Intent to Sole Source Contract to Harvard Pilgrim Health Care Inc. .
Closed Special Notice Posted
- Solicitation number
- FDA_716A2026
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541 Professional, Scientific, and Technical Services
- Place of performance
- Silver Spring, Maryland 20993, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration issued a notice of intent to sole source a firm fixed price contract to Harvard Pilgrim Health Care Inc. for data retention and analysis services supporting the FDA's pharmaceutical safety surveillance mission, with a capability statement submission deadline of July 30, 2026, at 11:00 AM EST. The sole source justification cites FAR 6.103-1, finding only one responsible source can satisfy agency requirements. The contract period runs four years from September 29, 2026, through September 28, 2030, and is a follow-on to contract 75F40126C00029 with the same vendor. Scope includes retention of de-identified summary-level datasets at the contractor's site, maintenance of data partner access through contract end, quarterly data lifecycle reviews with deletion eligibility assessment per existing Data Retention SOP, and project manager oversight. Deliverables are quarterly lifecycle reviews (December 31, March 31, June 30, September 30), annual retention reports (due October 31, 2027–2030), and a final report due September 30, 2030. Optional add-on services provide analytical capacity for reanalysis of stored data upon FDA written request, with three tiered options covering up to 3, 5, or 10 studies across the performance period. Any interested party may submit a written capability statement to howard.yablon@fda.hhs.gov by the deadline; the Government will review submissions for capability, with award to Harvard Pilgrim anticipated within ten working days of notice unless another organization demonstrates capability.
Notice text
2 versions
Update #2 · Latest ·
Data retention and analysis services from Harvard Pilgrim Health Care Inc. (HPHCI) to support the continuation of critical surveillance safety research. This Statement of Work establishes the scope, deliverables, and cost estimates for a four-year period from September 29, 2026, through September 28, 2030, and includes both base requirements and optional add-on services.
See attachments for Intent Notice and Statement of Work
Update #1 ·
See attachments for Intent Notice and Statement of Work
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