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Grant Analysis

Purpose & Target

The core objective of this grant is to support fundamental research into the mechanisms of chemical toxicity affecting the lungs and eyes, with the goal of identifying molecular and genetic targets for developing medical countermeasures against acute chemical threat agent exposure.
This grant targets a wide range of U.S.-based research organizations, including universities, non-profits, for-profit businesses (small and large), and various governmental entities.
This is a SECTOR-SPECIFIC grant, focused on health, environmental health, toxicology, and biomedical research.
The geographic scope is primarily the United States, though U.S. organizations may include foreign components in their projects.
Key filtering criteria include a focus on acute pulmonary and/or ocular exposure to specific 'Chemicals of Concern' (CoCs) from the U.S. Department of Homeland Security list, and a prohibition on clinical trials or studies of prolonged environmental/occupational exposure.
This funding opportunity (RFA-ES-24-005) is a reissue of a previous RFA, indicating it is a recurring program within the broader Chemical Countermeasures Research Program (CCRP), which was established in 2006.

Financial Structure

Total funding commitment: NIH intends to commit $3,000,000.0 in FY 2025 for up to five awards.
Award budget limitation: Applications are limited to $300,000.0 direct costs per year.
Specific budget limitation: The budget allocation for 'in vitro' and/or 'in silico' research cannot exceed $200,000.0 in direct costs per year.
Eligible costs: Must reflect the actual needs of the proposed project. Includes travel support for the PD/PI to attend the Annual CounterACT Network Research Symposium for each project year, and travel for post-doctoral, pre-doctoral, and junior investigators.
Ineligible costs: Not explicitly detailed beyond the overall scope exclusions (e.g., efficacy studies are not funded).
Matching fund requirements: This NOFO does not require cost sharing.
Payment schedule: Not explicitly detailed; subject to NIH standard payment mechanisms.
Financial reporting requirements: Annual Research Performance Progress Report (RPPR) and financial statements are required for multi-year awards. A final RPPR, invention statement, and Federal Financial Report expenditure data are required for closeout. Subaward reporting to FSRS is required for subawards over the threshold.
Audit requirements: Not explicitly detailed; subject to general NIH grant policies and federal regulations (2 CFR Part 200).
Financial sustainability expectations: Not explicitly addressed beyond the project period.
Indirect cost policies: Not explicitly mentioned, but subject to NIH Grants Policy Statement.

Eligibility Requirements

Eligible organization types (lead applicant must be U.S.-based):
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (with or without 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 Governments (Federally Recognized or Other))
- Federal Governments (Eligible Agencies, 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
Required Registrations (must be active and complete prior to application submission):
- System for Award Management (SAM) with active registration (annual renewal required)
- Unique Entity Identifier (UEI) (issued via SAM.gov)
- eRA Commons registration for organization (with at least one Signing Official and one Program Director/Principal Investigator (PD/PI) account)
- Grants.gov registration
Eligible Individuals:
- Any individual with the skills, knowledge, and resources to carry out the proposed research as PD(s)/PI(s).
- All PD(s)/PI(s) must have an eRA Commons account.
Geographic Restrictions:
- Non-domestic (non-U.S.) Entities are not eligible to apply as the lead applicant.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to be the lead applicant, but 'foreign components' of a U.S. organization's project are allowed.
Exclusion Criteria (Applications will be considered non-responsive and not reviewed if they):
- Propose to study chemicals not on the DHS 'Chemicals of Concern' (CoC) list.
- Address health outcomes due to prolonged or persistent environmental/occupational chemical exposure.
- Propose efficacy studies (e.g., creation and validation of candidate medical countermeasures).

Application Process

Application Process Timeline

Posted Date: June 07, 2024
Open Date (Earliest Submission Date): August 24, 2024
Letter of Intent Due Date(s): 30 days before each application due date (optional, but encouraged).
Application Due Dates: September 24, 2024; September 24, 2025; September 23, 2026 (latest).
Application Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Scientific Merit Review Periods: March 2025, March 2026, March 2027.
Advisory Council Review Periods: May 2025, May 2026, May 2027.
Earliest Start Dates: July 2025, July 2026, July 2027.
Expiration Date of NOFO: September 24, 2026.

Required Documentation and Materials

Standard Forms: 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 (including Research Strategy, Resource Sharing Plan, Other Plan(s) for Data Management and Sharing Plan).
Letters of Support:
- Letter from appropriate institutional biosafety officials indicating studies are safe for personnel and environment.
- Letter from appropriate Department of Defense (DoD) officials if utilizing restricted chemical agents (e.g., chemical warfare agents).
- Formal letter of support (and estimated budget, if applicable) for all proposed collaborative, consultative, and/or contractual arrangements, especially for restricted chemicals.
Human Subjects/Clinical Trials Information: PHS Human Subjects and Clinical Trials Information form (if applicable), including Study Record or Delayed Onset Study record.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys). Publications or other materials not allowed.

Submission Procedures

Submission Platforms: Applications must be submitted electronically through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Pre-application Registrations: Applicant organizations must complete and maintain active registrations with SAM (including UEI), eRA Commons, and Grants.gov prior to submission. PD(s)/PI(s) must have an eRA Commons account.
Corrections: Applicants are encouraged to submit early to allow time for corrections. Errors identified during system checks must be corrected and a changed/corrected application resubmitted by the due date.

Project Implementation and Reporting

Project Period: Not explicitly stated but budget is per year; subject to NIH standard project periods for R01 grants.
Reporting Obligations: Annual Research Performance Progress Report (RPPR). A final RPPR, invention statement, and Federal Financial Report expenditure data for closeout. Subaward reporting (FSRS) if applicable.
Monitoring and Evaluation: Applications undergo scientific and technical merit evaluation by NIH peer review (Scientific Review Group), followed by a second level of review by the appropriate Advisory Council or Board.

Post-Award Requirements and Compliance

Notice of Award (NoA): Formal notification from NIH; costs incurred before NoA are at recipient's risk.
Terms and Conditions: Awards are subject to NIH Grants Policy Statement, including Federalwide Standard Terms and Conditions for Research Grants, prohibition on certain telecommunications equipment, acknowledgment of Federal funding, and nondiscrimination laws.
IRB/IEC Approval: Recipient institutions must ensure protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data Management and Sharing: Recipients must adhere to the 2023 NIH Policy for Data Management and Sharing and implement their approved Data Management and Sharing Plan.

Evaluation Criteria

Scored Review Criteria

Overall Impact: Assesses the likelihood for the project to exert a sustained, powerful influence on the research field(s).
Significance: Evaluates the importance of the proposed research, including how it will advance scientific knowledge and inform medical countermeasure discovery.
Investigator(s): Assesses the qualifications, experience, and expertise of the PD(s)/PI(s) and other key personnel.
Innovation: Reviews the novelty of the scientific ideas, new model systems, tools, or technologies proposed.
Approach: Examines the soundness of the overall strategy, methodology, and analyses. Includes plans for rigor, unbiased approaches, handling potential problems, and addressing relevant biological variables (e.g., sex).
Environment: Determines if the scientific environment, institutional support, equipment, and resources are adequate and contribute to success, especially unique features or collaborative arrangements.

Additional Review Criteria (Considered but not separately scored)

Protections for Human Subjects: Evaluates justification for involvement of human subjects and proposed protections against risks.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Assesses plans for inclusion/exclusion based on sex, race, ethnicity, and age, as justified by scientific goals.
Vertebrate Animals: Evaluates justification for animal use, appropriate species/strains/sexes, and methods to limit discomfort.
Biohazards: Assesses potential hazards to research personnel/environment and adequacy of proposed protections, especially for highly toxic chemicals.
Resubmissions: Evaluated based on responses to prior review comments and changes made.

Additional Review Considerations (Considered but not separately scored, and do not influence overall impact score)

Foreign Organizations: Assesses if the project presents special opportunities through unique talent, resources, or conditions not readily available in the U.S.
Select Agent Research: Reviews information on Select Agent use, registration status, monitoring procedures, and biosafety/security plans.
Resource Sharing Plans: Comments on the reasonableness of proposed sharing plans (e.g., for model organisms) or the rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Comments on plans for identifying and ensuring validity of resources.
Budget and Period of Support: Considers whether the budget and requested period are justified and reasonable.
Intellectual Property (IP) Strategy: If applicable, reviewers comment on addressed IP issues, freedom to operate, known constraints, and IP filing plans, especially for multi-institutional involvement.

Compliance & Special Requirements

Regulatory Compliance

Federal Regulations: Compliance with Public Health Service Act (42 USC 241 and 284), 42 CFR Part 52, and 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
Human Subjects Research: Compliance with 45 CFR Part 46 and NIH guidelines for human subjects protection, inclusion, and oversight (IRB/IEC approval).
Animal Research: Compliance with NIH guidelines for vertebrate animal research, including justification for use, species selection, and pain/distress mitigation.
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws (agreed upon when registering in SAM.gov).

Data Protection and Intellectual Property

Data Management and Sharing: A Data Management and Sharing Plan is required for research generating scientific data, outlining how data will be managed and shared.
Intellectual Property (IP): Reviewers will assess potential IP issues (e.g., freedom to operate, filing plans, IP sharing across institutions) for therapeutics being developed, if applicable.

Risk Management and Security

Biosafety: Rigorous biosafety precautions are required for working with highly toxic chemicals. A letter from institutional biosafety officials confirming safety is mandatory. For restricted chemical agents (e.g., chemical warfare agents), a letter from appropriate Department of Defense (DoD) officials is required.
Hazard Assessment: Reviewers assess potential hazards to research personnel and the environment and the adequacy of proposed protections.
Select Agents: If applicable, robust procedures for monitoring possession, use, transfer, biosafety, biocontainment, and security of Select Agents must be described.

Unique Aspects and Strategic Opportunities

Focus on Acute Exposure: The grant specifically targets acute (short-term) exposure effects, excluding prolonged or persistent environmental/occupational exposures.
Fundamental Mechanisms: Emphasis is on understanding fundamental pathophysiological mechanisms rather than direct efficacy studies or clinical trials.
Model Diversity Encouraged: Applications are encouraged to use diverse models (animal, organoid, ex vivo, in vitro, in silico) with specific requirements for multi-cell/multi-species/multi-toxicant/multi-timepoint studies to ensure robustness and comparability.
Comorbidity Factors: Studies investigating the impact of diverse comorbidity factors such as age, sex, pregnancy, and/or pre-existing disease conditions are encouraged.
Ocular Research Depth: For ocular research, projects investigating multiple angles of the injury/recovery cascade, the role of the tear film, delayed responses, and discovery of biologically active tools are particularly valued.
Innovation and Collaboration: The R01 mechanism emphasizes novel ideas. Collaboration with certified laboratories for restricted agents is strongly encouraged.

Cross-Cutting Considerations

Inclusion: For human subjects research, plans for inclusion of individuals based on sex, race, ethnicity, and across the lifespan are required and reviewed.
Research Rigor: Strong emphasis on methodological rigor, statistical analysis, blinding, randomization, and reproducibility of results for all proposed studies and supporting data.

Grant Details