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Risk Model Contract

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 involves providing technical support and ongoing enhancements to a risk-based site selection tool used by the Food and Drug Administration (FDA) for scheduling inspections of outsourcing facilities and compounders. This tool applies a multi-attribute risk management model that incorporates risk analysis, operations research, and mathematical modeling techniques to prioritize firms for surveillance inspections effectively. The contractor's role includes maintaining and updating the software to ensure accurate and efficient risk rankings, enabling the FDA to allocate inspection resources based on continuously evolving data and risk factors. The contract is forecasted by the FDA under NAICS code 541519 and focuses heavily on the contractor's expertise in risk modeling and software development. The support includes performance upgrades, functional enhancements, and the integration of new data into the tool. Continuous updates are essential to maintain the relevance and precision of the risk assessments, helping the FDA to improve the oversight and safety of compounding operations. The agency point of contact for this contract includes a program liaison, with details provided, while the contracting officer position remains to be determined.

General Info

Providing technical support, upgrades, and enhancements for FDA's risk-based site selection inspection tool.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related ServicesView NAICS

Place of Performance

US

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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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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FDA must inspect outsourcing facilities according to a risk-based schedule based on several factors. This tool provides a risk-based ranking of outsourcing facilities & compounders for surveillance inspections. OCQC needs contractor support to update and maintain the Compounding risk-based site selection tool. The contractor is to provide technical support, performance and functional enhancements to the software. The contractor's expertise is risk analysis, operations research, modeling, and other relevant mathematical methods, to support, implement, and evaluate multi-attribute risk management model and application software that will support risk-based inspections from the existing tool. The tool requires continuous upgrades and data updates in order to accurately and efficiently rank firms for inspection.

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Bureau Of Industry And Security

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