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

Forms and Documents

Document Name	Status
Form 3-New Instruments for Wave 2 of the PATH Study Form and Instruction	Modified
Change Request - PATH Study Wave 2 (0925-0664) May 8_2015 ver2.docx Justification for No Material/Nonsubstantive Change	2015-05-18
12_Consent_Materials_Spanish-revised 5-8-15.pdf Supplementary Document	2015-05-18
12_Consent_Materials-revised 5-8-15 (2).pdf Supplementary Document	2015-05-18
22_List_of_Statistical_Consultants.pdf Supplementary Document	2014-07-31
21_PATH_Study_Interim_Report_for_OMB.pdf Supplementary Document	2014-07-31
20_Sample_Analysis_Plans.pdf Supplementary Document	2014-07-31
4_Sample_Conceptual_Models.pdf Supplementary Document	2014-07-31
3_PATH_Crosswalk.pdf Supplementary Document	2014-07-31
16_NIH_Privacy_Act_SORN.pdf Supplementary Document	2014-07-22
15_IRB_Approval_Memo.pdf Supplementary Document	2014-07-22
14_Assurance_of_Confidentiality.pdf Supplementary Document	2014-07-22
13_NIH_Confidentiality_Certificate_AM4.pdf Supplementary Document	2014-07-22
11_List_of_Consultants_v7.pdf Supplementary Document	2014-07-22
7_PATH_Study_Privacy_Impact_Assessments_(PIA).pdf Supplementary Document	2014-07-22
1_NIDA's_Data_Collection_Authority.pdf Supplementary Document	2014-07-22
PATH W2 SSB 6-26-2014.docx Supporting Statement B	2014-07-22
PATH W2 SSA 7-24-2014-revised 5-8-15.docx Supporting Statement A	2015-05-18
0925-0664 Change Request to Drop Buccal Cell Collection- PATH Study baseline 5-14.docx Justification for No Material/Nonsubstantive Change	2014-06-05
Non- sub change request memo - PATH Study 12-18-13.doc Justification for No Material/Nonsubstantive Change	2013-12-18

IC Document Collections

IC ID	Document Title	Status
212557	Instruments for Wave 2 of the PATH Study Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0664	ICR Reference No: 201505-0925-001
Status: Historical Active	Previous ICR Reference No: 201407-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No: 21181
Title: Population Assessment of Tobacco and Health (PATH) Study (NIDA)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/19/2015
	Date Received in OIRA: 05/18/2015
Terms of Clearance: Previous terms continue: This approval covers Wave 2 of PATH. A full revision is necessary for the collection of Wave 3 data. Before submitting the information collection request for Wave 3 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 2 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	09/30/2016	09/30/2016	09/30/2016
Responses	192,858	0	193,243
Time Burden (Hours)	58,340	0	56,939
Cost Burden (Dollars)	0	0	0

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Abstract: This is a revision request (OMB 0925-0664, expires 11/30/2015) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the second wave of data collection. The PATH Study is a national longitudinal cohort study on tobacco use behavior, attitudes, and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17. The PATH Study conducts annual interviews and collects biospecimens from adults to measure and report within-person changes and between-person differences in tobacco product use behaviors, attitudes, and health effects within the cohort over time. Data from the PATH Study will enhance the knowledge base that informs FDA's regulatory decisions and actions under the 2009 Family Smoking Prevention and Tobacco Control Act (TCA). The TCA authorized FDA to regulate tobacco products, including tobacco-product advertising, labeling, marketing, constituents, ingredients, and additives.

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

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:
	79 FR 7206	02/06/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 37754	07/02/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Instruments for Wave 2 of the PATH Study	1-Rev, 1, 2, 2, 3-New, 3-New	PATH Verification Form ,   PATH Validation Form ,   English Version ,   Spanish Version ,   Follow up, Retention and Tracking Documents - English Version ,   Follow up, Retention and Tracking Documents - Spanish Version

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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	192,858	193,243	0	-385	0	0
Annual Time Burden (Hours)	58,340	56,939	0	1,401	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: See the Justification memo for non-substantive change details.

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Annual Cost to Federal Government: $65,148,000

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: 05/18/2015

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