Agency Information Collection Request: 30-Day Public Comment Request, 77127-77128 [2022-27262]
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Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices
incorrect dates for these electronic study
data standards. This document corrects
those errors.
FOR FURTHER INFORMATION CONTACT:
Chenoa Conley, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117,
Silver Spring, MD 20993–0002, 301–
796–0035, cderdatastandards@
fda.hhs.gov, or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, Bldg.
71, Rm. 7301, Silver Spring, MD 20993–
0002, 240–402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 20, 2020 (85
FR 51450), in FR Doc. 2020–18236, the
following correction is made:
On page 51450, in the second and
third columns, the last paragraph of the
document is corrected to read as
follows: ‘‘On page 40659, in the first
column, the last three sentences of the
document are corrected to read as
follows: Support for version 1.7 of the
CDISC SDTM, version 3.3 of the
SDTMIG, and version 2.1 of the DefineXML will begin on March 15, 2021, and
the date that the requirement begins will
be on March 15, 2022, for new drug
applications, abbreviated new drug
applications, and certain biologics
license applications. For certain
investigational new drug applications,
the date that requirement begins will be
March 15, 2023. Support and
requirement for version 1.3 of the CDISC
SDTM and version 3.1.3 of the SDTMIG
will end on March 15, 2021.’’
Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27346 Filed 12–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0990-new]
Agency Information Collection
Request: 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
ACTION:
VerDate Sep<11>2014
20:05 Dec 15, 2022
Jkt 259001
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before January 17, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041, or PRA@HHS.GOV.
When submitting comments or
requesting information, please include
the document identifier 0990-New-30D
and project title for reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: National
Strategy for a Resilient Public Health
Supply Chain Paperwork Reduction Act
Clearance.
Type of Collection: New Father
Generic ICR.
OMB No. 0990-new—Administration
for Strategic Preparedness and
Response—Office of Strategy, Policy,
Planning, and Requirements.
Abstract: The Office of Strategy,
Policy, Planning, and Requirements,
within the Department of Health and
Human Services (HHS), Administration
for Strategic Preparedness and Response
(ASPR), is seeking OMB approval of a
SUMMARY:
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77127
new Generic clearance. In July 2021, the
White House published the National
Strategy for a Resilient Public Health
Supply Chain (National Strategy), which
provides a strategic approach to design,
build, and sustain a long-term capability
in the United States to manufacture
supplies for future pandemics and
biological threats. HHS is working with
the White House and across the federal
interagency to launch a multiyear
implementation of the National Strategy
involving the identification and
coordination of measurable activities
across the U.S. government, State, Local,
Tribal, and Territorial (SLTT)
jurisdictions, and the private sector.
HHS is requesting a 3-year PRA
generic clearance for purposes of
implementation to engage with SLTTs,
trade groups, mixed cross-sector
audiences, non-governmental
organizations, manufacturers, academia,
healthcare providers and facilities, local
communities, and other partners to: gain
a better understanding of the public
health supply chain; develop future
strategic goals and recommendations for
building immediate and long-term
resilience through increased visibility,
agility, and robustness in the public
health supply chain to prepare for and
mitigate future public health
emergencies; and to ensure ASPR, HHS,
and the broader U.S. government have
current data and information to inform
program and policy decision-making.
Cross-sectoral engagement underpins
many of the interdependent
implementation activities. For example,
one such activity involves information
collection from SLTT partners on
facility, local, and state stockpiling
plans to ensure coordinated plans are in
place for a future public health
emergency. Other potential engagements
include, but are not limited to
questionnaires, stakeholder meetings,
requests for information, town hall
meetings, and workshops. Stakeholder
engagement frequency will vary
depending on the type of stakeholder
and the information collection needs.
Therefore, some engagements may only
occur once, while others may require a
series of recurring meetings.
E:\FR\FM\16DEN1.SGM
16DEN1
77128
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE OVER THREE YEARS
Average
burden per
response
(in hours)
Total burden
hours
Number of respondents
Private sector companies, SLTT, Trade
groups and associations, NGOs, Manufacturers, distributors, Academia, Healthcare
delivery providers/facilities, Public, USG
Supply chain inventory holders, Biopharmaceutical industry, Biotechnology development companies, Communities, GPOs,
standards development organizations, logistics, third party contractors, purchasing
organizations, professional associations/societies, Mixed cross-sector audience, labor
unions, workforce training providers, organizations, state and local workforce boards.
32800 (Form: Informed consent) ...................
32800 (Form: Demographics standardized
questionnaire with decision logic allowing
some questions to be omitted).
1
1
5/60
15/60
2734
8200
6000(Form: Cognitive questionnaire) .............
6600(Form: Formative interviews and focus
groups).
10200 (Form: Town halls and public meetings).
1000 (Form: Supply chain questionnaires) ....
6000 (Form: Knowledge-based questionnaires).
3000 (Form: Interviews and focus groups) ....
1
2
8
4
48000
52800
2
8
163200
156
1
30/60
30/60
78000
3000
1
1
3000
........................
........................
358,934
Total .........................................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–27262 Filed 12–15–22; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
ACTION:
Office of the Secretary, HHS.
Notice.
Findings of research
misconduct have been made against
Alice C. Chang, Ph.D. (formerly named
Chun-Ju Chang) (Respondent), who was
an Associate Professor of Basic Medical
Sciences, College of Veterinary
Medicine, Purdue University (PU).
Respondent engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Cancer Institute
(NCI), National Institutes of Health
(NIH), grants P30 CA023168 and R37
CA215087. The administrative actions,
including debarment for a period of ten
(10) years, were implemented beginning
on December 7, 2022, and are detailed
below.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number
responses per
respondent
Type of respondent
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Acting
Director, Office of Research Integrity,
VerDate Sep<11>2014
20:05 Dec 15, 2022
Jkt 259001
.........................................................................
1101 Wootton Parkway, Suite 240,
Rockville, MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Alice C. Chang, Ph.D., Purdue
University: Based on the report of an
investigation conducted by PU and
additional analysis conducted by ORI in
its oversight review, ORI found that Dr.
Alice C. Chang (formerly named ChunJu Chang), former Associate Professor of
Basic Medical Sciences, College of
Veterinary Medicine, PU, engaged in
research misconduct in research
supported by U.S. Public Health Service
(PHS) funds, specifically National
Cancer Institute (NCI), National
Institutes of Health (NIH), grants P30
CA023168 and R37 CA215087.
ORI found that Respondent engaged
in research misconduct by knowingly,
intentionally, or recklessly falsifying
and/or fabricating data included in the
following sixteen (16) grant applications
submitted for PHS funds:
• R21 CA191797–01, ‘‘Targeting
miR–200c for early detection of
aggressive breast cancer,’’ submitted to
NCI, NIH, on 02/17/2014.
• R21 CA194474–01, ‘‘The role of
miRNA regulated-cell polarity
machinery in breast cancer stem cell
fate decision,’’ submitted to NCI, NIH,
on 06/19/2014.
• R03 CA198606–01, ‘‘Targeting cell
polarity machinery to exhaust breast
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Fmt 4703
Sfmt 4703
cancer stem cell pool,’’ submitted to
NCI, NIH, on 10/28/2014 (funded).
• R01 CA205940–01, ‘‘Epigenetic
regulation governing ATRA-mediated
cellular programming,’’ submitted to
NCI, NIH, on 06/04/2015.
• R01 CA208325–01, ‘‘Epigenetic
mechanism underlying retinoic acid
resistance in breast cancer stem cells,’’
submitted to NCI, NIH, on 10/05/2015.
• R01 CA208325–01A1, ‘‘Epigenetic
mechanism underlying retinoic acid
resistance in tumor stem cells,’’
submitted to NCI, NIH, on 11/07/2016.
• R21 CA215908–01, ‘‘Targeting
EMT-induced mitochondrial
heterogeneity in breast cancer,’’
submitted to NCI, NIH, on 06/24/2016.
• R01 CA211063–01, ‘‘The role of
mitochondrial regulation in directing
the cancer stem cell fate,’’ submitted to
NCI, NIH, on 01/28/2016.
• R01 CA215087–01, ‘‘Targeting
metformin-directed stem cell fate in
triple negative breast cancer,’’ submitted
to NCI, NIH, on 06/03/2016.
• R37 CA215087–01A1, ‘‘Targeting
metformin-directed stem cell fate in
triple negative breast cancer,’’ submitted
to NCI, NIH, on 03/06/2017 (funded).
• R01 CA226951–01, ‘‘(PQ11) Role of
DHA in directing luminal differentiation
and therapy response in triple-negative
breast cancer,’’ submitted to NCI, NIH,
on 06/22/2017.
• R01 CA231940–01, ‘‘Regulation of
Tet2 in programming mammary stem
cell fate,’’ submitted to NCI, NIH, on 10/
05/2017.
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77127-77128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27262]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier OS-0990-new]
Agency Information Collection Request: 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before January 17,
2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 264-0041, or [email protected]. When submitting comments or
requesting information, please include the document identifier 0990-
New-30D and project title for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: National Strategy for a Resilient Public
Health Supply Chain Paperwork Reduction Act Clearance.
Type of Collection: New Father Generic ICR.
OMB No. 0990-new--Administration for Strategic Preparedness and
Response--Office of Strategy, Policy, Planning, and Requirements.
Abstract: The Office of Strategy, Policy, Planning, and
Requirements, within the Department of Health and Human Services (HHS),
Administration for Strategic Preparedness and Response (ASPR), is
seeking OMB approval of a new Generic clearance. In July 2021, the
White House published the National Strategy for a Resilient Public
Health Supply Chain (National Strategy), which provides a strategic
approach to design, build, and sustain a long-term capability in the
United States to manufacture supplies for future pandemics and
biological threats. HHS is working with the White House and across the
federal interagency to launch a multiyear implementation of the
National Strategy involving the identification and coordination of
measurable activities across the U.S. government, State, Local, Tribal,
and Territorial (SLTT) jurisdictions, and the private sector.
HHS is requesting a 3-year PRA generic clearance for purposes of
implementation to engage with SLTTs, trade groups, mixed cross-sector
audiences, non-governmental organizations, manufacturers, academia,
healthcare providers and facilities, local communities, and other
partners to: gain a better understanding of the public health supply
chain; develop future strategic goals and recommendations for building
immediate and long-term resilience through increased visibility,
agility, and robustness in the public health supply chain to prepare
for and mitigate future public health emergencies; and to ensure ASPR,
HHS, and the broader U.S. government have current data and information
to inform program and policy decision-making.
Cross-sectoral engagement underpins many of the interdependent
implementation activities. For example, one such activity involves
information collection from SLTT partners on facility, local, and state
stockpiling plans to ensure coordinated plans are in place for a future
public health emergency. Other potential engagements include, but are
not limited to questionnaires, stakeholder meetings, requests for
information, town hall meetings, and workshops. Stakeholder engagement
frequency will vary depending on the type of stakeholder and the
information collection needs. Therefore, some engagements may only
occur once, while others may require a series of recurring meetings.
[[Page 77128]]
Estimated Annualized Burden Table Over Three Years
----------------------------------------------------------------------------------------------------------------
Average
Number burden per Total burden
Type of respondent Number of respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Private sector companies, SLTT, Trade 32800 (Form: Informed 1 5/60 2734
groups and associations, NGOs, consent). 1 15/60 8200
Manufacturers, distributors, 32800 (Form:
Academia, Healthcare delivery Demographics
providers/facilities, Public, USG standardized
Supply chain inventory holders, questionnaire with
Biopharmaceutical industry, decision logic allowing
Biotechnology development companies, some questions to be
Communities, GPOs, standards omitted).
development organizations, logistics,
third party contractors, purchasing
organizations, professional
associations/societies, Mixed cross-
sector audience, labor unions,
workforce training providers,
organizations, state and local
workforce boards.
6000(Form: Cognitive 1 8 48000
questionnaire).
6600(Form: Formative 2 4 52800
interviews and focus
groups).
10200 (Form: Town halls 2 8 163200
and public meetings).
1000 (Form: Supply chain 156 30/60 78000
questionnaires).
6000 (Form: Knowledge- 1 30/60 3000
based questionnaires).
3000 (Form: Interviews 1 1 3000
and focus groups).
-----------------------------------------------
Total............................. ........................ .............. .............. 358,934
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2022-27262 Filed 12-15-22; 8:45 am]
BILLING CODE 4150-37-P
