Notice of Intent.pdf
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- Solicitation number
- FDA-2026-132855
About this file
This is a Presolicitation Notice of Intent for a Sole-Source procurement issued by the U.S. Food and Drug Administration (FDA).
The FDA intends to award a sole-source task order to Assured Information Systems, Ltd., doing business as ENNOV (located at 5 Eaton Court Road, Colmworth Business Park, ST NEOTS, Cambridgeshire, PE19 8ER, United Kingdom), for consultative and technical support services related to the Center for Veterinary Medicine's (CVM) Pharmacovigilance (PV) Works VET platform. The contract will cover one base year with two one-year option periods for the PV Works suite of tools, a pharmacovigilance system used by CVM to receive and evaluate animal drug adverse event reports for both approved and unapproved drugs in support of the FDA's Adverse Event Monitoring System. ENNOV is identified as the sole vendor capable of meeting the requirement, as it is the only commercial veterinary Pharmacovigilance vendor with both the CVM dictionary and VeDDRA dictionary of clinical terms installed, breed sub-registry capabilities, and compliance with VICH and CVM adverse event requirements. The NAICS code is 513210 (Software Publishers).
Any firm believing it can meet these requirements may submit a written response via email to Alicia Baltimore (Alicia.Baltimore@fda.hhs.gov) no later than May 19, 2026 at 12:00 PM Eastern Time, providing supporting evidence demonstrating capability to comply with the requirement. The Government retains sole discretion to determine whether to compete the acquisition based on responses received. The anticipated award date for the purchase order is on or about June 16, 2026.
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| File | Type | Posted |
|---|---|---|
| Attachment 1 - SOW_PV Works.pdf |
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#FDA-2026-132855
PRESOLICITATION NOTICE OF INTENT FOR A SOLE-SOURCE
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA) hereby issues a notice of intent to award a sole source task order in accordance with FAR 5.201. Pursuant to RFO 12.102(b), as it has been deemed that only one source is available to meet this specific requirement. The FDA will sole source with Assured Information Systems, Ltd., doing business as ENNOV, 5 Eaton Court Road, Colmworth Business Park, ST NEOTS, Cambridgeshire, PE19 8ER, United Kingdom, for consultative and technical support services for Center for Veterinary Medicine’s (CVM) existing adverse event monitoring and reporting system, Pharmacovigilance (PV) Works VET platform. ENNOV is the only company able to meet the requirement of this procurement.
The FDA intends to award a task order contract to ENNOV for one (1) base year with two (2) one-year option periods, 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. The NAICS code is 513210 - Software Publishers.
This notice is not a request for competitive quotations. However, any firm that believes it can meet these requirements may submit a written response via email to Alicia Baltimore at the email address below no later than May 19, 2026 at 12:00 PM Eastern Time (ET). Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information received will be considered; however, a determination by the Government not to compete the proposed acquisition based on responses to this notice is solely within the discretion of the Government. If no responses are received, the FDA will proceed with the sole source award to Assured Information Systems, Ltd., doing business as ENNOV, 5 Eaton Court Road, Colmworth Business Park, ST NEOTS, Cambridgeshire, PE19 8ER, United Kingdom. The anticipated award date of this purchase order is on or about June 16, 2026. If you have any questions regarding this announcement, please contact Alicia Baltimore via email Alicia.Baltimore@fda.hhs.gov.
mailto:Alicia.Baltimore@fda.hhs.gov
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