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Grant Analysis

Purpose & Target

The core objective of this grant is to invite eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. The aim is to develop innovative products, processes, or services for commercialization that will improve minority health and/or reduce and ultimately eliminate health disparities in one or more populations that experience health disparities within the United States and its territories. The grant is SECTOR-SPECIFIC, primarily targeting healthcare and health technology innovations. It seeks solutions that are effective, affordable, and culturally acceptable for racial/ethnic minority populations, disadvantaged socioeconomic groups, and underserved rural populations in the U.S. This is a recurring grant program, reissued annually, with multiple application cycles.

Financial Structure

Funding Amounts

Phase I Awards: Total funding support (direct costs, indirect costs, fee) normally may not exceed $306,872.
Phase II Awards: Total funding support (direct costs, indirect costs, fee) normally may not exceed $2,045,816.
Waiver Exceptions: For specific approved topics, NIH has received a waiver from SBA to exceed these caps. For example, the National Institute on Aging (NIA) will not fund applications above $500,000 total costs in Phase I and $2.5 Million in Phase II for applications fitting approved waiver topics. Applicants are strongly encouraged to contact program officials prior to submitting any application exceeding the standard hard caps.

Currency

All financial amounts are in United States Dollars (USD).

Matching Fund Requirements

None. This Notice of Funding Opportunity (NOFO) does not require cost sharing.

Eligible Costs

Costs generally include direct costs, indirect costs (F&A), and a fee. Pre-award costs are allowable as described in the NIH Grants Policy Statement.

Consortium/Subcontracting Costs (Portion of Research Effort)

Phase I: Normally, two-thirds (67%) of the research or analytical effort must be carried out by the small business concern. The total amount for all consultant and contractual arrangements to third parties is generally not more than one-third (33%) of the total amount requested (direct, F&A/indirect, and fee).
Phase II: Normally, one-half (50%) of the research or analytical effort must be carried out by the small business concern. The total amount for consultant and contractual arrangements to third parties is generally not more than one-half (50%) of the total Phase II amount requested (direct, F&A/indirect, and fee).
Deviations from these requirements may be considered on a case-by-case basis but require written approval from the Grants Management Officer (GMO) after consulting with the agency SBIR Program Manager/Coordinator.

Financial Reporting Requirements

Annual Research Performance Progress Report (RPPR).
Final RPPR (within 120 days of the end of the grant budget period).
Final Invention Statement and Certification (HHS 568) (within 120 days).
Annual Invention Utilization Reports.
Federal Financial Report (FFR) (within 120 days).
Federal Funding Accountability and Transparency Act (FFATA) requirements for reporting information about first-tier subawards and executive compensation for subawards over the threshold via the Federal Subaward Reporting System (FSRS).
Semiannual disclosures regarding civil, criminal, and administrative proceedings for recipients with cumulative Federal awards greater than $10,000,000.

Recovery of Funds

An SBC will be required to repay all amounts received if a material misstatement is made that poses a risk to national security, or if there is a change in ownership, entity structure, or other substantial change posing a security risk.

Eligibility Requirements

Eligible Organizations

Only United States small business concerns (SBCs) are eligible. An SBC must meet the following criteria at the time of award:
Organized for profit, with a place of business located in the United States, which primarily operates within the United States or makes a significant contribution to the U.S. economy through payment of taxes or use of American products, materials, or labor.
Must be in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative.
If a joint venture, there must be less than 50% participation by foreign business entities.
Ownership: Must be more than 50% directly owned and controlled by one or more individuals (who are U.S. citizens or permanent resident aliens), other business concerns (each >50% directly owned and controlled by U.S. citizens/permanent residents), an Indian tribe, Alaska Native Corporation (ANC), or Native Hawaiian Organization (NHO), or any combination of these.
OR, for SBIR-only applications, more than 50% owned by multiple venture capital operating companies, hedge funds, or private equity firms. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern unless it qualifies as a small business concern primarily owned/controlled by U.S. citizens/permanent residents.
Has, including its affiliates, not more than 500 employees.

Geographic Location

Must be located in the United States.
Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply.
Foreign components (e.g., subcontracted work) may be allowed if they contribute to improving minority health or eliminating health disparities in the U.S.

Individual (PD/PI) Requirements

The primary employment of the Program Director/Principal Investigator (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 PD/PIs, at least one must meet this requirement.

Performance Benchmarks (for companies with prior SBIR/STTR awards)

Phase I to Phase II Transition Rate Benchmark: Companies with more than 20 Phase I awards over the past 5 fiscal years (excluding the most recently completed year) must meet or exceed a minimum transition rate of 0.25 to be eligible to apply for a Phase I, Fast-Track, or Direct Phase II award. For companies with more than 50 Phase I awards, the benchmark is 0.5 to receive more than 20 total Phase I and Phase II awards.
Phase II to Commercialization Benchmark: Companies with more than 15 Phase II awards over the past 10 fiscal years (excluding the two most recently completed years) must show an average of at least $100,000 in revenues and/or investments per Phase II award OR at least 0.15 patents per Phase II award. Higher benchmarks apply for companies with more than 50 or 100 Phase II awards.

Exclusion Criteria

Applications with similar or highly overlapping research focus submitted by the same applicant organization and under review at the same time will not be accepted.
Companies that fail to meet the specified Phase I to Phase II Transition Rate or Phase II to Commercialization Rate benchmarks will be ineligible to apply for new awards for a period of one year.

Application Process

Application Procedure

All applications must be submitted electronically via Grants.gov.
Applicants can use the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace to prepare and submit their application.
Paper applications will not be accepted.

Submission Deadlines and Key Dates

Applications are due by 5:00 PM local time of the applicant organization on the specified dates.
Latest Application Due Date: December 09, 2026.
Other Application Due Dates: June 10, 2024; December 10, 2024; June 10, 2025; December 09, 2025; June 10, 2026.
Letter of Intent Due Date: 30 days prior to the application due date (encouraged, but not required).
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
No late applications will be accepted.

Application Tracking

Applicants must track the status of their application in the eRA Commons.
Errors found during submission must be corrected, and a changed/corrected application must be submitted by the due date and time.

Required Documentation and Materials

Applicants must strictly follow the SBIR/STTR (B) Instructions in the How to Apply – Application Guide and any program-specific instructions outlined in this NOFO.
Mandatory Forms: SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, R&R Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS 398 Research Plan (including Research Strategy), PHS Human Subjects and Clinical Trials Information, PHS Assignment Request Form.
Specific Requirements within Application:
Facilities and Other Resources: Describe the organization's and/or partners' history of success in working with racial and ethnic minority or other populations that experience health disparities.
SBIR Application Certification: Required for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms. This specific PDF document must be named 'SBIR Application VCOC Certification.pdf'.
Research Strategy: Must explain how activities improve minority health/reduce health disparities, address unmet needs, identify innovative elements, are informed by lived experiences, discuss partner roles, use relevant scientific theories (biomedical, social-behavioral, minority health/health disparities), and how the technology is effective, affordable, culturally acceptable, easily accessible, and unlikely to sustain/create health disparity.
Resource Sharing Plans: Compliance required as per the SF424 (R&R) SBIR/STTR Application Guide.
Data Management and Sharing Plan: Required for all applicants, regardless of direct costs requested. This plan can incorporate the SBIR/STTR data rights, which allow retention of data for up to 20 years after the award date.
Appendix: Phase I SBIR/STTR Appendix materials are not permitted. Only limited items are allowed for other small business applications.

Pre-application Requirements

All applicant organizations must complete and maintain active registrations with:
System for Award Management (SAM) (requires annual renewal).
Obtain a Unique Entity Identifier (UEI) (issued through SAM.gov registration).
SBA Company Registry.
eRA Commons (requires an organizational account with at least one Signing Official and one Program Director/Principal Investigator account).
Grants.gov (requires SAM registration first).
These registrations can take 6 weeks or more; applicants should begin early.
A Letter of Intent is encouraged (due 30 days prior to application).
Applicants proposing budgets exceeding the normal hard caps are strongly encouraged to contact program officials prior to submission.

Post-Award Requirements

Compliance with all terms and conditions of the NIH Grants Policy Statement.
ClinicalTrials.gov Registration and Reporting: Required for applicable clinical trials.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Required for all protocols involving human subjects.
Data and Safety Monitoring: Required for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).
Investigational New Drug (IND) or Investigational Device Exemption (IDE): Required for clinical research involving unapproved investigational therapeutics, vaccines, or medical interventions.
Required financial and progress reporting as outlined in the Financial Structure section (Annual RPPR, Final RPPR, FFR, etc.).
Ongoing monitoring and reporting of foreign relationships; updated Disclosure Forms are required with RPPRs or within 30 days of significant changes.

Evaluation Criteria

Overall Impact Reviewers will provide an overall impact score reflecting the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. Scored Review Criteria

Significance: Assesses how the proposed activities, including those at foreign sites, will improve racial/ethnic minority health and/or assist in reducing or eliminating health disparities in the United States. This includes whether the work addresses an important unmet need or solves an unaddressed problem in racial/ethnic minority health or health disparities.

Additional Review Criteria (Considered, but Not Scored)

Study Timeline.
Applications with Foreign Components.

Funding Decision Factors After scientific peer review, funding decisions will consider: - Scientific and technical merit of the proposed project. - Availability of funds. - Relevance of the proposed project to program priorities (i.e., improving minority health and eliminating health disparities). - Security risk as assessed by the HHS Due Diligence Program, particularly regarding ties to foreign countries of concern. Innovation Requirements Applicants must explicitly identify the innovative elements of the proposed research and product development, and discuss how these elements may lead to improving minority health or reducing/eliminating one or more health disparities. Social Impact Expectations

The proposed technology, service, or product must be designed to be effective, affordable, culturally acceptable, and easily accessible to racial/ethnic minorities and other populations experiencing health disparities.
It should be designed to be unlikely to contribute to sustaining or creating a health disparity.
Applicants are encouraged to leverage the NIMHD Research Framework to inform product conceptualization and design, which identifies factors within socioecological domains that influence health outcomes.

Competitive Advantage Factors Applicants should discuss: - How the proposed approach and product are informed by the lived experiences and needs of racial/ethnic minorities or health disparity populations. - The involvement and role of potential partners in furthering the goals toward improving minority health and reducing health disparities. - How the work will use concepts or theories from biomedical, social-behavioral, minority health, or health disparities sciences to guide research and product development efforts. - The organization's and/or partners' demonstrated history of success in working with racial and ethnic minorities or other populations that experience health disparities.

Compliance & Special Requirements

Regulatory Compliance

Adherence to the NIH Grants Policy Statement and relevant federal regulations (e.g., 2 CFR Part 200).
Compliance with 13 C.F.R. Part 121, which outlines regulations for Small Business Concerns (SBCs).
All awards are subject to the SBIR Policy Directive.
For projects involving human subjects, strict adherence to ethical standards, including obtaining Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval, is mandatory.
Clinical research projects involving investigational products must comply with Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
Compliance with nondiscrimination laws; recipients must submit an Assurance of Compliance (HHS-690).
Subject to Federal Awardee Performance and Integrity Information System (FAPIIS) requirements, where information about an applicant's integrity and performance record may be reviewed.
Compliance with Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment.

Data Protection and Privacy

All applicants are required to comply with the NIH Policy for Data Management and Sharing, which necessitates a Data Management and Sharing Plan.
SBIR/STTR recipients may retain rights to data generated during the performance of an award for up to 20 years after the award date.

Foreign Relationships and Security Risk

Applicants must disclose all funded and unfunded relationships with foreign countries for all owners and 'covered individuals' (senior key personnel) upon request, using the 'Required Disclosures of Foreign Affiliations or Relationships to Foreign Countries' form (part of the Just-In-Time process).
Prior to award, NIH will determine if the SBC:
Has an owner or covered individual party to a malign foreign talent recruitment program.
Has a business entity, parent company, or subsidiary in the People's Republic of China or another 'foreign country of concern'.
Has an owner or covered individual with a foreign affiliation with a research institution in the People's Republic of China or another 'foreign country of concern'.
An award may be denied if such foreign involvement meets specific risk criteria, including interfering with activities, creating duplication, presenting conflicts of interest, being undisclosed, violating federal law/terms, or posing a risk to national security.
Recipients must continuously monitor and update their foreign relationship disclosures throughout the award period. Failure to do so, material misstatements, or changes posing a security risk can lead to award termination or repayment of funds.

Special Considerations

Clinical Trial Optional: This grant accepts applications that either propose or do not propose clinical trials. However, specific NIH Institutes/Centers (ICs) participating in this NOFO have particular policies:
NIDCR and NCATS: Do not support clinical trials through the SBIR/STTR mechanism.
NIBIB: Only supports mission-focused, early-stage clinical trial applications (e.g., feasibility, Phase I, first-in-human, safety trials) that inform early-stage technology development. It does not support pivotal, Phase II, III, IV, or efficacy/effectiveness trials.
Focus on Underserved Populations: Emphasis on developing technologies, services, and products that are effective, affordable, and culturally acceptable for populations experiencing health disparities, including considerations for health literacy, language, and cultural competency.
No Cost Sharing: Explicitly stated that cost sharing is not required for this NOFO.

Grant Details