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The National Institute on Drug Abuse – Intramural Research Branch (NIDA-IRP) Clinical Program is seeking Capability Statements from Other than Small Business organizations to provide the Government su... The National Institute on Drug Abuse – Intramural Research Branch (NIDA-IRP) Clinical Program is seeking Capability Statements from Other than Small Business organizations to provide the Government support for participant renumeration, travel and subsistence at the NIDA IRP Clinical Program. This is a SOURCES SOUGHT NOTICE. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and (2) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method. The established NAICS code is 541611, Administrative Management and General Management Consulting Services. The U.S. Small Business Administration establishes a size standard for 541611 as $24,500,000 in revenue or less. BACKGROUND INFORMATION AND OBJECTIVE: The mission of the National Institute on Drug Abuse (NIDA) Intramural Research Program (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 conceptually integrates 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. NIDA requires a Contractor to provide support services for the remuneration, travel and subsistence of eligible research participants who participate in human research studies, as well as associated study supplies, conducted by the NIDA IRP as part of their ongoing mission. NIDA IRP enrolls a highly targeted and representative study population of 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 need to be made to the sensitive nature of the data collected when working with these populations. PROJECT REQUIREMENTS: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment not otherwise provided by the Government, as needed to perform the following tasks for the remuneration, travel and subsistence of NIDA research participants. A. Task 1: Remuneration 1. Disbursing of Remuneration. The Contractor shall: a. Be responsible for disbursing, tracking and accounting for all the NIDA IRP clinical research program participant remuneration, travel, and subsistence. Remuneration regulations and amount particulars exist and will be provided to the successful offeror at time of award. b. Disburse remuneration to staff or participants directly in keeping with the NIDA Remuneration Policy, as participants complete sections of a protocol. At pre-determined times within each protocol the Contractor shall disburse remuneration to staff or directly to participants. Remuneration may be in the form of cash, checks, paying bills for the participant, gift cards, debit cards or online methods, as defined by each protocol. When cash is distributed to staff, there must be a clear chain of custody for accounting purposes. All remuneration will be recorded in the participant’s electronic medical record, at minimum. c. Develop and document a clear chain of custody of all funds for remuneration. i. Manage security of and limit access to all funds. ii. Confirm debits and credits via a tiered system to ensure accuracy. d. Record the funds distributed per participant and per study and track weekly credits and debits, in real-time, which is required to match what is entered by study staff in the electronic medical records system. e. Track the individual PI and study usage of remuneration allowances; PI remuneration allowance amounts will be reported to the Contractor by the COR at the time of contract award or at the time of programmatic changes. The Contractor shall notify the COR alternate COR, Clinical Director or designee, and the PI immediately via email any time the costs exceed 75% of any PI’s remuneration allowance to ensure the actual costs shall not exceed the cost limitations for each study/PI/protocol allowance. Reports on all participant remuneration shall be provided in accordance with the deliverable’s requirement of this Statement of Work. 2. Travel and Subsistence The Contractor shall: a. Coordinate and provide transportation as needed and as described in each protocol (e.g., taxi, train, bus, plane, Uber, Lyft), in accordance with NIH and NIDA policies. UberHealth is mostly used for these services, but Circulation (acquired by LogistiCare Solutions, LLC) is another alternative the Government has used. The contractor may propose other alternatives as well. b. Provide local hotel accommodations as needed, per approved protocol. Contingency plans for unexpected hotel and travel accommodations will need to be planned for in cases where participants are delayed at NIDA or their flights are canceled due to weather or other unforeseen circumstances. c. Provide transportation services that are cost effective and less burdensome to participants. As some studies require multiple visits, transportation can be a challenge for some participants due to irregular public transit. d. Provide transportation 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. e. Transportation shall include text options and reminders and be user-friendly for staff booking the transportation and participants to receive notifications. f. Order and arrange delivery of meals and/or snacks, as appropriate, for participants while at NIDA IRP conducting research procedures if they are here during typical mealtime hours or as required per the protocol. The Contractor shall also coordinate meal orders, meal deliveries, tracking related expenses and shall keep non-perishable food and drink items stocked. g. Snacks and meals must accommodate protocols or participants with strict dietary limitations or guidelines. h. 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. i. Provide accurate accounting of all expenses for travel and accommodation, cancelations, confirmations and participant satisfaction. 3. Other Research-related supplies a. Place orders for, arrange for delivery, and keep an inventory of medical testing, screening materials, and other supplies needed for participant screening and research studies. b. Purchase screening and research data from outside vendors (e.g., MTurk, Qualtrics, etc.). When identifying a third-party to conduct digital or cloud-based platform collection of online survey data and provide subsequent remuneration to those survey participants, the successful vendor must obtain all associated approvals including Automated Data Processing (ADP), Information System Security Officer (ISSO), Institutional Review Board (IRB) prior to procurement and implementation. c. Purchase other consumables as required by the protocol (e.g., mints, alcohol or cigarettes). For example, some protocols may allow the purchase of cigarettes for participants who cannot be in withdrawal but did not bring cigarettes with them to the study session. d. Purchase advertising as directed by NIDA study teams. NIDA may request purchase of ad space in radio, newspaper, bus/metro, digital venues, and other forms of advertisement. NIDA will provide placement details and supply IRB approved ads and creative materials. e. Purchase materials or supplies related to NIDA’s outreach initiatives such as venue entry fees, booth fees, fees and expenses associated with printing of flyers and advertisements and related expense for NIDA’s attendance at various outreach events. B. Task 2: Contract Administration 1. Communication and Coordination of all components of Key Objectives The Contractor shall: a. Generate and maintain updated information for electronic reports regarding the above Objectives and Tasks using an automated system to track and generate reports on all expenses for the remuneration, travel and subsistence, and research supplies for NIDA participants. All tracking shall be done in real-time so reports can be generated quickly, easily and accurately. Regular and Ad Hoc reports will be required as noted in the Deliverables below. b. The Contractor shall maintain spending and budget information updated so that it can be provided upon request within two (2) business days. For example, if an order has been placed, but not billed for yet, accounting for that order shall be tracked so that NIDA knows what charges were made. Similarly, if a participant is paid by check, but it has not yet been cashed within 7 business days, the uncashed check should be tracked as an expense (with a notation that the check has not been cashed). When participants do not cash checks within 7 business days, the Contractor shall notify NIDA staff at that time so that discrepancies can be reconciled with participants. c. Provide Ad Hoc reports as requested by the COR, Clinical Director or study investigators. d. Provide all other deliverables as set forth in Section 7 – Deliverables. e. Provide NIDA IRP with open and continuous access to real-time information of all charges and expenses. 2. Flexible Staffing Capabilities The Contractor shall: a. Provide project management support for the reporting requirements of this contract as detailed under each Task and in the deliverables section of this statement of work. b. Provide proper invoicing. In particular, the Contractor shall ensure the inclusion in all invoices of costs associated with the participant screening process, such as participant transportation and meals, if needed, as well as the staffing hours, ads developed and run, and tracking of participant remuneration. c. Provide a plan to have payments available during normal business hours as well as after hours, including evenings and weekends to accommodate participants. d. When necessary and as directed by NIDA, the Contractor shall partner with third-party companies (e.g., local catering or restaurants) on an ad hoc or regular basis to accomplish the aforementioned Objectives and unique projects that may arise (e.g., a study providing a unique form of payment or accommodating a participant with food restrictions). 3. Other Administrative Tasks As directed by NIDA, the Contractor shall purchase supplies for NIDA IRP’s Clinical Program which could include but not be limited to items and supplies such as folders, paper, pens, etc. The Contractor may also be required to purchase protocol supplies which could include but not be limited to items and supplies such as testing strips for urine drug tests, HIV tests, pregnancy tests, cigarettes, cable television, water cooler stations, fees associated with advertising (e.g., booth fee at outreach events and media purchases), etc. 4. Administrative Transitional Tasks At the direction of the COR, the Contractor shall perform transition services necessary to ensure an effective transition-in and transition-out of Contractor support and continued operations, as well as an orderly transition period without any interruption or loss of proficiency of services. The Contractor shall submit a Draft Transition-In and Transition-out Plan as part of its technical proposal to enable a seamless transition of services from the incumbent to an incoming Contractor/Government personnel (as required). The Draft Transition-In Plan shall identify points-of-contact (POC) for liaison between the Government, the prime Contractor, and other contracted industry partners to ensure a proper and orderly transition and transfer of services and assets between the parties cited. The Draft Transition Plans shall communicate the Contractor’s transition strategy in the Contractor’s written technical proposal. The Final Transition-In Plan shall reflect any changes, additions, or revisions as required by NIDA and shall be delivered no later than three (3) working days after the Contract Kick-Off Meeting. Similarly, the Contractor shall develop a Draft Transition-Out Plan that shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming Contractor/Government personnel at the expiration of the contract. The Draft Transition-Out Plan shall be submitted with the offeror’s written technical proposal or as a supplement to the offeror’s written technical proposal. INSTRUCTIONS: Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The established NAICS code is 541611. Respondents must provide clear and convincing documentation of their capability of providing the products and support services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) capability to perform the work; (c) prior completed projects of similar nature; and (d) compliance with requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. 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. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required. 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, Rob Bailey at Rob.Bailey@nih.gov, NO LATER THAN 4:00 p.m. EST on April 6, 2023. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements. THIS NOTICE 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. 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 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 provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. 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).