Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed) is sponsored by National Center for Advancing Translational Sciences (NCATS) / National Institutes of Health (NIH). This Notice of Funding Opportunity (NOFO) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I, Phase II, and Fast-Track grant applications.

Expired RFA-TR-23-018: Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed) 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 Center for Advancing Translational Sciences ( NCATS ) Funding Opportunity Title Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed) UT1 Small Business Technology Transfer (STTR) Cooperative Agreement Phase I UT2 Small Business Technology Transfer (STTR) Cooperative Agreements - Phase II September 15, 2025 - Notice of Extension for RFA-TR-23-018 "Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed)".

See Notice NOT-TR-26-005 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. April 04, 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 (SBIR) Cooperative Agreements - Phase I/ Small Business Innovation Research (SBIR) Cooperative Agreements - Phase II See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number Notice of Funding Opportunity Purpose Microphysiological Systems (MPS) are bioengineered microfluidic devices seeded with human cells and tissues that recapitulate organ systems and function.

MPS systems are starting to emerge as an alternative to 2-D culture and animal studies and play a crucial role in drug discovery, regulatory approval, safety and efficacy assessment and precision medicine studies. However, the MPS systems so far require extensive time, personnel effort, and cost for acquiring and analyzing data.

In order to achieve industry adoption and regulatory acceptance, the miniaturization and automation of assays is required. NCATS funded a Chips in Space consortium which further developed MPS systems to be used in Low Earth Orbit (LEO) biomedical research under microgravity conditions.

Through partnerships between NCATS, NASA and the Center for Advancement of Science in Space, the Tissue Chips in Space program has made key technological innovations towards automation and miniaturization required for space flight.

This Miniaturization and Automation of Tissue Chip Systems (MATChS) NOFO has the central goal of improving the instrumentation platform that supports tissue chips using general principles of automation and miniaturization similar to the experiences from the Tissue Chips in Space program that will result in ease of use and broader accessibility of tissue chips for use on Earth.

This NOFO provides support using the STTR cooperative agreement mechanisms for the development of MATChS. Applications in response to this NOFO would include those proposing research and development of tools and turnkey technologies for higher throughput automated measures with on-line sensing, rapid acquisition and analysis of data to reduce manual handling..

Funded projects will result in an increased availability of miniaturized automated tissue chip platforms for use in drug development and across multiple applications as a major research tool in biomedical research laboratories.

As a cooperative agreement, small business concerns (SBCs) will be expected to develop milestones and benchmarks, and work with NIH staff towards progress in the aims of the project to develop an automated system and demonstrable pathways to commercialization. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Dates in bold and italics reflect changes per NOT-TR-26-005 .

Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed February 22, 2024 February 22, 2024 Not Applicable June 2024 October 2024 December 2024 February 24, 2025 February 24, 2025 Not Applicable June 2025 October 2025 December 2025 February 23, 2026 February 23, 2026 Not Applicable June 2026 October 2026 December 2026 September 4, 2026 September 4, 2026 Not Applicable November 2026 January 2027 April 2027 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 Application Guide and the NOFO) 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.

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 This Notice of Funding Opportunity (NOFO) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) Phase I, Phase II, and Fast-Track grant applications.

The funding opportunity will utilize a UT1/UT2 cooperative agreement to support small business concerns (SBCs) to propose applications to create bench top, portable, automated, self-contained systems that maintain 3D tissue constructs (e.g., precise thermal control, fluid pumping and sampling) and provide biologically relevant outputs of tissue health and function.

The companion Small Business Innovation Research (SBIR) NOFO allows for submission of Phase I, Phase II, Fast-Track, and Direct to Phase II grant applications. NCATS has consistently shown leadership in the development of tissue chip technology, in the demonstration of its utility in drug development for safety, efficacy and precision medicine, and in the dissemination of the technology ( https://ncats. nih.

gov/tissuechip/about ). FDA Modernization Act 2. 0 declared that the FDA no longer requires animal tests before drug trials in humans, which stimulated increased interest in in vitro New Approach Methods (NAMs) that are more predictive of human response in the safety and efficacy assessment of leading therapeutics.

Tissue/organs on chips systems are considered as one of the NAMs. However, the widespread dissemination of tissue chip technology is hindered by the relatively large and complex instrumentation system needed to support the function of the chips, low throughput and specialized expertise needed to operate the systems.

The instrumentation typically requires a multidisciplinary team of biomedical engineers and microfluidics experts to assure smooth operations, and biologists to acquire and analyze the data. This underscores the need for improvements in design towards systems capable of real-time, repeated measurements, with ease of manufacturability, and broader user-friendliness.

Through partnerships between NCATS, NASA and the Center for Advancement of Science in Space, the Tissue Chips in Space program has enabled advances in the study of microgravity-associated age? related conditions and has made key technological improvements in the tissue chips instrumentation systems towards automation and miniaturization required for space flight.

This Miniaturization and Automation of Tissue Chip Systems (MATCHs) NOFO seeks to translate the lessons learned from the Tissue Chips in Space program in engineering tissue chip platforms towards a smaller footprint and the simplification of systems for ease of use.

Previously, NASA has partnered with NIH, BARDA and FDA to develop extended longevity tissue chips (cell culture life up to 6 months) with a focus on the development of systems requiring minimal human intervention.

Working with spaceflight payload implementation partners, NCATS-supported tissue chip investigators have developed compact, robust, and reliable platforms which integrate basic support systems (incubation, refrigeration, thermal control, fluid reservoirs, microfluidic pumping systems etc.) as well as technologies to monitor cell health and function (pH, gas concentrations, repeated fluid sampling, microscopy, electrophysiology etc.).

This Miniaturization and Automation of Tissue Chip Systems (MATCHs) NOFO seeks to engineer tissue chip platforms towards a smaller footprint and the simplification of systems for ease of use that will result in ease of use and broader accessibility of tissue chips in drug discovery and biomedical research.

This NOFO seeks to fund technology development research efforts in instrumentation innovation and approaches for automation and miniaturization of MPS. The technology development proposed should have the potential to significantly propel the field of MPS forward and have the potential to have a large impact on the future analysis of safety and efficacy assessment of therapeutics.

A main objective for this funding opportunity would be to create a bench top, portable, easy-to-use, automated MPS with integrated in-line sensors, flow generator with system control and data processing software to provide rapid and reproducible high-throughput analysis. The project could integrate manual methods into an automated system to develop a standalone module.

Improved tissue chips instrumentation systems should demonstrate automation capabilities in maintaining culture without external intervention and can be monitored remotely through real-time biosensing and readout capabilities, including telemetry operations.

Automation may include automation of tissue preculture and loading, system operation, perfusion systems with or without pumps, automation of cell culture conditions, monitoring and sensing, include in-line sensors, e.g., pressure, pH and oxygen sensors.

This self-contained system should maintain 3D tissue constructs (via precise thermal control, fluid pumping and sampling) for extended periods of time and provide biologically relevant outputs of tissue health and function (e.g., by means of fluid sampling, electrode incorporation, microscopy, biosensors). If automated chip exchange is proposed, the system should have proper optical, mechanical, and electrical couplings.

The fabrication procedure must be cost effective, mass producible, and robust. The application may include development of a software for instrument control, data acquisition and real-time detection, fast data processing and analysis for high throughput measurements. Performance metrics of an integrated system for a multi-day protocol should be developed once standard protocols are established and instrument performance is assessed.

Once optimal assay parameters are identified, and optimized chips created and integrated for use in the fully automated system with alignment features ensuring proper connection of the fluidic path to the chip, the performance of the system should be characterized and validated. An automated system may be validated by demonstrating compatibility with developed chips and organ-on a chip model and by pre-market end-user testing.

The NOFO deliberately does not specify cost, quality, scale, sensitivity, dynamic range, throughput, or other key metrics since achievable endpoints are likely to substantially differ from one technology to another.

However, the applicant must propose quantitative metrics so progress can be evaluated and present convincing rationale that the proposed technology has the potential to scale long-term and to achieve a throughput compatible with widespread adoption by the biomedical and clinical research community.

It is expected that applicants will develop and detail scientific and practical definitions of optimal throughput, cost, accuracy, sensitivity, dynamic range, and scale. The long-term goal is to achieve technological advances that enable generation of data at sufficient scale, speed, cost and accuracy to use routinely in safety and efficacy assessment of therapeutics.

MATChS is expected to accelerate commercialization and catalyze the widespread use of tissue chips through automation and miniaturization of the instrumentation systems and will lead to the general utility of tissue chips in drug development and regulatory decision-making, as well as in biomedical research in general as a major research tool.

The STTR U1/U2 cooperative agreement mechanism is milestone-driven and involves significant input from NIH program staff regarding project and milestone planning, monitoring of research progress, and go/no-go decision-making. Applicants are encouraged to contact staff at NCATS per Agency Contacts below to ensure that their study design and objectives are in line with the goals of the NOFO.

Award recipients will be expected to work with NCATS staff post-award.

Examples of responsive activities and corresponding STTR Phase assignment includes but is not limited to the following technological developments: Development of components of the system Development of real-time biosensing Development of automated readout capabilities Automation of tissue preculture and loading Automation of system operation Development of perfusion systems Development of automation to maintain 3D tissue Integration of the system Development of a stand-alone instrument prototype Militarization of the system Development of software for instrument control and data processing software Assessment of instrument performance System characterization and validation Pre-market end-user testing UT2 Phase I/II Transition Applicants can submit separate Phase 1 (UT1) or Phase II (UT2) applications.

However, if Phase I and Phase II are submitted together in one application (UT2 Fast-Track), then an administrative review will be conducted by NCATS Program staff to decide whether a project will be considered for transition from the Phase I to Phase II. Phase II eligible projects must successfully accomplish milestones of Phase 1 as defined in Milestones Plan.

Funding for the Phase II application will be contingent upon (1) assessment of the Phase I progress report and determination that the Phase I goals and milestones were achieved; (2) an update (as necessary) of the Commercialization Plan; (3) determination of the project's potential for meeting the mission of the awarding component and for commercial success; (4) review and approval of other documents necessary for continuation; and (5) availability of funds.

The continuation application package is due 2 months prior to the anticipated start date of Phase II. Applications Not Responsive to this NOFO Applications not proposing to develop automation and miniaturization of MPS and focused solely on development of healthy and diseased MPS are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

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

Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for this NOFO. Application Types Allowed New (Phase I, Fast-Track) Resubmission (All Phases) 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 NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NCATS intends to commit up to $2. 15 M towards 2 Phase I awards and a maximum of 1 Phase II award in FY 2024.

Budgets up to $350,000 total costs per year for Phase I and up to $2. 15M total costs per year for Phase II may be requested utilizing waiver topics listed in Appendix A of PHS 2022-02 SBIR/STTR Program Description and Research Topics for the NIH, CDC, and FDA https://seed. nih.

gov/sites/default/files/HHS_Topics_for_Budget_Waivers. pdf According to statutory guidelines, award periods normally may not exceed 1 year for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project.

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: 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.

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 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 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-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 100 Phase II awards from all agencies over the past 10-fiscalyears (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-fiscal year 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 , are not allowed.

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 Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. 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. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. SBA Company Registry See How to Apply Application Guide for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a UEI to complete this registration.

SBA Company registration is NOT required before SAM, Grants. gov or eRA Commons registration. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; 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 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.

Eligible Individuals (Program Director/Principal Investigator) 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

For the STTR program, the PD(s)/PI(s) may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.

Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration.

The How to Apply 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 How to Apply Application Guide . This NOFO does not require cost sharing as defined in the