Questionnaire Cognitive Interviewing and Pretesting (NCI)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 2 Follow-Up-Debriefing	Form and Instruction	New	Available
Form 1 Survey Screenshots	Form and Instruction	New	Available
Form 6 Interview Protocol - Spanish	Form and Instruction	New	Available
Form 5 Interview Protocol - English	Form and Instruction	New	Available
Form 4 Consent Form - Spanish	Form and Instruction	New	Available
Form 3 Consent Form - English	Form and Instruction	New	Repair queued
Form 2 Screener - Revised - Spanish	Form and Instruction	New	Available
Form 1 Screener - Revised - English	Form and Instruction	New	Available
Form 1 GEM-DM Survey	Form and Instruction	New	Repair queued
Form 3 English Cognitive Interview Script	Form and Instruction	New	Available
Form 4 Spanish Cognitive Interview Script	Form and Instruction	New	Available
Form 2 Spanish Screener	Form and Instruction	New	Available
Form 1 English Screener	Form and Instruction	New	Available
Form 1 ARP Website Survey	Form and Instruction	New	Available
Form 1 Screener (English)	Form and Instruction	Modified	Available
Form 4 Interview Protocol (Spanish)	Form and Instruction	Modified	Available
Form 2 Screener (Spanish)	Form and Instruction	Modified	Available
Form 3 Interview Protocol (English)	Form and Instruction	Modified	Available
Form 7 Teen Cognitive Interview Guide	Form and Instruction	Modified	Available
Form 6 Parent Cognitive Interview Guide	Form and Instruction	Modified	Available
Form 5 Teen Physical Activity Survey and Recall	Form and Instruction	Modified	Available
Form 1 FLASHE Screener	Form and Instruction	Modified	Available
Form 4 Teen Diet and Demographic Survey	Form and Instruction	Modified	Available
Form 3 Parent Physical Activity Survey and Checklist	Form and Instruction	Modified	Available
Form 2 Parent Diet and Demographic Survey	Form and Instruction	Modified	Available
Form 3 HINTS Cycle 2 Screener	Form and Instruction	Modified	Available
Form 1 HINTS Cycle 2 Questionnaire	Form and Instruction	Modified	Available
Form 2 HINTS Cycle 2 Cognitive Interview Protocol	Form and Instruction	Modified	Available
Form 2 #2_GEM Attach 2C 2D Survey and Guide	Form and Instruction	Modified	Available
Form 1 #1_ASA 24 Screener and Guide	Form and Instruction	Modified	Available
Change Request memo_0925-0589 GW.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2013-02-22	Available
Attach G_IRB Approval.pdf	Supplementary Document	Uploaded 2013-02-27	Available
Attach F_Reminder Letter.docx	Supplementary Document	Uploaded 2013-02-27	Available
Attach D_Advertisements.docx	Supplementary Document	Uploaded 2013-02-27	Available
Attach C-2_Consent Form Spanish.docx	Supplementary Document	Uploaded 2013-02-27	Available
Attach A-2_Questionnaire to Test_Spanish.docx	Supplementary Document	Uploaded 2013-02-27	Available
Attach A-1_Questionnaire to Test_English.docx	Supplementary Document	Uploaded 2013-02-27	Available
Justif Memo 12-5-12.doc	Supplementary Document	Uploaded 2013-02-27	Available
Attach C-1_Consent Form English.docx	Supplementary Document	Uploaded 2013-02-27	Available
Attach 4E FLASHE Cognitive Testing Plan.docx	Supplementary Document	Uploaded 2013-02-27	Available
Attach 4D Reminder Letter-Email.docx	Supplementary Document	Uploaded 2013-02-27	Available
Justification Memo.doc	Supplementary Document	Uploaded 2013-02-27	Available
Generic Sub-Study Form.doc	Supplementary Document	Uploaded 2013-02-27	Available
Attach 4C Informed Consent Forms - Parent and Teen.docx	Supplementary Document	Uploaded 2013-02-27	Available
#3_Justif_MemoAttachments_C_D_F_G_HINTS_Cycle2_01-12-12.DOC	Supplementary Document	Uploaded 2013-02-27	Available
#2_Justifi Memo Attach 2A 2B_GEM_FINAL.docx	Supplementary Document	Uploaded 2013-02-27	Available
Gen IC Forms #1 and #2_ASA-24 & GEM Usability Testing.doc	Supplementary Document	Uploaded 2013-02-27	Available
Memo to OMB_Key To Bundled #1 and #2.doc	Supplementary Document	Uploaded 2013-02-27	Available
#1 Justif Memo Attach 1B 1D_5-18-2011.doc	Supplementary Document	Uploaded 2013-02-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
210644	Sub-study #10_Requirement Gathering for a Biobank Economic Modeling Tool (BEMT)	Form and Instruction	New	Follow-Up-Debriefing
210644	Sub-study #10_Requirement Gathering for a Biobank Economic Modeling Tool (BEMT)	Form and Instruction	New	Survey Screenshots
210410	Sub-study #9_Health Information National Trends Survey 4 (HINTS 4) Cog Test of Cycle 4 (Revised)	Form and Instruction	New	Interview Protocol - Spanish
210410	Sub-study #9_Health Information National Trends Survey 4 (HINTS 4) Cog Test of Cycle 4 (Revised)	Form and Instruction	New	Interview Protocol - English
210410	Sub-study #9_Health Information National Trends Survey 4 (HINTS 4) Cog Test of Cycle 4 (Revised)	Form and Instruction	New	Consent Form - Spanish
210410	Sub-study #9_Health Information National Trends Survey 4 (HINTS 4) Cog Test of Cycle 4 (Revised)	Form and Instruction	New	Consent Form - English
210410	Sub-study #9_Health Information National Trends Survey 4 (HINTS 4) Cog Test of Cycle 4 (Revised)	Form and Instruction	New	Screener - Revised - Spanish
210410	Sub-study #9_Health Information National Trends Survey 4 (HINTS 4) Cog Test of Cycle 4 (Revised)	Form and Instruction	New	Screener - Revised - English
209051	Sub-study #7_Development of Consensus Measures of Distress for the Grid Enabled Measures-Distress Measurement (GEM-DM) Workspace	Form and Instruction	New	GEM-DM Survey
208745	Sub-study #6_Resubmission of Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of HINTS-FDA Instrument	Form and Instruction	New	English Cognitive Interview Script
208745	Sub-study #6_Resubmission of Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of HINTS-FDA Instrument	Form and Instruction	New	Spanish Cognitive Interview Script
208745	Sub-study #6_Resubmission of Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of HINTS-FDA Instrument	Form and Instruction	New	Spanish Screener
208745	Sub-study #6_Resubmission of Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of HINTS-FDA Instrument	Form and Instruction	New	English Screener
207597	Sub-study #7_Survey Instrument Designed to Assess Users' Perceptions of Website Changes	Form and Instruction	New	ARP Website Survey
205099	Sub-study #5: Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 3 Instrument	Form and Instruction	Modified	Screener (English)
205099	Sub-study #5: Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 3 Instrument	Form and Instruction	Modified	Interview Protocol (Spanish)
205099	Sub-study #5: Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 3 Instrument	Form and Instruction	Modified	Screener (Spanish)
205099	Sub-study #5: Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 3 Instrument	Form and Instruction	Modified	Interview Protocol (English)
202800	Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	Form and Instruction	Modified	Teen Cognitive Interview Guide
202800	Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	Form and Instruction	Modified	Parent Cognitive Interview Guide
202800	Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	Form and Instruction	Modified	Teen Physical Activity Survey and Recall
202800	Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	Form and Instruction	Modified	FLASHE Screener
202800	Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	Form and Instruction	Modified	Teen Diet and Demographic Survey
202800	Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	Form and Instruction	Modified	Parent Physical Activity Survey and Checklist
202800	Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	Form and Instruction	Modified	Parent Diet and Demographic Survey
200806	Sub-study #3_Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 2 Instrument	Form and Instruction	Modified	HINTS Cycle 2 Screener
200806	Sub-study #3_Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 2 Instrument	Form and Instruction	Modified	HINTS Cycle 2 Questionnaire
200806	Sub-study #3_Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 2 Instrument	Form and Instruction	Modified	HINTS Cycle 2 Cognitive Interview Protocol
198056	Bundled Website Usability Testings #1 (ASA24) and #2 (GEM)	Form and Instruction	Modified	#2_GEM Attach 2C 2D Survey and Guide
198056	Bundled Website Usability Testings #1 (ASA24) and #2 (GEM)	Form and Instruction	Modified	#1_ASA 24 Screener and Guide

ICR Details

OMB Control No: 0925-0589	ICR Reference No: 201302-0925-007
Status: Historical Active	Previous ICR Reference No: 201103-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No: 18889
Title: Questionnaire Cognitive Interviewing and Pretesting (NCI)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/04/2013
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/28/2013
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2014	04/30/2014	04/30/2014
Responses	4,800	0	3,600
Time Burden (Hours)	6,000	0	3,600
Cost Burden (Dollars)	0	0	0

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Abstract: A generic clearance is requested from OMB for general questionnaire development and pretesting activities to be carried out in 2011-2014 by the staff of the Applied Research Program, in the Division of Cancer Control and Population Sciences. Four types of activities will be carried out: survey questionnaire development and pretesting based on cognitive interviewing methodology, research on the cognitive aspects of survey methodology, research on computer-user interface design for computer-assisted instruments (including Web-based surveys), also known as Usability Testing, and Pilot Household interviews.

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Authorizing Statute(s): US Code: 42 USC 410 Name of Law: Public Health Service Act
   US Code: 42 USC 412 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 79009	12/17/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 12979	03/09/2011
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Bundled Website Usability Testings #1 (ASA24) and #2 (GEM)	1, 2	#1_ASA 24 Screener and Guide ,   #2_GEM Attach 2C 2D Survey and Guide
Sub-study #10_Requirement Gathering for a Biobank Economic Modeling Tool (BEMT)	1, 2	Survey Screenshots ,   Follow-Up-Debriefing
Sub-study #3_Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 2 Instrument	2, 1, 3	HINTS Cycle 2 Cognitive Interview Protocol ,   HINTS Cycle 2 Questionnaire ,   HINTS Cycle 2 Screener
Sub-study #4: Cognitive Testing of the Family Life, Activity, Sun, Health, and Eating (FLASHE) Survey	2, 3, 4, 1, 5, 6, 7	Parent Diet and Demographic Survey ,   Parent Physical Activity Survey and Checklist ,   Teen Diet and Demographic Survey ,   FLASHE Screener ,   Teen Physical Activity Survey and Recall ,   Parent Cognitive Interview Guide ,   Teen Cognitive Interview Guide
Sub-study #5: Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 3 Instrument	3, 2, 4, 1	Interview Protocol (English) ,   Screener (Spanish) ,   Interview Protocol (Spanish) ,   Screener (English)
Sub-study #6_Resubmission of Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of HINTS-FDA Instrument	4, 3, 1, 2	English Screener ,   Spanish Screener ,   Spanish Cognitive Interview Script ,   English Cognitive Interview Script
Sub-study #7_Development of Consensus Measures of Distress for the Grid Enabled Measures-Distress Measurement (GEM-DM) Workspace	1	GEM-DM Survey
Sub-study #7_Survey Instrument Designed to Assess Users' Perceptions of Website Changes	1	ARP Website Survey
Sub-study #9_Health Information National Trends Survey 4 (HINTS 4) Cog Test of Cycle 4 (Revised)	2, 1, 3, 4, 5, 6	Screener - Revised - English ,   Screener - Revised - Spanish ,   Consent Form - English ,   Consent Form - Spanish ,   Interview Protocol - English ,   Interview Protocol - Spanish

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ICR Summary of Burden

table that charts list 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	4,800	3,600	0	1,200	0	0
Annual Time Burden (Hours)	6,000	3,600	0	2,400	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: It is anticipated that a generic sub-study will be submitted shortly to request approval to perform formative research necessary to calibrate a self-report instrument to collect information relevant to Social Security Disability Insurance, from the NIH Clinical Center, and that testing is anticipated to require the use of approximately 2,200 hours. As a result, the program staff is asking for an increase in burden hours from 3,600 hours to 6,000 hours to accommodate this interest.

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Annual Cost to Federal Government: $244,000

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: 02/28/2013

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