U.S.-Russia Collaborative Research Program in HIV/AIDS and Comorbidities [A Partnership between NIH and the Russian Foundation f

Generic Clearance to Conduct Formative Research 11-25-20_NIAID_v3.docx

Generic Clearance to Conduct Formative Research (NIAID)

U.S.-Russia Collaborative Research Program in HIV/AIDS and Comorbidities [A Partnership between NIH and the Russian Foundation f

OMB: 0925-0755

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Mini Supporting Statement A





U.S.-Russia Collaborative Research Program in HIV/AIDS

and Comorbidities

[A Partnership between NIH and the Russian Foundation for

Basic Research (RFBR)]



OMB # 0925-0755, exp., date 3/31/2021

January 22, 2021



Candace Sibley, Colleen Choi, Natalie Tomitch

Office of AIDS Research

Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH

5601 Fishers Ln., Rockville, MD 20852

240-292-4955

candace.sibley@nih.gov

NIH/Program Official

Mini Supporting Statement A



  1. Justification



The U.S.-Russia Collaborative Research Partnership in HIV/AIDS and Comorbidities is one of several trans-NIH bilateral programs that support collaborative biomedical and behavioral and social science research through joint funding by NIH and the corresponding foreign funding partner. The U.S-Russia bilateral program is an NIH initiative with the Russian Foundation for Basic Research (RFBR), established in 2011 to support meritorious joint projects engaging scientists from the U.S. and Russia on priority HIV research topics of mutual interest to both countries.

Assessing the NIH-RFBR program for effectiveness will provide an in-depth view regarding the strengths and weaknesses (i.e., areas that need improvement) of the program, to render a recommendation about whether to continue, discontinue, or continue the program with modifications.



A.1 Circumstances Making the Collection of Information Necessary



The NIH-RFBR program has provided joint funding to U.S.-Russian teams through three successive "funding rounds," supporting both extramural and intramural U.S. investigators, as well as Russian scientists. The investigator teams completed collaborative projects under Round 3, for which NIH funding was provided in FY 2017-FY 2019; RFBR funding ended in the Spring of 2020.

This program specifically aims to support "Fundamental and multidisciplinary biomedical research, addressing prevention and treatment of HIV/AIDS and HIV-associated co-morbidities" (2015 Addendum to Implementing Arrangement of the NIH-RFBR program).

The NIH Office of AIDS Research (OAR) leads this NIH program, with participation by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute of Neurological Diseases and Stroke (NINDS), and Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

OAR requests OMB approval to administer a survey to awardees to assess the NIH-RFBR program for overall program effectiveness. The purpose of this assessment is two-fold: (1) determine whether the program met its original goal of facilitating collaborative research efforts between scientists from the U.S. and Russia and identify challenges encountered; and (2) examine how well the program has served as a platform for generating scientific accomplishments, providing training opportunities, and leveraging new research funding and capacity development. The program efficacy assessment will be based on feedback provided by the program participants (i.e., awardees).

Data collected from program participants will be systematically analyzed to generate program outcomes. The analyses are based on a mixed-method design, employing content and thematic analyses for open-ended responses, and various univariate analyses for the closed-ended responses.



The results will be shared with participating NIH Institutes and RFBR. OAR does not expect to disseminate the results publicly.





A.2 Purpose and Use of the Information Collection



Data collection efforts will be managed by one OAR lead with expertise in program assessments. The data to be collected under this generic clearance will allow OAR to make appropriate adjustments and modifications to the program concerning content and features.



Data will be collected by administering a 30-item questionnaire to the program participants. The questionnaire primarily consists of closed-ended items and several open-ended questions. The items were developed to solicit feedback about the participants' experiences and their perceptions about the program.



This questionnaire was initially developed by the NIAID Office of Global Research (OGR) to collect similar data on other NIH bilateral programs; however, several questions will be repurposed for relevance to the U.S.-Russia program managed by OAR. This questionnaire allows the program to delve deeply into the respondents' experiences with the NIH-RFBR program. Data collected with this instrument will also allow staff to make a more informed recommendation about the value and ongoing feasibility of the NIH-RFBR program.





A.3 Use of Information Technology to Reduce Burden



The questionnaire will be administered in Survey Monkey. The participants will complete the survey by accessing an e-mailed link. This will allow the survey to be easily accessed by the participants and retrieved by the staff member conducting the assessment.



A Privacy Impact Assessment (PIA) was not done for the data collection instrument. No PIA is being collected for this study. The survey information will be stored in a password protected SurveyMonkey account that will only be accessed by authors of this clearance document.





A.4 Efforts to Identify Duplication



There will be no duplication with this project.



A.5 Impact on Small Businesses or Other Small Entities

N/A



A.6 Consequences of Collecting the Information Less Frequently



This item is irrelevant to this project, as data will be collected once.



A.7 Special Circumstances Relating to the Guidelines of 5 CFR 1320.5



This survey will be implemented in a manner that fully complies with 5 C.F.R. 1320.5. *Standard text*



A.8 Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency

N/A



A.9 Explanation of Any Payment of Gift to Respondents



No cash payments, gifts, or other incentives will be provided for participating in the survey.



A.10 Assurance of Confidentiality Provided to Respondents



All U.S. investigators/awardees who participated in the third (most recent) funding round of the NIH-RFBR program (i.e., grantees from FY 2017- 2019) will be solicited for their input. RFBR will conduct a parallel assessment, using the NIH survey instrument modified as necessary, and share their results with OAR.



The identities of the survey participants will be known to the staff member conducting the assessment. However, their identities will not be revealed in the analysis or the report. The data will be aggregated, and the results will be summarized as groups. Selected individual responses to open-ended questions will be reported only to support the analyses—the identities of the respondents will not be revealed.



A.11 Justification for Sensitive Questions



The questionnaire does not contain any items of a sensitive nature.



A.12.1 Estimated Annualized Burden Hours



A.12-1 Estimated Annualized Burden Hours

Form Name

Type of Respondent

Number of Respondents

Number of Responses per Respondent

Average Burden Per Response

(in hours)

Total Annual Burden Hour

Bilateral Russia Electronic survey

Private Sector

12

1

10/60

2

TOTAL



12


2






























A.12-2 ANNUALIZED COST TO RESPONDENTS



A.12-2 Annualized Cost to the Respondents



Type of Respondent

Total Annual Burden Hours

Hourly Wage Rate*

Respondent Cost

U.S. Investigators

2

$36.87

$73.74

TOTAL



$73.74

*Source: bls.gov/news.release/empsit.t19.htm



A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers



None.





A.14 Annualized Cost to the Federal Government




Staff


Grade/Step

Salary

% of Effort

Fringe (if applicable)

Total Cost to Gov't

Federal Oversight






Health Policy Analyst

13

$ 112,930

25%


$28,232.50







Contractor Cost












Travel






Other Cost












Total





$28,232.5




A.15 Explanation for Program Changes or Adjustments

N/A



A.16 Plans for Tabulation and Publication and Project Time Schedule



Tabulation/analytical techniques: Data collected from the questionnaire will be compressed, analyzed and tabulated. This information collection does not involve rigorous statistical methods. Univariate l analyses will be performed to generate and report the results.

Publications of results: The final report—which includes the survey results and analyses—will be made available to internal OAR staff. It also will be shared with participating NIH ICs and RFBR. OAR does not expect to disseminate the results publicly.



Timeline:



Task

*Start

*End

Duration

(in Business Day(s))

Apply and obtain clearance

11/27

12/8

6 Days

Edit questionnaire if necessary, based on feedback from the Project Clearance Branch

12/8

12/10

2 Days

Distribute questionnaires to respondents via e-mail

12/11

12/11

1 Day

Respondents complete questionnaire

12/14

1/4

10 Days

1st Reminder sent to respondents to complete the questionnaire

1/4

1/7

1 Day

2nd Reminder sent to respondents to complete the questionnaire

1/7

1/8

1 Day

3rd Reminder sent to respondents to complete the questionnaire; late submissions accepted

1/11

1/12

1 Day

Analyses and reporting of Results

1/18

2/1

11 Days

Report Draft 1

2/1

2/15

11 Days

Report Draft 2

2/15

2/24

8 Days

Report Draft 3 or Final

2/24

3/4**

6 Days



A.17 Reason(s) Display of OMB Expiration Date is Inappropriate



We are not requesting an exemption to the display of the OMB Expiration date.



A.18 Exceptions to Certification for Paperwork Reduction Act Submissions



This survey will comply with the requirements in 5 CFR 1320.9.

9


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