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, 55971-55972 [2019-22760]
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Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Notices
Food and Drug Administration
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.
[Docket No. FDA–2019–N–0444]
Electronic Submissions
agenda to maximize the educational
benefit. After a site is selected, OPQ will
communicate with the contact person
for the site to determine the actual dates
for the visit. Proposals submitted
without this minimum information will
not be considered. Based on response
rate and type of responses, OPQ may or
may not consider alternative pathways
to meeting our training goals.
Dated: October 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22767 Filed 10–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
Notice of public meeting;
request for comments.
ACTION:
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
SUMMARY:
VerDate Sep<11>2014
16:37 Oct 17, 2019
Jkt 250001
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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
55971
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/201523389.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.
E:\FR\FM\18OCN1.SGM
18OCN1
55972
Federal Register / Vol. 84, No. 202 / Friday, October 18, 2019 / Notices
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,
William.Lewallen@fda.hhs.gov.
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
VerDate Sep<11>2014
16:37 Oct 17, 2019
Jkt 250001
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.
(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-usfda-joint-consultation-on-ich-tickets63004743885. 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: https://wcms-internet.fda.gov/drugs/
news-events-human-drugs/healthcanada-and-united-states-food-anddrug-administration-joint-regionalconsultation 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)
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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-jointconsultation-on-ich-tickets63004743885.
Dated: October 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22760 Filed 10–17–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0370,
FDA–2013–N–0065, FDA–2012–N–0427,
FDA–2012–N–0536, FDA–2012–N–0873,
FDA–2015–N–3662, FDA–2012–N–0976,
FDA–2013–N–0297, FDA–2011–D–0893, and
FDA–2019–N–1265]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\18OCN1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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: https://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]
BILLING CODE 4164-01-P