Notice To Announce the Updated Significant Changes to the Revised NIH Grants Policy Statement for Fiscal Year 2023, 78698-78699 [2022-27770]
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78698
Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
industry parties in detailed technical
harmonization work and the application
of a science-based approach to
harmonization through a consensusdriven process that results in the
development of ICH guidelines. The
regulators around the world are
committed to consistently adopting
these consensus-based guidelines,
realizing the benefits for patients and for
industry.
As a Founding Regulatory Member of
ICH, FDA plays a major role in the
development of each of the ICH
guidelines, which FDA then adopts and
issues as guidance for industry. FDA’s
guidance documents do not establish
legally enforceable responsibilities.
Instead, they describe the Agency’s
current thinking on a topic and should
be viewed only as recommendations,
unless specific regulatory or statutory
requirements are cited.
In September 2022, the ICH Assembly
endorsed the draft guideline entitled
‘‘M11 Clinical Electronic Structured
Harmonised Protocol (CeSHarP)’’ and
two supplemental documents entitled
‘‘M11 Template,’’ and ‘‘M11 Technical
Specification’’ and agreed that the
materials should be made available for
public comment. The draft guideline
and supplemental documents are the
product of the Multidisciplinary Expert
Working Group of the ICH. Comments
about these draft guidances will be
considered by FDA and the
Multidisciplinary Expert Working
Group.
The draft guidance provides
recommendations for a harmonized
clinical trial protocol including the
organization of standardized content
and formatting. The draft template
identifies headers, common text, and a
set of data fields and terminologies that
will be the basis for efficiencies in data
exchange. The technical specification
recommends the use of an open,
nonproprietary standard to enable
electronic exchange of clinical protocol
information. The intent of the draft
guidance and supporting documents is
to create an international standard for
the content and exchange of clinical
trial protocol information facilitating
review and assessment by regulators,
sponsors, ethical oversight bodies,
investigators, and other stakeholders.
The draft guidance has been left in the
original ICH format. The final guidance
and supporting materials will be
reformatted and edited to conform with
FDA’s good guidance practices
regulation (21 CFR 10.115) and style
before publication. The draft guidance,
template, and technical specification
when finalized, will represent the
current thinking of FDA on the topics
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they address. They do not establish any
rights for any person and are not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312
pertaining to clinical trial design and
protocols have been approved under
OMB control number 0910–0014. The
collections of information pertaining to
good clinical practice and for the
implementation of improved and
efficient approaches to clinical trial
design have been approved under OMB
control number 0910–0843.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance, template,
and technical specification at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27832 Filed 12–21–22; 8:45 am]
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the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel Fellowships in
Digestive Diseases and Nutrition.
Date: February 16–17, 2023.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Diabetes and Digestive
and Kidney Diseases, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Jian Yang, Ph.D., Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes of Health, Room
7011, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7799, yangj@
extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: December 16, 2022.
David W Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–27823 Filed 12–21–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice To Announce the Updated
Significant Changes to the Revised
NIH Grants Policy Statement for Fiscal
Year 2023
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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ACTION:
Notice.
The National Institutes of
Health (NIH) announces publication of
the updated Significant Changes that
have already been made to the NIH
Grants Policy Statement (NIHGPS) in
fiscal year 2022 that will be reflected in
the GPS for fiscal year 2023. The
NIHGPS provides both up-to-date policy
guidance that serves as NIH standard
terms and conditions of award for all
NIH grants and cooperative agreements,
and extensive guidance to those who are
interested in pursuing NIH grants. This
update incorporates significant changes
for FY 2023, such as new and modified
SUMMARY:
National Institutes of Health
PO 00000
National Institutes of Health,
HHS.
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Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
requirements, clarifies certain policies,
and implements changes in statutes,
regulations, and policies that have been
implemented through appropriate legal
and/or policy processes since the
previous version of the NIHGPS dated
December 2021.
The Significant Changes to the
revised NIHGPS for Fiscal Year 2023 is
now available for viewing.
DATES:
Please visit our website to
view the updated Significant Changes
for Fiscal Year 2023 and NIHGPS at
https://grants.nih.gov/policy/nihgps/
index.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Xanthia James, Director, Division of
Grants Policy, Office of Policy for
Extramural Research Administration,
NIH, Rockledge I, Suite 350, Bethesda,
MD 20817. Email: Xanthia.James@
nih.gov. Phone number (301) 435–0949.
The
requirements set out in the NIHGPS are
aligned with 2 CFR part 200, as
implemented for the Health and Human
Services (HHS) at 45 CFR part 75,
Uniform Administrative Requirements,
Cost Principles, and Audit
Requirements for HHS Awards. This
update is applicable to all NIH grants
and cooperative agreements with budget
periods beginning on or after October 1,
2022. This update supersedes, in its
entirety, the NIHGPS dated December
2021. Previous versions of the NIHGPS
remain applicable as standard terms and
conditions of award for all NIH grants
and cooperative agreements with budget
periods that began prior to October 1,
2022. This update incorporates new and
modified requirements, clarifies certain
policies, and implements changes in
statutes, regulations, and policies that
have been implemented through
appropriate legal and/or policy
processes since the previous version of
the NIHGPS dated December 2021. The
current version of the NIHGPS, in both
HTML and PDF formats, as well as
previous versions of the NIHGPS and
documents summarizing significant
changes implemented with each
revision, are available at https://
grants.nih.gov/policy/nihgps/index.htm.
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Dated: December 1, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National
Institutes of Health.
[FR Doc. 2022–27770 Filed 12–21–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of Support for Research
Excellence (SuRE) Program (R16).
Date: March 23, 2023.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medicine
Science, Natcher Building, 45 Center Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Lee Warren Slice, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health 45,
Center Drive, Room 3AN12, Bethesda, MD
20892, 301–435–0807, slicelw@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: December 16, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–27829 Filed 12–21–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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78699
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel Using the
Science of Science to Accelerate Progress on
Alzheimer’s Disease.
Date: January 24, 2023.
Time: 12:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Aging, Gateway
Building, 7201 Wisconsin Avenue, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Joshua Jin-Hyouk Park,
Ph.D., Scientific Review Officer, National
Institutes of Health, National Institute on
Aging, Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20892,
(301) 496–6208 joshua.park4@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: December 16, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–27822 Filed 12–21–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\22DEN1.SGM
22DEN1
]]>Agencies
[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78698-78699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27770]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice To Announce the Updated Significant Changes to the Revised
NIH Grants Policy Statement for Fiscal Year 2023
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) announces publication
of the updated Significant Changes that have already been made to the
NIH Grants Policy Statement (NIHGPS) in fiscal year 2022 that will be
reflected in the GPS for fiscal year 2023. The NIHGPS provides both up-
to-date policy guidance that serves as NIH standard terms and
conditions of award for all NIH grants and cooperative agreements, and
extensive guidance to those who are interested in pursuing NIH grants.
This update incorporates significant changes for FY 2023, such as new
and modified
[[Page 78699]]
requirements, clarifies certain policies, and implements changes in
statutes, regulations, and policies that have been implemented through
appropriate legal and/or policy processes since the previous version of
the NIHGPS dated December 2021.
DATES: The Significant Changes to the revised NIHGPS for Fiscal Year
2023 is now available for viewing.
ADDRESSES: Please visit our website to view the updated Significant
Changes for Fiscal Year 2023 and NIHGPS at https://grants.nih.gov/policy/nihgps/index.htm.
FOR FURTHER INFORMATION CONTACT: Xanthia James, Director, Division of
Grants Policy, Office of Policy for Extramural Research Administration,
NIH, Rockledge I, Suite 350, Bethesda, MD 20817. Email:
[email protected]. Phone number (301) 435-0949.
SUPPLEMENTARY INFORMATION: The requirements set out in the NIHGPS are
aligned with 2 CFR part 200, as implemented for the Health and Human
Services (HHS) at 45 CFR part 75, Uniform Administrative Requirements,
Cost Principles, and Audit Requirements for HHS Awards. This update is
applicable to all NIH grants and cooperative agreements with budget
periods beginning on or after October 1, 2022. This update supersedes,
in its entirety, the NIHGPS dated December 2021. Previous versions of
the NIHGPS remain applicable as standard terms and conditions of award
for all NIH grants and cooperative agreements with budget periods that
began prior to October 1, 2022. This update incorporates new and
modified requirements, clarifies certain policies, and implements
changes in statutes, regulations, and policies that have been
implemented through appropriate legal and/or policy processes since the
previous version of the NIHGPS dated December 2021. The current version
of the NIHGPS, in both HTML and PDF formats, as well as previous
versions of the NIHGPS and documents summarizing significant changes
implemented with each revision, are available at https://grants.nih.gov/policy/nihgps/index.htm.
Dated: December 1, 2022.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2022-27770 Filed 12-21-22; 8:45 am]
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