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

Forms and Documents

Document Name	Status
0925-0663 Generic CT Supporting Statement Part A 10-26-15 (rev 3-9-16) (2).docx Supporting Statement A	2016-03-10
4. Assurance of Confidentiality.docx Supplementary Document	2015-10-16
3. Privacy Act SORN.pdf Supplementary Document	2015-10-16
2. Cognitive Interview and Focus Group Consultants.docx Supplementary Document	2015-10-16
1. NIDA's Data Collection Authority.docx Supplementary Document	2015-10-16
PATH 30-day Notice.pdf Supplementary Document	2015-10-16
0925-0663 Generic CT Supporting Statement Part B 10-07-2015.docx Supporting Statement B	2015-10-16

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0925-0663	ICR Reference No: 201510-0925-004
Status: Historical Active	Previous ICR Reference No: 201209-0925-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/10/2016
	Date Received in OIRA: 10/20/2015
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	03/31/2019	36 Months From Approved	03/31/2016
Responses	15,900	0	12,000
Time Burden (Hours)	7,851	0	6,000
Cost Burden (Dollars)	0	0	0

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Abstract: This is a revision request (OMB 0925-0663, expires 11/30/2015) for the Population Assessment of Tobacco and Health (PATH) Study to conduct cognitive interviews and focus groups, to support the development of the Study’s questionnaires and other materials. The PATH Study is a national longitudinal cohort study of tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17; the Study conducts annual interviews and collects biospecimens from adults to inform FDA’s regulatory actions under the Family Smoking Prevention and Control Act. Cognitive interviews and focus groups are qualitative methods to assess how people interpret, process, retrieve, and respond to phrases, questions, response options, and product images that may be used in the development of the PATH Study's questionnaires and other materials. These methods have previously been used to help the PATH Study improve the comprehensibility of its materials for Study participants, and to increase efficiencies in data collection and reduce duplication and its associated burden on participants and the public.

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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:
	80 FR 37276	06/30/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 61829	10/14/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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	15,900	12,000	0	3,900	0	0
Annual Time Burden (Hours)	7,851	6,000	0	1,851	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 revision request (OMB 0925-0663, expires 11/30/2015) for the Population Assessment of Tobacco and Health (PATH) Study to conduct cognitive interviews and focus groups, to support the development of the Study’s questionnaires and other materials. Annually there is an increase of 617 estimated burden hours, but over the three years it's 1851 burden hours between the generic clearance approved by OMB in 2012 (2,000) and the current revision request (2,617 and 7,851 over the three years). Factors accounting for the increase include the following: (1) addition of an activity, which is examination of concepts to be measured in the PATH Study; and (2) screening for respondents to participate in this activity.

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Annual Cost to Federal Government: $1,018,000

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? 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: 10/20/2015

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