Request for Information: Population Assessment of Tobacco and Health (PATH) Study for the National Institute on Drug Abuse

This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for market research and project planning purposes for the continuation of the Population Assessment of Tobacco and Health (PATH) Study, to inform the National Institute on Drug Abuse (NIDA) and the Food and Drug Administration (FDA)’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act.Background:The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed by President Barack Obama on June 22, 2009, created the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) and granted it the authority to regulate the manufacturing, marketing, and distribution of tobacco products including cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco in order to protect public health. In 2016, FDA finalized a rule, commonly referred to as “deeming”,

that extends FDA's regulatory authority to all tobacco products including electronic cigarettes or electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, hookah tobacco, and other tobacco products such as nicotine gels. The Population Assessment of Tobacco and Health (PATH) Study is a national cohort study designed to generate longitudinal epidemiologic data on tobacco use behaviors including patterns of use, attitudes, beliefs, exposures, and related health outcomes. This study began in 2011 and is a collaboration between the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) and the U.S. FDA Center for Tobacco Products. Wave 1 of the PATH Study began in 2013 and included interviews and biospecimen collection with annual data collections through Wave 4, which began in 2016. The study transitioned to biennial data collection of interview data starting from Wave 5, which began in 2018. The collection of biospecimen was completed at Wave 5 in 2018 and will continue with Wave 7 in 2022.The PATH Study currently consists of two cohorts (see Public Use File (PUF) Fig. 1 located: https://www.icpsr.umich.edu/files/NAHDAP/documentation/ug36498-all.pdf), and is a household-based, nationally representative sample of approximately 46,000 participants. These include both youth (12 to 17 years) and adult (18 years and older) current users of a wide array of tobacco products, former tobacco product users, and never users.  Participants were recruited from 156 geographical primary sampling units (PSUs) across the U.S., with each PSU consisting of a county or group of counties. The multi-wave design allows for the detailed longitudinal assessment of participants’ patterns of tobacco product use, tobacco product exposures, tobacco-related attitudes and beliefs, and tobacco-related health outcomes, and provides important information used to protect the Nation’s public health and reduce the burden of tobacco-related morbidity and mortality. Currently the full cohort data collections (“main waves”) are implemented every second year and a wave of data collection is completed in approximately one year.The PATH Study conducts interviews and collects biospecimens with both continuing and replenishment samples. The Wave 1 Cohort was replenished at Wave 4, with a probability sample of adults, youth, and shadow youth ages 10 to 11 selected from the civilian noninstitutionalized population at the time of Wave 4. All interviews and biospecimen collections in Waves 1-5 were conducted in-person. Due to the COVID-19 pandemic, starting mid-Wave 5.5 data collection, the Study conducted phone interviews with continuing participants.  A combination of in-person and telephone modalities will be available to Field Interviewers (FIs) during the Wave 6 data collection, depending on the pandemic-related conditions in their specific locations, as well as on respondent preferences.  Field Interviewers (FI) asked each adult respondent who completed an interview in Wave 1 to consent to provide up to three biospecimens (blood, urine, and buccal cells). Providing biospecimens is voluntary and not a condition of participation in the PATH Study. Since not all respondents interviewed agreed to provide biospecimens during Wave 1, the Wave 1 Biomarker Core is a subsample of the adults who did provide them. Please refer to Table 1 (page 2) in the PATH Study Biomarker Restricted-Use Files User Guide for the number of adults who provided urine biospecimens in Wave 1 (nW1=21,801) and the number of continuing Wave 1 Biomarker Core respondents whose urine was selected for analysis at each wave (nW1=11,522; nW2=9,012; nW3=8,643; nW4=8,333). The number of adults who provided blood biospecimens in Wave 1 was (n=14,520) and the number of blood specimens selected for analysis was (n=7,159) (located: https://www.icpsr.umich.edu/files/NAHDAP/documentation/ug36840-all_REST.pdf). Buccal cells were collected for a limited time during Wave 1, but the specimens were not sent for laboratory analysis and were not collected in subsequent waves. In Waves 2, 3, 4 and 5 urine specimens were collected from a subsample of adult respondents. In Wave 4, all youth respondents were asked to provide urine specimens for the first time, and urine was collected from a subsample of these youth in Wave 5. Blood specimens have not been collected from adult respondents since Wave 1, apart from aged-up adults (i.e., youth who turned 18), who were requested to provide both urine and blood specimens at the time of their first interview as an adult. Biospecimen collection for these aged-up adults have been collected in Waves 2, 3, 4, and 5. Future plans include additional blood and urine collections from subsamples.Blood collection appointments are scheduled with a certified phlebotomist following completion of the interview. Urine samples are collected by FIs at the time of the interview and shipped in temperature-controlled collection containers to a biospecimen repository.Additional information on the PATH Study sample design, data collection, and weighting procedures can be found in the PATH Study Biomarker Restricted-Use Files User Guide and PATH Study Restricted Use Files User Guide (located: https://www.icpsr.umich.edu/files/NAHDAP/documentation/ug36840-all_REST.pdf).Additional PATH Study publications related to design and methods:Hyland A, Ambrose BK, Conway KP, et al. Design and methods of the Population Assessment of Tobacco and Health (PATH) Study. Tobacco Control 2017; 26:371-378.Piesse, Andrea, Opsomer, Jean, Dohrmann, Sylvia, DiGaetano, Ralph, Morganstein, David, Taylor, Kristie, Carusi, Charles, Hyland, Andrew. Longitudinal uses of the Population Assessment of Tobacco and Health Study. Tobacco Regulatory Science. 2021; 7(1): 3-16.Purpose and Objectives:The purpose of this request for information is to enable the PATH Study to continue to promote scientific understanding of tobacco-product use behaviors and related health outcomes over time and to inform FDA’s regulatory activities under the FSPTCA. More specifically, the PATH Study will:Collect, analyze, and disseminate longitudinal behavioral data to enhance the evidence base that informs FDA's regulatory decisions under the FSPTCACollect and analyze biospecimens and disseminate biomarker data to assess changes over time in exposure to harmful and potentially harmful constituents of tobacco useCollect and analyze self-reported data on existing and incident disease potentially related to tobacco use over timeDevelop and implement special data collections  to inform emerging topics on tobacco use behaviors and related health outcomes.Project Requirements:The PATH Study has 3 proposed main activities. These activities are to: 1. Develop and implement a national, probability-based sampling designCollect behavioral data at least biennially for the main cohorts, with an option to follow-up youths and other subgroups of interest annually with a sample size that allows national, longitudinal estimates of tobacco use, and includes replenishment as needed; Ensure appropriate sample size and composition that allows for national estimates of tobacco use that best informs the FDA’s regulatory efforts;Ensure adequate sample sizes to be able to detect statistically significant associations in subgroup analyses;Establish and maintain a sample of shadow youth for continual replenishment of the youngest age groups at each main wave, in addition to the replenishment of youths;2. Develop and implement protocols for the collection and handling of biospecimens among youth and adultsCollect biospecimens and health measures, including but not limited to, urine and blood samples from youth and adults;Arrange to requisition, process, track and ship biospecimens from the repository for laboratory analysis; to coordinate and perform selected laboratory analysis; and to link biomarker data with behavioral data;Establish a committee to evaluate applications by independent researchers for biospecimen access; arrange to requisition, process, track, and ship biospecimens from the repository to researchers; and as necessary, arrange for the shipment of residual biospecimens from researchers to the repository.3. Analyze and disseminate behavioral and biomarker data and conduct special data collectionsCreate de-identified, cleaned data for interim preliminary and final analytic data files, data tables, and codebooks for restricted- and for public-use, as appropriate;Plan, coordinate, and conduct analytical activities, ranging from short-turnaround analyses on time-sensitive issues and high-priority questions to in-depth analyses that produce research papers and analytic reports for publications and/or presentations; andDesign and develop one or more special data collection studies with random or targeted subsamples of the PATH Study cohorts and/or external samples to conduct during and/or after a wave of behavioral data and biospecimen collection as appropriate.Other Important Considerations:The PATH Study Series webpage (located: https://www.icpsr.umich.edu/web/NAHDAP/series/606) provides additional details on the PATH Study, including the user guides and questionnaires.Information Sought:The program is seeking information on how to best plan for future biospecimen data collections in the upcoming waves of the PATH Study. Given its longitudinal nature, it is critical to assess proposed changes and enhancements to the PATH Study biospecimen collection protocol both in terms of immediate benefits and limitations as well as long-term implications for the study cohorts and biomarker cores over time as well as their impact on the anticipated costs.The analytic requirements of the PATH Study, including the PATH Study biospecimen program, are as follows:Ability to produce national-level estimates of behavioral and health measures, including biomarkers with sufficient power to stratify analyses by such factors as tobacco user status (current, former, never), type of tobacco product(s) used, race/ethnicity, age, gender, and/or other characteristics.Assess within-person changes and between-person differences in tobacco-product use behaviors and related health conditions over time.Ensure high rates of cohort response over future waves of behavioral data and biospecimen collection.Conduct assessment of non-response bias.However, while the analytic requirements are fixed, the sampling plan and biospecimen collection methodology and frequency are flexible provided the analytic requirements are met and maintained over the data collection cycles.Please provide detailed responses for any of the following five topic areas. Responses should include sufficient detail in terms of their relevance and responsiveness to the needs of tobacco regulatory science research and impact on the longitudinal analysis of PATH Study data, as well as in terms of providing for cost efficiencies.1. Optimal sample size and composition for longitudinal biospecimen collection NIDA is seeking information on the optimal sample size and composition for the PATH Study longitudinal biospecimen collection using the current PATH Study sample size as a point of reference for each of the following topic areas:Minimum sample size for a nationally representative sample of biospecimens from PATH Study participants to be able to assess health outcomes among priority groups, (e.g., tobacco users, youths, and African Americans).Acceptable range for decreasing sample sizes while maintaining current study’s ability to assess changes over time in biomarkers related to exposure to harmful and potentially harmful constituents of tobacco products.Potential impact of reducing the sample size of certain subgroups (e.g., non-users of tobacco products) on longitudinal analysis of biomarker data.Potential alternative approaches to sample composition, including potential scenarios for targeted recruitment based on respondent characteristics of interest (e.g., demographic, tobacco product use, use of specific tobacco product class, other) and the main characteristics of interest for such targeted recruitment.2. Optimal frequency of biospecimen collection NIDA is seeking information on (1) the optimal frequency of urine biospecimen collection; (2) the optimal frequency of blood biospecimen collection; (3) the optimal time between the biospecimen collections in order for this collection to be responsive to the needs of tobacco regulatory science; and (4) the types of information and research questions that can be generated from different time schedules. This optimal frequency of biospecimen collection must be performed within the available budget and provide for the necessary cost efficiencies.Please provide responses and high-level discussion of cost estimates for the following questions and refer to Table 2 (page 3) in the PATH Study Biomarker Restricted-Use Files User Guide for a general list of biomarkers analyzed by Wave (located: https://www.icpsr.umich.edu/files/NAHDAP/documentation/ug36840-all_REST.pdf).What is the maximum period of time between biospecimen collections that would accommodate meaningful longitudinal analyses for the following:Blood biospecimen collections?Urine biospecimen collections?What types of information can be generated, and what research questions can be answered to inform tobacco regulatory science if blood is collected on the following schedules? Please provide responses for at least one, up to all, of the bullets listed below.AnnualBiennialEvery 3-5 yearsEvery 5-8 yearsOther biospecimen collection frequency not listed above (please specify the frequency)What types of information can be generated, and what research questions can be answered to inform tobacco regulatory science if urine is collected on the following schedules? Please provide responses for at least one, up to all, of the bullets listed below.AnnualBiennialEvery 3-5 yearsEvery 5-8 yearsOther biospecimen collection frequency not listed above (please specify the frequency)3. Strategies for Maintaining or Improving Response Rates and Alternative Approaches to Biospecimen Collection Given the anticipated overall environment of the upcoming waves and continued uncertainty related to the COVID-19 pandemic, NIDA is seeking information on potential strategies that could be used to maintain or enhance the biospecimen collection response rates and population coverage (for continuing participants and new participants recruited during replenishment waves) while still meeting analytic requirements.  Potential strategies may include implementation of multiple modes of biospecimen collection (e.g., in person by an interviewer or health professional or by self-collection), novel approaches to refusal conversion, as well as other approaches that would result in maintaining or improving response rates. In addition, NIDA seeks information on alternative and more economical approaches to biospecimen collection that would result in cost efficiencies. Responses should include sufficient detail regarding the mode of collection and its impact on data quality.4. Additional biomarker data to inform tobacco regulatory scienceSeveral tobacco-related biomarkers are and have been selected for analyses in the PATH Study (Table 2) (located: https://www.icpsr.umich.edu/files/NAHDAP/documentation/ug36840-all_REST.pdf).Current Biomarker PanelsCreatinineBiomarkers of Tobacco Exposure (BOE)o Metalso Nicotine and its metabolites (UNICM/UCOT)o Polycyclic Aromatic Hydrocarbons (PAH)o Serum Cotinine & trans 3’-hydroxycotinine (SCOT)o Speciated Arsenic (W1 & 2 only)o Tobacco Specific Nitrosamines (TSNA)o Volatile Organic Compounds Metabolites (VOCM)Biomarkers of Potential Harm (BOPH)High Sensitivity C-reactive Protein (hsCRP)F2-isoprostaneFibrinogen ActivityInterleukin-6 (IL-6)Soluble intercellular adhesion molecule 1 (sICAM-1)NIDA is seeking information on whether additional biomarkers should be prioritized for analysis to inform tobacco regulatory science and meet the study’s research priorities. Responses should include the biomarker name, clinical significance, and a detailed explanation of how it would inform tobacco regulatory science and meet research priorities.5. Cost ImpactsPlease explain if and how suggested changes to the data collection frequency and / or biospecimen collection mode will impact costs at a high-level (e.g. relative costs of primary cost-driving elements, impact of study design changes, impact on cost per study participant, impact on number of participants from whom biospecimen can be collected per wave, impact on national representativeness of the sample, etc.). Specific costs are not asked for or required.6. Other Include other opportunities/ideas/innovations regarding biospecimens and/or biomarkers, that are not included in this list, if any, that would benefit the PATH Study and maintain at least the analytics requirements specified above.Information Submission Instructions. All correspondence is to be with the Contracting Specialist (PATHStudy-RFI@nida.nih.gov).  The Government will accept questions regarding this RFI. All questions will be reviewed and answered as decided by the Government and must be submitted via email by 1:00 PM EST on August 13, 2021.Please ensure that any e-mail responses have "75N95023R00001_RFI" in the subject line. Any responses received after the specified response due date and time will not be accepted or acknowledged.The response to this request for information is due by1:00 PM EST on August 30, 2021.Responses are limited to 25 pages, double-spaced, in Times New Roman 12 font, and 1" margins. NIDA is interested in receiving responses to all the questions listed above, but individual respondents are welcome to address as many or as few questions as they choose.No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).Disclaimer and Important Notes:This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.Any solicitation resulting from the analysis of information obtained will be announced to the public in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation.