Generic Clearance for Methodological Studies in the Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Forms and Documents

Document Name	Status
Form B-2 Focus Groups to Support Development for PATH Study Wave 4 Items Form and Instruction	New
Form B. The Population Assessment of Tobacco and Health (PATH) Study- Focus Groups to Support Development of E-Cigarette and Hookah Questionnaire Items Form and Instruction	New
Generic Methodological Studies SSB 1-24-13.docx Supporting Statement B	2013-02-28
Att6 PATH Study Privacy Impact Assessments.pdf Supplementary Document	2013-02-28
Att5 Privacy Act and SORN.pdf Supplementary Document	2013-02-28
Att4 PATH_Confidentiality_Certificate.pdf Supplementary Document	2013-02-28
Att2 Public Comments from 60-day FRN.pdf Supplementary Document	2013-02-28
Att1 Examples of potential methodological studies to inform the PATH Study.pdf Supplementary Document	2013-02-28
Att3 List of Consultants v4.pdf Supplementary Document	2013-02-28
Generic_Methodological_Studies_SSA May 15 2013 FINAL.docx Supporting Statement A	2013-05-17

IC Document Collections

IC ID	Document Title	Status
217824	Focus Groups to Support Development for PATH Study Wave 4 Items Form and Instruction	New
210595	The Population Assessment of Tobacco and Health (PATH) Study- Focus Groups to Support Development of E-Cigarette and Hookah Questionnaire Items Form and Instruction	New

ICR Details

OMB Control No: 0925-0675	ICR Reference No: 201303-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No: 18997
Title: Generic Clearance for Methodological Studies in the Population Assessment of Tobacco and Health (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 with change	Conclusion Date: 05/22/2013
	Date Received in OIRA: 03/04/2013
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. Standard incentive amount is remuneration is $40.00; requests for higher levels must be justified (e.g., very difficult recruitments), two-hour focus groups, etc.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved
Responses	20,000	0	0
Time Burden (Hours)	89,250	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a new 3-year clearance request for methodological studies to support the Population Assessment of Tobacco and Health (PATH) Study. The methodological studies will use a variety of approaches and will be limited in size, scope, and duration to identify ways to improve how the PATH Study achieves its objectives in each aspect of its implementation, data collection procedures, and techniques for achieving and maintaining high response, retention, and follow up rates.

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Authorizing Statute(s): US Code: 42 USC 285o Name of Law: NIDA in partnership with FDA
  

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 70451	11/26/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 12335	02/22/2013
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Focus Groups to Support Development for PATH Study Wave 4 Items	A-1, A-2, B-1, B-2, B-3, B-4	Moderator Guide ,   Moderator Guide ,   Card Sort Images ,   Recruitment Screener ,   Recruitment Screener ,   Moderator Guide
The Population Assessment of Tobacco and Health (PATH) Study- Focus Groups to Support Development of E-Cigarette and Hookah Questionnaire Items	D,, E., F., B., C.	Screener for E-cigarette and Hookah Focus focus group ,   E-Cigarette Focus Group Moderator Guide ,   Hookah Moderator's Guide ,   Hookah Focus Group Moderator Guide - Online ,   Consent for Participation in a In-person Focus Group for the PATH Study

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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	20,000	0	0	20,000	0	0
Annual Time Burden (Hours)	89,250	0	0	89,250	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 ICR.

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Annual Cost to Federal Government: $464,000

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: 03/04/2013

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