Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)

Forms and Documents

Document Name	Status
Form 1 Bundled Sub-Studies #20 (Concise ICD), #21 (Accrual CT), and #22 (Spanish Consent) Form and Instruction	New
Form 19 Sub-study #19: Addendum to Pilot Study Proposed New Model for the CIRB Participating Institution Form and Instruction	New
Form 1 Bundled sub-studies #17 (CIS) and #18 (Message) Form and Instruction	New
Form 14 Bundled Sub-studies #14, #15, #16 (#14 WYNTK, #15 Accrual CT, #16 CIRB Pilot) Form and Instruction	New
Form 1 Bundled Sub-study #11, 12 and #13 (#11 Mentorship Program; #12 Medical Oncologist Practice of Care; #13 Nightshift Work and Sleep in China) Form and Instruction	New
Form 2 Bundled Sub-study #9 and #10 (#9 IRB Policy Regarding NCI Action Letters and; #10 NCI Cancer Research Imaging Camp) Form	New
Form 2 Bundled Sub-studies #7 (PSA Decision Making Focus Groups) and #8 (PIO Customer Satisfaction Survey) Form and Instruction	New
Form 1 Bundled Sub-studies #5 (Focus Groups) and #6 (Survey) to Test Messages and Raise Public Awareness about NIH Clinical Trials Form and Instruction	New
Form 1 Revised_#3 and #4 Bundled Sub-studies for Interviews-Focus Groups for Nursing Education (#3) and Message testing for Genomics and Genetics (#4) Form and Instruction	New
Form 5 Sub-Study #3_NCI Cancer.gov Evolution - User Focus Groups and Triads Form and Instruction	Unchanged
Form 1 2010 NCI Cancer Bulletin Reader Survey (sub-study #1) Form and Instruction	Unchanged
#2_Change Request to name.doc Justification for No Material/Nonsubstantive Change	2010-08-23
SSB_Generic Pretesting and Customer_9-30.doc Supporting Statement B	2009-12-19
ATTACH 5_Memo from NIH OHSR.pdf Supplementary Document	2009-12-19
ATTACH 4_Privacy Act Memo.pdf Supplementary Document	2009-12-19
ATTACH 3_Prior sub-study descriptions_9-22.doc Supplementary Document	2009-12-19
ATTACH 2_Data collection methods_9-22.doc Supplementary Document	2009-12-19
ATTACH 1_Types of research_9-22.doc Supplementary Document	2009-12-19
Comments.pdf Supplementary Document	2009-12-19
SSA_Generic Pretesting and Customer_12 31 REV 1-21.doc Supporting Statement A	2010-01-22

IC Document Collections

IC ID	Document Title	Status
201931	Bundled Sub-Studies #20 (Concise ICD), #21 (Accrual CT), and #22 (Spanish Consent) Form and Instruction	New
199940	Sub-study #19: Addendum to Pilot Study Proposed New Model for the CIRB Participating Institution Form and Instruction	New
198803	Bundled sub-studies #17 (CIS) and #18 (Message) Form and Instruction	New
197863	Bundled Sub-studies #14, #15, #16 (#14 WYNTK, #15 Accrual CT, #16 CIRB Pilot) Form and Instruction	New
197264	Bundled Sub-study #11, 12 and #13 (#11 Mentorship Program; #12 Medical Oncologist Practice of Care; #13 Nightshift Work and Sleep in China) Form and Instruction	New
196948	Bundled Sub-study #9 and #10 (#9 IRB Policy Regarding NCI Action Letters and; #10 NCI Cancer Research Imaging Camp) Form	New
195829	Bundled Sub-studies #7 (PSA Decision Making Focus Groups) and #8 (PIO Customer Satisfaction Survey) Form and Instruction	New
195272	Bundled Sub-studies #5 (Focus Groups) and #6 (Survey) to Test Messages and Raise Public Awareness about NIH Clinical Trials Form and Instruction	New
194814	Revised_#3 and #4 Bundled Sub-studies for Interviews-Focus Groups for Nursing Education (#3) and Message testing for Genomics and Genetics (#4) Form and Instruction	New
193546	Sub-Study #3_NCI Cancer.gov Evolution - User Focus Groups and Triads Form and Instruction	Unchanged
192713	2010 NCI Cancer Bulletin Reader Survey (sub-study #1) Form and Instruction	Unchanged

ICR Details

OMB Control No: 0925-0046	ICR Reference No: 201008-0925-004
Status: Historical Active	Previous ICR Reference No: 201001-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (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: 09/13/2010
	Date Received in OIRA: 08/23/2010
Terms of Clearance: Prior terms of clearance continue.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	02/28/2013	02/28/2013
Responses	33,000	0	33,000
Time Burden (Hours)	7,050	0	7,050
Cost Burden (Dollars)	0	0	0

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Abstract: To help ensure that health messages, materials, strategies, and information services developed by NCI's Office of Communications (OC) have the potential of being received, understood, and accepted by their target audiences, OC will pretest them while they are under development. Respondents include cancer patients and their families, members of the public, health professionals, and organizations/groups that interface with these publics.

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Authorizing Statute(s): US Code: 42 USC 285a-2 Name of Law: NCI's education and information dissemination activities
  

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:
	74 FR 55558	10/28/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 69340	12/31/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Sub-Study #3_NCI Cancer.gov Evolution - User Focus Groups and Triads	2, 1, 3, 4, 5, 6	#2_Attach 5_Screener Research Triad_Cancer evol ,   #2_Attach 6_Screener Advocate Triad_Cancer evol ,   #2_Attach 2_Mod Guide Triad ,   #2_Attach 1_Mod Guide Focus Group ,   #2_Attach 3_Screener Patient-Friends-Family_Cancer evol ,   #2_Attach 4_Screener HCP Triad_Cancer evol
Bundled Sub-studies #7 (PSA Decision Making Focus Groups) and #8 (PIO Customer Satisfaction Survey)	1, 2, 1	#8_Attach 8A_PIO Survey ,   REVISED #7 ,   #7 Attach 7A, 7B, 7F Screener, FG Guide, Questionnaire
Bundled Sub-study #11, 12 and #13 (#11 Mentorship Program; #12 Medical Oncologist Practice of Care; #13 Nightshift Work and Sleep in China)	1, 2, 3	Mentee Application and Competancy Assessment ,   MISC Survey ,   Nightshift and Sleep Qx.
Sub-study #19: Addendum to Pilot Study Proposed New Model for the CIRB Participating Institution	19	#19_Attach 19A_19B_CIRB Addendum
Bundled Sub-studies #5 (Focus Groups) and #6 (Survey) to Test Messages and Raise Public Awareness about NIH Clinical Trials	1, 2	#5 Moderators Guide and Screener ,   #6 Web-based Survey
Bundled sub-studies #17 (CIS) and #18 (Message)	1, 2	#17 Email Form and Survey ,   #18 Moderator's Guide and Screener
2010 NCI Cancer Bulletin Reader Survey (sub-study #1)	1	NCI Cancer Bulletin Survey
Revised_#3 and #4 Bundled Sub-studies for Interviews-Focus Groups for Nursing Education (#3) and Message testing for Genomics and Genetics (#4)	2, 1	#3_Nurses Study_Attach A3-5, A7, A9 Discuss Guides ,   #4_Rev_Attach B2, B3, B4, and B5_Genomics
Bundled Sub-studies #14, #15, #16 (#14 WYNTK, #15 Accrual CT, #16 CIRB Pilot)	14, 15, 16	Attach 14A and 14B (Interview Guide and Screener) ,   Attach 15A and 15B Oncology Survey & Staff Survey ,   #16_Attach 16B 16C 16D 16E 16F Survey and Forms
Bundled Sub-Studies #20 (Concise ICD), #21 (Accrual CT), and #22 (Spanish Consent)	9, 1, 2, 3, 4, 5, 6, 7, 8	Screener ICD ,   Survey Screenshots ICD ,   Oncology Survey Screenshots Accrual CT ,   Staff Survey Screenshots Accrual CT ,   Concept Survey Screenshots Accrual CT ,   Prospective Survey Screenshots Accrual CT ,   Screener Spanish Consent ,   English Interview Guide - Spanish Consent ,   Spanish Interview Guide - Spanish Consent
Bundled Sub-study #9 and #10 (#9 IRB Policy Regarding NCI Action Letters and; #10 NCI Cancer Research Imaging Camp)	2, 1	#10_Attach 10C_Camp Survey ,   #9_Attach 9B_IRB Policy Survey

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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	33,000	33,000	0	0	0	0
Annual Time Burden (Hours)	7,050	7,050	0	0	0	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: $92,740

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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