must register by April 2, 2020, 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 http://wcms-internet.fda.gov/drugs/news-events-human-drugs/health-canada-and-fda-joint-public-consultation-international-council-harmonisation-technical-0 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 March 20, 2020.
Persons attending FDA's meetings are advised that FDA is not
responsible for providing access to electrical outlets.
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 March 20, 2020.
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 2, 2020. 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/fdahealthcanada/. To register to attend via
webcast, please visit the following website: https://ich_regional_consultation_2020.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 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04754 Filed 3-6-20; 8:45 am]
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