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NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)

US · MD · Bethesda National Institutes of Health – National Institute on Deafness and Other Communication Disorders (NIDCD) grant open #PAR-25-343
Response due Oct 18, 2027 · 00:00 UTC

Summary

The National Institute on Deafness and Other Communication Disorders (NIDCD), part of NIH, is soliciting cooperative agreement applications (U01 mechanism) to support clinical trials focused on communication disorders. This is a federal grant/cooperative agreement opportunity requiring an embedded clinical trial component. The program is open for a multi-year application window spanning from January 2025 through October 2027, suggesting a rolling submission cycle with multiple receipt dates.

What they want

Applicants must propose and conduct a clinical trial investigating interventions, diagnostics, or therapeutics related to one or more communication disorders within NIDCD's mission (hearing, balance, smell, taste, voice, speech, or language). As a U01 cooperative agreement, NIH program staff will have substantial programmatic involvement and collaboration with awardees throughout the project period. The clinical trial component is required, not optional.
Technical requirements
  • Clinical trial must be included as a required component of the application
  • Must comply with NIH U01 Cooperative Agreement mechanism requirements
  • Application must address communication disorders as defined by NIDCD mission areas (hearing, balance, smell, taste, voice, speech, language)

How they evaluate

Submission: Grants.gov electronic submission portal (PAR-25-343)

Risks & flags

  • Very long open window (Jan 2025 – Oct 2027) suggests rolling receipt dates rather than a single competition — applicants should confirm specific submission deadlines in the full FOA
  • Minimal detail provided in synopsis; full Program Announcement (PAR-25-343) must be reviewed on Grants.gov/NIH for complete requirements, budget caps, and eligibility rules
  • U01 cooperative agreement mechanism implies substantial NIH programmatic involvement, which may limit investigator independence

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.

NIDCD Cooperative Agreement for Clinical T…
Due Oct 18
Onboard ↗