Inactive

This is a PRE-SOLICITATION NOTICE AND SYNOPSIS. The National Institute on Drug Abuse (NIDA), in partnership with the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) (collec... This is a PRE-SOLICITATION NOTICE AND SYNOPSIS. The National Institute on Drug Abuse (NIDA), in partnership with the Center for Tobacco Products (CTP) of the Food and Drug Administration (FDA) (collectively, the Government), plans to solicit proposals under full and open competition procedures from qualified organizations having the knowledge, expertise, experience and capability to continue collection of behavioral data and biospecimens among new participants, aged-up participants and continuing participants in a national longitudinal study. BACKGROUND: The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed by President Barack Obama on June 22, 2009, created the 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. Food and Drug Administration (FDA) Center for Tobacco Products. Wave 1 of the PATH Study began in 2013 and included the collection of questionnaire and biospecimen data with annual data collections through Wave 4, which began in 2016. The study transitioned to biennial data collection starting with Wave 5 in 2018. The PATH Study cohort 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. OBJECTIVES OF THE CONTRACT: The Research Objectives of the PATH Study are to enhance the evidence base to inform FDA’s regulatory actions under the Family Smoking Prevention and Tobacco Control Act (TCA) to protect the Nation’s public health and reduce its burden of tobacco-related morbidity and mortality by examining tobacco product use behaviors, identifying factors that affect tobacco product use trajectories among both users and non-users, assessing health outcomes associated with tobacco product use, including biomarkers of exposure and potential harm, evaluating the impacts of TCA-regulations on those outcomes and assess all of the above among special subpopulations, as well as to conduct additional data collections in response to emerging regulatory needs as appropriate. The purpose of this Research and Development (R&D) contract is to continue data collection and analysis for the PATH Study among new and continuing participants, including both users and non-users of tobacco products, for at least four main waves of data collection including up to two waves of replenishment, as well as for any special data collections. The contract also supports the dissemination of research findings and products generated from the PATH Study. By monitoring and assessing behaviors, attitudes, biomarkers, and health outcomes associated with tobacco products use in the United States, the PATH Study helps enhance the evidence base available to inform FDA’s regulatory activities related to tobacco products. Charged with generating data to inform regulatory actions based on the Population Health Standard, weighing potential benefits and harm to current, former, and never users of tobacco products, the PATH Study provides longitudinal data on the impact of tobacco products on the health of the population as a whole, including data on the potential of tobacco products to encourage cessation among current tobacco users and the potential to prevent relapse/reuptake by former tobacco users and initiation by new tobacco users, particularly youth. The PATH Study has eight overarching objectives rooted in the scientific partnership between NIDA and FDA to enhance the evidence base that informs FDA's regulatory decisions under the TCA. The longitudinal design of the PATH Study allows for the recurring and sequential achievement of the objectives. That is, the first and second project periods of the PATH Study addressed each objective, which shall continue, iteratively and cumulatively, under this contract. The PATH Study objectives are: Objective 1: Assess between-person differences and within-person changes in tobacco product use patterns, which may include initiation, the rate and length of use by specific product type and brand, product and brand switching over time, uptake of new products, cessation, relapse/reuptake, and multiple product use (i.e., dual- and poly- use of tobacco products within the same time period), as well as partial or complete switching between multiple products. Objective 2: Assess between-person differences and within-person changes for factors that may affect trajectories of tobacco product use, initiation, new product uptake, switching and/or multiple product use, cessation, and relapse/reuptake, including attitudes, beliefs and risk perceptions regarding harmful and potentially harmful constituents; new and emerging tobacco products, flavors, device types and other attributes and design features of tobacco products; packaging and labeling; as well as other factors such as social influences and individual preferences. Objective 3: Characterize the natural history of tobacco product initiation, use, escalation, dependence, cessation, and relapse/reuptake, including readiness and self-efficacy to quit, motivations for quitting, the number and length of quit attempts, switching and/or multiple product use and the length of abstinence related to various tobacco products. Objective 4: Assess between-person differences and within-person changes in attitudes, beliefs, and risk perceptions among non-users of tobacco products (e.g., former and never users) as well as changes in relapse/reuptake and indicators of tobacco product exposure and health outcomes among former users. Objective 5: Assess between-person differences and within-person changes over time in health outcomes and intermediate endpoints related to patterns of tobacco product use including switching and/or multiple product use, through the collection and analysis of health measures, such as self-reported health information, objective health measures, and/or biospecimens. Objective 6: Assess associations between TCA-specific regulatory actions and tobacco product use; attitudes, beliefs, and risk perceptions; uptake/initiation among never users, relapse/reuptake among former users, use patterns and cessation outcomes among current users; and tobacco-related intermediate endpoints or health outcomes. Objective 7: Assess between-person differences and within-person changes over time in attitudes, beliefs, and risk perceptions; exposure to tobacco products and tobacco use behaviors; and health outcomes and tobacco-related intermediate endpoints among and within population sub-groups identified by such characteristics as race-ethnicity, sex, sexual orientation or gender identity, and/or age, or by risk factors or other health conditions such as pregnancy, concurrent substance use, or mental health disorders. Objective 8: Inform emerging priority tobacco regulatory science research questions by conducting special data collections during or independent of the PATH Study’s main waves. MANDATORY CRITERIA: HUMAN SUBJECT EVALUTION: Under federal regulations, it is mandatory that offerors possess an approved Federal Wide Assurance (FWA) issued by the National Institutes of Health (NIH) Office for Human Research Protections (OHRP) in order to conduct clinical research in humans. Sites that do not possess this certification must demonstrate that they have submitted required documentation to OHRP for the issuance of an FWA. Procedures for registering Institutional Review Boards (IRBs) and filing FWAs on the Protection of Human Subjects are available at http://www.hhs.gov/ohrp/assurances/index.html. ADDITIONAL INFORMATION: NIDA anticipates to award one cost-reimbursement completion type contract. This requirement will include the use of Options to Extend the Period of Performance and Options for Increased Quantity for additional tasks and services as described in the Statement of Work. Given the progress, scope, and objectives to collect nationally representative data for the PATH Study, NIDA anticipates one (1) 5-year base period and up to eight (8) 5-year option periods as necessary to achieve the requirements of this contract. If all options are exercised, NIDA estimates the period of performance shall be January 1, 2024 through December 31, 2036. This award is a competitive renewal of HHSN271201600001C, titled “The Population of Tobacco and Health (PATH) Study”. RFP No. 75N95023R00001 will be available electronically on or about June 2, 2023. You can access the RFP through www.SAM.gov or through the NIDA website https://nida.nih.gov/funding/nida-office-acquisitions-contracting#RFP. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 60 days from the release date. NIDA anticipates a December 2023 award date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

Inactive

This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is for market research to obtain knowledge and information... This is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this RFI is for market research to obtain knowledge and information for planning purposes only, in conjunction with the Population Assessment of Tobacco and Health (PATH) Study to inform 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 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 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 FDA and CTP. Wave 1 of the PATH Study began in 2013 and included collection of questionnaires and biospecimen data with annual data collections through Wave 4, which began in 2016. The study transitioned to biennial data collection starting with Wave 5 in 2018 and will continue with Wave 6 in 2021. The PATH Study cohort 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. Additional information on the PATH Study sample design, data collection, and weighting procedures can be found in the PATH Study Restricted-Use Files User Guide located: https://www.icpsr.umich.edu/web/ICPSR/studies/36231/versions/V14/datasets/0/files/1253955/downloadDoc/doc?path=/pcms/studies/0/3/6/2/36231/V14/files/1253955 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 RFI is to inform the PATH Study in its efforts 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 tasks under the PATH Study include but are not limited to: Collect, analyze, and disseminate longitudinal behavioral data to enhance the evidence base that informs FDA's regulatory decisions under the FSPTCA; Collect and analyze biospecimens and disseminate biomarker data to assess changes over time in exposure to harmful and potentially harmful constituents of tobacco use; Collect and analyze self-reported data on existing and incident disease potentially related to tobacco use over time; Develop and implement formative and/or nested studies to inform emerging topics on tobacco use behaviors and related health outcomes. Project Overview. The PATH Study has 3 main activities. These activities are to: 1. Develop and implement a national, probability-based sampling design Collect behavioral data at least biennially for the main cohort, 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 biennial wave, in addition to the replenishment of youths; 2. Develop and implement protocols for the collection and handling of biospecimens among youth and adults Biospecimen collection includes (a) urine samples from subsample of youth ages 12 to 17 years; (b) blood and urine samples from a subsample of 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 laboratory analytical results with behavioral data; 3. Analyze and disseminate behavioral and biospecimen data and conduct formative and/or nested studies Create de-identified, cleaned data for interim preliminary and final analytic data files, data tables, and codebooks for restricted and for public use; Plan, coordinate, and conduct analytical substudies, 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; and Design and develop one or more nested studies with random or targeted subsamples of the PATH Study cohort and/or external samples to conduct during and/or after a wave of behavioral data and biospecimen collection. Estimated Period of Performance. NIDA anticipates a study period of 9 years which includes at least 4 biennial waves of adult and youth data collection. Other Important Considerations. The PATH Study Series located: https://www.icpsr.umich.edu/web/NAHDAP/series/606 provides additional details on the PATH Study, including the data user guides and questionnaires. The analytic requirements of the PATH Study are as follows: Ability to produce national-level estimates of behavioral and health measures, including biomarkers, with an average relative standard error of no more than 5 percent and 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 and biospecimen collection. Conduct assessment of non-response bias. However, while the analytic requirements are fixed, the sampling plan and data collection methodology are flexible provided the analytic requirements are met and maintained over the survey data collection cycles. Information Sought. NIDA is seeking information to inform its plans for future data collection waves. Given the PATH Study’s longitudinal nature, it is critical to assess any potential changes to the PATH Study both in terms of immediate benefits and limitations as well as long-term implications for the study cohorts over time as well as their impact on the anticipated costs. Specifically, NIDA is seeking information relevant to the following topics: 1. Accelerate Availability of Nationally Representative Data Currently a wave of data collection is completed in approximately one year, with creation of weights within 5 months after completion of data collection. NIDA is seeking information on ways to accelerate availability of nationally representative data that still meet the analytic requirements. Responses must include sufficient detail on the proposed strategies on the sample size needed and impact of implementing one or more of the proposed strategies on the longitudinal analysis of PATH Study data. 2. Sampling Design The PATH Study’s Wave 1 target population is the civilian household population 9 years of age or older in the United States (all 50 States and the District of Columbia). The current study design involves an in-person replenishment every four years to maintain sample size. In addition, the PATH Study oversampled for the following adults at Waves 1 and 4: tobacco users, young adults ages 18–24, and Blacks/African Americans. Currently, youth and shadow youth who were not oversampled on any criteria (e.g., tobacco use) “age up” and continue to be followed as adults after they become 18 years old. While this helps maintain the adult sample size (in addition to replenishment), it has also diluted the effect of oversampling for tobacco users at Waves 1 and 4 and resulted in an increasing proportion of adults who are never tobacco users. NIDA is seeking information on whether alternative designs (e.g. extending the replenishment interval, changing the oversampling criteria, dropping a portion of never tobacco users from follow-up) could be implemented while ensuring that the study still meets the analytic requirements. Responses must include sufficient detail regarding the implementation of the proposed design (e.g. impact of the alternative designs on sample size, optimal criteria for dropping a portion of never tobacco users). 3. Maintain or Improve Response Rates The PATH Study conducts interviews with both continuing and replenishment samples, and all interviews in Waves 1-5 were conducted in-person. However, due to the COVID 19 pandemic, starting mid-Wave 5.5 data collection, the Study has been conducting phone interviews from continuing participants. Given the anticipated overall environment of the upcoming waves, including the uncertainty related to the pandemic, NIDA is seeking information on potential strategies that could be used to maintain or enhance the survey’s response rates, population coverage, and data quality for behavioral data collection for continuing participants and for new participants recruited during the replenishment waves, while still meeting the analytic requirements. The potential strategies may include implementation of multiple modes of data collection as well as other approaches that would result in maintaining and improving response rates. Responses must include sufficient detail regarding the mode of data collection. 4. Cost Impacts Please explain if and how suggested changes to the study design and data collection methodologies will create efficiencies in 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 that can be interviewed per year, impact on national representativeness of the sample, etc.). Specific costs are not asked for or required. 5. Other Include other opportunities/ideas/innovations, 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 to by 1:00 PM EST on March 19, 2021. Please ensure that any e-mail responses have "Response to RFI No. 75N95023R00001" in the subject line. The response to this request for information is due by 3:00 PM EST on April 5, 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). Concluding paragraphs. Disclaimer and Important Notes. This RFI is for market research purposes only and 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 Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to a solicitation.