The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its ts congressionally mandated regulatory mission across 16 project areas
FDA · FDA NEGOTIATED CONTRACTS BRANCH
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 FDASSOC136354 in this department, oldest first.
- Sep 14, 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) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its congressionally mandated regulatory mission across 16 project areas addressing high-priority regulatory science gaps and public health challenges. The work � spanning structured stakeholder engagement, independent scientific convening, and landscape research � is a prerequisite to FDA's ability to develop sound regulatory frameworks and fulfill statutory obligations. Each project area targets a specific gap where FDA cannot act without the … (show all)
scientific foundation, stakeholder input, or evidence infrastructure this contract provides. The contract is framed as a high-value investment: the cost of inaction � measured in delayed regulatory frameworks, preventable harm, and eroded public trust � exceeds the cost of the engagement. See Attachment for Intent to Sole Source Posting See Attachment for Draft Statement of Work
Who won similar work
24 award notices on SAM.gov in the last 24 months. Matched by: Same agency (FDA), any industry: a loose match.
Loose match: same agency, any industry. Read the titles before treating these as competitors.
Single-winner award sizes (24): middle half $402K to $19.1M, median $2.6M; range $82K to $120.8M.
| Winner | Awards | Value | Last |
|---|---|---|---|
| Please_See_Spreadsheet Silver Spring MD 20993 USA | 3 | $153.2M | Oct 8, 2026 |
| DCT, INCORPORATED | 1 | $52.8M | Sep 15, 2026 |
| TRANQUIL CLINICAL AND RESEARCH CONSULTING SERVICES LLC | 1 | $50.0M | Sep 16, 2025 |
| NATI-NVE Support Services, LLC | 1 | $49.0M | May 21, 2026 |
| HARVARD PILGRIM HEALTH CARE INC | 1 | $31.7M | Mar 30, 2026 |
| TOXICOLOGIC PATHOLOGY ASSOCIATES INC | 1 | $26.1M | Sep 15, 2025 |
| IHRC, INCORPORATED | 1 | $14.5M | Sep 16, 2026 |
| VITALANT Scottsdale AZ 85258 USA | 1 | $10.0M | Sep 8, 2025 |
| WE PHARMA, INC. | 1 | $4.0M | Sep 11, 2026 |
| THE BIONETICS CORP | 1 | $2.8M | Jul 21, 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. Revenue next to a ticker is the company's last annual revenue from its 10-K.
- 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
- Sep 24, 2026TRADESPACE INC$82KPlatform Subscription to Support Transfer Program Commercial Assessment Leads
- Sep 24, 2026TURBOFIL PACKAGING MACHINES, LLC$454KAutomated Vial Capper Machine and Labeler system
- Sep 22, 2026ABIDE INTERNATIONAL, INC.$1.8MBuilding Exterior Repair Project � FDA Pacific Southwest Laboratory
- Sep 17, 2026LUSARDI CONSTRUCTION CO. San Marcos CA 92078 USA$779KIRV Exhaust and Vacuum Pump Replacement
- Sep 16, 2026IHRC, INCORPORATED$14.5MFDA Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) IDIQ
- Sep 15, 2026DCT, INCORPORATED$52.8MNational Center for Toxicological Research (NCTR) on-site facility Operations and Maintenance (O&M) support services
- Sep 11, 2026WE PHARMA, INC.$4.0MPharmaceutical Products for CDER Research Studies - IDIQ
- Aug 31, 2026GOVERNMENT SCIENTIFIC SOURCE INC$399KDigital Slide Scanner System
- Aug 21, 2026Z-SPEC, INC.$123KPost-Award Public Notice
Competitive landscape
For the 8 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. A sale marked 10b5-1 was made under a trading plan set up in advance.
- 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.