Opportunity Information: Apply for PAR 27 098
The SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional), Funding Opportunity Number PAR-27-098, is a National Institutes of Health (NIH) grant program designed to help small business concerns move an NIH-funded SBIR or STTR project from late-stage development into real-world commercialization. In practical terms, it is meant for companies that already have meaningful progress from earlier SBIR/STTR funding (typically Phase II or similar late-stage efforts) and now need targeted support to cross the gap between a strong prototype or validated concept and a product that can be approved, manufactured reliably, and brought to market.
A key feature of this CRP program is that it funds activities that are often difficult to cover under traditional SBIR Phase II or Phase IIB Strategic Breakthrough awards. The emphasis is on later-stage research and development and specialized technical assistance that directly reduces commercialization risk. Supported work can include independent replication or confirmation of key studies (useful when investors, partners, or regulators require third-party confirmation of core findings), IND- or IDE-enabling studies (the types of preclinical, analytical, and process development work needed before filing with the FDA for drugs/biologics through an Investigational New Drug application or for devices through an Investigational Device Exemption), clinical studies when appropriate, and manufacturing scale-up activities along with associated quality systems work. The program also explicitly recognizes that companies often need regulatory and other specialized technical support at this stage, such as consulting around FDA strategy, quality management systems, verification and validation planning, design controls, or preparing regulatory-ready documentation.
The funding opportunity also makes it clear that subcontracting is acceptable and can be substantial. This reflects the reality that commercialization readiness work often requires outside expertise and infrastructure, such as contract research organizations, GMP manufacturers, specialized testing labs, or regulatory consultants. The CRP structure is therefore well-suited to a small business that needs to assemble a capable external team to hit specific development, regulatory, and manufacturing milestones.
Eligibility is centered on the applicant being a United States small business concern (SBC) as defined by the Small Business Administration (SBA). While the source listing may show a broad set of eligible applicant types, the opportunity description itself emphasizes that only U.S. SBCs meeting SBA requirements are eligible to submit under this particular CRP program, and applicants are directed to the Notice of Funding Opportunity (NOFO), especially Section III (Eligibility Information), for the definitive rules. On the international side, the restrictions are strict: non-U.S. entities are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to be included as funded components. However, the notice indicates that certain unfunded international collaborations or unfunded foreign components may be allowed, consistent with NIH Grants Policy definitions, meaning a project may sometimes interact scientifically with foreign collaborators as long as NIH funds are not supporting that foreign work and all policy requirements are met.
Administratively, this is a discretionary grant opportunity offered by NIH under the health funding activity category, and it is associated with multiple CFDA (Assistance Listing) numbers across NIH institutes and centers. The original closing date shown for this opportunity is 2029-04-05, indicating it is structured as a long-running parent-style announcement with multiple submission cycles over time rather than a single one-time deadline. The listing does not provide an award ceiling or expected number of awards, so applicants should rely on the full NOFO and relevant institute guidance for budget expectations, project period norms, and competitiveness factors. Overall, the program is best understood as NIH support for the high-cost, high-specialization steps required to turn an SBIR/STTR-backed technology into a product that is ready for regulatory review, scalable production, and commercial launch.Apply for PAR 27 098
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.143, 93.172, 93.173, 93.233, 93.242, 93.273, 93.286, 93.307, 93.313, 93.350, 93.351, 93.393, 93.394, 93.395, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2026-05-28.
- Applicants must submit their applications by 2029-04-05.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIH SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional) - PAR-27-098
What is the SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)?
It is a National Institutes of Health (NIH) grant program intended to help a small business move an NIH-funded SBIR or STTR project from late-stage development into real-world commercialization. It focuses on supporting the work needed to cross the gap between a strong prototype or validated concept and a product that can be approved, manufactured reliably, and brought to market.
What is the Funding Opportunity Number (FON) for this program?
The Funding Opportunity Number is PAR-27-098.
Who is this CRP program designed for?
The program is designed for small business concerns that already have meaningful progress from earlier SBIR/STTR funding and are now pursuing commercialization-focused milestones. The description notes that applicants typically come from Phase II or similar late-stage SBIR/STTR efforts and need targeted support to reduce commercialization risk.
What stage of development does this funding target?
This opportunity targets late-stage research and development and specialized technical assistance that directly supports commercialization readiness. It is positioned for work that often comes after a prototype or validated concept, when the company needs to demonstrate reproducibility, prepare for regulatory pathways, and build manufacturing capability and quality systems.
How is CRP different from traditional SBIR Phase II or Phase IIB Strategic Breakthrough awards?
The CRP program emphasizes activities that can be hard to support under traditional SBIR Phase II or Phase IIB Strategic Breakthrough awards, especially later-stage steps that reduce commercialization risk. Examples called out include third-party confirmation of key results, IND- or IDE-enabling work, manufacturing scale-up, quality systems development, and regulatory/specialized technical support.
What kinds of activities can CRP funding support?
The description highlights support for later-stage development and specialized technical assistance, including:
- Independent replication or confirmation of key studies (for investor, partner, or regulator confidence)
- IND-enabling studies for drugs/biologics (work needed prior to an FDA Investigational New Drug application)
- IDE-enabling studies for devices (work needed prior to an FDA Investigational Device Exemption)
- Clinical studies, when appropriate
- Manufacturing scale-up
- Associated quality systems work
- Regulatory and specialized technical support (FDA strategy, quality management systems, verification and validation planning, design controls, regulatory-ready documentation)
Does the program allow funding for independent replication or confirmation of studies?
Yes. A key example listed is independent replication or confirmation of key studies, which can be important when investors, partners, or regulators expect third-party confirmation of core findings.
Does the program support IND- or IDE-enabling work?
Yes. The description explicitly includes IND- or IDE-enabling studies, described as the types of preclinical, analytical, and process development work needed before filing with the FDA (IND for drugs/biologics and IDE for devices).
Are clinical studies allowed under this CRP opportunity?
The description indicates that clinical studies may be supported when appropriate, and the opportunity is labeled "Clinical Trial Optional."
Can CRP funds be used for manufacturing scale-up and quality systems?
Yes. Manufacturing scale-up activities and associated quality systems work are specifically included as examples of supported activities.
Does the opportunity support regulatory consulting and specialized technical assistance?
Yes. The description explicitly notes that companies may need regulatory and specialized technical support at this stage. Examples listed include consulting around FDA strategy, quality management systems, verification and validation planning, design controls, and preparing regulatory-ready documentation.
Is subcontracting allowed, and can it be a large portion of the work?
Yes. The opportunity states that subcontracting is acceptable and can be substantial. This is presented as a practical fit for commercialization readiness efforts that often require outside organizations such as contract research organizations, GMP manufacturers, specialized testing labs, or regulatory consultants.
What kinds of external partners are implied as common subcontractors?
The description mentions external expertise and infrastructure such as contract research organizations (CROs), GMP manufacturers, specialized testing labs, and regulatory consultants as examples of the types of organizations a small business might subcontract with to meet development, regulatory, and manufacturing milestones.
Who is eligible to apply?
Eligibility is centered on the applicant being a United States small business concern (SBC) as defined by the Small Business Administration (SBA). The description emphasizes that only U.S. SBCs meeting SBA requirements are eligible for this CRP program and directs applicants to the Notice of Funding Opportunity (NOFO), especially Section III (Eligibility Information), for the definitive rules.
Are non-U.S. entities eligible to apply?
No. The description states that non-U.S. entities are not eligible to apply.
Can a U.S. applicant include a non-U.S. component as a funded part of the project?
No. The description states that non-U.S. components of U.S. organizations are not eligible to be included as funded components.
Are any international collaborations allowed?
The description indicates that certain unfunded international collaborations or unfunded foreign components may be allowed, consistent with NIH Grants Policy definitions. The key condition described is that NIH funds are not supporting the foreign work and all NIH policy requirements are met.
Where should applicants look for the definitive eligibility rules?
The description directs applicants to the Notice of Funding Opportunity (NOFO), particularly Section III (Eligibility Information), for the definitive eligibility requirements.
What type of grant opportunity is this?
It is described as a discretionary grant opportunity offered by NIH under the health funding activity category.
Is this opportunity tied to specific NIH funding listings?
Yes. The description notes that it is associated with multiple CFDA (Assistance Listing) numbers across NIH institutes and centers.
Is there a single one-time deadline for this opportunity?
The description indicates it is structured as a long-running parent-style announcement with multiple submission cycles over time rather than a single one-time deadline.
What is the closing date shown for this opportunity?
The original closing date shown is 2029-04-05.
Does the listing provide an award ceiling or the expected number of awards?
No. The information provided states that the listing does not provide an award ceiling or an expected number of awards. Applicants are advised to rely on the full NOFO and relevant institute guidance for budget expectations, project period norms, and competitiveness factors.
What is the main purpose of CRP funding in practical commercialization terms?
The program is positioned as NIH support for high-cost, high-specialization steps required to turn an SBIR/STTR-backed technology into a product that is ready for regulatory review, scalable production, and commercial launch.
What kinds of commercialization risks does the program aim to reduce?
Based on the examples provided, the program aims to reduce risks tied to technical reproducibility (independent confirmation), regulatory readiness (IND/IDE enabling work and regulatory documentation), clinical readiness (when appropriate), and manufacturing readiness (scale-up and quality systems).
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