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Grant Analysis

Purpose & Target

The 'Advancement and Innovation in Measurement of Language Development and Predictors' grant aims to encourage community-engaged research that broadens how we think about environmental factors supporting language development in children and focuses on creating new ways to measure children's language skills. The main goal is to build a collection of tools that are positive, respectful of different cultures and languages, and can be used widely to better understand language development and any difficulties.

Target Recipient Type: Research institutions, non-profits, for-profit organizations, and government entities, including international organizations.
Target Size: Not specified, but R01 grants typically support substantial projects.
SECTOR-SPECIFIC: This grant is specifically focused on health and social sciences, particularly language development and measurement.
Geographic Scope: United States and international (non-U.S.) entities are eligible.
Key Filtering Criteria: Focus on novel language measurement, community engagement, and not clinical trials or interventions.
Grant Frequency: Recurring with multiple application deadlines through September 2027. It's a reissue of a previous funding opportunity (PAR-24-243), indicating an ongoing program.

Financial Structure

This grant opportunity provides financial assistance.

Budget Range and Limitations: Application budgets are not limited but must directly reflect the actual needs of the proposed project. There are no specified minimum or maximum grant amounts per application.
Eligible Costs: Allowable costs include those associated with the implementation of the required Community Engagement (CE) plan, in addition to standard research project costs as defined by NIH policies.
Matching Fund Requirements: This grant does not require cost sharing.
Co-financing Requirements: Not specified; cost sharing is explicitly not required.
Payment Schedule and Mechanisms: Not explicitly detailed in the provided text, but typical NIH grant payments are made through designated HHS payment systems.
Financial Reporting Requirements: Recipients must submit annual financial statements as required by the NIH Grants Policy Statement.
Audit Requirements: Not explicitly detailed, but implied by compliance with 2 CFR Part 200 (Uniform Administrative Requirements).
Financial Guarantees Required: None specified.
Indirect Cost Policies: Standard NIH indirect cost policies apply. Note that consortium F&A (Facilities & Administrative costs) are excluded when calculating whether direct costs meet the $500,000 threshold for pre-application contact.

Eligibility Requirements

To be eligible for this grant, organizations and individuals must meet specific formal criteria: Eligible Organizations

Higher Education Institutions: Both Public/State Controlled and Private Institutions of Higher Education.
Nonprofits: Includes those with 501(c)(3) IRS Status and those without.
For-Profit Organizations: Both Small Businesses and other For-Profit Organizations.
Local Governments: State, County, City or Township, Special District, Indian/Native American Tribal Governments (Federally Recognized or Other).
Federal Governments: Eligible Agencies of the Federal Government and U.S. Territory or Possession.
Other Organizations: 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): Foreign organizations and non-U.S. components of U.S. Organizations are eligible to apply and receive funding.

Required Registrations (Applicant Organizations)

System for Award Management (SAM): Must have an active registration, renewed annually. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Unique Entity Identifier (UEI): Obtained through SAM.gov registration; must be consistent across all registrations and the application.
eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Requires active SAM registration.

Eligible Individuals (Program Director/Principal Investigator)

Any individual with the necessary skills, knowledge, and resources can serve as PD(s)/PI(s).
Must have an eRA Commons account, affiliated with the applicant organization.

Application Limits

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

Exclusion Criteria

Clinical Trials: Applications proposing clinical trials are not allowed.
Interventions: Development or implementation of interventions will not be considered responsive.
Unrelated Measures: Development of measures of concepts with no theoretical or evidential link to children's language development will not be considered responsive.
Community Engagement (CE) Plan: Applications that fail to include a CE Plan will be considered incomplete and will be withdrawn.
Cost Sharing: Not required.

Application Process

Applying for this grant involves several steps and adherence to specific instructions: Application Deadlines and Timeline

Earliest Submission Date: January 05, 2025
New Application Due Dates:
February 05, 2025 (Scientific Merit Review: July 2025, Earliest Start Date: December 2025)
June 05, 2025 (Scientific Merit Review: November 2025, Earliest Start Date: April 2026)
October 05, 2025 (Scientific Merit Review: March 2026, Earliest Start Date: July 2026)
February 05, 2026 (Scientific Merit Review: July 2026, Earliest Start Date: December 2026)
June 05, 2026 (Scientific Merit Review: November 2026, Earliest Start Date: April 2027)
October 05, 2026 (Scientific Merit Review: March 2027, Earliest Start Date: July 2027)
February 05, 2027 (Scientific Merit Review: July 2027, Earliest Start Date: December 2027)
June 05, 2027 (Scientific Merit Review: November 2027, Earliest Start Date: April 2028)
All applications are due by 5:00 PM local time of the applicant organization.
Applicants are encouraged to apply early to allow time for corrections.
If a due date falls on a weekend or Federal holiday, the deadline extends to the next business day.
Grant Expiration Date: September 08, 2027.

Submission Method and Format

Electronic submission is mandatory; paper applications are not accepted.
Applications must be submitted through one of these options:
NIH ASSIST system.
Institutional system-to-system (S2S) solution.
Grants.gov Workspace.
Applicants must track their application status in eRA Commons.

Required Documentation and Materials

Standard SF424(R&R) application forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R or Modular Budget, PHS 398 Cover Page Supplement, PHS Human Subjects and Clinical Trials Information, PHS Assignment Request Form).
Community Engagement (CE) Plan: A required 'Other Attachment' (PDF, maximum 2 pages) detailing how community engagement strategies and community input will be incorporated throughout the study, including partner roles, engagement activities, and feasibility.
Data Management and Sharing Plan (DMS Plan): Required for all applications generating scientific data, regardless of direct costs requested.
Research Plan: Must adhere to NIH guidance for rigor and transparency.
Resource Sharing Plan: Required.
Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys); no publications or other materials.

Pre-Application Requirements

For applications requesting $500,000 or more in direct costs in any single year (excluding consortium F&A), applicants must contact a Scientific/Research Contact at least 6 weeks before submitting the application.

Post-Award Requirements

Reporting: Annual Research Performance Progress Report (RPPR) and financial statements are required.
Closeout: A final RPPR, invention statement, and expenditure data are required for award closeout.
Data Management and Sharing: Recipients must implement their approved DMS Plan.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Recipient institutions must ensure protocols are reviewed by their IRB/IEC.

Application Assistance

eRA Service Desk: For issues with ASSIST, eRA Commons, application errors, system problems.
General Grants Information: For application instructions, processes, and NIH resources.
Grants.gov Customer Support: For Grants.gov registration and Workspace issues.
Scientific/Research Contact(s) (e.g., Virginia Salo, NICHD): For scientific inquiries and discussing fit to NOFO.
Peer Review Contact(s): For questions regarding the peer review process.
Financial/Grants Management Contact(s) (e.g., Marianne Galczynski, NICHD): For financial and grants management inquiries.

Evaluation Criteria

Applications are reviewed for scientific and technical merit through the NIH peer review system. An 'Overall Impact' score reflects the likelihood of the project's sustained, powerful influence on the research field. Scored Review Criteria Reviewers assess the following three factors, with Factor 1 and 2 also receiving separate criterion scores:

Importance of the Research (Significance and Innovation):
Does the project address an important problem or critical barrier?
Does it propose new concepts, approaches, or methods?
Are the aims novel?
Will successful completion lead to an improved understanding of language development or better tools?
Does it challenge existing paradigms?
Does it foster strengths-focused, culturally and linguistically responsive, and generalizable tools?
Rigor and Feasibility (Approach):
Are the overall strategy, methodology, and analyses well-reasoned and appropriate?
Is the experimental design rigorous and robust, minimizing bias?
Are potential problems, alternative strategies, and benchmarks for success addressed?
Is the Community Engagement (CE) plan well-integrated, meaningful, and feasible?
Are research practices transparent (e.g., clear rationale, defined tools/parameters, blinding, randomization, sample size, handling missing data, pre-planned analyses)?
Is there a plan to address any ambiguities or weaknesses in prior research?
Expertise and Resources (Investigator(s) and Environment):
Are the investigators well-suited to the project, with appropriate experience and complementary expertise?
Is the research environment suitable (e.g., necessary facilities, resources, collaborative arrangements)?
Does the project benefit from unique features of the environment or subject populations?
Does the CE plan demonstrate capacity for successful community engagement and effective collaboration?

Additional Review Criteria (Considered but Not Scored)

Protections for Human Subjects: Adequacy of protections for research participants.
Vertebrate Animals: Justification for animal use, minimization of discomfort, and euthanasia methods if applicable.
Biohazards: Evaluation of hazardous materials/procedures and proposed protection.
Resubmissions: Assessment of the updated application.
Renewals: Progress made in the previous funding period (not applicable for new grants).
Revisions: Appropriateness of proposed scope expansion (not applicable for new grants).
Authentication of Key Biological and/or Chemical Resources: Plans for ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the requested budget and project period in relation to the proposed research.

Selection Criteria Funding decisions are based on: - Scientific and technical merit of the proposed project (from peer review). - Availability of funds. - Relevance of the proposed project to program priorities.

Compliance & Special Requirements

This grant has specific compliance and special requirements that applicants must adhere to: Regulatory Compliance

NIH Grants Policy Statement: All awards are subject to its terms and conditions, cost principles, and other considerations.
2 CFR Part 200: Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws (agreed upon when registering in SAM.gov).
Federal Statutes and Regulations: Compliance with all federal statutes and regulations relevant to federal financial assistance.
Termination: NIH may terminate awards under certain circumstances as per 2 CFR Part 200.340 and NIH Grants Policy Statement Section 8.5.2.

Data Protection and Sharing

Data Management and Sharing Policy: All research generating scientific data requires a Data Management and Sharing Plan (DMS Plan) compliant with the 2023 NIH Policy. Data is expected to be accessible as soon as possible, no later than publication or award end.
Data/Biospecimen Sharing: Awardees are expected to share data and/or biospecimens through broad-sharing repositories.

Ethical Standards

Human Subjects: Strong emphasis on protections for human subjects. Requires PHS Human Subjects and Clinical Trials Information form. Clinical trials are explicitly not allowed.
Vertebrate Animals: If applicable, adherence to criteria for the humane care and use of animals.
Biohazards: Adequate protection must be proposed for research involving hazardous materials or procedures.

Scientific Rigor and Transparency

All applications must emphasize rigor and transparency in research, minimizing bias, ensuring validity, and transparently reporting results. This includes clear rationale, defined tools, blinding, randomization, adequate sample size, appropriate data handling, and pre-planned analyses.

Community Engagement (CE) Plan

Mandatory Requirement: A Community Engagement (CE) plan is required and must be submitted as an 'Other Attachment'.
Meaningful Engagement: The plan should outline how communities will be engaged as 'equal partners' throughout the research process (from conceptualization to dissemination).
Collaboration: Describes community partners (e.g., advisory boards, organizations, families from appropriate backgrounds), their roles, and how they will be collaboratively engaged (activities, frequency, duration).
Feasibility: Demonstration of feasibility, including letters of support or formal roles (co-investigator, consultant) for community partners.
Resources: Plan for providing appropriate resources to community partners based on their time and effort, with mutual benefit and recognition (e.g., authorship).
Monitoring: Outlines methods and metrics to monitor community engagement efforts.

Intellectual Property Policies

Not explicitly detailed in the provided text, but NIH's general intellectual property policies would apply.

Unique Aspects and Challenges

Focus on Novel Measures: A core objective is the development of new, strengths-focused, culturally and linguistically responsive, and generalizable tools for language development and prediction, moving beyond traditional paradigms like the '30 million word gap'.
Exclusion of Interventions: This NOFO is for measurement and understanding, not for developing or implementing interventions.
NINDS Interest: The National Institute of Neurological Disorders and Stroke (NINDS) has a specific interest in applications focusing on language acquisition/communication difficulties in the context of neurological conditions.

Grant Details