Notice of Sole-Source for Rhapsody Application Implementation Enhancements

The U.S. Department of Health and Human Services, through the Food and Drug Administration’s Center for Tobacco Products, has awarded a sole-source modification to Deloitte Consulting LLP under the GSA Federal Supply Schedule contract GS-35F-0617Y to extend support for the Rhapsody application, a critical system used in the regulatory review of tobacco marketing applications. This modification, issued as a BPA call order under 75F40120A00010 and identified as P00002, is justified under GSAR 538.7104-3(b)(3)(ii) as a logical follow-on to existing work, ensuring continuity of institutional knowledge and operational efficiency. The scope of work falls under Task Area 8 and 8.1.2 of the original Statement of Work, focusing on requirements gathering, functional enhancements, development, implementation, and ongoing support for Rhapsody use-cases tied to PMTA Acceptance Reviews, with all efforts aligned to comply with 21 CFR Part 1114 and the Tobacco Control Act’s Sections 904, 905, and 910. The contract is structured as a time-and-materials, labor-hour BPA call order with a base performance period running from September 29, 2024, through September 2026, and an exercised option to extend services through March 2027, with a potential additional value of $2,635,113.62 if fully utilized. The total estimated contract value ranges from $18,560,183.43 to $21,195,297.05, encompassing the original BPA value and the full potential of the option extension. Performance is to be conducted in Rockville, Maryland, at the FDA’s facility, with no remote work provisions indicated. The Contracting Officer is Renee Jones-Chuang of HHS Office of Mission Acquisition Solutions, and the Contracting Officer’s Representative is Joe Stolkovich, who oversees technical execution. No specific invoicing platform, payment office details, or accounting codes were provided, though funding originates from the FDA CTP. The award was determined using a best value trade-off approach based on price, past performance, and technical merit, with no set-aside used and Deloitte confirmed as other than small. Special requirements include an option to extend