RSAR: Post-marketing RX Drug Abuse Surveill Data Denver Health Data Source
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $25,000 to $250,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Points of contact
-
- CDER Acquisition Liaison cderacquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration seeks to procure post-marketing prescription and over-the-counter drug abuse surveillance data from Denver Health as part of its Rare Serious Adverse Reaction (RSAR) program. This Option Year 4 continuation contract will enable the FDA to conduct active surveillance of adverse drug events to inform regulatory actions and abuse prevention programs, utilizing data generated from individuals entering or being assessed for substance abuse treatment. The estimated solicitation release date is January 1, 2026, with an anticipated award date of March 1, 2026.
The estimated award value ranges from $25,000 to $250,000, with funding split between PDUFA and GDUFA sources to support all CDER medical products. The proposed increase in funding is intended to enhance data granularity and enable receipt of additional stratified results for improved program analysis. Questions or inquiries should be directed to the FDA's Acquisition Liaison at cderacquisitions@fda.hhs.gov.
Forecast text
Program continuity - Option Year 4 services. Allows FDA to conduct active surveillance of ADEs to inform regulatory actions and abuse prevention programs. Contract to obtain post-marketing prescription and over-the-counter drug abuse surveillance data generated from individuals entering or being assessed for substance abuse treatment. Fund Type Rationale: Funding to ensure program continuity. An increase in funding is proposed to increase the granularity of data for the receipt of additional stratified results. The fund type is split between PDUFA and GDUFA and involves all CDER medical products.
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