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Grant Analysis

Purpose & Target

This grant aims to stimulate exploratory and developmental HIV/AIDS research focused on hearing, balance, taste, smell, voice, speech, and language disorders, specifically benefiting people living with HIV. The grant targets a wide range of organizations, including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities, of unspecified size, capable of conducting research. This is a SECTOR-SPECIFIC grant with a global geographic scope. Key filtering criteria include: research must be HIV/AIDS related and fall within NIDCD's mission areas (communication disorders), must address high-priority NIH Office of AIDS Research (OAR) areas, and only low-risk clinical trials are supported. This is a recurring funding opportunity (reissue of PAR-23-106) for exploratory/developmental research (R21 activity code) within the National Institutes of Health (NIH) framework.

Financial Structure

Maximum direct costs for the two-year project period may not exceed $275,000.
No more than $200,000 may be requested in any single year.
The total project period may not exceed 2 years.
Currency: USD
Cost sharing is not required.
Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Budget and requested period of support must be fully justified and reasonable.

Eligibility Requirements

Eligible Organization Types

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 510(c)(3) IRS Status)
For-Profit Organizations (including Small Businesses)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal (Federally Recognized or Other))
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, Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations).

Geographic Location

Applicants from any country (domestic or non-U.S. entities) are eligible.

Required Registrations and Certifications

System for Award Management (SAM) – must be active and maintained. Includes Unique Entity Identifier (UEI).
NATO Commercial and Government Entity (NCAGE) Code – required for foreign organizations (in lieu of CAGE code).
eRA Commons – organization must be registered with a Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account.
Grants.gov – active registration required.
PD/PIs must have an eRA Commons account affiliated with the applicant organization.

Financial Requirements

Cost sharing is not required.

Clinical Trial Specifics

Only low-risk clinical trials are supported.
Low-risk clinical trials do not require FDA oversight (e.g., Investigational New Drug (IND) or Investigational Device Exemption (IDE) approval).
Potential for physical or psychological harm of the intervention is low (e.g., risks no greater than routine medical care).
Intended to gather scientific data/evidence to inform subsequent studies, not aimed or sufficiently powered to directly change health policy or standard of care.
Not an NIH-defined Phase III Clinical Trial.

Exclusion Criteria

Applications proposing clinical trials that require FDA oversight, exceed the NOFO's budget limits, are intended to formally establish efficacy (NIH-defined Phase III clinical trial), or have high potential risks for physical/psychological harm will be considered non-responsive and will not be reviewed.
Duplicate or highly overlapping applications under review at the same time are not accepted.

Application Process

Key Dates & Deadlines

Open Date (Earliest Submission Date): April 07, 2025
Letter of Intent Due Date(s): 30 days prior to application due date (encouraged, not required).
Application Due Dates:
May 07, 2025 (AIDS - New/Renewal/Resubmission/Revision)
September 07, 2025 (AIDS - New/Renewal/Resubmission/Revision)
January 07, 2026 (AIDS - New/Renewal/Resubmission/Revision)
May 07, 2026 (AIDS - New/Renewal/Resubmission/Revision)
September 07, 2026 (AIDS - New/Renewal/Resubmission/Revision)
January 07, 2027 (AIDS - New/Renewal/Resubmission/Revision)
May 07, 2027 (AIDS - New/Renewal/Resubmission/Revision)
September 07, 2027 (AIDS - New/Renewal/Resubmission/Revision)
January 07, 2028 (AIDS - New/Renewal/Resubmission/Revision)
Latest Submission Deadline: January 07, 2028, by 5:00 PM local time of applicant organization.
Expiration Date: January 08, 2028.
Applications are automatically extended to the next business day if the due date falls on a weekend or Federal holiday.

Application Submission

Electronic submission is mandatory. Paper applications are not accepted.
Use NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Applicants must track application status in eRA Commons.
Corrections to errors found during submission must be made, and a changed/corrected application submitted on or before the due date.

Required Documentation & Materials

SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget)
PHS 398 forms (Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form)
Resource Sharing Plan.
Data Management and Sharing Plan (required for all applications, regardless of direct costs requested).
Research Strategy section: must demonstrate alignment with NIDCD mission areas and NIH OAR HIV/AIDS research priorities.
Collaborations: If applicable, describe partnerships and maintenance plan.
Leveraging existing resources: If applicable, briefly describe how existing HIV/AIDS cohorts, clinical trials, and/or infrastructure will be leveraged.
Appendix: Limited materials allowed. No publications or other material (except blank questionnaires/surveys).

Project Implementation & Reporting

Project period may not exceed 2 years.
Annual Research Performance Progress Report (RPPR) is required.
Final RPPR, invention statement, and expenditure data (Federal Financial Report) are required for closeout.
Clinical trials require registration and results reporting on ClinicalTrials.gov.
Recipient institutions must ensure all protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and safety monitoring required for human biomedical and behavioral intervention studies.

Support Offered

Financial assistance in the form of a grant.

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

Factor 1. Importance of the Research (Significance and Innovation): Evaluates the importance of the research and its novelty or potential to significantly advance knowledge. For R21, emphasizes conceptual framework, innovation, and potential for impact. Preliminary data are not required.
Factor 2. Rigor and Feasibility (Approach): Assesses the soundness of the proposed research design, methodology, and analysis plan.
Factor 3. Expertise and Resources (Investigator(s) and Environment): Evaluates the qualifications of the research team and the adequacy of the proposed research environment and resources.

Additional Review Criteria (Considered, but not scored)

Protections for Human Subjects: Adequacy of plans for human subject protection.
Vertebrate Animals: Evaluation of proposed procedures involving animals, justification for use, interventions to minimize discomfort, and justification for euthanasia method if not standard.
Biohazards: Assessment of significant hazards to research personnel/environment and proposed protection.
Resubmissions: Evaluation of the revised application as presented.
Renewals: Evaluation of progress made in the previous funding period.
Revisions: Evaluation of the appropriateness of expanding the project scope.

Additional Review Considerations (Considered, but not scored)

Authentication of Key Biological and/or Chemical Resources: Brief plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period in relation to proposed research.

Compliance & Special Requirements

Regulatory Compliance

Awards are subject to:
2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
NIH Grants Policy Statement.
Applicable nondiscrimination laws (via SAM.gov registration and submission of HHS-690 Assurance of Compliance).
All federal statutes and regulations relevant to federal financial assistance.

Data Protection & Privacy

A Data Management and Sharing Plan is required for all research generating scientific data.
Recipients with ongoing access to HHS information/systems, or who receive/process PII/PHI from HHS, must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical Standards

Research involving human subjects must adhere to protections outlined in the application and be approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and safety monitoring requirements apply to human biomedical and behavioral intervention studies.

Intellectual Property & Technology

If award funding involves implementing, acquiring, or upgrading health IT, it must meet standards and implementation specifications in 45 CFR part 170, Subpart B.
For eligible clinicians in ambulatory settings or hospitals, health IT must be certified under the ONC Health IT Certification Program if certified technology can support the activity.

Risk Management

Projects involving human subjects, vertebrate animals, or biohazards will be evaluated for appropriate protections and risk mitigation.
Mandatory disclosure required for violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (2 CFR 200.113).

Unique Aspects

This R21 Exploratory/Developmental Grant supports novel scientific ideas and approaches; extensive background material or preliminary information is not required.
Specific focus on the intersection of HIV/AIDS and communication disorders (hearing, balance, taste, smell, voice, speech, language).
Emphasis on low-risk clinical trials only, with strict criteria for what constitutes 'low-risk' and non-responsive exclusions for higher-risk or FDA-regulated trials.

Strategic Opportunities

Strong encouragement for multidisciplinary collaborations between communication disorders and HIV/AIDS investigators.
Opportunities to leverage existing HIV/AIDS cohorts, clinical trials, and infrastructure.

Grant Details