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

Forms and Documents

Document Name	Status
Form 1 PATH/Baseline-Adults-Biospecimen: Blood Form and Instruction	Unchanged
Form 1 PATH/Baseline-Adults-Biospecimen: Buccal Form and Instruction	Modified
Form 1 PATH - Adults - Followup/Tracking Participant Information Form for Shadow Sample Youth(completed ny Parents)/Field Test Form and Instruction	Unchanged
Form 1 PATH/Baseline- Adults - Followup/Tracking Participant Information Form for Youth (completed by parents) Form and Instruction	Unchanged
Form 1 PATH/Baseline- Adult-Parent Interview Form and Instruction	Unchanged
Form 1 PATH/Baseline-Youth Extended Interview Form and Instruction	Unchanged
Form 1 PATH/Baseline- Adults-Followup/Tracking Participant Information Form Form and Instruction	Unchanged
Form 1 PATH/Baseline- Adults -Tobacco Use Form Form and Instruction	Unchanged
Form 1 PATH/Baseline-Adults-Biospecimen: Urine Form and Instruction	Unchanged
Form 1 PATHBaseline- Adult Extended Interview Form and Instruction	Unchanged
Form 1 PATH/Baseline - Adults Individual Screener Form and Instruction	Unchanged
Form 1 PATH/Baseline- Adults Household Screener Form and Instruction	Unchanged
RS10 Adult Receipt_Urine Blood V1_04-14-14 REVISED.docx Supplementary Document	2014-06-05
CM4a Urine and Blood Collection Signature Form V1_04-14-14 REVISED.docx Supplementary Document	2014-06-05
CM4 Urine and Blood Collection Pamphlet V1_04-14-14 REVISED.docx Supplementary Document	2014-06-05
0925-0664 Change Request to Drop Buccal Cell Collection- PATH Study baseline 5-14.docx Justification for No Material/Nonsubstantive Change	2014-06-05
FRT2 Adult Participant Information Form REVISED 121313.doc Supplementary Document	2013-12-18
FRT2 Adult Participant Information Form OMB-APPROVED 121313.doc Supplementary Document	2013-12-18
Non- sub change request memo - PATH Study 12-18-13.doc Justification for No Material/Nonsubstantive Change	2013-12-18
3d-Spanish. Biospecimen Collection Forms.pdf Supplementary Document	2013-06-28
3d-Spanish. Biospecimen Collection Forms.pdf Supplementary Document	2013-06-28
3j-Spanish. Followup Tracking Participant Information Form - Shadow Sample Youth.pdf Supplementary Document	2013-06-28
3i-Spanish. Followup Tracking Participant Information Form - Youth.pdf Supplementary Document	2013-06-28
3h. Spanish. PATH Wave 1 Parent Interview 7.5 2013-06-10.pdf Supplementary Document	2013-06-28
3g. Spanish. PATH Wave 1 Youth Extended Interview 7.5 2013-06-10.pdf Supplementary Document	2013-06-28
3e. Spanish. PATH Wave 1 Tobacco Use Form 2013-06-10.pdf Supplementary Document	2013-06-28
3d-Spanish. Biospecimen Collection Forms.pdf Supplementary Document	2013-06-28
3c. Spanish. PATH Wave 1 Adult Extended Interview 7.5 2013-06-10.pdf Supplementary Document	2013-06-28
3b. Spanish. PATH Wave 1 Individual Screener 7.5 2013-06-10.pdf Supplementary Document	2013-06-28
3a. Spanish. PATH Wave 1 Household Screener 7.5 2013-06-10.pdf Supplementary Document	2013-06-28

IC Document Collections

IC ID	Document Title	Status
207613	PATH/Baseline-Adults-Biospecimen: Blood Form and Instruction	Unchanged
207612	PATH/Baseline-Adults-Biospecimen: Buccal Form and Instruction	Modified
203772	PATH - Adults - Followup/Tracking Participant Information Form for Shadow Sample Youth(completed ny Parents)/Field Test Form and Instruction	Unchanged
203763	PATH/Baseline- Adults - Followup/Tracking Participant Information Form for Youth (completed by parents) Form and Instruction	Unchanged
203762	PATH/Baseline- Adult-Parent Interview Form and Instruction	Unchanged
203761	PATH/Baseline-Youth Extended Interview Form and Instruction	Unchanged
203760	PATH/Baseline- Adults-Followup/Tracking Participant Information Form Form and Instruction	Unchanged
203759	PATH/Baseline- Adults -Tobacco Use Form Form and Instruction	Unchanged
203758	PATH/Baseline-Adults-Biospecimen: Urine Form and Instruction	Unchanged
203757	PATHBaseline- Adult Extended Interview Form and Instruction	Unchanged
203756	PATH/Baseline - Adults Individual Screener Form and Instruction	Unchanged
203755	PATH/Baseline- Adults Household Screener Form and Instruction	Unchanged

ICR Details

OMB Control No: 0925-0664	ICR Reference No: 201406-0925-001
Status: Historical Active	Previous ICR Reference No: 201312-0925-006
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: 06/05/2014
	Date Received in OIRA: 06/05/2014
Terms of Clearance: This approval only covers the baseline wave of data collection. A full revision is necessary for the second wave. Before submitting the second wave of data collection to OMB for approval under the PRA, NIDA/FDA should report to OMB regarding the response rates associated with the baseline (screening, interview completion, and bio-specimen response, the results of their nonresponse analysis and statistical approach for addressing non-response, as well as implications for the study going forward. 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 . Results based on the bio-specimen data cannot publicly disseminated until OMB approves a change request under the PRA that explains 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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	11/30/2015	11/30/2015
Responses	546,222	0	560,451
Time Burden (Hours)	132,620	0	136,889
Cost Burden (Dollars)	0	0	0

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Abstract: Enactment of the FSPTCA granted FDA regulatory authority over tobacco products to protect public health and reduce tobacco use among Americans, particularly young people. 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; and serve to establish a regulatory science framework for FDA's development, implementation, and evaluation of effective product regulations to reduce tobacco-related diseases, disabilities, and deaths in the U.S. population. The PATH study also fills a data gap with its longitudinal cohort design. It is 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.

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

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

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
PATH/Baseline- Adults-Followup/Tracking Participant Information Form	1, 1	Follow-up/Tracking Participant Information Form ,   Revised Adult Tracking Information Form
PATH/Baseline-Youth Extended Interview	1	Youth Extended Interview
PATH/Baseline- Adult-Parent Interview	1	Parent Interview
PATH/Baseline- Adults - Followup/Tracking Participant Information Form for Youth (completed by parents)	1	Follow-up/Tracking Participant Information Form (completed by parents)
PATH/Baseline-Adults-Biospecimen: Buccal	1	Buccal Collection
PATH - Adults - Followup/Tracking Participant Information Form for Shadow Sample Youth(completed ny Parents)/Field Test	1	Shadow Sample
PATH/Baseline-Adults-Biospecimen: Blood	1	Blood Collection
PATH/Baseline- Adults Household Screener	1	Household Screener
PATH/Baseline - Adults Individual Screener	1	Individual Screener
PATHBaseline- Adult Extended Interview	1	Extended Interview
PATH/Baseline-Adults-Biospecimen: Urine	1	Urine Collection
PATH/Baseline- Adults -Tobacco Use Form	1	Tobacco Use 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	546,222	560,451	0	-14,229	0	0
Annual Time Burden (Hours)	132,620	136,889	0	-4,269	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The program is requesting the termination of the collection of buccal cells for the remainder of this wave of the study. This request reflects the decrease in the burden hours as well as the forms that were slightly modified due to the program's decision.

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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

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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: 06/05/2014

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