Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

The core objective of this grant is to support highly innovative mechanistic research focused on developing effective precision probiotic interventions. It aims to identify, understand, and address human heterogeneity that leads to inconsistent responses to probiotic treatments.

Target recipients: Research-performing organizations, including higher education institutions, nonprofits, for-profit businesses (small and large), and various government entities.
SECTOR-SPECIFIC: This grant is highly sector-specific, focusing on health, microbiome research, and the development of precision probiotic therapies.
Geographic scope: Organizations based in the United States are eligible to apply. Foreign components (collaborators) are allowed as part of a US-led project, but foreign organizations cannot be lead applicants.
Key filtering criteria: Focus on mechanistic research on probiotics, requiring preliminary data on host biological patterns, and excluding efficacy or effectiveness clinical trials.
Grant frequency: This is a recurring funding opportunity, noted as a 'Reissue' of a previous PAR.

Financial Structure

Award Budget: The application budget must not exceed $350,000 in direct costs per year.
Project Period: The total project period may not exceed 4 years.
Eligible Costs: Costs must align with the NIH Grants Policy Statement.
Ineligible Costs: Not explicitly detailed, but efficacy or effectiveness clinical trials are not supported.
Matching Fund Requirements: This funding opportunity does not require cost sharing.
Pre-award Costs: Allowable only as described in the NIH Grants Policy Statement Section 7.9.1.
Financial Reporting: Recipients are required to submit annual Research Performance Progress Reports (RPPR) and financial statements.
Audit Requirements: Subject to general federal audit requirements (2 CFR Part 200).
Indirect Cost Policies: Subject to NIH Grants Policy Statement.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: With 501(c)(3) IRS Status (other than Institutions of Higher Education), Without 501(c)(3) IRS Status (other than Institutions of Higher Education).
For-Profit Organizations: Small Businesses, Other For-Profit Organizations.
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized and 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 (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations.
Foreign Organizations: Not eligible to apply as the lead applicant. Foreign components are allowed.

Registration Requirements

Applicant organizations must complete and maintain active registrations with:
- System for Award Management (SAM) - requires annual renewal.
- Unique Entity Identifier (UEI) - issued as part of SAM.gov registration; must be consistent across all registrations.
- eRA Commons - organization must identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov.
For foreign organizations participating as components, a NATO Commercial and Government Entity (NCAGE) Code is required for SAM registration.
All Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account, affiliated with the applicant organization.

Project/Research Requirements

Proposed projects must focus on testing the causality of potential host biological patterns affecting probiotic responses.
Applications must be based on a clear scientific premise and compelling rationale, supported by preliminary data demonstrating identified host patterns correlated with probiotic usage/interventions.
Studies must be rigorously designed, using relevant/innovative animal models or human subjects.
This NOFO will not support efficacy or effectiveness clinical trials.
For clinical trials, only mechanistic trials (designed to understand biological processes or mechanism of action, not efficacy/safety) are in scope. Prior FDA consultation for Investigational New Drug (IND) application is required if applicable.

Application Process

Application Deadlines and Submission

Earliest Submission Date: May 02, 2025.
Application Due Dates (New/Renewal/Resubmission/Revision):
- June 02, 2025
- February 02, 2026
- October 01, 2026
- June 02, 2027 (Latest deadline)
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Submission Process: Applications must be submitted electronically via NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Letter of Intent (LOI): Not required, not binding, but encouraged by specific dates (e.g., May 02, 2025 for June 02, 2025 deadline). Includes descriptive title, PD/PI contact info, key personnel, participating institutions, funding opportunity number/title.

Required Documentation and Materials

SF424(R&R) Forms: Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R Budget, R&R Subaward Budget.
PHS 398 Forms: Cover Page Supplement, Research Plan.
- Research Strategy: Must include a clear outline of preliminary data supporting the biological rationale for studying host patterns and evidence of health effect from probiotic intervention.
- Resource Sharing Plan: Required.
- Data Management and Sharing Plan: Required for all projects generating scientific data, regardless of direct costs.
PHS Human Subjects and Clinical Trials Information: Required if human subjects research, clinical research, and/or NIH-defined clinical trials are involved.
PHS Assignment Request Form.
Appendix: Only limited materials allowed (e.g., blank questionnaires). No publications.

Review and Award Cycle (for June 02, 2027 deadline)

Scientific Merit Review: November 2027.
Advisory Council Review: January 2028.
Earliest Start Date: April 2028.

Post-Award Requirements

Reporting: Annual Research Performance Progress Reports (RPPR), final RPPR, invention statement, and expenditure data for closeout.
ClinicalTrials.gov Registration: Required for applicable clinical trials, and NIH expects registration and results reporting for all trials.
IRB/IEC Approval: 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.
Investigational New Drug (IND) or Investigational Device Exemption (IDE): Required for clinical research projects involving investigational therapeutics/devices.
Mandatory Disclosures: Any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award must be disclosed.

Evaluation Criteria

Applications will be evaluated for scientific and technical merit by NIH's peer review system. The focus is on determining the causation of host biological patterns to identify probiotic responder subgroups and enhance therapeutic outcomes. Overall Impact

Reviewers provide an overall impact score based on the likelihood of the project to exert a sustained, powerful influence on the research field.

Scored Review Criteria

Factor 1: Importance of the Research (Significance and Innovation)
- Does the project address an important problem or critical barrier to progress in the field?
- Does the project challenge existing paradigms or develop new methodologies/technologies?
- Does it contribute to understanding human heterogeneity in probiotic responses?
Factor 2: Rigor and Feasibility (Approach)
- Is the research strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims?
- Are potential problems, alternative strategies, and benchmarks for success presented?
- Is the proposed work sufficiently rigorous to yield robust and unbiased results?
- Does the application provide clear outline of preliminary data supporting biological rationale for host patterns?
- Does it show clear evidence of a meaningful and detectable health effect of the probiotic intervention from preclinical or clinical studies?
- For clinical trials, are definitions and restrictions for mechanistic trials met?
Factor 3: Expertise and Resources (Investigator(s) and Environment)
- Are the PD/PI(s) and other key personnel well-suited to the project?
- Does the project environment contribute to the probability of success?
- Is there access to necessary facilities, equipment, and other resources?

Additional Review Considerations (not scored, but influence overall impact)

Protections for Human Subjects: Adequacy of protections for human research participants.
Vertebrate Animals: Appropriate use and care of vertebrate animals.
Biohazards: Identification and mitigation of biohazards.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justification and reasonableness of the budget and requested project period in relation to the proposed research.
Cross-cutting themes: Inclusion of sex as a biological variable is highly valued, particularly for understanding differential responses to probiotic interventions.

Compliance & Special Requirements

Regulatory Compliance

FDA Regulations: Research involving probiotics as drugs must adhere to relevant FDA regulations. Prior contact with FDA to determine if an Investigational New Drug (IND) application is necessary is required. If required, applicant must hold or reference an open IND with no clinical hold prior to award.
Federal Regulations: All awards are subject to 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and 42 CFR Part 52.
Nondiscrimination: Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).

Data Management and Privacy

Data Management and Sharing Plan: Required for all projects that generate scientific data. Recipients must adhere to and implement the plan upon approval.
Cybersecurity: Recipients and subrecipients with ongoing access to HHS systems or data (PII/PHI) must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical Standards

Human Subjects Research: Strict compliance with protection for human subjects is required, including IRB/IEC approval and data/safety monitoring.
Vertebrate Animals: Compliance with regulations regarding the care and use of vertebrate animals in research.
Biohazards: Proper management and mitigation of biohazards.

Specific Research Considerations

Focus: This grant specifically targets mechanistic research to understand causality of host factors on probiotic responses, not efficacy or effectiveness clinical trials.
Preliminary Data: Strong emphasis on providing compelling preliminary data for identified host biological patterns correlated with probiotic usage.
Interdisciplinary Approach: Projects leveraging advanced computational and Artificial Intelligence (AI) approaches to understand complex systems (microbiome, host, environment) are encouraged.
Sex as a Biological Variable (SABV): Applicants are encouraged to account for sex as a biological variable in their research designs, particularly given observed variability in probiotic responses between sexes.
Participating Institutes' Interests: Applicants should align their research with the specific interests of participating NIH institutes (NCCIH, NIA, NIDCR, NCI) and co-funding offices (ORWH, ODS).
Office of Dietary Supplements (ODS): ODS does not award grants directly but co-funds relevant projects; applications must also be relevant to a participating NIH Institute/Center.

Grant Details