Introduction: The National Institutes of Health (NIH), through the National Institute on Drug Abuse – Intramural Research Program (NIDA IRP), is seeking capability statements from BOTH Other than Small Business and Small Business organizations to provide the Government support for participant remuneration, travel and subsistence at the NIDA IRP Clinical Program. This is a SOURCES SOUGHT NOTICE to determine the availability of BOTH Other than Small Business and 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) with the capability to meet the objectives and requirements described below. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Background: The mission of NIDA IRP is to conduct state-of-the-art research on basic mechanisms that underlie substance use disorders (SUDs), and to develop new methods for the treatment of SUDs. Research is supported at the molecular, genetic, cellular, animal, and human clinical levels and is conceptually integrated and utilizes highly innovative strategies and techniques. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of SUDs (and associated diseases), and to translate this knowledge into improved strategies for prevention, treatment, and reduction of negative consequences for the individual and for society caused by substance use disorders. Using volunteer human participants, the NIDA IRP clinical program conducts residential and nonresidential research studies that interrelate with pre-clinical laboratory work. In general, these studies include assessment of drug-use patterns, investigation of underlying brain mechanisms, and testing of a variety of SUD behavioral or biomedical treatments. Purpose and Objectives: The purpose of this Sources Sought Notice and market research is to identify vendors with demonstrated experience and capabilities in providing services for the remuneration, travel and subsistence of eligible research participants for inclusion in human research studies conducted by the NIDA IRP as part of their ongoing mission. NIDA IRP enrolls a highly targeted and representative study population of unique research participants including those with active SUDs (e.g. nicotine, alcohol, cocaine, marijuana, opioids) who are not seeking treatment, those who are seeking treatment, people who use these substances occasionally and healthy controls who match the other populations with respect to characteristics such as age, gender, socio-economic status (SES), IQ, etc. The NIDA IRP is also conducting studies requiring HIV-positive populations. Special attention and consideration needs to be made to the sensitive nature of the data collected when working with these populations. General Requirements: A Capable Vendor must demonstrate its experience and ability to perform the following key requirements: Remuneration, Travel and Subsistence Provide remuneration services to participants as they complete sections of a protocol. Remuneration may be dispersed as cash, checks, gift cards, online payments or paying bills directly on behalf of the participant, as defined by the protocol. All expenses must be tracked in the participants’ electronic medical record in addition to overall record keeping of all funds distributed. Coordinate and track participant progress within each study, and account for all remuneration paid to participants through the various forms of compensation. Develop and document a clear chain of custody of all funds for remuneration. Manage security of and limit access to all funds. Confirm debits and credits via a tiered system to ensure accuracy. Provide and coordinate travel and subsistence for participants requiring transportation lodging and/or meals, as needed and as described in each protocol. This may include but not be limited to car services, taxi, train, bus, or plane, as well as local hotel accommodations when required (in accordance with NIH policies). Transportation shall be provided via a platform that provides safeguards and administrative controls for study teams to manage transportation. Features shall include ability to book in advance, book ad-hoc travel, ride price information (notifications and price caps), flexible rebooking, ride distance caps, and allowable vehicle types, to monitor expenses and prevent unauthorized costs. Transportation shall include text options and reminders and be user-friendly for staff booking the transportation and participants to receive notifications. Provide accurate accounting of all expenses for travel and accommodation, cancelations, confirmations and participant satisfaction. Provide and coordinate snacks, meals and drinks as needed to accommodate participants and as described in approved protocols. Snacks and meals must accommodate protocols or participants with strict dietary limitations or guidelines. Snacks and meals must be ordered and delivered according to protocol requirements and timelines. Adherence with respect to providing or restricting meals based on protocol requirements is also required (e.g. study may have a fasting blood draw or meal required before or after drug administration). Accommodations for these protocol specific needs is required and may change over time. Provide tracking of expenses, participant satisfaction and minimize waste of food and resources. Flexible Staffing Support the effective communication and coordination of all requirements through regular reporting and the implementation of an automated system to track and generate specific performance and accounting reports, as well as maintain close communication with study staff to determine and optimize participant needs for travel, meals and remuneration. Provide staffing solutions with flexible and adaptive hours, (including evenings and weekends) capable of conducting remuneration, travel and subsistence services. Instructions: Interested organizations must demonstrate and document in the submitted capability statement extensive experience in the technical areas and requirements listed above. Furthermore, organizations should include relevant and specific information on each of the following qualifications: 1) Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above. 2) Personnel: Name, professional qualifications of personnel with specific experience in the work requested and knowledge of, and experience in, the field of biomedical research. 3) Facilities: Availability and description of the facilities and equipment required to conduct this type of work. 4) Compliance with Requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. The Government will assess the appropriateness of professional and technical personnel classifications. The Government will consider any other specific and relevant information about this particular announcement that would improve our assessment of respondents. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, contracts in which the organization performed equivalent tasks (Government and commercial); references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability; and awards or commendations. All capability statements also should include the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type(s) of business, if applicable (e.g., Other than Small, Small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone). THIS IS NOT A REQUEST FOR PROPOSAL : 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 the preparation of 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 to provide feedback to respondents with respect to any information submitted. The information submitted must be in a clear and concise format that addresses each of the elements of the project requirement listed above. A cover page and an executive summary may be included but is not required. The response is limited to fifteen (15) pages not including a cover page or executive summary. Responses must include your technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Additional marketing materials, pamphlets, and information not relevant to the requirements identified above should not be submitted with the capability statement. Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Josh Lazarus at
[email protected], NO LATER THAN 4:00 p.m. EST on Wednesday, February 26, 2020 . The Subject line for the submission should include this Sources Sought Number. NIDA will not accept paper or faxed capability statements.