Notice of Intent to Sole Source: Vaccine Adverse Event Reporting System (VAERS) & Safety Monitoring Support
FDA · FDA OFFICE OF ACQ GRANT SVCS
Capture briefs (a one-page, shareable copy of this page) are part of Pro. The CSV here holds the notice, its timeline and past awards.
Where this opportunity stands
Every notice posted under solicitation CBER-2026-133723 in this department, oldest first.
- Sep 10, 2026 · this noticeSpecial Notice
Next steps for this stage
Standard steps for the notice type; not advice about this buyer.
- Answer the notice: this is when the requirement can still be shaped.
- Contact the contracting officer named on the notice.
- Check who won similar work; they are the likely bidders.
What the notice says
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.
Who won similar work
4 award notices on SAM.gov in the last 24 months. Match: Same agency (FDA), same industry group (NAICS 5417).
| Winner | Awards | Value | Last |
|---|---|---|---|
| Please_See_Spreadsheet Silver Spring MD 20993 USA | 3 | $153.2M | Oct 8, 2026 |
| TRANQUIL CLINICAL AND RESEARCH CONSULTING SERVICES LLC | 1 | $50.0M | Sep 16, 2025 |
Value counts single-winner awards. "Shared" awards are multiple-award contracts that list every winner with the same total ceiling; that ceiling is not one company's win, so it is not added in.
- Oct 8, 2026Please_See_Spreadsheet Silver Spring MD 20993 USA$120.8MFY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
- Jan 13, 2026Please_see_Spreadsheet Silver Spring MD 20993 USA$16.7MFY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
- Jan 8, 2026Please_see_Spreadsheet Silver Spring MD 20993 USA$15.7MFY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
- Sep 16, 2025TRANQUIL CLINICAL AND RESEARCH CONSULTING SERVICES LLC$50.0MFood and Drug Administration (FDA) Office of Clinical Pharmacology (OCP) � Multi-phase/Multi- site Clinical Studies and Laboratory Support Indefinite Delivery-Indefinite Quantity (IDIQ) Type Contract
Competitive landscape
For the 2 most frequent past winners above. Lobbying is matched by the company's exact name or exact ticker; agencies are as named on the filings.
- 0 of these past winners lobbied Food & Drug Administration (FDA) since 2024 (0 filings)
- 0 of their lobbyists list a past Food & Drug Administration (FDA) job
- No corporate PAC money from them to the overseeing committees since 2024
- 0 foreign-agent (FARA) registrations
Policy around it
Bills the past winners named while lobbying this agency's issues, rules from the department, and executive orders that name the agency, last 12 months.
- 0 bills named on the past winners' lobbying filings
- 129 rules from the department in the last 12 months
- 0 executive orders naming the agency in the last 12 months
Market
For past winners matched exactly to a listed company. Insider trades are open-market buys and sells (Form 4) in the last 90 days, shown as facts; our own study found insiders do not reliably buy ahead of awards.
- 0 of the past winners are listed companies
- 0 insider buys and 0 insider sells at them in the last 90 days
Sources: SAM.gov notices and award notices; Senate LDA lobbying filings; FEC filings; FARA; Federal Register; congress.gov; SEC Form 4. Every row above links to its record.
Companies are matched to tickers by exact name only. A company we could not match shows no market rows; that is a miss, not a finding.