NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)
ID: 355039Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Small Businesses

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is offering the "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research," aimed at supporting U.S. small businesses in advancing medical technology and biotechnology projects toward commercialization, particularly in the neurological field. This funding opportunity encourages applications from small business concerns that have previously received NIH SBIR or STTR Phase II awards, focusing on projects that evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral, or rehabilitation therapies. The initiative seeks to bridge the funding gap for clinical trials, promoting partnerships with third-party investors and requiring a detailed Commercialization Plan from applicants. The total funding support for a Phase II award is capped at $2,045,816, with applications due by April 5, 2027. Interested parties can find more information and submit applications through Grants.gov or the NIH ASSIST system, and inquiries can be directed to grantsinfo@nih.gov.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services is issuing a Notice of Funding Opportunity (NOFO) titled "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research," aimed at supporting U.S. small businesses in transitioning medical technology and biotechnology projects toward commercialization. This NOFO specifically targets projects in the neurological field previously funded under SBIR or STTR Phase II grants, helping bridge the funding gap often referred to as the "Valley of Death." Applicants are encouraged to establish partnerships with third-party investors and must demonstrate plans for diverse perspectives. Key funding components include support for exploratory clinical trials, regulatory compliance, and plans to recruit diverse populations. The total funding support for a Phase II award is capped at $2,045,816, with specific eligibility requirements focused on small business concerns. Applications should be submitted through Grants.gov or the NIH ASSIST system, with deadlines specified for 2024-2027. The initiative reflects NINDS's commitment to advancing innovative solutions for neurological disorders while fostering a diverse research workforce. Compliance with robust application guidelines is imperative to ensure eligibility and funding approval.
    Similar Opportunities
    NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)
    Active
    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 Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
    Active
    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 Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for small business concerns (SBCs) through the NINDS Exploratory Clinical Trials program (R43/R44), aimed at supporting investigator-initiated exploratory clinical trials related to neurological disorders. This program invites applications for studies that evaluate drugs, biologics, devices, or therapies, generating preliminary data to inform future clinical development, with a focus on enhancing diverse perspectives within research teams. Eligible U.S.-based SBCs can apply for funding caps of up to $295,924 for Phase I and $1,972,828 for Phase II, with applications due by September 5, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-23-311.html.
    NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (FON PAR-24-099) aimed at small business concerns proposing investigator-initiated clinical trials that align with the NIAID's research mission. This program supports hypothesis-driven and milestone-driven clinical trials, particularly those classified as high-risk, which may involve unique interventions or the use of licensed products for unapproved indications. The initiative underscores the government's commitment to advancing innovative clinical research to address significant healthcare challenges, with funding of up to $1 million annually available for meritorious applications. Interested applicants must adhere to strict guidelines and submit their applications by the various deadlines, with the first due date on April 12, 2024, and the final deadline on January 13, 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) have announced the PHS 2024-2 Omnibus Solicitation for Small Business Innovation Research (SBIR) grant applications, specifically requiring clinical trials. This funding opportunity is aimed at U.S. small businesses with the necessary research capabilities to contribute to the missions of the NIH and CDC, encouraging innovation and the commercial viability of health technologies. Eligible applicants can receive funding up to $306,872 for Phase I and $2,045,816 for Phase II, with a submission deadline of April 5, 2025. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PA-24-246.html.
    PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced the PHS 2024-2 Omnibus Solicitation for Small Business Technology Transfer (STTR) grant applications, inviting eligible U.S. small businesses to submit proposals that include at least one clinical trial. This funding opportunity aims to support research and development projects that align with the scientific missions of participating NIH Institutes and Centers, emphasizing the importance of innovation in health-related technologies. Eligible applicants must be U.S.-based small businesses with majority ownership by U.S. citizens or resident aliens, and the grants provide funding caps of up to $306,872 for Phase I and $2,045,816 for Phase II projects. Interested parties should note that the application deadline is April 5, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), in collaboration with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), has announced the PHS 2024-2 Omnibus Solicitation for Small Business Innovation Research (SBIR) Grant Applications. This funding opportunity invites eligible U.S. small businesses to submit applications for Phase I, Phase II, Fast-Track, and Direct to Phase II projects that align with the research missions of the NIH, CDC, and FDA, with a focus on stimulating technological innovation and commercialization of federal R&D investments. Notably, applications must not include clinical trials, and funding levels are capped at $306,872 for Phase I and up to $2,045,816 for Phase II, with a submission deadline of April 5, 2025. Interested applicants can find more information and guidelines at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the Small Business Transition Grant for New Entrepreneurs (R41/R42 Clinical Trial Required) to support early-career scientists transitioning into entrepreneurial roles within small businesses. This funding opportunity aims to facilitate the career development of investigators by providing entrepreneurial training, mentorship, and support for research and development projects that align with NIH's mission to improve health. Eligible small business concerns (SBCs) can apply for Phase I and Fast-Track grants, with funding amounts typically reaching $306,872 for Phase I and $2,045,816 for Phase II awards. Applications will be accepted starting August 5, 2024, with a closing date of April 5, 2027. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-24-134.html.
    NINDS Exploratory Clinical Trials (UG3/UH3 Clinical Trial Required)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Neurological Disorders and Stroke (NINDS), is offering a funding opportunity for investigator-initiated exploratory clinical trials under the UG3/UH3 mechanism. This initiative aims to support Phase 1 and Phase 2 clinical trials that address critical questions related to neurological disorders, focusing on studies involving drugs, biologics, devices, and early interventions. The program emphasizes rigorous research design and encourages diverse and innovative research teams, with grants potentially spanning up to five years, beginning with a planning phase before transitioning to execution. Interested applicants can find more information and application details at the provided link, with a submission deadline of March 10, 2025, and no cost-sharing or matching requirement.
    Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) invites applications for the Blueprint Neurotherapeutics Network (BPN), aimed at supporting small businesses in advancing small molecule drug discovery and development for disorders of the nervous system. This funding opportunity, categorized as a Cooperative Agreement under the U44 Small Business Innovation Research (SBIR) program, encourages applicants to conduct disease-specific assays and collaborate with NIH-funded consultants and contract research organizations to facilitate the transition of promising drug candidates from discovery to clinical testing. The program emphasizes compliance with Good Laboratory and Clinical Practices, rigorous study designs, and diversity in research teams, making it a vital resource for small businesses lacking the necessary infrastructure for clinical development. Applications will be accepted starting January 9, 2024, with a closing date of August 19, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.