A Generic Submission for Theory Development and Validation (NCI)

Forms and Documents

Document Name	Status
Form 1 Self-affirmation and affect Form and Instruction	New
SSA_Generic Theory Development.docx Supporting Statement A	2014-10-13
ATTACH 4 Information on Incentives.docx Supplementary Document	2014-10-13
ATTACH 3_Experts Consulted.doc Supplementary Document	2014-10-13
ATTACH 2_Mission Statments and Key Initiatives.doc Supplementary Document	2014-10-13
ATTACH 1_Working Groups Meeting Information.doc Supplementary Document	2014-10-13
SSB_Generic Theory Development.doc Supporting Statement B	2014-10-13

IC Document Collections

IC ID	Document Title	Status
214721	Self-affirmation and affect Form and Instruction	New

ICR Details

OMB Control No: 0925-0645	ICR Reference No: 201410-0925-004
Status: Historical Active	Previous ICR Reference No: 201111-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: A Generic Submission for Theory Development and Validation (NCI)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/13/2014
	Date Received in OIRA: 10/15/2014
Terms of Clearance: Previous terms continue: NCI will submit individual collections under this generic clearance to OMB that will include details that highlight the purpose, methodology, participants and burden of each project.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2017	36 Months From Approved	12/31/2014
Responses	9,999	0	11,500
Time Burden (Hours)	6,000	0	6,000
Cost Burden (Dollars)	0	0	0

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Abstract: This is a revision information request to conduct formative research related to behavioral science theory development and validation for the next three years. Formative research in the area of theory development and validation would provide the basis for developing effective cancer prevention and control strategies, allow for a better understanding of theoretical constructs that influence decisions and actions related to cancer, and ultimately contribute to reducing the U.S. cancer burden. Sub-studies proposed under this generic clearance would involve methodological testing and a standard set of research approaches, including surveys (internet, phone, and paper-and-pencil) and focus groups. Respondents would include individuals in the general public, recruited through established online panels or internet/ newspaper advertisements. Development of each study or survey would involve consulting with NCI scientists as well as experts from the behavioral science research community.

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Authorizing Statute(s): US Code: 42 USC 285a-1 (412) Name of Law: Public Health Service Act
   US Code: 42 USC 285 (410) Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 40763	07/14/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 60859	10/08/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Self-affirmation and affect	1	Survey Screenshots

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	9,999	11,500	0	-1,501	0	0
Annual Time Burden (Hours)	6,000	6,000	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $355,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/15/2014

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