Intent to Sole Source Sentinel 2.0 Bridge Contract for Health Data Analysis

Intent to Award Sole Source Contract 1/23/2026 The Food and Drug Administration (FDA) intends to award a sole source bridge contract to Harvard Pilgrim Health Care Inc to extend Sentinel 2.0 operations. This bridge contract will provide uninterrupted service for the Sentinel system which includes the following: ARIA System RWE Claims-EHR linked data Leadership and Program Management, Atlassian Access and Supporting FISMA Compliance

Period of Performance: Base Period: 3/29/2026 – 9/28/2026 (six months) Option Period 1: 9/29/2026 – 3/28/2027 (six months) Option Period 2: 3/29/2027 – 9/28/2027 (six months) Justification: Harvard Pilgrim Health Care Inc., as the incumbent contractor, possesses the necessary expertise and knowledge to ensure continuity of operations during the bridge period. This temporary measure will maintain current service levels until the competitive follow-on contract (Sentinel 3.0) is awarded. The sole source award to Harvard Pilgrim Health Care Inc. is a necessary step to prevent a lapse in critical services and to ensure that the program's momentum is maintained until a long-term, competitively awarded contract can be put in place. Program

Background: The Sentinel System is a Congressionally mandated program (FDAAA

2007) that requires FDA to collaborate with public, academic, and private entities to develop methods for obtaining access to disparate data sources and to validate means of linking and analyzing safety data from multiple sources. FDA has created a national electronic Active Post-market Risk Identification and Analysis (ARIA) system with at least 100 million individuals. ARIA fulfills FDA's mandate (section 505(o)(3)(D)(i) of the Federal Food, Drug, and Cosmetic Act) to modernize safety surveillance by capitalizing on electronic healthcare data, advancing epidemiological methods, and expanding the FDA's capabilities. The Sentinel System also responded to the congressionally-mandated Real-World Evidence Medical Data Enterprise that requires a “Queryable–EHR” with at least 10 million lives. This aligns with the 21st Century Cures Act (“Cures Act”) which promotes and strengthens the use of Real-World Evidence (RWE) to support or satisfy post-approval study

requirements. The Sentinel System uses RWE for this purpose and is dedicated to developing new analytical approaches and more efficient mechanisms to access data from electronic healthcare data, including electronic health records (EHRs) for at least ten million individuals. The Sentinel System delivers on these statutory

requirements and helps to fulfill the (OSE) mission to monitor and evaluate the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. The Sentinel System portfolio of work included in this Bridge Contract supports the Tasks needed to support, monitor, and operationalize the Sentinel System as well as to support the Sentinel System’s presence in the public sphere to provide the public with transparency on Sentinel System work. Response to Notice: Be advised that the aforementioned information is anticipatory in nature and is not binding. This notice is not a request for competitive proposals; however, any firm believing that they can fulfill the requirement of providing these services may be considered by the Agency. Interested parties shall identify their interest and capabilities in response to this synopsis within 15 calendar days of publication and must clearly demonstrate their ability to successfully fulfill all the above