National Institutes of Health (NIH)
R44 Small Business Innovation Research (SBIR) Grant - Phase II only
See Notices of Special Interest associated with this funding opportunity
September 11, 2024 - Notice of Intent to Publish a Funding Opportunity Announcement for 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). See Notice NOT-HL-24-030.
December 18, 2023 -Notice of Pre-Application Webinar for NHLBI SBIR Phase IIB Small Market Awards and Bridge Awards (RFA-HL-23-008 and RFA-HL-23-009). See Notice NOT-HL-23-125.
November 14, 2023 - Clarification of Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See Notice NOT-OD-24-029
June 12, 2023 - Implementation of the NIH SBIR and STTR Foreign Disclosure Pre-award and Post-Award Requirements. See NOT-OD-23-139. (See updates incorporated into NOFO content in Sections IV, V, VI, and VIII applicable for applications submitted for due dates on or after September 5, 2023.)
March 16, 2023 -NHLBI Notice of Clarification and Availability of Frequently Asked Questions (FAQs) for RFA-HL-23-008 and RFA-HL-23-009. See Notice NOT-HL-23-082.
February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants. See Notice NOT-OD-23-092.
December 9, 2022 - Notice of Pre-Application Webinar for NHLBI SBIR Phase IIB Small Market Awards and Bridge Awards (RFA-HL-23-008 and RFA-HL-23-009). See Notice NOT-HL-22-062
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
The Small Business Innovation Research (SBIR) Program is an important National Institutes of Health (NIH) funding mechanism used to develop innovative solutions that address public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of biomedical products is often impeded by a significant funding gap between the end of the SBIR Phase II award and the commercialization stage. This gap is increased by the barriers associated with technologies under development for small commercial markets, such as those focused on rare diseases or young pediatric populations. This Funding Opportunity Announcement (FOA) invites small businesses to submit SBIR grant applications to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR or STTR (Small Business Technology Transfer) Phase II awards that address rare diseases or young pediatric populations (aged 0-12 years and defined in Section IV, part 7), and will require eventual Federal regulatory approval/clearance. The goal of this FOA and the resulting Phase IIB awards is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product to regulatory approval and commercialization by promoting partnerships between small business awardees and third-party investors and/or strategic partners, including patient advocacy organizations.
- Proposed projects MUST be relevant to the NHLBI?mission?(see B. Scientific/Technical Scope) and require ultimate approval/clearance by a Federal regulatory agency. NCATS intends to co-fund applications that meet the NCATS mission to develop innovations that reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process, to speed the development and delivery of new drugs, diagnostics, medical devices and behavioral interventions to patients. For a description of the NCATS SBIR/STTR research priorities, please refer to?http://ncats.nih.gov/smallbusiness/priorities?(http://ncats.nih.gov/smallbusiness/priorities.
- This FOA is specifically intended to benefit clinical practice by accelerating the commercialization of novel products
- that address a rare disease or young pediatric populations (aged 0-12 years and defined in Section IV, part 7). The primary indication of the product under development would:
- Address a rare disease as defined in the Orphan Drug Act Amendment of 1984 as any disease or condition that affects less than 200,000 persons in the United States; or
- Qualify as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year;
- OR be targeted at a young pediatric population, defined as including neonates (0-28 days), infants (<2 years), and/or children (2-12 years of age), as indicated in the?FDA Premarket Assessment of Pediatric Medical Devices.
This FOA will give competitive preference and funding priority to applications deemed likely to result in a commercial product as indicated by the applicant’s ability to secure independent third-party investor funds that equal or exceed one-third of the requested NHLBI funds (total costs) being requested for the entire project period of the Phase IIB Small Market Award.
January 28, 2022; January 28, 2023; January 28, 2024
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | February 28, 2022 | Not Applicable | July 2022 | October 2022 | December 2022 |
| Not Applicable | February 28, 2023 | Not Applicable | July 2023 | October 2023 | December 2023 |
| Not Applicable | February 28, 2024 | Not Applicable | July 2024 | October 2024 | December 2024 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the SBIR/STTR (F) Instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease.? It provides an important funding mechanism for bringing new interventions to patients and clinicians. The SBIR program is structured in three phases. The objective in Phase I is to establish the technical merit and feasibility of a proposed research and development (R&D) effort, while in Phase II it is to continue the R&D effort for successful Phase I projects. The expectation is that in Phase III, a Small Business Concern (SBC) will be able to launch a product commercially with non-SBIR funds.
However, many projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to complete the validation studies required to obtain regulatory approval and launch a product. In particular, the development of therapeutics, medical devices, and combined technologies often requires a number of years and substantial capital investments because of the costs associated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process.
Companies developing products that have small potential revenue streams or target small patient populations face additional barriers to market entry that make them less attractive at preclinical or early clinical stages of development to investors and strategic partners. In addition, many of these technologies require complex clinical trial designs because of small and geographically diverse patient populations.
Thus, despite the extensive R&D performed on such products during Phase II projects, the results are often insufficient to attract the substantial private investment needed for the eventual commercialization of the product. Many small businesses therefore become cash-starved before reaching the next critical milestone along the path toward commercialization.? Hence, this FOA is designed to address this funding gap between the end of the SBIR or STTR Phase II award and the point at which non-SBIR financing can be secured for the subsequent stages of product development.
A number of public and private organizations recognize the challenges associated with this funding gap and are taking steps to provide additional resources to advance a greater number of promising early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but are also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the preclinical stages of development, and some of these firms have established technology incubators to provide development support, including regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies. In the rare disease area, patient advocacy groups and foundations have organized to accelerate progress in the development of treatments for their disease.
Such programs can provide additional financing and commercialization support for SBIR awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors.?It is anticipated that funding by third-party investors will be predicated on significant due diligence, thus encouraging awardees to formulate credible business plans for product commercialization. In addition, it is expected that third-party investors will maintain an active role in supporting the awardee during the product development phase and during pursuit of follow-on funding for commercialization.
Specific Objectives for SBIR Phase IIB Small Market Award Applications
A. Independent Third-Party Investor Funds
This FOA specifically encourages business relationships between applicant SBCs and third-party investors/strategic partners who can provide financing to help accelerate the commercialization of promising new products whose development was initiated with SBIR funding. Applicants are expected to leverage their previous SBIR support, as well as the opportunity to compete for additional NHLBI funding under this FOA, to attract and negotiate third-party financing needed to advance a product or technology toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed one-third of the total amount of the NHLBI funds being requested over the entire Phase IIB Small Market Award project period will help to validate the commercial potential that is essential for the SBIR projects solicited under this FOA. This potential will be strongly considered in review (refer to Section V. Application Review Information) and making funding decisions.
If a Phase IIB Small Market Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (i.e., the Finance Plan submitted as part of the application) will become a term of award as described in Section VI.1 Award Notices.
It is anticipated that many of the partnerships between applicant SBCs and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NHLBI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in commercializing emerging biomedical technologies addressing rare diseases or young pediatric populations, as well as engaging with the patient advocacy groups and foundations that focus on the indication of the developing technology.?Applicants are encouraged to explore existing resources and groups to engage with the relevant communities, such as the?NCATS Genetic and Rare Diseases Information Center (GARD), the?NCATS Therapeutics for Rare and Neglected Diseases (TRND) program, the?National Organization for Rare Disorders (NORD),?FasterCures, and the?Patient-Centered Outcomes Research Institute(PCORI).
B. Scientific/Technical Scope
The technical and commercial objectives described in the SBIR Phase IIB Small Market Award application MUST represent an extension of the development efforts that were pursued in a previously funded SBIR or STTR Phase II award. It is essential that significant progress was accomplished during the current/preceding SBIR or STTR Phase II project and that the proposed product has significant commercial potential. Applicants are expected to demonstrate that the proposed product has a clear advantage over existing and/or competing products and to define an appropriate path toward ultimate product commercialization.
This FOA is specifically designed to provide additional support for products that require ultimate approval/clearance by a Federal regulatory agency and those that are small markets or for rare diseases. In these circumstances, it is critically important for Federal investment to de-risk investment by third parties.
Although projects previously funded by another NIH Institute/Center or another Federal agency are eligible for funding under this FOA, proposed projects MUST be relevant to the NHLBI mission. Applicants are strongly encouraged to contact the NHLBI Scientific/Research Contact (listed in Section VII) to discuss whether their proposed project meets this criterion.
The NHLBI supports development of technologies to detect, prevent, or treat cardiovascular, lung, blood and sleep disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources. The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on products related to the?mission?of the NHLBI. The NHLBI program priority areas for technology development research are listed below.
NCATS intends to co-fund applications that meet the NCATS mission to develop innovations that reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process, to speed the development and delivery of new drugs, diagnostics, medical devices and behavioral interventions to patients. Additionally, NCATS is interested in co-funding applications that address rare diseases, and in particular, that can help speed the development of treatments for multiple rare diseases. For a description of the NCATS SBIR/STTR research priorities, please refer to?http://ncats.nih.gov/smallbusiness/priorities.
The NHLBI program priority areas for technology development research include:
Blood Diseases and Resources areas:
In vitro diagnostic devices and therapeutic biologics, devices, and drugs for rare diseases, and diseases affecting young children and neonates, including, but not limited to: coagulation and other laboratory based assays; transfusion/infusion and non-transfusion/non-infusion treatments for bleeding complications in acquired and inherited bleeding disorders; point of care diagnostics for Sickle Cell Disease and other hemoglobinopathies to facilitate testing in low resource settings to provide earlier diagnosis and access to medical interventions; devices that facilitate transfusion of small volumes of blood components; and long-term, indwelling catheters for transfusion, blood sample collection or medication administration that provide very low thrombosis/infection risk. Other blood disease and resource areas may be proposed, as areas of interest are not limited to those listed.
Cardiovascular Diseases areas:
Diagnostics, therapeutics (including cell and gene therapies), or instruments for treating congenital or acquired heart disease in young pediatric populations, including heart pumps and valves, atrial septal defect closure devices, surgical tools, and devices for cardiac catheterization; diagnostics and therapies for rare arrhythmias (such as LQTS-1, -2, and -3, Brugada's, and Timothy's syndromes) and lipid disorders (such as lecithin-cholesterol acyltransferase or lipoprotein deficiencies or genetic diseases such as Pompedisease); technologies, instruments, and therapeutics for heart (and lung) transplantation, including devices for perfusion of donor organs and technologies for less invasive tissue biopsies and detection of organ rejection. Other cardiovascular disease areas may be proposed, as areas of interest are not limited to those listed.
Lung Diseases areas:
Diagnostics and therapeutics for rare lung diseases and those affecting young pediatric populations, including, but not limited to: respiratory distress syndrome, cystic fibrosis, adult and pediatric pulmonary arterial hypertension, adult and childhood interstitial lung diseases, lymphangioleiomyomatosis, and sarcoidosis. Examples include, but are not limited to, noninvasive monitoring of cardiopulmonary function for neonates and young children, portable imaging systems compatible with Intensive Care Unit environments, therapies to prevent bronchopulmonary dysplasia, improved aerosol delivery devices for young children, portable home diagnostic and treatment devices for sleep disordered breathing in young pediatric populations. Other lung disease areas may be proposed, as areas of interest are not limited to those listed.
Examples of appropriate development activities to be proposed under this FOA include, but are not limited to, the following areas:
-
For projects pertaining to the development of therapeutics - Applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application or clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA).
-
For projects pertaining to imaging technologies, interventional devices, and in vivo diagnostics - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE) application, or an Investigational Device Exemption (IDE) application.
-
For projects pertaining to ex vivo or in vitro diagnostics, prognostics, and screening tests - Applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE) application, an Investigational New Drug (IND) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay.
NHLBI expects that activities to be pursued under this FOA should address any relevant requirements for clinical validation and regulatory approval, as necessary and required for commercialization of the technology. Specific activities to be proposed will vary among applications.
C. Plan for Full Commercialization (all applications)
The goal of the SBIR Phase IIB Small Market Award is to advance SBIR Phase II projects toward ultimate commercialization. All applicants are expected to describe a realistic plan (extending beyond the SBIR Phase IIB Small Market Award project period) that outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be developed as part of the Commercialization Plan. The full commercialization plan for the product should extend beyond the period of SBIR funding.
Applicants are encouraged to leverage other available Federal resources where appropriate, including existing FDA incentives to increase and accelerate small market product development, such as Orphan Drug designation, Humanitarian Device Exemption, the Pediatric Exclusivity Provision, and the?Orphan Products Clinical Trials Grants Program?to assist with expenses related to clinical trials. Additional information about relevant FDA programs and resources may be found on the?Developing Products for Rare Diseases & Conditions?industry page. ?
See?Section VIII. Other Information?for award authorities and regulations.
Criteria for Complete, Compliant, and Responsive Applications
Applications deemed to be non-responsive will not proceed to review. The following are considered non-responsive to this FOA:?
-
Applications that do not propose a budget amount and project period that conform to the limits described under Section II ("Award Budget" and "Award Project Period")
-
Applications that do not propose R&D that represents the continuation of work conducted under a previously-funded SBIR or STTR Phase II award (grant or contract)
-
Applications that do not propose a product under development with a primary indication that:
- Addresses a rare disease as defined in the Orphan Drug Act Amendment of 1984 as any disease or condition that affects fewer than 200,000 persons in the United States;
- OR qualifies as a Humanitarian Use Device, defined as a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 persons in the United States per year;
- OR targets a young pediatric population, defined as including neonates (0-28 days), infants (<2 years), and/or children (2-12 years of age), as indicated in the FDA Premarket Assessment of Pediatric Medical Devices
-
Applications that do not propose R&D that falls within the technical scope of this FOA as described under Section I (Specific Objectives for SBIR Phase IIB Small Market Award Applications)
-
Applications that do not contain a Commercialization Plan that includes all sections (a-l) and the required elements for each section, as described under Section IV ("SBIR/STTR Information: Commercialization Plan")
-
Applications that do not include letters of support from third-party investors in the Letters of Support section ("PHS 398 Research Plan") and/or documentation of support from third-party investors in the Other Project Information section ("Other Attachments")
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Resubmission - (Phase IIB previously submitted under this FOA or RFA-HL-19-018)
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for the FOA.
Need help determining whether you are doing a clinical trial?
NHLBI and NCATS intend to commit total costs of up to $2,000,000 in FY2023; $4,000,000 in FY2024; $6,000,000 in FY2025; $4,000,000 in FY2026; and $2,000,000 in FY2027 to fund up to 2 new awards in FY2023, FY2024, and FY2025.
Total funding support (direct costs, indirect costs, fee) for the entire budget period MUST not exceed $3,000,000. For any single year of the project period, it is recommended that the budget not exceed $1,000,000 total costs. Applicants that intend to request budgets greater than $1,000,000 total costs in any year are strongly encouraged to communicate with the Scientific / Research Contact(s) listed under Section VII before applying. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.
Durations up to 3 years for Phase IIB may be requested.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
- Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
- Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;
-
- SBIR and STTR. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR
- SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States; OR
- SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements.
- Has, including its affiliates, not more than 500 employees.
If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.
If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.
Definitions:
- Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
- Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- Venture capital operating company means an entity described in 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- ANC means Alaska Native Corporation.
- NHO means Native Hawaiian Organization.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.
Performance Benchmark Requirements
Phase I to Phase II Transition Rate Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022. The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The Transition Rate requirement, agreed upon and established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).
- For SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.25 will not be eligible to apply for a Phase I, Fast-Track, or Direct Phase II (if available) award for a period of one year from the date of the application submission. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the prior 5-fiscal year period.
- For application deadlines that fall on or after April 5, 2023: For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.5 will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase I awards over the 5-fiscal year period.
On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements.SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies. More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.
Phase II to Commercialization Benchmark: In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).
- For companies that have received more than 15 Phase II awards from all agencies over the past 10 fiscal years (excluding the two most recently completed fiscal year): Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 (15%) patents per Phase II award resulting from these awards during the past 10- fiscal year period. Applicants that fail this benchmark will not be eligible to apply for New Phase I, Fast-track or Direct Phase II (if applicable) awards for a period of one year. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.
- For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the 10-fiscalyear period, excluding the two most recently-completed fiscal years.
- For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscalyear period, excluding the two most recently-completed fiscal years.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- SBA Company Registry See Section IV. Application and Submission Information, SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
- eRA Commons - Applicants must have an active DUNS number number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.
Eligibility Requirements for Phase IIB Small Market Award
The SBIR Phase IIB Small Market Award application must represent a continuation of the R&D efforts performed under a previously funded SBIR or STTR Phase II award. Applications must be predicated on a previously funded SBIR or STTR Phase II grant or contract award. Qualifying "parent" SBIR or STTR Phase II projects may be renewed only once. Following the Phase IIB Small Market Award period (i.e., up to 3 years), recipient SBCs are expected to pursue the full commercialization of these SBIR-funded projects using non-SBIR funds.
NOTE: Applicants who intend to submit a Phase IIB Small Market Award application that is predicated on an SBIR Phase II contract or a Phase II award from a non-NIH Federal agency MUST contact the NHLBI prior to submission (see?Section VII. Agency Contacts) so that the NHLBI can properly arrange for such applications to be accepted. See NIH FAQs for more information about submitting a Phase IIB application based on a Phase II contract or Phase II award from a non-NIH Federal agency: https://sbir.nih.gov/faqs#app-prep-sub26.
To qualify for renewal under the Phase IIB Small Market Award, the prior Phase II award could have been funded in response to any Federal SBIR or STTR solicitation and could have been funded by the NHLBI, by another NIH Institute/Center, or by another Federal agency. However, the proposed objectives for the Phase IIB application must fall within the technical scope required for this FOA as defined in Section I (under Specific Objectives for SBIR Phase IIB Small Market Award Applications ). In addition, the development activities completed under the previous Phase II award must provide the appropriate technical foundation to justify continued development of the technology for an NHLBI mission-related indication/use. Platform technologies that were initially developed for a non-NHLBI mission-related indication/use (i.e., certain Phase II projects funded by another NIH Institute/Center or another Federal agency) may be eligible for continued support under this FOA only if the earlier data demonstrate technical proof-of-concept that is scientifically relevant to the NHLBI mission-related indication/use. For all projects supported under this FOA, the aims of the project should focus on an NHLBI mission-relevant indication/use as the primary product or service. SBIR Phase IIB Small Market awards are non-renewable.
The NHLBI and NCATS will accept only one new Phase IIB Competing Renewal application and one Phase IIB Resubmission application for a particular project. For Resubmissions, the NIH policy described in?NOT-OD-14-082?applies.
In all cases, the Phase II project period must end before a Phase IIB Small Market Award can be issued.
In Phase II, normally, a minimum of one-half or 50% of the research or analytical effort is carried out by the small business concern. The total amount of consultant and contractual arrangements to third parties for portions of the scientific and technical effort may not exceed 50% of the total Phase II amount requested (direct, F&A/indirect, and fee).
Deviations from these requirements may be considered on a case by case basis. Please contact a program officer for additional information. Deviations must be approved in writing by the Grants Management Officer (GMO) after consultation with the agency SBIR Program Manager/Coordinator. In Phase I and Phase II, at least 40% of the research or analytical effort must be performed by the small business concern and at least 30% of the research or analytical effort must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct, F&A/indirect costs, and fee attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of the SF424 (R&R) application forms.
A small business concern may subcontract a portion of its SBIR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.
The basis for determining the percentage of work to be performed by each of the cooperative parties in Phase I or Phase II will be the total of the requested costs attributable to each party, unless otherwise described and justified in Consortium/Contractual Arrangements of the PHS 398 Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide.
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the SBIR/STTR (B) Instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed with the following additional instructions:
Facilities & Other Resources (Applicable to applications submitted for due dates on or after September 5, 2023)
In addition to describing the scientific environment and the company support, the applicant must describe the business environment and resources, or how the company will obtain access to the appropriate business resources, for completing and commercializing the proposed product or service. This includes any relevant intellectual property associated with the project necessary to facilitate commercialization.
Other Attachments:
1. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms
Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive. Follow the instructions below.
Applicants small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.
- Download the VCOC Certification.pdf at the NIH SBIR Forms webpage.
- Answer the 3 questions and check the certification boxes.
- The authorized business official must sign the certification.
- Save the certification using the original file name. The file must be named SBIR Application VCOC Certification.pdf . DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
- When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the Research and Related Other Project Information form.
2. Include copies of letters, emails or minutes documenting interactions with the FDA or other regulatory agencies provided as an attachment using the filename "Agencies Interactions.pdf".
3. Include documentation of support from third-party investors (other than letters of support) such as term sheets or redacted bank statements as an attachment using the filename "Third-party.pdf"
- At the time of application, applicants must provide detailed, verifiable documentation (e.g., redacted bank statement or other documentation) of any independent third-party investor support that has been secured up to one year prior to the application receipt date.
- Applicants should also provide detailed, verifiable documentation of any independent third-party investor support that will be provided to the SBC during the proposed Phase IIB Small Market Award project period. Documentation of support from third-party investors should corroborate the Finance Plan.
- Adequate documentation of planned (i.e., future/expected) third-party funding may include, but is not limited to, a term sheet from the third party (or parties) stipulating the terms of the proposed investment. At the time of application, evidence of a firm third-party commitment is ideal, but not required. Appropriate documentation of third-party investor support may include a conditional commitment stating that the third-party funding is contingent upon NIH selecting the application for an award. Partners should indicate any actual or planned/conditional financial commitment (as a specific dollar figure or range).
Applicants seeking further information regarding preferred sources and/or types of support that would demonstrate a third-party investor commitment are strongly encouraged to communicate with the Scientific/Research Contact(s) listed under?Section VII.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) applicants are required to address a Data Management and Sharing Plan, regardless of the amount of direct costs requested for any one year. However, SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
Letters of Support:
At the time of application, applicants must provide letters of support that detail any independent third-party investor support that has been secured up to one year prior to the application due date. Applicants should also provide letters of support of any independent third-party investor support that will be provided to the SBC during the proposed Phase IIB Small Market Award project period. These letters of support from third-party investors should corroborate the Finance Plan.
Adequate documentation of planned (i.e., future/expected) third-party funding may include, but is not limited to, a letter of commitment from the third party (or parties) stipulating the terms of the proposed investment. At the time of application, evidence of a firm third-party commitment is ideal, but not required. Appropriate documentation of third-party investor support may include a conditional letter of commitment stating that the third-party funding is contingent upon NIH selecting the application for an award. Partners should indicate any actual or planned/conditional financial commitment (as a specific dollar figure or range).
Appendix:
Note that Phase I SBIR/STTR Appendix materials are not permitted. Limited items are allowed in the Appendix of other small business applications. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.
SBIR/STTR Information
Commercialization Plan: All applications are expected to describe a realistic plan (extending beyond the SBIR Phase IIB Small Market Award project period) that outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be presented as part of the 12-page Commercialization Plan. The full commercialization plan for the product should extend beyond the period of SBIR funding.
The following subsections must be included within the page limit of the Commercialization Plan, in addition to the requirements listed in the SF424 Application Guide:
a) Value of the SBIR/STTR Project, Expected Outcomes, and Impact: Follow the instructions provided in the SF424 Application Guide.
b) Company: Follow the instructions provided in the SF424 Application Guide. Highlight how the proposed project relates to the company's core competencies.
c) Market, Customer, and Competition: Follow the instructions provided in the SF424 Application Guide.
d) Intellectual Property (IP) Protection: Follow the instructions provided in the SF424 Application Guide.
e) Finance Plan [this section replaces section e Finance Plan described in the SF424 Application Guide].
Consistent with achieving the goals of this program, applicants must provide a Finance Plan. This plan must include the following information:
- A detailed and specific plan for securing substantial, independent third-party investor funds. Any third-party investment support received up to ONE year prior to the application receipt date may be counted toward the total.
- The type(s) of independent third-party investor funds (i.e., cash, convertible debt, etc.) that will be secured during the project period.
- The source(s) of independent third-party investor funds (e.g., venture capital, state funds) that will be secured during the project period.
- The total amount of independent third-party investor funds that will be secured during the project period.
- The anticipated schedule for receiving independent third-party investor funds, including any relevant terms and conditions.
- A table summarizing the above information, with rows corresponding to each year of the project and the year prior to the receipt date and columns including the name of source, the type of funds, the amount, a concise description of terms and conditions, and the type of evidence provided and its location in the application (e.g., Letter of Support or bank statement in Other Project Information, Other Attachments).
The NHLBI considers the raising of independent third-party investor funds to be an important means to facilitate and accelerate the capital-intensive steps that are required to commercialize new products emerging from SBIR/STTR Phase II projects. As such, it is expected that applicants for the Phase IIB Small Market Award will secure substantial independent third-party investor funds. In all cases, it is expected that the level of this independent third-party funding will equal or exceed one-third of the NHLBI funds (total costs) being requested overthe entire Phase IIB Small Market Award project period. If the project period spans multiple years, the portion of the total third-party investment received in any given year should represent a substantial portion of the total investment, generally at least $250,000 in any given year. Phase IIB Small Market Award grantees who proposed three-year project plans may defer raising third-party investor funds until the second year of their projects.
Examples of third-party investors include, but are not necessarily limited to, another company, a venture capital firm, an angel investor, a foundation, a university, a research institution, a state or local government, or any combination of the above. Third-party investors generally should not include owners of the applicant SBC, their family members, and/or affiliates of the applicant SBC, or other Federal sources of funding. Preferred independent third-party investor funds under this FOA include cash, liquid assets, and/or convertible debt. Independent third-party investor funds generally should not include intangible assets, self-funding, and/or other debt. Applicants must clearly indicate within their third-party Finance Plan the total amount of funding that will be secured from the preferred sources listed above.
SBIR-eligible public companies may include as part of their fundraising plan the issuance of stock. In such a case, the preferred documentation is a letter of commitment, signed by the Chairman of the Board of Directors, which stipulates the following: (1) the amount of capital raised from the issuance of stock; (2) the amount of capital that will be dedicated to the proposed project under this FOA; (3) sufficient information regarding the use of the dedicated capital to demonstrate a substantial, value-added contribution toward the development and commercialization of the product to be developed under this FOA (see instructions below, Use of Third-Party Investment Funds ).
It is likely that several months will have elapsed between the time an application is submitted and the time it is peer reviewed and subsequently considered for possible funding. Accordingly, applicants must present a detailed summary of all past and/or planned (i.e., future/expected) third-party investor funds that clearly shows, relative to the estimated award date, when these funds have been and/or will be secured. For example, if the fundraising efforts of the SBC are in progress, and/or if the third-party investment is contingent upon NIH selecting the application for funding, then such plans must be clearly described in the Finance Plan.
Applicants are expected to document any independent third-party investor support that has been secured up to one year prior to the application receipt date and any independent third-party investor support that will be provided to the SBC during the proposed Phase IIB Small Market Award project period. Third-party funds (or plans for raising them) must be documented as concretely as possible including the names of specific partners and investors and any actual or planned/conditional financial commitment (as a specific dollar figure or range). Specific evidence supporting the applicant's fundraising plan should be provided as described in PHS 398 Research Plan, "Letters of Support and Other Project Information, Other Attachments".
Applicants seeking further information regarding preferred sources and/or types of support that would demonstrate a third-party investor commitment are strongly encouraged to communicate with the Scientific/Research Contact(s) listed under Section VII.
In addition to the expected independent third-party funding equal to or exceeding one-third of the NHLBI funds being requested over the entire Phase IIB Small Market Award project period, the NHLBI encourages applicants to secure in-kind contributions that will add value to the SBC and the project in a way that accelerates the commercialization of the technology being developed.
- explain how the in-kind contributions facilitate the research and commercialization plan;
- provide a detailed and specific plan for securing independent in-kind contributions and the anticipated schedule for receiving them, including any relevant terms and conditions; and,
- provide a detailed analysis of the value of in-kind contributions (e.g., standard market rates for consultant work, value of equipment).
In-kind contributions will not be considered as part of the independent third-party funding expected to equal or exceed one-third of the NHLBI funds being requested over the entire Phase IIB Small Market Award project period.
f) Production and Marketing Plan: Follow the instructions provided in the SF424 Application Guide.
g) Revenue Stream: Follow the instructions provided in the SF424 Application Guide.
h) SBIR/STTR Commercialization History: Applicants must provide an SBIR/STTR Commercialization History that addresses the questions listed below. The following questions should be addressed for all SBIR/STTR awards received from ANY Federal agency:
- Has the SBC gone through any name changes within the past five years? If so, list all previous company names in the application.
- Is the SBC a subsidiary or a spinoff? If so, provide the name of the parent company.
- What percentage of the SBC's revenue was derived from SBIR/STTR funding during each of the past 5 years, including both Phase I and Phase II awards? Report a percentage value for each year individually.
- What is the total number of SBIR/STTR Phase II awards that the SBC has received from the Federal government? For each award, provide (as a table):
1) the award number, the award amount, project duration, and the name of the awarding agency.
2) the product name resulting from the award project.
3) the current status of the project (preclinical development; clinical development; commercially available; discontinued).
4) FDA approval status of the product resulting from the project (PMA, IND, NDA, etc.; not yet submitted; submitted; approved; not approved).
5) follow-on funding (amount and investor name), strategic partnership (name of partner), or out-licensing (name of licensee).
6) the total revenues generated to date as a result of commercialization of the award project.
- What are the total revenues that have been generated to date as a result of the commercialization of the SBIR/STTR projects funded in the past 5 years?
i) Project Management Plan
Applicants must provide a Project Management Plan detailing how the research and commercialization plans will be kept on track. The plan should include:
- Specific milestones for the research and development of the product.
- Specific milestones for the commercialization of the product.
- A description of how the third-party investor will contribute to milestone-driven project management processes for the technology development and commercialization. For example, will the third-party investor have a seat on the Board of Directors or the Scientific Advisory Board?
j) Statement of Need
Applicants must provide a concise Statement of Need that includes evidence indicating that the project meets the responsiveness criteria for developing a product primarily designed to address a rare disease or young pediatric populations. In addition, the applicant must provide evidence that the eventual product faces specific commercialization barriers as a result of addressing a rare disease or young pediatric populations, such as the small size of the commercial market or the difficulty or expense of running clinical trials. Appropriate evidence could include an independent analysis of the net present value of the investment required to commercialize the product for the indicated market.
In addition, this statement is expected to provide answers to the questions listed below:
- What is the perceived funding gap for the product under development?
- Why is additional government funding critically needed to advance the development of the product toward commercialization? Specifically, what activities are being proposed under this FOA that would not otherwise be possible through independent third-party investments OR would be significantly delayed without additional NIH support?
- To what extent would a possible award under this FOA advance the product far enough to attract independent third-party financing and/or strategic partnerships to commercialize the product?
k) Use of Third-party Investment Funds
The Federal funds provided by a Phase IIB Small Market Award can only be used for advancing the research-related elements of the project. The use of any third-party investor funds will be at the discretion of the SBC. Applicants must provide sufficient information regarding the use of any third-party support to demonstrate a substantial, value-added contribution toward the development and commercialization of the product. Applicants are expected to address the following questions regarding the use of third-party funds:
- What are the specific activities that the third-party investor funds will support?
- Have the investors attached any restrictions/triggers/milestones to future payments (i.e., tranches)? If so, what are they?
- Have the investors indicated a commitment to the development of the technology for the rare or pediatric indication, even if a larger market exists and is part of the overall commercialization strategy?
l) Regulatory Plan
Applicants must provide a regulatory plan describing the regulatory pathway that is being or will be pursued and a timeline for achieving regulatory approval with discrete milestones. Applicants are strongly encouraged to submit evidence that they have contacted the appropriate regulatory authority and that their research plan and objectives follow the relevant requirements or guidance of that authority. Examples that provide evidence of appropriate interactions are letters or emails between the SBC and the appropriate FDA Center personnel or meeting minutes concerning a presubmission meeting or regarding a 510(k), IDE, PMA, HDE, BLA, IND, or NDA application. Copies of these letters, emails or minutes should be attached in the Other Project Information, "Other Attachments" section in the PHS398 Research Plan form.
PHS Human Subjects and Clinical Trials Information
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Appendix:
Note that Phase I SBIR/STTR Appendix materials are not permitted. Only limited items are allowed in the Appendix of other small business applications. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide Instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and time. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Updated documentation regarding third-party funding and regulatory agency communications are allowed as Post Submission materials to be submitted no later than 30 days prior to the scheduled review meeting and within the page limits defined in?NOT-OD-19-083
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field?Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)
Specific to this FOA:
What is the quality of the evidence provided that the product faces specific commercial barriers because of its focus on a rare disease or young pediatric population?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? For a Phase I application, are there clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific to this FOA:
How promising are the outcomes of the previously-funded SBIR or STTR Phase II project upon which the proposed Phase IIB Small Market Award is predicated? To what extent does the progress justify the continuation of the development efforts? How appropriate are the proposed milestones for the Phase IIB Small Market Award in determining whether the awardee has successfully reached the specified goals (e.g., IND filing)?
If the product proposed for development is based on a platform technology that was initially developed for a non-NHLBI mission-relevant indication/use, to what extent have the Phase II activities provided a solid foundation (i.e., relevant proof-of-concept) to support the continued development of the technology?
How sound is the proposed plan to meet Federal regulatory requirements?
How successful has the SBC been in commercializing prior SBIR/STTR projects supported by any Federal agency??
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Commercialization Plan
Value Proposition.?How compelling is the product's value proposition, and to what extent does the application demonstrate a substantial market-pull for the product under development? How well does the application describe the market niche(s) for the product and how urgent is the unmet medical need(s) being addressed? How well does the application identify the potential customers for the product and demonstrate a clear understanding of their needs?
Market, Customers, and Competitive Environment. How well has the application demonstrated an understanding of the competitive environment in which the product will be sold? To what extent has the application identified realistic, market-based milestones that can be achieved over the next five years? Does the SBC display an understanding of the hurdles that may delay or prevent acceptance of their product? How reasonable are the plans for generating a revenue stream, and how realistic are the revenue projections?
Company. To what extent do the prior experience and qualifications of the project team members lend confidence that the team will be successful in commercializing the proposed product or service? For example, how successful have the PD(s)/PI(s) been in commercializing other SBIR/STTR-supported technologies and discoveries in the past? To what extent does the applicant SBC have the ability to address regulatory issues, either through their own staff members or through appropriate arrangements with external regulatory consultants? To what extent is the applicant SBC concentrating on its core competencies in order to maximize its chances of success? How well can the applicant SBC sustain itself and grow as a business? To what extent will the applicant's business alliances and/or corporate partnerships help in facilitating commercialization? For example, will the third-party investors play an active role in facilitating the commercialization of the product or service, and if so to what extent?
Intellectual Property.?How strong is the applicant SBC's intellectual property (IP) portfolio/position (pertinent to the proposed project), and to what extent does the SBC have a reasonable strategy to protect its IP going forward?
Fundraising Plan.?How well does the application support the ability of the SBC to secure independent third-party investor funds (i.e., third-party funds that equal or exceed the NHLBI funds being requested over the entire Phasee IIB Small Market Award project period), including the preferred types of liquid, third-party investor funds (i.e., cash, liquid assets, and/or convertible debt), as expected under this FOA? How detailed is the documentation (e.g., term sheet) that has been provided by the applicant SBC to corroborate the Finance Plan? If the third-party investors have attached restrictions and/or triggers and/or milestones to future payments, to what extent have these restrictions been clearly stipulated in the application? To what extent does the applicant SBC have access to resources needed to sustain itself and grow as a business? To what extent has the application demonstrated that the third-party investor support will provide a substantial, value-added contribution toward the development and commercialization of the product? For example, has the application described the specific activities that the third-party investor funds will support?
Phase II Applications
Not Applicable
Phase I/Phase II Fast-Track Applications
Not Applicable
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Phase IIB Competing Renewals
For Phase IIB Applications, the committee will consider the following:
1) the progress made in the last funding period.
2) the commercial potential (i.e. the probability that an application will result in a commercial product), which may be validated by the applicant's ability to secure substantial independent third-party investor funds (i.e., third-party funds that equal or exceed the requested NIH funds).
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications with Foreign Components
Reviewers will consider whether work to be performed outside of the United States is thoroughly justified, based on a rare and unique circumstance, and necessary to the overall completion of the project.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan.
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Heart, Lung, and Blood Advisory Council. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
- Security risk as assessed by the HHS Due Diligence Program (for due dates on or after September 5, 2023).
Disclosure Requirements Regarding Ties to Foreign Countries (Applicable for applications submitted for due dates on or after September 5, 2023)
Upon request applicants are required to disclose all funded and unfunded relationships with foreign countries, using the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form (referred to as the "Disclosure Form" hereafter), for all owners and covered individuals. A "covered individual" is defined as all senior key personnel identified by the SBC in the application (i.e., individuals who contribute to the scientific development or execution of a project in a substantive, measurable way).
Upon request, applicants must submit the completed Disclosure Form and any additional agency-specific information electronically in eRA Commons via the Just-In-Time (JIT) process as described in the NIH Grants Policy Statement (GPS) Section 2.5.1 Just-in-Time Procedures. Applicants must continue to comply with NIH Other Support disclosure requirements as provided in NIH GPS Section 2.5.1 and may be required to provide similar information on the Disclosure Form for covered individuals identified in the application. If participating in this NOFO, SBC applicants applying to CDC and FDA will follow each agency's policies for submitting additional documents during the pre-award process. Applicants that do not submit the completed Disclosure Form during the JIT process will be deemed noncompliant and not be considered for funding.
Denial of Awards (Applicable for applications submitted for due dates on or after September 5, 2023)
Applicants are encouraged to consider whether their entity's relationships with foreign countries of concern will pose a security risk. Prior to issuing an award, NIH (and CDC or FDA, as applicable) will determine whether the SBC submitting the application:
- has an owner or covered individual that is party to a malign foreign talent recruitment program;
- has a business entity, parent company, or subsidiary located in the People's Republic of China or another foreign country of concern; or
- has an owner or covered individual that has a foreign affiliation with a research institution located in the People's Republic of China or another foreign country of concern.
A finding of foreign involvement with countries of concern will not necessarily disqualify an applicant. Final award determinations will be based on the above finding of foreign involvement and whether
the applicant's involvement falls within any of the following risk criteria, per the Act:
- interfere with the capacity for activities supported by NIH, CDC, or FDA to be carried out;
- create duplication with activities supported by NIH, CDC, or FDA;
- present concerns about conflicts of interest;
- were not appropriately disclosed to NIH, CDC, or FDA;
- violate Federal law or terms and conditions of NIH, CDC, or FDA; or
- pose a risk to national security.
Generally, NIH, CDC, and FDA will not provide SBC applicants the opportunity to address any identified security risks prior to award. NIH, CDC, and FDA will not issue an award under the SBIR/STTR program if the covered relationship with a foreign country of concern identified in this guidance is determined to fall under any of the criteria provided .
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
For applications submitted for due dates on or after September 5, 2023, SBIR and STTR applicants under consideration for award will be required to submit the SBA U.S. Small Business Administration (SBA) issued the Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries form during the JIT process. Applicants that fail to submit a Disclosure Form will not be considered for funding.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
SBIR Phase IIB Small Market Award Terms and Conditions
If a Phase IIB Small Market Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (i.e., the Finance Plan submitted as part of the application) will become a term of award. Prior to the issuance of an award, NIH will request Just-In-Time information from the applicant to verify compliance with the Finance Plan. Once the NHLBI grants management official has notified the SBC that their application is being considered for funding, the SBC is encouraged to submit all of the requested Just-In-Time information as soon as possible.
Just-In-Time information related to the Finance Plan may include, but is not limited to, the following:
-
An updated, signed, fully-executed, and binding agreement(s) between the SBC and all investors and all sources of third-party investor funds that have been committed over the entire project period;
-
Substantial, detailed, verifiable proof (e.g., redacted bank statement or other documentation) of third-party investor funds that have been received by the SBC;
-
Substantial, detailed, verifiable proof that the SBC will receive (or has already received) third-party investor funds that equal or exceed one-third of the NHLBI funds requested during the first year of the project period;
-
Other information as necessary (in consultation with NHLBI SBIR program staff and the NHLBI Office of Grants Management), which adequately documents the third-party commitment as stipulated in the applicant’s Commercialization Plan.
Prior to the issuance of an award, any substantive change to the applicant’s original Finance Plan (as reviewed by the Special Emphasis Panel) must be discussed with the assigned Program Director during the administrative review process. Substantive changes to the original Finance Plan may include, but are not necessarily limited to the following: (1) one or more of the original investors has withdrawn or substantially reduced their committed level of support; (2) the financing mechanism or instrument, or other terms associated with the third-party investment, have been significantly altered relative to the originally proposed plan.
Prior to the issuance of award, if the applicant proposes to modify the Finance Plan, the assigned Program Director must verify that the updated type(s), source(s), total amount(s), and anticipated schedule(s) for receiving funds represent an equivalent or superior plan as compared to the originally evaluated Finance Plan.
All substantive changes to the original Finance Plan (i.e., the plan evaluated by the Special Emphasis Panel) will be evaluated on a case-by-case basis. All substantive changes to the applicant’s original Finance Plan must be appropriately addressed in a revised fundraising plan. If a revised Finance Plan is proposed, it must be approved by the Director of the Office of Translational Alliances and Coordination and the NHLBI Office of Grants Management prior to award. In such a case, the revised Finance Plan supersedes the original plan and becomes a term of award.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federal-wide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
- Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.
Not Applicable
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement (GPS). Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. SBIR and STTR recipients may retain the rights to data generated during the performance of an SBIR or STTR award for up to 20 years after the award date, per the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive. An acceptable Data Management and Sharing plan can reference and incorporate these data rights. Further information about SBIR and STTR data rights are enumerated in the NIH GPS.
3. Reporting
NIH requires that SBIR/STTR recipients submit the following reports within 120 days of the end of the grant budget period unless the recipient is under an extension. When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
- Final RPPR (requirements have recently changed - please see the NOT-OD-17-085)
- Final Invention Statement and Certification (HHS 568)
- Annual Invention Utilization Reports
- Federal Financial Report (FFR)
- SBIR.gov
- Quarterly reports are due to the Payment Management System 30 days following the end of each calendar quarter.
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
SBIR Phase IIB Small Market Award: Compliance with the Finance Plan (Reporting)
As described above, the applicant’s Finance Plan submitted at the time of application (or the revised Finance Plan approved by the NHLBI), becomes a term of award. Throughout the Phase IIB Small Market Award project period, grantees will be expected to provide detailed, verifiable documentation (e.g., redacted bank statement or other documentation) of independent third-party investor support that is planned/expected, according to the schedule that is stipulated in the Finance Plan.
A grantee’s failure to comply with the terms of award may cause NIH to take one or more enforcement actions, including suspension of the grant, withholding of support, or termination, depending on the severity and duration of the noncompliance. NIH will undertake any such action in accordance with applicable statutes, regulations, and policies.
Disclosure of Foreign Relationships Reporting Requirements (Applicable for applications submitted for due dates on or after September 5, 2023)
Recipients are responsible for monitoring their relationships with foreign countries of concern post-award, for any changes that may impact previous disclosures. SBCs receiving an award under the SBIR/STTR program are required to submit an updated Disclosure Form to report any of the following changes to NIH (and CDC or FDA, as applicable) throughout the duration of the award:
- any change to a disclosure on the Disclosure Form;
- any material misstatement that poses a risk to national security; and
- any change of ownership, change to entity structure, or other substantial change in circumstances of the SBC that NIH, CDC, and FDA determine poses a risk to national security.
Regular, annual updates are required at the time of all SBIR/STTR annual, interim, and final Research Performance Progress Reports (RPPRs). For changes that occur between RPPR submissions, updated Disclosure Forms are required within 30 days of any change in ownership, entity structure, covered individual, or other substantive changes in circumstance, as described above. Recipients are required to upload these updated disclosures using the Additional Materials (AM) tool in eRA Commons.
If the recipient reports a covered foreign relationship that meets any of the risk criteria prohibiting funding described in this NOFO, NIH, CDC, and FDA may deem it necessary to terminate the award for material failure to comply with the federal statutes, regulations, or terms and conditions of the federal award. Refer to NIH GPS Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support for more information. Recipients are encouraged to monitor their covered foreign relationships post-award and avoid entering into relationships, both funded and unfunded, that may pose a security risk and jeopardize their ability to retain their award.
Agency Recovery Authority and Repayment of Funds
An SBC will be required to repay all amounts received from NIH under the award if either of the following determinations are made upon assessment of a change to their disclosure:
- the SBC makes a material misstatement that NIH determine poses a risk to national security; or
- there is a change in ownership, change in entity structure, or other substantial change in circumstances of the SBC that NIH determine poses a risk to national security.
The repayment requirements and procedures provided in Section 8.5.4 Recovery of Funds of the NIH GPS apply and may also be subject to additional noncompliance and enforcement actions as described in Section 8.5.2 of the GPS. Recipients are required to follow the repayment procedures provided in the Guidance for Repayment of Grant Funds to the NIH.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg
Stephanie Davis, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-8412
Email: stephanie.davis3@nih.gov
Krishna Balakrishnan, PhD, MBA
Office of Strategic Alliances
National Center For Advancing Translational Sciences (NCATS)
Phone: 3301-827-7149
E-mail: balki@nih.gov
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: nhlbichiefreviewbranch@nhlbi.nih.gov
Andre Walker
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8061
Email: andre.walker@nih.gov
Imoni Malaika Washington
National Center For Advancing Translational Sciences (NCATS)
Phone: (301) 435-2939
E-mail: imoni.washington@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 45 CFR Part 75 and 2 CFR Part 200.
The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.
The STTR Program is mandated by the Small Business Reauthorization Act of 1997 (P.L. 105-135), and reauthorizing legislation, P.L. 107-50, P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011), as reauthorized and extended under P.L. 114-328, Section 1834, P.L. 115-232, and P.L. 117-183. The basic design of the NIH STTR Program is in accordance with the Small Business Administration (SBA) STTR Policy Directive.
and Human Services (HHS)
