Intent to Sole Source for Sentinel 2.0 Bridge Contract to Harvard Pilgrim Health Care Inc.

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. The contract will provide uninterrupted service for the Sentinel system, which includes the ARIA System, RWE Claims-EHR linked data, and leadership and program management. The contract has a base period of six months, with two option periods of six months each. The sole source award is necessary 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. • The contract includes the ARIA System, RWE Claims-EHR linked data, and leadership and program management. • The contract has a base period of six months, with two option periods of six months each. • The sole source award is necessary 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. • The Sentinel System is a Congressionally mandated program 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.