SOLICITATION NOTICE
A -- Population Assessment of Tobacco and Health (PATH) Study for the National Institute on Drug Abuse
- Notice Date
- 5/19/2023 12:57:51 PM
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023R00001
- Response Due
- 6/2/2023 8:00:00 AM
- Point of Contact
- Shaun Rostad, Phone: 3015949516, Josh Lazarus, Phone: 301-827-6923
- E-Mail Address
-
shaun.rostad@nih.gov, josh.lazarus@nih.gov
(shaun.rostad@nih.gov, josh.lazarus@nih.gov)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/864eaa1b5a144883b624e1160a9f53e5/view)
- Record
- SN06688527-F 20230521/230519230109 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
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