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Grant Analysis

Purpose & Target

This grant aims to advance research at the intersection of HIV and aging. Its core objective is to improve understanding of the biological, clinical, and socio-behavioral aspects of aging through the lens of HIV infection and its treatment. Additionally, it seeks to enhance approaches for testing, preventing, and treating HIV infection, and managing related comorbidities in diverse populations and settings by applying current aging science approaches.

Explicit identification of target recipient type and size: Organizations capable of conducting biomedical, social, and behavioral research.
MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Healthcare, Medical Research)
Geographic scope and any location requirements: United States and Non-U.S. (Foreign Organizations) are eligible.
Key filtering criteria for initial grant screening: Proposed research must be consistent with the HIV/AIDS Research Priorities outlined by NIH's Office of AIDS Research (OAR), specifically NOT-OD-20-018. Applications not aligned will not be reviewed.
Grant frequency and program context: Reissue of PAR-24-091, indicating a recurring opportunity. This program addresses the significant and growing population of older adults living with HIV and the complex interplay between HIV infection, its treatment, and the aging process.

Financial Structure

Funding Instrument: Grant (financial assistance).
Budget Range and Limitations: Application budgets are not limited but must reflect the actual needs of the proposed project.
Matching Fund Requirements: No cost sharing is required.
Project Period: The maximum project period is 5 years.
Pre-award Costs: Allowable as described in the NIH Grants Policy Statement Section 7.9.1.
Large Direct Cost Requests: Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/Research Contact at least six weeks before submitting the application.

Eligibility Requirements

Organizational Eligibility

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

Geographic Location Requirements

Organizations from the United States and foreign (non-U.S.) entities are eligible to apply.

Registration Requirements

Applicant organizations must complete and maintain active registrations prior to submission:
System for Award Management (SAM) - requires annual renewal.
NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations).
Unique Entity Identifier (UEI) - issued as part of SAM.gov registration.
eRA Commons - organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov - requires active SAM registration.
PD(s)/PI(s) must have an eRA Commons account and affiliate it with the applicant organization.

Number of Applications

Applicant organizations may submit more than one application, provided each is scientifically distinct.
NIH will not accept duplicate or highly overlapping applications under review simultaneously.

Cost Sharing

Cost sharing is not required.

Application Process

Application Types

New applications
Renewal applications
Resubmission applications
Revision applications

Application Procedure and Submission

Applications must be submitted electronically through one of the following methods:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
Applicants must follow the instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', supplemented by specific instructions in this NOFO.
Non-compliance with instructions may result in application delay or rejection.
All page limitations specified in the Application Guide and Table of Page Limits must be followed.

Required Documentation and Materials

Standard Federal forms (SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
Budget forms (R&R or Modular Budget, R&R Subaward Budget).
Public Health Service (PHS) forms (PHS 398 Cover Page Supplement, PHS 398 Research Plan).
Specific plans required within the Research Plan:
Resource Sharing Plan.
Data Management and Sharing Plan (required for all research generating scientific data).
PHS Human Subjects and Clinical Trials Information form (if human subjects research or clinical trials are involved).
PHS Assignment Request Form.
Limited Appendix materials allowed; no publications or other material except blank questionnaires/surveys.

Application Deadlines and Review Cycles

All applications are due by 5:00 PM local time of the applicant organization.
If a due date falls on a weekend or Federal holiday, the deadline is extended to the next business day.
Latest Application Due Date: January 07, 2027
Associated Review and Award Cycles:
For January 07, 2027 due date:
- Scientific Merit Review: March 2027
- Advisory Council Review: May 2027
- Earliest Start Date: July 2027

Submission and Tracking

Applicants are encouraged to apply early to correct any submission errors.
Must track application status in the eRA Commons.
Changed/corrected applications must be submitted by the due date.

Post-Submission Requirements

Follow NIH policy for post-submission materials.
If system issues prevent on-time submission, follow 'Dealing with System Issues' guidance.

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score reflecting the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluates the importance of the proposed research, its potential to advance the field, and its innovative aspects.
Rigor and Feasibility (Approach): Assesses the soundness of the proposed research design, methods, and analyses, and the feasibility of achieving the stated objectives.
Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications of the investigator(s) and the adequacy of the institutional environment and resources to conduct the proposed research.

Additional Review Criteria (Not Scored, but considered for Overall Impact)

Protections for Human Subjects: Evaluates the adequacy of protection for human subjects involved in the research.
Vertebrate Animals: Assesses the humane care and use of vertebrate animals, if applicable.
Biohazards: Examines the management and protection from potential biohazards.
Resubmissions, Renewals, Revisions: Evaluates specific aspects pertinent to the application type (e.g., progress made for renewals, appropriateness of scope expansion for revisions).

Additional Review Considerations (Not Scored, but considered for Overall Impact)

Authentication of Key Biological and/or Chemical Resources: Evaluates plans for ensuring the validity of resources.
Budget and Period of Support: Determines if the budget and requested project period are justified and reasonable.

Selection Process

Applications undergo scientific peer review by Scientific Review Groups (SRGs) convened by the Center for Scientific Review.
A written critique is provided for all applications.
Only applications with the highest scientific and technical merit (generally top half) may be discussed and assigned an overall impact score.
Funding decisions are based on:
Scientific and technical merit as determined by peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

Compliance & Special Requirements

Regulatory Compliance

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) is required.
Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Compliance with all federal statutes and regulations relevant to federal financial assistance.
Awards may be terminated under certain circumstances as per 2 CFR Part 200.340 and NIH Grants Policy Statement.

Health IT and Cybersecurity Requirements

If funding involves implementing, acquiring, or upgrading health IT, recipients must use standards and implementation specifications adopted in 45 CFR part 170, Subpart B, and ONC Health IT Certification Program if applicable.
For ongoing access to HHS IT systems or processing of PII/PHI, recipients must develop plans and procedures modeled after the NIST Cybersecurity framework.

Data Management and Sharing

Recipients are required to adhere to the 2023 NIH Policy for Data Management and Sharing, and implement their approved Data Management and Sharing Plan.

Research-Specific Compliance

Clinical Trial Optional: This NOFO accepts applications that either propose or do not propose clinical trial(s).
Human Subjects Research: Requires Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval and compliance with data and safety monitoring requirements.
Investigational Products: If involving investigational therapeutics, vaccines, or medical interventions, studies must be performed under an FDA investigational new drug (IND) or investigational device exemption (IDE).

Reporting Requirements

Annual Research Performance Progress Report (RPPR).
Financial statements as required.
A final RPPR, invention statement, and expenditure data are required for award closeout.

Non-Responsiveness Criteria

Applications not aligned with NIH's Office of AIDS Research (OAR) priority areas (NOT-OD-20-018) will be considered non-responsive and will not be reviewed. Examples of non-aligned research include:
Research on natural history/epidemiology entirely focused on a co-morbidity without HIV focus.
Research on co-infecting pathogens not in the context of HIV infection.
Basic immunology studies or cancer-related immunology studies not specific to HIV.
Studies on co-morbidities of general relevance not in the context of HIV.
Data analysis and systems tools not HIV-related.
Studies of behaviors or social conditions where HIV/AIDS is only one of many outcomes without a specific focus on HIV's uniqueness in that context.

Unique Aspects

Encourages multidisciplinary studies of HIV/AIDS and aging, including biological, clinical, and socio-behavioral aspects.
Emphasis on clinical orientation, focus on older ages (70+), attention to geriatric outcomes, leveraging existing NIH resources, selection of appropriate controls, and characterization of phenotypes.
Exploratory/Developmental nature is appropriate, encouraging new directions with little or no preliminary data.
NIA CROMS (Clinical Research Operations & Management System) interaction and use are required for NIA grantees supporting human subjects research.

Grant Details