Sub-study template form

`Request for Approval under the “Generic Clearance for NIH Citizen Science and Crowdsourcing Projects”

(OMB#: 0925-0766 Exp., date: 07/2023)

TITLE OF INFORMATION COLLECTION:

PURPOSE:

INTENDED USE OF THIS INFORMATION:

DESCRIPTION OF RESPONDENTS:

TYPE OF COLLECTION: (Check one)

[ ] Data Catalogue [ ] Repository of Tools and Best Practices

[ ] Recommendations of scientific reviewers [ ] Resources

[ ] Call for Nominations [ ] Other: ______________________

FREQUENCY OF REPORTING: (Check one)

[ ] Once [ ] Quarterly

[ ] Monthly [ ] On Occasion

[ ] Annually [ ] Other ___________________

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

5. 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:

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

Personally Identifiable Information:

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

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

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No

4. Privacy Act Systems of Records Title: _______________________ FR Citation ____FR

Gifts or Payments:

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

ESTIMATED BURDEN HOURS and COSTS

Category of Respondent	No. of Respondents	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Totals

COST TO RESPONDENT

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Totals

*Cite source per bls.gov if applicable

FEDERAL COST: The estimated annual cost to the Federal government is ____________

Staff	Grade/Step	Salary*	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Contractor Cost
Travel
Other Cost
Total

*the Salary in table above is cited from https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2023/DCB.pdf

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? [ ] Yes [ ] No [ ] Not Applicable

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?

Administration of the Instrument

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

[ ] Web-based or other forms of Social Media

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

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

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

PLEASE DO NOT SUBMIT INSTRUCTIONS WITH FINAL 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.

INTENDED USE OF THIS INFORMATION: Explain how the information you are collecting is necessary and how, by whom, it will be used. There should be some specific planned use, by a federal program, for the resulting data.

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.

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

BURDEN HOURS and COSTS:

Category of Respondents: Identify who you expect the respondents to be in terms of the following categories: (1) Individuals or Households; (2) Private Sector ( for profit or not-for-profit); (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.

Average Burden per Response: 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). Describe the amount in fractions if the time is less than an hour (e.g., 5 minutes would be 5/60)

Total Burden Hours: Provide the number of burden hours by multiplying the # of responses x the # of responses per respondent x the average burden per response.

Burden Cost: Multiply Total Burden Hours x Wage Rate to get the Total Burden Cost.

FEDERAL COST: Provide an estimate of the annual cost to the Federal government. Fill out table to itemize the Federal cost of the collection. At a minimum there should be Federal cost.

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.

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

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