Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF OCTOBER 01, 2025 SAM #8710
SPECIAL NOTICE

D -- Notice of Intent to Sole Source

Notice Date

9/29/2025 10:57:33 AM
 

Notice Type

Special Notice
 

NAICS

513210 —
 

Contracting Office

FOOD AND DRUG ADMINISTRATION Rockville MD 20841 US
 

ZIP Code

20841
 

Response Due

10/6/2025 5:00:00 AM
 

Archive Date

10/06/2025
 

Point of Contact

Narissa Charles
 

E-Mail Address

narissa.charles@fda.hhs.gov
(narissa.charles@fda.hhs.gov)
 

Small Business Set-Aside

NONE No Set aside used
 

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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/workspace/contract/opp/c6065c363e5c40d3b9d2a84c346a092e/view)
 

Place of Performance

Address: St Neots, GB-CAM PE19-8ER, GBR

Zip Code: PE19-8ER

Country: GBR
 

Record

SN07607151-F 20251001/250929230040 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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