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Grant Analysis

Purpose & Target

GRANT PURPOSE AND TARGET: - The core objective of this grant is to support small research projects that analyze genomic and phenotypic data from the Gabriella Miller Kids First Pediatric Research Program (Kids First) related to childhood cancers and structural birth defects. - It also supports the development of new approaches, tools, or algorithms for analyzing this Kids First data. - Target recipients are diverse organizations with research capacity, including universities, non-profits, for-profits, and various government entities. - This grant is SECTOR-SPECIFIC, focusing on pediatric health research, genomics, and data science applied to childhood cancer and structural birth defects. - Geographic scope is international, as Non-domestic (non-U.S.) Entities are eligible. - Key filtering criteria: Applicant must have access to or propose to use Kids First X01 datasets; project must not involve clinical trials; focus on data analysis or tool development related to pediatric cancer/birth defects genomics. - This is a recurring funding opportunity, a reissue of a previous announcement (PAR-23-075), indicating an ongoing program context.

Financial Structure

FINANCIAL STRUCTURE: - Award Budget: The combined budget for direct costs for the two-year project period may not exceed $200,000. - Grant Type: This is an R03 Small Grant Program, intended for discrete, well-defined projects requiring limited funding. - Cost Sharing: This funding opportunity does not require cost sharing. - Eligible Costs: Standard NIH cost principles apply, including allowable pre-award costs as described in the NIH Grants Policy Statement. - Financial Reporting: Awardees are required to submit an annual Research Performance Progress Report (RPPR) and financial statements. - Closeout Reporting: A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for closeout.

Eligibility Requirements

ELIGIBILITY REQUIREMENTS: Organizational Types

UNIVERSITY: Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education
NGO: 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)
SME: Small Businesses
ENTERPRISE: For-Profit Organizations (Other than Small Businesses)
PUBLIC: Local Governments (State, County, City or Township, Special District), Indian/Native American Tribal Governments (Federally Recognized, Other), Eligible Agencies of the Federal Government, U.S. Territory or Possession, Public Housing Authorities/Indian Housing Authorities
OTHER: Independent School Districts, 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 Organizations).

Geographic and Legal Requirements

Foreign organizations (non-U.S. entities) and non-domestic components of U.S. organizations are eligible.
Applicant organizations must complete and maintain active registrations in:
System for Award Management (SAM) with annual renewal.
NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations).
Unique Entity Identifier (UEI) (issued via SAM.gov).
eRA Commons (requires identifying at least one Signing Official and one Program Director/Principal Investigator).
Grants.gov.
All registrations must be completed prior to application submission; can take 6+ weeks.

Project Scope Limitations

Projects must NOT involve clinical trials. Only applications that do not propose clinical trials are accepted.
Proposed data analyses must utilize Kids First X01 datasets (available via Kids First Data Resource Portal and dbGaP).
Co-analysis with other whole genome sequence data is eligible if external data is publicly accessible through a controlled access database or can be shared through one.

Individual Qualifications

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must have the skills, knowledge, and resources necessary for the proposed research.
Multiple PDs/PIs are allowed, requiring a leadership plan.

Application Process

APPLICATION PRACTICAL INFORMATION: Application Submission Deadlines

Applications are due by 5:00 PM local time of the applicant organization on the following dates:
February 16, 2025
June 16, 2025
October 16, 2025 (latest deadline)
If a due date falls on a weekend or Federal holiday, the deadline is extended to the next business day.
Applicants are encouraged to submit early to allow time for corrections.

Submission Method

Applications must be submitted electronically through one of the following:
NIH ASSIST system.
An institutional system-to-system (S2S) solution.
Grants.gov Workspace.

Required Registrations (must be completed before submission)

System for Award Management (SAM) registration (requires annual renewal).
Unique Entity Identifier (UEI) (assigned via SAM.gov).
eRA Commons registration (requires a Signing Official and Program Director/Principal Investigator account).
Grants.gov registration.
Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', unless specified otherwise in this NOFO.
Standard forms include 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, PHS Human Subjects and Clinical Trials Information (if applicable), PHS Assignment Request Form.
Research Strategy: Must describe Kids First X01 datasets (and/or external data) to be used, including dbGaP 'phs' study accession number(s).
Resource Sharing Plan: Required to address how tools, workflows, and/or pipelines created or used will be shared (open-source practices encouraged).
Data Management and Sharing Plan: Required for all applications generating scientific data, outlining how scientific data and metadata will be managed and shared (must be submitted in 'Other Plans' attachment).
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys); no publications or other materials.

Project Duration and Reporting

Project duration may be up to two years.
Annual Research Performance Progress Reports (RPPR) and financial statements are required.
A final RPPR, invention statement, and expenditure data are required for closeout.

Post-Submission

Applicants are required to follow instructions for post-submission materials.
If a system issue beyond control threatens timely submission, follow the 'Dealing with System Issues' guidance.

Application Assistance

eRA Service Desk: For questions on ASSIST, eRA Commons, application errors, system problems.
General Grants Information: For application instructions, processes, and NIH grant resources.
Grants.gov Customer Support: For Grants.gov registration and Workspace issues.
Scientific/Research Contacts, Peer Review Contacts, and Financial/Grants Management Contacts are provided in the NOFO for specific inquiries.

Evaluation Criteria

EVALUATION CRITERIA: Overall Impact Score

Reviewers will provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field(s).
This score is based on the scored review criteria and additional review criteria.

Scored Review Criteria (Factors 1, 2, and 3 contribute to scientific merit and overall impact; Factors 1 and 2 receive separate criterion scores)

Factor 1. Importance of the Research (Significance and Innovation):
Does the project address an important problem?
Will the project shift current research paradigms or provide new insights?
Is the proposed research novel and innovative in its concepts, approaches, or tools?
Factor 2. Rigor and Feasibility (Approach):
Are the overall strategy, methodology, and analyses well-reasoned and appropriate?
Are potential problems, alternative strategies, and benchmarks for success presented?
Is the project design robust and unbiased?
Is the proposed work feasible within the R03 small grant scope (discrete, well-defined, limited funding, completable in two years)?
For data analysis, is the use of Kids First X01 datasets and/or external data clearly described and justified?
Factor 3. Expertise and Resources (Investigator(s) and Environment):
Do the investigator(s) possess appropriate background, training, and expertise?
For multiple PDs/PIs, is the leadership plan effective for coordination and collaboration?
Are institutional resources appropriate and adequate for successful execution?

Additional Review Criteria (considered for overall impact, but not separately scored)

Protections for Human Subjects (if applicable):
Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge gained, data and safety monitoring.
For exempt research: justification for exemption, human subjects involvement/characteristics, sources of materials.
Vertebrate Animals (if applicable):
Description of procedures, justification for use, interventions to minimize discomfort, justification for euthanasia method (if applicable).
Biohazards (if applicable):
Evaluation of hazardous materials/procedures and proposed protections.
Resubmissions:
The full application as presented will be evaluated.

Additional Review Considerations (do not receive scores)

Authentication of Key Biological and/or Chemical Resources (if applicable):
Plans for identifying and ensuring validity of resources.
Budget and Period of Support:
Evaluation of whether the budget and requested period are justified and reasonable.

Compliance & Special Requirements

COMPLIANCE AND SPECIAL REQUIREMENTS: Regulatory and Legal Compliance

All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
Compliance with Federal Regulations (2 CFR Part 200, 42 CFR Part 52) and the Public Health Service Act is required.
Awardees must comply with applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
Mandatory disclosure of federal criminal law violations (fraud, bribery, gratuity) to NIH and HHS Office of Inspector General.

Data Management and Sharing

A Data Management and Sharing Plan (DMSP) is mandatory for all applications and will be reviewed and approved prior to award.
Scientific data generated (raw, derived, aggregated, summary) must be shared with the wider scientific community as soon as possible, no later than publication or end of award.
Controlled access data must be submitted to the Kids First Data Resource Center or an NIH-approved repository (e.g., dbGaP).
Open access data may be shared through any established repository meeting NIH criteria.
Resource Sharing Plan (for tools, workflows, pipelines) is also required, encouraging open-source practices.
If co-analyzing non-Kids First genomic data not in an NIH-approved repository, a plan for submission to an NIH-approved repository and an Institutional Certification (or Provisional Certification) is required.

Ethical Standards and Oversight

Human Subjects Protections: If human subjects are involved, compliance with 45 CFR Part 46 and IRB/IEC approval is mandatory.
Vertebrate Animals: If applicable, involvements must adhere to specified criteria.
Biohazards: If applicable, adequate protection for personnel/environment must be proposed.

Special Programmatic Requirements

Projects must focus on analyses of Kids First genomic/phenotypic datasets (childhood cancer and/or structural birth defects) or development of related tools/algorithms.
Clinical trials are explicitly not allowed.
Collaboration with the Kids First Data Resource Center is encouraged to avoid redundancy or foster partnerships.

Unique Aspects and Challenges

This grant leverages a significant existing data resource (Kids First data) to advance pediatric health research.
Emphasis is on data reuse, integration, and the development of new analytical methodologies.
A key requirement is the commitment to data and tool sharing, promoting open science and reproducibility within the pediatric research community.
Potential challenge for applicants lies in obtaining evidence of approval to access proposed datasets (e.g., dbGaP Data Access Requests) prior to award, if applicable.

Grant Details