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Grant Analysis

Purpose & Target

This grant, RFA-MD-24-007 (STTR), aims to provide seed funding to small businesses for developing technologies, products, or services. The core objective is to improve minority health and reduce health disparities in NIH-defined populations. - Target recipient type: United States small business concerns (SBCs). - Target recipient size: Small businesses with not more than 500 employees. - SECTOR-SPECIFIC: Healthcare, Biomedical, Medical Technology, Public Health, Dental/Oral Health, Nursing. - Geographic scope: United States. Proposed activities at foreign sites may be allowed if they contribute to improving minority health and/or reducing health disparities in the United States. - Key filtering criteria: Focus on health disparities, technology development, small business status, mandatory partnership with a non-profit research institution. - Grant frequency: Recurring, with multiple application deadlines through December 2026.

Financial Structure

Funding Instrument: Grant (financial assistance).
Minimum Funding: Not explicitly stated as a general minimum, but the Phase I award cap is $306,872.
Maximum Funding (per award):
Phase I: Normally up to $306,872 total costs (direct, indirect, fee).
Phase II: Normally up to $2,045,816 total costs (direct, indirect, fee).
Note: NIH may exceed these caps for specific approved topics; contact program officials if proposing a budget higher than the normal caps.
Currency: USD (implied, as a US federal grant).
Cost Sharing: Not required as defined by NIH Grants Policy Statement.
Eligible Costs: Covers direct costs, indirect costs (F&A), and fee. Applicants should propose a budget that is reasonable and appropriate for the research project.
Co-financing/Matching Funds: Not explicitly stated as required, but the STTR structure mandates specific percentages of research effort by the small business and the partnering research institution, which implies a cost distribution.
Pre-award Costs: Allowable only as described in the NIH Grants Policy Statement.
Financial Reporting Requirements: Recipients must submit Federal Financial Report (FFR) and Annual Invention Utilization Reports.

Eligibility Requirements

Organizational Eligibility

Organized for profit.
Place of business located in the United States, operating primarily within the U.S. or significantly contributing to the U.S. economy.
Legal forms include: individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative.
For joint ventures, less than 50% participation by foreign business entities.
Ownership: More than 50% directly owned and controlled by one or more U.S. citizens or permanent resident aliens, other eligible business concerns, Indian tribes, Alaska Native Corporations (ANCs), or Native Hawaiian Organizations (NHOs).
Crucially, small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, or private equity firms are NOT eligible for this STTR program.
Employee Count: Has, including its affiliates, not more than 500 employees.
Must meet performance benchmark requirements for Phase I to Phase II transition and Phase II to Commercialization, if applicable based on prior awards.

Geographic Requirements

Applicant organization must be located in the United States.
Foreign components (parts of the project performed outside the U.S.) may be allowed, but must be thoroughly justified as rare, unique, and necessary, and contribute to improving U.S. minority health/health disparities.

Consortium/Partnership Requirements

Mandatory consortium for STTR grants: At least 40% of research/analytical effort must be performed by the small business concern (SBC) and at least 30% by a single, 'partnering' non-profit research institution.

Registration and Certification Requirements

Must complete and maintain active registrations in:
System for Award Management (SAM) - requires annual renewal.
Unique Entity Identifier (UEI) - issued via SAM.gov.
SBA Company Registry.
eRA Commons (for organization and PD/PIs).
Grants.gov.

Individual Eligibility (Program Director/Principal Investigator - PD/PI)

PD/PI(s) must have an eRA Commons account.
PD/PI(s) may be employed by the SBC or the partnering non-profit research institution, but must have a formal appointment or commitment to the applicant SBC.
Each PD/PI must commit a minimum of 10% effort to the project.

Application Process

Application Deadlines

Latest Application Due Date: December 09, 2026 by 5:00 PM local time of the applicant organization.
Other deadlines exist for June 10, 2024; December 10, 2024; June 10, 2025; December 09, 2025; June 10, 2026. The latest listed is Dec 09, 2026.
Letter of Intent Due Date(s): 30 days prior to the application due date (not required, but encouraged).

Application Submission

Applications must be submitted electronically via:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
No late applications will be accepted.
Applicants are encouraged to submit early to allow time for corrections.
Applications are evaluated for completeness and compliance by Center for Scientific Review and responsiveness by participating organizations. Incomplete, non-compliant, or non-responsive applications will not be reviewed.

Required Documentation and Materials

Follow instructions in the SBIR/STTR (B) How to Apply – Application Guide.
Specific additions/deviations for this NOFO include:
Facilities and Other Resources: Describe the organization's/partners' history of success working with health disparity populations.
Research Strategy: Explain how proposed research/product activities will improve minority health or reduce disparities in the U.S. Discuss innovation, how the approach is informed by lived experiences, role of partners, use of scientific concepts/theories, and how the technology is effective, affordable, culturally acceptable, and accessible.
Data Management and Sharing Plan: Required for all applicants, regardless of direct costs requested. Plan should adhere to 2023 NIH Policy and can reference STTR data rights (retention for up to 20 years).
Resource Sharing Plans: Required.
PHS Human Subjects and Clinical Trials Information: Required if human subjects or clinical trials are involved.
Appendix: Phase I SBIR/STTR Appendix materials are not permitted. Limited items only allowed for other small business applications.

Review and Selection Process

Applications are evaluated for scientific and technical merit by peer review (Scientific Review Groups).
Critiques are provided for all applications.
Only top applications (generally top half) will be discussed and assigned an overall impact score.
Appeals of initial peer review are not accepted.
Funding decisions consider:
Scientific and technical merit.
Availability of funds.
Relevance to program priorities.
Security risk as assessed by HHS Due Diligence Program.

Post-Award Requirements

Reporting: Annual Research Performance Progress Reports (RPPR), Final RPPR, Final Invention Statement and Certification (HHS 568), Annual Invention Utilization Reports, Federal Financial Report (FFR), and SBIR.gov updates.
ClinicalTrials.gov: If applicable, registration and results reporting for NIH-defined clinical trials.
IRB/IEC Approval: Required for all human subjects research.
Data and Safety Monitoring: Required for human biomedical and behavioral intervention studies.
IND/IDE Requirements: Required for clinical research involving investigational therapeutics/devices.
Disclosure of Foreign Relationships: Required upon request (Just-in-Time process) and for ongoing monitoring post-award. Updated disclosure forms required within 30 days of changes to ownership, entity structure, covered individual, or other substantial changes in circumstances that pose national security risk. Regular updates required with RPPRs.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project exerting a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria (Key Factors for Scientific Merit)

Significance: How well the proposed research addresses a critical need in improving minority health or reducing/eliminating health disparities. Considers the importance of the problem, the potential for significant impact, and relevance to the NIMHD Research Framework.
Innovation: The innovative elements of the proposed technology, product, or service and how they may improve minority health or reduce/eliminate health disparities. This includes new concepts, approaches, tools, or applications.
Approach: The soundness of the research design, methods, and analyses. Includes the feasibility of the proposed work, management plan, and risk mitigation strategies. This criterion also considers:
- How the 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 achieving grant goals.
- The use of biomedical, social, behavioral, minority health, or health disparities sciences concepts/theories.
- How the technology is designed to be effective, affordable, culturally acceptable, and easily accessible.
- How the product is designed to not contribute to sustaining or creating a health disparity.
Investigator(s): Qualifications, experience, and ability of the PD/PI(s) and other key personnel to carry out the proposed project. Considers the team's expertise in minority health or health disparities research.
Environment: The support and resources available to the project, including institutional support and collaborative arrangements. Emphasizes the applicant organization's (and partners') history of success in working with racial/ethnic minority or other health disparity populations.

Additional Review Criteria (Considered but Not Separately Scored)

Human Subjects: Adequacy of protections for human subjects, including recruitment plans, data collection, and consent processes.
Vertebrate Animals: If applicable, the justification for animal use and adherence to ethical guidelines.
Biohazards: Identification and mitigation of potential biohazards.
Study Timeline: The appropriateness and realism of the proposed project timeline.

Additional Review Considerations (Not Scored, but Impact Overall Assessment)

Applications with Foreign Components: Justification for work performed outside the U.S. and its contribution to improving U.S. minority health/eliminating health disparities.
Select Agent Research: Plans for safe handling, monitoring, and security of select agents.
Resource Sharing Plans: Reasonableness of plans for sharing research resources or justification for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for ensuring the validity of these resources.
Budget and Period of Support: Justification and reasonableness of the proposed budget and project duration relative to the research.

Compliance & Special Requirements

Regulatory Compliance

All awards subject to NIH Grants Policy Statement terms and conditions, cost principles, and other considerations.
Compliance with federal regulations 45 CFR Part 75 and 2 CFR Part 200.
Adherence to nondiscrimination laws and submission of Assurance of Compliance (HHS-690).

Data and Intellectual Property

Data Management and Sharing Plan: Mandatory for all applicants. SBIR/STTR recipients may retain rights to data for up to 20 years after award date.
Intellectual Property: SBIR/STTR Policy Directive governs intellectual property rights.

Risk Management and Security

Foreign Disclosure Requirements: Applicants must disclose all funded and unfunded relationships with foreign countries. This includes relationships of owners and 'covered individuals' (senior key personnel).
Foreign Involvement with Countries of Concern: NIH, CDC, and FDA will assess security risks from relationships with foreign countries of concern. A finding of such involvement may lead to denial of award or termination if it:
Interferes with supported activities.
Creates duplication.
Presents conflicts of interest.
Was not appropriately disclosed.
Violates Federal law or terms/conditions.
Poses a risk to national security.
Reporting Fraud, Waste, and Abuse: Mechanisms for reporting mismanagement in HHS programs.

Ethical Standards

Protocols must be reviewed by Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for human subjects research.
Data and safety monitoring for clinical trials.

Unique Aspects & Strategic Opportunities

Clinical Trial Optional: Applications can propose or not propose clinical trials. However, specific participating NIH Institutes (NIBIB, NIDCR, NCATS) have strict limitations on the types of clinical trials they will support through this mechanism (e.g., NIBIB only early-stage; NIDCR, NCATS do not support clinical trials via STTR).
Focus on Disparities: Projects must explicitly address minority health or health disparities. Applications not addressing this will not be reviewed.
Cultural Competency: Technologies, products, and services should be culturally acceptable and accessible, considering health literacy and language barriers.
Multi-IC Participation: Opportunity to align with priorities of multiple NIH institutes (NIMHD, NIBIB, NIDCR, NINDS, NINR, NCATS), each with specific research interests within the overarching theme.

Grant Details