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Grant Analysis

Purpose & Target

Grant Purpose and Target

Core Objective: To support formative research, intervention development, and pilot-testing of interventions, or formative implementation research to inform adaptation of evidence-based interventions, or development/selection of implementation strategies to optimize HIV prevention and care continuum outcomes.
Target Recipient Type and Size: Open to a wide range of organizations including higher education institutions, non-profits, for-profit organizations (including small businesses), and various levels of government entities. No specific size restrictions are defined, allowing for diverse organizational capacities.
SECTOR-SPECIFIC: Healthcare, specifically focusing on HIV prevention and treatment research.
Geographic Scope: Worldwide, as non-domestic (non-U.S.) entities are eligible to apply.
Key Filtering Criteria: Focus on research related to HIV prevention and care continuum, ability to conduct pilot/formative studies (R34 mechanism), commitment to data sharing (especially via NIMH Data Archive), and adherence to human subjects research protocols.
Grant Frequency and Program Context: This is a recurring funding opportunity, a reissue of a previous announcement (PA-20-141), with multiple application due dates until its expiration in January 2026. It is part of the National Institute of Mental Health's (NIMH) Division of AIDS Research (DAR) initiatives, aligning with NIH's broader Strategic Plan for HIV and HIV-Related Research.

Financial Structure

Funding Instrument: Grant (R34 Planning Grant).
Budget Range and Limitations: Direct costs are limited to $225,000 per year and a total of $450,000 over the 3-year project period.
Currency: USD.
Matching Fund Requirements: Not required.
Cost Sharing: Not required.
Financial Reporting Requirements: Recipients must submit an annual Research Performance Progress Report (RPPR) and financial statements as required by the NIH Grants Policy Statement. A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report (FFR) are required for closeout.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types:
Higher Education Institutions: Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education.
Nonprofits: Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education).
For-Profit Organizations: Small Businesses, For-Profit Organizations (Other than Small Businesses).
Local Governments: State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized).
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 tribal governments), Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Institutions).
Geographic Location Requirements: Open to both domestic (U.S.) and non-domestic (non-U.S.) entities.
Required Registrations:
System for Award Management (SAM): Active registration required, renewed annually. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) code to register in SAM.
Unique Entity Identifier (UEI): Issued as part of the SAM.gov registration process, must be consistent across all registrations and the application.
eRA Commons: Organizations must register once UEI is established; requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Requires active SAM registration.
Individual (PD/PI) Requirements:
Any individual with the skills, knowledge, and resources to conduct the proposed research.
All PD(s)/PI(s) must have an eRA Commons account.
Cost Sharing: Not required.
Number of Applications: Applicant organizations may submit more than one application, provided each is 'scientifically distinct'. Duplicate or highly overlapping applications will not be accepted if submitted before summary statement issuance from a prior review.

Application Process

Application Practical Information

Application Submission Methods: Applications must be submitted electronically via NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Key Dates:
Posted Date: January 11, 2023
Open Date (Earliest Submission Date): April 09, 2023
Application Due Dates: Multiple, with the latest listed as January 09, 2026, for new, renewal, resubmission, and revision applications. All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date: January 10, 2026.
Required Documentation and Materials: Applicants must follow instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, supplemented by FOA-specific instructions. This includes:
SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: Includes a mandatory Data Management and Sharing Plan (attached in Other Plan(s) for due dates on or after January 25, 2023) and specific Appendix limitations (only blank questionnaires/surveys allowed; no publications or other material).
PHS Human Subjects and Clinical Trials Information form (if applicable).
PHS Assignment Request Form.
Submission Guidance: Applicants are strongly encouraged to apply early to allow time for corrections. If a submission date falls on a weekend or Federal holiday, the deadline extends to the next business day. Applicants are responsible for viewing their application in eRA Commons before the due date to ensure successful submission.
Pre-Application Requirements: Strongly encouraged to consult with NIH staff/Program Officer early to discuss alignment with NIMH priorities.
Review Process: Applications undergo scientific and technical merit evaluation by an appropriate Scientific Review Group (peer review), followed by a second-level review by the relevant national Advisory Council or Board. Funding decisions consider scientific merit, fund availability, and relevance to program priorities.
Post-Award Requirements:
Compliance with NIH Grants Policy Statement terms and conditions.
For clinical trials: Mandatory registration and results reporting to ClinicalTrials.gov, IRB/IEC approval, and adherence to NIH data and safety monitoring requirements.
Annual Research Performance Progress Reports (RPPR) and financial statements.
Reporting of first-tier subawards and executive compensation through the Federal Subaward Reporting System (FSRS).
Compliance with Federal Awardee Performance and Integrity Information System (FAPIIS) requirements regarding civil, criminal, and administrative proceedings.

Evaluation Criteria

Overall Impact: Assesses the likelihood for the project to exert a sustained, powerful influence on the research field(s).
Scored Review Criteria:
Significance: Addresses an 'important problem' or 'critical barrier to progress'. Evaluates rigor of prior research, improvement of scientific knowledge, technical capability, and/or clinical practice. For clinical trials, assesses scientific rationale, necessity, and whether it advances scientific understanding.
Investigator(s): Evaluates suitability of PD(s)/PI(s), collaborators, and other researchers based on experience, training, and record of accomplishments. For collaborative/multi-PD/PI projects, assesses complementary expertise and appropriate leadership/organizational structure. For clinical trials, reviews expertise in study coordination, data management, and statistics.
Innovation: Determines if the application challenges existing paradigms using 'novel theoretical concepts, approaches or methodologies, instrumentation, or interventions'. For clinical trials, assesses innovative elements that enhance sensitivity or potential for scientific advancement.
Approach: Assesses the 'overall strategy, methodology, and analyses' for their reasoning and appropriateness. Reviews plans to address weaknesses in prior research, ensure a 'robust and unbiased approach', and manage risky aspects. For human subjects/clinical research, evaluates protection of human subjects, justification for inclusion/exclusion (sex, race, ethnicity, age), and ethical considerations. For clinical trials, evaluates study design, power, population, intervention, duration, recruitment, data collection quality, data management, and statistical analysis plans.
Environment: Considers whether the scientific environment, institutional support, equipment, and physical resources are adequate. Assesses benefit from unique features or collaborative arrangements. For clinical trials, reviews appropriateness of administrative, data coordinating, enrollment, and laboratory/testing centers, site capability, and complexity of international sites or multi-site coordination.
Additional Review Criteria (not scored but considered):
Study Timeline: Feasibility and justification of the timeline, including start-up, enrollment rate, and follow-up. Considers potential challenges and solutions.
Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge gained, and data/safety monitoring.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion or exclusion based on scientific goals and research strategy.
Vertebrate Animals: Description of procedures, justification for use, interventions to minimize discomfort, and justification for euthanasia methods.
Biohazards: Assessment of potential hazards and proposed protections.
Resubmissions: Evaluation considers responses to comments from previous reviews and changes made.
Renewals: Progress made in the last funding period is considered.
Revisions: Appropriateness of proposed scope expansion and adequacy of responses to previous comments.
Foreign Organizations: Assesses if the project presents 'special opportunities' (unusual talent, resources, populations, environmental conditions) not readily available in the U.S. or that augment existing U.S. resources.
Resource Sharing Plans: Review for reasonableness.
Authentication of Key Biological and/or Chemical Resources: Review of plans for identifying and ensuring validity.

Compliance & Special Requirements

Compliance and Special Requirements

Regulatory Compliance: Adherence to Sections 301 and 405 of the Public Health Service Act, and Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.
Human Subjects and Clinical Trials Compliance: Strict compliance with NIH policies and guidance regarding human research protection and clinical research data and safety monitoring (e.g., NOT-MH-19-027). This includes timely registration and results submission to ClinicalTrials.gov, IRB/IEC approval, and ongoing data and safety monitoring.
Data Protection and Sharing: Mandatory compliance with the NIH Policy for Data Management and Sharing (effective for due dates on or after January 25, 2023). All scientific data generated are expected to be shared via the National Institute of Mental Health Data Archive (NDA) using Global Unique Identifier (GUID) and Data Dictionary technology. Semi-annual submission of descriptive/raw data (January 15 and July 15) is required. Expected collection of Common Data Elements (CDEs) for human subjects research (NOT-MH-22-255, NOT-MH-22-260).
Ethical Standards and Non-discrimination: Recipients of federal financial assistance must complete an HHS Assurance of Compliance form (HHS 690), agreeing to administer programs in compliance with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, and disability. This also includes ensuring meaningful access for persons with limited English proficiency, effective communication with persons with disabilities, and programs free of sexual harassment. Compliance with federal conscience and religious nondiscrimination laws.
Risk Management: Applicants may be subject to review under the Federal Awardee Performance and Integrity Information System (FAPIIS).
Strategic Alignment and Collaboration: Strong encouragement for multidisciplinary research approaches. Involvement of community members, community-based or HIV service organizations, and academic/Department of Health (or Ministry of Health) partnerships are highly recommended and should be reflected in the budget. Collaboration with relevant organizations (e.g., health service providers, public health agencies, justice systems, school systems, faith-based organizations) is expected.
Innovation Preferences: Encouragement for strategies leveraging technology and social media, novel mechanisms for behavior change, and approaches optimizing reach/impact through system/structural modifications.
Project Scope Considerations: Given the R34 mechanism's 'pilot nature', conducting formal tests of clinical outcomes or attempting to obtain a precise effect size estimate is often not justified due to typically limited sample sizes.

Grant Details

Grant Analysis

Purpose & Target

Financial Structure

Eligibility Requirements

Application Process

Evaluation Criteria

Compliance & Special Requirements

Grant Details