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Grant Analysis

Purpose & Target

This grant, PA-23-317, aims to provide financial support for the expansion of existing NIH-funded single project research grants and cooperative agreements. Its core objective is to allow current NIH award recipients to increase the scope of their ongoing projects. It is specifically designed for existing research organizations (not individuals or pre-revenue startups) that already hold a single project research grant or cooperative agreement from the National Institutes of Health. The grant is SECTOR-SPECIFIC, focusing exclusively on health and biomedical research under the broad mission of the NIH. The geographic scope is global, as both U.S. and non-U.S. entities are eligible to apply. A key filtering criterion for initial screening is that applicants must already possess an active NIH single project award and their application must be a direct response to a specific competitive revision Notice of Special Interest (NOSI). This is a recurring funding opportunity, building upon the previous PA-20-163.

Financial Structure

This grant provides funding for the expansion of existing NIH research projects. While no specific total budget, minimum, or maximum grant amounts are listed in this general announcement, it states that "Specific budget limits may be specified in the competitive revision NOSI" that your application must respond to. Budgeting and Costs:

Eligible Costs: You should only include funds requested for the additional supplement activities. Your application budget must be reasonable and clearly reflect the actual needs of your proposed expansion project, not the existing parent award.
Large Requests: If your proposed project requests $500,000 or more in direct costs in any single year, you are required to contact a Scientific/Research Contact at least 6 weeks before submitting your application. This is a critical pre-submission step for large requests.
Indirect Costs: Your institution's current Facility and Administrative (F&A) rate will apply to the new funding, meaning the rate in effect when the new funding is provided.
Matching Funds/Cost Sharing: Cost sharing is generally NOT required for this funding opportunity, unless explicitly specified otherwise within the competitive revision NOSI you are applying under.

Payment and Reporting:

Payment Mechanisms: Funds will be provided through either a grant (money for an approved project) or a cooperative agreement (money with substantial Federal scientific or programmatic involvement).
Financial Reporting: You will be required to submit annual financial statements as part of your Research Performance Progress Report (RPPR). A final financial report is necessary for award closeout.

Eligibility Requirements

To be considered for this funding, your organization must meet several hard, non-negotiable criteria:

Existing Parent Award: Your organization must currently administer an active NIH single project research grant or cooperative agreement. This grant is not for new projects or organizations without prior NIH funding through this specific mechanism.
Parent Award Remaining Period: The existing parent award must have a minimum of two years remaining within its current approved project period at the time you submit your application for this revision.
Response to NOSI: Your application must be a direct response to a competitive revision Notice of Special Interest (NOSI) published by an NIH Institute or Center. Applications submitted without explicitly referencing a relevant NOSI will not be considered.
Principal Investigator (PD/PI) Status: The individual(s) designated as the Program Director(s)/Principal Investigator(s) on your revision application must already be the PD/PI(s) on the active parent award. You cannot use this revision to change or add new PD/PIs to the parent award.
Organizational Registrations: Before you even submit your application, your organization must complete and maintain active registrations with:
- System for Award Management (SAM): This includes obtaining a Unique Entity Identifier (UEI). Renewal of SAM registration is required annually and can take several weeks.
- eRA Commons: Your organization must be registered, and you must have at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov: You must have an active SAM registration to complete this registration.
Foreign Organizations: If you are a non-U.S. entity, you are eligible to apply. You will need to obtain a NATO Commercial and Government Entity (NCAGE) Code in lieu of a CAGE code to register in SAM.

Eligible Organization Types: This grant is open to a wide range of established entities, provided they meet the 'existing parent award' criterion. Eligible organization types include, but are not limited to:

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS Status, other than Institutions of Higher Education)
For-Profit Organizations (including Small Businesses and other For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments)
Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)
Other: 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.

Exclusion Criteria:

Projects that are entirely new and not an expansion of an existing, active NIH single project grant/cooperative agreement.
Applications that do not explicitly respond to a competitive revision NOSI.
Applications submitted by individuals, as they must be affiliated with an eligible organization.

Application Process

Applying for this grant requires careful adherence to specific procedures and deadlines, as detailed in the relevant competitive revision NOSI and the NIH's standard application guides. Application Deadlines and Timeline:

Application Due Dates: The specific due dates for applications are not listed in this general announcement but will be found within the competitive revision Notice of Special Interest (NOSI) you are responding to. Always refer to the NOSI for the precise deadline.
NOFO Expiration Date: This Funding Opportunity Announcement (NOFO) itself expires on November 24, 2026. Applications cannot be submitted after this date.
Earliest Submission Date: You could start submitting applications as early as November 24, 2023.
Project Duration: The competitive revision support can be requested for up to two years, but it must fall within the currently approved project period of your existing parent award. The parent award must also have at least two years remaining at the time you submit your revision application.

Application Procedure and Submission:

Electronic Submission: All applications must be submitted electronically. Paper applications will not be accepted.
Submission Platforms: You must use one of the following systems:
- NIH ASSIST (an online system to prepare, submit, and track your application)
- An institutional system-to-system (S2S) solution (check with your institution's officials)
- Grants.gov Workspace
NOSI Requirement: Your application must explicitly be in response to a competitive revision NOSI that refers to this PA-23-317 announcement.
Content Focus: When completing forms, remember to reflect only the proposed new activities for the supplement, not the funding or activities of the original parent award.

Required Documentation and Materials: Key documents and forms required for your application include: * SF424 (R&R) forms: This is the standard federal grant application package. * PHS 398 Research Plan: This section must include a summary or abstract of your currently funded parent award, along with detailed plans for the proposed expansion activities. * Data Management and Sharing (DMS) Plan: You must address this plan based on the policies applicable to your parent award. If the parent award is subject to the DMS Policy and the revision changes the approved approach, an updated plan is required. * IACUC and/or IRB Documentation: If your proposed activities involve animal or human subjects research, you must attach PDF documents indicating approval by your Institutional Animal Care and Use Committee (IACUC) or Institutional Review Board (IRB). * PHS Human Subjects and Clinical Trials Information form: Required if your project involves human subjects research or clinical trials. * SF424(R&R) Senior/Key Person Profile: List the PD/PI first, and include any other Senior/Key Personnel being added or for whom additional funds are requested. * R&R Budget and Subaward Budget: Only include funds and details for the additional supplement activities. Post-Award Reporting and Compliance: If awarded, you will have ongoing responsibilities: * Annual Reporting: You must submit an annual Research Performance Progress Report (RPPR) and financial statements. * Closeout: A final RPPR, invention statement, and expenditure data are required at the end of the award period. * Subaward Reporting: If you make subawards, you must report this information to the Federal Subaward Reporting System (FSRS). * ClinicalTrials.gov: If your award involves one or more clinical trials, you are legally required to register and submit results information on ClinicalTrials.gov. * IRB/IEC Approval: Your institution must ensure all protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC). * Data and Safety Monitoring: For clinical trials, NIH requires oversight and monitoring to ensure participant safety and data integrity. * IND/IDE Requirements: Clinical research involving investigational therapeutics or devices must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.

Evaluation Criteria

Applications for this grant will undergo a rigorous scientific and technical peer review process, with reviewers providing an 'Overall Impact' score based on several specific criteria: Scored Review Criteria: These five core areas will receive individual scores and contribute to the overall impact assessment:

Significance: How important is the proposed expansion? Does it address a critical problem or a significant barrier? How will it improve scientific knowledge, technical capabilities, or clinical practice?
Investigator(s): Are the PD/PI(s) and other key personnel well-suited to the project? Do they have appropriate experience, qualifications, and a demonstrated track record of accomplishment?
Innovation: Does the proposed expansion challenge existing paradigms or develop new methodologies or technologies? Are the concepts, approaches, or instrumentation novel?
Approach: Is the proposed research plan sound and well-reasoned? Are the strategies, methodologies, and analyses well-developed and appropriate for the objectives? Are potential problems identified and alternative strategies considered?
Environment: Is the institutional environment where the work will be done appropriate? Do the proposed studies benefit from unique features of the environment or access to resources? Is there sufficient institutional support?

Additional Review Criteria (Not Individually Scored, but Impact Overall Score): These aspects are evaluated but do not receive separate numerical scores:

Study Timeline (for clinical trials only): Is the timeline detailed, feasible, and justified? Does it incorporate efficiencies and address potential challenges like enrollment shortfalls?
Protections for Human Subjects: If human subjects are involved, are risks minimized and adequately protected against? Are potential benefits and the importance of knowledge to be gained clearly articulated? Is data and safety monitoring robust?
Inclusion of Women, Minorities, and Individuals Across the Lifespan: For human studies, are proposed plans for inclusion (or exclusion) scientifically justified based on sex, race, ethnicity, and age?
Vertebrate Animals: If live vertebrate animals are used, is their involvement justified, are procedures described, and are measures to limit discomfort and pain adequate?
Biohazards: Are potential hazards to research personnel or the environment identified, and are adequate protections proposed?
Revisions: Reviewers will specifically assess the appropriateness of the proposed expansion of the scope of the project. If the revision relates to a previously unapproved line of investigation from the original application, reviewers will check if responses to prior comments are adequate and if substantial changes are evident.

Additional Review Considerations (No Scores, but Provide Context):

Foreign Organizations: Do applications from non-U.S. entities present special opportunities for research through unique talent, resources, or populations not readily available in the U.S.?
Select Agent Research: Are the procedures for handling select agents appropriate and secure?
Resource Sharing Plans: Are plans for sharing resources (e.g., data, model organisms) reasonable, or is the rationale for not sharing justified?
Authentication of Key Biological and/or Chemical Resources: Are there brief plans to ensure the validity of key resources?
Budget and Period of Support: Is the requested budget and project duration fully justified and reasonable in relation to the proposed research activities?

While not explicitly tied to Sustainable Development Goals (SDGs), given the focus on health and biomedical research, successful projects often contribute significantly to SDG3: Good Health and Well-being.

Compliance & Special Requirements

This grant emphasizes compliance with federal regulations and ethical standards pertinent to health and biomedical research: Regulatory Compliance:

NIH Grants Policy Statement: All awards are subject to the comprehensive terms and conditions outlined in the NIH Grants Policy Statement.
Human Subjects Protections (45 CFR Part 46): Strict adherence to regulations concerning human subjects research is mandatory. This includes obtaining necessary IRB approvals and ensuring adequate protections against risks.
FDA Regulations: Clinical research projects involving investigational drugs, vaccines, or devices must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
ClinicalTrials.gov: If your project includes clinical trials, you are legally mandated to register and report results on ClinicalTrials.gov.

Data, Environmental, and Ethical Standards:

Data Management and Sharing (DMS) Policy: As of January 25, 2023, the NIH Policy for Data Management and Sharing is in effect. You are required to submit and adhere to a Data Management and Sharing Plan for applicable awards. This promotes broad access to research data.
Biohazards: Applications will be assessed for potential hazards to research personnel or the environment, and adequate protection measures must be proposed.
Ethical Review: Beyond regulatory compliance, ethical considerations are embedded in the review process, particularly concerning human subjects and animal welfare.

Special Considerations:

Focus on Expansion: A unique aspect of this grant is its exclusive focus on expanding existing NIH single project awards. This is not a mechanism for entirely new research initiatives, but rather for building upon established, ongoing projects.
Necessity of NOSI: A critical and unique requirement is that all applications must be submitted in response to a specific competitive revision Notice of Special Interest (NOSI). Without a direct link to a relevant NOSI, your application will not be considered.
Strategic Alignment: This opportunity is best suited for organizations looking to strategically grow successful research avenues already supported by NIH, demonstrating continued impact and scientific potential.
Cross-Cutting Themes: The grant strongly emphasizes inclusion in research, specifically the appropriate inclusion of women, minorities, and individuals across the lifespan in human studies. Data sharing is also a significant cross-cutting theme, reflecting current federal priorities for transparency and accessibility of research outcomes.
Risk Management: Reviewers will evaluate plans for managing risks associated with human subjects, vertebrate animals, and biohazards, ensuring robust safety and ethical oversight.

Grant Details