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Grant Analysis

Purpose & Target

Core objective: Advance low-risk therapeutic and diagnostic devices for disorders affecting the nervous or neuromuscular systems by supporting translational activities and small clinical studies.
Explicit identification of target recipient type and size: The grant targets investigators across a broad range of organization types, including academic institutions, non-profits, for-profit businesses (small and large), and various government entities.
SECTOR-SPECIFIC: Healthcare (Medical Devices - Neurology/Neuromuscular).
Geographic scope and any location requirements: Open to organizations within the United States and Non-domestic (non-U.S.) Entities (Foreign Organizations).
Key filtering criteria for initial grant screening: Must focus on low-risk therapeutic or diagnostic neural devices for a single neurological or neuromuscular disorder, follow a two-phase (R61/R33) development model (non-clinical testing leading to a small clinical study), and exclude high-risk clinical trials or basic research.
Grant frequency and program context: This is a recurring funding opportunity, noted as a reissue of PAR-24-151.

Financial Structure

Funding instrument: Grant, providing financial assistance (money, property, or both).
Award budget: Application budgets are not limited but must reflect the actual needs of the proposed project and be reasonable and appropriate.
Cost sharing: Not required as defined in the NIH Grants Policy Statement.
Currency: Assumed to be USD (United States Dollar), common for NIH grants.
Funding rate: Not explicitly stated as a percentage, but typically covers eligible costs.
Pre-award costs: Allowable only as described in the NIH Grants Policy Statement Section 7.9.1.

Eligibility Requirements

Organization Type

Eligible organizations include:
Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (501(c)(3) IRS Status, Non-501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other For-Profit Organizations)
Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal - Federally Recognized and Other)
Federal Government (Eligible Agencies, U.S. Territory or Possession)
Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations - other than Federally recognized, Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities/Foreign Organizations)
Non-domestic (non-U.S.) components of U.S. Organizations are eligible.

Location Requirements

Applicants can be from the U.S. or any non-U.S. entity (foreign organization).

Registration Requirements

Applicant organizations must complete and maintain active registrations prior to application submission:
System for Award Management (SAM) with annual renewal.
NATO Commercial and Government Entity (NCAGE) Code for foreign organizations (in lieu of CAGE code).
Unique Entity Identifier (UEI) obtained through SAM.gov.
eRA Commons account for the organization, requiring at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov registration (requires active SAM registration).
PD(s)/PI(s) must also have an eRA Commons account affiliated with the applicant organization.

Project Scope Requirements

Projects must focus exclusively on a condition within the mission of the National Institute of Neurological Disorders and Stroke (NINDS).
The proposed device must be a low-risk therapeutic or diagnostic device for the nervous or neuromuscular systems.
Projects must have two phases:
R61 phase: Supports non-clinical testing to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) clinical study (1-2 years).
R33 phase: Supports a small NSR clinical study (1-3 years).
The total project period for both phases must not exceed 5 years.
Non-responsive activities (applications will be withdrawn):
Basic research and studies of disease mechanisms.
Animal model development (all in vivo models must be well-established and characterized).
Fundamental basic/applied research using existing market-approved devices for their labeled uses.
Significant Risk (SR) clinical studies or studies requiring an Investigational Device Exemption (IDE) from the FDA.
Delayed-onset clinical studies.
Projects focused on technologies for augmentation of healthy individuals.
Applications lacking a clinical study protocol synopsis.
Applications missing required attachments (Gantt chart, IP Strategy, Needs Assessment, Long-term Care Plan for Patients, Team Management Plan) or exceeding page limits for these attachments.
Each application must focus on only one neurological disorder or disease.

Technical Prerequisites

Projects should have comprehensive supporting data (bench, in vitro, and/or in vivo models) representative of the intended patient population and indication.
Applicants must have identified one or more clinically meaningful device outcome measures based on stakeholder input.
A compelling case for successful IRB approval for an NSR study is required, with all regulatory approvals in place prior to the R33 phase start.
For novel devices, proof-of-concept data of device function obtained using a prototype close to the final device design are required.

Application Process

Application Submission

Earliest Submission Date: December 28, 2024.
Application Due Dates: Multiple cycles are available, with the latest application due date being 2027-01-28 17:00:00.
All applications are due by 5:00 PM local time of the applicant organization.
Applicants are encouraged to submit early to allow time for corrections.
Applications must be submitted electronically via NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must include their eRA Commons ID.
Applications that are incomplete, non-compliant, or non-responsive will not be reviewed.

Pre-Application

Letter of Intent: Not required, not binding, but encouraged 60 days prior to the receipt date. Should include descriptive title, PD/PI contact information, key personnel, participating institutions, and the Funding Opportunity Number (FON).
Pre-application consultation: Strongly encouraged with NIH program staff, ideally at least 12 weeks before a receipt date, especially for this milestone-driven phased award mechanism.
For applications requesting $500,000 or more in direct costs in any single year (excluding consortium F&A), applicants must contact a Scientific/Research Contact at least 6 weeks before submission.

Required Documentation/Materials

Applicants must follow instructions in the Research (R) Instructions and the How to Apply - Application Guide, adhering to all page limits.
Mandatory Attachments:
Gantt Chart (1 page max).
Intellectual Property (IP) Strategy (3 pages max).
Needs Assessment (3 pages max).
Long-term Care Plan for Patients (3 pages max).
Team Management Plan (part of PHS Human Subjects and Clinical Trials Information, Section 3.5 - 2 pages max).
Optional Attachments (if applicable, with page limits):
Schematics (1 page max).
Communications with the IRB (5 pages max).
FDA Communications (10 pages max, including a 1-page summary).
Required Research Plan Components:
Specific Aims (for both non-clinical testing and clinical study).
Research Strategy, including sections on Significance (Clinical Impact and Feasibility), Supporting Data for Entry, Technology Translation Plan, and Detailed Plans for Research Strategy.
Resource Sharing Plan.
Data Management and Sharing Plan.
PHS Human Subjects and Clinical Trials Information form (if human subjects are involved), including a Neuroethics section and Data Safety and Monitoring Plan.

Project Period

The R61 phase must not exceed 2 years.
The R33 phase must not exceed 4 years.
The total combined duration of the R61 and R33 phases must not exceed 5 years.

Reporting and Post-Award Requirements

Annual Research Performance Progress Report (RPPR).
A final RPPR, invention statement, and expenditure data for closeout of the award.
Registration and results reporting for all clinical trials on ClinicalTrials.gov.
Recipient institutions must ensure all protocols are reviewed by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements if applicable.
Mandatory disclosure of any violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Evaluation Criteria

Overall Impact

Reviewers provide an overall impact score reflecting the likelihood of the project to exert a sustained, powerful influence on the research field.
Assessment is based on scored criteria (Significance, Rigor and Feasibility, Investigator(s)/Environment) and additional criteria.

Factor 1: Importance of the Research (Scored)

Significance: Evaluates if the research addresses an important knowledge gap, solves a critical problem, or creates a valuable conceptual/technical advance. Assesses the rationale and rigor of the scientific background.
Innovation: Evaluates the application of novel concepts, methods, or technologies, or novel uses of existing ones. Applications are not penalized for comparatively smaller market sizes if sustainable.
Specific to this NOFO:
Supporting Data for Entry:
- For novel devices, proof-of-concept data must be from a prototype close to the final design.
- Device and capabilities must be clearly described and appropriate for proposed clinical study.
- For Non-Significant Risk (NSR) studies, preliminary IRB communications must indicate a sufficient pre-clinical testing plan.
Needs Assessment:
- Must incorporate input from all relevant stakeholders (patients, clinicians, caregivers) regarding device performance requirements.
- Must describe beneficiaries and how their needs were identified.

Factor 2: Rigor and Feasibility (Scored)

Rigor: Evaluates the potential for unbiased, reproducible data, experimental design, controls, sample size justification, and plans for analysis/interpretation. Addresses biological variables (sex, age).
Feasibility: Evaluates if the approach is sound and achievable, including plans for problems. Assesses adequacy of plans to recruit/retain diverse participants and feasibility of study timeline/milestones.
Specific to this NOFO:
Technology Translation Plan:
- Regulatory plan must be reasonable regarding path to market and FDA data requirements.
- Estimated clinical adoption timeline must include feasible key translation benchmarks.
- Must address how key stakeholders will be engaged.
Detailed Plans for Research Strategy:
- Project plans must lead to development and testing of the therapeutic device.
- Proposed plans must show likelihood of obtaining IRB approval for an NSR study by the end of the R61 phase.
- Neuroethical concerns related to the study design must be adequately addressed.
Long-term Patient Care Plan:
- Must anticipate key long-term care needs related to trial participation.
- Plan for patient care at study end must be reasonable, considering access, risks/benefits, and feasibility.
- Addresses financial liability for injury, device removal, maintenance, etc., if applicable.
Milestone Plan:
- Gantt chart must provide sufficient detail of projected timeline and tasks.
- Milestones must be timely, robust, and include clear, quantitative go/no-go criteria.
- Timelines for milestones must be realistic yet efficient.
- Milestones reflecting planned regulatory requirements (e.g., IRB approval for NSR) must be included.

Factor 3: Expertise and Resources (Scored)

Investigator(s): Evaluates background, training, and expertise. For multiple PD/PIs, assesses leadership plan.
Environment: Evaluates appropriateness of institutional resources.
Specific to this NOFO:
Team Management Plan:
- Team governance and organizational structure must be appropriate.
- Scientific Steering Group (SSG) members must be appropriate and reflect an interdisciplinary team.

Additional Review Criteria (Not Scored, but considered)

Protections for Human Subjects (if applicable).
Vertebrate Animals (if applicable).
Biohazards (if applicable).
Intellectual Property (IP) Strategy:
Evaluates how potential IP landscape issues, known constraints, and hurdles are addressed.
Assesses whether IP filing plans are well-described and appropriate.
For multiple institutions/companies, evaluates adequacy of IP sharing plans.
Authentication of Key Biological and/or Chemical Resources.
Budget and Period of Support (justification and reasonableness).

Compliance & Special Requirements

Regulatory Compliance

Projects must obtain Institutional Review Board (IRB) approval for Non-Significant Risk (NSR) studies; all regulatory approvals must be in place before the R33 phase.
Adherence to FDA (Food and Drug Administration) requirements, including Design Control and Quality Systems processes for medical devices.
Development activities should consider Quality System requirements.
Compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP) is expected for device testing and manufacturing processes.
Testing must comply with relevant standards such as ISO 11135, ISO 10993, Electromagnetic Compatibility (EMC), and International Electrotechnical Commission (IEC).
Projects involving investigational therapeutics or devices must comply with FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.

Ethical Standards

Applications involving human subjects must include a Neuroethics section. This section must address ethical considerations related to study design and conduct, including safety assessment, participant capacity, autonomy and agency, privacy and confidentiality of neural data, potential malign uses of neuroscience tools, cautious translation into medical/nonmedical uses, public engagement, justice, and sharing of neuroscience research benefits.
A Data Safety and Monitoring Plan is required for all human biomedical and behavioral intervention studies, considering guidelines for monitoring clinical research.

Data Management & Sharing

A Data Management and Sharing Plan is mandatory for all research generating scientific data.
Data collected should conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
The use of NIH Common Data Elements (CDEs) and United States Core Data for Interoperability (USCDI) standards is encouraged.
For genomic data, compliance with the NIH Genomic Data Sharing Policy is required.

Intellectual Property (IP)

The program strongly encourages recipients to obtain and retain intellectual property (IP) developed during the project period.
Applicants are encouraged to identify and foster relationships with potential licensing and commercialization partners early.
PD/PI(s) are expected to work with their institution's technology transfer officials to ensure timely royalty agreements, patent filings, and commercialization plans.
For rare diseases, alternative strategies for commercialization should be discussed with Scientific/Research staff.

Special Focus Areas

Commitment to 'Health for All' principles, aiming to improve neurological health for all people.
Explicit dedication to addressing neurological health disparities and prioritizing minority health research, recognizing Social Determinants of Health (SDOH) as drivers of disparities.

Risk Management

Projects are milestone-driven, with go/no-go decisions made by NIH program staff. Continued funding is contingent upon successful achievement of defined milestones.
The Team Management Plan must describe the governance and organizational structure for decision-making on scientific direction, intellectual property, and procedures for resolving conflicts.
An inherent rate of attrition is anticipated due to the risky nature of device development.

Grant Details