Opportunity Information: Apply for PAR 16 026
Apply for PAR 16 026
- The HHS-NIH11 in the education, environment, food and nutrition, health sector is offering a public funding opportunity titled "SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.068, 93.135, 93.143, 93.233, 93.273, 93.286, 93.350, 93.837, 93.838, 93.839, 93.847, 93.853, 93.866,.
- 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 (SB1) grant opportunity (PAR 16-026) is a discretionary grant from the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH). It is designed specifically for small business concerns that already have NIH-funded SBIR or STTR Phase II projects and need targeted, practical help to push those projects over the gap between successful R and D and real-world commercialization. Rather than funding more core research the way Phase II typically does, this program focuses on the kinds of specialized, commercialization-oriented activities that are often essential for market entry but are not usually supported under standard Phase II or Phase IIB budgets.
The central goal of the FOA is to accelerate the transition of previously funded Phase II innovations toward products and services that can be deployed in the marketplace, especially in areas relevant to NIH missions such as health and biomedical technology. The CRP mechanism recognizes that even strong Phase II outcomes can stall because companies lack the resources to tackle regulatory, intellectual property, clinical planning, and other late-stage readiness tasks. By paying for technical assistance that fills these gaps, the program aims to de-risk commercialization and shorten the timeline to getting technologies into use.
Examples of supported technical assistance include preparing documentation needed for a Food and Drug Administration submission, building or refining an intellectual property strategy, and planning for a clinical trial. In practice, that could mean hiring expert regulatory consultants to assemble and polish an FDA package, engaging patent counsel or IP strategists to strengthen freedom-to-operate and protection plans, or working with clinical experts to design trial protocols and operational plans that are credible to regulators and investors. The emphasis is on work that makes a technology commercially and operationally ready, not on exploratory science.
A notable feature of this opportunity is that substantial portions of the work may be subcontracted to outside organizations, which is often necessary for specialized commercialization services. However, the small business awardee is still expected to retain clear oversight and active management of the project, including responsibility for the direction of the R and D-related activities and coordination of all subcontracted efforts. In other words, the company can bring in outside expertise, but it cannot hand off control of the project; it must remain accountable for execution, milestones, and outcomes.
Administratively, the opportunity was posted on November 2, 2015, with an application closing date of April 5, 2017. Eligible applicants are limited to small businesses. The listing includes multiple CFDA program numbers (including 93.068, 93.135, 93.143, 93.233, 93.273, 93.286, 93.350, 93.837, 93.838, 93.839, 93.847, 93.853, 93.866), reflecting NIH’s use of this mechanism across different institutes and program areas. The funding instrument type is a grant, and the activity category is shown broadly across areas such as health (and related categories), consistent with NIH’s role and the SBIR/STTR focus.
Overall, this FOA is best understood as a bridge-to-market support program for SBIR/STTR Phase II awardees: it provides additional, commercialization-critical technical assistance funding to help a small business complete regulatory preparation, IP positioning, and clinical readiness steps that commonly determine whether a promising innovation can successfully reach commercialization.
Frequently Asked Questions (FAQs)
What is the SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1) opportunity?
It is a discretionary grant opportunity from the U.S. Department of Health and Human Services, National Institutes of Health (HHS-NIH) under FOA PAR 16-026. The program provides targeted technical assistance funding to help NIH-funded SBIR or STTR Phase II projects move from successful R and D toward real-world commercialization.
Who is the funding agency for this opportunity?
The funding agency is HHS-NIH (U.S. Department of Health and Human Services, National Institutes of Health).
What is the purpose of this program?
The purpose is to accelerate the transition of previously funded NIH SBIR/STTR Phase II innovations into products and services that can be deployed in the marketplace, particularly in areas aligned with NIH missions such as health and biomedical technology.
Who is eligible to apply?
Eligible applicants are limited to small business concerns that already have NIH-funded SBIR or STTR Phase II projects.
Is this program intended to fund more core research?
No. Unlike typical Phase II support for core research, this program focuses on specialized, commercialization-oriented technical assistance activities that help technologies become commercially and operationally ready for market entry.
What kinds of needs is the CRP Technical Assistance grant meant to address?
It is designed to address common late-stage gaps that can stall commercialization even after strong Phase II results, such as regulatory preparation, intellectual property strategy, and clinical planning and readiness.
What are examples of technical assistance activities that may be supported?
Examples described include preparing documentation needed for a Food and Drug Administration (FDA) submission, building or refining an intellectual property (IP) strategy, and planning for a clinical trial.
Does this grant support FDA submission preparation?
Yes. The opportunity specifically notes preparing documentation needed for an FDA submission as an example of supported technical assistance.
Does this grant support intellectual property strategy work?
Yes. Building or refining an IP strategy is listed as a supported example, including work such as strengthening freedom-to-operate considerations and protection plans.
Does this grant support clinical trial planning?
Yes. Planning for a clinical trial is included as an example, such as designing trial protocols and operational plans that are credible to regulators and investors.
Can a company hire outside experts or consultants using this funding?
Yes. The program anticipates specialized commercialization services may be needed, such as regulatory consultants, patent counsel, IP strategists, or clinical experts.
Are subcontractors allowed, and can a large portion of work be subcontracted?
Yes. A notable feature is that substantial portions of the work may be subcontracted to outside organizations, which can be important for specialized commercialization services.
If subcontracting is used, who is responsible for managing the project?
The small business awardee must retain clear oversight and active management of the project. The company cannot hand off control; it remains accountable for direction, coordination of subcontracted efforts, execution, milestones, and outcomes.
How does this program help with the commercialization "gap" after Phase II?
It pays for targeted technical assistance that addresses regulatory, IP, and clinical readiness tasks that are often essential for market entry but are not usually supported under standard Phase II or Phase IIB budgets. This approach aims to de-risk commercialization and shorten the timeline to deployment.
What is the funding instrument type?
The funding instrument type is a grant.
What is the overall focus area or activity category?
The activity category is broadly shown across areas such as health (and related categories), consistent with NIH’s role and the SBIR/STTR focus on health and biomedical technology.
What is the FOA identifier for this opportunity?
The opportunity is identified as PAR 16-026.
When was the opportunity posted?
It was posted on November 2, 2015.
What was the application closing date?
The closing date listed is April 5, 2017.
What CFDA program numbers are associated with this opportunity?
The listing includes multiple CFDA program numbers: 93.068, 93.135, 93.143, 93.233, 93.273, 93.286, 93.350, 93.837, 93.838, 93.839, 93.847, 93.853, 93.866.
Why are there multiple CFDA numbers listed?
The multiple CFDA numbers reflect NIH’s use of this mechanism across different institutes and program areas.
How should this FOA be understood in simple terms?
It is a bridge-to-market support program for NIH SBIR/STTR Phase II awardees, providing commercialization-critical technical assistance funding for regulatory preparation, IP positioning, and clinical readiness steps that can determine whether a promising innovation reaches commercialization.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 026) also looked into and applied for these:
| Funding Opportunity |
|---|
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24) Apply for PA 16 206 Funding Number: PA 16 206 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Native American Research Centers for Health (NARCH) (S06) Apply for PAR 16 297 Funding Number: PAR 16 297 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health Funding Amount: $1,000,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32) Apply for PA 16 307 Funding Number: PA 16 307 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31) Apply for PA 16 309 Funding Number: PA 16 309 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31 - Diversity) Apply for PA 16 308 Funding Number: PA 16 308 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Administrative Supplements for Research on Dietary Supplements (Admin Supp) Apply for PA 16 319 Funding Number: PA 16 319 Agency: HHS-NIH11 Category: Education, Environment, Food and Nutrition, Health Funding Amount: $100,000 |
| Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial Not Allowed) Apply for PA 19 029 Funding Number: PA 19 029 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Specialized Centers of Research Excellence (SCORE) on Sex Differences (U54 Clinical Trial Optional) Apply for RFA OD 19 013 Funding Number: RFA OD 19 013 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: $1,000,000 |
| Development of Highly Innovative Tools and Technology for Analysis of Single Cells (STTR) (R41/R42) Apply for PA 17 148 Funding Number: PA 17 148 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Development of Highly Innovative Tools and Technology for Analysis of Single Cells (SBIR) (R43/R44) Apply for PA 17 147 Funding Number: PA 17 147 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Administrative Supplements for Research on Dietary Supplements (Admin Supp) Apply for PA 17 307 Funding Number: PA 17 307 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: $100,000 |
| Administrative supplements for validation studies of analytical methods for dietary supplements and natural products (Admin. Suppl.) Apply for PA 17 447 Funding Number: PA 17 447 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Administrative Supplements for Validation Studies of Analytical Methods for Dietary Supplement Constituents (Admin Supp - Clinical Trial Not Allowed) Apply for PA 18 818 Funding Number: PA 18 818 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Methods to Improve Reproducibility of Human iPSC Derivation, Growth and Differentiation (SBIR) (R44 Clinical Trial Not Allowed) Apply for RFA GM 19 001 Funding Number: RFA GM 19 001 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: $375,000 |
| SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, R44) Clinical Trial Not Allowed Apply for PAR 19 334 Funding Number: PAR 19 334 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| USAID Cambodia Integrated Early Childhood Development Activity Apply for 72044220RFA00001 Funding Number: 72044220RFA00001 Agency: Cambodia USAID-Phnom Penh Category: Education, Environment, Food and Nutrition, Health Funding Amount: $15,000,000 |
| Community Interventions to Address the Consequences of the COVID-19 Pandemic among Health Disparity and Vulnerable Populations (R01- Clinical Trial Optional) Apply for PAR 20 237 Funding Number: PAR 20 237 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: $500,000 |
| SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance (SB1, Clinical Trial Not Allowed) Apply for PAR 20 128 Funding Number: PAR 20 128 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Validation Studies of Analytical Methods for Dietary Supplement Constituents (Admin Supp - Clinical Trial Not Allowed) Apply for PA 20 252 Funding Number: PA 20 252 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
| Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) Apply for PA 20 272 Funding Number: PA 20 272 Agency: National Institutes of Health Category: Education, Environment, Food and Nutrition, Health Funding Amount: Case Dependent |
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