Generic PRA Supp Statement - MVP COVID-19 Survey

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 2900-XXXX)

T ITLE OF INFORMATION COLLECTION:

Million Veteran Program (MVP) COVID-19 Survey

PURPOSE:

The Million Veteran Program (MVP) is a national, voluntary, medical research program. MVP establishes an ongoing partnership with Veteran participants who give their informed consent to authorize access to electronic health record data, provide biospecimens for further analysis in conjunction with their health status, and provide self-reported data through methods such as personal logs and surveys.

In response to the COVID-19 pandemic, all MVP participants will be invited to complete the MVP COVID-19 Survey. The survey collects demographics, COVID-19 symptoms and treatment, comorbidity, healthcare utilization, well-being, and psychosocial outcomes. MVP participants can complete the survey up to 4 times. MVP is uniquely positioned to analyze survey data in conjunction with biospecimens and assist with identification of potential biomarkers, as well as allow researchers to analyze the incidence and outcomes of COVID-19 using genomic data.

DESCRIPTION OF RESPONDENTS:

MVP study participants who have given informed consent and HIPAA authorization to share data with researchers, including self-reported data collected via surveys.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software) [ ] Small Discussion Group

[ ] Focus Group [x ] Other: Research Survey

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name, Position Title and Credentials:

Sumitra Muralidhar, Ph.D.

Director, Million Veteran Program

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ x ] Yes [ ] No

2. If Yes, will any information that is collected be included in records that are subject to the Privacy Act of 1974? [ x ] Yes [ ] No

3. If Yes, has an up-to-date System of Records Notice (SORN) been published? [ x ] Yes [ ] No

Data is collected per Code of Federal Regulations Title 38, Part 16, and the MVP research protocol approved by the VA Central Institutional Review Board.

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [ x ] No

ANNUAL BURDEN HOURS

Category of Respondent	No. of Respondents	X No. of responses	X No. of minutes	Divided by 60 =	Number of hours
MVP participants	1,000,000	Up to 4	25 minutes		1,666,667
Totals

FEDERAL COST: The estimated annual cost to the Federal government is $2,832,172.

	Projected	Cost/unit	Total
1st invite full survey	29,959	$3.17	$94,970
1st invite 1-page invitation to go online	339,019	$0.87	$294,947
1st invite emailed invitation	360,647	$0.00	$0
Survey requested by Veterans	39,679	$2.27	$90,071
2nd invite full survey	647,000	$2.27	$1,468,690
Survey Scans	290,623	$3.04	$883,494
Total Costs			$2,832,172
Assumes a response rate of 40%

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [x ] Yes [ ] No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

All current MVP participants, approximately 830,000 will be prompted to complete the survey. All new MVP participants will be asked to complete the MVP COVID-19 survey as part of enrollment.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ x ] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ x ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [ ] Yes [x ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the subject of the request. (e.g. Comment card for soliciting feedback on xxxx)

PURPOSE: Provide a brief description of the purpose of this collection and how it will be used. If this is part of a larger study or effort, please include this in your explanation.

DESCRIPTION OF RESPONDENTS: Provide a brief description of the targeted group or groups for this collection of information. These groups must have experience with the program.

TYPE OF COLLECTION: Check one box. If you are requesting approval of other instruments under the generic, you must complete a form for each instrument.

CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the collection will be returned as improperly submitted or it will be disapproved.

Personally Identifiable Information: Provide answers to the questions. Note: Agencies should only collect PII to the extent necessary, and they should only retain PII for the period of time that is necessary to achieve a specific objective.

Gifts or Payments: If you answer yes to the question, please describe the incentive and provide a justification for the amount.

BURDEN HOURS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households;(2) Private Sector; (3) State, local, or tribal governments; or (4) Federal Government. Only one type of respondent can be selected per row.

No. of Respondents: Provide an estimate of the Number of respondents.

Participation Time: Provide an estimate of the amount of time required for a respondent to participate (e.g. fill out a survey or participate in a focus group)

Burden: Provide the Annual burden hours: Multiply the Number of responses and the participation time and divide by 60.

FEDERAL COST: Provide an estimate of the annual cost to the Federal government.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents. Please provide a description of how you plan to identify your potential group of respondents and how you will select them. If the answer is yes, to the first question, you may provide the sampling plan in an attachment.

Administration of the Instrument: Identify how the information will be collected. More than one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or facilitators (e.g., for focus groups) used.

Submit all instruments, instructions, and scripts are submitted with the request.

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