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

Forms and Documents

Document	Type	Status	Availability
Form 1-Rev Instruments for Wave 3 of the PATH Study	Form and Instruction	Unchanged	Available
Change request_PATH Study Statistical Approach for Biospecimen Weighting_Wave 1 Sept 15-2015.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2015-10-05	Available
3 Crosswalk.pdf	Supplementary Document	Uploaded 2015-06-19	Available
Change Request - PATH Study Wave 2 (0925-0664) May 8_2015Ver3.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2015-05-19	Repair queued
Change Request - PATH Study Wave 2 (0925-0664) May 8_2015 ver2.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2015-05-18	Repair queued
12_Consent_Materials_Spanish-revised 5-8-15.pdf	Supplementary Document	Uploaded 2015-05-18	Available
12_Consent_Materials-revised 5-8-15 (2).pdf	Supplementary Document	Uploaded 2015-05-18	Available
22 Statistical Consultants.pdf	Supplementary Document	Uploaded 2015-06-19	Repair queued
21 PATH Study Interim Report for OMB.pdf	Supplementary Document	Uploaded 2015-06-19	Repair queued
20 Sample Analysis Plans.pdf	Supplementary Document	Uploaded 2015-06-19	Available
4 Sample Conceptual Models.pdf	Supplementary Document	Uploaded 2015-06-19	Repair queued
16 NIH Privacy Act SORN.pdf	Supplementary Document	Uploaded 2015-06-19	Repair queued
15_IRB_Approval_Memo.pdf	Supplementary Document	Uploaded 2015-06-19	Repair queued
14 Assurance of Confidentiality.pdf	Supplementary Document	Uploaded 2015-06-19	Available
13 NIH Confidentiality Certificate.pdf	Supplementary Document	Uploaded 2015-06-19	Available
11 List of Consultants.pdf	Supplementary Document	Uploaded 2015-06-19	Available
7 PATH Study Privacy Impact Assessments (PIA).pdf	Supplementary Document	Uploaded 2015-06-19	Available
1 NIDA's Data Collection Authority.pdf	Supplementary Document	Uploaded 2015-06-19	Repair queued
PATH Study - SSB for Wave 3 ICR June 10-2015.docx	Supporting Statement B	Uploaded 2015-06-19	Available
PATH Study - SSA for Wave 3 ICR June 10-2015 (4).docx	Supporting Statement A	Uploaded 2015-08-07	Available
0925-0664 Change Request to Drop Buccal Cell Collection- PATH Study baseline 5-14.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2014-06-05	Repair queued
Non- sub change request memo - PATH Study 12-18-13.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2013-12-18	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
212557	Instruments for Wave 3 of the PATH Study	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0925-0664	ICR Reference No: 201510-0925-001
Status: Historical Active	Previous ICR Reference No: 201506-0925-002
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: 10/09/2015
	Date Received in OIRA: 10/07/2015
Terms of Clearance: Note that weighting class methods will be used to adjust adult raked weights for the adults who provided each type of biospecimen so that the adjusted weights may attempt to account for the persons who did not provide biospecimens.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	08/31/2018	08/31/2018
Responses	192,858	0	192,858
Time Burden (Hours)	54,434	0	54,434
Cost Burden (Dollars)	0	0	0

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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.

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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:
	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

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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	1-Rev, 2, 3-New, 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

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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	192,858	0	0	0	0
Annual Time Burden (Hours)	54,434	54,434	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	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: No

Burden Reduction Due to:

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.

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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

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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: 10/07/2015

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