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Grant Analysis

Purpose & Target

This grant aims to significantly advance the understanding of early language learning and delay in 'late talking children' by leveraging and integrating existing datasets. It focuses on creating open and shared data resources to identify developmental patterns, predictors, mechanisms, risk factors, and sequelae related to late talking. - Target recipients: Research organizations of various types, including higher education, nonprofits, for-profits (small businesses and others), and government entities. - SECTOR-SPECIFIC: This grant is highly sector-specific, focusing on biomedical research related to developmental language acquisition, communication disorders, and data science. - Geographic scope: Open to domestic (U.S.) and non-domestic (foreign) entities globally. - Key filtering criteria: Must propose research on 'late talking children' using existing data, involving data sharing, secondary data analysis, and/or improving data utility. Clinical trials are not allowed. - Grant frequency: This is a recurring funding opportunity (Reissue of PAR-24-045) with multiple annual application deadlines under the NIH Tackling Acquisition of Language in Kids (TALK) initiative.

Financial Structure

Award budget: The combined direct costs for the two-year project period may not exceed $275,000.
Per year limitation: No more than $200,000 may be requested in any single year.
Indirect costs: Facilities and administrative costs of consortia, when applicable, are exclusive of the direct cost caps.
Cost sharing: This funding opportunity does not require cost sharing.
Financial reporting: Recipients must submit annual Research Performance Progress Reports (RPPR) and financial statements.
Closeout requirements: A final RPPR, invention statement, and expenditure data are required for award closeout.
Pre-award costs: Allowable only as described in the NIH Grants Policy Statement.

Eligibility Requirements

Organizational Eligibility

Eligible organization types include:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with or without 501(c)(3) IRS status)
For-Profit Organizations (Small Businesses and others)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal - Federally Recognized and other)
Federal Governments (Eligible Agencies, U.S. Territory or Possession)
Other entities such as Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations.
Non-domestic (non-U.S.) Entities (Foreign Organizations) and non-U.S. components of U.S. Organizations are eligible.

Registration and Certification

All applicant organizations must complete and maintain active registrations prior to application submission:
System for Award Management (SAM) - requires annual renewal.
NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (in lieu of CAGE code).
Unique Entity Identifier (UEI) - assigned as part of SAM.gov registration.
eRA Commons - requires at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov - requires active SAM registration.
All PD(s)/PI(s) must have an eRA Commons account.

Geographic and Scope Requirements

Open to organizations located domestically (U.S.) and internationally.
Projects must involve research studies using human data; animal models are excluded.
Must clearly address how the proposed activities will advance research on and understanding of development in children identified as late talkers.

Exclusion Criteria

Applications will not be reviewed if they:
Propose studies that do not include 'late talking children', those at-risk for 'late talking', or those with a history of 'late talking'.
Do not propose data mining, data sharing, and/or secondary data analysis of datasets that include 'late talking children'.
Only propose data mining with no data sharing and/or secondary data analysis component.
Propose archiving of data solely to meet the data sharing requirement for grant applications submitted to NIH for January 25, 2023, and subsequent receipt dates.
Propose de novo (new) data collection.
Are classified as clinical trials.

Application Process

Application Instructions: Applicants must follow the Research (R) Instructions in the 'How to Apply - Application Guide' unless specifically instructed otherwise in this funding opportunity.
Submission Method: Applications must be submitted electronically via one of these options:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
Application Package: Access forms through ASSIST, Grants.gov Workspace, or an institutional S2S solution.

Key Dates and Deadlines

Open Date (Earliest Submission Date): January 03, 2025
Application Due Dates (for New, Renewal, Resubmission, Revision applications):
February 03, 2025
June 02, 2025
October 02, 2025 (latest deadline)
All applications are due by 5:00 PM 'local time of applicant organization' on the due date. Applicants are encouraged to apply early to correct any submission errors.
If a due date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.
Expiration Date: October 03, 2025 (latest possible submission/reissue cycle for this specific announcement).
Review and Award Cycles (approximate):
Scientific Merit Review: July 2025, November 2025, March 2026.
Advisory Council Review: October 2025, January 2026, May 2026.
Earliest Start Date: December 2025, April 2026, July 2026.

Required Documentation and Materials

Standard application forms (SF424(R&R) series, PHS 398 series) as per the Application Guide.
Resource Sharing Plan: All applications must include a plan detailing how tools, workflows, and/or pipelines created will be shared with the scientific community (aligned with open-source practices and NIH Best Practices for Software Sharing).
Data Management and Sharing Plan (DMS Plan): Required for all applications generating scientific data, regardless of direct costs. This plan outlines how scientific data and metadata will be managed and shared, adhering to NIH Policy for Data Management and Sharing.
Appendix: Only limited materials are allowed; generally, no publications or other material except blank questionnaires/surveys.

Post-Award Requirements

Reporting: Annual Research Performance Progress Reports (RPPR) and financial statements are required. A final RPPR, invention statement, and expenditure data are needed for closeout.
Compliance: Recipients must adhere to all applicable nondiscrimination laws, federal statutes, and regulations. They must also comply with the NIH Grants Policy Statement terms and conditions. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval is required for human subjects research.

Evaluation Criteria

Overall Impact

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

Scored Review Criteria

These factors receive separate scores and contribute to the overall impact:
Factor 1. Importance of the Research (Significance and Innovation): Assesses the significance and innovative aspects of the proposed work. For R21 grants, emphasis is on 'conceptual framework', 'level of innovation', and potential for 'significant impact'.
Factor 2. Rigor and Feasibility (Approach): Evaluates the scientific rigor, methodological soundness, and feasibility of the proposed approach. Research activities must be based on rigorous supporting data, minimize bias, and ensure validity of experimental results.
Factor 3. Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications of the project team and the adequacy of the research environment and available resources to successfully conduct the project.

Additional Review Criteria (Not Scored, but Impact Overall Score)

Protections for Human Subjects: Evaluation of justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge to be gained, and data/safety monitoring.
Vertebrate Animals: If applicable, evaluation of procedures, justification for use, interventions to minimize discomfort, and euthanasia methods.
Biohazards: Assessment of hazardous materials/procedures and proposed protection measures.
Resubmissions/Renewals/Revisions: Evaluation of the full application as presented (resubmissions), progress made (renewals), or appropriateness of scope expansion (revisions).
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Assessment of whether the budget and requested period are justified and reasonable.

Specific Considerations for R21 Grants

R21 'Exploratory/Developmental Research Grants' support investigation of novel scientific ideas or new model systems, tools, or technologies. Extensive background material or preliminary information is not required, but may be included if available.

Compliance & Special Requirements

Regulatory and Ethical Compliance

Human Subjects Research: Requires strict adherence to protections for human subjects, including justification for involvement, adequacy of protection, and data/safety monitoring. IRB or IEC approval is mandatory.
Data Protection and Privacy: Proposed activities must protect and maintain confidentiality for research subjects and follow all protections outlined in consent forms. Compliance with the NIH Data Management and Sharing Policy (DMS Policy) is required.
Cybersecurity: For recipients handling 'Personal Identifiable Information (PII)' or 'Personal Health Information (PHI)' from HHS, plans and procedures modeled after the 'NIST Cybersecurity framework' are expected.
Health IT: If funding involves implementing, acquiring, or upgrading health IT, use of health IT meeting standards in 45 CFR part 170, Subpart B, and/or certified under the ONC Health IT Certification Program (if applicable to eligible clinicians/hospitals) is required.
Mandatory Disclosure: Recipients must disclose any federal criminal law violations (fraud, bribery, gratuity) affecting the federal award.

Data Management and Sharing

Open Science: This NOFO explicitly emphasizes creating open and shared data resources. Resources developed, including datasets, metadata, algorithms, and code, are expected to be made publicly available.
FAIR Data Principles: Efforts are expected to be informed by 'FAIR' principles ('Findable, Accessible, Interoperable, and Reusable') for data.
Resource Sharing Plan: Must describe how tools, workflows, and/or pipelines will be shared timely to enable replication and future research, aligning with open-source practices.

Unique Aspects and Exclusions

Clinical Trial Not Allowed: This grant strictly excludes funding for clinical trials.
Existing Data Focus: The grant is specifically for leveraging extant (existing) data; applications proposing de novo (new) data collection are non-responsive.
Rigor and Transparency: Applications must adhere to NIH's instructions related to rigor and transparency in research, ensuring methods minimize bias and reporting is transparent.
Strategic Alignment: Projects including data from underserved or at-risk communities are especially welcome.

Legal Framework

Awards are made under the authority of Sections 301 and 405 of the Public Health Service Act and Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

Grant Details