Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- Clinical Trial Optional)

Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- Clinical Trial Optional) is sponsored by National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS). This opportunity provides funding for small business concerns to develop products, processes, or services aimed at improving minority health and/or reducing and ultimately eliminating health disparities in one or more NIH-defined population groups.

Expired RFA-MD-24-007: Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- 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 on Minority Health and Health Disparities ( NIMHD ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Neurological Disorders and Stroke ( NINDS ) Participation Added May 30, 2024 ( NOT-NS-24-077 ) National Institute of Nursing Research ( NINR ) National Center for Advancing Translational Sciences ( NCATS ) Funding Opportunity Title Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- Clinical Trial Optional) R41 / R42 Small Business Technology Transfer (STTR) Grant - Phase I, Phase II, and Fast-Track 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 Grants (SBIR) - Phase I/ Small Business Innovation Research Grants (SBIR) - Phase II See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number 93. 307, 93. 121, 93.

350, 93. 286, 93. 361, 93.

853 Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications that propose to develop a product, process or service for commercialization with the aim of improving minority health and/or reducing health disparities in one or more NIH-defined populations that experience health disparities.

Appropriate technologies should be effective, affordable, and culturally acceptable. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date 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. No late applications will be accepted for this Notice of Funding Opportunity (NOFO). 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 Despite continued improvement in the health of the U.S. population with the introduction of medical and scientific advances, there continues to be a disproportionate burden of illness among certain population groups.

The mission of the NIMHD is to lead scientific research aimed at the development of innovative diagnostics, treatments, and prevention strategies to improve minority health and reduce health disparities in NIH-designated populations that experience health disparities in the United States and its territories.

NIMHD focuses on all aspects of health and health care for the full continuum of health disparity causes as well as the interrelation of these causes.

The purpose of the Notice of Funding Opportunity (NOFO ) is to engage and support small businesses in providing seed (i.e., early-stage investment) funding for developing technologies, services, and products that engage, empower, and motivate individuals and communities, including clinicians and healthcare institutions that take care of populations experiencing health disparities.

In using this funding, recipients will hopefully lay the groundwork for sustainable health promoting activities and interventions that lead to improved health, healthcare delivery, and the elimination of health disparities.

Other considerations relevant to the technology and products and the organization should include: Effectiveness in improving the current quality of care or research access for populations that experience health disparities. Affordability for the population with existing community resources or an organization’s existing infrastructure. Acceptability such as health literacy, language, and cultural competency considerations.

Physical Location – Factors such as proximity to healthcare facilities and transportation. Knowledge - Health literacy and language barriers. Infrastructure - Healthcare resources in various settings, such as rural health clinics, federally qualified health centers, and critical access hospitals.

Economic Resources - Public and private insurance coverage or financial resources Culture - Beliefs and practices shared among social and organizational groups.

Specific Areas of Research Interest Technologies, services, and products that might achieve the objectives of this initiative include, but are not limited to: Facilitate or enhance disease self-management, patient-healthcare provider, or system communication, and/or care coordination between primary care clinicians, family care givers, hospital emergency department staff, specialty physicians, dental health professionals, nurse practitioners, clinicians of mental health and behavioral health services, and patient navigators in medically underserved communities and regions.

Culturally attuned behavioral or evidenced-based interventions that test products and/or strategies for individuals, families, social networks, and communities to engage in health-seeking behaviors and health-promoting activities (diet choice, exercise/physical activity, oral hygiene, medication adherence) and to avoid risky behaviors (smoking, vaping, alcohol/drug misuse, unsafe sex, sedentary lifestyle, unhealthy nutrition).

Detecting, measuring, and assessing a broad array of unhealthy social and environmental exposures (stress, pollutants, allergens, noise, crime), and for characterizing cumulative exposures across multiple individuals and communities and linking this information to physiological responses and health indicators at the individual and population levels.

These technologies may include efforts to improve and standardize data collection and the integration of social determinants of health (SDOH) and other data across data sources, including clinical patient data, electronic medical records, public health data, census data, housing data, employment data, and crime statistics.

Engage, empower, and motivate individuals, families , and communities to enhance the quality of life and to sustain health gains. Culturally appropriate survey instruments, tools, modules, and databases to promote community-based research engaging populations that experience health disparities.

Culturally appropriate, evidence-based health empowering promotion and disease prevention educational media , such as software, informational videos, and printed materials. Innovative software, tools and technology for science and health education curriculum materials, interactive teaching aids, serious and applied games, models for classroom instruction for K-12 and undergraduate students , and the public.

Mobile health (mHealth) and telehealth/telemedicine technologies and apps for improving communication among health care clinicians and between patients, families, and physicians and healthcare clinicians, medication adherence, diagnosis, monitoring, evaluation, medical management, screening, tracking, and treatment in underserved community settings and rural and remote locations.

Promote big data science or enhance data scientist training to address health disparities and/or minority health research, for example software or tools developed to link demographics (e.g., years of education, race/ethnicity, age, sex) and social determinants of health with large datasets such as electronic health record (EHR), genomic information, census data, national surveys, and other state or community-level data sources.

Such technology will be instrumental in understanding fundamental causes of health disparities and developing meaningful interventions. Linking family medical histories and family ancestries. Technologies for clinical trials and biobanking, such as the rapid identification in human specimens (e.g., blood, buccal swabs, etc.) of genes and/or genomic variants of known importance.

Transitioning technologies from the bench to the bedside. Promoting precision medicine and other precision-based strategies such as utilizing All of Us Research Program research tools. Utilizing NIH data systems, such as ScHARe ( S cience C ollaborative for H ealth Disparities and A rtificial intelligence bias RE duction ), the All of Us Research Hub or other data services, or other NIH Data repositories.

Utilizing cutting-edge digital health care and research technologies and approaches, such as digital therapeutics, decentralized and digital clinical trials, and remote devices for the engagement, recruitment, and retention of participants. The development of services and products that strengthen infrastructure and workforce for delivering care and clinical research that expands access.

Leveraging electronic health records and communication technologies to deliver and evaluate interventions seeking to reduce health disparities by increasing accessibility and health literacy, facilitating population tailoring and personalization, and decreasing costs. Understanding the causes of health disparities and associated variables such as SDOH for preventing one or more health disparities.

Using systems modeling, artificial intelligence, or other techniques to predict relationships between health disparities and health determinants and to assess health disparities interventions outcomes. Creating and testing tailored algorithms that identify interventions tailored, target, and optimized for community implementation and seeking to reduce disparities in one or more specific health conditions, disease, or health outcomes.

Leveraging robotic and autonomous systems for improving health, and preventing, reducing, and eliminating health disparities. Preventing and minimizing adverse exposures and health risks (post-traumatic stress) or promoting health, well-being, resilience, and recovery resulting from disasters or the threat of a disaster.

Examples may include new tools, apps, education, curricula, or other technologies to detect, screen, treat, or prevent or otherwise mitigate adverse health outcomes or leverage community and or population resilience and prevention efforts. Topics of Interest to NIBIB: The NIBIB is interested in the above topics for this NOFO as they pertain to NIBIB mission.

NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological functions or pathological mechanisms.

Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology.

Potential applicants are encouraged to send a draft specific aims page to the NIBIB Small Business Program ( [email protected] ) to determine if their research fits within the NIBIB mission and scientific program areas of interest. NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications."

Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

Topics of Interest to NIDCR: The NIDCR is interested in supporting the development of use-inspired technologies and products that promote dental, oral, and craniofacial (DOC) health for all and enhance effectiveness, acceptability, access, affordability, and sustainability of DOC health care and self-management in populations disproportionately affected by DOC diseases and conditions.

NIDCR’s areas of interest include, but are not limited to: Enhancing efficiency, quality, and patient-centeredness in team-based DOC health care. Creating and testing statistical models and algorithms to predict DOC health risks taking into account the influence of social determinants to advance personalized DOC health care delivery that improves clinical outcomes.

Creating community-level opportunities to address DOC health determinants and enable DOC health promoting lifestyles in underserved communities. Aiding long-term adherence to DOC health recommendations and self-management capacity. NIDCR does not use the SBIR/STTR mechanism to support clinical trials.

Topics of Interest to NCATS: The NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline to speed the delivery of new drugs, diagnostics and medical devices to patients.

Projects of most interest to NCATS include those that focus on drug discovery and development, biomedical, clinical and health research informatics and clinical, dissemination and implementation research. Applicants are strongly encouraged to contact program staff at [email protected] prior to submitting an application. For additional information on NCATS SBIR areas of interest, please refer to https://ncats.

nih. gov/smallbusiness/priorities . Please note that the NCATS SBIR program does not support applications that include clinical trials.

Topics of Interest to NINR: The NINR supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR discovers solutions to health challenges through the lenses of social determinants of health, population and community health, prevention and health promotion, and systems and models of care.

Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.

Applications Not Responsive to the NOFO : Applications that do not explicitly address minority health or health disparities will be considered not responsive and will not be reviewed. Potential applicants are encouraged to discuss the project with the appropriate IC Scientific Contact. 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 financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. 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.

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 The following NIH components intend to commit the following amounts in FY 2025, FY 2026, and FY 2027: NIMHD, up to $1,000,000 total costs, 3-4 awards. NIDCR, up to $250,000 total costs, 1 award.

NCATS, up to $1,000,000 total costs, 1-3 awards. NIBIB, up to $300,000 total costs, 1 award. Total funding support (direct costs, indirect costs, fee) normally may not exceed $306,872 for Phase I awards and $2,045,816 for Phase II awards.

NIH has received a waiver from SBA, as authorized by statute, to exceed these total award amount hard caps for specific topics. The current list of approved topics can be found at https://seed. nih.

gov/sites/default/files/HHS_Program_Descriptions. pdf . Applicants are strongly encouraged to contact program officials prior to submitting any application more than the hard caps listed above and early in the application planning process.

In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. 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: 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 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-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-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-fiscal year period, excluding the two most recently completed fiscal years.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2. 3. 9.

2 Electronically Submitted Applications for additional information. 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