NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44)

NHLBI SBIR Phase IIB Small Market Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44) is sponsored by National Institutes of Health (NIH). Provides funding to small businesses to accelerate the commercialization of technologies for heart, lung, blood, and sleep disorders.

Expired RFA-HL-26-015: 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) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies .

Contact the eRA Service Desk for any submission issues. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) National Center for Advancing Translational Sciences ( NCATS ) Funding Opportunity Title 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) R44 Small Business Innovation Research (SBIR) Grant - Phase II only March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. November 22, 2024 - Notice of Pre-Application Webinar for NHLBI SBIR Phase IIB Small Market Awards and Bridge Awards (RFA-HL-26-014 and RFA-HL-26-015). See Notice NOT-HL-24-035 .

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 . 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 .

February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants­­. See NOT-OD-23-092 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity Small Business Innovation Research Grants (SBIR) - Phase II See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number 93. 838, 93. 837, 93.

839, 93. 233, 93. 840, 93.

350 Notice of Funding Opportunity Purpose 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 Notice of Funding Opportunity (NOFO) 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 NOFO 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 .

This NOFO 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 NOFO 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). Funding Opportunity Goal(s) 93.

837 Cardiovascular Diseases Research Fosters heart and vascular research in the basic, translational, clinical and population sciences, and to foster training to build talented young investigators in these areas, funded through competitive research training grants.

As described by the Small Business Administration (SBA), the statutory purpose of the Small Business Innovation Research (SBIR) program is to strengthen the role of innovative small business concerns (SBCs) in federally-funded research or research and development.

The purpose of the Small Business Technology Transfer (STTR) program is to stimulate a partnership of ideas and technologies between innovative SBCs and non-profit Research Institutions.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) January 26, 2025; January 26, 2026; January 26, 2027 Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

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. New Date November 17, 2025 per issuance of NOT-OD-26-006 .

Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply – Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply – Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply – Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description 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 varied 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 NOFO 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 NOFO 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 NOFO 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 or STTR funding.

Applicants are expected to leverage their previous SBIR or STTR support, as well as the opportunity to compete for additional NHLBI funding under this NOFO, 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 proposed under this NOFO. 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) , the NIH Pediatric Research Consortium , the FDA Pediatric Device Consortia Grants Program , 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 NOFO is specifically designed to provide additional support for products that require ultimate approval/clearance by a Federal regulatory agency. Although projects previously funded by another NIH Institute/Center or another Federal agency are eligible for funding under this NOFO, proposed projects MUST be relevant to the NHLBI mission .

Applicants are strongly encouraged to contact the NHLBI 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 NHLBI mission .

The NHLBI program priority areas for technology development research include but are not limited to those listed below: 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 Pompe disease); 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.

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.

Examples of appropriate development activities to be proposed under this NOFO 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, 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, 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 NOFO will 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. For more information about the areas of science supported by this NOFO, please visit the NHLBI section of https://seed.

nih. gov/sites/default/files/HHS_Program_Descriptions. pdf .

NCATS Scientific Areas : 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. As detailed in NOT-TR-18-025 , NCATS is limited to direct support of clinical trials through phase IIB with the exception of phase III ( 21 CFR definition ) clinical trials for treatment of a rare disease or condition .

For a description of the NCATS SBIR/STTR research priorities, please refer to http://ncats. nih. gov/smallbusiness/priorities .

C. Plan for Full Commercialization The goal of the SBIR Phase IIB Small Market Award is to advance SBIR or STTR 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 presented as part of the 12-page 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. Applications deemed to be non-responsive will not proceed to review.

The following are considered non-responsive to this NOFO: 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 R&D that falls within the technical scope of this NOFO as described under Section I (Specific Objectives for SBIR Phase IIB Small Market Award Applications) 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 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") Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Renewal (Phase IIB) - Phase IIB Competing Renewal (Phase IIB) Resubmission (All Phases) - (Phase IIB previously submitted under this NOFO or RFA-HL-23-008 ) The OER Glossary and the How to Apply – Application Guide provide details on these application types. Only those application types listed here are allowed for the NOFO.

Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NHLBI and NCATS intend to commit total costs of $2,333,333 in FY2026; $4,666,667 in FY2027; $7,000,000 in FY2028; $4,666,667 in FY2029; and $2,333,333 FY2030 to fund up to two new awards in FY2026, FY2027, and FY2028 Total funding support (direct costs, indirect costs, fee) for the entire budget period MUST not exceed $3,500,000.

For any single year of the project period, it is recommended that the budget not exceed $1,166,667 total funding support. Applicants that intend to request budgets greater than $1,166,667 total funding support 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. Applicants are permitted to request up to $50,000 in funding for Technical and Business Assistance to help them address their most pressing product development needs. The TABA allowance will not be counted toward the budget cap for this NOFO.

For more information on how to request TABA funds, please use the How to Apply - Application Guide or visit https://seed. nih. gov/product-development-support/technical-business-assistance-program/taba-funding .

Phase IIB is an allowable application type. Durations of up to 3 years 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 NOFO.

Section III. Eligibility Information 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: 1.

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; 2.

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.

4. 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.

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 How to Apply – Application Guide should be referenced for detailed eligibility information. 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