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RSAR: Post-marketing RX Drug Abuse Surveill Data Denver Health Data Source

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The contract supports the continuation of active surveillance for adverse drug events and prescription and over-the-counter drug abuse through data collected from individuals entering or assessed for substance abuse treatment, primarily leveraging Denver Health as the data source. This effort enables the Food and Drug Administration to monitor post-marketing drug abuse trends and inform regulatory decisions and public health initiatives aimed at prevention and intervention. Funding is allocated under both PDUFA and GDUFA to cover all CDER-regulated medical products, with increased resources proposed to enhance data granularity and enable more detailed stratified analysis. The contract isForecasted for October 2026 with a projected posting date of May 25, 2026, and falls under the NAICS code 541990 for other scientific and technical consulting services. The point of contact for program inquiries is the CDER Acquisition Liaison, while the contracting officer role remains to be determined. All activities are focused on maintaining uninterrupted surveillance capabilities critical to public health safety.

General Info

Contract funds FDA’s active surveillance of drug abuse data to enhance regulatory decisions and analysis.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541990 - All Other Professional, Scientific, and Technical ServicesView NAICS

Place of Performance

US

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Organization / Agency
Food and Drug Administration → Food And Drug Administration
Office AddressN/A
Contacts
Cder Acquisition Liaison
To Be Determined To Be DeterminedContracting Officer

Full Description

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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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