NIH-AARP Comprehensive Lifestyle Interview by Computer (CLIC) Study (NCI)

Forms and Documents

Document Name	Status
Form 9 Evaluation Questionnaire Form	New
Form 8 Web Re-Entry CLIC Form	New
Form 7 Enrollment CLIC Form	New
Form 4-4B Diet and Health History Questionnaire (DHQ) Form	New
Form 4-3B Lifestyle and Health History Questionnaire (LHQ) Form	New
Form 4-1B Automatic Self-Administered 24-hour Dietary Recall (ASA24) Form	New
Revised_Att 14_iCLIC Consent Form_11-25-08.pdf Supplementary Document	2008-12-01
Revised_Supporting Statement B_CLIC_11-25-08.doc Supporting Statement B	2008-12-01
Att 15-1 to 15-5 _ Email messages sent to participants.pdf Supplementary Document	2008-08-13
Att 14_CLIC Study Consent Statement.doc Supplementary Document	2008-08-13
Att 13_NCI IRB Approval.pdf Supplementary Document	2008-08-13
Att 12_Westats Procedures for Keeping Data Confidential.doc Supplementary Document	2008-08-13
Att 11_Privacy Act Memo.pdf Supplementary Document	2008-08-13
Att 10_External Working Group and Steering Commimittee Members.doc Supplementary Document	2008-08-13
Att 5_NIH AARP CLIC Study Summary 05_16_08.doc Supplementary Document	2008-08-13
Att 2_Bibliography.doc Supplementary Document	2008-08-13
Att 1_NIH-AARP DHS Original Study Summary.doc Supplementary Document	2008-08-13
CLIC Cover Memo 05_16_08.doc Supplementary Document	2008-08-13
Revised_Supporting Statement A_CLIC_11-25-08.doc Supporting Statement A	2008-12-01

IC Document Collections

IC ID	Document Title	Status
186348	Evaluation Questionnaire Form	New
186347	Web Re-Entry CLIC Form	New
186346	Enrollment CLIC Form	New
186345	Pre-Enrollment CLIC Instruction	New
186344	Invitation Letter Instruction	New
186343	Diet and Health History Questionnaire (DHQ) Form	New
186342	Lifestyle and Health History Questionnaire (LHQ) Form	New
186341	Automatic Self-Administered 24-hour Dietary Recall (ASA24) Form	New
186340	Activities Completed by Time in 24 Hours (ACT-24) Instruction	New

ICR Details

OMB Control No: 0925-0594	ICR Reference No: 200808-0925-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: NIH-AARP Comprehensive Lifestyle Interview by Computer (CLIC) Study (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 with change	Conclusion Date: 12/05/2008
	Date Received in OIRA: 08/28/2008
Terms of Clearance: Clearance is provided for this feasibility study. Detailed results from this evaluation, particularly related to burden times and participant characteristics, must be provided to OMB if/when NIH seeks approval for use of these techniques in other studies.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2010	24 Months From Approved
Responses	17,969	0	0
Time Burden (Hours)	2,991	0	0
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 newly 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 15,000 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.

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Authorizing Statute(s): US Code: 42 USC 285a-2 Name of Law: Public Health Service Act
   US Code: 42 USC 285a-1 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:
	73 FR 32717	06/10/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 49210	08/20/2008
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
Enrollment CLIC	7	Enrollment Questionnaire
Web Re-Entry CLIC	8	Web Re-Entry
Activities Completed by Time in 24 Hours (ACT-24)	4-2B	ACT-24 instrument
Automatic Self-Administered 24-hour Dietary Recall (ASA24)	4-1B	ASA24 instrument
Lifestyle and Health History Questionnaire (LHQ)	4-3B	LHQ instrument
Diet and Health History Questionnaire (DHQ)	4-4B	DHQ instrument
Invitation Letter
Pre-Enrollment CLIC
Evaluation Questionnaire	9	Evaluation Questionnaire

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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	17,969	0	0	17,969	0	0
Annual Time Burden (Hours)	2,991	0	0	2,991	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 collection of information.

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Annual Cost to Federal Government: $68,500

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? Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 08/28/2008

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