Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)

Open Posted

Opportunity number
PAR-25-383
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Cooperative Agreement
Categories
  • Income Security and Social Services
  • Health
  • Education
Eligible applicants
  • Independent School Districts
  • Non-501(c)(3) Nonprofits
  • Tribal Governments (Federally Recognized)
  • Higher Education Inst. (Private)
  • Special District Governments
  • 501(c)(3) Nonprofits
  • For Profit Organizations
  • State Governments
  • County Governments
  • Tribal Organizations (Not Federally Recognized)
  • City/Township Governments
  • Small Businesses
  • Public or Indian Housing Auth.
  • Higher Education Inst. (Public)
  • Other
Points of contact
Full announcement

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institutes of Health Blueprint for Neuroscience Research, through participating NIH Institutes and Centers, is soliciting applications for translational activities and clinical studies to advance medical device development for nervous system and neuromuscular disorders under the UG3/UH3 cooperative agreement mechanism, with an application due date of January 28, 2028.

Applicants span a broad eligibility spectrum: independent school districts, nonprofit and for-profit organizations, tribal governments (federally recognized and non-federally recognized), higher education institutions (public and private), state and local government entities, small businesses, special districts, public or Indian housing authorities, and other eligible applicant categories. The program also welcomes Alaska Native and Native Hawaiian Serving Institutions, HBCUs, TCCUs, Hispanic-serving institutions, AANAPISIs, faith-based and community-based organizations, regional organizations, non-domestic entities, and U.S. territories. Individuals, institutions, or businesses developing their own devices or with established collaborations with device manufacturers are encouraged to apply directly.

The Blueprint MedTech program provides non-dilutive funding and additional resources to support investigators through late-stage technology development, optimization, and first-in-human clinical studies. Supported activities include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation, obtaining an Investigational Device Exemption (IDE) for Significant Risk studies or Institutional Review Board approval for Non-Significant Risk studies, and clinical feasibility studies. Clinical studies are expected to provide information about device function or design that cannot practically be obtained through non-clinical assessments due to device novelty or intended use.

The program operates as a milestone-driven cooperative agreement requiring NIH program staff participation in negotiating the final project plan before award and monitoring research progress. Participants receive funding for activities conducted in their own laboratories and collaborate with NIH-funded consultants in regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Applicants may augment projects with NIH contract research organizations specializing in large animal testing, sterilization, biocompatibility assessment, manufacturing, and medical monitoring.

The opportunity falls under multiple federal grant programs: Mental Health Research Grants (CFDA 93.242), Extramural Research Programs in Neurosciences and Neurological Disorders (CFDA 93.853), and Discovery and Applied Research for Technological Innovations to Improve Human Health (CFDA 93.286).

This is a forecast announcement; applications are not currently being solicited. Notice is provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

Synopsis

The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilization testing, biocompatibility assessment, manufacturing, and medical monitoring. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. For more information see BP MedTech website.

Eligibility

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Files

File Type Posted
PAR-25-383-Full-Announcement.html HTML file
PKG00290980.pdf PDF

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