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Grant Analysis

Purpose & Target

SECTOR-SPECIFIC: This grant aims to cultivate a highly integrated cohort of pre-doctoral and post-doctoral trainees and early career investigators, and to develop career development resources to accelerate kidney, urologic, and hematologic research.
It targets higher education institutions, nonprofits, and government entities capable of establishing large-scale, interdisciplinary training programs.
Geographic Scope: Primarily US-based institutions. Non-domestic entities are not eligible to apply.
Key filtering criteria: Focus on kidney, urologic, and hematologic research training, cooperative agreement (U2C-TL1) mechanism, clinical trial not allowed for the overall program, but clinical trial experience for trainees is permitted.
Grant Frequency: Recurring, with multiple application due dates until September 2025, reissued from a previous program.

Financial Structure

Budget range: Not specified. Funds are contingent on NIH appropriations and meritorious applications.
Maximum project period: 5 years.
Award structure: Two linked parts, U2C (Administrative, Professional Development, Networking Cores) and TL1 (NRSA Training Core), with separate budgets after award.
Budget limitation: Total costs of U2C components (Administrative, Professional Development, Networking) should not exceed 70% of the total cost of the TL1 (NRSA Training Core).
Eligible costs: NRSA stipend levels and allowable costs for trainees. Salary support for Overall PIs and Core Directors not to exceed six calendar months per year total across all U2C cores and the TL1 core. Travel for PDs/PIs and Core PDs/PIs to annual meeting. Budget for hosting one annual meeting during the project period.
Ineligible costs: Costs related to direct clinical trials (as the overall grant is 'Clinical Trial Not Allowed').
Matching fund requirements: None. Cost sharing is not required.
Co-financing requirements: Not specified beyond the U2C/TL1 budget split.
Payment schedule: Not specified, but annual reporting is required.
Financial reporting: Annual Research Performance Progress Report (RPPR) and financial statements required. Final RPPR, invention statement, and expenditure data for closeout.
Audit requirements: Subject to 45 CFR Part 75 and 2 CFR Part 200 regulations.
Financial guarantees: Not specified.
Indirect cost policies: For applications requesting $500,000 or more in direct costs in any year, consortium F&A is excluded from this calculation.

Eligibility Requirements

Eligible Organizations

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

Geographic Requirements

Must be a U.S. organization. Non-domestic (non-U.S.) Entities are not eligible.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible.
Foreign components (as defined by NIH Grants Policy Statement) are allowed within a U.S. organization's application.
Strong encouragement for a single, consolidated application from several institutions within the same Metropolitan Statistical Area (MSA).

Organizational Capacity and Structure

Only one application per institution (identified by unique DUNS or NIH IPF number) is allowed per receipt date.
Must propose to support a minimum of 5 trainees across benign Kidney, Urologic, and Hematologic (KUH) research areas through the TL1 award.
Upon receipt of an award, the institution is expected to relinquish all active NIDDK/KUH T32 grants.
No subsequent new NIDDK/KUH U2C-TL1 applications will be allowed from the awarded institution.

Required Registrations

System for Award Management (SAM) with active registration (annual renewal required).
Unique Entity Identifier (UEI) (issued via SAM.gov).
eRA Commons account for the organization and for all Program Directors/Principal Investigators (PD/PIs) and Project Leads.
Grants.gov registration.
Registration processes can take 6 weeks or more; must be completed prior to application submission.

Eligible Individuals (Program Director/Principal Investigator - PD/PI)

Must be an active investigator in a scientific area relevant to the NIDDK/KUH mission.
Must be capable of providing administrative and scientific leadership to the program.
Responsible for selection and appointment of trainees, overall program direction, management, administration, and evaluation.
Multiple PD/PIs are encouraged if they bring complementary expertise.
At least one PD/PI should have an active research program in basic, translational, or clinical science aligned with KUH mission.
Other PD/PIs may have experience in science education, program evaluation, mentoring, or career development.

Eligible Trainees (for TL1 component)

Must be a U.S. citizen, noncitizen national, or lawfully admitted for permanent residence at the time of appointment.
Must pursue research training full time (normally 40 hours/week).
Appointments are typically in 12-month increments; minimum 9 months for initial appointment (with prior NIH approval).
Pre-doctoral trainees: Must have a baccalaureate degree by start of NRSA appointment and be enrolled in a Ph.D. or equivalent research doctoral degree program. Health-professional students interrupting studies for full-time research are eligible. Training grant support in the first three years of graduate research training is encouraged.
Post-doctoral trainees: Must have a Ph.D., M.D., D.D.S., D.M.D., or comparable doctoral degree from an accredited domestic or foreign institution by the start of NRSA appointment. Engage in a temporary, defined period of mentored advanced training.
Maximum NRSA support: 5 years at pre-doctoral level, 3 years at post-doctoral level (aggregate, including institutional and individual awards).
Individuals currently supported by other Federal funds are not eligible for trainee support.

Application Process

Application Deadlines

Latest Application Due Date: September 26, 2025 (5:00 PM local time of applicant organization).
Other deadlines: November 15, 2023; September 27, 2024.
Letter of Intent Due Date: 30 days prior to the application due date (encouraged but not required/binding).

Submission Process

Applications must be submitted electronically through Grants.gov using either the NIH ASSIST system or an institutional system-to-system (S2S) solution.
It is critical to follow the Multi-Project (M) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions in this NOFO.
Errors found during submission (by NIH and Grants.gov systems) must be corrected, and a changed/corrected application submitted on or before the due date.
Applicants are responsible for viewing their application in eRA Commons before the due date to ensure accurate and successful submission.

Required Documentation and Materials

Overall Component (Page Limit: 6 pages):
SF424(R&R) Cover, PHS 398 Cover Page Supplement, Research & Related Other Project Information (primary site only), Research and Related Senior/Key Person Profile (overall PD/PIs only).
PHS 398 Research Plan: Introduction (for Resubmission/Revision), Specific Aims, Research Strategy (vision, mission, institutional track record, collaborative research, fostering trainee cohort), Letters of Support (from department chairs, committing resources).
Resource Sharing Plan: Not applicable for this NOFO.
Data Management and Sharing Plan: Not applicable for this NOFO.
Appendix: Limited items only.
Administrative Core (Page Limit: 6 pages): Specific Aims, Research Strategy (organizational structure, governance, collaboration, communication, evaluation plans, annual meeting organization, External Evaluation Board plans).
Professional Development Core (Page Limit: 6 pages): Specific Aims, Research Strategy (curricula for trainee professional development, preceptor training/improvement).
Network Core (Page Limit: 6 pages): Specific Aims, Research Strategy (peer network development, community outreach).
Training Core (Page Limit: 12 pages): PHS 398 Research Training Program Plan (Training Program Faculty, Trainees, Training Record, Other Training Program Sections).
Requires specific Training Data Tables (1, 2, 3, 4, 5A, 5B, 8A, 8C depending on pre/postdoctoral focus).
Program Plan Background, Proposed Training activities, Training Program Evaluation, Institutional Environment and Commitment.
Plan for Instruction in the Responsible Conduct of Research.
Biographical Sketches for all Senior/Key persons.
Letters of Support: Should be included in the Overall component, describing institutional support and commitment from participating departments.

Application Support

eRA Service Desk: For ASSIST, eRA Commons, application errors (online or phone).
General Grants Information: For application instructions, processes, NIH resources (email or phone).
Grants.gov Customer Support: For registration and Workspace (phone or email).
Scientific/Research, Peer Review, and Financial/Grants Management Contacts are provided in Section VII of the NOFO.
Pre-application webinar mentioned in related notices (NOT-DK-23-032).

Evaluation Criteria

Overall Impact Reviewers will assess the likelihood that the project will exert a sustained, powerful influence on the research field(s) involved. Scored Review Criteria (Overall Application Components)

Significance:
How well the proposed program addresses an important problem or critical barrier in KUH research or research education.
Potential for the aims to change biomedical research capacity or develop a pool of scientists pursuing biomedical careers.
Clarity and consistency of the overall vision with the goal of promoting an interdisciplinary workforce in benign kidney, non-malignant, and hematologic research fields.
Robustness of the plan to measure and evaluate program goals.
Investigator(s):
Suitability of PD(s)/PI(s) and other personnel for their roles.
Experience and training in managing career development and training activities.
Experience with coordinating collaborative research.
Complementary expertise, leadership approach, governance, and conflict resolution plans for multi-PD/PI applications.
Innovation:
Novel organizational concepts and management strategies in coordinating the training network.
Novelty of the overall vision and conceptual framework for research training of TL-1 component trainees.
Approach:
Reasonableness and appropriateness of the overall strategy, operational plan, and organizational structure to achieve program goals.
Promotion of strategies for robust and unbiased scientific approaches.
Presentation of potential problems, alternative strategies, and benchmarks for success.
Feasibility and reasonableness of approaches for fostering trainee networking and inter-departmental collaboration.
Adequacy of plans to ensure consideration of relevant biological variables (e.g., sex).
Environment:
Contribution of the institutional environment to the program's success.
Adequacy of institutional support, equipment, and physical resources.
Benefit from unique features of the institutional environment or personnel.
Robustness of the applicant's track record in preparing trainees across multiple career stages.
Strength of the track record in inter-departmental collaboration and ability to promote inter-disciplinary research.

Scored Review Criteria (Training Core)

Training Program and Environment:
Conduciveness of research facilities and environment for preparing scientists.
Effectiveness of objectives, design, and direction in ensuring training.
Opportunities for skill acquisition in rigorous/reproducible methodologies, state-of-the-art methods, data science.
Provision of appropriate inter- or multidisciplinary research training.
Likelihood of preparing trainees for research-intensive/related careers.
Sufficiency of institutional commitment (administrative, research training support).
How the program distinguishes itself from other external funding at the institution.
Cohesiveness of training experience and enhancement of trainee competitiveness.
Likelihood of encouraging careers in benign kidney, urologic, or hematologic research.
How institutional resources are leveraged to enhance the program.
Commitment of participating departments to program success.
Training Program Director(s)/Principal Investigator(s):
Scientific background, expertise, administrative, and training experience for strong leadership.
Commitment of sufficient effort.
Justification and leadership approach for multiple PDs/PIs.
Preceptors/Mentors:
Sufficiency of experienced preceptors/mentors with appropriate expertise and funding.
Strong research records (publications, funding).
Strong records of training individuals.
Plans to ensure effective mentoring for those lacking experience.
Mentor expertise in clinical trials if trainees will gain such experience.
Trainees:
Proposed recruitment plan's likelihood to attract qualified trainees.
Presence of a competitive applicant pool of sufficient size and quality.
Well-defined and justified selection, reappointment, and retention criteria.
Training Record:
Success of trainees (or past students/postdocs in similar training) in program completion.
Trainee productivity (research accomplishments, publications, subsequent appointments/awards).
Trainee success in achieving productive scientific careers (positions, grants, honors, patents, leadership).
Benefit of subsequent positions from NRSA-supported training to the biomedical research enterprise.
Rigorous evaluation plan to assess quality and effectiveness.
Mechanisms for obtaining feedback from current and former trainees.
Appropriateness of the evaluation framework tied to program goals.

Additional Review Considerations (Not Scored)

Protections for Human Subjects (justification, protection, benefits, knowledge, data/safety monitoring).
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan.
Vertebrate Animals (description, justification, minimization of discomfort, euthanasia justification).
Biohazards (assessment of risk, proposed protection).
Resubmissions (response to previous comments, changes made).
Renewals (progress made, program accomplishments, evolution, improved training experience).
Training in Methods for Enhancing Reproducibility (scientific reasoning, rigorous design, experimental methods, biological variables, authentication, quantitative approaches, data analysis).
Budget and Period of Support (justification and reasonableness).
Training in the Responsible Conduct of Research (RCR) (format, subject matter, faculty participation, duration, frequency, monitoring; rated ACCEPTABLE or UNACCEPTABLE).
Select Agent Research (use, registration, monitoring, biosafety/biocontainment/security).

Compliance & Special Requirements

Regulatory Compliance

All NIH awards are subject to the NIH Grants Policy Statement, 45 CFR Part 75, and 2 CFR Part 200.
Award recipients must complete an HHS Assurance of Compliance form (HHS 690) agreeing to non-discrimination based on race, color, national origin, age, sex, disability, and compliance with federal conscience laws.
Compliance with Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.

Data and Privacy

Genomic Data Sharing Plans and NIH Data Management and Sharing Policy apply generally, but a Data Management and Sharing Plan is not applicable for this specific NOFO.
Recipients retain custody and primary rights to data and software developed, subject to Government policies.

Ethical Standards and Training

Plan for Instruction in the Responsible Conduct of Research (RCR) is required, covering: format (face-to-face interaction required, online-only not acceptable), broad subject matter (conflict of interest, authorship, data management, human subjects, animal use, research misconduct), faculty participation, minimum 8 contact hours, and frequency (at least once per career stage, no less than every 4 years).
IRB or IEC approval required for human subjects research.

Special Programmatic Requirements (Cooperative Agreement)

This is a Cooperative Agreement, indicating substantial Federal scientific or programmatic involvement from NIH.
NIH staff (Program Official, Grants Management Specialist, Project Scientist) will assist, guide, coordinate, and participate in project activities.
Key responsibilities of recipients (PD/PIs): Adherence to program goals, administrative/programmatic/evaluation aspects, trainee recruitment/progress, mentor/trainee development, collaboration with other awardees, providing progress reports, supporting peer network, participating in Steering Committee.
Joint Responsibilities (with NIH): Steering Committee (main governing body, develops annual meeting agenda, coordinates data collection, shares best practices) with voting members from awardees and NIH Project Scientist. Independent Training Program Evaluation Board (reviews progress, makes recommendations).
Dispute Resolution process outlined for scientific or programmatic matters between awardees and NIH.

Unique Aspects & Challenges

The program aims to replace traditional, smaller T32 grants with fewer, larger, and more integrated institutional awards.
Specific budget ratio: U2C costs cannot exceed 70% of TL1 costs.
Requirement for institutions to relinquish existing NIDDK/KUH T32s upon receiving this award, and no future U2C-TL1 applications from the same institution.
Strong emphasis on interdisciplinary research, team science, and comprehensive professional development and networking for trainees and mentors.
The overall grant is 'Clinical Trial Not Allowed', meaning the proposed program itself cannot be a clinical trial. However, trainees within the program are permitted to obtain research experience in a clinical trial led by a mentor.

Grant Details