Generic Clearance for Cognitive Testing of Instrumentation and Materials for the PATH Study (NIDA)

Forms and Documents

Document Name	Status
Form A-1 Cognitive Testing for the PATH Study Wave 4 Questionnaires Form and Instruction	New
Form 1 Cognitive Interviews to Support Development of Questionnaire Items for Wave 3 Form and Instruction	New
Generic CT Supporting Statement Part B 8-7-12.docx Supporting Statement B	2012-09-05
Generic- Privacy Act SORN.pdf Supplementary Document	2012-09-05
Generic- Examples of Consent Materials.pdf Supplementary Document	2012-09-05
Generic- Description of Cognitive InterviewingTesting.pdf Supplementary Document	2012-09-05
Generic- Cognitive Testing Statistical Consultants.pdf Supplementary Document	2012-09-05
Generic -Cognitive Testing Consultants v2.pdf Supplementary Document	2012-09-05
Generic- Assurance of Confidentiality.pdf Supplementary Document	2012-09-05
PATH Generic_CT_Supporting_Statement_Part_A_revised final 2011-6-12.doc Supporting Statement A	2012-11-07

IC Document Collections

IC ID	Document Title	Status
217825	Cognitive Testing for the PATH Study Wave 4 Questionnaires Form and Instruction	New
212388	Cognitive Interviews to Support Development of Questionnaire Items for Wave 3 Form and Instruction	New

ICR Details

OMB Control No: 0925-0663	ICR Reference No: 201209-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Generic Clearance for Cognitive Testing of Instrumentation and Materials for the PATH Study (NIDA)
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 without change	Conclusion Date: 11/27/2012
	Date Received in OIRA: 09/14/2012
Terms of Clearance: NIH will submit individual collections under this generic clearance to OMB. OMB will strive to provide feedback on the individual collections within ten working days, whenever possible, as is currently the case. Standard remuneration of respondents for cognitive testing is $40.00. Higher remunerations may be requested with justification for difficult recruitments, focus groups, etc. If the OIRA desk officer is given a 'heads up' regarding the content and timing of a submittal for a generic IC, she/he will try to approve each request in less than 21 calendar days

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	36 Months From Approved
Responses	12,000	0	0
Time Burden (Hours)	6,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This request is for cognitive interviewing and testing of instrumentation and materials associated with the NIH/FDA study called PATH. PATH is designed to establish a population-based framework to monitor the behavioral and health impacts of smoking prevention programs. This generic clearance is designed to inform the development of the instrumentation for the PATH study's baseline and follow-up waves of data and biospecimens collection. Cognitive testing will help to ensure that their design and content are valid and meet the PATH study's objectives. Additionally, results from cognitive testing will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of the information collection to help minimize its estimated cost and public burden. The study will use descriptive methods in analysis.

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Authorizing Statute(s): None

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:
	77 FR 30540	05/23/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 55217	09/07/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Cognitive Testing for the PATH Study Wave 4 Questionnaires	A-2, A-1, A-3, A-4, B-1, B-2, B-3, B-4, B-5, B-6, B-7, B-8, B-9, B-10, B-11, B-12, B-18, B-19, B-20, B-21, B-14 , B-13, B-15, B-16, B-17	Recruitment Screener ,   Recruitment Screener ,   Recruitment Screener ,   Recruitment Screener ,   Adult Interview Intro. ,   ENDS Interview Into. ,   Youth Interview Intro ,   Screening Module ,   Screening Module Images ,   Adult Cigarettes Modlue ,   Adult Hookah Module ,   Adult Smokeless/Snus Module ,   Adult Harm Perceptions Module ,   Adult Media Module ,   Social Media Card Sort Imagines ,   Adult Barcode Module ,   Adult ENDS Module ,   Young Adult Cigarettes Module ,   Young Adult Hookah Module ,   Young Adult Demographics Module ,   Youth Cigarettes Modulle ,   Youth Hookah Module ,   Youth Social Norms Module ,   Youth Harm Perceptions Module ,   Youth Media Module
Cognitive Interviews to Support Development of Questionnaire Items for Wave 3	2, 1, 3, 4, 5, 6	Recruitment Interview - English ,   Spanish Interviews ,   Adult Consent ,   Youth Assent ,   Study Protocol - Spanish ,   Study Protocol - Spanish

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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	12,000	0	0	12,000	0	0
Annual Time Burden (Hours)	6,000	0	0	6,000	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 data collection.

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Annual Cost to Federal Government: $0

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]? 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: 09/14/2012

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