Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Forms and Documents

Document Name	Status
Form 2i PATH - Adults - Followup/Tracking Participant Information Form for Youth(completed ny Parents)/Field Test Form	New
Form 2h PATH - Adult- Parent Interview/Field Test Form	New
Form 2g PATH - Youth Extended Interview/Field Test Form	New
Form 2f PATH - Adults- Followup/Traacking Participant Information Form/Field Test Form	New
Form 2e PATH - Tobacco Use Form/Field Test Form	New
Form 2d PATH - Biospecimen Collection Forms/Field Test Form and Instruction	New
Form 2c PATH - Adults - Extended Interview/Field Test Form	New
Form 2b PATH - Adults - Individual Screener/Field Test Form	New
Form 2a PATH - Adults Household Screener/Field Test Form	New
Form 2i PATH/Baseline- Adults - Followup/Tracking Participant Information Form for Youth (completed by parents) Form	New
Form 2h PATH/Baseline- Adult-Parent Interview Form	New
Form 2g PATH/Baseline-Youth Extended Interview Form	New
Form 2f PATH/Baseline- Adults-Followup/Tracking Participant Information Form Form	New
Form 2e PATH/Baseline- Adults -Tobacco Use Form Form	New
Form 2d PATH/Baseline-Adults-Biospecimen Collection Forms Form and Instruction	New
Form 2c PATHBaseline- Adult Extended Interview Form	New
Form 2b PATH/Baseline - Adults Individual Screener Form	New
Form 2a PATH/Baseline- Adults Household Screener Form	New
PATH_Confidentiality_Certificate.pdf Supplementary Document	2012-11-20
PATH Study Advance_Ltr-Household_revised 11-21-12.pdf Supplementary Document	2012-11-23
PATH Study_Brochure_revised 11-21-12.pdf Supplementary Document	2012-11-23
3a Crosswalk_V2.pdf Supplementary Document	2012-11-19
For OMB - SSB Final 11-19-12.doc Supporting Statement B	2012-11-19
17. Field Data Collection Materials 8-3-12.pdf Supplementary Document	2012-08-14
11. Consent Materials 11-8-12.pdf Supplementary Document	2012-11-19
7. Followup, Retention, and Tracking Materials 073012.pdf Supplementary Document	2012-08-14
20. List of Statistical Consultants v3.pdf Supplementary Document	2012-08-13
19 PATH Study Field Test Experiment 2012-11-08_V3a.pdf Supplementary Document	2012-11-19
18. Sample Analysis Plans.pdf Supplementary Document	2012-08-13
16. ICPSR Data Use Agreement.pdf Supplementary Document	2012-08-13
15. Procedures for Keeping Data Confidential.pdf Supplementary Document	2012-08-13
14. Privacy Act SORN.pdf Supplementary Document	2012-08-13
13. IRB Approval Memo.pdf Supplementary Document	2012-08-13
12. Assurance of Confidentiality.pdf Supplementary Document	2012-08-13
10. Advance Materials 11-8-12 v2.pdf Supplementary Document	2012-11-19
9. List of Consultants v3.pdf Supplementary Document	2012-08-13
6. Key Design Features-SOURCE.pdf Supplementary Document	2012-11-19
5. PATH Study Privacy Impact Assessments.pdf Supplementary Document	2012-08-13
4. PATH analyte by specimen and biomarker.pdf Supplementary Document	2012-11-19
3b. Sample Conceptual Models v2.pdf Supplementary Document	2012-11-19
1. NIDA's Data Collection Authority.pdf Supplementary Document	2012-08-13
For_OMB_-_SSA_Final_11-26-12.doc Supporting Statement A	2012-11-26

IC Document Collections

IC ID	Document Title	Status
203772	PATH - Adults - Followup/Tracking Participant Information Form for Youth(completed ny Parents)/Field Test Form	New
203771	PATH - Adult- Parent Interview/Field Test Form	New
203770	PATH - Youth Extended Interview/Field Test Form	New
203769	PATH - Adults- Followup/Traacking Participant Information Form/Field Test Form	New
203768	PATH - Tobacco Use Form/Field Test Form	New
203767	PATH - Biospecimen Collection Forms/Field Test Form and Instruction	New
203766	PATH - Adults - Extended Interview/Field Test Form	New
203765	PATH - Adults - Individual Screener/Field Test Form	New
203764	PATH - Adults Household Screener/Field Test Form	New
203763	PATH/Baseline- Adults - Followup/Tracking Participant Information Form for Youth (completed by parents) Form	New
203762	PATH/Baseline- Adult-Parent Interview Form	New
203761	PATH/Baseline-Youth Extended Interview Form	New
203760	PATH/Baseline- Adults-Followup/Tracking Participant Information Form Form	New
203759	PATH/Baseline- Adults -Tobacco Use Form Form	New
203758	PATH/Baseline-Adults-Biospecimen Collection Forms Form and Instruction	New
203757	PATHBaseline- Adult Extended Interview Form	New
203756	PATH/Baseline - Adults Individual Screener Form	New
203755	PATH/Baseline- Adults Household Screener Form	New

ICR Details

OMB Control No: 0925-0664	ICR Reference No: 201208-0925-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: 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: 11/27/2012
	Date Received in OIRA: 08/17/2012
Terms of Clearance: OMB approves only the field test, including an incentive experiment, at this time. No specific incentive structure is pre-approved for the first wave of PATH (i.e., the baseline for the full study). After the field test has been completed but before commencing the first wave of data collection, NIH must submit a non-substantive change that clearly justifies the structure of incentives, addresses OMB concerns regarding the wording for some survey items, and otherwise ensures that the protocol and instruments maximize the utility of the data collection, minimize burden on participants, avoid duplication with existing Federal surveys, and comply with HHS data standards. If NIH plans to make significant changes (e.g., to the sample design) a full revision may be necessary.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	36 Months From Approved
Responses	450,546	0	0
Time Burden (Hours)	121,572	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The NIH, through NIDA, is partnering with FDA's newly established Center for Tobacco Products (CTP) in a large-scale collaboration to conduct the PATH study. This national longitudinal study of tobacco use and health will provide epidemiological, population-based data about attitudes and perceptions related to the use of different existing and emerging tobacco products; patterns and trends in use of existing and emerging tobacco products; knowledge of the contents of tobacco products and of the consequences of their use; and on near- and longer-term health outcomes associated with tobacco product use. These data will advance the scientific knowledge base on tobacco use behaviors and health. In addition, the longitudinal component will serve to establish a science framework for FDA to track the potential behavioral and health impacts of specific FSPTCA-related smoking prevention programs as well as informing the development of new programs and policies. It will be the only national longitudinal study of tobacco use. As such, this study provides a unique opportunity to monitor and assess changes over time in patterns of use of tobacco products among study respondents. The study will collect national longitudinal survey data from a cohort of approximately 59,587 current, former, and never tobacco product users ages 12 years and older in the U.S. Biospecimens will also be collected from adult respondents to assess objective measures of exposure and prospectively monitor indicators of tobacco use-related harm.

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Authorizing Statute(s): US Code: 42 USC 285o Name of Law: Title 42 USC 285o
  

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 29667	05/18/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 48994	08/15/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
PATH/Baseline- Adults Household Screener	2a	Adult- Household Screener/Baseline
PATH/Baseline - Adults Individual Screener	2b	Adults Individual Screener/Baseline
PATHBaseline- Adult Extended Interview	2c	Adults Extended Interview/Baseline
PATH/Baseline-Adults-Biospecimen Collection Forms	2d	Biospecimen Collection Forms/Baseline
PATH/Baseline- Adults -Tobacco Use Form	2e	Tobacco Use Form/Baseline
PATH/Baseline- Adults-Followup/Tracking Participant Information Form	2f	Adult-Followup/Tracking/Baseline
PATH/Baseline-Youth Extended Interview	2g	Youth Extended Interview/Baseline
PATH/Baseline- Adult-Parent Interview	2h	Parent Interview/Baseline
PATH/Baseline- Adults - Followup/Tracking Participant Information Form for Youth (completed by parents)	2i	Followup/Tracking Youth/Baseline
PATH - Adults Household Screener/Field Test	2a	Household Screener/Field Test
PATH - Adults - Individual Screener/Field Test	2b	Individual Screener/Field Test
PATH - Adults - Extended Interview/Field Test	2c	Extended Interview/Field Test
PATH - Biospecimen Collection Forms/Field Test	2d	Biospecimen Collection Forms/Field Test
PATH - Tobacco Use Form/Field Test	2e	Tobacco Use Form/Field Test
PATH - Adults- Followup/Traacking Participant Information Form/Field Test	2f	Followup Tracking Participant/Field Test
PATH - Youth Extended Interview/Field Test	2g	Youth Extended Interview/Field Test
PATH - Adult- Parent Interview/Field Test	2h	Parent Interview/Field Test
PATH - Adults - Followup/Tracking Participant Information Form for Youth(completed ny Parents)/Field Test	2i	Followup/Tracking Youth

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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	450,546	0	0	450,546	0	0
Annual Time Burden (Hours)	121,572	0	0	121,572	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: $696,000

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: 08/17/2012

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