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
11/30/2015
11/30/2015
11/30/2015
560,451
0
450,546
136,889
0
121,572
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.
US Code:
42
USC 285o Name of Law: Title 42 USC 285o
This is a non-substantive
change request to begin the baseline wave of data collection for
the PATH Study. This data collection is based on the completion of
a field test approved by OMB on 11/30/12. The estimated burden for
the baseline wave is 136,889 hours. This is lower than the
estimated burden of 138,514 hours reported for the baseline in the
original package approved for the field test. The lower number
results from a combination of fewer youth and parent interviews
estimated for the baseline and refinements made to several
instruments based on the field test to reduce burden on
participants.
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 PATH/Baseline-Adults-Biospecimen: Blood
PATH terms of clearance - draft2 8-22-13.doc
23 List of Statistical Consultants v3.pdf
PATH/Baseline-Adults-Biospecimen: Blood