Proposed Collection: 60-Day Comment Request; Generic Clearance to Support the Safe to Sleep® Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development, 80123-80124 [2020-27192]
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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
• R01 HL142576–01, submitted to
National Heart, Lung, and Blood
Institute (NHLBI), NIH
• R01 NR016957–02, submitted to
NINR, NIH
ORI found that Respondent
knowingly, intentionally, or recklessly
falsified and/or fabricated histological
images and bar graphs of fluorescent
signal data for the production of reactive
oxygen species (ROS) in rat lung tissue
slices and isolated alveolar type-2 cells
by reusing and relabeling previously
published figures to represent results
from different experiments in twelve
(12) figures and related text included in
six (6) grant applications. Specifically,
Respondent falsified data in:
• Figures 4 and 5 in R01 NR016242–01
• Figures 2 and 3 in R01 NR016242–
01A1
• Figures 3A and 3B in R01 NR016957–
01
• Figures 3A and 3B in R01 NR016957–
01A1
• Figures 3A and 3B in R01 HL142576–
01
• Figures 3A and 3B in R01 NR016957–
02
Respondent entered into an
Agreement and agreed to the following:
(1) Respondent agreed to have his
research supervised for a period of four
(4) years beginning on November 18,
2020. Respondent agrees that prior to
the submission of an application for
PHS support for a research project on
which Respondent’s participation is
proposed and prior to Respondent’s
participation in any capacity on PHSsupported research, Respondent shall
ensure that a plan for supervision of
Respondent’s duties is submitted to ORI
for approval. The supervision plan must
be designed to ensure the scientific
integrity of Respondent’s research
contribution. Respondent agrees that he
shall not participate in any PHSsupported research until such a
supervision plan is submitted to and
approved by ORI. Respondent agrees to
maintain responsibility for compliance
with the agreed upon supervision plan.
(2) The requirements for Respondent’s
supervision plan are as follows:
i. A committee of 2–3 senior faculty
members at the institution who are
familiar with Respondent’s field of
research, but not including
Respondent’s supervisor or
collaborators, will provide oversight and
guidance for a period of four (4) years
from the effective date of the
Agreement. The committee will review
primary data from Respondent’s
laboratory on a quarterly basis and
submit a report to ORI at six (6) month
intervals, setting forth the committee
VerDate Sep<11>2014
23:25 Dec 10, 2020
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meeting dates and Respondent’s
compliance with appropriate research
standards and confirming the integrity
of Respondent’s research.
ii. The committee will conduct an
advance review of any PHS grant
applications (including supplements,
resubmissions, etc.), manuscripts
reporting PHS-funded research
submitted for publication, and abstracts.
The review will include a discussion
with Respondent of the primary data
represented in those documents and
will include a certification to ORI that
the data presented in the proposed
application/publication are supported
by the research record.
(3) Respondent agreed that for a
period of four (4) years beginning on
November 18, 2020, any institution
employing him shall submit, in
conjunction with each application of
PHS funds, or report, manuscript, or
abstract involving PHS-supported
research in which Respondent is
involved, a certification to ORI that the
data provided by Respondent are based
on actual experiments or are otherwise
legitimately derived and that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract.
(4) If no supervisory plan is provided
to ORI, Respondent agreed to provide
certification to ORI at the conclusion of
the supervision period that he has not
engaged in, applied for, or had his name
included on any application, proposal,
or other request for PHS funds without
prior notification to ORI.
(5) Respondent agreed to exclude
himself voluntarily from serving in any
advisory capacity to PHS including, but
not limited to, service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant for
a period of four (4) years, beginning on
November 9, 2020.
Dated: December 8, 2020.
Elisabeth A. Handley,
Director, Office of Research Integrity, Office
of the Assistant Secretary for Health.
[FR Doc. 2020–27309 Filed 12–10–20; 8:45 am]
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80123
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection: 60-Day Comment
Request; Generic Clearance to Support
the Safe to Sleep® Campaign at the
Eunice Kennedy Shriver National
Institute for Child Health and Human
Development
AGENCY:
National Institutes of Health,
HHS.
ACTION:
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
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATE: 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: Lorena Kaplan, M.P.H., CHES,
Office of Communications, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
National Institutes of Health, 31 Center
Drive, Room 2A32, Bethesda, Maryland
20892, or call non-toll free number (301)
496–6670 or Email your request,
including your address to
lorena.kaplan@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
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
SUMMARY:
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80124
Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
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: Generic
Clearance to Support the Safe to Sleep®
Campaign at the Eunice Kennedy
Shriver National Institute for Child
Health and Human Development
(NICHD), 0925–0701, exp., date 02/28/
2021, REVISION, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This is a request for a
revision to a generic clearance used for
submissions specific to the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD) Safe to Sleep® (STS) public
education campaign. Submissions for
the STS campaign will be used to assess
the understanding and reach of STS
campaign materials and messages, and
to monitor and improve campaign
activities such as training workshops
and overall implementation. The
purpose of this information collection is
to monitor and modify campaign
activities, to plan future campaign
activities, to develop messages and
materials, and to develop distribution
and outreach strategies that are effective
(5) inform and/or change practices and
behaviors of program participants.
Examples of the types of information
collections that could be included under
this generic clearance include: Focus
groups and key informant interviews
with parents/caregivers and/or health
professionals to get feedback on
distribution and outreach activities,
and/or campaign messages; and Surveys
with parents/caregivers and/or health
professionals to: (1) Assess the
usefulness of the new STS campaign
materials, including print and on-line
multi-media materials, (2) track
outreach experiences of program
participants, (3) assess training
participants’ changes in knowledge
related to safe infant sleep behavior and
implementation of learned outreach and
education methods, and (4) assess
program participants’ resource needs.
The sub-studies for this generic
clearance will be small in scale,
designed to obtain results frequently
and quickly to guide campaign
development and implementation,
inform campaign direction, and be used
internally for campaign management
purposes. NICHD’s current scope and
capacity for STS generic sub-studies is
non-existent and this request would fill
this gap.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
13,305.
at communicating their message to bring
about the intended response, awareness,
and/or behavioral change for the target
audiences. This generic clearance will
enable the NICHD to: (1) More
efficiently assess the implementation of
campaign activities; (2) better
understand the target audiences’
knowledge, attitudes, and beliefs toward
STS messages and materials; (3) better
understand how the campaign activities
have influenced the target audiences’
behaviors and practices; and (4) monitor
and improve activities such as trainings,
materials, and messages. Having a way
to gather feedback on the STS campaign
activities is critical to assessing the
reach and effect of campaign efforts.
Data collected for the campaign can
inform where future STS campaign
resources can produce the most
meaningful results.
Data collected for the STS campaign
generic clearance will be used by a
number of audiences, including STS
campaign staff, NICHD leadership, STS
campaign collaborators, Federal SUID/
SIDS Workgroup members, SUID/SIDS
stakeholders, clinical and maternal and
child health professionals. These
audiences may use the information
collections to: (1) Develop new
campaign messages, materials, and/or
training curricula; (2) monitor and
improve campaign activities; (3) make
decisions about campaign activities; (4)
inform current campaign activities; and
ESTIMATED ANNUALIZED BURDEN HOURS
Number of responses per
respondent
General Public ..................................
General Public ..................................
General Public ..................................
Health Professionals ........................
Health Professionals ........................
Health Educators ..............................
215
50
3,000
20,000
3,000
20
1
1
2
2
1
2
1
1
15/60
15/60
30/60
1
215
50
1,500
10,000
1,500
40
...........................................................
26,285
49,305
........................
13,305
Type of respondents
Focus Groups ...................................
Interviews ..........................................
Pre-/Post-Tests .................................
Pre-/Post-Tests .................................
Surveys .............................................
Tracking/Feedback Form ..................
Total ...........................................
Dated: December 7, 2020.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver National Institute of Child Health and
Human Development, National Institutes of
Health.
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[FR Doc. 2020–27192 Filed 12–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
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23:25 Dec 10, 2020
Average burden per response, in
hours
Number of respondents
Form name
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Total Annual
Burden Hours
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request a copy of
these documents, call or email the
SAMHSA Reports Clearance Officer at
(240) 276–0361 or carlos.graham@
samhsa.hhs.gov.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
E:\FR\FM\11DEN1.SGM
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Agencies
[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80123-80124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27192]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection: 60-Day Comment Request; Generic Clearance to
Support the Safe to Sleep[supreg] Campaign at the Eunice Kennedy
Shriver National Institute for Child Health and Human Development
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD), the National Institutes of
Health (NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
DATE: 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: Lorena
Kaplan, M.P.H., CHES, Office of Communications, Eunice Kennedy Shriver
National Institute of Child Health and Human Development, National
Institutes of Health, 31 Center Drive, Room 2A32, Bethesda, Maryland
20892, or call non-toll free number (301) 496-6670 or Email your
request, including your address to [email protected]. 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 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
[[Page 80124]]
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: Generic Clearance to Support the Safe to
Sleep[supreg] Campaign at the Eunice Kennedy Shriver National Institute
for Child Health and Human Development (NICHD), 0925-0701, exp., date
02/28/2021, REVISION, Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD), National Institutes of
Health (NIH).
Need and Use of Information Collection: This is a request for a
revision to a generic clearance used for submissions specific to the
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) Safe to Sleep[supreg] (STS) public education
campaign. Submissions for the STS campaign will be used to assess the
understanding and reach of STS campaign materials and messages, and to
monitor and improve campaign activities such as training workshops and
overall implementation. The purpose of this information collection is
to monitor and modify campaign activities, to plan future campaign
activities, to develop messages and materials, and to develop
distribution and outreach strategies that are effective at
communicating their message to bring about the intended response,
awareness, and/or behavioral change for the target audiences. This
generic clearance will enable the NICHD to: (1) More efficiently assess
the implementation of campaign activities; (2) better understand the
target audiences' knowledge, attitudes, and beliefs toward STS messages
and materials; (3) better understand how the campaign activities have
influenced the target audiences' behaviors and practices; and (4)
monitor and improve activities such as trainings, materials, and
messages. Having a way to gather feedback on the STS campaign
activities is critical to assessing the reach and effect of campaign
efforts. Data collected for the campaign can inform where future STS
campaign resources can produce the most meaningful results.
Data collected for the STS campaign generic clearance will be used
by a number of audiences, including STS campaign staff, NICHD
leadership, STS campaign collaborators, Federal SUID/SIDS Workgroup
members, SUID/SIDS stakeholders, clinical and maternal and child health
professionals. These audiences may use the information collections to:
(1) Develop new campaign messages, materials, and/or training
curricula; (2) monitor and improve campaign activities; (3) make
decisions about campaign activities; (4) inform current campaign
activities; and (5) inform and/or change practices and behaviors of
program participants.
Examples of the types of information collections that could be
included under this generic clearance include: Focus groups and key
informant interviews with parents/caregivers and/or health
professionals to get feedback on distribution and outreach activities,
and/or campaign messages; and Surveys with parents/caregivers and/or
health professionals to: (1) Assess the usefulness of the new STS
campaign materials, including print and on-line multi-media materials,
(2) track outreach experiences of program participants, (3) assess
training participants' changes in knowledge related to safe infant
sleep behavior and implementation of learned outreach and education
methods, and (4) assess program participants' resource needs.
The sub-studies for this generic clearance will be small in scale,
designed to obtain results frequently and quickly to guide campaign
development and implementation, inform campaign direction, and be used
internally for campaign management purposes. NICHD's current scope and
capacity for STS generic sub-studies is non-existent and this request
would fill this gap.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 13,305.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response, Total Annual
respondents respondents respondent in hours Burden Hours
----------------------------------------------------------------------------------------------------------------
Focus Groups.................. General Public.. 215 1 1 215
Interviews.................... General Public.. 50 1 1 50
Pre-/Post-Tests............... General Public.. 3,000 2 15/60 1,500
Pre-/Post-Tests............... Health 20,000 2 15/60 10,000
Professionals.
Surveys....................... Health 3,000 1 30/60 1,500
Professionals.
Tracking/Feedback Form........ Health Educators 20 2 1 40
---------------------------------------------------------------------------------
Total..................... ................ 26,285 49,305 .............. 13,305
----------------------------------------------------------------------------------------------------------------
Dated: December 7, 2020.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2020-27192 Filed 12-10-20; 8:45 am]
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