Investigating Associations Between Acute Abuse Liability Outcomes and Switching Behavior

The contract seeks a contractor to investigate associations between acute abuse liability outcomes and switching behavior, focusing on clinical studies involving experienced combusted cigarette users and Electronic Nicotine Delivery Systems (ENDS). The work encompasses recruiting participants, selecting and obtaining tobacco products based on market popularity and FDA authorization, administering products in controlled laboratory and ambulatory settings, and collecting behavioral, pharmacological, and biological data. The contractor must conduct statistical analyses of nicotine pharmacokinetics and user behaviors, produce a draft and final clinical study protocol with peer review, secure OMB and IRB clearances, and deliver a final study report within two months of receiving FDA feedback, with a possible revised report if additional comments arise. Performance is to occur at the contractor’s facility over a four-year period under a firm-fixed-price contract, with deliverables including biweekly meetings, monthly progress reports due by the 10th of each month, kick-off and NPI form submissions within 10 and 30 business days of award, and weekly recruitment updates once recruitment begins. The government will not provide any property or materials, and no travel or unique security requirements exist. The solicitation requires active SAM registration with a valid UEI, compliance with FAR and HHSAR clauses including safeguarding information systems, whistleblower protections, equal opportunity, contractor ethics, and combating trafficking in persons, with the deviation clause 52.212-4 applying. Offerors must submit a technical proposal not exceeding 15 pages with a project timeline and a separately formatted price proposal listing labor categories, hours, pricing discounts, and a completed pricing table. Past performance must include up to three comparable federal, foundation, or private contracts completed within the past five years, with points of contact provided. Proposals must be emailed to Janice Heard by July 6, 2026, at 2:00 p.m. ET, in Microsoft Office format without macros or executable files. Evaluation favors technical understanding and approach as the most important factor, followed by past performance, staffing plan, key personnel qualifications, and price, with best value as the basis for award and non-price factors significantly more important than price. Payment is electronic via the Treasury’s IPP system, contingent on government acceptance and certification of deliverables, with payment withheld for nonconforming work or stoppages beyond FDA control, and must include an invoice log addendum tracking all prior payments and remaining estimated amounts. The contract is not set aside for small businesses.