OpenResearch announcementOpportunity PA-27-101

NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional)

National Institutes of Health · Department of Health and Human Services

At a glance

NIH Small Business Innovation Research (SBIR) Phase IIB Strategic Breakthrough Award (Parent [R44] Clinical Trial Optional) is an open federal grant opportunity from the National Institutes of Health (Department of Health and Human Services). Applications are due April 5, 2029. Applicant types listed as eligible include small businesses. Cost sharing or matching is required. It is funded under Assistance Listing 93.233 (National Center on Sleep Disorders Research) and 20 other listings.

Summary assembled from the official notice's fields. The official notice governs.

Key facts

May 28, 2026Posted
Apr 5, 2029Application deadlinenext date
Mar 1, 2027 (est.)Est. award date
Jun 4, 2029Archived

Posted: May 28, 2026
Close date: Apr 5, 2029
Archive date: Jun 4, 2029
Est. award date: Mar 1, 2027
Award floor: Not specified
Award ceiling: Not specified
Est. total funding: Not specified
Expected awards: Not specified
Cost sharing: Required
Funding instrument: Grant
Opportunity category: Discretionary

Typical awards for this program (SAM.gov listing for ALN 93.233, not this notice): Grants: $45 to $2,585,120: $457,671. SBIR Phase I - $319,005; Phase II - up to $301,224; STTR Phase I - $128,047; Phase II – up to $654,527

Who can apply

Small businesses

Additional information on eligibility (from the notice)

Only United States small business concerns (SBCs) that have previously received an NIH SBIR or STTR Phase II award are eligible to submit applications for this opportunity. Only one NIH Phase IIB Strategic Breakthrough award is allowed per project. This NOFO supports Renewal/Resubmission "Type 2" Applications from recipients with NIH Phase II SBIR/STTR awards that are submitted within the first six due dates following the expiration of their budget period. 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.

Can your organization apply?

A quick check against the listed applicant types — other requirements in the notice still apply.

Based on the published notice. Review the official notice for complete eligibility requirements.

What it funds

Official synopsis as published by the agency, formatted for readability.

The NIH Phase IIB Strategic Breakthrough award bridges the funding gap between the end of a Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Phase II award and commercialization. The Phase IIB Strategic Breakthrough provides previously funded NIH SBIR or STTR projects additional support for later-stage research and development (R&D).

Full announcement & documents

The full announcement has the complete rules — page limits, required attachments, evaluation criteria and any letter-of-intent dates. Files download directly from Grants.gov.

PA-27-101-Revised-Full-Announcement.htmlRevised Full Announcement · PA-27-101-Revised-Full-Announcement.htmlHTML · 170 KB

How to apply

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Read the full announcement (NOFO)Eligibility, evaluation criteria, page limits and required attachments are in the full notice on Grants.gov. Open ↗
Confirm eligibility and fitCheck your organization type above, and plan for the required cost sharing/match.
Register (or renew) in SAM.gov and get a UEIFree. New registrations can take several weeks; registrations must be renewed every year. Open ↗
Set up Grants.gov accessCreate a Grants.gov account and make sure someone has the Authorized Organization Representative (AOR) role. Open ↗
Open the application packageUse opportunity number PA-27-101 on Grants.gov (Grants.gov Workspace). Open ↗
Prepare narrative, budget and attachmentsFollow the notice's format exactly — page limits and required forms are common reasons applications are rejected.
Ask the agency contact any questions earlyNational Institutes of Health · SEEDinfo@nih.gov Open ↗
Submit before April 5, 2029Submit a few days early and keep your Grants.gov confirmation and validation emails.

Assistance Listings

What is an ALN?

Reported obligations under ALN 93.233

Historical data · not a prediction

FY24

$105M

FY25

$116M

FY26

— est.

Source: SAM.gov Assistance Listing 93.233. Program-wide totals, not awards from this specific opportunity.

Agency contact (as published)

National Institutes of Health
SEEDinfo@nih.gov
301-402-2541

Quick answers

When is the deadline for this opportunity?

According to the official notice, applications are due April 5, 2029. Confirm the deadline and submission time on Grants.gov before applying.

Who is eligible to apply for this opportunity?

The official notice lists these applicant types as eligible: Small businesses. Additional restrictions may apply; review the full notice.

How do I apply for this opportunity?

Applications are submitted through the official source, not through GrantsJunction. Open the official notice on Grants.gov (opportunity PA-27-101), and review the full announcement and application package. Organizations applying through Grants.gov generally need an active SAM.gov registration and a Grants.gov account, which can take several weeks to set up.

Matched on shared Assistance Listings, agency, categories and eligible applicant types.

OpenResearchALN 93.113, 93.121…