Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80123 

• 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 

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 

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. 

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 

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 


jbell on DSKJLSW7X2PROD with NOTICES
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 

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

Form name Type of respondents Number of respondents 

Number of responses per 

respondent 

Average burden per response, in 

hours 

Total Annual 

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 Professionals ........................ 20,000 2 15/60 10,000 

Surveys ............................................. Health Professionals ........................ 3,000 1 30/60 1,500 

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 

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 

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 


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