NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (U44)

 
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    CFDA#

    93.853
     

    Funder Type

    Federal Government

    IT Classification

    B - Readily funds technology as part of an award

    Authority

    U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH)

    Summary

    This program seeks to encourage the translation of research discoveries into new treatments for neurological disorders and stroke that fall under the National Institute of Neurological Disorders and Stroke (NINDS) mission.

    This funding opportunity will utilize a U44 cooperative agreement mechanism to support pre-clinical testing to enable an Investigational Device Exemption (IDE) submission and a subsequent small clinical study (e.g. Early Feasibility Study). For Non-Significant Risk (NSR) clinical studies that do not require an IDE, IRB approval is considered sufficient. This program supports pre-clinical and clinical studies to inform a final device design that would have to go through most, if not all, of the preclinical testing on the path to clinical trials and market approval. This program also supports development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. Activities that can be supported in this program include implementation of clinical prototype devices, design verification and validation activities, demonstration of preclinical safety and efficacy, pursuit of U.S. regulatory approval for clinical study, and a small clinical study.

    Projects must focus on a single disorder that falls within the mission of NINDS. Devices within the scope of this program are expected to require most, if not all, of the in vitro and preclinical animal testing necessary to enable an IDE submission after completion of the Phase II.

    For entry to the program, projects should have:

    • Comprehensive Supporting Data: Ideally, preliminary proof-of-concept data would be obtained using an in vivo model representative of the intended patient population.
    • A compelling case to for a successful IDE submission by the end of Phase I or IRB approval for a Non-Significant Risk (NSR) study at the end of Phase I.
    • Overall device development plan, including when contact with the appropriate regulatory bodies is planned, clinical considerations, and a needs assessment.
    • Identified one or more clinically meaningful device outcome measures based on input from both clinicians and patients
    • Non-binding FDA Pre-Submission (formerly pre-IDE) feedback clearly denoting that the proposed pre-clinical testing plan is sufficient to support a successful FDA submission for an IDE by the end of Phase I. For Non-Significant Risk (NSR) studies, preliminary communications (e.g. letter or other documentation) with the IRB indicating what pre-clinical testing will be necessary to support the NSR clinical study is sufficient.
    Examples of studies that can be proposed during the U44 Phase I include, but are not limited to:

    • Non-GLP (Good Laboratory Practice) animal studies to develop surgical techniques relevant to the device, define relevant therapeutic parameters, and refine device design in preparation for subsequent GLP testing for regulatory approval
    • In vitro and animal testing to meet FDA Recognized ISO/ASTM Standards
    • Activities to become GMP (Good Manufacturing Practice) compliant
    • Activities to bring the development process under Design and Quality Systems Control
    • Device, software, and firmware design verification and validation activities
    • Regulatory affairs
    • GLP compliant large animal model safety and/or testing of an implanted device
    • IDE submission
    The U44 Phase II will support a clinical study to inform a final device design, or test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. It should be noted that clinical studies are only supported for projects where the preclinical activities are conducted under this funding mechanism.
     

    History of Funding

    None is available.

    Additional Information

    Examples of Activities Inappropriate for this program include:

    • Basic research and studies of disease mechanisms
    • Animal model development: All in vivo models must have been established and characterized in the applicants or collaborators laboratory.
    • Development of diagnostics, or diagnostic devices.
    • Rehabilitation strategies.
    • Imaging technologies.
    • Definitive clinical trials of therapeutic devices, such as a full Feasibility study and/or Pivotal Trial
    • Pre-clinical studies and related clinical studies to enable 510(k) or 510(k) De Novo submission
    • Pre-clinical studies to enable IDE submission, where the immediate next steps upon completion of an Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption), i.e. changes to the system design informed by the Early Feasibility Study will be minor and not require additional animal testing.
    • Efforts to develop neurotechnology for fundamental study of the nervous system.
    • Fundamental basic/applied research projects that employ existing market approved devices for their labeled uses are outside the scope of the present program but may be within scope of the Bioengineering Research Grants and Partnerships program announcements.
    • Projects focused on neural prosthetic technologies for augmentation of healthy individuals.

    Contacts

    Tijuanna Decoster, Ph.D.

    Tijuanna Decoster, Ph.D.
    U.S. Department of Health and Human Services (HHS)
    National Institute of Neurological Disorders and Stroke (NINDS)
    NSC BG RM 3258
    6001 Executive Blvd Mail Stop: 9537
    Rockville, MD 20852
    (301) 496-9231
    (301) 402-0219
    For a complete list of contacts, please see the guidance.
     

  • Eligibility Details

    Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

    • Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
    • Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture;
    • (i) SBIR and STTR. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR
      • (ii) SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR
      • (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
    • Has, including its affiliates, not more than 500 employees.

    Deadline Details

    All non-AIDS applications must be submitted by 5:00 p.m. local time of applicant organization on the following dates: October 21, 2014; February 11, 2015; August 11, 2015; February 11, 2016; August 11, 2016; February 8, 2017.

    All AIDS applications must be submitted by 5:00 p.m. local time of applicant organization on the following dates: January 7, 2015; May 7, 2015; September 7, 2015; May 7, 2016; September 7, 2016; May 7, 2017. 

    Award Details

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited but must reflect the actual needs of the proposed project. Applicants should rarely exceed $1,000,000 direct costs per year for Phase I and $1,500,000 direct costs per year for Phase II. Durations of up to 2 years for Phase I and up to 3 years for Phase II may be requested. Cost sharing/matching is not required.

    Related Webcasts Use the links below to view the recorded playback of these webcasts


    • Highlights of Grants to Manage and Expand Access to Health Data - Sponsored by NetApp - Playback Available
    • Funding for Healthcare Technology to Connect Providers and Patients - Sponsored by Panasonic - Playback Available
    • NSF Funding for Campus Cyberinfrastructure in Higher Education - Sponsored by NetApp - Playback Available

 

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