Notice of Intent for PV Works (VET) PV Express 2

The U.S. Food and Drug Administration (FDA) hereby issues a notice of intent to award a sole source contract in accordance with FAR 5.201. Pursuant to FAR 6.302-1, “Only One Responsible Source and No Other Supplies or Services Will Satisfy the Requirements”, the FDA will sole source with Assured Information Systems, Ltd., doing business as ENNOV (DUNS 525625786), 5 Eaton Court Road, Colmworth Business Park, ST NEOTS, Cambridgeshire, PE19 8ER, United Kingdom, for (annual) veterinary adverse event pharmacovigilance analytical software licenses and related maintenance support. ENNOV is the only company able to meet the requirement of this procurement.

The FDA intends to award a contract to ENNOV for one (1) year for Pharmacovigilance (PV) Works (VET) PV Express 2 to support the FDA’s Center for Veterinary Medicine (CVM) Adverse Event Program. 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 by noon on June 5, 2025. 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 July 7, 2025. If you have any questions regarding this announcement, please contact Alicia Baltimore at via. email Alicia.Baltimore@fda.hhs.gov.