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Grant Analysis

Purpose & Target

The core objective of this R01 grant is to encourage research that develops novel screening approaches and/or therapeutic interventions for screenable disorders in newborns. This includes conditions already part of newborn screening panels and potentially fatal or disabling genetic conditions that could benefit from early detection. - Target recipients: A wide range of organizations including Higher Education Institutions, Nonprofits, For-Profit Organizations (including Small Businesses), various levels of Government (Local, State, Federal, Tribal), Independent School Districts, Public Housing Authorities, Tribal Organizations, Faith-based/Community-based Organizations, Regional Organizations, and Foreign Organizations. - Organizational size: Not explicitly limited, open to organizations of various capacities capable of conducting research. - Designation: SECTOR-SPECIFIC (Healthcare/Biomedical Research). - Geographic scope: Eligible organizations from the United States and non-U.S. entities (foreign organizations) are welcome to apply. - Key filtering criteria: Projects must focus on research related to newborn screening technologies, assays, or therapeutic interventions for genetic and congenital disorders in infants. - Grant frequency: This is a recurring grant opportunity with multiple application due dates until its expiration in November 2027, reissuing a previous program.

Financial Structure

Budget range: Application budgets are not limited but must reflect the actual needs of the proposed project.
Eligible costs: Not exhaustively detailed, but generally covers costs associated with research projects, as per NIH Grants Policy Statement and cost principles. Pre-award costs are allowable as described in NIH Grants Policy Statement Section 7.9.1.
Ineligible costs: Not specifically listed; implied by adherence to NIH Grants Policy Statement.
Matching fund requirements: No cost sharing is required by this funding opportunity.
Co-financing requirements: No co-financing is required.
Payment schedule: Not explicitly defined in the NOFO, subject to standard NIH grant disbursement mechanisms.
Financial reporting requirements: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements. A final RPPR and expenditure data are required for closeout.
Audit requirements: Subject to 2 CFR Part 200, which typically requires audits for entities expending $750,000 or more in Federal awards in a fiscal year.
Indirect cost policies: Not specified in this NOFO, but NIH grants generally cover indirect costs based on negotiated institutional rates.
Financial guarantees: Not specified.
Budget flexibility: Not specified, but budgets must be justified and reasonable relative to the research.
Special budget consideration: Applicants requesting $500,000 or more in direct costs (excluding consortium F&A) in any single year must contact a Scientific/Research Contact at least six weeks before submitting the application.

Eligibility Requirements

Organization Types

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: With or without 501(c)(3) IRS Status (other than Institutions of Higher Education).
For-Profit Organizations: Small Businesses, Other than Small Businesses.
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal (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: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are eligible.

Registrations

System for Award Management (SAM): Applicants must complete and maintain an active registration, requiring annual renewal. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) code to register in SAM.
Unique Entity Identifier (UEI): Obtained as part of the SAM.gov registration process, and must be used consistently across all registrations and the grant application.
eRA Commons: Organizations must register with eRA Commons, identifying at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Applicants must have an active SAM registration to complete Grants.gov registration.
All required registrations must be completed prior to application submission.

Principal Investigator Requirements

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research can serve as Program Director(s)/Principal Investigator(s).
All PD(s)/PI(s) must have an eRA Commons account, affiliated with the applicant organization.

Application Limitations

Applicant organizations may submit more than one application, provided each application is scientifically distinct.
Duplicate or highly overlapping applications under review at the same time are not accepted.

Application Process

Application Process & Submission

Application Package Access: Available via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Instructions: Applicants must strictly follow the "Research (R) Instructions in the How to Apply - Application Guide" unless program-specific instructions deviate.
Submission Format: Applications must be submitted electronically; paper applications are not accepted.
Submission Flow: Submit to Grants.gov, then track application status in eRA Commons.
Submission Timing: Early submission is encouraged to allow time for error correction. If a due date falls on a weekend or federal holiday, the deadline is extended to the next business day.
Verification: Applicants are responsible for reviewing their application in eRA Commons before the due date to ensure accurate and successful submission.
Required IDs: All Program Director(s)/Principal Investigator(s) must include their eRA Commons ID.
Entity ID Consistency: The organization's Unique Entity Identifier (UEI) must match across SAM, eRA Commons, and the application.
Review Readiness: Applications will be screened for completeness and compliance by the Center for Scientific Review; incomplete or non-compliant applications will not be reviewed.
Mandatory Disclosures: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity that could affect the federal award.

Key Dates

Open Date (Earliest Submission Date): January 05, 2025.
Application Due Dates (New applications):
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 (Latest for new applications)
Application Due Dates (Renewal/Resubmission/Revision):
March 05, 2025
July 05, 2025
November 05, 2025
March 05, 2026
July 05, 2026
November 05, 2026
March 05, 2027
July 05, 2027
November 05, 2027 (Latest for renewal/resubmission/revision applications)
Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date of NOFO: November 17, 2027.

Project Period & Milestones

Grant Duration: The maximum project period allowed is 5 years.
Project Planning: The scope of the proposed project should determine the requested project period.
Clinical Trial Milestones: If a clinical trial is proposed, a Milestone Plan must be included, detailing timelines for regulatory approvals, participant enrollment (at 25%, 50%, 75%, 100%), data collection completion, and primary/secondary endpoint analysis.

Post-Award Requirements & Reporting

Annual Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required.
Closeout Reporting: A final RPPR, an invention statement, and expenditure data are required for award closeout.
ClinicalTrials.gov Reporting: If the award involves clinical trials, the responsible party must register and submit results information on ClinicalTrials.gov.

Supporting Materials & Documentation

Data Management and Sharing Plan (DMS Plan): Required for all applications that will generate scientific data, regardless of the direct costs requested. The plan must address elements described in NOT-OD-21-014.
Appendix Materials: Only limited Appendix materials are allowed, specifically blank questionnaires or blank surveys. No publications or other materials are permitted.
Human Subjects/Clinical Trials Information: If human subjects research is involved, a human subjects study record using the PHS Human Subjects and Clinical Trials Information form is required.

Evaluation Criteria

Overall Impact

Reviewers assess 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): Assesses the project's potential contribution and novelty. Scored separately.
Factor 2: Rigor and Feasibility (Approach): Evaluates the soundness of the research design and its practicability. Scored separately.
Factor 3: Expertise and Resources (Investigator(s) and Environment): Considers the qualifications of the research team and the adequacy of the proposed research environment.

Additional Review Criteria (considered, but not scored)

Protections for Human Subjects: Assessment of safeguards for human participants, if applicable.
Vertebrate Animals: Evaluation of procedures involving animals, justifications, interventions to minimize discomfort, and euthanasia methods, if applicable.
Biohazards: Assessment of significant hazards and proposed protections for research personnel/environment, if applicable.
Resubmissions: Review of the complete, re-submitted application.
Renewals: Evaluation of progress made during the previous funding period.
Revisions: Assessment of the appropriateness of any proposed expansion in project scope.

Additional Review Considerations (considered, but not scored)

Authentication of Key Biological and/or Chemical Resources: Review of plans for validating these resources.
Budget and Period of Support: Evaluation of whether the requested budget and project duration are justified and reasonable for the proposed research.

Project Specific Requirements for Evaluation

Relevance: Applications must be relevant to conditions currently included in newborn screening panels or those that would benefit from presymptomatic detection and early intervention.
Innovation: Proposed projects must clearly demonstrate innovation through the development of new therapies, screening tools, technologies, or the novel application of existing ones.
Scaling Up: Projects focused on screening approaches should outline implications or strategies for scaling up methods/findings to newborn screening settings or supporting state health agencies.
Multiplexed Technology: For new screening assays, development of multiplexed technology allowing simultaneous screening for multiple disorders is encouraged.
Pilot Tests: For pilot tests of screening technologies, efforts to recruit diverse, underrepresented groups and understand epidemiology/assay performance across populations should be described.
Preclinical Studies: Should address gaps required to develop screening or therapy for newborn screening conditions.
Therapeutics: Projects focusing on therapeutics must clearly explain how they facilitate therapeutic development for target conditions and specify validated primary and major secondary endpoints.

Compliance & Special Requirements

Regulatory Compliance

Federal Regulations: All awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement, Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Non-discrimination: Recipients must comply with all applicable non-discrimination laws and submit an Assurance of Compliance (HHS-690).
Health IT Standards: If award funding involves health IT implementation/acquisition/upgrading, the IT must meet standards in 45 CFR part 170, Subpart B, and if for eligible clinicians/hospitals, be ONC Health IT Certified.
Cybersecurity: Recipients handling HHS-owned information or PII/PHI must develop plans/procedures modeled after the NIST Cybersecurity framework.

Data Management & Sharing

NIH Policy Compliance: Adherence to the 2023 NIH Policy for Data Management and Sharing is mandatory for projects generating scientific data.
DMS Plan: A detailed Data Management and Sharing Plan (DMS Plan) is required with the application, to be reviewed and approved by NIH Program Staff prior to award.
Human Data Sharing: For human data, the NICHD encourages the use of the Data and Specimen Hub (DASH). For large-scale human genetic data, applicants should provide a Provisional or Institutional Certification for sharing via an NIH-approved repository (e.g., dbGaP, Sequence Read Archive) in line with the NIH Genomic Data Sharing Policy.

Ethical & Human Subjects Requirements

IRB/IEC Approval: All human subject protocols must be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Data and Safety Monitoring: Oversight and monitoring are required for all NIH-supported human biomedical and behavioral intervention studies (clinical trials) to ensure participant safety and data integrity.
IND/IDE Requirements: Clinical research involving investigational therapeutics, vaccines, or medical interventions must be performed under an FDA investigational new drug (IND) or investigational device exemption (IDE).

Research Scope and Focus

Clinical Trial Option: This funding opportunity is 'Clinical Trial Optional', meaning applications proposing or not proposing clinical trial(s) are accepted.
Core Research Areas: The grant specifically targets research on novel screening approaches and therapeutic interventions for conditions included in newborn screening panels or potentially benefiting from early detection (e.g., metabolic disorders, lysosomal disorders, hemoglobinopathies, neuromuscular disorders, congenital heart disease, genetic conditions leading to intellectual disabilities).
Technical Scope: Includes development/validation of new screening technologies/assays (especially multiplexed ones), adaptation for low-resource settings, use of AI/computational modeling, preclinical testing, and clinical trials.
Cross-cutting Themes: The grant encourages research addressing the ethical, legal, and social implications (ELSI) of novel screening technologies/therapies, and studies on health systems outcomes/access to care, especially for medically underserved communities.
Strategic Alignment: Applicants proposing clinical trials or interventional studies are strongly encouraged to contact Scientific/Research staff prior to submission.

Grant Details