A Generic Submission for Theory Development and Validation (NCI)

Forms and Documents

Document Name	Status
Form 1 Self-affirmation and defensiveness to cancer risk information for the self vs. a close other Form and Instruction	New
Form 2 Goals and Values in Physical Activity Sub-Study #7 Form and Instruction	New
Form 1 Sub-study #8_Refining and validating a theory of risk perceptions Form and Instruction	New
Form 1 Sub-study #6_Validating scale to assess cancer-related risk perceptions Form and Instruction	New
Form 1 Sub-study #5_Patient Perspectives and Simulated Clinical Interactions Form and Instruction	New
Form 2 Sub-study #4_Alternative Tobacco Products Study Form and Instruction	New
Form 1 Sub-Study #2_Informed Consent and Incidental Emotion Form and Instruction	New
Form 1 Sub-study #3 Self-Affirmation REVISED Form and Instruction	New
Form 1 Sub-study #1_Self-Affirmation and Affect Form and Instruction	New
SSB_BRP_Generic_Theory_10-27-2011.doc Supporting Statement B	2011-10-27
ATTACH 3_Experts_Theory.doc Supplementary Document	2011-10-06
ATTACH 2_Mission_Theory.doc Supplementary Document	2011-10-06
ATTACH 1_Working Groups_Theory.doc Supplementary Document	2011-10-06
Cover Letter_2011_10-6-2011.doc Supplementary Document	2011-10-06
SSA_BRP_Generic_Theory_10-27-2011.doc Supporting Statement A	2011-10-27

IC Document Collections

IC ID	Document Title	Status
212842	Self-affirmation and defensiveness to cancer risk information for the self vs. a close other Form and Instruction	New
212182	Goals and Values in Physical Activity Sub-Study #7 Form and Instruction	New
210991	Sub-study #8_Refining and validating a theory of risk perceptions Form and Instruction	New
208373	Sub-study #6_Validating scale to assess cancer-related risk perceptions Form and Instruction	New
208125	Sub-study #5_Patient Perspectives and Simulated Clinical Interactions Form and Instruction	New
207184	Sub-study #4_Alternative Tobacco Products Study Form and Instruction	New
204704	Sub-Study #2_Informed Consent and Incidental Emotion Form and Instruction	New
203967	Sub-study #3 Self-Affirmation REVISED Form and Instruction	New
201753	Sub-study #1_Self-Affirmation and Affect Form and Instruction	New

ICR Details

OMB Control No: 0925-0645	ICR Reference No: 201111-0925-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: A Generic Submission for Theory Development and Validation (NCI)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/12/2011
	Date Received in OIRA: 11/02/2011
Terms of Clearance: 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	12/31/2014	36 Months From Approved
Responses	11,500	0	0
Time Burden (Hours)	6,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In order to carry out NCI's legislative mandate to conduct and support research with respect to the causes and prevention of cancer, it is beneficial for NCI, through initiatives in the Behavioral Research Program (BRP), to conduct and support behavioral research informed by and informing theory. 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. Data collections that result from this generic clearance would inform and clarify the use of theory in BRP-supported initiatives and funding announcements. Specifically, this research would allow NCI to conduct research to: 1) Identify psychological, biobehavioral, demographic, and individual difference predictors of cancer prevention and control behaviors and outcomes; 2) Develop and refine integrative theories; 3) Identify and observe theoretical and innovative trends in cancer prevention and control research; and 4) Determine feasibility and usefulness of collaborative and multidisciplinary approaches to cancer prevention and control. Respondents will be members of the public including, but not limited to, health professionals, physicians, and researchers.

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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:
	76 FR 46307	08/02/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 62421	10/07/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Self-affirmation and defensiveness to cancer risk information for the self vs. a close other	1	Self-Affirmation Survey Screenshots
Sub-study #8_Refining and validating a theory of risk perceptions	1	Screenshots
Sub-study #6_Validating scale to assess cancer-related risk perceptions	1, 2, 3	Survey 1 ,   Survey 2 ,   Survey 3
Sub-study #1_Self-Affirmation and Affect	1	Self-Affirmation Survey
Sub-study #4_Alternative Tobacco Products Study	2, 1, 5, 3, 4, 2 and 3	Baseline Survey ,   Screener ,   Moderators Guide and Interview ,   Eye Tracking Survey ,   Moderator Guide & Focus Group ,   Attachment B and D Screenshots
Sub-study #5_Patient Perspectives and Simulated Clinical Interactions	1	Simulated Clinical Interaction Survey
Sub-study #3 Self-Affirmation REVISED	1	Self-Affirm Survey
Goals and Values in Physical Activity Sub-Study #7	1 , 2, 3	Survey ,   Focus Group Protocol ,   Screener
Sub-Study #2_Informed Consent and Incidental Emotion	1, 2	Screener ,   Questionnaire (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	11,500	0	0	11,500	0	0
Annual Time Burden (Hours)	6,000	0	0	6,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new generic clearance request.

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Annual Cost to Federal Government: $352,979

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: 11/02/2011

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