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Grant Analysis

Purpose & Target

The NIH Exploratory/Developmental Research Project Grant (R21) aims to support high-risk, high-reward exploratory and developmental research projects in biomedical, behavioral, and clinical fields. This funding is designed for the early and conceptual stages of projects that introduce novel scientific ideas, techniques, or technologies with the potential for significant breakthroughs or major impact. It specifically targets research that is exploratory and novel, rather than long-term projects or those in well-established areas. This grant is SECTOR-SPECIFIC, focusing on biomedical, behavioral, and clinical research. It is open to a very broad range of organization types, including academic institutions, non-profits, for-profit entities (small and large businesses), and various levels of government and community organizations, both domestic (US) and international. The geographic scope is worldwide, as non-U.S. entities are eligible to apply.

Financial Structure

Funding Amounts

Maximum Grant Amount: The combined budget for direct costs for the two-year project period cannot exceed $275,000.
Annual Limit: No more than $200,000 may be requested in any single year.

Cost Sharing/Matching Funds

This funding opportunity does not require cost sharing or matching funds from the applicant.

Eligible and Ineligible Costs

All costs must align with the terms and conditions outlined in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1, 'Selected Items of Cost'.

Financial Reporting

Recipients are required to submit a Research Performance Progress Report (RPPR) annually.
Financial statements are required as outlined in the NIH Grants Policy Statement Section 8.4.1, 'Reporting'.
For project closeout, a final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required.

Eligibility Requirements

Eligible Organizations This grant has very broad eligibility, welcoming a wide array of organization types. If your organization falls into any of the categories below, you are likely eligible:

Higher Education Institutions: This includes both public/state-controlled and private institutions of higher education (universities, colleges).
Nonprofits: Both 501(c)(3) IRS status and other non-profit organizations are eligible.
For-Profit Organizations: This covers both small businesses and larger for-profit entities.
Government Entities: Local governments (County, City, Township, Special District), State Governments, Indian/Native American Tribal Governments (Federally Recognized and others), and Eligible Agencies of the Federal Government.
Other Specific Types: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized), Faith-based or Community-based Organizations, and Regional Organizations.
International Entities: Non-domestic (non-U.S.) Entities (Foreign Organizations) are explicitly eligible to apply, as are non-U.S. components of U.S. Organizations. Foreign components (e.g., international collaborators) are also allowed.

Individual Eligibility Any individual with the necessary skills, knowledge, and resources to conduct the proposed research as a Program Director/Principal Investigator (PD/PI) is invited to apply through their organization. Applications can involve multiple PDs/PIs. Required Registrations All applicant organizations must complete and maintain the following registrations before submitting an application. This process can take 6 weeks or more, so plan accordingly:

System for Award Management (SAM): Requires active registration, renewed annually. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Unique Entity Identifier (UEI): Issued as part of the SAM.gov registration process and must be used consistently across all registrations and the application.
eRA Commons: Organizations must register here once their UEI is established. Requires identifying at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI).
Grants.gov: Requires an active SAM registration.

All PDs/PIs must also have an eRA Commons account, affiliated with their organization.

Application Process

Application Process & Submission Applications must be submitted electronically through one of the following platforms:

NIH ASSIST system: For preparing, submitting, and tracking your application online.
Institutional system-to-system (S2S) solution: Check with your institution's officials for availability.
Grants.gov Workspace: For preparing and submitting your application.

It is crucial to adhere strictly to the instructions in the Research (R) Instructions in the How to Apply - Application Guide, along with any program-specific instructions in this funding announcement. Applications that do not comply may be delayed or rejected. Key Deadlines Applications are due by 5:00 PM local time of the applicant organization on the specified dates. It's highly recommended to submit early to allow time for correcting any errors.

Latest Application Deadline: November 16, 2027 (for Renewal / Resubmission / Revision applications).
Earliest Submission Date (Open Date): January 16, 2025.
Expiration Date for this Funding Opportunity: January 08, 2028.

Required Documentation & Materials Applicants must complete standard federal forms and specific NIH forms:

SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
R&R or Modular Budget forms, R&R Subaward Budget (if applicable).
PHS 398 Cover Page Supplement, PHS 398 Research Plan (includes Resource Sharing Plan, and a Data Management and Sharing Plan).
PHS Human Subjects and Clinical Trials Information form (if human subjects are involved).
PHS Assignment Request Form.
Appendix: Only limited materials are allowed; no publications or other materials except blank questionnaires or surveys.

Project Implementation & Reporting

Project Period: The total project duration cannot exceed 2 years.
Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR and invention statement are required for closeout.

Application Assistance For system questions (ASSIST, eRA Commons, errors), contact the eRA Service Desk (online, phone: 301-402-7469 or 866-504-9552). For general grant information, contact NIHGrantsInfo (email: [email protected], phone: 301-480-7075). For Grants.gov support, contact Grants.gov Customer Support (phone: 800-518-4726).

Evaluation Criteria

Applications are evaluated based on their scientific and technical merit by NIH's peer review system, with an emphasis on innovation and potential for significant impact. The reviewers will provide an 'overall impact score' considering the likelihood of the project to powerfully influence the research field. Scored Review Criteria Reviewers will score applications based on these three main factors:

Importance of the Research (Significance and Innovation): How significant and novel is the proposed research? Is it likely to advance knowledge or understanding in a meaningful way? This R21 grant specifically emphasizes the conceptual framework, the level of innovation, and the potential to significantly advance knowledge. Preliminary data are not required but can be included if available.
Rigor and Feasibility (Approach): Is the proposed research approach sound, well-reasoned, and feasible? Does it appropriately consider variables, controls, and methods to ensure robust and unbiased results?
Expertise and Resources (Investigator(s) and Environment): Do the investigators have the necessary experience and qualifications? Does the research environment provide the resources and support needed for the successful execution of the project?

Additional Review Criteria (Considered, but Not Scored) Reviewers will also consider the following aspects when determining scientific and technical merit and the overall impact:

Protections for Human Subjects: If human subjects are involved, evaluation includes the justification for their involvement, protection against risks, potential benefits, importance of knowledge to be gained, and data/safety monitoring.
Vertebrate Animals: If live vertebrate animals are used, evaluation covers proposed procedures, justification for animal use, minimization of discomfort, and euthanasia methods.
Biohazards: Assessment of potential hazards to personnel/environment and proposed protections.
Resubmissions/Renewals/Revisions: Specific considerations for applications that are resubmitted, renewed, or revised.

Additional Review Considerations (Not Scored, Not Part of Overall Impact Score)

Authentication of Key Biological and/or Chemical Resources: Plans to ensure the validity of these resources.
Budget and Period of Support: Evaluation of whether the requested budget and project duration are justified and reasonable for the proposed research.

Compliance & Special Requirements

Regulatory Compliance

All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement and other applicable federal regulations (e.g., 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws, as agreed upon during SAM.gov registration, and must submit an Assurance of Compliance (HHS-690).
Health IT Requirements: If the award involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets specified standards (45 CFR part 170, Subpart B) and, for eligible clinicians/hospitals, health IT certified under the ONC Health IT Certification Program.

Data Protection & Cybersecurity

Data Management and Sharing Plan: All applications for research generating scientific data must include and comply with a Data Management and Sharing Plan, consistent with the 2023 NIH Policy.
Cybersecurity: If recipients or subrecipients have consistent access to HHS systems or handle Personally Identifiable Information (PII) or Protected Health Information (PHI) from HHS, they must develop plans and procedures modeled after the NIST Cybersecurity framework to protect these systems and data.

Ethical Standards

Human Subjects Research: If human subjects are involved, protocols must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). NIH must receive copies of documents related to major changes in ongoing protocols.
Vertebrate Animals: If vertebrate animals are used, compliance with animal welfare regulations and guidelines is required.

Other Special Considerations

Clinical Trials Not Allowed: This specific grant does not accept applications proposing clinical trial(s). Ensure your project does not involve a clinical trial.
Novelty and Risk: The grant encourages projects that are exploratory and novel, potentially involving considerable risk, but with the aim of leading to significant breakthroughs.
Strategic Alignment: Projects should introduce new ideas, model systems, tools, agents, targets, and technologies that could substantially advance biomedical, behavioral, and clinical research. Long-term projects or those in well-established areas are not suitable.
Mandatory Disclosure: Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Grant Details