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OMB Control No: 0925-0664	ICR Reference No: 201506-0925-002
Status: Historical Active	Previous ICR Reference No: 201505-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No: 21181
Title: Population Assessment of Tobacco and Health (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 without change	Conclusion Date: 08/17/2015
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/20/2015
Terms of Clearance: This approval extends through Wave 3 of PATH. A full revision is necessary for the data collection for Wave 4 or yet to be defined sub-studies. Before submitting the information collection request for Wave 4 to OMB, NIDA/FDA should report to OMB regarding: a) the response rates associated with the full baseline wave, including screening, interview completion, and bio-specimen response; b) Wave 3 retention, recruitment rates for the “age in to adult” and “age in of shadow” subsamples; c) the results of nonresponse analysis and statistical approach for addressing non-response, as well as implications for the study going forward; and d) the statistical approach to be applied to the bio-specimen data to address potential non-response bias from lower consent and cooperation rates with this aspect of the study. Per prior terms of clearance, NIDA and FDA will create a public use dataset from each wave’s data, making it available to the public on-line within 18 months of completion of each wave. Data underlying government-funded scientific publications will be made available to the public, consistent with NIH guidelines for implementing OSTP’s Public Access to the Results of Federally Funded Research. This study is not specifically designed to provide nationally representative estimates of prevalence. As such, FDA and NIDA will always present such cross-sectional prevalence estimates in conjunction with estimates from HHS’ signature nationally representative studies such as CPS-TUPS, NHIS, NATS, and NSDUH.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	36 Months From Approved	09/30/2016
Responses	192,858	0	192,858
Time Burden (Hours)	54,434	0	59,023
Cost Burden (Dollars)	0	0	0

Abstract: This is a revision request (OMB 0925-0664, expires 9/30/2016) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the third wave of data collection. 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 assess within-person changes and between-person differences in tobacco-product use behaviors and related health conditions over time. Its longitudinal, population-based data will help to enhance the evidence base that informs the Food and Drug Administration's regulatory actions under the Family Smoking Prevention and Control Act to protect the Nation's public health and reduce its burden of tobacco-related morbidity and mortality.

Authorizing Statute(s): US Code: 42 USC 285o Name of Law: Public Health Service Act

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:
	80 FR 7619	02/11/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 34684	06/17/2015
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	192,858	192,858	0
Annual Time Burden (Hours)	54,434	59,023	-4,589
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a revision request (OMB 0925-0664, expires 9/30/2016) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the third wave of data collection. There is a reduction of 4,589 estimated burden hours between Wave 2 (59,023) and Wave 3 (54,434). Factors accounting for this reduction include the following: (1) an 86 percent response rate for interviews with continuing adults, (2) an 87 percent response rate for interviews with aged-up adults, (3) a 91 percent response rate for interviews with continuing youth, and (4) an 89 percent response rate for interviews with aged-up youth.

Annual Cost to Federal Government: $66,490,924

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

Agency Contact: Saleda Perryman

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