Sub-Study Template

Request for Approval under the “Generic Clearance for the Collection of Customer Participation and Satisfaction with NIH Programs, Processes, Products, and Services” (OMB#: 0925-XXXX, Expiration Date: XX/XX/XXXX)

TITLE OF INFORMATION COLLECTION:

PURPOSE:

INTENDED USE OF THIS INFORMATION:

DESCRIPTION OF RESPONDENTS:

TYPE OF COLLECTION: (Check all that apply)

[ ] Performance Measurement [ ] Feedback

[ ] Program Monitoring [ ] Resource Management

[ ] Grantee Effectiveness [ ] Program Evaluations

[ ] Forms [ ]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 a low burden for respondents and a 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 to inform effective policy decisions substantially.

5. The collection is targeted at soliciting opinions from respondents who have experience with 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 [ ] NA

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

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

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

Gifts or Payments:

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

Amount: _________

The explanation for incentive: (include the number of visits, etc.)

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

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

*The wage rate must be cited using bls.gov or another source.

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 the table above is cited from: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/23Tables/html/DCB.aspx

If you are conducting a focus group or 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? [ ]Yes [ ] No [ ] NA

2. If yes, describe below. If the answer is no, please explain how you plan to identify your potential respondents and how you will select them. (For example, if you have 1,000 members on our listserv, and you estimate 30% will respond, your total number of respondents would be 300).

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

[ ] Paper

[ ] Other, Explain

2. Will interviewers, facilitators, or research coordinators be used? [ ] Yes [ ] No [ ] NA

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

Instructions for completing Request for Approval under the “Generic Clearance for the Collection of Customer Participation and Satisfaction with NIH programs, processes, products, and Services.”

PLEASE DO NOT SUBMIT INSTRUCTIONS WITH THE FINAL REQUEST

TITLE OF INFORMATION COLLECTION: Provide the collection’s name subject to the request. (e.g., Comment card for soliciting feedback on XXXX)

PURPOSE: Provide a brief description of the purpose of this collection. Please include this more extensive explanation if this is part of a larger study or effort.

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: Briefly describe the targeted group or groups for this information collection. These groups must have experience with the program.

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

FREQUENCY OF REPORTING: Check one box.

CERTIFICATION: Please read the certification carefully. The collection will be returned as improperly submitted or disapproved if you do not certify correctly.

Personally Identifiable Information: Provide answers to the questions.

Gifts or Payments: If yes, please describe the incentive and justify the amount.

BURDEN HOURS and COSTS:

Category of Respondents: Identity whom 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 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 annual cost estimate to the Federal government. Fill out the table to itemize the Federal cost of the collection. At a minimum, there should be Federal cost.

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

The selection of your targeted respondents. Please describe how you plan to identify your potential group of respondents and how you will select them. If yes, you may attach the sampling plan to the first question.

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

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

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