# PVWorks Functions with FDA Adverse Event Monitoring (AEM) Support

Canonical: https://abierto.us/opportunities/fda2026132855

- Solicitation number: FDA-2026-132855
- Notice type: Presolicitation
- Status: Closed. Deadline was May 19, 2026 at 12:00 PM EDT
- Department: Department of Health and Human Services
- Agency: Food and Drug Administration
- Contracting office: FDA Center for Veterinary Medicine (75DJJV)
- Product or service code: DA01 Support services for activities involved with application development and support to include analysis, design, development, coding, testing, and release packaging, as well as support of off-the-shelf Business Applications.
- Place of performance: St Neots, GB-CAM, GBR
- First posted: May 12, 2026
- Last posted: May 12, 2026
- SAM.gov: https://sam.gov/workspace/contract/opp/0c92709128cb464f9cafc8bd9da26041/view

## Description

The FDA intends to award a sole source task order contract to Assured Information Systems, Ltd., doing business as ENNOV for PV Works suite of tools, a pharmacovigilance system that CVM uses for receipt and evaluation of animal drug adverse events reports for both approved and unapproved animal drugs to support the FDA’s Adverse Event Monitoring System.

ENNOV (formerly Assured Information Systems, Ltd.) is the only vendor that makes software and provides interfaces and screen customization for regulators and sponsors for veterinary Pharmacoviligence analytics. ENNOV is the only commercial veterinary Pharmacoviligence vender that has installed both the CVM dictionary and the VeDDRA dictionary of clinical terms, breed sub-registry and meets the VICH and CVM adverse event requirements.

## Publications

- May 12, 2026: Presolicitation, due May 19, 2026 at 12:00 PM EDT. Notice 0c92709128cb464f9cafc8bd9da26041. https://sam.gov/workspace/contract/opp/0c92709128cb464f9cafc8bd9da26041/view

## Points of contact

- Alicia Baltimore, Alicia.Baltimore@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/fda2026132855.