Opportunity Information: Apply for PAR 19 335
The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required opportunity (NIH FOA PAR-19-335) is a discretionary grant program designed to help small business concerns move promising NIH-funded SBIR/STTR projects from the later stages of research into real-world commercialization. It specifically targets projects that have already been supported under SBIR or STTR Phase II or Phase IIB and now need additional, practical support to cross the gap between a successful development program and a market-ready product. The central idea is to provide funding for activities that are often necessary for commercialization but can fall outside what typical Phase II/IIB awards comfortably cover, especially when the next steps involve major validation work, regulatory preparation, or clinical progress.
A major focus of this FOA is late-stage development and technical assistance that de-risks the product for investors, strategic partners, regulators, and eventual customers. Examples of supported work include independent replication of key studies (important for credibility and to confirm performance claims), IND-enabling studies for therapeutics (such as toxicology, pharmacology, or other preclinical packages needed to support an Investigational New Drug application), clinical studies, manufacturing and scale-up costs, and regulatory assistance. In practice, that means the program is meant for companies that are past early proof-of-concept and are now dealing with the expensive, operationally complex steps needed to enter or advance through clinical trials, demonstrate robust and reproducible results, and prepare a product for approval and launch.
The funding mechanism is an SBIR grant using the R44 activity code, and the FOA is explicitly marked "Clinical Trial Required," signaling that the work proposed is expected to include a clinical trial component rather than being purely preclinical or non-human validation. This makes the opportunity particularly relevant to small businesses developing drugs, biologics, devices, diagnostics, or digital health tools where clinical evidence is a gating factor for regulatory clearance, adoption, reimbursement, or partnership. Even when certain tasks are contracted out, the small business remains responsible for overall project leadership. NIH notes that a substantial portion of the CRP-supported work may be subcontracted to external organizations (for instance, CROs, manufacturing partners, specialized testing labs, or regulatory consultants), but the awardee is expected to maintain strong oversight, project management, and accountability for the full R and D effort.
Eligibility is limited to U.S. small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some cases, which generally means limited, well-justified foreign involvement could be permitted when it is necessary for the project and compliant with NIH policy, but the applicant and primary organizational footing must remain domestic. The sponsoring agency is the National Institutes of Health, and the funding activity category is Health. The FOA is associated with multiple CFDA numbers (including 93.173, 93.233, 93.242, 93.273, and several others), reflecting that multiple NIH institutes or centers may participate or that the program spans several health and biomedical domains.
Key administrative details included in the source information are that the FOA was created on 2019-08-05 and listed an original closing date of 2020-07-10. The dataset excerpt does not specify an award ceiling or expected number of awards, which typically means applicants would need to rely on the full FOA text and NIH budget guidance for allowable costs, project periods, and any institute-specific constraints. Overall, this opportunity is best understood as a bridge-to-commercialization program for SBIR/STTR awardees who have a technology with demonstrated promise and now need resources to complete the high-stakes, late-stage work (including required clinical trial activities) that turns a strong R and D result into a viable commercial product.Apply for PAR 19 335
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.233, 93.242, 93.273, 93.837, 93.838, 93.839, 93.840, 93.853, 93.866, 93.867.
- This funding opportunity was created on 2019-08-05.
- Applicants must submit their applications by 2020-07-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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FAQs: NIH SBIR/STTR Commercialization Readiness Pilot (CRP) - Technical Assistance and Late Stage Development (SB1, R44) Clinical Trial Required (PAR-19-335)
What is this funding opportunity?
This opportunity is the NIH SBIR/STTR Commercialization Readiness Pilot (CRP) Program for Technical Assistance and Late Stage Development under the SBIR R44 mechanism (FOA PAR-19-335). It is a discretionary grant program intended to help small businesses move promising NIH-funded SBIR/STTR projects from later-stage research into real-world commercialization.
What is the main purpose of the CRP program in this FOA?
The main purpose is to fund late-stage development and technical assistance activities that help a company cross the gap between a successful development program and a market-ready product. The emphasis is on practical, commercialization-focused work that may be difficult to cover under typical SBIR/STTR Phase II or Phase IIB budgets, especially when the next steps involve major validation work, regulatory preparation, manufacturing readiness, or clinical progress.
Who is this opportunity designed for?
It specifically targets small business concerns that already have SBIR or STTR Phase II or Phase IIB support and now need additional support to advance toward commercialization. In other words, it is aimed at projects that are beyond early proof-of-concept and are facing the expensive, complex steps required to become market-ready.
Is prior SBIR/STTR funding required?
Yes. The program is described as targeting projects that have already been supported under SBIR or STTR Phase II or Phase IIB, and are now seeking help to move from late-stage development into commercialization.
What funding mechanism and activity code does this FOA use?
The FOA uses an SBIR grant mechanism with the NIH activity code R44.
Does the proposed project need to include a clinical trial?
Yes. The FOA is explicitly labeled "Clinical Trial Required," which signals that the proposed work is expected to include a clinical trial component rather than being purely preclinical or limited to non-human validation.
What types of activities does the CRP program support under this FOA?
The FOA emphasizes late-stage development and technical assistance activities that de-risk the product for investors, strategic partners, regulators, and customers. Examples mentioned include independent replication of key studies, IND-enabling studies for therapeutics (such as toxicology and pharmacology), clinical studies, manufacturing and scale-up costs, and regulatory assistance.
Why would a company pursue this CRP award instead of relying only on Phase II or Phase IIB support?
The FOA is positioned for activities that are often necessary for commercialization but may fall outside what Phase II or Phase IIB awards "comfortably cover," especially when the next steps involve expensive validation, regulatory preparation, manufacturing/scale-up, or clinical advancement.
What does "de-risking" mean in the context of this FOA?
In this FOA, de-risking refers to generating the kind of credible, decision-grade evidence and operational readiness that increases confidence for investors, partners, regulators, and customers. The examples provided include independent replication of key studies, IND-enabling preclinical packages, clinical studies, manufacturing and scale-up work, and regulatory assistance.
What is meant by independent replication of key studies?
Independent replication refers to having key findings confirmed outside the original development environment, which can strengthen credibility and validate performance claims. The FOA lists this as an example of the type of work supported to improve confidence among stakeholders.
What are IND-enabling studies, as described here?
For therapeutics, IND-enabling studies are preclinical studies (such as toxicology and pharmacology) and related packages needed to support an Investigational New Drug (IND) application. The FOA includes these as examples of supported late-stage development work.
What types of products or technologies are a fit for this FOA?
The FOA is described as particularly relevant to small businesses developing drugs, biologics, devices, diagnostics, or digital health tools where clinical evidence is a gating factor for regulatory clearance, adoption, reimbursement, or partnership.
Can project work be subcontracted to other organizations?
Yes. NIH notes that a substantial portion of CRP-supported work may be subcontracted to external organizations, such as CROs, manufacturing partners, specialized testing labs, or regulatory consultants.
If we subcontract work, who remains responsible for the project?
The small business awardee remains responsible for overall project leadership. Even when certain tasks are contracted out, the awardee is expected to maintain strong oversight, project management, and accountability for the full research and development effort.
Who is eligible to apply?
Eligibility is limited to U.S. small businesses.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply under this opportunity.
Are non-U.S. components of U.S. organizations eligible?
No. Non-U.S. components of U.S. organizations are not eligible.
Are any foreign components allowed at all?
Potentially, yes in limited cases. The information provided notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some cases. This implies limited, well-justified foreign involvement could be permitted when necessary for the project and compliant with NIH policy, while the applicant and primary organizational footing remain domestic.
Which agency sponsors this FOA?
The sponsoring agency is the National Institutes of Health (NIH).
What is the funding activity category?
The funding activity category listed is Health.
What CFDA numbers are associated with this opportunity?
The information provided states the FOA is associated with multiple CFDA numbers, including 93.173, 93.233, 93.242, 93.273, and several others.
What does it mean that multiple CFDA numbers are associated with the FOA?
Based on the description provided, the multiple CFDA numbers indicate that multiple NIH institutes or centers may participate or that the program spans several health and biomedical domains.
When was this FOA created?
The source information states the FOA was created on 2019-08-05.
What closing date is listed in the provided information?
The dataset excerpt lists an original closing date of 2020-07-10.
Does the provided information include an award ceiling or the expected number of awards?
No. The dataset excerpt does not specify an award ceiling or an expected number of awards.
What kinds of costs might be relevant under this FOA, based on the description?
The examples of supported work include clinical studies, manufacturing and scale-up costs, independent replication studies, IND-enabling work (for therapeutics), and regulatory assistance. The excerpt does not provide detailed budget limits, project periods, or institute-specific constraints.
Where does this FOA fit in the SBIR/STTR pathway?
It is positioned as a bridge-to-commercialization program for NIH-funded SBIR/STTR projects that have already progressed through Phase II or Phase IIB and now need resources to complete late-stage work, including clinical trial activities, to move toward a viable commercial product.
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