International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials; Public Meeting, 50848-50849 [2019-20935]
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50848
Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices
Description: The proposed collection
is a continuation of the current
collection and comprised of two
components: An application including a
strategic plan that is due once every five
years, and an annual self-assessment.
The next collection (annual selfassessment) will be due June 30, 2020.
The next five-year application will be
due in 2021.
Respondents: We anticipate the
highest state court of every state, Puerto
Rico and the US Virgin Islands to
respond. All 52 jurisdictions currently
participate in the program.
ANNUAL BURDEN ESTIMATES
Collection
Average
burden
hours per
response
Total burden
hours
Complete Application ...........................................................
Complete Program Assessment Report ..............................
2021
2020
2021
2022
52
52
52
52
1
1
1
1
92
77
77
77
4784
4004
4004
4004
Total ..............................................................................
........................
........................
........................
........................
16,796
Estimated Total Annual Burden
Hours: 4004 hours in 2020 and 2022;
8788 hours in 2021 (when both the selfassessment and the 5-year application
are due within the year)
Authority: Sec. 50761, P.L. 115–123.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–20890 Filed 9–25–19; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3935]
International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use Global Meeting on E8(R1)
Guideline on General Considerations
for Clinical Trials; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting
The Food and Drug
Administration (FDA or Agency) is
announcing a public meeting entitled
‘‘International Council on
Harmonisation (ICH) Global Meeting on
E8(R1) Guideline on General
Considerations for Clinical Trials.’’ The
purpose of the public meeting is to
provide information on the draft revised
E8(R1) Guideline ‘‘General
Considerations for Clinical Trials’’ (ICH
E8 Guideline) following the closing of
the FDA comment period and closing of
the regional consultations conducted in
other ICH regions. The ICH E8
Guideline is being revised to provide
updated guidance that is both
appropriate and flexible enough to
address the increasing diversity of
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Year
VerDate Sep<11>2014
16:48 Sep 25, 2019
Jkt 247001
clinical trial designs and data sources
being employed to support regulatory
and other health policy decisions, while
retaining the underlying principles of
human subject protection and data
quality.
DATES: The public meeting will be held
on Thursday, October 31, 2019, from
8:30 a.m. to 5 p.m. 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 (nonFDA 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 in advance of
the meeting.
FOR FURTHER INFORMATION CONTACT:
Amanda Roache, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6364,
Silver Spring, MD 20993–0002, 301–
796–4548, Amanda.Roache@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The ICH was established in 1990 as a
joint regulatory/industry project to
improve, through harmonization, the
efficiency of the process for developing
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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.
This is accomplished through the
development of internationally
harmonized guidelines developed
through a process of scientific
consensus with regulatory and industry
experts. FDA participates in ICH as a
founding member and implements all
ICH guidelines as FDA guidance.
In 2015, 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 regulatory members
and observers. Expanded involvement is
also anticipated from global regulated
pharmaceutical industry parties, joining
as ICH industry members and observers.
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.
The ICH E8 Guideline sets out general
principles on the conduct of clinical
trials, was adopted in 1997, and has not
undergone revision. Since its adoption,
clinical trial design and conduct have
become more complex, impacting the
time and cost required to develop drugs.
A wide range of both trial designs and
data sources play a role in drug
development and are not adequately
addressed in the original ICH E8
Guideline. Approaches are needed for
E:\FR\FM\26SEN1.SGM
26SEN1
Federal Register / Vol. 84, No. 187 / Thursday, September 26, 2019 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
optimizing trial quality, which promote
the reliability, efficiency, and patient
focus of clinical trials. This involves
identifying the factors that are critical to
the quality of a clinical trial at the
design stage and planning the trial
conduct proportionate to the risks to
these quality factors, thereby protecting
human subjects and ensuring the
reliability of trial results. To resolve
these issues, the ICH Assembly initiated
a revision of the ICH E8 Guideline in
November 2017 to provide updated
guidance that is both appropriate and
flexible enough to address the
increasing diversity of clinical trial
designs and data sources being
employed to support regulatory and
other health policy decisions, while
retaining the underlying principles of
human subject protection and data
quality.
II. Topics for Discussion at the Public
Meeting
The draft revised ICH E8 Guideline
was endorsed by the ICH Assembly in
May 2019 and made available for public
comment. In the Federal Register of
August 1, 2019 (84 FR 37649), FDA
published a notice announcing the
availability of a draft guidance entitled
‘‘E8(R1) General Considerations for
Clinical Studies’’ (ICH E8(R1)
Guideline) (available at https://
www.fda.gov/media/129527/download).
The notice gave interested persons an
opportunity to submit comments by
September 30, 2019. As part of a broader
outreach process, ICH is holding public
meetings before the finalization of the
revised ICH E8(R1) Guideline. One of
these public meetings will be hosted by
FDA in Silver Spring, MD, on October
31, 2019 (see DATES and ADDRESSES).
The purpose of the public meeting is to
provide an overview of the new
concepts presented in the revised ICH
E8(R1) Guideline, allow for stakeholders
who will be affected by the revised
guideline to share their perspective, and
allow for public input.
Public consultation is a standard part
of all ICH guideline development, and it
is conducted within each region of ICH
Regulatory Members who commit to
adoption of the finalized ICH guideline.
This meeting is part of the ICH ‘‘Good
Clinical Practice (GCP) Renovation’’
strategy to update the ICH guidelines
related to clinical trial design, planning,
management, and conduct, starting with
the revision of the ICH E8 Guideline and
followed by the revision of the ICH E6
Guideline for Good Clinical Practice.
For more information, see the document
‘‘ICH Reflection on ‘GCP Renovation’:
Modernization of ICH E8 and
Subsequent Renovation of ICH E6,’’
VerDate Sep<11>2014
16:48 Sep 25, 2019
Jkt 247001
available at https://www.ich.org/
fileadmin/Public_Web_Site/ICH_
Products/Reflection_Papers/ICH_
Reflection_paper_GCP_Renovation_Jan_
2017_Final.pdf.
III. Participating in the Public Meeting
Registration: Persons interested in
attending this public meeting must
register online by October 25, 2019,
11:59 p.m. Eastern Time. To register for
the public meeting, please visit the
following website: https://
globalichmeeting_e8r1_2019_
americas.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. 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 is
available on the internet and can be
viewed at the following link: https://
www.fda.gov/news-events/fda-meetingsconferences-and-workshops/ich-globalmeeting-ich-e8r1-guideline-generalconsiderations-clinical-trials-1031201910312019.
If you need special accommodations
due to a disability, please contact
Amanda Roache (see FOR FURTHER
INFORMATION CONTACT) no later than
October 18, 2019.
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
October 18, 2019. Presentation slots may
be limited and will be granted on a firstcome, first-served basis. Any public
presentations should be limited to 5
minutes or less. 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 Amanda Roache (see
FOR FURTHER INFORMATION CONTACT) no
later than October 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
during the meeting will also be available
between 8 a.m. and 8:30 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/
ich103119/. To register to attend via
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
50849
webcast, please visit the following
website: https://globalichmeeting_e8r1_
2019_americas.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: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20935 Filed 9–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0994]
Modified Risk Tobacco Product
Applications for VLNTM King and
VLNTM Menthol King, Combusted,
Filtered Cigarettes, Submitted by 22nd
Century Group, Inc.; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
correction.
ACTION:
The Food and Drug
Administration is correcting a document
entitled ‘‘Modified Risk Tobacco
Product Applications for VLNTM King
and VLNTM Menthol King, Combusted,
Filtered Cigarettes, Submitted by 22nd
Century Group, Inc.’’ that published in
the Federal Register of July 25, 2019.
The document announced the
availability of modified risk tobacco
product applications for public
comment. The document published
with incorrect submission tracking
numbers. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT: Paul
Hart, Center for Tobacco Products, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993–0002, 1–877–
287–1373, AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 25, 2019 (84 FR
35869), in FR Doc. 2019–15831,
appearing on page 35869, the following
correction is made:
1. On page 35870, in the third
column, in the third full paragraph, the
submission tracking numbers
‘‘MR0000140: VLNTM’’ and
SUMMARY:
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50848-50849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20935]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3935]
International Council for Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on
General Considerations for Clinical Trials; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting entitled ``International Council on Harmonisation
(ICH) Global Meeting on E8(R1) Guideline on General Considerations for
Clinical Trials.'' The purpose of the public meeting is to provide
information on the draft revised E8(R1) Guideline ``General
Considerations for Clinical Trials'' (ICH E8 Guideline) following the
closing of the FDA comment period and closing of the regional
consultations conducted in other ICH regions. The ICH E8 Guideline is
being revised to provide updated guidance that is both appropriate and
flexible enough to address the increasing diversity of clinical trial
designs and data sources being employed to support regulatory and other
health policy decisions, while retaining the underlying principles of
human subject protection and data quality.
DATES: The public meeting will be held on Thursday, October 31, 2019,
from 8:30 a.m. to 5 p.m. 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
in advance of the meeting.
FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6364, Silver Spring, MD 20993-0002, 301-
796-4548, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The ICH 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. This is accomplished through the development of
internationally harmonized guidelines developed through a process of
scientific consensus with regulatory and industry experts. FDA
participates in ICH as a founding member and implements all ICH
guidelines as FDA guidance.
In 2015, 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 regulatory members and observers. Expanded
involvement is also anticipated from global regulated pharmaceutical
industry parties, joining as ICH industry members and observers. 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.
The ICH E8 Guideline sets out general principles on the conduct of
clinical trials, was adopted in 1997, and has not undergone revision.
Since its adoption, clinical trial design and conduct have become more
complex, impacting the time and cost required to develop drugs. A wide
range of both trial designs and data sources play a role in drug
development and are not adequately addressed in the original ICH E8
Guideline. Approaches are needed for
[[Page 50849]]
optimizing trial quality, which promote the reliability, efficiency,
and patient focus of clinical trials. This involves identifying the
factors that are critical to the quality of a clinical trial at the
design stage and planning the trial conduct proportionate to the risks
to these quality factors, thereby protecting human subjects and
ensuring the reliability of trial results. To resolve these issues, the
ICH Assembly initiated a revision of the ICH E8 Guideline in November
2017 to provide updated guidance that is both appropriate and flexible
enough to address the increasing diversity of clinical trial designs
and data sources being employed to support regulatory and other health
policy decisions, while retaining the underlying principles of human
subject protection and data quality.
II. Topics for Discussion at the Public Meeting
The draft revised ICH E8 Guideline was endorsed by the ICH Assembly
in May 2019 and made available for public comment. In the Federal
Register of August 1, 2019 (84 FR 37649), FDA published a notice
announcing the availability of a draft guidance entitled ``E8(R1)
General Considerations for Clinical Studies'' (ICH E8(R1) Guideline)
(available at https://www.fda.gov/media/129527/download). The notice
gave interested persons an opportunity to submit comments by September
30, 2019. As part of a broader outreach process, ICH is holding public
meetings before the finalization of the revised ICH E8(R1) Guideline.
One of these public meetings will be hosted by FDA in Silver Spring,
MD, on October 31, 2019 (see DATES and ADDRESSES). The purpose of the
public meeting is to provide an overview of the new concepts presented
in the revised ICH E8(R1) Guideline, allow for stakeholders who will be
affected by the revised guideline to share their perspective, and allow
for public input.
Public consultation is a standard part of all ICH guideline
development, and it is conducted within each region of ICH Regulatory
Members who commit to adoption of the finalized ICH guideline. This
meeting is part of the ICH ``Good Clinical Practice (GCP) Renovation''
strategy to update the ICH guidelines related to clinical trial design,
planning, management, and conduct, starting with the revision of the
ICH E8 Guideline and followed by the revision of the ICH E6 Guideline
for Good Clinical Practice. For more information, see the document
``ICH Reflection on `GCP Renovation': Modernization of ICH E8 and
Subsequent Renovation of ICH E6,'' available at https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Reflection_Papers/ICH_Reflection_paper_GCP_Renovation_Jan_2017_Final.pdf.
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online by October 25, 2019, 11:59 p.m. Eastern Time. To
register for the public meeting, please visit the following website:
https://globalichmeeting_e8r1_2019_americas.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. 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 is available on the internet and
can be viewed at the following link: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/ich-global-meeting-ich-e8r1-guideline-general-considerations-clinical-trials-10312019-10312019.
If you need special accommodations due to a disability, please
contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later
than October 18, 2019.
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 October 18, 2019.
Presentation slots may be limited and will be granted on a first-come,
first-served basis. Any public presentations should be limited to 5
minutes or less. 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 Amanda Roache (see FOR
FURTHER INFORMATION CONTACT) no later than October 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
during the meeting will also be available between 8 a.m. and 8:30 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/ich103119/. To register to attend via webcast,
please visit the following website: https://globalichmeeting_e8r1_2019_americas.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: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20935 Filed 9-25-19; 8:45 am]
BILLING CODE 4164-01-P
