Opportunity Information: Apply for RFA HL 19 018
The NHLBI SBIR Phase IIB Small Market Award (R44; clinical trial optional) is a National Institutes of Health funding opportunity from the National Heart, Lung, and Blood Institute designed to help small businesses push promising health technologies closer to real-world use when the target market is inherently limited. It specifically supports companies that already completed a Phase II SBIR or STTR award and are now working on products tied to NHLBI priorities in heart, lung, blood, or sleep disorders and diseases, with a clear emphasis on either rare diseases or conditions affecting very young pediatric populations. The central idea is to fund the additional technical and clinical validation work that is often still needed before private investors, strategic partners, or other non-federal sources are willing to fully finance the next steps toward commercialization.
A key requirement is that applicants submit a detailed Commercialization Plan. This plan is not a formality; it is meant to show a credible path to market and to demonstrate that the company is actively building financial and strategic support beyond NIH. The announcement expects independent third-party funding either already in hand or anticipated during the project period, and the expectation is that this outside support will total at least one-third of the NHLBI funds requested over the life of the award. In practice, that means the program is looking for projects that are scientifically and operationally ready for late-stage development and that have enough market and investor interest to attract meaningful non-government backing, even though the eventual market may be small.
The funded work can cover preclinical development, clinical development, or a combination of both, depending on what is necessary to de-risk the product for commercialization. Clinical trials are allowed when they make sense for the technology and stage of development, but a clinical trial is not mandatory. Regardless of whether the work is preclinical or clinical, projects must involve a product that will ultimately require federal regulatory approval or clearance, such as through the FDA. This requirement signals that the program is aimed at true translational commercialization efforts (for example, drugs, biologics, devices, diagnostics, or certain digital health products that fall under regulatory oversight), rather than basic research or tools that do not require a regulatory pathway.
Administratively, this is a discretionary grant opportunity (not a contract) offered by the U.S. Department of Health and Human Services through NIH/NHLBI. Eligible applicants are small businesses. The opportunity number is RFA-HL-19-018. The listed award ceiling is $1,000,000, and NHLBI anticipated making about 2 awards under this announcement. The program is associated with CFDA numbers 93.233, 93.350, 93.837, 93.838, 93.839, and 93.840. The opportunity was created May 16, 2018, with an original closing date of July 9, 2020.
Overall, the opportunity is best understood as a targeted “bridge” for SBIR/STTR Phase II graduates working in small-market areas, where traditional financing can be more difficult because revenue potential is constrained by rarity of disease or limited patient populations. NHLBI funding is meant to help generate the validation evidence and regulatory progress needed so the product can continue forward with private funding after the NHLBI support ends.Apply for RFA HL 19 018
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.350, 93.837, 93.838, 93.839, 93.840.
- This funding opportunity was created on May 16, 2018.
- Applicants must submit their applications by Jul 09, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Small businesses.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: NHLBI SBIR Phase IIB Small Market Award (R44; Clinical Trial Optional)
What is the NHLBI SBIR Phase IIB Small Market Award (R44)?
It is a National Institutes of Health (NIH) funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) that helps small businesses move promising health technologies closer to real-world use when the target market is inherently limited. The award is intended to support late-stage development work that can bridge a product from Phase II results toward commercialization.
Which NIH institute offers this opportunity?
The opportunity is offered by the National Heart, Lung, and Blood Institute (NHLBI) within the National Institutes of Health (NIH), under the U.S. Department of Health and Human Services (HHS).
What is the funding opportunity number?
The funding opportunity number is RFA-HL-19-018.
Who is eligible to apply?
Eligible applicants are small businesses. The announcement specifically targets companies that have already completed a Phase II SBIR or STTR award.
Do applicants need to have completed a Phase II award before applying?
Yes. The program is designed for companies that already completed a Phase II SBIR or STTR award and are now advancing the same or related product toward commercialization in alignment with NHLBI priorities.
What problem is this award designed to solve?
It is meant to address the financing gap that often occurs after Phase II when additional technical and clinical validation is still needed, but private investors or strategic partners may hesitate to fund the next steps. This gap can be especially challenging when the market is small due to rare diseases or limited patient populations.
What kinds of markets does “Small Market” refer to in this program?
“Small market” refers to products aimed at inherently limited markets, with a clear emphasis on rare diseases or conditions affecting very young pediatric populations.
What disease areas are in scope for this NHLBI opportunity?
Projects should be tied to NHLBI priorities in heart, lung, blood, or sleep disorders and diseases.
Is a clinical trial required?
No. Clinical trials are optional under this opportunity. They are allowed when appropriate for the technology and development stage, but a clinical trial is not mandatory.
What types of work can the award fund?
The funded work can include preclinical development, clinical development, or a combination of both, depending on what is needed to de-risk the product and support commercialization.
Does the product need a federal regulatory pathway?
Yes. Projects must involve a product that will ultimately require federal regulatory approval or clearance, such as through the FDA. This reflects the program’s focus on translational commercialization rather than basic research.
What kinds of technologies does this opportunity typically support?
The announcement indicates support for true translational commercialization efforts, such as drugs, biologics, devices, diagnostics, or certain digital health products that fall under federal regulatory oversight.
Is basic research a fit for this award?
The program emphasis is on late-stage development and validation work needed to advance a regulated product toward commercialization, rather than basic research or tools that do not require a regulatory pathway.
What is the Commercialization Plan requirement?
Applicants must submit a detailed Commercialization Plan. The plan is a core requirement intended to demonstrate a credible path to market and show that the company is building financial and strategic support beyond NIH.
How important is the Commercialization Plan for this opportunity?
It is not described as a formality. The announcement emphasizes that the plan should show a realistic route to market and provide evidence that the company is actively pursuing non-federal support to help carry the product forward.
Is third-party (non-federal) funding expected?
Yes. The announcement expects independent third-party funding either already secured or anticipated during the project period, reflecting the intent to combine NHLBI support with outside financial or strategic backing.
How much third-party funding is expected relative to the NHLBI request?
The expectation is that outside support will total at least one-third of the NHLBI funds requested over the life of the award.
What does the program mean by a “bridge” award?
It functions as a targeted bridge for SBIR/STTR Phase II graduates working in small-market areas, helping generate the validation evidence and regulatory progress needed so the product can continue forward with private funding after NHLBI support ends.
Is this funding a grant or a contract?
This is a discretionary grant opportunity (not a contract) offered through NIH/NHLBI.
What is the maximum award amount (award ceiling)?
The listed award ceiling is $1,000,000.
How many awards did NHLBI anticipate making under this announcement?
NHLBI anticipated making about 2 awards under this announcement.
Which CFDA program numbers are associated with this opportunity?
The opportunity is associated with CFDA numbers 93.233, 93.350, 93.837, 93.838, 93.839, and 93.840.
When was this opportunity created, and what was the original closing date?
The opportunity was created on May 16, 2018, and the original closing date listed is July 9, 2020.
What is the main goal of the funded work at this stage?
The central goal is to support the additional technical and clinical validation work that reduces risk (de-risks the product) and helps make the project attractive for the next stage of commercialization financing from private investors, strategic partners, or other non-federal sources.
Why does this program focus on rare diseases and very young pediatric populations?
The program is designed for inherently limited markets where traditional financing can be harder because revenue potential is constrained by small patient populations, which is common in rare diseases and certain very young pediatric conditions.
Browse more opportunities from the same category: Health
Next opportunity: FY 2018 Notice of Funding Opportunity: NGO Small Grants Program
Previous opportunity: Strengthening Investigative Journalism on Corruption and Illicit Finance through Capacity Building and Awareness Raising in the Western Hemisphere
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA HL 19 018
Applicants also applied for:
Applicants who have applied for this opportunity (RFA HL 19 018) also looked into and applied for these:
| Funding Opportunity |
|---|
| NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44 - Clinical Trial Optional) Apply for RFA HL 19 017 Funding Number: RFA HL 19 017 Agency: Department of Health and Human Services, National Institutes of Health Category: Health Funding Amount: $1,000,000 |
| Limited Competition: Cardiothoracic Surgical Trials Network (CTSN) Data Coordinating Center (U01 Clinical Trial Required) Apply for RFA HL 19 010 Funding Number: RFA HL 19 010 Agency: Department of Health and Human Services, National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Cardiothoracic Surgical Trials Network (CTSN) Linked Clinical Research Centers (UM1 Clinical Trial Not Allowed ) Apply for RFA HL 19 009 Funding Number: RFA HL 19 009 Agency: Department of Health and Human Services, National Institutes of Health Category: Health Funding Amount: $400,000 |
| ARC Congressional Grant Apply for HQ0034 18 1 0002 Funding Number: HQ0034 18 1 0002 Agency: Department of Defense Category: Health Funding Amount: $24,000,000 |
| ARMM Health Capacity Building Activity Apply for 72049218APS00001 02 Funding Number: 72049218APS00001 02 Agency: Agency for International Development, Philippines USAID-Manila Category: Health Funding Amount: $16,000,000 |
| RISE II HEALTH SERVICES DELIVERY ACTIVITY Apply for RFI 625 18 RISEII HSD Funding Number: RFI 625 18 RISEII HSD Agency: Agency for International Development, Senegal USAID-Dakar Category: Health Funding Amount: Case Dependent |
| Vulnerable Rural Hospitals Assistance Program Apply for HRSA 18 121 Funding Number: HRSA 18 121 Agency: Department of Health and Human Services, Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Diabetes and Heart Disease & Stroke Prevent Programs-Improving the Health of Americans through Prevention and Management of Diabetes and Heart Disease and Stroke Apply for CDC RFA DP18 1815 Funding Number: CDC RFA DP18 1815 Agency: Department of Health and Human Services, Centers for Disease Control - NCCDPHP Category: Health Funding Amount: $3,000,000 |
| Community-Based Violence Prevention and Linkages to Response in South Africa Apply for 72067418RFA00008 Funding Number: 72067418RFA00008 Agency: Agency for International Development, South Africa USAID-Pretoria Category: Health Funding Amount: $19,800,000 |
| Health Financing Improvement Program Apply for 72066318RFA00001 Funding Number: 72066318RFA00001 Agency: Agency for International Development, Ethiopia USAID-Addis Ababa Category: Health Funding Amount: $40,000,000 |
| Expansion of the Family-to-Family Health Information Centers Apply for HRSA 18 115 Funding Number: HRSA 18 115 Agency: Department of Health and Human Services, Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| NIH Directors Transformative Research Award (R01 - Clinical Trial Optional) Apply for RFA RM 18 009 Funding Number: RFA RM 18 009 Agency: Department of Health and Human Services, National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIH Directors New Innovator Award Program (DP2 - Clinical Trial Optional) Apply for RFA RM 18 008 Funding Number: RFA RM 18 008 Agency: Department of Health and Human Services, National Institutes of Health Category: Health Funding Amount: $300,000 |
| Behavioral Health Workforce Education and Training (BHWET) Program – Supplemental Funding Apply for HRSA 18 112 Funding Number: HRSA 18 112 Agency: Department of Health and Human Services, Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Provider’s Clinical Support System – Universities (Short Title: PCSS-Universities) Apply for TI 18 014 Funding Number: TI 18 014 Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Adminis Category: Health Funding Amount: $150,000 |
| National Technical Assistance Resource Center for the Prevention of Sexual Violence Apply for CDC RFA CE13 13060501SUPP18 Funding Number: CDC RFA CE13 13060501SUPP18 Agency: Department of Health and Human Services, Centers for Disease Control - NCIPC Category: Health Funding Amount: $1,500,000 |
| Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program Apply for HRSA 19 033 Funding Number: HRSA 19 033 Agency: Department of Health and Human Services, Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
| Living Well-Model Approaches for Enhancing the Quality, Effectiveness and Monitoring of Home and Community Based Services for Individuals with Developmental Disabilities Apply for HHS 2018 ACL AOD DNIQ 0301 Funding Number: HHS 2018 ACL AOD DNIQ 0301 Agency: Department of Health and Human Services, Administration for Community Living Category: Health Funding Amount: $435,000 |
| Radiation Protection of the Public as Practiced by the State and Local Radiation Programs Apply for CDC RFA EH18 1803 Funding Number: CDC RFA EH18 1803 Agency: Department of Health and Human Services, Centers for Disease Control - NCEH Category: Health Funding Amount: $200,000 |
| Dental Faculty Loan Repayment Program Apply for HRSA 18 120 Funding Number: HRSA 18 120 Agency: Department of Health and Human Services, Health Resources and Services Administration Category: Health Funding Amount: Case Dependent |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA HL 19 018", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.