80122 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

each of the objectives proposed during 

the entire period of performance. The 

current standardized format and data 

submission by applicants increases 

efficiency in reviewing, awarding, and 

monitoring each project. 

This revision to the clearance package 

will incorporate an additional form for 

participants, the QPU. The QPU is 

completed via HRSA’s Electronic 

Handbook and prompts recipients to 

report on progress of activities that were 

submitted using the SWP in the original 

application. The QPU will automatically 

populate activities from the recipient’s 

SWP form on a quarterly basis. For each 

activity listed in the submitted SWP for 

any particular quarter within the project 

period, recipients will select and submit 

a single selection response for each 

activity status from a pull-down menu 

with five options: Activity is on 

Schedule, Activity is Complete, Timing 

is off track, Activity will be missed if 

action is not taken, and Activity cannot 

be achieved. Information provided will 

be utilized by the program staff to 

regularly assess overall progress of 

program requirements and analyze data 

in order to monitor award recipient 

compliance and track progress against 

proposed targets and goals. Information 

gathered will allow for an improved and 

more efficient method for identifying 

whether projects’ goals are being 

advanced or achieved, as set forth in 45 

CFR 75.342. Program staff will also use 

information provided over the period of 

performance to see emerging trends and 

to assess whether an award recipient 

requires technical assistance to address 

challenges that the award recipient may 

be experiencing with the 

implementation of the project. Seeking 

OMB approval comports with the 

regulatory requirement imposed by 45 

CFR 75.206(a), Paperwork clearances. 

Likely Respondents: Recipients of 

HRSA Bureau of Health Workforce’s 

research and training grants and 

cooperative agreements. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of respondents 

Number of responses per 

respondent 

Total responses 

Average burden per response (in 

hours) 

Total annual 

burden hours 

Standardized Work Plan (SWP) .......................................... 1,000 1 1,000 1.00 1,000 

Quarterly Progress Update (QPU) Form ............................. 1,000 4 4,000 .10 400 

Total .............................................................................. 1 1,000 ¥ 5,000 ¥ 1,400 

1The 1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active grants. 

HRSA specifically requests comments 

on (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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2020–27318 Filed 12–10–20; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Charles A. Downs (Respondent), former 

Adjunct Assistant Professor, Arizona 

Health Sciences Center, University of 

Arizona (UA). Respondent engaged in 

research misconduct in research 

supported by U.S. Public Health Service 

(PHS) funds, specifically National 

Center for Advancing Translation 

Sciences (NCATS), National Institutes of 

Health (NIH), grant UL1 TR000454. The 

administrative actions, including 

supervision for a period of four (4) 

years, were implemented beginning on 

November 18, 2020, and are detailed 

below. 

FOR FURTHER INFORMATION CONTACT: 

Elisabeth A. Handley, Director, Office of 

Research Integrity, 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: 

Charles A. Downs, University of 

Arizona: Based on the report of an 

investigation conducted by UA and 

analysis conducted by ORI in its 

oversight review, ORI found that 

Respondent, former Adjunct Assistant 

Professor, Arizona Health Sciences 

Center, UA, engaged in research 

misconduct in research supported by 

PHS funds, specifically NCATS, NIH, 

grant UL1 TR000454. 

Respondent neither admits nor denies 

ORI’s findings of research misconduct. 

Respondent and ORI desire to close this 

matter without further expense of time 

and other resources and thus have 

entered into a Voluntary Settlement 

Agreement (Agreement). 

ORI found that Respondent engaged 

in research misconduct by intentionally, 

knowingly, or recklessly falsifying and/ 

or fabricating data included in the 

following six (6) grant applications 

submitted for PHS funds: 

• R01 NR016242–01, submitted to the 

National Institute of Nursing Research 

(NINR), NIH 

• R01 NR016242–01A1, submitted to 

NINR, NIH 

• R01 NR016957–01, submitted to 

NINR, NIH 

• R01 NR016957–01A1, submitted to 

NINR, NIH 


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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 


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