National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 78698 [2022-27823]
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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The draft guidance provides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 The intent of the draft
guidance and supporting documents is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The draft guidance has been left in the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]
BILLING CODE 4164–01–P
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
Frm 00068
Fmt 4703
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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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]]>Agencies
[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Page 78698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27823]
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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.
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,
[email protected].
(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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