Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

Establish NIDA Core 'Centers of Excellence' (P30) to enhance and extend existing research in substance use/misuse, addiction, and HIV.
Facilitate interdisciplinary collaborations and promote new research directions.
Provide research opportunities for new and early-career investigators.
Target recipient type: Higher education institutions, non-profits, for-profit organizations (small and large), local and federal governments, U.S. territories/possessions.
Target size: Organizations capable of supporting a minimum of 3 separate federally funded research project grants, with at least 2 distinct PDs/PIs.
SECTOR-SPECIFIC: Health/Biomedical Research (Substance Use/Misuse, Addiction, HIV).
Geographic scope: United States. Foreign institutions are not eligible to apply as the lead organization, but foreign components of U.S. organizations are allowed.
Key filtering criteria: Existing federal research funding base, ability to foster interdisciplinary collaboration, commitment to new investigator development, U.S. institutional base.
Grant frequency: Recurring (multiple annual deadlines).
Program context: Reissue of previous program (PAR-20-267).

Financial Structure

Budget range: Application budgets are not limited but must reflect actual project needs.
Co-financing requirements: No cost sharing required.
Eligible vs. ineligible costs: Funding covers activities clearly related to the specialized research needs of the Center. Pilot projects may not supplement or prolong ongoing research or be used as bridge funds.
Matching fund obligations: Not required.
Payment schedules and mechanisms: Not explicitly detailed in this document; standard NIH grant payment policies apply.
Financial guarantees required: None mentioned.
Tax implications and financial reporting requirements:
- Annual Research Performance Progress Report (RPPR).
- Annual financial statements.
- Final RPPR, invention statement, and expenditure data for closeout.
- Reporting of subawards over the threshold to the Federal Subaward Reporting System (FSRS).
- Semiannual disclosures on proceedings in SAM if cumulative federal awards exceed $10,000,000.
Specific budget limitation: A Pilot Research Project Core may not have an annual budget exceeding 10% direct costs of the annual budget for the NIDA Core Center.
Indirect cost policies: F&A (indirect) costs are handled per NIH Grants Policy Statement. Applicants requesting $500,000 or more in direct costs (excluding consortium F&A) in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

Eligibility Requirements

Eligible Organizations

Higher Education Institutions: Public/State Controlled, Private.
Nonprofits: With 501(c)(3) IRS Status (excluding higher ed), without 501(c)(3) IRS Status (excluding higher ed).
For-Profit Organizations: Small Businesses, Other than Small Businesses.
Governments: Local (State, County, City/Township, Special District, Indian/Native American Tribal - Federally Recognized and Other), Federal Agencies, U.S. Territory or Possession.

Geographic Requirements

Primary applicant must be a U.S. organization.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply as the main applicant.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible.

Foundational Research Requirements

Applicant must bring together investigators currently funded by NIH or other Federal or non-Federal sources.
Center must enhance a minimum of 3 separate federally funded research project grants.
Each identified grant must have at least two years of funding remaining at the time of application submission.
Minimum of 2 distinct Program Directors/Principal Investigators (PDs/PIs) associated with these projects.

Registration and Account Requirements

Applicant organizations must complete and maintain active registrations in:
- System for Award Management (SAM) with annual renewal.
- Unique Entity Identifier (UEI) (issued via SAM.gov).
- eRA Commons (organization registration required).
- Grants.gov (requires active SAM registration).
All Program Directors/Principal Investigators (PDs/PIs) must have an eRA Commons account affiliated with the applicant organization.

Principal Investigator (PD/PI) Requirements

The Center Director (PD/PI) must be an 'outstanding, productive, senior researcher'.
PD/PI must demonstrate scientific achievements, publications, patents, honors, and track record of leading large groups.
PD/PI must have ability to lead administrative and operational aspects of the Center and develop/maintain its role as a national resource.
PD/PI (Center Director) must commit at least 2.4 person months effort to Center administration.

Cost Sharing

This FOA does not require cost sharing.

Application Limitations

Organizations may submit more than one application if each is scientifically distinct.
NIH will not accept duplicate or highly overlapping applications under review concurrently.
Resubmissions (A1) are accepted.

Application Process

Application Deadlines and Submission

Latest application deadline: September 25, 2025 at 5:00 PM local time of applicant organization.
Other specific deadlines: September 25, 2023, September 25, 2024 (all 5:00 PM local time).
Expiration Date for FOA: November 18, 2025.
Applicants are encouraged to apply early to correct errors.
If a submission date falls on a weekend or Federal holiday, the deadline extends to the next business day.
Letter of Intent: Optional, but requested 30 days prior to application due date to [email protected] (email obfuscated in source).

Required Registrations (Pre-Application)

System for Award Management (SAM) registration, renewed annually.
Unique Entity Identifier (UEI) (assigned via SAM.gov).
eRA Commons registration for organization and all PDs/PIs/component Project Leads.
Grants.gov registration.
Registrations can take 6 weeks or more; must be completed prior to application submission.

Required Documentation and Materials

Application package accessed via NIH ASSIST system or institutional system-to-system (S2S) solution.
Conformance to SF424 (R&R) Application Guide and Multi-Project (M) Instructions.
Specific components required:
- Overall (required): PHS 398 Cover Page Supplement, Research & Related Other Project Information, Project/Performance Site Locations (primary site only), Research and Related Senior/Key Person Profile (PD/PI only), Budget (summary only), PHS 398 Research Plan (Introduction for Resub/Rev, Specific Aims, Research Strategy, Preliminary Studies/Progress Report for renewals), Letters of Support (if appropriate), Other Plan(s) (including Data Management and Sharing Plan), Appendix (limited items), PHS Human Subjects and Clinical Trials Information.
  - Overall Component Specific Attachments: Center Organizational Structure diagram (PDF), Table of Research Core Utilization (PDF).
- Administrative Core (required): PHS 398 Cover Page Supplement, Research & Related Other Project Information (Human Subjects, Vertebrate Animals only), Project/Performance Site Location(s), Research & Related Senior/Key Person Profile (Core Lead as 'Other' with 'Center Director'), Budget, PHS 398 Research Plan (Specific Aims, Research Strategy, Introduction for Resub/Rev), Appendix, PHS Human Subjects and Clinical Trials Information.
- Research Support Core (required, one or more): SF424 (R&R) Cover (limited fields), PHS 398 Cover Page Supplement, Research & Related Other Project Information (Human Subjects, Vertebrate Animals only), Project/Performance Site Location(s), Research & Related Senior/Key Person Profile (Core Lead as 'Other' with 'Core Lead'), Budget, PHS 398 Research Plan (Specific Aims, Research Strategy, Introduction for Resub/Rev), Appendix, PHS Human Subjects and Clinical Trials Information.
- Pilot Research Project Core (required): SF424 (R&R) Cover (limited fields), PHS 398 Cover Page Supplement, Research & Related Other Project Information (Human Subjects, Vertebrate Animals only), Project/Performance Site Location(s), Research & Related Senior/Key Person Profile (Core Lead as 'Other' with 'Core Lead'), Budget, PHS 398 Research Plan (Specific Aims, Research Strategy, Introduction for Resub/Rev), Appendix, PHS Human Subjects and Clinical Trials Information.
Page Limitations: Strict adherence to SF424 Application Guide and Table of Page Limits (e.g., Overall: 12 pages; Admin Core: 6 pages; Research Support Core: 12 pages; Pilot Research Project Core: 12 pages).

Submission Process and Review

Electronic submission to Grants.gov.
Track application status in eRA Commons.
Applications evaluated for completeness and compliance; incomplete/non-compliant applications will not be reviewed.
Post-submission materials: Follow NIH policy.

Support Offered

Funding (grants).
Assistance with application submission (eRA Service Desk, Grants.gov Customer Support, NIH General Grants Information).
Scientific/Research Contact, Peer Review Contact, Financial/Grants Management Contact for inquiries.

Project Implementation Timeline and Reporting

Maximum project period: 5 years.
Annual Research Performance Progress Report (RPPR).
Final RPPR, invention statement, and expenditure data for closeout.
Pilot projects typically 1-2 years duration.

Post-Award Requirements and Compliance

Adherence to NIH Grants Policy Statement terms and conditions.
Registration and results reporting on ClinicalTrials.gov if applicable.
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval for human subjects.
Data and Safety Monitoring Requirements for human intervention studies.
Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.
Prior NIH approval for recipient-selected pilot projects involving clinical trials or greater than minimal risk to human subjects.
Compliance with federal civil rights laws (non-discrimination, limited English proficiency access, disability access, sexual harassment, religious nondiscrimination).
Data Management and Sharing Plan implementation.
FSRS reporting for subawards.
SAM reporting for civil/criminal/administrative proceedings.

Evaluation Criteria

The review process assesses the likelihood of the project exerting a sustained, powerful influence on the research field. Overall Impact

Likelihood for the project to exert a sustained, powerful influence on the research field(s).

Scored Review Criteria Significance

Addresses important problems or critical barriers in substance use/misuse and addiction research.
Rigor of prior research supporting the proposed project.
Improvement of scientific knowledge, technical capability, and/or clinical practice.
Potential to change concepts, methods, technologies, treatments, services, or preventative interventions.
Specific to FOA:
- Scientific compellingness of the proposed Center.
- Likelihood of the Center becoming a national scientific research resource for substance use research.
- Value added by the proposed Center to existing substance use research activities at the applicant institution(s).
For Clinical Trials: Scientific rationale, necessity for testing intervention, and potential to advance scientific understanding or change clinical practice/public health.

Investigator(s)

Suitability of PD(s)/PI(s), collaborators, and other researchers.
Appropriate experience and training for Early Stage Investigators.
Established record of accomplishments for senior investigators.
For collaborative/multi-PD/PI projects: Complementary and integrated expertise; appropriate leadership approach, governance, and organizational structure.
Specific to FOA:
- Sufficiency of scientific and managerial experience, leadership skills, and time commitment of Center's leadership.

Innovation

Challenges and shifts current research or clinical practice paradigms.
Utilizes novel theoretical concepts, approaches, methodologies, instrumentation, or interventions.
Proposes refinement, improvement, or new application of existing concepts/approaches.
Specific to FOA:
- Level of innovation in plans for promoting multi-disciplinary collaborations within and across basic and clinical research fields.
- How individual Cores contribute towards the innovation of the Center.

Approach

Overall strategy, methodology, and analyses are well-reasoned and appropriate.
Plans to address weaknesses in rigor of prior research.
Strategies to ensure robust and unbiased approach.
Presentation of potential problems, alternative strategies, and benchmarks for success.
Plans to address relevant biological variables (e.g., sex).
Specific to FOA:
- Strong coordination and synergy among proposed Cores.
- Integration of proposed Cores and Projects.
- Involvement of different scientific disciplines/subdisciplines and substantial interaction among scientists.
- Enhancement of scientific communication, outreach, synergy, and training by Center's structure/organization.
- Administrative Core: Adequacy of organizational structure and plans for coordination/management; plan for prioritizing, allocating, and managing fiscal resources; development of plans for thematic integration; evaluation of individual Cores, Pilot Projects, and the Center.
- Research Support Cores: Well-integrated; provision of opportunities not otherwise available; adequate plans for resource allocation, user prioritization, quality control, and utilization; likelihood of fostering collaborative/new research directions and increasing productivity.
- Pilot Research Project Core: Appropriateness of proposed pilot projects; well-developed plan for evaluating pilot projects; appropriate plans for attracting new researchers to substance use research.
For Human Subjects/Clinical Research: Plans for protection of human subjects and inclusion/exclusion criteria for sex, race, ethnicity, and age.
For Clinical Trials: Justification of study design, scientific rationale, power, study populations, ethical issues, recruitment plans, quality control, data management, and statistical analysis.

Environment

Contribution of scientific environment to project success.
Adequacy of institutional support, equipment, and physical resources.
Benefit from unique features, subject populations, or collaborative arrangements.
Plans for development and maintenance of environment promoting high-quality research, innovation, and leadership.
Specific to FOA:
- Leveraging existing institutional resources (e.g., letters of support, allocated space/resources, institutional commitment to Center goals).
- Appropriate and adequate facilities for administrative, research, and shared resources, including a clearly identifiable physical location.
- Likelihood of the Center becoming a national scientific research resource for substance use research.
For Clinical Trials: Appropriateness of administrative/data/enrollment/laboratory centers; capability of sites to conduct trials; handling international sites; ability to enroll, adhere to protocol, collect/transmit data, and operate within structure.

Additional Review Criteria (Not Scored)

Study Timeline (for clinical trials): Detailed, feasible, justified, incorporates efficiencies, addresses challenges.
Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, importance of knowledge, data/safety monitoring. Justification for exemption if applicable.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Justified plans for inclusion/exclusion based on scientific goals.
Vertebrate Animals: Description of procedures, justification for use, interventions to minimize discomfort, justification for euthanasia method if non-standard.
Biohazards: Assessment of hazardous materials/procedures and proposed protection.
Resubmissions: Evaluation of responses to previous comments and changes made.
Renewals: Consideration of progress made in the last funding period, impact, and innovative work for new period.
Revisions: Appropriateness of scope expansion; adequacy of responses to comments if related to prior disapproved line of investigation.
Select Agent Research: Information on select agents, registration status, monitoring procedures, biosafety/biocontainment/security plans.
Resource Sharing Plans: Reasonableness of sharing plans 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 in relation to proposed research.

Compliance & Special Requirements

Regulatory Compliance

Compliance with Public Health Service Act (Sections 301 and 405).
Compliance with Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.
Adherence to NIH Grants Policy Statement.
ClinicalTrials.gov registration and results reporting for applicable clinical trials.
FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements for certain human clinical research.
Federal Awardee Performance and Integrity Information System (FAPIIS) requirements for award review.
Compliance with Federal Civil Rights laws:
- Prohibition on discrimination based on race, color, national origin, age, sex, disability.
- Meaningful access for persons with Limited English Proficiency (LEP).
- Effective communication with persons with disabilities.
- Programs free of sexual harassment.
- Compliance with federal religious nondiscrimination laws.

Data Protection and Privacy

Mandatory Data Management and Sharing Plan for research generating scientific data (effective for due dates on/after January 25, 2023).
Genomic Data Sharing Plan (if applicable).

Ethical Standards

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required for all protocols involving human subjects.
Data and safety monitoring for NIH-supported human biomedical and behavioral intervention studies.
Ethical issues in clinical trials must be adequately addressed.
Informed consent process must be appropriate.

Risk Management and Security

For clinical trials, study design should address potential problems and alternative strategies.
Data and safety monitoring is required for clinical trials.
Biosafety/biocontainment/security plans for Select Agent Research.

Intellectual Property Policies

Not specifically detailed in this FOA, but standard NIH policies apply regarding inventions and data sharing.

Unique Aspects and Challenges

Center of Excellence Structure: Requires integration of an Administrative Core, one or more Research Support Cores, and a Pilot Research Project Core.
Leveraging Existing Research: Grant funds must enhance existing federally funded research projects (minimum of 3, with at least 2 distinct PIs, each with >2 years funding remaining).
Pilot Project Limitations: Pilot projects cannot exceed 10% of the NIDA Core Center's annual direct costs and must not supplement or prolong ongoing research or act as bridge funds.
National Resource Expectation: Centers are expected to serve as national research resources in the substance use/misuse field.
Leadership Effort: Center Director must commit at least 2.4 person months effort.
Core Utilization: No single core should be used more than 50% of the time by a single PD/PI.

Strategic Opportunities

Opportunity for institutions with established research portfolios in substance use/HIV to formalize and strengthen interdisciplinary collaboration.
Pathway for attracting and mentoring new/early career investigators into the field.
Enhances institutional standing as a leader in addiction/HIV research.

Cross-Cutting Themes

Inclusion: Required consideration of sex, race, ethnicity, and age in human subjects research.
Innovation: Explicitly evaluated; expected in multidisciplinary collaborations and core contributions.
Knowledge Sharing: Emphasized through the 'national resource' expectation and Data Management and Sharing requirements.

Grant Details