Think Trends Software Implementation and Support

Solicitation No. 75F40126R00097 Think Trends Software Implementation and Support DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION REQUEST FOR PROPOSAL (RFP) SOLICITATION NO. 75F40126R00097 ThinkTrends Software Implementation and Support Indefinite Delivery, Indefinite Quantity (IDIQ) Contract Field Information Solicitation Number: 75F40126R00097 Solicitation Type: Request for Proposal (RFP) Set-Aside: Total Small Business Set-Aside NAICS Code: 541511 – Custom Computer Programming Services Small Business Size Standard: $34 Million Contract Type: Single Award IDIQ – Firm Fixed Price (FFP) with Labor-Hour (LH) Task Orders Estimated Maximum Contract Value: $49,000,000.00 Minimum Guarantee: $2,500.00 Proposals Due: September 28, 2026, 1:00 PM EST Contracting Officer: Lilibeth Deato | lilibeth.deato@fda.hhs.gov Posting: SAM.gov -- 1 of 47 -- Solicitation No. 75F40126R00097 Think Trends Software Implementation and Support PART I – THE SCHEDULE SECTION A – SOLICITATION/CONTRACT FORM A.1 NOTICE OF COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL SERVICES This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR 12.202(b)(1) as implemented through the Revolutionary Federal Acquisition Regulation Overhaul (RFO) (Apr. 20, 2026), adopted via HHS FAR Class Deviation (CD) No. 2025-09, Amendment 1 (Nov. 3, 2025). This announcement constitutes the solicitation only; a separate written solicitation will not be issued. Solicitation Number 75F40126R00097 is issued as a Request for Proposal (RFP) for the ThinkTrends Software Implementation and Support Indefinite Delivery, Indefinite Quantity (IDIQ) Contract, in accordance with RFO FAR Part 12 – Acquisition of Commercial Products and Commercial Services. A.2 NOTICE OF SET-ASIDE This acquisition is a Total Small Business Set-Aside pursuant to FAR 19.502-2. The NAICS code is 541511 – Custom Computer Programming Services. The small business size standard is $34 million. A.3 PROPOSAL DUE DATE All Offerors shall submit proposals electronically via email to lilibeth.deato@fda.hhs.gov no later than September 28, 2026, by 1:00 PM EST. All electronic documents must be submitted without macros. Do NOT include .exe, .mso, or other executable file types. Submissions containing macros or executable files will be considered non-responsive with no opportunity to correct prior to award. A.4 APPLICABLE REGULATIONS AND FAR CIRCULAR This solicitation incorporates FAR provisions and clauses in effect through Federal Acquisition Circular (FAC) 2026-01, effective March 13, 2026. Full text of FAR provisions and clauses may be accessed at https://www.acquisition.gov/far/part-52 and https://www.acquisition.gov/far-overhaul/far-part-deviation- guide/far-overhaul-part-52. The Department of Health and Human Services (HHS) Acquisition Regulation (HHSAR) provisions and clauses referenced in this solicitation can be found on the following websites: • HHSAR (effective February 2, 2022): https://www.acquisition.gov/hhsar/part-352-solicitation-provisions-and- contract-clauses • HHSAR Class Deviations: https://www.hhs.gov/grants-contracts/contracts/contract-policies- regulations/index.html • RFO HHSAR Part 352: https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/index.html -- 2 of 47 -- Solicitation No. 75F40126R00097 Think Trends Software Implementation and Support SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS B.1 BRIEF DESCRIPTION OF REQUIREMENT The Food and Drug Administration (FDA) requires comprehensive technical expertise to support the implementation of ThinkTrends software and related human interventions across various FDA operations. This IDIQ contract aims to leverage cutting-edge Artificial Intelligence (AI) technologies to significantly improve FDA's operational efficiency, data management, and regulatory processes. B.2 CONTRACT TYPE This is a single-award Indefinite Delivery, Indefinite Quantity (IDIQ) contract, Firm Fixed Price (FFP) type contract vehicle, with authorized task order types of Labor-Hour (LH) and Firm-Fixed-Price (FFP), in accordance with FAR 16.504. B.3 MINIMUM AND MAXIMUM CONTRACT VALUE In accordance with FAR 16.504(a)(1), the Government guarantees a minimum ordering obligation of $2,500.00 (two thousand five hundred dollars) under this contract, to be satisfied by award of the initial task order. The maximum ceiling contract value shall not exceed $49,000,000.00, inclusive of all option periods. B.4 PRICING TERMS B.4.1 General Pricing The Contractor's pricing schedules shall contain fully burdened hourly rates inclusive of wages, indirect costs, fringe benefits, overhead, G&A costs, and profit. Rates apply at both Government and non-Government sites. (See Attachment #1 – Pricing Worksheet.) B.4.2 Firm Fixed Price Task Orders FFP task order pricing is fixed for the period of performance and not subject to adjustment, except as a result of direct Government action or inaction causing delays. The Contractor shall comply with FAR Clause 52.232-1, Payments (APR 1984). B.4.3 Labor Hour Task Orders Each LH task order shall contain a Not-to-Exceed (NTE) obligated ceiling price. Unit labor hour prices are fixed for the task order period of performance and not subject to adjustment except through modification. The Contractor shall not perform or be paid for work exceeding the NTE price. The Contractor shall comply with FAR 52.232-7, Payments Under Time-and-Materials and Labor-Hour Contracts (NOV 2021). B.5 AUTHORIZED ORDERING OFFICIALS Only FDA Office of Acquisitions & Grant Services (OAGS) Contracting Officers are authorized to place task orders under this IDIQ contract. B.6 ORDERING PROCEDURES When a need for services arises, the FDA will issue a Request for Task Order Proposal (RFTOP) and place individual orders in accordance with FAR 16.505. The process for awarding orders will generally be as follows: 1. The FDA OAGS Contracting Officer or Specialis…