INTENT TO SOLE SOURCE FOR SENTINEL 2.0 BRIDGE CONTRACT TO HARVARD PILGRIM HEALTH CARE INC. FDAINTENTTOSOLESOURCEBRIDGESENTINEL2

Intent to Award Sole Source Contract 1/28/2026 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: Active Risk Identification and Analysis System (ARIA Real World Claims (RWE)-Electronic Health Records (ERH) linked data Leadership and Program Management, Atlassian Access and Supporting Federal Information Security Modernization Act (FISMA) Compliance Period of Performance: Base Period: 3/29/2026 through 9/28/2026 (six months) Option Period 1: 9/29/2026 through 3/28/2027 (six months) Option Period 2: 3/29/2027 through 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 Office of Surveillance and Epidemiology (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 7 calendar days of publication and must clearly demonstrate their ability to successfully fulfill all the above requirements. The Government reserves the right not to respond to any expressions of interest received. Only written comments, questions, or concerns regarding this notice will be accepted. Please submit them via e-mail to Howard Yablon at howard.yablon@fda.hhs.gov within the timeframe specified in this special notice. The Government will not reimburse any submissions. All costs associated with submitting a response will be the sole responsibility of the submitting party. A determination by the Government not to compete this proposed contract action based upon responses to this notice will be made at the sole discretion of the Government. The Government will review all submitted information solely to determine whether to pursue a competitive procurement process. If the Government decides to award the proposed sole source contract, the justification and approval documentation will be posted on this website. All information received in response to this notice that is marked Proprietary will be handled accordingly. The Government shall not be liable for or suffer any consequential damages for any proprietary information not properly identified. Proprietary information will be safeguarded in accordance with the applicable Government regulations. Submissions will not be returned.

See J and A Attachment