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]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 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 Jkt 253001 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] BILLING CODE 4150–31–P PO 00000 Frm 00134 Fmt 4703 Sfmt 4703 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: E:\FR\FM\11DEN1.SGM 11DEN1 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. jbell on DSKJLSW7X2PROD with NOTICES [FR Doc. 2020–27192 Filed 12–10–20; 8:45 am] BILLING CODE 4140–01–P 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 VerDate Sep<11>2014 23:25 Dec 10, 2020 Average burden per response, in hours Number of respondents Form name Jkt 253001 PO 00000 Frm 00135 Fmt 4703 Sfmt 4703 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 11DEN1

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]


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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]
BILLING CODE 4140-01-P


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