National Center for Complementary & Integrative Health; Notice of Closed Meeting, 76630-76631 [2022-27216]
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Federal Register / Vol. 87, No. 240 / Thursday, December 15, 2022 / Notices
regimens with treatment-shortening
regimens with improved safety and
efficacy. Thus, in this revised draft
guidance more detail is provided for
nonclinical models, early phase studies
and trial design considerations,
including the demonstration of efficacy
using superiority or noninferiority (NI)
trial designs. Additionally, updates are
made to pediatric patients being
included in trials, endpoint and safety
considerations, and labeling. The
Appendix is also updated with an
example of an NI margin justification.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Pulmonary Tuberculosis:
Developing Drugs for Treatment.’’ It
does not establish any rights for any
person and is 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 have
been approved under OMB control
numbers 0910–0014. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338. The collections of
information in 21 CFR 201.56 and
201.57 have been approved under OMB
control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27186 Filed 12–14–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–N–1048; FDA–
2012–N–0386; FDA–2019–N–0430; FDA–
2019–N–5553; FDA–2021–N–0555; FDA–
2013–N–0242; and FDA–2019–N–1517]
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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Medical Devices; Humanitarian Use Devices .........................................................................................................
Tobacco Product Establishment Registration and Submission of Certain Health Information ...............................
Generic Clearance for Quick Turnaround Testing of Communication Effectiveness .............................................
Right to Try Act: Reporting Requirements ..............................................................................................................
Medical Device Labeling Regulations .....................................................................................................................
Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs .....................................
Abbreviated New Animal Drug Applications ............................................................................................................
Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27192 Filed 12–14–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; 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.
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0910–0332
0910–0650
0910–0876
0910–0893
0910–0485
0910–0667
0910–0669
Date approval
expires
10/31/2025
10/31/2025
10/31/2025
10/31/2025
11/30/2025
11/30/2025
11/30/2025
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.
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Federal Register / Vol. 87, No. 240 / Thursday, December 15, 2022 / Notices
Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel; Promoting Research
on Music and Health: Phased Innovation
Award for Music Interventions (R61/R33)
Clinical Trial Optional.
Date: January 13, 2023.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Complementary
and Integrative, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Shiyong Huang, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, Division of Extramural Activities,
NCCIH/NIH, 6707 Democracy Boulevard,
Suite 401, Bethesda, MD 20817,
shiyong.huang@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: December 12, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–27216 Filed 12–14–22; 8:45 am]
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MSC 7804, Bethesda, MD 20892, 301–408–
9916, sizemoren@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 12, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–27219 Filed 12–14–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Assurance (Interinstitutional,
Foreign, and Domestic) and Annual
Report; Office of the Director (OD)
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Center for Scientific Review; Notice of
Closed Meeting
lotter on DSK11XQN23PROD with NOTICES1
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: Center for Scientific
Review Special Emphasis Panel; PA Panel:
Oncology Fellowships.
Date: January 3, 2023.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Nywana Sizemore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6189,
16:51 Dec 14, 2022
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
Office of Laboratory Animal Welfare
(OLAW) in the Office of Extramural
Research will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Jane J. Na, Director, Division of
Assurances, Office of Laboratory Animal
Welfare, NIH, call (301) 496–7163 or
email your request to olawdoa@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires written
comments and/or suggestions from the
public and affected agencies are invited
SUMMARY:
National Institutes of Health
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to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Assurance
(Interinstitutional, Foreign, and
Domestic) and Annual Report, OMB
#0925–0765, Expiration Date 11/30/
2022, REINSTATEMENT WITH
CHANGE, Office of the Director (OD),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The Office of Laboratory
Welfare (OLAW) is responsible for the
implementation, general administration,
and interpretation of the Public Health
Service (PHS) Policy on Humane Care
and Use of Laboratory Animals (Policy)
as codified in 42 CFR 52.8. The PHS
Policy implements the Health Research
Extension Act (HREA) of 1985 (Pub. L.
99–158 as codified in 42 U.S.C. 289d).
The PHS Policy requires entities that
conduct research involving vertebrate
animals using PHS funds to have an
Institutional Animal Care and Use
Committee (IACUC), provide assurance
that requirements of the Policy are met,
and submit an annual report. An
institution’s animal care and use
program is described in the Animal
Welfare Assurance (Assurance)
document and sets forth institutional
compliance with PHS Policy. The
purpose of the Assurance
(Interinstitutional, Foreign, and
Domestic) and Annual Report is to
provide OLAW with documentation to
satisfy the requirements of the HREA,
illustrate institutional adherence to PHS
Policy, and enable OLAW to carry out
its mission to ensure the humane care
and use of animals in PHS-supported
research, testing, and training, thereby
contributing to the quality of PHSsupported activities.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
9,219.
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[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Pages 76630-76631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27216]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Complementary & Integrative Health; 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.
[[Page 76631]]
Name of Committee: National Center for Complementary and
Integrative Health Special Emphasis Panel; Promoting Research on
Music and Health: Phased Innovation Award for Music Interventions
(R61/R33) Clinical Trial Optional.
Date: January 13, 2023.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Center for Complementary and Integrative,
Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Shiyong Huang, Ph.D., Scientific Review Officer,
Office of Scientific Review, Division of Extramural Activities,
NCCIH/NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, MD 20817,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.213,
Research and Training in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: December 12, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-27216 Filed 12-14-22; 8:45 am]
BILLING CODE 4140-01-P
