# Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)

Source: https://welltoldgrants.com/grants/par-21-282-blueprint-medtech-small-business-translator-u44-clinical/  
Official notice: https://www.grants.gov/search-results-detail/335384

> National Institutes of Health offered grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on September 28, 2024.

| Field | Value |
|---|---|
| Opportunity number | PAR-21-282 |
| Agency | National Institutes of Health |
| Status | Forecast |
| Deadline | September 28, 2024 |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.853 |

## Who can apply

- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)

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.

## What the grant funds

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and limited-size clinical 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 effectivenesting, design verification and validation activities leading to submission of an Investigational Device Exemption (IDE) to the FDA or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) 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. SBCs developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or any of the companion opportunities. For more information see: https://neuroscienceblueprint.nih.gov/neurotherapeutics/blueprint-medtech

## Questions people ask

### Is PAR-21-282 still open?

No. It closed on September 28, 2024.

### Who can apply for Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)?

National Institutes of Health accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)?

Closed September 28, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### Who has been funded under PAR-21-282?

NIH RePORTER lists 5 projects funded under PAR-21-282 in fiscal 2023 to 2026, at 5 institutions. The most were at NEURO42, Inc., Cari Health, Inc., Instanosis, Inc.

### Who has won Extramural Research Programs in the Neurosciences and Neurological Disorders grants before?

The largest recipients over five fiscal years were The General Hospital Corporation, The Regents of the University of California, San Francisco, The Johns Hopkins University. The program made 8,641 awards worth $9.1 billion in that time.