The 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 estimated total cost of the contract is $1,142,283.29. The NAICS code is 511210 - Software Publishers.
The FDA intends to award an indefinite delivery, indefinite quantity (IDIQ) contract to ENNOV for one (1) base year with four (4) option years, for PV Works (VET) tool suite licenses and maintenance 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.
This notice is not a request for competitive quotes or proposal. No solicitation document is available and telephone requests will not be accepted. Respondents may submit information pertaining to their capabilities to perform the services required above within a timely manner to Michele Andrews at michele.andrews@ fda.hhs.gov, which may be considered by the agency.
A determination to compete this procurement from the responses received shall be based upon the discretion of the Government. It is anticipated that an award will be issued to ENNOV on approximately August 28, 2018, unless, the Government determines another vendor has the capabilities of meeting this requirement and is more advantageous to the Government. All responses to this notice of intent shall be received no later than 3:00 PM Eastern Time (ET) on June 14, 2018 via email to Michele Andrews at [email protected].

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