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Grant Analysis

Purpose & Target

This grant aims to fund research projects focused on current topics in Alzheimer's Disease (AD) and its related dementias (ADRD). It encourages biomedical, social, and behavioral research and training to better understand aging processes and related diseases.

Core Objective: To invite applications for research on current topics in Alzheimer's disease and its related dementias (ADRD).
Target Recipient Type and Size: Open to a wide range of organizations including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities (local, state, federal, tribal). There are no explicit size restrictions, allowing for a broad range of organizational scales.
SECTOR-SPECIFIC: This grant is SECTOR-SPECIFIC for health and medical research, particularly neuroscience and aging studies.
Geographic Scope: Worldwide, as non-domestic (non-U.S.) entities are eligible to apply.
Key Filtering Criteria: Focus on AD/ADRD research, organizational type (must be one of the listed categories), and ability to meet extensive federal compliance and reporting requirements.
Grant Frequency and Context: This is a recurring opportunity, a reissue of a previous Notice of Funding Opportunity (NOFO) PAR-22-093, indicating an ongoing commitment to this research area. It is developed in response to recommendations from AD/ADRD Research Summits and the National Alzheimer's Project Act (NAPA).

Financial Structure

This grant provides financial assistance for research projects related to Alzheimer's Disease and its related dementias.

Funding Instrument: Grant.
Budget Range: Application budgets are not limited but must accurately reflect the actual needs of the proposed project.
Minimum/Maximum Funding Per Application: No specific minimum or maximum grant amount is stated.
Matching Fund Requirements: No cost sharing or matching funds are required.
Eligible Costs: Costs must align with the NIH Grants Policy Statement and be necessary for the proposed project. Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1.
Ineligible Costs: Not explicitly detailed, but implied to exclude costs not directly related to the project or not permitted by the NIH Grants Policy Statement.
Payment Schedule and Mechanisms: Not explicitly detailed in this NOFO, but governed by standard NIH award administration processes.
Financial Reporting Requirements: Recipients must submit annual financial statements and a final Federal Financial Report (FFR) upon closeout of the award.
Audit Requirements: Awards are subject to the uniform administrative requirements, cost principles, and audit requirements for federal awards as described in 2 CFR Part 200.
Indirect Cost Policies: Not specifically detailed in this section, but typically subject to negotiated indirect cost rates for the recipient institution. Direct costs of $500,000 or more in any single year (excluding consortium Facilities & Administrative costs) require prior contact with a Scientific/Research Contact.

Eligibility Requirements

To be considered for this grant, your organization must meet the following formal criteria: Organization Type and Status

Any of the following organization types are eligible:
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 (including Small Businesses and other For-Profit Organizations)
Local Governments (State, County, City/Township, Special District, Indian/Native American Tribal Governments - Federally Recognized and Other)
Federal Governments (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, Regional Organizations, Non-domestic (non-U.S.) Entities (Foreign Organizations).

Geographic Location

Organizations from any country (domestic U.S. and foreign) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are also eligible.

Required Registrations

System for Award Management (SAM): Must complete and maintain an active registration, which requires annual renewal. This includes obtaining a Unique Entity Identifier (UEI). Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code.
eRA Commons: Must register with eRA Commons. Organizations need to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account.
Grants.gov: Must have an active SAM registration to complete Grants.gov registration.

Individual Eligibility (Program Director/Principal Investigator)

Any individual with the necessary skills, knowledge, and resources to carry out the proposed research is eligible to be a PD/PI.
All PD/PIs must have an eRA Commons account and ensure it's affiliated with the applicant organization.

Application Restrictions

Applicant organizations may submit multiple applications, but each must be scientifically distinct.
Duplicate or highly overlapping applications are not permitted under simultaneous review.

Cost Sharing

No cost sharing (matching funds) is required for this grant.

Application Process

Applying for this grant requires careful adherence to federal guidelines and specific submission procedures. Application Timeline and Deadlines

Open Date (Earliest Submission Date): February 11, 2025
Application Due Dates: Multiple deadlines are available. All applications are due by 5:00 PM local time of the applicant organization.
March 11, 2025 (Review: July 2025, Start: December 2025)
June 05, 2025 (Review: November 2025, Start: April 2026)
October 05, 2025 (Review: March 2026, Start: July 2026)
February 05, 2026 (Review: July 2026, Start: December 2026)
June 05, 2026 (Review: November 2026, Start: April 2027)
October 05, 2026 (Review: March 2027, Start: July 2027)
February 05, 2027 (Review: July 2027, Start: December 2027)
June 05, 2027 (Review: November 2027, Start: April 2028)
October 05, 2027 (Review: March 2028, Start: July 2028)
Expiration Date: November 06, 2027.
Extension Policy: If a submission date falls on a weekend or federal holiday, the deadline is automatically extended to the next business day.

Application Procedure and Submission

Applications must be submitted electronically via one of the following methods:
NIH ASSIST system: For online preparation, submission, and tracking.
Institutional system-to-system (S2S) solution: Check with your institutional officials.
Grants.gov Workspace: For preparation and submission.
Applicants are encouraged to submit early to allow time for error correction.
Applications are checked for completeness and compliance by the Center for Scientific Review (NIH); incomplete or non-compliant applications will not be reviewed.

Required Documentation and Materials

Follow instructions in the Research (R) Instructions in the How to Apply - Application Guide, supplemented by this NOFO.
Standard forms include:
SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile.
R&R or Modular Budget, R&R Subaward Budget.
PHS 398 Cover Page Supplement, Research Plan.
PHS Human Subjects and Clinical Trials Information (if applicable), including specific attachments for study population characteristics, eligibility criteria, and recruitment/retention plans.
Data Management and Sharing Plan: Required for all applications that generate scientific data, regardless of direct costs requested.
Appendix: Only limited materials are allowed (e.g., blank questionnaires/surveys). Publications or other materials are not permitted.
eRA Commons ID: All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form.

Pre-Application Requirements

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

Post-Award Reporting Obligations

Research Performance Progress Report (RPPR): Required annually.
Financial Statements: Required annually.
Final Reports: A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for closeout.
ClinicalTrials.gov: If the award involves one or more clinical trials, the 'responsible party' must register and submit results information on ClinicalTrials.gov.

Application Assistance Availability

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors, warnings, system problems).
General Grants Information: For application instructions, processes, and NIH grant resources.
Grants.gov Customer Support: For Grants.gov registration and Workspace issues.
Scientific/Research Contact(s): For scientific or research-related inquiries (e.g., Jean Yuan, Ph.D., NIA).
Financial/Grants Management Contact(s): For financial or grants management inquiries (e.g., Philip Smith, NIA).
Dealing with System Issues: Guidance is provided if system issues threaten on-time submission.

Evaluation Criteria

Applications will be evaluated for scientific and technical merit based on the following criteria, influencing the 'overall impact score': Scored Review Criteria (Factors 1, 2, and 3 contribute to overall impact and receive separate factor scores):

Factor 1. Importance of the Research (Significance and Innovation):
Assesses the project's potential to exert a powerful influence on the research field.
Considers the significance of the research question and the innovativeness of the approach.
Factor 2. Rigor and Feasibility (Approach):
Evaluates the soundness of the research design, methods, and analyses.
Assesses the feasibility of the proposed work and the management of potential risks.
Factor 3. Expertise and Resources (Investigator(s) and Environment):
Examines the qualifications, experience, and track record of the Program Director(s)/Principal Investigator(s) and the research team.
Considers the adequacy of the institutional support and resources available for the project.

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

Protections for Human Subjects: Assessment of safeguards for participants in research involving human subjects.
Vertebrate Animals: Evaluation of proposed procedures involving animals, justification for their use, and measures to minimize discomfort.
Biohazards: Assessment of hazardous materials/procedures and proposed protection measures.
Resubmissions: Review of the updated application, considering previous feedback.
Renewals: Evaluation of progress made during the prior funding period.
Revisions: Assessment of the appropriateness of proposed project expansion.

Additional Review Considerations (considered, but not scored or included in overall impact):

Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring the validity of essential resources.
Budget and Period of Support: Evaluation of whether the budget and requested project duration are justified and reasonable.

Selection Criteria and Priorities

Scientific and technical merit, as determined by peer review.
Availability of funds.
Relevance of the proposed project to the program's priorities (e.g., current topics in AD/ADRD, recommendations from Research Summits).
Compliance with data management and sharing policies.

Cross-Cutting Themes and Impact Expectations

Inclusivity and Diversity: Strong emphasis on proposals that involve understudied populations and address NIH-designated Populations with Health Disparities in recruitment and retention plans.
Social Impact: Projects are expected to contribute to understanding and addressing health disparities related to AD/ADRD.
Innovation: Explicitly evaluated as a scoring factor. Proposals should demonstrate innovative and proactive recruitment strategies.
Quality Thresholds: Applications must meet the quality and ethical standards for human subjects research and data management as outlined by NIH and other federal regulations.

Compliance & Special Requirements

Adherence to a broad range of regulatory, ethical, and operational standards is crucial for this grant. Regulatory Compliance Requirements

Federal Regulations: All awards are subject to the NIH Grants Policy Statement, 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards), Public Health Service Act (Sections 301 and 405), and Federal Regulations 42 CFR Part 52.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws.
Health IT Standards: If the award involves health IT activities, use health IT that meets standards in 45 CFR part 170, Subpart B and is certified under the ONC Health IT Certification Program if applicable.
FDA Requirements: Clinical research projects involving investigational therapeutics/products in humans must be performed under an FDA investigational new drug (IND) or investigational device exemption (IDE).

Data Protection and Privacy Regulations

Data Management and Sharing Plan: All applicants generating scientific data must submit a plan outlining data management and sharing practices.
Cybersecurity: If handling personally identifiable information (PII) or protected health information (PHI) from HHS, recipients must develop plans and procedures modeled after the NIST Cybersecurity framework.

Ethical and Human Subjects Standards

Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Approval: Required for all protocols involving human subjects.
Data and Safety Monitoring: Required for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).
Mandatory Disclosure: Recipients must disclose violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award (2 CFR 200.113).

Unique Aspects and Considerations

Clinical Trial Optional: The grant specifically accepts applications that either propose or do not propose clinical trials, offering flexibility.
Focus on Heterogeneity: Encourages interdisciplinary research to understand the diverse nature and multiple causes of AD/ADRD.
Inclusion and Diversity: Strong emphasis on recruitment strategies that involve understudied populations and address NIH-designated Populations with Health Disparities. Applications should provide rationale for eligibility criteria that support the inclusion of these populations.
NIA CROMS: Investigators conducting clinical research funded by NIA (including pilots/exploratory studies) are required to interact with and use the NIA Clinical Research Operations & Management System (CROMS) for data management.
OutreachPro: Grantees are encouraged (but not required) to use OutreachPro for developing customizable and culturally appropriate recruitment materials in multiple languages.
Intellectual Property: Not explicitly detailed in this NOFO, but generally governed by NIH Grants Policy Statement and federal regulations.
Risk Management: Beyond human subjects, projects involving biohazards must demonstrate adequate protection measures. Overall project risks are assessed through the 'Rigor and Feasibility' evaluation criterion.
Knowledge Sharing: Requires a Data Management and Sharing Plan and adherence to ClinicalTrials.gov reporting for clinical trials.

Grant Details