Opportunity Overview
The U.S. Food and Drug Administration Center for Biologics Evaluation and Research (CBER), Office of Biostatistics and Pharmacovigilance, Division of Pharmacovigilance, has posted Notice of Intent to Sole Source: Vaccine Adverse Event Reporting System (VAERS) & Safety Monitoring Support, CBER-2026-133723. FDA states that the requirement supports post-market safety monitoring of vaccines and biologics approved under a Biologics License Application or authorized under an Emergency Use Authorization.
Deadline
Responses are due September 18, 2026 at 3:30 PM Eastern Daylight Time.
Scope
The contractor is expected to furnish the services and qualified personnel required by the attached FDA Statement of Work for VAERS and related vaccine and biologic safety-monitoring support. The attached Attachment Statement of Work CBER-2026-133732.pdf is part of the controlling federal notice and should be reviewed in full before any response.
Competition and Classification
The federal notice is a Special Notice identified as an intent to sole source and is classified as an 8(a) Set-Aside under FAR 19.8. The notice uses NAICS 541720, Research and Development in the Social Sciences and Humanities, and PSC AJ11, General Science and Technology R&D Services: General Science and Technology: Basic Research. The listed place of performance is Carmel, California.
Funding / Contract Value
No contract value or ceiling is stated in the public SAM.gov notice.
Submission Guidance
The public SAM.gov notice provides the response deadline and contracting contact but does not state a complete response format or submission package in the visible notice text. Prospective respondents should review the live SAM.gov record, the attached Statement of Work, and any subsequent amendments or instructions before submitting capability information or any other response. Do not assume eligibility or required response documents that are not stated by FDA.
Qualification Guidance
Any prospective respondent should be able to demonstrate applicable 8(a) eligibility and documented capability relevant to vaccine or biologic pharmacovigilance, adverse-event review, and safety-monitoring support. Eligibility and capability should be verified from current federal and organizational records rather than assumed.