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Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed

US · MD Food and Drug Administration (HHS-FDA) grant unknown #FOR-FD-25-009

Summary

The FDA is seeking a cooperative agreement (U01 mechanism) to support research and programmatic activities related to analgesics, anesthetics, and addiction. Clinical trials are explicitly allowed under this opportunity. The cooperative agreement format implies active FDA involvement in the supported activities. This is a forecasted opportunity, meaning full solicitation details have not yet been released.

What they want

Technical requirements
  • Clinical trials must be permitted under award terms
  • Cooperative agreement structure requires active FDA programmatic involvement

Risks & flags

  • Forecasted status only — full solicitation details not yet available; scope, eligibility, and evaluation criteria are unknown
  • U01 cooperative agreement mechanism implies FDA co-participation, which may limit eligible applicants to established research institutions with existing FDA relationships

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Health Care & Social Assistance
NAICS 621511
US market size
$2.7T
Typical award
$50K – $100M
Typical buyers
VAHHSDoD MHSIHS
Commonly required
Joint CommissionCMS

Sector-level estimate — full code lookup not yet in catalog.

Cooperative Agreement to Support Activitie…
$unknown
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