# Notice of Intent to Sole Source

Canonical: https://abierto.us/opportunities/c6065c363e5c40d3b9d2a84c346a092e

- Notice type: Special notice
- Status: Closed. Deadline was October 6, 2025 at 8:00 AM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: Food and Drug Administration (n-FOODANDDRUGADMINISTRATION)
- NAICS: 513210 Software Publishers
- Product or service code: DA10 Support services, delivered as a service contract (SaaS or Subscription) involved with the analysis, design, development, code, test and release packaging services associated with application development projects, as well as off-the-shelf Business software.
- Place of performance: St Neots, GB-CAM, GBR
- First posted: September 29, 2025
- Last posted: September 29, 2025
- SAM.gov: https://sam.gov/workspace/contract/opp/c6065c363e5c40d3b9d2a84c346a092e/view

## Description

The Food and Drug Administration (FDA) requires consultative and technical support services for Center for Veterinary Medicine’s (CVM’s) existing adverse event reporting system, Pharmacovigilance (PV) Works VET platform. The support is needed to obtain deliverables for FDA’s priority initiative of developing streamlined, consolidated enterprise-wide adverse event monitoring (AEM) system.

The PV Works suite of tools is the Pharmacovigilance (PV) system that CVM uses for receipt and evaluation of animal drug adverse events reports for both approved and unapproved animal drugs. Though PV Works VET suite is a customizable commercial product manufacturer as defined in Federal Acquisition Regulation (FAR) subpart 2.101, the software is proprietary to the original equipment (OEM) Ennov, doing business as Assured Information Systems (AIS).

The code and knowledge required by FDA to support the FDA AEM directive is unique to the OEM. The required services include validation of systems analysis documentation, mapping, data extraction and migration support.

## Publications

- September 29, 2025: Special notice, due October 6, 2025 at 8:00 AM EDT. Notice c6065c363e5c40d3b9d2a84c346a092e. https://sam.gov/workspace/contract/opp/c6065c363e5c40d3b9d2a84c346a092e/view

## Points of contact

- Narissa Charles, narissa.charles@fda.hhs.gov

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Source: SAM.gov Contract Opportunities bulk extract. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/c6065c363e5c40d3b9d2a84c346a092e.