Limited Competition: Renewal of Existing NINDS-Supported Clinical Trial Cooperative Agreement Awards (U01 - Clinical Trials Required)
ID: 356870Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/356870

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-149.html
Timeline
    Description

    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), is offering a limited competition for the renewal of existing clinical trial cooperative agreement awards (U01) that require additional time and resources to complete ongoing research on neurological disorders. This funding opportunity is specifically aimed at supporting extramural research efforts and emphasizes the importance of collaboration between NIH and award recipients to achieve significant advancements in the field. Eligible applicants include various federal entities, independent school districts, and tribal organizations, with the application submission period opening on February 5, 2025, and deadlines extending throughout the year. For further details, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-25-149.html.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-149.html
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Stroke (NINDS), announces a limited competition for the renewal of existing clinical trial cooperative agreements (U01). This funding opportunity aims to support ongoing extramural research focused on various aspects of neurological disorders, necessitating additional time and resources to complete clinical trials. Key dates include the opening of application submissions on February 5, 2025, with deadlines for applications throughout 2025. Eligible organizations include federal entities, independent school districts, and tribal organizations, among others. The application process requires adherence to specific guidelines and registrations, including SAM and eRA Commons. Notably, applicants must focus solely on renewing original proposals, as introducing new aims will disqualify their submissions. The funding is also contingent upon the merit of applications received, which will follow a structured review process assessing the significance, innovation, approach, and expertise of the proposed studies. Overall, this NOFO emphasizes collaboration and shared responsibility between NIH and cooperative award recipients to achieve impactful advancements in neurological research while adhering to rigorous ethical and administrative standards.
    Similar Opportunities
    NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering NINDS Renewal Awards of Small Business Innovation Research (SBIR) Phase II Grants (Phase IIB) to support clinical trials and clinical research projects focused on neurological disorders. This funding opportunity encourages small business concerns (SBCs) to seek additional funding for projects previously funded by NIH SBIR and STTR Phase II awards, with an emphasis on facilitating the transition of these projects to commercialization through partnerships with third-party investors. The initiative aims to address the "Valley of Death" funding gap in medical biotechnology, particularly for products related to the mission of the National Institute of Neurological Disorders and Stroke (NINDS). Interested applicants must submit a Commercialization Plan and a Plan for Enhancing Diverse Perspectives (PEDP), with the application opening on August 5, 2024, and a closing date of April 5, 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Research Program Award (R35 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a Research Program Award (R35 Clinical Trial Optional) aimed at providing long-term support and flexibility for Program Directors (PDs) and Principal Investigators (PIs) in the field of neurological research. This grant, which does not require cost sharing or matching, is designed to alleviate the administrative burdens associated with managing multiple grant applications, allowing researchers to focus on their scientific endeavors and mentorship roles. The funding, with an award ceiling of $750,000 and a floor of $350,000, is intended to foster innovative research that aligns with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). Interested applicants can reach out to Alisa Schaefer at nindsr35@ninds.nih.gov for further information, with the estimated synopsis posting date set for April 15, 2026, and a projected award date of March 1, 2027.
    NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "NeuroNEXT Small Business Innovation in Clinical Trials," aimed at encouraging small businesses to conduct exploratory clinical trials of investigational agents related to neurological disorders. This initiative seeks applications for Phase II Small Business Innovation Research (SBIR) projects, with a budget of up to $3 million over five years, focusing on trials that align with the strategic plan of the National Institute of Neurological Disorders and Stroke (NINDS). The program is designed to foster public-private partnerships to enhance the development and commercialization of innovative therapies, ultimately improving clinical outcomes in neuroscience research. Interested applicants must adhere to a Community Engagement and Research Inclusion (CERI) plan, with the first application deadline set for January 5, 2025, and additional deadlines throughout 2026 and 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders (U01 - Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Translational Efforts to Advance Gene-based Therapies for Ultra-Rare Neurological and Neuromuscular Disorders" (PAR-25-327), aimed at supporting Investigational New Drug (IND)-enabling studies and preparations for First-in-Human (FIH) clinical trials. This initiative focuses on advancing innovative gene-based therapies, such as oligonucleotides and viral vector approaches, for ultra-rare disorders affecting fewer than 6,000 patients, with an emphasis on projects that demonstrate robust proof of concept data and readiness for clinical trials. Eligible applicants include a wide range of organizations, including higher education institutions and various nonprofit and for-profit entities, with applications requiring detailed project planning and compliance with Good Manufacturing Practices (GMP). The application period opens on January 9, 2025, with a close date of October 8, 2027, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is announcing a forthcoming funding opportunity titled "NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required)" aimed at soliciting applications for research on exploratory and efficacy clinical trials that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). This initiative will focus on evaluating various interventions, including drugs, biologics, devices, and therapies related to surgical, behavioral, and rehabilitation approaches. The opportunity is particularly significant for researchers with expertise in neurological disorders, as it encourages the development of meaningful collaborations and responsive projects in this critical health area. Interested applicants can reach out to Jeremy Brown, MD, via email at ExploratoryEfficacyTrials@ninds.nih.gov for further information, with the estimated synopsis posting date set for November 12, 2025, and applications expected to close by February 10, 2026.
    NINDS Research Education Programs for Residents and Fellows in Neurological Disorders and Stroke (UE5 - Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NINDS Research Education Programs for Residents and Fellows in Neurological Disorders and Stroke" (UE5 Program) aimed at enhancing the training of clinician-scientists in the field of neurological disorders. This initiative seeks to support educational activities that provide research experiences and career development workshops, with a focus on preparing physicians to secure independent NIH research funding and transition into physician-scientists. The program is open to a variety of eligible applicants, including accredited medical schools, hospitals, and various educational institutions, with funding available for up to three increments totaling a maximum of 36 months, and an award ceiling of $850,000. Interested applicants should submit letters of intent and adhere to the application guidelines outlined in the full announcement, with the closing date for applications set for January 28, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." This initiative aims to support the clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders, focusing on establishing their clinical sensitivity and specificity in accordance with FDA guidelines. The program is particularly significant as it seeks to enhance public health outcomes by facilitating the implementation of validated biomarkers in clinical settings, thereby addressing critical healthcare needs in these areas. Interested applicants should note that the application period opens on January 21, 2025, and closes on June 22, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-055.html.
    NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)" aimed at supporting Small Business Concerns (SBCs) in conducting investigator-initiated exploratory clinical trials related to neurological disorders. This initiative encourages applications for Phase I and II studies focusing on drugs, biologics, devices, and therapies that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS), emphasizing the inclusion of a Plan for Enhancing Diverse Perspectives (PEDP) to foster innovation. The maximum funding amounts are $295,924 for Phase I and $1,972,828 for Phase II projects, with applications required to demonstrate readiness for eventual FDA regulatory approval. Interested applicants can begin submitting proposals on December 5, 2023, with the application deadline set for September 5, 2026; for further inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) to support pre-clinical research aimed at bridging funding gaps that impede the commercialization of medical biotechnology products. This funding opportunity specifically targets previously funded SBIR or STTR Phase II projects, with the objective of advancing products or technologies that require federal regulatory approval, while fostering partnerships between small businesses and external investors to enhance commercialization prospects. Applicants are encouraged to secure independent third-party funding that equals or exceeds one-third of the requested NINDS funds, and must include a Plan for Enhancing Diverse Perspectives (PEDP) to promote inclusivity in the research environment. The application deadline is April 5, 2027, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. More details can be found in the full announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-24-222.html.
    NINDS Research Education Opportunities (R25 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), has announced a funding opportunity titled "NINDS Research Education Opportunities (R25 Clinical Trial Not Allowed)" aimed at enhancing research education in biomedical, behavioral, and clinical research. This initiative seeks applications for innovative educational activities that provide hands-on research experiences and skills development, particularly in the field of neuroscience, with a maximum funding of $250,000 per year for up to five years. The program emphasizes diversity recruitment and significant institutional commitment, requiring applicants to include a comprehensive evaluation plan and adhere to strict guidelines. Interested parties can find more information and apply by July 14, 2026, and should direct inquiries to NIH Grants Information at grantsinfo@nih.gov.