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Grant Analysis

Purpose & Target

This grant, PAR-25-218, aims to support the development of novel research infrastructure that will advance the science of aging through interdisciplinary partnerships and collaborations. The core objective is to create sustainable infrastructure that benefits the larger research community, not just individual investigators. It is a SECTOR-SPECIFIC grant, focusing primarily on healthcare, biomedical, social, and behavioral research related to aging. Eligible applicants must be U.S.-based organizations, while foreign components can be involved in the project.

Financial Structure

This is a grant providing financial assistance. While there is no explicit total budget for the call, the annual direct costs for each individual award must remain under $500,000 for both the R61 and R33 phases. Key Financial Details:

Maximum Annual Direct Costs: $500,000 USD per year.
Cost Sharing/Matching Funds: Not required. You do not need to provide matching funds or cost sharing for this opportunity.
Eligible/Ineligible Costs: These are generally governed by the NIH Grants Policy Statement. Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Reporting: Annual Research Performance Progress Reports (RPPR) are required, along with a final RPPR and Federal Financial Report (FFR) at closeout.
Currency: All financial amounts are in U.S. Dollars (USD).

Eligibility Requirements

To be eligible for this grant, your organization must be based in the United States. Foreign organizations (non-U.S. entities) are not eligible to apply as the primary applicant, although foreign components can be part of the project. Eligible Organization Types:

Higher Education Institutions: This includes both public/state controlled and private universities and colleges.
Nonprofits: Organizations with or without 501(c)(3) IRS status.
For-Profit Organizations: This covers both small businesses and larger for-profit entities.
Local Governments: Including state, county, city or township, special district, and both federally recognized and other Indian/Native American Tribal Governments.
Federal Governments: Eligible agencies within the U.S. Federal Government and entities in U.S. Territories or Possessions.
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than federally recognized tribal governments), Faith-based or Community-based Organizations, and Regional Organizations.

Key Qualifications and Registrations:

Applicants must complete and maintain active registrations with the System for Award Management (SAM), obtain a Unique Entity Identifier (UEI) (issued through SAM.gov), and register with eRA Commons prior to submission. This registration process can take 6 weeks or more, so plan accordingly.
The grant utilizes a phased R61/R33 award structure. Therefore, applications must propose both an R61 phase (initial developmental activities) and an R33 phase (expanded activities) with clear milestones for each. Applications that only propose one phase will be considered non-responsive.
While specific organizational size or extensive prior track record is not strictly defined, successful applicants should demonstrate the necessary skills, knowledge, and resources to carry out the proposed research and infrastructure development.

Application Process

Application Submission Dates:

New Applications: July 02, 2025, and November 03, 2025.
Renewal/Resubmission/Revision: August 04, 2025, and December 02, 2025.
All applications are due by 5:00 PM local time of the applicant organization. You are encouraged to apply early to resolve any potential submission errors.

Submission Process: Applications must be submitted electronically through one of the following platforms: * NIH ASSIST system * An institutional system-to-system (S2S) solution * Grants.gov Workspace Required Documentation:

Standard NIH application forms (SF424(R&R) series, PHS 398).
Specific Aims: Must include aims for both the R61 and R33 phases with timelines.
Research Strategy: This section must describe both the R61 and R33 phases, explain how the infrastructure will advance aging research, and how it benefits the broader research community. A critical component is a specific section labeled 'Milestones' with SMART milestones for both phases.
Data Management and Sharing Plan: All applications, regardless of cost, must include this plan.
Resource Sharing Plan.
Limited Appendix Materials: Only blank questionnaires or surveys are allowed.

Project Duration and Reporting:

The entire R61/R33 award period cannot exceed 5 years.
- The R61 phase (initial developmental) can be up to 2 years.
- The R33 phase (expanded activities) can be up to 3 years.
Annual Progress Reports (RPPR) are required. A final RPPR and expenditure data are needed for closeout.

Pre-Application Guidance:

Applicants are strongly encouraged to contact the Scientific/Research Contact(s) listed in the NOFO before preparing an application to ensure alignment with NIH/NIA program priorities and budgetary limits.

Evaluation Criteria

Applications will be judged on their scientific and technical merit through a peer review system, ultimately leading to an 'Overall Impact' score. This score reflects the likelihood of your project having a sustained, powerful influence on the research field. Scored Review Criteria:

Importance of the Research (Significance and Innovation): How crucial and groundbreaking is the research your infrastructure will enable?
Rigor and Feasibility (Approach): How well-designed, robust, and achievable is your plan for developing the research infrastructure?
Expertise and Resources (Investigator(s) and Environment): Does your team have the right skills, knowledge, and access to necessary resources and environment to succeed?

Additional Review Considerations: Reviewers will also consider these points, though they won't receive a separate score: * Human Subjects Protection: Adequacy of plans for protecting human participants, especially for clinical trials (which are optional). * Vertebrate Animals and Biohazards: If applicable, plans for ethical treatment of animals and management of hazardous materials. * Milestones: The clarity, feasibility, and scientific justification of your proposed SMART (Specific, Measurable, Achievable, Relevant, Time-bound) milestones for both the R61 and R33 phases are crucial for a successful transition to the R33 phase. * Sustainability Plan: The application must clearly describe a plan for sustaining the developed infrastructure after the grant period ends. * Benefit to the Research Community: Your proposed infrastructure must be designed to benefit a larger research community, not solely your team's interests.

Compliance & Special Requirements

Regulatory and Ethical Compliance:

Adherence to the NIH Grants Policy Statement and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is mandatory.
Human Subjects Research: If your project involves human subjects, it must comply with all NIH policies. This includes obtaining Federal-Wide Assurance (FWA) and Institutional Review Board (IRB) approval. For multi-site studies, Single IRB (sIRB) requirements apply.
Clinical Trials: If your project includes NIH-defined clinical trials (which are optional), you must register and submit results to ClinicalTrials.gov.
Data and Safety Monitoring: Projects involving human interventions require an adequate Data and Safety Monitoring Plan (DSMP).
Investigational Interventions: Clinical research involving investigational therapeutics or devices must comply with Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
Data Protection and Cybersecurity: Projects that involve implementing or upgrading health IT, or handling Personally Identifiable Information (PII) or Personal Health Information (PHI) from HHS systems, must develop cybersecurity plans modeled after the NIST Cybersecurity Framework.

Unique Aspects and Strategic Opportunities:

Phased R61/R33 Award: This unique two-phase structure requires milestone-driven progress for transition from the initial developmental R61 phase to the expanded R33 phase. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART). Successful completion of these milestones is key to continuing to the R33 phase without a new application.
Focus on Infrastructure: This grant is specifically for developing novel research infrastructure, not solely for conducting research projects. However, the infrastructure is expected to produce new knowledge, tools, or tangible scientific results.
Sustainability Plan: A crucial requirement is a clear plan for sustaining the research infrastructure developed through the grant after the funding period ends.
Interdisciplinary Collaboration: The grant actively seeks to support infrastructure that fosters interdisciplinary partnerships to address complex aging research questions. Projects should clearly articulate how they will bridge disciplinary silos.
Cross-Cutting Themes: The grant encourages applications that incorporate a focus on health disparities and the purposeful accounting of sex as a biological variable (SABV), particularly within women's health research (supported by ORWH).

Grant Details