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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
Retrieve Notice of Action (NOA)	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

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.

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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	450,546	450,546
Annual Time Burden (Hours)	121,572	121,572
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Seleda Perryman 202 690-5521

View ICR - OIRA Conclusion