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

Open Posted

Opportunity number
PA-27-100
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Grant
Category
  • Health
Eligible applicants
  • Small Businesses
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration are soliciting applications for Small Business Innovation Research (SBIR) Phase I, Phase II, Direct to Phase II (NIH only), and Fast-Track (NIH only) grant applications by September 5, 2026, using activity code R43/R44 under the parent SBIR program (PA-27-100).

Eligible applicants are United States small business concerns independently owned and operated for profit with no more than 500 employees (including affiliates) that are majority-owned and controlled by U.S. citizens, permanent resident aliens, or venture capital/private equity firms meeting specific criteria. The Program Director/Principal Investigator must be primarily employed by the small business at the time of award and during project conduct. For Phase I, the small business must perform at least 67 percent of research effort; for Phase II, at least 50 percent.

Participating NIH Institutes and Centers include NEI, NHLBI, NHGRI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDCR, NIDDK, NIDA, NIEHS, NIGMS, NIMH, NINDS, NINR, NIMHD, NLM, NCCIH, NCATS, ORIP, NCI, and ORWH, along with CDC and FDA components. Phase I budgets range from $400,000 to $700,000 for most components; Phase II budgets range from $2.5 million to $3 million, with some components following Standard Small Business Administration guidelines. Project periods normally do not exceed six months for Phase I and two years for Phase II. Clinical trials are optional; however, NIAMS, NIDCR, NCATS, ORIP, and all FDA components do not accept clinical trial applications under this NOFO.

Applications undergo peer review for scientific and technical merit, evaluated on significance, investigator qualifications, innovation, approach, environment, commercialization potential (Phase II), and regulatory planning for clinical trials. Applicants must register in SAM.gov, obtain unique entity identifiers, register with the SBA Company Registry and eRA Commons, and include ORCID identifiers for all PD/PIs. Foreign subawards and subcontracts are prohibited except in rare justified circumstances. Recipients must comply with NIH Grants Policy Statement requirements, cybersecurity standards, and foreign relationship disclosure obligations regarding entities in China or countries of concern.

Synopsis

The Small Business Innovation Research (SBIR) program helps United States small business concerns (SBCs) bring scientific innovations to the marketplace. The SBIR program supports feasibility studies to later research and development (R & D) needed to develop a commercial product.

Eligibility

Only United States small business concerns (SBCs), as defined by the Small Business Administration (SBA)(sbir.gov/apply) are eligible to submit applications for this opportunity.Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility. Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Unfunded international collaborations or unfunded foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Files

File Type Posted
PA-27-100-Revised-Full-Announcement.html HTML file
PKG00292976.pdf PDF
PA-27-100-Full-Announcement.html HTML file

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