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NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)

US · IL National Institutes of Health (NIH), in coordination with CDC and FDA grant unknown #PA-27-100

Summary

This is a federal Small Business Innovation Research (SBIR) grant opportunity issued jointly by NIH, CDC, and FDA under the Parent SBIR program (R43/R44 activity codes). It supports small businesses conducting innovative research and development across a broad range of biomedical and health-related topics, with clinical trials permitted but optional. Phase I (R43) supports feasibility studies and Phase II (R44) supports full R&D efforts. The opportunity is currently in forecasted status under announcement number PA-27-100.

What they want

The solicitation invites small business concerns to submit SBIR grant applications under the Parent SBIR program. R43 awards support Phase I (feasibility/proof-of-concept) research, while R44 awards support Phase II (full-scale R&D and commercialization) research. Clinical trials are permitted under this announcement but are not required. Applications may span any scientific area supported by NIH, CDC, or FDA mission areas. Applicants must demonstrate significant innovation, commercial potential, and technical feasibility relevant to public health or biomedical science.
Technical requirements
  • Clinical trials optional but permitted
  • Must qualify as a Small Business Concern (SBC)
  • Applications must align with NIH, CDC, or FDA mission areas
  • Phase I (R43) for feasibility; Phase II (R44) for full R&D

How they evaluate

  • Scientific and technical merit
  • Innovation
  • Commercial potential and feasibility
  • Qualifications of principal investigator and team
  • Relevance to public health mission
Submission: Grants.gov federal grants portal (electronic submission)

Eligibility & certifications

Small Business Concern (SBC) status per SBA definitionSAM registration

Risks & flags

  • Opportunity is listed as 'forecasted' — final requirements, deadlines, and award amounts are not yet confirmed
  • No response due date, dollar values, or detailed eligibility criteria are provided in the source text — key parameters cannot be verified

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.

R&D in Physical, Engineering, Life Sciences (except Nanotech & Biotech)
NAICS 541715
US market size
$95B
Typical award
$100K – $50M+
Typical buyers
DoDNSFNIHNASADOE
Commonly required
DCAA-compliant accountingITARCMMC L2
NIH, CDC and FDA Small Business Innovation…
$unknown
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