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Grant Analysis

Purpose & Target

Core Objective: To fund early-stage translational research for the discovery and development of novel, non-opioid, non-addictive treatments for pain, specifically focusing on assay development, screening, and characterization of potential therapeutic agents.
Target Recipient Type and Size: Open to a wide range of organizations including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government and tribal entities. There are no explicit size restrictions based on employee count.
SECTOR-SPECIFIC
Geographic Scope: Applicants must be based in the United States, though foreign components of U.S. organizations are permitted.
Key Filtering Criteria: Focus on preclinical, non-clinical trial research for non-addictive pain treatments. Projects must advance towards meeting Pain Therapeutics Development Program (PTDP) criteria.
Grant Frequency: This is a reissue (RFA-NS-25-023) of a previous funding opportunity (RFA-NS-25-012), indicating a recurring program with multiple application submission windows until January 2027.

Financial Structure

Budget Range: Application budgets are limited to direct costs of $350,000 per year.
Total Project Period: Up to three years, so a single award could potentially total $1,050,000 in direct costs over three years.
Total Funding Available: The NIH HEAL Initiative intends to commit an estimated total of $2,500,000 to fund 4-5 awards in FY 2025.
Currency: USD (implied by funding organization: NIH, a U.S. government agency).
Eligible Costs: Direct costs associated with research, including personnel, equipment, supplies, and travel. Costs to ensure publications are immediately publicly available (e.g., open access fees) should be included in budget requests.
Ineligible Costs: Pre-award costs are only allowable as described in the NIH Grants Policy Statement.
Matching Fund Requirements: None. Cost sharing is not required.
Payment Mechanism: Financial assistance provided as a grant.
Financial Reporting Requirements: Annual financial statements as required by NIH Grants Policy Statement.

Eligibility Requirements

Organizational Type & Structure

Eligible: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (501(c)(3) and other), For-Profit Organizations (Small Businesses and other), Local Governments (State, County, City/Township, Special District, Federally Recognized Indian/Native American Tribal Governments, Other Indian/Native American Tribal Governments), Federal Government (Eligible Agencies, U.S. Territory or Possession), Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.
Ineligible: Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply (though foreign components, as defined in NIH Grants Policy Statement, are allowed for activities performed abroad).

Geographic Requirements

Applicant organizations must be based in the United States. While foreign components of U.S. organizations are allowed, foreign organizations themselves cannot apply.

Registration Requirements

System for Award Management (SAM) registration, renewed annually. Requires a Unique Entity Identifier (UEI).
NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (if applicable, for components).
eRA Commons account for the organization and for all Program Directors/Principal Investigators (PD/PIs).
Grants.gov registration.

Project Specific Requirements

Clinical trials are not allowed.
Projects must be focused on initial translational efforts in drug discovery for novel, non-opioid, non-addictive pain treatments.
The proposal must include clear activities for both an R61 phase (preparatory) and an R33 phase (main project), with distinct timelines and no overlap.
Quantitative Go/No-Go Project Milestones are required in the Research Strategy for transition from R61 to R33.
An Intellectual Property (IP) Strategy must be submitted as an attachment.

Application Process

Application Submission

Submission Methods: Applicants must use the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Application Due Dates: Multiple deadlines. The latest is January 15, 2027, by 5:00 PM local time of the applicant organization.
Other dates: January 28, 2025; May 16, 2025; September 17, 2025; January 16, 2026; May 15, 2026; September 17, 2026.
Letter of Intent: Encouraged 30 days prior to the application due date, but not required or binding.

Required Documentation and Materials

SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R Budget (for both R61 and R33 phases).
PHS 398 Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information (if applicable), Assignment Request Form.
Intellectual Property (IP) Strategy: Required as an 'Other Attachment' (2 pages maximum). Must describe IP landscape, constraints, and future filing plans, and how IP will be managed with multiple PD/PIs/institutions.
Letters of Support: Required from consultants, contractors, collaborators, and institutional technology transfer officials. If collaborating with a private entity, a letter from a high official addressing agreements on agents, study limits, data sharing, and licensing.
Resource Sharing Plan: Required as per the How to Apply-Application Guide.
Data Management and Sharing Plan: Required for all applicants, including specific HEAL Initiative compliance guidelines (e.g., using HEAL-Compliant data repository, study registration with HEAL platform, metadata submission).

Project Implementation and Reporting

Grant Duration: Total project period not to exceed three years, with a maximum of two years for the R61 phase and two years for the R33 phase (phases cannot overlap).
Key Milestones: Must include clearly specified, well-defined, measurable, quantitative Go/No-Go Project Milestones for transition from the R61 to the R33 phase.
Reporting: Annual Research Performance Progress Report (RPPR). A Non-Competing Continuation Progress Report is required at the transition to the R33 phase. A final RPPR, invention statement, and expenditure data are required for closeout.
Public Access: Publications from HEAL Initiative-funded studies must be immediately publicly available upon publication (costs for open access are allowable).
Post-Award Requirements: Compliance with 2 CFR Part 200, NIH Grants Policy Statement, and specific HEAL Initiative data sharing and public access policies. Participation in annual HEAL Scientific Meetings and other coordination activities is expected.

Evaluation Criteria

Overall Impact

Reviewers provide an 'Overall Impact Score' based on the likelihood of the project to significantly influence the research field.

Importance of the Research

Significance:
Addresses an important knowledge gap or solves a critical problem.
Rationale for study and scientific background (prior literature/preliminary data) are rigorous and justify the proposed work.
Innovation:
Uses novel concepts, methods, or technologies, or applies existing ones in new ways.
For this NOFO: Proposed strategy is distinct from existing therapeutic approaches and has a reasonable chance of success considering the therapeutic landscape. Project, if successful, will produce results that support future therapeutic discovery and lead to substantial improvements over existing pain management.
For in vivo studies: Therapeutic agent(s) are clearly defined and sufficiently characterized in vitro, with physicochemical/biological properties suitable for in vivo testing. Data rigor and transparency (e.g., blinding, randomization, sample size justification) are adequate.

Rigor and Feasibility (Approach)

Rigor:
Potential to produce unbiased, reproducible, robust data.
Rigor of experimental design, appropriate controls, sufficient and justified sample size.
Plans for analysis, interpretation, and reporting of results are high quality.
Addresses relevant biological variables (e.g., sex, age).
Feasibility:
Proposed approach is sound and achievable within the timeframe, with plans for addressing challenges.
For this NOFO: Developed assays are robust, reliable, and have sufficient throughput for future analgesic discovery. Process for selecting compounds/biologics is clear. Suitability of the library for screening is justified, and plans for follow-up hits are appropriate. In vivo efficacy studies are well-informed by PK/PD studies. Therapeutic discovery plan provides sufficient evidence for future development decisions.
Milestones:
Milestones are clearly specified, well-defined, scientifically justified, and include measurable, quantitative criteria for go/no-go decisions.
Milestones assess progress in R61 phase and ensure confidence for R33 phase implementation.

Expertise and Resources

Investigator(s): Demonstrated background, training, and expertise. For Multiple PI applications, a strong leadership plan for coordination and collaboration.
Environment: Institutional resources are appropriate for successful project execution.
For this NOFO: Investigative team possesses sufficient preclinical and drug discovery expertise relevant to the proposed therapeutic modality and aligned with the therapeutic discovery plan.

Additional Review Criteria (No Separate Scores)

Protections for Human Subjects (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).
Resubmissions: Evaluated based on responses to prior comments and changes made.
Intellectual Property (IP) Strategy: Assessed for potential constraints, reasonableness of plans to protect IP, and management if multiple parties are involved.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and validating resources.

Compliance & Special Requirements

Regulatory Compliance Requirements

Compliance with all applicable federal statutes and regulations relevant to federal financial assistance, including 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Adherence to NIH Grants Policy Statement terms and conditions.
Mandatory disclosures for violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Data Protection and Privacy

All HEAL-generated data must be shared through the HEAL Initiative Data Ecosystem following HEAL's compliance guidance.
Requirement to select a HEAL-Compliant data repository and follow its requirements.
Study registration with the HEAL platform within one year of award.
Submission of HEAL-defined study-level metadata within one year of award.
Submission of data dictionaries to the HEAL Data Ecosystem, if applicable.
For clinical studies: Use of HEAL core Common Data Elements (CDEs) and integration of broad data sharing consent language into informed consent forms.
All data collected under the NIH HEAL Initiative are under a Certificate of Confidentiality.

Intellectual Property Policies

A 2-page Intellectual Property (IP) Strategy is required, describing the IP landscape, known constraints, future filing plans, and how IP will be shared/managed if multiple PIs/institutions are involved.
Applicants are encouraged to consult their institution's technology transfer officials for the IP strategy.
If using agents with IP not owned by the applicant's institution, a letter from the IP owner is required, indicating no limitations on studies or product that would impede funding program goals.

Ethical Standards & Research Rigor

Emphasis on rigor and transparency in experimental design, data collection, analysis, and reporting. This includes clear rationale for models, appropriate controls, adequate sample size, blinding/randomization, and transparent reporting.
If human subjects or vertebrate animals are involved, specific protections, justifications, and review processes apply.

Strategic Alignment and Collaboration

Projects must align with the NIH HEAL Initiative's goal of developing novel, non-opioid, non-addictive pain treatments.
Multidisciplinary teams, including academic and industry experts (e.g., biostatisticians, clinicians, drug development experts), are strongly encouraged.
Meaningful engagement of people with lived experience (patients, advocates, caregivers, community leaders) in the research process is highly encouraged. This engagement should address mutual learning and benefits.
High level of coordination and sharing expected among all NIH HEAL Initiative recipients, including participation in annual HEAL Scientific Meetings.

Grant Details