Advancing Research on Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) SBIR/STTR

Advancing Research on Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) SBIR/STTR is sponsored by National Institute on Aging (NIA). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAS-22-196: Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/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 Institute of Neurological Disorders and Funding Opportunity Title Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional) R43 / R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, Direct-to-Phase II, Phase IIB, and Fast-Track Notices of Special Interest associated with this funding opportunity 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 . ( 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.

) February 23, 2023 - Notice of Change to Minimum Performance Standards for SBIR and STTR Applicants. See Notice NOT-OD-23-092 .

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-NS-23-049 - Notice of NINDS Specific Interest in AD/ADRD for PAS-22-196 "Advancing Research on Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) (R43/R44 Clinical Trial Optional)" NOT-AG-22-037 - Notice of Change to Key Dates to PAS-22-196 NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 June 30, 2022 - Notice of Change in Required Registrations for SBIR and STTR Funding Opportunity Announcements RFA-DA-23-019, RFA-DA-23-020, PAS-22-196, PAS-22-197.

See Notice NOT-OD-22-165 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity R41 / R42 Small Business Technology Transfer (STTR) Grants - Phase I/ * Small Business Technology Transfer (STTR) Grants - Phase II See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites applications to the National Institute on Aging's (NIA) Small Business Innovation Research (SBIR) program.

The aim of this FOA is to support research that may lead to the development of innovative products and/or services that have the potential to advance progress in preventing and treating Alzheimer's disease (AD) and AD-related dementias (ADRD) and/or caring for and treating patients living with AD/ADRD.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk. 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.

Required Application Instructions It is critical that applicants follow the SBIR/STTR (B) 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.

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

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.

Funding Opportunity Description Recommendations and milestones for Alzheimer's disease (AD) and AD-related dementias (ADRD) research from the National Alzheimer’s Project Act and the 2015 , 2018 , 2019, and 2021 Alzheimer's Disease Research Summits present a wide range of research and development proposals which, if pursued, have the potential to reduce the human burden and healthcare costs associated with AD/ADRD.

Examples of research areas of interest include, but are not limited to, the following: Behavioral, environmental, pharmacological, and nutritional interventions to prevent and/or remediate brain biochemical and/or neurophysiological changes caused by neurodegenerative diseases, including age-related sensory dysfunction, motor dysfunction, or age-related decrements in balance and postural control, gait performance, and mobility.

Programs to support cognitive training to improve cognitive function in the elderly.

Examples of topics appropriate for such programs include, but are not limited to, the following: Rapid development of novel, engaging, computer-based cognitive-training programs based on empirically-established approaches using cognitive training to target a specific neural system/functional domain; Augmentation of existing computerized cognitive interventions that can be individually tailored to engage, adapt, challenge, and optimize functional cognitive abilities to enhance cognitive functioning and performance of activities of daily living; and Development of interventions to remediate age-related cognitive decline, especially using technology platforms with wide acceptance among older adults.

Sensitive, specific, and standardized tests for diagnostic screening of mild cognitive impairment (MCI) and dementia, including the development of new, cost-effective, minimally-invasive biomarkers that could be used for screening in the general population and in community settings. In addition, this FOA encourages research that would identify new biomarkers that could serve as surrogate measures for disease progression in AD/ADRD.

Other advances might include the development of new instrumentation, imaging technology, related devices, and software packages for use in visualizing neural activity during cognitive, emotional, motor, or sensory behavior in older adults. Biosensors and prosthetic devices, technologies, and related software development to aid in the assessment, diagnosis, and remediation of age-related cognitive decline.

Machine-learning tools and cognitive batteries that can be integrated into Electronic Medical Records (EMR) for diagnosis of MCI and AD/ADRD. New approaches for the assessment of persons living with multiple chronic conditions in clinical practice, including development and validation of brief cognitive-screening measures.

Discovery, development, and/or evaluation of drugs and/or biological or natural products, including central nervous system delivery systems, to remediate age-related cognitive decline and treat the cognitive impairment and/or behavioral symptoms associated with MCI, AD/ADRD, and other dementias of aging.

In addition, this FOA invitess research on therapies that might slow and/or reverse the course of AD/ADRD, or prevent them entirely through the application of systems-biology and systems-pharmacology approaches. Therapeutics addressing novel targets are of particular interest.

Clinical trials to test the safety and efficacy of drug, nutritional, behavioral, cognitive, or other types of interventions to remediate age-related cognitive decline and treat cognitive impairment and/or behavioral symptoms associated with MCI, AD/ADRD, and other dementias of aging, as well as to slow and/or reverse the course of AD/ADRD or to prevent their onset.

New technologies for in-home use, or for coordination or delivery of services to sustain in-home living for individuals living with MCI or AD/ADRD.

Examples include, but are not limited to, the following: Systems and devices to evaluate, monitor, improve, or adapt to changes in cognition; Improvements in health-service delivery; Improvements in the preservation of functional independence; Technologies supporting independent living and the conduct of everyday tasks at home; Provision of information to healthcare providers and family members enabling assessment of patient needs and/or intervention(s); and Promotion of effective communication and interaction between individuals living with dementia in the community or in institutional settings and their healthcare providers, friends, and family members.

Assistive robotics technology that can support a person in order to maintain or improve their independence, safety, and well-being when diagnosed with AD/ADRD and alleviate the burden of care. Such efforts might include the development of socially-assistive robots that can support engagement, social participation, and leisure activities of patients living with MCI and AD/ADRD.

Cost-effective technology to create dementia-friendly cities and environments for individuals diagnosed with AD/ADRD. This might include the development of alarm technology and tracking and location-monitoring devices to alert caregivers and others of the whereabouts of individuals living with AD/ADRD.

Other advances might include innovative research to develop safer home environments, such as automatic shut-off valves for water (e.g. a sink could overflow when one forgets to turn off faucet) and electricity and gas (e.g. forgetting to turn off stove). Comprehensive telecare systems that can be used to support independence and personal safety of an individual living with AD/ADRD and other dementias.

Such telecare systems might include community alarms, medication reminders, sensors for floods or extreme temperatures, detection of absence from normal activities (e.g. sitting in a chair, going to bed), fall detection, and unobtrusive sensors to monitor activities of daily living and vital signs that can be reported to a healthcare provider.

Other advances might include the development of technology that would allow for in-place monitoring of individuals at all stages of AD/ADRD. Ideally, such information would be integrated with other patient-relevant data in EMR. Wearable, mobile, or other technology to enable direct, objective, and continuous data capture of everyday functions in individuals living with AD/ADRD.

Recent reviews of relevant scientific literature revealed the presence of disparities of care between diverse racial and ethnic minority populations of individuals with AD/ADRD. To address such disparities, this FOA encourages research to develop educational training programs for physicians, nursing assistants, home-care aids, and long-term-care services.

These programs would focus on training healthcare staff to provide culturally-appropriate care to the patient at the right time and in the right setting. Novel technologies to monitor, assist, or maintain daily functioning of older individuals living with AD/ADRD and other cognitive impairments.

Manuals and training materials for existing evidence-based interventions that reduce the burden of caregiving for AD/ADRD caregivers which can be used by community-based agencies and/or healthcare organizations. A tool that could be sold to Medicare Advantage (MA) plans to allow them to accurately project future costs of caring for patients living with AD/ADRD and other forms of dementia.

Such a tool would be based on incidence and cost data and would be capable of being tailored for use by participating MA plans to address the unique demographics and risk characteristics of its coverage pool. Technology and analytical tools to investigate genetic, epigenetic, transcriptomic, proteomic, metabolomic, and cell stress pathways in neurons and glia of the aging and AD/ADRD brain.

Such efforts might include the development of molecular-imaging technology and/or chip-based technology for in-vitro and in-vivo analysis of gene, epigenome, proteostasis, lipidomics, and metabolomics and metabolic function in the normal aging brain and in AD/ADRD.

Improved technology for the analysis of structural and functional brain connectivity at the cell, neural circuitry, and global network levels to define the trajectory of changes in brain structure and function in aging and AD/ADRD. Such technology might include the development of non-invasive methods and novel probes that monitor and manipulate the plasticity of neural circuits in the adult and aged nervous system.

Further advances might include the development of novel markers of neural stem-cell function (e.g., proliferation, migration, and differentiation) as well as methods to assess the integration and function of stem cells in the aging and/or diseased nervous system. Chip-based tools modeling human AD/ADRD for applications in AD/ADRD drug screening and development.

Development of novel therapeutics for the treatment of AD/ADRD has proven to be a lengthy, costly, and relatively unproductive process, with drug attrition rates of over 90%. Several studies have indicated the lack of appropriate preclinical AD/ADRD models as one of the barriers for successful development of AD/ADRD therapeutics.

Although animal models of AD/ADRD have helped our understanding of AD/ADRD pathogenesis to some extent, key genes and proteins that are critical to the pathogenesis of this disease exhibit many inherent species-specific differences and, consequently, there is a critical need for translation platforms that can accurately and reproducibly mimic the AD/ADRD phenotype in vivo and be amenable to high-content screening and assay applications.

Recent advances in stem-cell technology allow for successful generation of human neural-progenitor cells from skin cells of normal and AD/ADRD patients. This technology could be exploited to develop cell-type-specific AD/ADRD disease models by replicating AD/ADRD pathobiology on microfluidic chips.

These chips could then provide a novel AD/ADRD model system that could be used in the translation process to: perform high-throughput screening for drug discovery and drug efficacy, develop in situ assays for measuring predictive biomarkers, and validate therapeutic target(s).

Approaches using artificial intelligence to assist with recruitment and monitoring of study participants for clinical trials of treatments or preventives for AD/ADRD. Clinical Research Operations Management System NIA supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research.

This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects.

It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of CROMS data templates as specified. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Phase I, Phase II, Fast-Track, Direct Renewal - Renewals of Phase II and Phase IIB only 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 FOA.

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 NIA intends to fund an estimated 40 awards, corresponding to a total of $20 million, for fiscal year 2023. Future year amounts will depend on annual appropriations.

According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $275,766 for Phase I awards and $1,838,436 for Phase II awards. However, the National Institutes of Health (NIH) has received a waiver from the Small Business Administration (SBA), as authorized by statute, to exceed these amount for specific topics. The current list of approved topics can be found here .

For projects that aim to address AD/ADRD, Phase I budgets of up to $500,000 and Phase II budgets of up to $2. 5M (for topics covered by the approved waiver from SBA) may be requested.

Phase IIB budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). According to statutory guidelines, award periods normally may not exceed 2 years for Phase I and 3 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 FOA. 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.

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. 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 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. 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. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; 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.

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.

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.

Such a relationship does not necessarily involve a salary or other form of remuneration The primary employment of the PD/PI must be with the SBC or the Research Institution (where they are PD/PI at) at the time of award and during the conduct of the proposed project. Each PD/PI must commit a minimum of 10% effort to the project.

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. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement .

3. Additional Information on Eligibility 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