Questionnaire Cognitive Interviewing and Pretesting (NCI)

Forms and Documents

Document Name	Status
Form 1 #10 Sub-study "Health Information National Trends Survey 4 (HINTS 4) Pilot Test " Form and Instruction	New
Form 1 #9 Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 1 Instrument Form and Instruction	New
Form 3 #6, #7, and #8 Bundled Sub-studies for HINTS, MDC and NExT Form and Instruction	New
Form 1 #3, #4, and #5 Bundled Sub-studies for Website Evaluations - Science of Team Science, SEER and Epi Genetics Research Programs Form and Instruction	Unchanged
Form 1 Pilot of a Survey Instrument Designed to Assess Users' Perceptions of Website Changes (Sub-Study #2) Form	Unchanged
Form 1 Assessing Survivors' Cognitive, Affective and Information-Seeking Responses to Different Formats to Communicate Cancer Survival Statistics - Sub-Study #1 Form	Unchanged
Change Request to burden.doc Justification for No Material/Nonsubstantive Change	2010-08-23
SSB_10-31-07.doc Supporting Statement B	2007-12-07
ATTACHMENT L Detailed explanation to participants.doc Supplementary Document	2007-12-07
ATTACHMENT K Participant data sheet.doc Supplementary Document	2007-12-07
ATTACHMENT J Sample script for answering machine.doc Supplementary Document	2007-12-07
ATTACHMENT I Sample Screening script.doc Supplementary Document	2007-12-07
ATTACHMENT H Newspaper script.doc Supplementary Document	2007-12-07
ATTACHMENT G OHSR Exemption approval.doc Supplementary Document	2007-12-07
ATTACHMENT F Consent to show recording.doc Supplementary Document	2007-12-07
ATTACHMENT E-2 Consent Groups.doc Supplementary Document	2007-12-07
ATTACHMENT E-1 Consent Interview.doc Supplementary Document	2007-12-07
ATTACHMENT D Letter from Privacy Act Officer.pdf Supplementary Document	2007-12-07
ATTACHMENT C HINTS 2005 Advance-letter.doc Supplementary Document	2007-12-07
ATTACHMENT B-2 Sample Qx Cancer Quality of Life.doc Supplementary Document	2007-12-07
ATTACHMENT B-1 Sample Qx TUS Population Survey.doc Supplementary Document	2007-12-07
ATTACHMENT A Cognitive Interviewing.doc Supplementary Document	2007-12-07
Cover Letter.doc Supplementary Document	2007-12-07
SSA_11-27-07.doc Supporting Statement A	2007-12-07

IC Document Collections

IC ID	Document Title	Status
196228	#10 Sub-study "Health Information National Trends Survey 4 (HINTS 4) Pilot Test " Form and Instruction	New
195979	#9 Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 1 Instrument Form and Instruction	New
195663	#6, #7, and #8 Bundled Sub-studies for HINTS, MDC and NExT Form and Instruction	New
193888	#3, #4, and #5 Bundled Sub-studies for Website Evaluations - Science of Team Science, SEER and Epi Genetics Research Programs Form and Instruction	Unchanged
188660	Pilot of a Survey Instrument Designed to Assess Users' Perceptions of Website Changes (Sub-Study #2) Form	Unchanged
187577	Assessing Survivors' Cognitive, Affective and Information-Seeking Responses to Different Formats to Communicate Cancer Survival Statistics - Sub-Study #1 Form	Unchanged

ICR Details

OMB Control No: 0925-0589	ICR Reference No: 201008-0925-003
Status: Historical Active	Previous ICR Reference No: 200802-0925-005
Agency/Subagency: HHS/NIH	Agency Tracking No:
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 with change	Conclusion Date: 09/22/2010
	Date Received in OIRA: 08/23/2010
Terms of Clearance: The total burden has been increased to 1200 hours because there is less than a year left on the approval. If the generic is renewed, the total burden, rather than just the annual burden, should be requested (for this collection, 600 hours x 3 years = 1800 hours) in order to avoid running out of hours before the end of the approval cycle.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2011	05/31/2011	05/31/2011
Responses	1,200	0	600
Time Burden (Hours)	1,200	0	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 2008-2010 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 412 Name of Law: Public Health Service Act
   US Code: 42 USC 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:
	72 FR 65969	11/26/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 6732	02/05/2008
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Assessing Survivors' Cognitive, Affective and Information-Seeking Responses to Different Formats to Communicate Cancer Survival Statistics - Sub-Study #1	1	Screener & Survey Sub-Study #1
Pilot of a Survey Instrument Designed to Assess Users' Perceptions of Website Changes (Sub-Study #2)	1	Survey to Evaluate Changes to Website Design
#6, #7, and #8 Bundled Sub-studies for HINTS, MDC and NExT	2, 3, 1, 2, 1, 1	#8_Attach 8A, 8E, 8F, & 8G_Email, Guide & Qx_NExT ,   #6_Attach 6A & 6D Screen and Guide ,   #7_REV_Justif Memo Attach 7B 7D and 7F_MDC ,   #6_REV_Attach 6A 6D Screen and Guide ,   #6_REV_Justif Memo and Attach 6B 6C 6E 6F 6G_HINTS ,   #7_Attach 7A 7C and 7E_MDC Cog Interview
#3, #4, and #5 Bundled Sub-studies for Website Evaluations - Science of Team Science, SEER and Epi Genetics Research Programs	2, 1, 3	#3 Attachments A1 and A4 ,   #4 Attachments B2, B5, B6 & B7 ,   #5 Attachments C2, C3, C4 & C5
#10 Sub-study "Health Information National Trends Survey 4 (HINTS 4) Pilot Test "	1	Pilot Test Questionnaire and Debriefing Questionnaire
#9 Health Information National Trends Survey 4 (HINTS 4) Cognitive Testing of Cycle 1 Instrument	1	HINTS 4 Attachment A, B, & E

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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	1,200	600	0	600	0	0
Annual Time Burden (Hours)	1,200	600	0	600	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: NIH is requesting a non-substantive, non-material change to the total burden that is reported in ICRAS/ROCIS for this generic information collection. This would be to correct an administrative error that has occurred; it is not a request to increase or decrease the burden hours or respondents. The original burden, based on the 2008 OMB-approved Supporting Statement A, p. 32 requested an annual participant burden of 600 hours with 600 respondents. The burden reported in the ICRAS/ROCIS is a total of 600 hours and respondents. This number should actually be 1800 hours and respondents, since this information collection was approved for three years.

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Annual Cost to Federal Government: $264,000

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]? Uncollected

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: 08/23/2010

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