Sub-study Template form

Mini Supporting Statement A

Name of Study

OMB# 0925-XXXX,

Expiration Date: XX/XX/XXXX

Generic Clearance for National Cancer Institute (NCI)

Resources, Software and Data Sharing Forms

Date (should be the date it was last revised)

Contact Information

NIH/Program Official

List of Attachments

Attachment 1: Request Data Access/Use Form

Attachment 2: Data Submission/Storage Form

Attachment 3: Request Access to Use NCI Resources/Software

Attachment 4: Project Renewal or Close-out Form

Attachment 5: Privacy Act Memo

Attachment 6: Privacy Impact Assessment

While not inclusive, this is a sampling of the types of forms we anticipate.

Mini Supporting Statement A

A.1 Circumstances Making the Collection of Information Necessary

Explain the circumstances that make the collection of information necessary for this specific study under the main generic clearance.

A.2 Purpose and Use of the Information Collection

Indicate how, by whom, and for what purpose the information is to be used.

Justify the data collection in terms of positive needs and the negative consequences of not having the information. Emphasize the practical utility to the government of the expected results. State the uses in specific and tangible terms.

A.3 Use of Information Technology to Reduce Burden

Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection.

Describe any consideration of using information technology to reduce the burden. Please identify if a Privacy Impact Assessment (PIA) was done for the database being used to collect the information.

A.4 Efforts to Identify Duplication

Describe efforts to identify duplication. (i.e., duplication of the information requested in a new rule or form) and describe how the agency identified efforts to avoid duplication.

A.5 Impact on Small Businesses or Other Small Entities

N/A

A.6 Consequences of Collecting the Information Less Frequently

Describe the consequences to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

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

This collection 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

Explain any decision to provide any payment or gift to respondents, except remuneration of contractors or grantees. Reference incentives based on recent studies (not more than 4 years old).

A.10 Assurance of Confidentiality Provided to Respondents

Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. Provide a Certificate of Confidentiality (COA), if not applicable state “private to the extent permitted by law.”

Additionally please include whether Personally Identifiable Information (PII) is collected. Indicate if Privacy Act applies or not. http://oma.od.nih.gov/public/MS/privacy/Pages/privacyact.aspx

A.11 Justification for Sensitive Questions

Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, race, gender, etc., and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

A.12.1 Estimated Annualized Burden Hours

Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

A.12-1 Estimated Annualized Burden Hours

Form Name	Type of Respondent	Number of Respondents	Number of Responses per Respondent	Average Time Per Response (in hours)	Total Annual Burden Hours
Totals

A.12-2 ANNUALIZED COST TO RESPONDENTS

Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included in Item A.14.

A.12-2 Annualized Cost to the Respondents

Type of Respondents	Total Annual Burden Hours	Hourly Wage Rate*	Respondent Cost
Total

*Source of the Hourly Wage Rate is provided by the Bureau of Labor Statistics, Occupation title “Medical Scientists” 19-1040 (or substitute another occupation title that is more appropriate), https://www.bls.gov/oes/2020/May/oes_nat.htm#19-1040.

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

Provide an estimate of the total annual cost burden to respondents or record-keepers resulting from the collection of information.

A.14 Annualized Cost to the Federal Government

Provide estimates of annualized cost to the Federal government. This includes FTE and contractor cost.

A.14-1 Annualized Cost to the Federal Government

Staff	Grade/Step	Salary**	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Title
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/pdf/2022/DCB.pdf

Highlighted shaded areas are exempt from data entry. At a minimum there should be federal oversight costs. Fill others as applicable.

A.15 Explanation for Program Changes or Adjustments

N/A.

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

For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

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 request will comply with the requirements in 5 CFR 1320.9.

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