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 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 . 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.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
11/30/2015
11/30/2015
11/30/2015
546,222
0
560,451
132,620
0
136,889
0
0
0
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.
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.
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.
PATH/Baseline-Adults-Biospecimen: Blood