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Notice of Intent to Sole Source: Vaccine Adverse Event Reporting System (VAERS) & Safety Monitoring Support

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CBER-2026-133723Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The FDA Center for Biologics Evaluation and Research, specifically the Division of Pharmacovigilance, is seeking a contractor to provide safety monitoring support for the Vaccine Adverse Event Reporting System. The primary objective of this engagement is to support the monitoring of vaccines and biologics that have been approved under a Biologic Licensing Application or authorized via Emergency Use Authorization. This opportunity is listed as a sole source notice under solicitation CBER-2026-133723 and is designated as an 8(a) set-aside. The contract falls under NAICS code 541720 and is managed by the Department of Health and Human Services. While the agency is based in Rockville, Maryland, the place of performance is located in Carmel, California. Responses are due by September 18, 2026.

General Info

FDA seeks 8(a) contractor for VAERS safety monitoring support in Carmel, California.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

541720 - Research and Development in the Social Sciences and HumanitiesView NAICS

Place of Performance

Carmel, CA, 93923, USA

Set-Aside

8A

Documents

(1)

CBER-2026-133732 Statement of Work - Post Market, Safety, and Surveillance Support

PDF•21 pages•sow

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts1 person available
OfficeRockville, MD, 20852, USA
Organization / Agency
Department Of Health And Human Services → FDA Office Of Acq Grant Svcs
View Agency Profile
Office AddressRockville, MD, 20852, USA
Contacts
Rodney D. Aytch
contact@example.gov
+1 (555) 000-0000

Full Description

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The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)’s Office of Biostatistics and Pharmacovigilance (OPBV)’s Division of Pharmacovigilance (DPV) is responsible for monitoring the safety of vaccines and biologics once they are approved for use under a Biologic Licensing Application (BLA) or authorized for use under an Emergency Use Authorization (EUA).


The Contractor shall furnish the necessary services and qualified personnel needed to perform the Statement of Work.

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