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Grant Details

https://www.grants.gov/search-results-detail/357962

Grant Analysis

Purpose & Target

This grant aims to stimulate the translation of scientific discoveries and engineering developments into practical methods and tools for understanding, assessing, detecting, preventing, diagnosing, treating, and managing diseases. It fosters collaboration by requiring academic-industrial partnerships.
  • Single, clear statement of grant's core objective: To translate biomedical scientific and engineering discoveries into new methods or tools for disease diagnosis and treatment through academic-industrial partnerships, explicitly excluding clinical trials.
  • Explicit identification of target recipient type and size: Research teams composed of at least one academic organization and one industrial organization, regardless of specific organizational size, but needing sufficient expertise and resources.
  • MUST state if grant is 'SECTOR-SPECIFIC' or 'SECTOR-AGNOSTIC': SECTOR-SPECIFIC (Healthcare, Biotechnology, Medical Research, Diagnostics, Medical Technology).
  • Geographic scope and any location requirements: Domestic (U.S.) and foreign organizations are eligible.
  • Key filtering criteria for initial grant screening:
    • Must propose an academic-industrial partnership.
    • Must focus on translation of technology/methods; clinical trials are not allowed.
    • Must not be for commercial production or basic research lacking a translational aim.
  • Grant frequency and program context: Recurring funding opportunity, reissued from PAR-21-166, with multiple recurring submission deadlines up to October 2027.

Financial Structure

  • Award Budget: Application budgets are limited to $499,000 (direct costs) per year.
  • Maximum Project Period: The maximum project period allowed is 5 years.
  • Cost Sharing/Matching Funds: Cost sharing or matching funds are not required.
  • Eligible Costs: Pre-award costs are allowable as described in the NIH Grants Policy Statement.
  • Ineligible Costs: Funding specifically does not support commercial production of technologies or products.
  • Budget Flexibility: Investigators have discretion to determine effort levels and apportion budget based on the timing and requirements of each research step.
  • Financial Reporting: Recipients are required to submit an Annual Research Performance Progress Report (RPPR) and financial statements. A final RPPR, invention statement, and expenditure data are required for award closeout.
  • Financial Sustainability Expectation: The project is expected to advance the product or service sufficiently to attract future independent third-party financing and/or strategic partnerships for full commercialization.

Eligibility Requirements

Organizational Type and Structure
  • Mandatory Partnership: Each application must include a partnership of at least one academic organization and one industrial organization. This partnership forms an inter-disciplinary, multi-institutional research team.
  • Eligible organization types:
    • Higher Education Institutions (Public/State Controlled, Private)
    • Nonprofits (with or without 501(c)(3) IRS Status)
    • For-Profit Organizations (Small Businesses, Other For-Profits)
    • Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal - Federally Recognized/Other)
    • Federal Governments (Eligible Agencies, U.S. Territory or Possession)
    • Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based/Community-based Organizations, Regional Organizations).
  • Foreign organizations (non-U.S. entities) are explicitly eligible to apply.
  • Non-domestic components of U.S. Organizations are eligible.
Geographic and Regulatory
  • Geographic Eligibility: Domestic (U.S.) and foreign organizations are eligible.
  • Required Registrations (must be completed before application submission, can take 6+ weeks):
    • System for Award Management (SAM) with active, annually renewed registration.
    • NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (in lieu of CAGE code for SAM registration).
    • Unique Entity Identifier (UEI) obtained during SAM.gov registration.
    • eRA Commons account for the organization, with at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
    • Grants.gov account (requires active SAM registration).
Project Scope and Limitations
  • Clinical Trials: Clinical Trials Not Allowed. Applications proposing clinical trials are non-responsive and will not be reviewed.
  • Focus: Must be on translation of scientific discoveries and engineering developments into methods or tools.
  • Exclusions:
    • Does not support commercial production of technologies or products.
    • Does not support basic research projects that do not have a primary translational motivation (i.e., adapting, optimizing, validating for a targeted problem).
    • Applications where the proposed technology or methods are already established (adapted, optimized, validated) are not responsive.
Additional Criteria
  • Applications must be scientifically distinct; duplicate or highly overlapping applications are not permitted under concurrent review.
  • Financial conflicts of interest, particularly for academic spin-off companies, must be managed in compliance with Department of Health and Human Services (HHS) and NIH policy (42 CFR part 50).
  • Any individual with the necessary skills and resources can be a Program Director/Principal Investigator (PD/PI).

Application Process

Application Submission
  • Application Opening Date: January 05, 2025.
  • Application Due Dates (latest listed):
    • October 05, 2027 (for New, Renewal, Resubmission, Revision applications).
  • Submission Time: All applications are due by 5:00 PM local time of the applicant organization.
  • Program Expiration Date: January 08, 2028.
  • Submission Methods: Electronic submission is mandatory and can be done via:
    • NIH ASSIST system.
    • An institutional system-to-system (S2S) solution.
    • Grants.gov Workspace.
  • Pre-submission Requirements: All required registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed and active prior to the application due date. This process can take 6 weeks or more.
  • Handling System Issues: Applicants must follow the 'Dealing with System Issues' guidance if a system problem beyond their control threatens on-time submission.
Required Documentation and Content
  • Applicants must rigorously follow the instructions in the Research (R) Instructions in the 'How to Apply - Application Guide' and any program-specific instructions provided in this Notice of Funding Opportunity (NOFO).
  • Page Limitations: All page limits specified in the 'How to Apply- Application Guide' and 'Table of Page Limits' must be adhered to.
  • Standard Forms Required: SF424(R&R) Cover, SF424(R&R) Project/Performance Site Locations, SF424(R&R) Other Project Information, SF424(R&R) Senior/Key Person Profile, R&R or Modular Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS 398 Research Plan, PHS Human Subjects and Clinical Trials Information (if applicable), and PHS Assignment Request Form.
  • Specific Requirements for PHS 398 Research Plan:
    • Specific Aims: Must clearly describe the new capability to be achieved, including performance targets, error estimates, statistical requirements, and a timeline with metrics.
    • Research Strategy: Must describe the strategic alliances and address the importance (Significance and Innovation), rigor and feasibility (Approach), and expertise and resources (Investigator(s) and Environment) of the proposed work.
    • Resource Sharing Plan: Required.
    • Data Management and Sharing Plan: Required for all applications that will generate scientific data, regardless of the direct costs requested.
Post-Submission Materials
  • Only limited Appendix materials are allowed, as per NIH policy. No publications or other external materials are permitted, with the exception of blank questionnaires or surveys.
Post-Award Requirements
  • Reporting Obligations: Recipients must submit an Annual Research Performance Progress Report (RPPR). This report should specifically detail accomplishments indicating translational progress, such as publications, patents (awarded, maintained, licensed, pending), FDA or other regulatory approvals, clinical trials (planned, underway, completed), and developed products (devices, agents, therapies, techniques, protocols, analytics).
  • Closeout Reporting: A final RPPR, invention statement, and expenditure data (from the Federal Financial Report) are required for award closeout.
  • Human Subjects Oversight: Recipient institutions must ensure that research protocols involving human subjects are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC). Copies of documents related to all major changes in ongoing protocol status must be provided to NIH.

Evaluation Criteria

Overall Impact
  • Reviewers will assess the likelihood of the proposed project to exert a sustained, powerful influence on the relevant research field(s).
Scored Review Criteria
  • Factor 1. Importance of the Research (Significance and Innovation):
    • Clear articulation of a biomedical-related problem, its significance, and the potential benefits of the proposed solution.
    • Innovation is specifically defined as the likelihood to deliver a new capability to end-users. This definition is broad to accommodate diverse projects.
    • Projects addressing non-clinical problems do not need to demonstrate direct clinical translation potential.
  • Factor 2. Rigor and Feasibility (Approach):
    • Presentation of a detailed and rational plan for translating the new method or technology.
    • Evidence demonstrating that the technology is ready for translation.
    • Inclusion of preliminary data supporting the study plan, feasibility, and the proposed validation approach.
    • Description of expected user groups and their operational environments.
  • Factor 3. Expertise and Resources (Investigator(s) and Environment):
    • Detailed description of the roles and contributions of all key investigators.
    • For projects with clinical applications, the inclusion of physicians with clinical expertise in the relevant area is crucial to ensure focus on clinical needs and utility.
    • Description of the strategic alliances, overall organizational structure, major tasks for each partnering organization, and contributions each partner brings.
    • Details on shared leadership, administration, conflict resolution, and technical, pre-clinical, and clinical responsibilities.
    • Assessment of how the grant award will help the product/service advance sufficiently to attract independent third-party financing or strategic partnerships for full commercialization.
Additional Review Criteria (Considered, but not scored)
  • Protections for Human Subjects
  • Vertebrate Animals
  • Biohazards
  • Resubmissions, Renewals, and Revisions (as applicable).
Additional Review Considerations (Considered, but not scored)
  • Authentication of Key Biological and/or Chemical Resources
  • Budget and Period of Support

Compliance & Special Requirements

Regulatory Compliance
  • Adherence to the NIH Grants Policy Statement for all grant policies, terms, and conditions.
  • Compliance with 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
  • Compliance with all applicable federal statutes and regulations relevant to federal financial assistance, including 42 CFR Part 52.
  • Health IT Standards: Where the award involves health IT, recipients must use technology meeting standards in 45 CFR part 170, Subpart B, and/or certified under the ONC Health IT Certification Program if applicable.
  • Cybersecurity: For recipients or subrecipients with access to HHS information/operational technology systems, or personal identifiable information (PII)/personal health information (PHI) from HHS, plans and procedures modeled after the NIST Cybersecurity framework are required.
  • Nondiscrimination: Compliance with all applicable nondiscrimination laws and submission of an Assurance of Compliance (HHS-690) are required.
Ethical and Professional Standards
  • Human Subject Protection: Protocols involving human subjects must receive Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
  • Good Practices: For clinically oriented projects, routine use of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) is encouraged to reduce risk and increase likelihood of meeting FDA standards.
  • Financial Conflicts: Financial conflicts of interests, particularly concerning academic spin-off technology companies, must be managed in compliance with Department of Health and Human Services and NIH policy (42 CFR part 50).
Intellectual Property (IP)
  • Industrial involvement from the outset is expected to facilitate a more efficient transfer of intellectual property into commercial settings.
Special Considerations
  • Translational Focus: The grant specifically supports translational research up to the point of pre-commercial production, but does not fund commercial production itself.
  • Innovation Definition: Innovation is broadly defined as the likelihood to deliver a new capability to end-users.
  • Dissemination and Sustainability: While commercialization is a common goal, it is not the only path to sustainable dissemination, which is a critical objective. Projects are expected to advance sufficiently to attract independent third-party financing and/or strategic partnerships for full commercialization.
  • Inclusivity: There is an encouragement to develop or adapt technology for low resource settings or underserved populations.
  • Prototype Placement: Support is provided for placing copies of prototypes in multiple research sites for study and validation of performance.

Grant Details

academic-industrial partnership technology translation medical diagnosis disease treatment r01 grant nih funding healthcare innovation biomedical research medical devices diagnostics disease management risk assessment prevention academic partnership industrial collaboration health sciences research and development prototype validation pre-commercialization health equity underserved populations low resource settings cancer research eye disease research dental research craniofacial research women's health machine learning in healthcare artificial intelligence in medicine genomic data liquid biopsy nanobody diagnostics wearable devices point-of-care tools biomedical engineering research grant
Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Not Allowed)
PAR-25-338
National Institutes of Health (NIH) Grants
UNIVERSITY NGO ENTERPRISE SME PUBLIC OTHER
US
HEALTHCARE TECHNOLOGY OTHER
DEVELOPMENT EARLY_MARKET
OTHER
SDG3 SDG9 SDG17
FUNDING RESEARCH_DEVELOPMENT INNOVATION_COMMERCIALIZATION
499000.00
None
499000.00
USD
None
Oct. 5, 2027, 5 p.m.
March 2028 - May 2028