This approval extends through Wave 3 of PATH. A full revision is necessary for the data collection for Wave 4 or yet to be defined sub-studies. Before submitting the information collection request for Wave 4 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 3 retention, recruitment rates for the âage in to adultâ and âage in of shadowâ 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 waveâs 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 OSTPâs 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 HHSâ signature nationally representative studies such as CPS-TUPS, NHIS, NATS, and NSDUH.
Inventory as of this Action
Requested
Previously Approved
08/31/2018
36 Months From Approved
09/30/2016
192,858
0
192,858
54,434
0
59,023
0
0
0
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.
US Code:
42 USC 285o
Name of Law: Public Health Service Act
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.
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.
Form 1-Rev Instruments for Wave 3 of the PATH Study
3 Crosswalk.pdf
Change Request - PATH Study Wave 2 (0925-0664) May 8_2015Ver3.docx
Non- sub change request memo - PATH Study 12-18-13.doc
Instruments for Wave 3 of the PATH Study