Population Assessment of Tobacco and Health (PATH) Study - Fourth Wave of Data Collection (NIDA)

Forms and Documents

Document Name	Status
Form 1 Path Study Data Collection Instruments Form and Instruction	New
Form 1-Rev Instruments for Wave 3 of the PATH Study Form and Instruction	Removed
Attach2a PATH Study Data Collection Instruments.pdf Supplementary Document	2016-11-04
Attach2b PATH Study Data Collection Instruments.pdf Supplementary Document	2016-11-04
Attach4 Summary of Changes to Instruments for Wave 4.pdf Supplementary Document	2016-11-04
PATH 30-day.pdf Supplementary Document	2016-07-01
Revised_ PATH Study W4 SSA 100716.docx Supporting Statement A	2016-11-04
Attach21. Statistical Consultants.pdf Supplementary Document	2016-06-27
Attach20. PATH Study Interim Report.pdf Supplementary Document	2016-06-27
Attach19. Sample Analysis Plans.pdf Supplementary Document	2016-06-27
Attach17. ICPSR Data Use Agreement.pdf Supplementary Document	2016-06-27
Attach16. Procedures for Keeping Data Confidential.pdf Supplementary Document	2016-06-27
Attach15. Privacy Act System of Records Notice.pdf Supplementary Document	2016-06-27
Attach14. IRB Approval Memo.pdf Supplementary Document	2016-06-27
Attach13. Assurance of Confidentiality.pdf Supplementary Document	2016-06-27
Attach12. NIH Confidentiality Certificate.pdf Supplementary Document	2016-06-27
Attach10. List of Consultants .pdf Supplementary Document	2016-06-27
Attach8. Key Design Features.pdf Supplementary Document	2016-06-27
Attach7. PATH Study Privacy Impact Assessments (PIA).pdf Supplementary Document	2016-06-27
Attach5. Sample Conceptual Models.pdf Supplementary Document	2016-06-27
Attach3. Crosswalk of PATH Study Objectives, Data Sources, Domains, and Analysis.pdf Supplementary Document	2016-06-27
Attach1. NIDA's Data Collection Authority.pdf Supplementary Document	2016-06-27
PATH W4 SSB final 062416.docx Supporting Statement B	2016-06-27

IC Document Collections

IC ID	Document Title	Status
222213	Path Study Data Collection Instruments Form and Instruction	New
212557	Instruments for Wave 3 of the PATH Study Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0664	ICR Reference No: 201606-0925-008
Status: Historical Active	Previous ICR Reference No: 201510-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 21181
Title: Population Assessment of Tobacco and Health (PATH) Study - Fourth Wave of Data Collection (NIDA)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/08/2016
	Date Received in OIRA: 07/05/2016
Terms of Clearance: OMB approval is provided for sample replenishment as well as data collection for Wave 4 of the PATH Study. A separate three-year clearance request will be submitted for subsequent waves, which may focus on selected subsamples. The revision will describe the response rate and characteristics of the sample replenishment. NIDA, FDA, and the PATH Study team will work together with OMB to ensure there is no duplication in the type of information generated by the PATH Study and other information collections, such as the recently-approved collection requests for FDA’s CTP.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	08/31/2018
Responses	442,123	0	192,858
Time Burden (Hours)	94,798	0	54,434
Cost Burden (Dollars)	0	0	0

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Abstract: This is a revision request (OMB number 0925-0664, expiration date 8/31/2018) for the Population Assessment of Tobacco and Health (PATH) Study to conduct the fourth wave of data collection. The PATH Study is collecting behavioral data and biospecimens among a national longitudinal cohort 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 FDA’s regulatory actions under the Family Smoking Prevention and Tobacco Control Act (TCA) to protect the Nation’s public health and reduce its burden of tobacco-related morbidity and mortality.

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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:
	81 FR 22290	04/15/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 43217	07/01/2016
Did the Agency receive public comments on this ICR? No

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

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

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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	442,123	192,858	0	249,265	0	0
Annual Time Burden (Hours)	94,798	54,434	0	40,364	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a revision request (OMB number 0925-0664, expiration date 8/31/2018) for the Population Assessment of Tobacco and Health (PATH) Study to conduct Wave 4 of data collection. An increase of 40,364 burden hours is estimated between Wave 3 (54,434) and Wave 4 (94,798). The factors accounting for this increase include the addition of: (1) household and shadow youth only screenings, (2) data collection for new adult and new youth participants, (3) urine and blood collection for new adults, and (4) urine collection for all youth.

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Annual Cost to Federal Government: $94,455,105

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: 07/05/2016

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