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

ICR 201505-0925-001

OMB: 0925-0664

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2015-05-18
Supplementary Document
2015-05-18
Supplementary Document
2015-05-18
Supplementary Document
2014-07-31
Supplementary Document
2014-07-31
Supplementary Document
2014-07-31
Supplementary Document
2014-07-31
Supplementary Document
2014-07-31
Supplementary Document
2014-07-22
Supplementary Document
2014-07-22
Supplementary Document
2014-07-22
Supplementary Document
2014-07-22
Supplementary Document
2014-07-22
Supplementary Document
2014-07-22
Supplementary Document
2014-07-22
Supporting Statement B
2014-07-22
Supporting Statement A
2015-05-18
Justification for No Material/Nonsubstantive Change
2014-06-05
Justification for No Material/Nonsubstantive Change
2013-12-18
IC Document Collections
IC ID
Document
Title
Status
212557 Modified
ICR Details
0925-0664 201505-0925-001
Historical Active 201407-0925-004
HHS/NIH 21181
Population Assessment of Tobacco and Health (PATH) Study (NIDA)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/19/2015
Retrieve Notice of Action (NOA) 05/18/2015
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
09/30/2016 09/30/2016 09/30/2016
192,858 0 193,243
58,340 0 56,939
0 0 0

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.

US Code: 42 USC 285o Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  79 FR 7206 02/06/2014
79 FR 37754 07/02/2014
Yes

  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
Yes
Miscellaneous Actions
No
See the Justification memo for non-substantive change details.

$65,148,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Saleda Perryman

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/18/2015


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