The NIH-AARP interactive Comprehensive Lifestyle Interview by Computer Study (iCLIC) (NCI)

Forms and Documents

Document Name	Status
Form 9 Evaluation Questionnaire (Attach 9) Form and Instruction	Modified
Form 8 Web Re-Entry iCLIC (Attach 8) Form and Instruction	Modified
Form 7 Enrollment iCLIC (Attach 7) Form and Instruction	Modified
Form 4 Pre-Enrollment iCLIC (Attach 6) Form and Instruction	Modified
Form 4 Diet and Health History Questionnaire (DHQ) (Attach 4-4) Form and Instruction	Modified
Form 3 Lifestyle and Health History Questionnaire (LHQ) (Attach 4-3) Form and Instruction	Modified
Form 2 Automatic Self-Administered 24-hour Dietary Recall (ASA24) (Attach 4-1) Form and Instruction	Modified
Form 1 Activities Completed by Time in 24 Hours (ACT-24) (Attach 4-2) Form and Instruction	Modified
SSB_iCLIC_v4.docx Supporting Statement B	2010-12-20
Att 17_ConfidentialityStatement.pdf Supplementary Document	2010-12-20
Att 16_PIA for iCLIC.pdf Supplementary Document	2010-12-20
Att 15-1 through 15-5_Email to Participants.docx Supplementary Document	2010-12-20
Att 14_Study Consent.pdf Supplementary Document	2010-12-20
Att 13_IRB approvals 2010.pdf Supplementary Document	2010-12-20
Att 11_Privacy Act Memo.pdf Supplementary Document	2010-12-20
Att 5_NIH AARP CLIC Study Summary 05_16_08.doc Supplementary Document	2010-12-20
Att 12_Westats Procedures for Keeping Data Confidential.doc Supplementary Document	2010-12-20
Att 10_External Working Group and Steering Commimittee Members.docx Supplementary Document	2010-12-20
Att 2_NIH-AARP Bibliography.pdf Supplementary Document	2010-12-20
Att 1_NIH-AARP DHS Original Study Summary.doc Supplementary Document	2010-12-20
Cover Memo_iCLIC.doc Supplementary Document	2010-12-20
SSA_iCLIC_v10.docx Supporting Statement A	2010-12-20

IC Document Collections

IC ID	Document Title	Status
186348	Evaluation Questionnaire (Attach 9) Form and Instruction	Modified
186347	Web Re-Entry iCLIC (Attach 8) Form and Instruction	Modified
186346	Enrollment iCLIC (Attach 7) Form and Instruction	Modified
186345	Pre-Enrollment iCLIC (Attach 6) Form and Instruction	Modified
186344	Invitation Letter (Attach 3) Instruction	Modified
186343	Diet and Health History Questionnaire (DHQ) (Attach 4-4) Form and Instruction	Modified
186342	Lifestyle and Health History Questionnaire (LHQ) (Attach 4-3) Form and Instruction	Modified
186341	Automatic Self-Administered 24-hour Dietary Recall (ASA24) (Attach 4-1) Form and Instruction	Modified
186340	Activities Completed by Time in 24 Hours (ACT-24) (Attach 4-2) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0594	ICR Reference No: 201012-0925-007
Status: Historical Active	Previous ICR Reference No: 200912-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The NIH-AARP interactive Comprehensive Lifestyle Interview by Computer Study (iCLIC) (NCI)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/27/2011
	Date Received in OIRA: 12/27/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2014	36 Months From Approved	02/28/2011
Responses	46,883	0	52,666
Time Burden (Hours)	6,886	0	11,007
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of the NIH and American Association of Retired Persons (AARP) CLIC Study is to evaluate the feasibility of using a developed computerized questionnaires to better assess dietary intake, physical activity, lifestyle and behavioral factors, and self-reported health conditions in a population of early-to-late-middle-aged men and women who are also members of the AARP. A total of 50,000 live, eligible participants will be asked to complete the NIH-AARP Comprehensive Lifestyle Interview by Computer (CLIC) Study. This feasibility study will utilize recent developments in computer technology to build upon the success of the current NIH-AARP Diet and Health Study [OMB#s 0925-0423 and 0925-0587], which is a prospective cohort study of diet and cancer that began in 1995. Information gathered as part of the NIH-AARP CLIC study, such as eligibility, response, and completion rates, as well as range of dietary intake, will be used for developing computerized questionnaire studies in larger cohorts. This is a request for an extension in time to the currently approved #0925-0594 so that additional responses from participants can be collected.

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Authorizing Statute(s): US Code: 42 USC 285a-1 Name of Law: Public Health Service Act
   US Code: 42 USC 285a-2 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:
	75 FR 63833	10/18/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 80828	12/23/2010
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Activities Completed by Time in 24 Hours (ACT-24) (Attach 4-2)	1	ACT-24
Automatic Self-Administered 24-hour Dietary Recall (ASA24) (Attach 4-1)	2	ASA24
Lifestyle and Health History Questionnaire (LHQ) (Attach 4-3)	3, 3	LHQ ,   LHQ Full
Diet and Health History Questionnaire (DHQ) (Attach 4-4)	4	DHQ
Invitation Letter (Attach 3)
Pre-Enrollment iCLIC (Attach 6)	4	Pre-Enrollment
Web Re-Entry iCLIC (Attach 8)	8	Web Re-entry
Evaluation Questionnaire (Attach 9)	9	Evaluation
Enrollment iCLIC (Attach 7)	7	Enrollment

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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	46,883	52,666	0	0	-5,783	0
Annual Time Burden (Hours)	6,886	11,007	0	0	-4,121	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: $51,500

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: 12/27/2010

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