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Grant Analysis

Purpose & Target

This grant seeks to fund research that identifies how HIV-induced changes to the body's immune-metabolism affect immune responses and increase the risk of developing tuberculosis (TB) or hepatitis B virus (HBV) infections. - Target recipients are public and private nonprofit institutions, individuals, for-profit organizations, and various governmental entities. - SECTOR-SPECIFIC: Focused on biomedical research, infectious diseases, and immunometabolism. - Geographic scope: Worldwide, as non-U.S. entities are explicitly eligible. - Key filtering criteria: Research must specifically investigate HIV-induced immunometabolic alterations related to TB or HBV risk; clinical trials are strictly prohibited. - Grant frequency: This is a recurring grant opportunity with multiple application deadlines through January 2028, operating as an R01 Research Project Grant within the National Institutes of Health (NIH).

Financial Structure

Funding is provided as a grant, a financial assistance mechanism.
Budget range: Application budgets are not limited but must accurately reflect the project's needs.
Matching fund requirements: This grant does not require cost sharing.
Project Period: The maximum project duration is five years.
Financial reporting: Recipients must submit a Research Performance Progress Report (RPPR) annually and financial statements as required by NIH. A final RPPR, invention statement, and expenditure data are required for closeout.
Pre-award costs: Allowable only as per NIH Grants Policy Statement Section 7.9.1.
No specific minimum or maximum award amounts are stated.

Eligibility Requirements

Organization Type

Eligible organizations include:
- Public and Private Institutions of Higher Education
- Nonprofits (with or without 501(c)(3) IRS Status)
- For-Profit Organizations (including Small Businesses and others)
- Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other)
- Federal Governments (Eligible Agencies of the Federal Government, U.S. Territory or Possession)
- Other types: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations, and Non-domestic (non-U.S.) Entities (Foreign Organizations).

Geographic Location

Applicants can be from any country; Non-domestic (non-U.S.) Entities are explicitly eligible.

Technical Expertise and Infrastructure

Program Directors/Principal Investigators (PDs/PIs) must demonstrate:
- Relevant background, training, and expertise.
- Prior leadership and management experience overseeing multidisciplinary teams.
Institutional resources must be adequate for the proposed research.
If existing clinical data or samples are used, documentation confirming their availability is required.

Registration Requirements

All applicant organizations must be registered and maintain active status in:
- System for Award Management (SAM) (requires annual renewal).
- NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations).
- Unique Entity Identifier (UEI) (obtained through SAM.gov).
- eRA Commons (with at least one Signing Official and one Program Director/Principal Investigator account).
- Grants.gov (requires active SAM registration).
All PDs/PIs must have an eRA Commons account affiliated with their organization.

Exclusion Criteria

Applications will be considered non-responsive and not reviewed if they propose:
- Elucidating immunometabolic changes driven by causes other than HIV infection.
- Exploring immunometabolic effects of HIV infection without co-infection (TB or HBV).
- Conducting clinical trials.
Duplicate or highly overlapping applications under review concurrently are not accepted.

Application Process

Application Deadlines and Submission

Applications are due by 5:00 PM local time of the applicant organization on the following dates:
- May 07, 2025
- September 07, 2025
- January 07, 2026
- May 07, 2026
- September 07, 2026
- January 07, 2027
- May 07, 2027
- September 07, 2027
- January 07, 2028 (latest deadline)
Open Date (Earliest Submission Date) is April 07, 2025.
The funding opportunity expires on January 08, 2028.
Applications must be submitted electronically via NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace. Paper applications are not accepted.
Applicants should apply early to allow time for error correction before the due date. If the due date falls on a weekend or federal holiday, the deadline is extended to the next business day.

Required Documentation and Materials

Applicants must follow instructions in the Research (R) Instructions in the How to Apply - Application Guide and specific NOFO instructions. This includes:
- SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
- R&R or Modular Budget forms, including R&R Subaward Budget if applicable.
- PHS 398 forms (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form).
- Research Plan must include: Specific Aims (broad objectives, hypotheses), Research Strategy (how project advances understanding of HIV-induced immunometabolic alterations in TB/HBV, multidisciplinary team plan, model system justification, novel machine learning/AI plan, leverage of existing human samples/clinical data).
- Letters of Support from collaborators and confirming availability of clinical samples (if used).
- Resource Sharing Plan and Data Management and Sharing Plan (required for all research generating scientific data).
Appendix materials are strictly limited (e.g., no publications, only blank questionnaires/surveys).

Review Process

Applications are evaluated for completeness and compliance by the Center for Scientific Review, and for responsiveness by NIAID. Incomplete, non-compliant, or non-responsive applications will not be reviewed.
Scientific and technical merit is assessed by Scientific Review Group(s) through NIH peer review.
High-merit applications (generally top half) may undergo a selection process for discussion and overall impact scoring.
Funding decisions consider scientific merit, fund availability, and relevance to program priorities.
"Just-in-time" information may be requested if an application is under consideration for funding.

Post-Award Requirements and Compliance

Annual submission of Research Performance Progress Report (RPPR) and financial statements.
Final RPPR, invention statement, and expenditure data are required for closeout.
NIH will review performance based on details and outcomes shared in the RPPR.

Evaluation Criteria

Overall Impact

Reviewers will assess the likelihood of the project having a sustained and powerful influence on the research field.

Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluates the broader significance and novelty of the proposed scientific inquiry.
Rigor and Feasibility (Approach): Assesses the scientific soundness, methodological rigor, and practicality of the research plan.
Expertise and Resources (Investigator(s) and Environment):
- Investigator(s): Evaluates the qualifications, experience, and leadership capacity of the PD(s)/PI(s), especially their experience leading multidisciplinary teams. For multiple PI applications, the quality of the leadership plan is assessed.
- Environment: Assesses if the institutional setting and available resources are appropriate and sufficient for successful project execution, including documented access to clinical samples if proposed.

Additional Review Criteria (Considered but Not Scored)

Protections for Human Subjects: If applicable, the justification for human involvement, protection measures, potential benefits, importance of knowledge, and data/safety monitoring.
Vertebrate Animals: If applicable, justification for animal use, appropriateness of species, interventions to minimize discomfort, and justification for euthanasia methods.
Biohazards: If applicable, assessment of risks from materials/procedures and proposed protections.
Resubmissions/Renewals/Revisions: Relevant progress, appropriateness of expansion, or adjustments based on prior reviews.

Additional Review Considerations (Considered but Not Scored)

Authentication of Key Biological and/or Chemical Resources: Plans for validating resources.
Budget and Period of Support: Justification and reasonableness of the proposed budget and project timeline.

Compliance & Special Requirements

Regulatory Compliance

All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Recipients must comply with all applicable nondiscrimination laws (as agreed upon during SAM.gov registration and via HHS-690 Assurance of Compliance).
Federal statutes and regulations relevant to federal financial assistance, including public policy requirements, must be adhered to.
NIH may terminate awards under certain circumstances (per 2 CFR Part 200.340 and NIH GPS Section 8.5.2).

Data Protection and Privacy

Compliance with the 2023 NIH Policy for Data Management and Sharing is required for research generating scientific data. An approved Data Management and Sharing Plan must be implemented.
For projects involving access to HHS systems or handling Personally Identifiable Information (PII) or Protected Health Information (PHI), recipients must develop plans modeled after the NIST Cybersecurity framework.

Ethical Standards

Research protocols involving human subjects must obtain Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.

Intellectual Property

An invention statement is required for the closeout of an award.

Technical Specifications (Health IT)

If the award funds activities involving health IT implementation, acquisition, or upgrading:
- Health IT must meet standards and specifications in 45 CFR part 170, Subpart B.
- If for eligible clinicians in ambulatory settings or hospitals, health IT must be certified under the ONC Health IT Certification Program.

Unique Aspects and Opportunities

This NOFO specifically encourages applicants to:
- Form inter-disciplinary teams leveraging diverse expertise.
- Apply novel machine learning or artificial intelligence (AI) approaches.
- Utilize existing clinical samples in conjunction with translational approaches.
Risk tolerance/mitigation: NIH conducts a review of the applicant's federal award history in SAM.gov to assess sound business practices and integrity, considering any comments made by the applicant.
Mandatory disclosure: Recipients must report violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Grant Details