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Grant Analysis

Purpose & Target

This grant, PAR-25-266, from the National Institutes of Health (NIH) through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), aims to fund exploratory or novel research projects (R21 activity code) focused on developing new screening methods or treatments for conditions that are part of newborn screening programs or could be added in the near future. The grant is SECTOR-SPECIFIC, targeting healthcare and research. It's open to a wide range of U.S. and international organizations, seeking to improve early detection and intervention for potentially fatal or disabling genetic conditions in newborns. This is a recurring funding opportunity.

Financial Structure

Funding Amounts This R21 grant supports projects with a maximum combined direct cost budget of $275,000 USD over the entire two-year project period. Within this, no more than $200,000 USD can be requested in any single year. There is no specified minimum grant amount per application. Cost Sharing Crucially, this funding opportunity does not require cost sharing or matching funds from the applicant organization. This means the grant is intended to cover 100% of the approved eligible direct costs within the stated limits. Eligible and Ineligible Costs All eligible costs and spending must align with the general principles outlined in the NIH Grants Policy Statement. Pre-award costs are generally allowable only under specific conditions detailed in the NIH Grants Policy Statement Section 7.9.1. Financial Reporting and Audit Recipients will be required to submit annual 'Research Performance Progress Reports' (RPPR) and financial statements as per NIH guidelines. A final RPPR, invention statement, and expenditure data are necessary for the closeout of the award. All awards are subject to the uniform administrative requirements, cost principles, and audit requirements for Federal Awards (2 CFR Part 200).

Eligibility Requirements

Who Can Apply This grant is open to a wide variety of organizations, both domestic (U.S.) and non-U.S. (foreign entities). Eligible organizations include:

Higher Education Institutions: This covers both public and private universities and colleges.
Nonprofits: Both those with and without 501(c)(3) IRS status.
For-Profit Organizations: This includes both 'Small Businesses' and other for-profit entities.
Government Entities: Local (county, city, township, special district), State, Indian/Native American Tribal Governments (federally recognized or not), and eligible agencies of the Federal Government.
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, and Regional Organizations.

Key Requirements for All Applicants

No Cost Sharing: This grant does not require any matching funds or cost sharing from the applicant organization.
Scientific Distinction: Organizations can submit more than one application, but each must be scientifically distinct. The NIH will not accept duplicate or highly overlapping applications.
Principal Investigator (PD/PI) Eligibility: Any individual with the necessary skills, knowledge, and resources to conduct the proposed research can serve as a PD/PI.

Mandatory Registrations Before Applying Your organization must complete and maintain several registrations to be eligible. These can take 6 weeks or more, so start early:

System for Award Management (SAM): Requires active registration and annual renewal.
NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations, in lieu of a CAGE code, to register in SAM.
Unique Entity Identifier (UEI): Issued during SAM.gov registration, must be used consistently across all registrations and the application.
eRA Commons: Once your organization's UEI is established, register with eRA Commons. The organization must identify at least one 'Signing Official' (SO) and one 'Program Director/Principal Investigator' (PD/PI) account.
Grants.gov: Requires active SAM registration to complete.

Exclusion Criteria Applications that are incomplete, non-compliant with instructions, or are duplicates/highly overlapping with other pending applications will not be reviewed or accepted.

Application Process

Application Submission Process Applications must be submitted electronically using one of the following methods:

NIH ASSIST system: For preparing, submitting, and tracking your application online.
Institutional system-to-system (S2S) solution: Check with your institution for availability.
Grants.gov Workspace: To prepare and submit your application.

Application Deadlines Applications are due by 5:00 PM local time of your applicant organization. If a due date falls on a weekend or federal holiday, the deadline is extended to the next business day. It's highly recommended to apply early to allow time for corrections. Multiple application cycles are available. The latest submission deadline for new applications is October 16, 2027, and for renewal/resubmission/revision applications, it is November 16, 2027. Project Timeline The total project period may not exceed 2 years. The scope of your proposed project should determine the exact project period. Required Documentation and Materials Applicants must follow the instructions in the 'Research (R) Instructions in the How to Apply - Application Guide', along with program-specific instructions outlined in this funding opportunity. Key components include:

SF424(R&R) forms: Standard cover, project/performance site locations, other project information, senior/key person profile, and budget (R&R or Modular).
PHS 398 Cover Page Supplement.
PHS 398 Research Plan: This section is critical and requires specific content:
- Research Strategy: Must be relevant to newborn screening conditions. Clearly explain the innovation, whether through new developments or novel application of existing methods/technologies. For screening, describe scaling-up strategies and potential for multiplexed technology. For preclinical studies, focus on gaps. For therapeutics, explain how the project facilitates intervention development.
- Resource Sharing Plan: Comply with instructions for sharing resources.
- Data Management and Sharing Plan (DMS Plan): Required for all applications generating scientific data, regardless of direct costs. This plan is reviewed prior to award.
PHS Human Subjects and Clinical Trials Information: If human subjects are involved, include at least one human subjects study record. For clinical trials, a Milestone Plan is required, detailing timelines for regulatory approvals, participant enrollment milestones, data collection/analysis, and the final study report.
PHS Assignment Request Form.

Post-Submission Requirements

Recipients must submit annual 'Research Performance Progress Reports' (RPPR) and financial statements.
A final RPPR, invention statement, and expenditure data are required for award closeout.

Evaluation Criteria

The applications for this grant are evaluated for their scientific and technical merit through a rigorous peer review system. Reviewers will assign an 'overall impact score' based on the potential of the project to have a significant, lasting influence on the research field. Scored Review Criteria Reviewers will specifically score three main factors:

Importance of the Research (Significance and Innovation): How significant and novel is the proposed work? For this R21 grant, 'innovation' is highly valued and can come from developing new therapies/screening tools/technologies, or from creatively applying existing ones to new conditions.
Rigor and Feasibility (Approach): How well-designed and realistic is the proposed research plan? For screening approaches, consider the validity, reliability, sensitivity, specificity, and ability to detect meaningful differences across diverse populations. For preclinical studies, address existing gaps. For therapeutics, clearly explain how the project facilitates intervention development and specify valid endpoints.
Expertise and Resources (Investigator(s) and Environment): Do the research team and the organizational environment have the necessary skills, knowledge, and resources to successfully carry out the project?

Additional Review Considerations (Not Scored Individually) Reviewers will also consider these aspects when determining the overall impact score:

Protections for Human Subjects: If human subjects are involved, evaluation will cover risks, protections, potential benefits, knowledge to be gained, and data/safety monitoring.
Vertebrate Animals: If applicable, justification for animal use, appropriateness of species, and measures to minimize discomfort.
Biohazards: Assessment of hazardous materials/procedures and proposed protections.
Resubmissions/Renewals/Revisions: Progress from previous funding periods or appropriateness of proposed scope expansion.
Authentication of Key Biological and/or Chemical Resources: Plans for validating resources.
Budget and Period of Support: Justification and reasonableness of the requested budget and project duration in relation to the proposed research.

Overall Emphasis For R21 applications, reviewers will place strong emphasis on the conceptual framework, the level of innovation, and the potential to significantly advance knowledge or understanding. Preliminary data is not required but may be included if available. Projects should clearly explain how they provide innovation. For screening approaches, implications and strategies for 'scaling up' to state newborn screening settings are encouraged, especially with multiplexed technology development.

Compliance & Special Requirements

Regulatory Compliance Award recipients must adhere to a broad range of federal regulations and policies:

Uniform Administrative Requirements: All awards are subject to '2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards'.
NIH Grants Policy Statement: This document forms part of the terms and conditions of all NIH awards.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws, confirmed during SAM.gov registration, and submit an 'Assurance of Compliance' (HHS-690).
Public Policy Requirements: Compliance with federal statutes and regulations highlighted in the NIH Grants Policy Statement Section 4.

Research-Specific Compliance

ClinicalTrials.gov: If the award involves one or more clinical trials, the 'responsible party' must register and submit results information for applicable trials on ClinicalTrials.gov.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: All protocols involving human subjects must be reviewed and approved by the recipient's IRB or IEC.
Data and Safety Monitoring: NIH policy requires oversight and monitoring for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure participant safety and data integrity.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) Requirements: Clinical research involving investigational therapeutics, vaccines, or devices must comply with FDA IND/IDE regulations.

Data Management and Sharing (DMS)

Applicants must submit a Data Management and Sharing Plan (DMS Plan). This plan should detail how scientific data will be managed and shared, aiming to maximize data sharing. For human data, NICHD encourages using the 'Data and Specimen Hub (DASH)'. For large-scale human genetic data, compliance with the 'NIH Genomic Data Sharing Policy' is required.

Cybersecurity and Data Protection

Recipients implementing, acquiring, or upgrading health IT must use systems meeting specific standards (45 CFR part 170, Subpart B) and, for certain clinical settings, certified under the ONC Health IT Certification Program.
Organizations with ongoing access to HHS information systems or handling Personally Identifiable Information (PII) or Protected Health Information (PHI) obtained from HHS must develop plans and procedures modeled after the NIST Cybersecurity framework to protect HHS systems and data.

Special Considerations for this R21 Grant

Exploratory/Developmental Focus: This R21 mechanism is specifically for projects that are exploratory, novel, break new ground, extend discoveries, or generate pilot data. It does not require extensive background material or preliminary information, allowing for high-risk, high-reward proposals.
Ethical, Legal, and Social Implications (ELSI): NICHD is interested in applications that include embedded studies exploring ELSI of novel screening technologies or therapeutic approaches.
Diversity and Inclusivity: For pilot tests of screening technologies, applicants are encouraged to describe efforts to recruit diverse, underrepresented groups to understand epidemiology and screening performance across populations.
Mandatory Disclosure: Recipients must report violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Grant Details