Opportunity Information: Apply for PAR 16 027
Apply for PAR 16 027
- The HHS-NIH11 in the food and nutrition, health sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late Stage Development (SB1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.242, 93.273, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, 93.867,.
- This funding opportunity was created on Nov 02, 2015 and posted on Nov 02, 2015.
- Applicants must submit their applications by Apr 05, 2017. (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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Opportunity Summary:
The SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late Stage Development (SB1) is a National Institutes of Health (NIH) funding opportunity designed to help small business concerns push already-funded SBIR or STTR Phase II projects across the difficult gap between successful research results and real-world commercial readiness. The core idea is straightforward: many Phase II projects generate promising outcomes, but the remaining steps required to reach commercialization are often expensive, specialized, or outside what Phase II (or even Phase IIB) typically supports. This program fills that gap by funding targeted late-stage development work and practical commercialization-enabling services so a small business can move a technology, product, or therapeutic candidate closer to market entry or downstream investment.
This opportunity is issued as a discretionary grant under Funding Opportunity Number PAR-16-027 and is administered by HHS/NIH. Eligibility is limited to small businesses, consistent with the SBIR/STTR focus on supporting innovation in the small business sector. The program spans NIH-related health areas reflected in the listed CFDA numbers (including 93.121, 93.242, 93.273, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, 93.867), indicating broad relevance across biomedical and health research domains rather than a narrow disease or technology niche. In practical terms, this means the opportunity is meant to support a wide range of health-related innovations as long as they originate from prior SBIR/STTR Phase II work and are at a stage where commercialization readiness activities are the main bottleneck.
The work supported under the CRP program is specifically oriented toward late-stage R and D and technical assistance that de-risks the project for commercialization. Examples highlighted in the announcement include independent replication of key studies (which can be critical for confirming robustness and building confidence among regulators, partners, or investors), IND-enabling studies for therapeutics (such as toxicology, pharmacology, and other preclinical packages needed to support an Investigational New Drug application), clinical studies (which may range from early clinical evaluation to other human-subject work that advances a product toward market), manufacturing costs (often a major hurdle when transitioning from lab-scale to scalable, compliant production), and regulatory assistance (which can include planning, documentation, strategy, and other support needed to navigate FDA or other regulatory pathways). The FOA makes it clear that award activities can involve a combination of these services, reflecting the reality that commercialization readiness often requires multiple coordinated workstreams rather than a single experiment or deliverable.
A notable feature of the program is its explicit allowance for substantial subcontracting. Many of the tasks mentioned, like specialized manufacturing, GLP toxicology, independent validation, regulatory consulting, or clinical operations, are commonly performed by contract research organizations, academic partners, or other specialized vendors. The CRP program recognizes this and permits much of the funded work to be performed by external institutions. At the same time, it places responsibility squarely on the small business awardee to remain in control: the SBC is expected to provide active oversight and management of the research and development throughout the award. In other words, outsourcing is acceptable, but the small business must still be the driver of the project, coordinating timelines, ensuring quality, managing risk, and keeping the commercialization path coherent.
From a timing and administrative standpoint, the opportunity was created and posted on November 2, 2015, with an application closing date of April 5, 2017 (both the original and current closing date are listed as the same). The opportunity category is discretionary, and the funding instrument is a grant. The source data does not provide an award ceiling or expected number of awards, so applicants would typically need to consult the full FOA and any associated NIH institute guidance to understand budget expectations, project period norms, and competitiveness factors.
Overall, this CRP FOA is best understood as a bridge funding mechanism: it is meant for small businesses that already have a Phase II foundation and now need focused resources to complete the high-value, commercialization-critical steps that validate the technology, satisfy regulatory expectations, enable manufacturing scale-up, or generate the clinical and technical evidence needed to attract partners, customers, or follow-on capital. The end goal is not basic research, but measurable progress toward a product that is ready for the market or for the next decisive stage of development.
FAQs: SBIR/STTR Commercialization Readiness Pilot (CRP) Program - Technical Assistance and Late Stage Development (SB1) (PAR-16-027)
What is the SBIR/STTR Commercialization Readiness Pilot (CRP) Program (SB1)?
The SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late Stage Development (SB1) is an NIH funding opportunity intended to help small businesses move already-funded SBIR or STTR Phase II projects from strong research outcomes to real-world commercialization readiness. It focuses on late-stage development work and commercialization-enabling services that are often not fully covered under Phase II (or even Phase IIB).
Who issues and administers this funding opportunity?
This opportunity is issued as a discretionary grant under the U.S. Department of Health and Human Services (HHS) and administered by the National Institutes of Health (NIH).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR-16-027.
What type of funding instrument is used?
The funding instrument is a grant, and the opportunity category is discretionary.
Who is eligible to apply?
Eligibility is limited to small business concerns (SBCs), consistent with the SBIR/STTR program focus on supporting innovation in the small business sector.
Does the project need to be based on prior SBIR/STTR work?
Yes. The program is designed to support commercialization readiness activities for technologies and projects that originate from previously funded SBIR or STTR Phase II work.
What problem is this program designed to solve?
The program targets the common "gap" between successful Phase II research results and commercialization. Many Phase II projects produce promising outcomes, but the remaining steps required to reach commercial readiness can be expensive, specialized, or outside what Phase II (or Phase IIB) typically supports. This FOA funds targeted work to close that gap.
What kinds of activities can be supported under this CRP program?
Supported activities are oriented toward late-stage R&D and technical assistance that de-risks the project for commercialization. Examples listed include independent replication of key studies, IND-enabling studies for therapeutics (such as toxicology and pharmacology), clinical studies, manufacturing costs, and regulatory assistance.
Can a project include more than one type of supported activity?
Yes. The FOA indicates that award activities can involve a combination of services (for example, pairing regulatory assistance with manufacturing work or independent validation), reflecting that commercialization readiness often requires multiple coordinated workstreams.
What is meant by "late-stage development" in this context?
In this FOA, late-stage development refers to commercialization-critical work that helps move a technology, product, or therapeutic candidate closer to market entry or downstream investment. The emphasis is on practical steps such as validation, regulatory readiness, manufacturing scale-up, and clinical or preclinical packages that make the project more investable or market-ready.
Does the program support independent replication of studies?
Yes. Independent replication of key studies is specifically highlighted as an example of work that can be supported, helping confirm robustness and build confidence among regulators, partners, or investors.
Does the program support IND-enabling studies for therapeutics?
Yes. The FOA includes IND-enabling studies as an example, such as toxicology, pharmacology, and other preclinical work needed to support an Investigational New Drug (IND) application.
Are clinical studies allowed under this opportunity?
Yes. Clinical studies are listed among the examples of supported activities, including early clinical evaluation or other human-subject work that advances a product toward market readiness.
Can grant funds be used for manufacturing-related costs?
Yes. Manufacturing costs are explicitly mentioned as a supported area, recognizing the challenges and expenses involved in transitioning from lab-scale work to scalable, compliant production.
Is regulatory assistance an allowable use of funds?
Yes. Regulatory assistance is highlighted as an example of supported work and may include planning, documentation, strategy, and other support needed to navigate FDA or other regulatory pathways.
Is subcontracting allowed?
Yes. A notable feature of the program is that it explicitly allows substantial subcontracting, which aligns with the reality that specialized tasks (manufacturing, GLP toxicology, regulatory consulting, clinical operations, and independent validation) are often performed by external organizations.
If subcontracting is allowed, what is the small business expected to do?
The small business awardee is expected to remain in control by providing active oversight and management of the research and development throughout the award. Outsourcing is acceptable, but the SBC must still drive the project and coordinate the overall commercialization path.
What health or research areas does this opportunity cover?
The opportunity spans a broad range of NIH-related health areas, as reflected in the listed CFDA numbers: 93.121, 93.242, 93.273, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, and 93.867. This suggests broad relevance across biomedical and health research domains rather than a narrow disease or technology niche.
What is the overall goal of the program?
The end goal is measurable progress toward commercialization readiness. The program is best understood as bridge funding to help an SBC complete high-value steps that validate the technology, satisfy regulatory expectations, enable manufacturing scale-up, and generate clinical or technical evidence needed for market entry or the next decisive development stage.
Is this program intended for basic research?
No. Based on the description provided, the focus is not basic research. It is intended for late-stage development and commercialization-enabling activities tied to an existing Phase II foundation.
When was this opportunity created and when did it close?
The opportunity was created and posted on November 2, 2015. The application closing date listed is April 5, 2017 (the original and current closing dates are the same in the provided information).
Does the provided information include an award ceiling or expected number of awards?
No. The source information does not provide an award ceiling or the expected number of awards.
What should applicants do if they need details like budget expectations or project period norms?
Because the provided information does not include budget ceilings, expected award counts, or similar parameters, applicants would typically need to consult the full FOA (PAR-16-027) and any associated NIH institute guidance for those specifics.
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| NIDDK Short-Term Research Experience Program for Underrepresented Persons (STEP-UP) (R25) Apply for RFA DK 16 021 Funding Number: RFA DK 16 021 Agency: HHS-NIH11 Category: Food and Nutrition, Health Funding Amount: Case Dependent |
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