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

This is a SMALL BUSINESS SOURCES SOUGHT NOTICE. This is NOT a solicitation for proposals, proposal of abstracts or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses); and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code 541715 should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for market research and information purposes only. Furthermore, it should be noted that any future solicitations that may be issued as a result of this notice, or in response to this requirement, may be issued using a different solicitation number from the one identified above. 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, and Wave 6 is currently in the field. 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 are 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 http://doi.org/10.3886/ICPSR36231.userguide. 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 The PATH Study Series (https://www.icpsr.umich.edu/web/NAHDAP/series/606) provides additional details on the PATH Study, including the data user guides and questionnaires. Requirement The purpose of the PATH Study is 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. As part of its market research and information gathering efforts, NIDA is seeking capability statements from small businesses having the demonstrated experience and technical capability 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. Interested small businesses shall submit a Capability Statement that clearly and effectively demonstrates their experience and technical capability to successfully complete the three main activities of the PATH Study. The three main activities include: 1. Developing and implementing a national, probability-based sampling design. A capable small business shall clearly and effectively demonstrate its experience and technical capability to: 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; Design the study to allow for an early nationally representative weighted data during the data collection period; Collect behavioral data using multiple modes such as in-person, phone, and online; Develop assessment instruments in English and Spanish for youth and adults that minimize respondent burden and maximize respondent cooperation and confidentiality; Design, coordinate, and conduct cognitive testing with specified samples to enrich the PATH Study's development of assessment instruments for each wave; 2. Developing and implementing protocols for the collection and handling of biospecimens among youth and adults. A capable small business shall clearly and effectively demonstrate its experience and technical capability to: Collect biospecimen 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 laboratory analytical results 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. Analyzing and disseminating behavioral and biospecimen data and conducting special data collection studies. A capable small business shall clearly and effectively demonstrate its experience and technical capability to: Create de-identified, cleaned data for interim preliminary and final analytic data files, data tables, and codebooks for restricted and public use; 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; and Design and develop one or more special data collections (quantitative and/or qualitative) 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. In addition to these key requirements, the PATH Study activities include: Managing complex projects that engage Federal, State, and local governments, private industry, and academic partners to discuss technical direction, analytic activities, and strategize research priorities for the PATH Study; Secure and protect Personally Identifiable Information (PII) of all participants; Obtain security certification and accreditation under the Federal Information Security Management Act of 2002 (FISMA, 44 U.S.C. - 3541, et seq); and Continuously monitor security controls and update system documentation on the study's information system to inform the NIDA Authorizing Official's decision on whether to authorize operations. Instructions: The established NAICS code is 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The U.S. Small Business Administration establishes a size standard for 541715 of 1,000 employees or fewer. Interested small business organizations shall demonstrate and document in the submitted capability statement extensive experience in the technical areas listed above. Furthermore, information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: Work Experience: Interested offerors must demonstrate their experience and capability to accomplish the tasks and objectives as described in the requirements above 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. Organizational Experience: Please describe previous similar projects in the area(s) specified above and where the work was of a similar size and scope. In the response, be sure to indicate if you were the prime contractor or a subcontractor. If a subcontractor, be sure to identify your roles and responsibilities as the subcontractor; what percentage of work your subcontract was responsible for; and identify the prime contractor. Personnel: NIDA requires personnel with the appropriate education, credentials, training, qualifications, experience, and competence to carry out the projects and the tasks identified above. Knowledge and experience in this field of work is critical, and the overall work efforts should be led by professionals who have earned a doctorate degree in a related field of study. Individual efforts and tasks should be led by professionals who have earned a master's degrees in a related field of study. Basic credentials for proposed personnel will require experience in clinical trials management, biostatistics, drug abuse research, data management, statistics. Capable Offerors shall demonstrate how they have staffed similar key personnel on other contracts. Facilities: A capable Offeror should have the physical space (e.g. offices, meeting rooms, server room, etc.) as well as access to the necessary facilities (laboratories, biorepositories, secure storage, etc.) to accommodate the required staff and equipment as well as the necessary mechanical systems (e.g. HVAC, fire suppression, redundant power, etc.); IT systems and hardware necessary to support the work including sufficient internet access, electronic data collection systems for study data, in-house or cloud based servers for storage of study data, and business software such as the MS Office suite; and security measures including physical and IT access controls, system monitoring, data backup processes, and firewalls. Interested Offerors should describe their facilities or demonstrate its ability to obtain the facilities necessary to support the requirements discussed above. The Government will assess the appropriateness of the responses based on the described work experience, organizational experience, personnel, and facilities described in the capability statement. If the Offeror proposes to team with another organization, please be sure to include the capabilities of any potential proposed partners. The Government will consider any other specific and relevant information about this procurement that would improve our consideration and assessment of the information presented. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. 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 to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or to provide feedback to respondents with respect to any information submitted. All capability statements must provide the following: 1) company name, address; and DUNS number; 2) point of contact; 3) phone/fax/email; 4) NAICS Code(s); 5) business size and status; 6) the capability information in response to the requirement and qualification identified in this notice; and; 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.). Capability statements must be SUBMITTED ELECTRONICALLY NO LATER THAN 3:00 P.M. (EST) August 25, 2021 to the primary point of contact. The Subject line for the submission should include the Title and this Small Business Sources Sought Number (75N95023R00001_SBSS).