Sumario: | <p>The Population Assessment of Tobacco and Health (PATH) Study is a collaboration between the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), and the Center for Tobacco Products (CTP), Food and Drug Administration (FDA). The study was launched in 2011 to inform the FDA's tobacco regulatory activities under the <a href="http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm">Family Smoking Prevention and Tobacco Control Act (TCA)</a>. For Wave 1 (baseline), the PATH Study sampled over 150,000 mailing addresses across the United States to create a national sample of tobacco users and non-users, yielding Wave 1 interviews with 45,971 adult and youth respondents. </p> <p>Each adult interview respondent, who completed the interview, was asked to provide up to three biospecimens as part of the PATH Study. However, providing biospecimens was voluntary and was not a condition of participation. To help with interpretation of biomarker results, respondents were asked to report on their use of all nicotine-containing products during a 3-day period prior to the time of any biospecimen collection (Nicotine Exposure Questions or NEQs). Of the 32,320 respondents who completed the adult interview, 21,801 provided a urine specimen and 14,520 provided a blood specimen.</p> <p>Buccal cells were collected for a limited time, from September 12, 2013, to May 18, 2014. There were 12,543 respondents who provided a buccal cell specimen. However, these specimens were not sent for laboratory analysis. There are no biomarker data files for buccal cells at this time, nor are there plans to create them.</p> <p>The Restricted-Use Biomarker Data Files (Biomarker RUF) consist of three different types of files:</p> <ul> <li>2 Collection and Nicotine Exposure Questions (NEQs) for Urine (DS1001) and Blood (DS1101)</li> <li>2 Biomarker Weight files including variables for use in variance estimation for Urine (DS1002) and Blood (DS1102)</li> <li>7 Urine Panels (DS1003 to DS1009) and 1 Serum Panel (DS1103) containing biomarker assay results</li> </ul> <p>References to the collection of biospecimens will be specified by the collected specimen, i.e., urine and (whole) blood. However, references to biomarker analyses and analytes will be specified by the type of medium (serum, plasma, or urine) used for the analysis.</p>
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