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Grant Analysis

Purpose & Target

Core objective: Expand knowledge of the natural history of disorders that currently are, or may become, part of statewide newborn screening programs to facilitate appropriate interventions.
Target recipient type and size: A broad range of organizations including Higher Education Institutions, Nonprofits, For-Profit Organizations (including Small Businesses), Local and Federal Governments, and other entities. There is no specified organizational size limit.
SECTOR-SPECIFIC: This grant is primarily focused on the Healthcare/Medical Research, Public Health, Child Health, Genetics, and Rare Diseases sectors.
Geographic scope: Organizations from the United States and non-U.S. (Foreign Organizations) are eligible to apply.
Key filtering criteria for initial grant screening: Applicants must focus on disorders related to newborn screening and propose research that addresses specific goals such as identifying underlying biological mechanisms, improving diagnostic accuracy, facilitating clinical trials, or establishing data collection systems.
Grant frequency and program context: This is a recurring funding opportunity with multiple application cycles per year until October 2027. It is a reissue of PAR-21-115 and is part of the Hunter Kelly Newborn Screening Research Program within NICHD, aligning with recommendations from the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) and the Recommended Uniform Screening Panel (RUSP).

Financial Structure

Budget: Application budgets are not limited; however, they must reflect the actual needs of the proposed project. There are no explicit minimum or maximum grant amounts per application stated.
Currency: The grant funding will be provided in USD (United States Dollar).
Cost Sharing: Co-financing or matching funds are not required for this grant opportunity.
Eligible costs: All NIH awards are subject to the terms, conditions, and cost principles described in the NIH Grants Policy Statement. Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Direct Costs: If an applicant requests $500,000 or more in direct costs in any single year (excluding consortium F&A), they must contact a Scientific/Research Contact at least 6 weeks before submitting their application.
Financial Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements as required by the NIH Grants Policy Statement. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award.
Audit Requirements: As a Federal award, projects are subject to audit requirements as per 2 CFR Part 200.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions:
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
Nonprofits Other Than Institutions of Higher Education:
- Nonprofits with 501(c)(3) IRS Status
- Nonprofits without 501(c)(3) IRS Status
For-Profit Organizations:
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments:
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
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
- Non-domestic (non-U.S.) Entities (Foreign Organizations)

Required Registrations

Applicant organizations must complete and maintain active registrations for:
- System for Award Management (SAM) – requires annual renewal.
- NATO Commercial and Government Entity (NCAGE) Code – required for foreign organizations in lieu of a CAGE code.
- Unique Entity Identifier (UEI) – issued as part of the SAM.gov registration process, must be used consistently across all registrations and the grant application.
- eRA Commons – organizational registration required, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
- Grants.gov – requires an active SAM registration.
All PD(s)/PI(s) must have an eRA Commons account affiliated with the applicant organization.
Registrations can take 6 weeks or more; early initiation is strongly advised as failure to complete registrations is not a valid reason for late submission.

Geographic Location

Organizations located in the United States and Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Application Limitations

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time.

Cost Sharing

This funding opportunity does not require cost sharing.

Application Process

Application Deadlines

Applications are due by 5:00 PM local time of the applicant organization on the following dates:
- February 05, 2025
- June 05, 2025
- October 05, 2025
- February 05, 2026
- June 05, 2026
- October 05, 2026
- February 05, 2027
- June 05, 2027
- October 05, 2027 (This is the latest possible submission deadline).
A Letter of Intent (LOI) is encouraged 30 days prior to the application due date, though it is not required nor binding.
If a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Submission Process

Applications must be submitted electronically through one of the following methods:
- NIH ASSIST system.
- An institutional system-to-system (S2S) solution.
- Grants.gov Workspace.
All required registrations (SAM, UEI, eRA Commons, Grants.gov) must be active and in place prior to submitting the application. Allow sufficient time for registration (6+ weeks).
Applicants are strongly encouraged to submit early to allow time for correcting any errors found during the submission process.
It is critical to adhere to all instructions provided in the 'Research (R) Instructions in the How to Apply - Application Guide' and any program-specific instructions outlined in the NOFO. Non-compliant applications may be delayed or not accepted for review.
Applicants must view their application in eRA Commons before the due date to ensure successful submission.

Required Documentation and Materials

Standard NIH application forms including SF424(R&R) (e.g., Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, Budget forms) and PHS 398 forms (e.g., Cover Page Supplement, Research Plan, Human Subjects and Clinical Trials Information, Assignment Request Form).
The Research Plan must include:
- A detailed Research Strategy that demonstrates the need for further natural history knowledge for the chosen condition(s) and explains how the proposed studies would either improve clinical decision-making or provide evidence to justify adding the condition(s) to newborn screening panels.
- A Resource Sharing Plan.
- A Data Management and Sharing Plan – required for all applications planning research that generates scientific data, regardless of the direct costs requested.
Appendix materials are strictly limited to blank questionnaires or blank surveys only.
All page limitations specified in the NIH 'Table of Page Limits' must be strictly followed.

Project Implementation Timeline

The maximum project period for this grant is 5 years. The scope of the proposed project should determine the requested project period.

Reporting Obligations

Annual Reporting: Recipients must submit a Research Performance Progress Report (RPPR) and financial statements annually.
Closeout Reporting: A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required for award closeout.
ClinicalTrials.gov Registration: If the award involves one or more clinical trials, the responsible party must register and submit results information on ClinicalTrials.gov.

Post-Award Requirements and Compliance

All activities conducted under the award are subject to the provisions outlined in the Notice of Award (NoA), the NIH Grants Policy Statement, and applicable statutory provisions.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols involving human subjects.
Clinical trials are subject to NIH policies on Data and Safety Monitoring Requirements.
Clinical research involving investigational therapeutics or devices may require Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE).
Recipients must adhere to mandatory disclosure requirements for violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Evaluation Criteria

Overall Impact

Reviewers will provide an overall impact score reflecting their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.

Scored Review Criteria

Factor 1. Importance of the Research (Significance and Innovation):
- Evaluates how the project addresses an important problem or a critical barrier to progress in the field.
- Assesses the project's novelty and potential to generate new concepts, approaches, or methodologies.
Factor 2. Rigor and Feasibility (Approach):
- Examines the conceptual framework, design, methods, and analyses for being well-reasoned and appropriate to accomplish the specific aims.
- Considers the scientific rigor of the proposed research to ensure robust and unbiased results.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
- Evaluates the appropriateness of the proposed project's team, including their experience, qualifications, and complementary expertise.
- Assesses the institutional support, facilities, and resources available to the project for its successful execution.

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

Protections for Human Subjects: Adequacy of protections for research participants, including ethical considerations and regulatory compliance.
Vertebrate Animals: If applicable, evaluation of proposed animal care and use plans.
Biohazards: Assessment of potential hazards from materials/procedures and the adequacy of proposed protection measures.
Resubmissions: Evaluation of the full application as newly presented, considering previous feedback.
Renewals: Assessment of the progress made in the previous funding period.
Revisions: Evaluation of the appropriateness and justification of any proposed expansion of the project's scope.

Additional Review Considerations (not scored, and do not directly influence the overall impact score)

Authentication of Key Biological and/or Chemical Resources: Review of plans for ensuring the validity and reproducibility of key resources.
Budget and Period of Support: Evaluation of whether the requested budget and project duration are fully justified and reasonable in relation to the proposed research scope.

Review and Selection Process

Applications undergo scientific and technical merit evaluation by a Scientific Review Group.
A second level of review is conducted by the National Advisory Child Health and Human Development (NACHHD) Council.
Funding decisions consider: (1) Scientific and technical merit, (2) Availability of funds, and (3) Relevance of the proposed project to program priorities.

Compliance & Special Requirements

Regulatory Compliance

Projects must comply with the Public Health Service Act (Sections 301 and 405) and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
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 all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).

Data Protection and Privacy

A Data Management and Sharing Plan is mandatory for all projects that result in the generation of scientific data.
For activities involving ongoing and consistent access to HHS-owned/operated information or operational technology systems, or handling Personal Identifiable Information (PII) or Personal Health Information (PHI) obtained from HHS, recipients are required to develop plans and procedures modeled after the NIST Cybersecurity framework.

Health Information Technology (Health IT) Requirements

If funding is used for implementing, acquiring, or upgrading Health IT, it must meet standards and implementation specifications adopted in 45 CFR part 170, Subpart B, where applicable.
For activities involving eligible clinicians in ambulatory settings or hospitals, Health IT must be certified under the ONC Health IT Certification Program, if certified technology can support the activity.

Ethical Standards and Oversight

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for all protocols involving human subjects.
Compliance with Data and Safety Monitoring Requirements is necessary for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).
Projects involving investigational therapeutics or devices must adhere to Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements, consistent with federal regulations.
Proposed research that includes biohazards will be evaluated for potential risks to personnel and environment, and the adequacy of proposed protection.

Unique Aspects and Innovation Expectations

While a natural history study by its nature may not be hypothesis-driven or innovative in its fundamental design, innovation is specifically sought in other aspects of the study, such as:
- Novel methods for screening and/or diagnosis that improve sensitivity, efficiency, or reliability.
- Novel insights regarding stratification of affected populations for understanding disease etiology, progression, or response to therapy.
- Novel approaches for identifying biomarkers or phenotypic features that predict disease course and/or response to intervention.
- Novel methods of reaching underserved patient populations.
The NOFO encourages applications proposing multi-state consortia of screening programs to provide natural history information for one or more disorders.
Emphasis is placed on the standardization of data collection, the use of existing NIH Common Data Elements (CDEs), and how these techniques will facilitate data integration and collaboration.
Applications should describe how proposed assessments have been, or will be, validated.

Mandatory Disclosures

Recipients must report any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Grant Details