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Grant Analysis

Purpose & Target

This grant aims to establish and support NIDA Research Centers of Excellence (P50 Specialized Centers) that conduct innovative, multidisciplinary research in substance use and addiction, including its intersection with HIV. These Centers are expected to transform scientific fields, foster collaborations, facilitate data and tool sharing, and serve as national resources for education and outreach.

Target Recipient Type: Research institutions capable of hosting complex, multidisciplinary research centers.
Target Recipient Size: Not explicitly defined by employee count, but implies a significant capacity for research and administration.
Designation: SECTOR-SPECIFIC (focused on substance use and addiction research).
Geographic Scope: Organizations within the United States and its territories/possessions are eligible to apply. Foreign components (e.g., international research collaborators) are allowed within a US-based application.
Key Filtering Criteria: Must be a research-focused organization with a strong track record in substance use/addiction research or related fields, capable of establishing a multidisciplinary center with integrated projects.
Grant Frequency and Program Context: This is a recurring funding opportunity (reissue of PAR-22-133) with multiple application due dates extending into 2025. It's part of the National Institutes of Health (NIH) P50 Specialized Center grant mechanism, designed for complex, multi-component research programs.

Financial Structure

Maximum Award Budget (Direct Costs): $10,000,000 for the entire 5-year project period. Budgets must reflect actual needs.
Eligible Costs: Funds are intended to provide reasonable support for activities clearly related to the specialized research needs of the Center.
Ineligible Costs: Funds may not be used for training not required to conduct the research. Pilot projects may not be used to supplement or prolong ongoing research, nor as bridge funds when other research support is no longer available.
Matching Fund/Cost Sharing: This funding opportunity does not require cost sharing.
Pilot Project Core Funding Limitation: Direct costs allocated to pilot projects in any year cannot exceed 25% of the Center grant's total direct costs in that year or $200,000, whichever is smaller.
Financial Reporting: Recipients are required to submit 'Research Performance Progress Reports (RPPR)' annually and financial statements ('Federal Financial Report') as required. A final RPPR and expenditure data are required for closeout.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions: Public/State Controlled and Private Institutions of Higher Education.
Nonprofits: With or without 501(c)(3) IRS status (excluding Higher Education Institutions).
For-Profit Organizations: Small Businesses and other For-Profit Organizations.
Governments: State, County, City or Township, Special District, and Federally Recognized/Other Indian/Native American Tribal Governments. Also, Eligible Agencies of the Federal Government and U.S. Territory or Possession entities.
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.

Geographic Requirements

Applicants: Must be based in the United States or its territories/possessions.
Foreign Institutions: Are not eligible to apply.
Non-domestic components of U.S. Organizations: Are not eligible to apply.
Foreign components (collaborators): Allowed, as defined by the NIH Grants Policy Statement.

Organizational Structure and Capacity

Must propose a Center structure that is multidisciplinary, thematically integrated, and synergistic.
The Center must include an 'Overall' component, an 'Administrative Core' (required), and a minimum of three 'Research Projects' (required).
'Research Cores' and 'Pilot Project Cores' are optional components.

Key Personnel Requirements

The 'Center Director' (Program Director/Principal Investigator - PD/PI) must be scientifically and administratively qualified, an outstanding, productive, senior researcher, and commit at least 2.4 person months effort to Center administration.
'Core Leads' (for Research Cores or Pilot Project Cores) must be scientifically and administratively well-qualified and commit at least 1.8 person months effort.
'Project Leads' (for Research Projects) must commit at least 1.8 person months effort to the Center.

Registration Requirements (Prior to Application Submission)

System for Award Management (SAM): Active registration, renewed at least annually. Includes obtaining a 'Unique Entity Identifier (UEI)'.
NATO Commercial and Government Entity (NCAGE) Code: Required for foreign organizations registering in SAM.
eRA Commons: Organization must be registered and identify at least one 'Signing Official (SO)' and one 'Program Director/Principal Investigator (PD/PI)' account.
Grants.gov: Active SAM registration is required to complete Grants.gov registration.

Application Process

Application Deadlines and Submission

Application Due Dates: September 25, 2023; September 25, 2024; September 25, 2025. All applications are due by 5:00 PM local time of the applicant organization.
Expiration Date of FOA: November 19, 2025.
Submission Method: Applications must be submitted electronically through Grants.gov using the NIH 'ASSIST' system or an institutional system-to-system (S2S) solution.
Letter of Intent: While not required or binding, applicants are encouraged to submit a 'Letter of Intent' 30 days prior to the application due date. This helps NIDA estimate the review workload.

Required Documentation and Materials

SF424 (R&R) Application Guide: Applicants must follow the 'Multi-Project (M) Instructions' from this guide, with program-specific deviations outlined in the FOA.
Components: The application must consist of:
'Overall' component (required)
'Administrative Core' (required)
Minimum of three 'Research Projects' (required)
'Research Core' (optional)
'Pilot Project Core' (optional)
Specific Attachments:
'Center Organizational Structure' diagram (PDF).
'Table of Research Core Utilization' (PDF), if Research Cores are included.
'Biosketches' for all Senior/Key personnel.
'Data Management and Sharing Plan' (required for due dates on or after January 25, 2023).
Resubmission/Revision Applications: Must include an 'Introduction to Application' in the 'Overall' component and potentially in other components affected by the revision.
Renewal Applications: Must include a 'Progress Report' summarizing accomplishments from the prior funding period and a 'Progress Report Publication List'.

Pre-Application Requirements

Registrations: Applicant organizations must complete and maintain active registrations with 'System for Award Management (SAM)', obtain a 'Unique Entity Identifier (UEI)', register with 'eRA Commons', and 'Grants.gov'. This process can take 6 weeks or more.
PD/PI eRA Commons Account: All Program Directors/Principal Investigators must have an 'eRA Commons' account affiliated with the applicant organization.

Review Process and Timeline

Scientific Merit Review: Applications undergo peer review by a Scientific Review Group convened by NIDA. For the September 25, 2025 deadline, scientific review is scheduled for March 2026.
Advisory Council Review: Recommended applications receive a second-level review by the National Advisory Council on Drug Abuse. For the September 25, 2025 deadline, Advisory Council Review is scheduled for May 2026.
Earliest Start Date: For the September 25, 2025 deadline, the earliest start date is July 2026.
Summary Statement: PD/PIs can access their 'Summary Statement' (written critique) via 'eRA Commons' after peer review.

Post-Award Requirements and Compliance

Award Notice: Formal notification is a 'Notice of Award (NoA)' provided by NIH.
Progress Reporting: Annual 'Research Performance Progress Reports (RPPR)' and financial statements ('Federal Financial Reports') are required.
ClinicalTrials.gov: If applicable, the responsible party must register and submit results information for certain clinical trials.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) Approval: Grantee institutions must ensure all protocols are reviewed by their IRB/IEC.
Data and Safety Monitoring: Required for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials).
Prior Approval for Pilot Projects: Recipient-selected pilot projects involving clinical trials or greater than minimal risk to human subjects require prior NIH approval.
FAPIIS/FSRS Reporting: Recipients must report information about subawards and civil/criminal/administrative proceedings in the Federal Awardee Performance and Integrity Information System (FAPIIS) and Federal Subaward Reporting System (FSRS) as applicable.

Evaluation Criteria

Applications will be evaluated for scientific and technical merit based on the following criteria, contributing to an 'Overall Impact' score: Scored Review Criteria

Significance:
Addresses an important problem or critical barrier in the field (substance use/addiction, incl. HIV).
Proposed projects and cores align closely with the Center's overarching theme.
Demonstrates synergy and coordination among research components.
Likelihood of the Center becoming a national scientific research resource for substance use research.
For clinical trials: Well-supported scientific rationale and need for the trial.
Investigator(s):
PD(s)/PI(s), collaborators, and other researchers are well-suited and experienced.
Center's leadership team demonstrates sufficient scientific and administrative experience and time commitment to develop/maintain the Center as a national resource.
Research Project and Core Investigators have multidisciplinary backgrounds and interests.
For HIV centers: Team has appropriate expertise at the intersection of substance use and HIV.
For clinical trials: Expertise, experience, and ability to manage and implement the trial.
Innovation:
Challenges existing paradigms using novel theoretical concepts, approaches, methodologies, instrumentation, or interventions.
Individual projects and cores contribute to the Center's innovation.
Addresses a long-standing controversy or previously unresolved question in the field.
For clinical trials: Design/research plan includes innovative elements to enhance sensitivity or advance knowledge.
Approach:
Overall strategy, methodology, and analyses are well-reasoned and appropriate.
Plans address weaknesses in prior research rigor and ensure an unbiased approach.
For renewal applications: Documented progress as a national resource, support to investigators, success of projects, benefits (collaboration, new directions, cost savings), publications from cores, effective administrative/enrichment programs.
Administrative Core: Appropriate processes for evaluating scientific direction, promoting thematic integration, and evaluating individual projects' contributions.
Research Core: Scientifically justified, well-integrated, adequately utilized.
Pilot Project Core: Scientifically justified, adequate measures to evaluate activities.
Research Projects: Adequately justified and well-integrated with the Center's overarching theme.
For human subjects research: Plans to protect human subjects and ensure inclusion/exclusion (sex, race, ethnicity, age) are justified.
For clinical trials: Study design, study populations, recruitment plans, quality assurance, data management, and statistical analysis are appropriate.
Environment:
Scientific environment contributes to success; institutional support, equipment, and physical resources are adequate.
Substantial commitment from the applicant institution for the Center and its public health goals.
For large data projects: Adequate facilities for data collection, storage, analysis, and sharing.
Administrative Core: Resource utilization plan for the Center is well-developed.
For clinical trials: Capability to conduct trials at proposed sites, appropriate administrative/data coordinating centers.

Additional Review Criteria (Not Separately Scored)

Study Timeline (for clinical trials): Feasibility and justification of the timeline, incorporation of efficiencies, discussion of potential challenges.
Protections for Human Subjects: Justification for involvement, adequacy of protection, potential benefits, importance of knowledge, data/safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Justification for inclusion/exclusion based on scientific goals.
Vertebrate Animals: Justifications for use, appropriateness of species, interventions to minimize discomfort, euthanasia methods.
Biohazards: Assessment of hazardous materials/procedures and proposed protection.
Resubmissions: Evaluation of responses to prior comments and changes made.
Renewals: Consideration of progress made in the last funding period.
Revisions: Appropriateness of scope expansion and responses to previous comments.
Select Agent Research: Information on select agents, registration, monitoring, biosafety.
Resource Sharing Plans: Reasonableness of plans for sharing model organisms or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity.
Budget and Period of Support: Justification and reasonableness of budget and requested duration.

Compliance & Special Requirements

Regulatory Compliance and Standards

NIH Grants Policy Statement: All awards are subject to the terms and conditions described in this policy, along with specific federal regulations (e.g., 42 CFR Part 52, 45 CFR Part 75, 2 CFR Part 200).
HHS Assurance of Compliance: Recipients of federal financial assistance from HHS are required to complete an 'HHS Assurance of Compliance form (HHS 690)', agreeing to comply with federal civil rights laws (non-discrimination based on race, color, national origin, age, sex, disability, and conscience laws).
Accessibility and Inclusion: Programs must be accessible to persons with limited English proficiency and individuals with disabilities, ensuring meaningful access and effective communication.
Harassment Policy: Programs must be administered in an environment free of sexual harassment, aligning with NIH's commitment to a safe and respectful work environment.
Prohibition on Certain Telecommunications: Awards are subject to prohibitions on certain telecommunications and video surveillance services or equipment.

Data and Research Ethics

Data Management and Sharing Policy: Effective for due dates on or after January 25, 2023, a 'Data Management and Sharing Plan' is required. Recipients must adhere to this plan upon approval.
Human Subjects Research: Requires strict compliance with protections against research risks, including justified inclusion/exclusion criteria (sex, race, ethnicity, age).
Clinical Trials: Requires compliance with 'ClinicalTrials.gov' registration and reporting, 'IRB/IEC' approval, and 'Data and Safety Monitoring' requirements. 'IND/IDE' may be necessary for investigational products.
Vertebrate Animals: Involves specific ethical review criteria for animal use, including justification, minimization of discomfort, and euthanasia methods.

Programmatic and Strategic Considerations

Center Transformation: Expected to transform the scientific fields of focus, not just conduct incremental work.
National Resource Role: Centers are expected to serve as national resources by providing educational and outreach activities to research communities, educational organizations, the general public, and policy makers.
Mentoring and Career Development: A key function is fostering the career development and mentoring of new and early career investigators, providing meaningful roles in Center activities.
Synergy and Integration: Applications must demonstrate clear linkages and interdependency among components, resulting in productivity and progress exceeding that of individual projects.
Institutional Commitment: Convincing evidence of the applicant institution's commitment to the Center is required.
Innovation: Emphasis on novel theoretical concepts, approaches, methodologies, instrumentation, and interventions that address long-standing controversies or unresolved questions.
Risk Tolerance/Mitigation: Projects involving human subjects or clinical trials require robust risk management and data safety monitoring plans.
Knowledge Sharing: Overarching goal is to advance research by facilitating collaborations, sharing of data, research tools, and reagents.

Grant Details