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Grant Analysis

Purpose & Target

The core objective of this grant is to identify new druggable targets for pain within the understudied druggable proteome. It aims to support pilot projects that generate preliminary data and tools for these targets, ultimately contributing to novel medications for pain and the opioid addiction cycle.

Explicit identification of target recipient type: This grant targets a broad range of research-focused entities, including higher education institutions, non-profits, for-profit organizations, and various governmental bodies with scientific research capacity.
Size: Not explicitly defined by employee count, but the 'R03 Small Grant Program' designation indicates a focus on projects of limited scope and budget.
SECTOR-SPECIFIC: This grant is highly sector-specific, focusing on HEALTHCARE, particularly biomedical research, pain management, and opioid addiction.
Geographic scope: Applicant organizations must be based in the United States. While foreign components (collaborators) are allowed, the primary applying entity must be U.S.-based.
Key filtering criteria for initial grant screening:
The project must focus on one or more of the explicitly listed understudied proteins within the NOFO.
The project must not involve clinical trials or clinical drug development studies.
The research must be related to pain and/or pain management.
The applicant organization must be U.S.-based.
Grant frequency: This is a recurring funding opportunity, noted as a reissue of a previous program (PAR-24-197).
Program context: This grant is part of the broader NIH HEAL Initiative (Helping to End Addiction Long-term), addressing the national opioid public health crisis.

Financial Structure

Budget limit: Application budgets are limited to $100,000 in direct costs for one year. Subcontract F&A (Facilities & Administrative) costs are excluded from this direct cost limit.
Project period: The maximum project period for an award under this NOFO is 1 year.
Matching funds: This funding opportunity does not require cost sharing.
Eligible costs:
Travel costs to support the attendance of one Program Director/Principal Investigator (PD/PI) at an annual 2-day, in-person HEAL Investigators meeting in the Washington DC area (for the 1-year duration).
Costs to ensure manuscripts are immediately publicly available upon publication (e.g., open access fees).
Ineligible costs: For NIH intramural scientists involved, salary and related fringe benefits for career, career conditional, or other Federal employees with permanent appointments, and costs related to administrative or facilities support (equivalent to F&A costs) are not eligible for direct funding through this grant. If an extramural application includes collaboration with an intramural scientist, no funds for the intramural scientist's support may be requested in the application.
Payment mechanism: Funding is provided as a grant, which is a financial assistance mechanism.

Eligibility Requirements

Organization Types

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (501(c)(3) IRS Status, Non-501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other than Small Businesses)
Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal - 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/Community-based Organizations, Regional Organizations)

Geographic Restrictions

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.
Foreign components (e.g., international collaborators on a U.S. led project) are allowed.

Project Scope Restrictions

The proposed project must focus on one or more of the specific 'understudied proteins' listed in the NOFO (e.g., specific Ion Channels, Transcription Factors, Transporters, Proteases, GPCRs). Applications not focusing on these listed proteins will be considered non-responsive and will not be reviewed.
Projects meeting the NIH definition of a 'clinical trial' are not allowed.
Applications proposing 'clinical drug development studies' for understudied proteins are not allowed.
Applications proposing studies of diseases/conditions not related to pain and/or pain management are not allowed.

Technical Requirements

The individual(s) designated as Program Director(s)/Principal Investigator(s) (PD/PI(s)) must possess the necessary skills, knowledge, and resources to conduct the proposed research.
Preliminary data are not required, but appropriate justification for the proposed approach must be provided through literature citations, data from other sources, or investigator-generated data.

Registration Requirements

Applicant organizations must complete and maintain active registrations with the System for Award Management (SAM) (requires annual renewal).
Organizations must have a Unique Entity Identifier (UEI) established through SAM.gov registration.
Organizations must be registered with eRA Commons. This requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Organizations must be registered with Grants.gov.
Foreign organizations (if allowed as a component) must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.

Application Process

Application Submission

Submission Options: Applications must be submitted electronically through one of the following methods:
NIH ASSIST system (online preparation, submission, and tracking).
An institutional system-to-system (S2S) solution.
Grants.gov Workspace (preparation and submission).
Submission Deadline: All applications are due by 5:00 PM local time of the applicant organization. The latest application due date for this funding opportunity is July 16, 2026 at 17:00:00-05:00.
Open Date (Earliest Submission Date): January 16, 2025.
Expiration Date: July 17, 2026.
Pre-Application Requirements: Applicants are strongly encouraged to begin the required registration processes (SAM, UEI, eRA Commons, Grants.gov) as soon as possible, as these can take 6 weeks or more to complete. Failure to complete registrations in advance is not a valid reason for a late submission.
Early Submission: Applicants are encouraged to submit early to allow adequate time for correcting any errors identified during the submission process.

Required Documentation

SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile).
R&R or Modular Budget forms.
R&R Subaward Budget forms (if applicable).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: Applicants must provide the protein acronym(s) from the eligible list (as detailed in Section I) at the top of page one of their Research Plan.
Resource Sharing Plan.
Data Management and Sharing Plan: This is mandatory for all applications, regardless of direct costs, and must specifically address HEAL Initiative requirements.
PHS Human Subjects and Clinical Trials Information form (if involving human subjects research; clinical trials themselves are not allowed).
PHS Assignment Request Form.

Application Content Guidelines

Applicants must strictly follow the instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', unless specific deviations are outlined in this NOFO.
All specified page limitations must be adhered to.
Preliminary data are not required, but appropriate justification must be provided.
Appendix materials are severely limited; only blank questionnaires or blank surveys are permitted. No publications or other external materials may be included.

Post-Award Requirements

Recipients are required to submit a Research Performance Progress Report (RPPR) annually and financial statements as required.
A final RPPR, an invention statement, and expenditure data are required for closeout of the award.
Publications resulting from HEAL Initiative-funded studies must be made immediately publicly available upon publication. Authors should include costs for open access publication in their budget requests.

Evaluation Criteria

Overall Impact Score

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

Scored Review Criteria

Importance of the Research (Significance and Innovation): Evaluates the significance and innovative aspects of the proposed research project within the context of identifying new pain targets.
Rigor and Feasibility (Approach): Assesses the scientific soundness, methodological rigor, and overall feasibility of the proposed research plan to achieve its objectives within the small grant framework.
Expertise and Resources (Investigator(s) and Environment): Evaluates the qualifications, experience, and expertise of the investigator(s) in relation to the proposed work. For multiple Principal Investigator (MPI) applications, the quality of the leadership plan is also assessed. The adequacy and appropriateness of institutional resources for executing the project are also evaluated.

Additional Review Criteria (Not scored but considered for overall impact)

Protections for Human Subjects: If human subjects are involved, evaluation of justification, proposed protections against risks, potential benefits, and importance of knowledge to be gained. For exempt research, justification, involvement, and sources of materials are evaluated.
Vertebrate Animals: If live vertebrate animals are involved, evaluation of procedures, justification for animal use/species, interventions to minimize discomfort, and justification for euthanasia method if not standard.
Biohazards: If biohazardous materials or procedures are involved, evaluation of potential risks to personnel/environment and proposed protections.
Resubmissions: For resubmitted applications, the full application is evaluated as presented.

Additional Review Considerations (Not scored or affecting overall impact score, but reviewed)

Authentication of Key Biological and/or Chemical Resources: Assessment of plans for identifying and ensuring the validity of essential resources.
Budget and Period of Support: Evaluation of whether the proposed budget and requested project duration are justified and reasonable for the scope of the proposed research.
Relevance to Program Priorities: Consideration of how the proposed project aligns with NIH HEAL Initiative goals and contributes to increasing the variety of approaches applied to the study of understudied proteins.

Compliance & Special Requirements

Data Management and Sharing

Compliance with the 2023 NIH Policy for Data Management and Sharing is mandatory.
HEAL Initiative Specific Data Sharing Requirements:
All HEAL Initiative award recipients must comply with the HEAL Public Access and Data Sharing Policy.
Data generated must be submitted to a HEAL-Compliant data repository.
The study must be registered with the HEAL platform within one year of the award, with annual updates.
HEAL-specific study-level metadata must be submitted within one year of the award.
Variable-level metadata must be submitted to the HEAL Platform at the time of data sharing or by the end of the project period.
HEAL pain clinical studies (if applicable to broader HEAL, but note clinical trials are not allowed for this NOFO) must use HEAL core Common Data Elements (CDEs).
Clinical studies using copyrighted questionnaires are required to obtain licenses prior to data collection.
Awardees are expected to integrate broad data sharing consent language into their informed consent forms to the extent possible.
Publications resulting from HEAL Initiative-funded studies must be immediately publicly available upon publication. Applicants should include costs for open access in their budget.

Regulatory Compliance

All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Recipients must comply with the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2 CFR Part 200).
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 is required.

Ethical Standards

For research involving human subjects, compliance with 45 CFR Part 46 protections is required.
For research involving live vertebrate animals, compliance with relevant guidelines is required.
For research involving biohazards, adequate protection measures must be proposed.

Intellectual Property (IP)

For NIH intramural scientists participating, intellectual property will be managed according to established NIH policy (Executive Order 10096, 45 CFR Part 7). Inventions developed in NIH facilities are NIH property unless rights are waived.
Extramural applications collaborating with intramural scientists cannot request funds for the support of the intramural scientist.

Mandatory Disclosure

Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity that could potentially affect the federal award. Disclosures should be sent to the NIH Chief Grants Management Officer and the HHS Office of Inspector Grant Self Disclosure Program.

Project-Specific Mandates

This grant supports 'small research grants (R03)' which are discrete, well-defined projects that can be completed in one year with limited funding.
The R03 grant mechanism is non-renewable.

Grant Details