Translational Neural Devices (R61/R33 - Clinical Trial Optional)

Key Facts

Status: Forecasted

Posted date: October 29, 2024

Archive date: March 5, 2027

Close date: January 28, 2027

Opportunity ID: 356903

Opportunity number: PAR-25-053

Opportunity category: Discretionary

Agency name: National Institutes of Health

Agency code: HHS-NIH11

Award floor: $0

Award ceiling: $0

Cost sharing required: No

Funding Instrument Types
  • Grant
Category of Funding Activity
  • Health
Eligible Applicants
  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • 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
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Tools
Categories (use these for quoted searches)
  • agency_code:hhs_nih11
  • category_of_funding_activity:health
  • cost_sharing_or_matching_requirement:false
  • eligible_applicants:city_or_township_governments
  • eligible_applicants:county_governments
  • eligible_applicants:for_profit_organizations_other_than_small_businesses
  • eligible_applicants:independent_school_districts
  • eligible_applicants:native_american_tribal_governments_federally_recognized
  • eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
  • eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:others
  • eligible_applicants:private_institutions_of_higher_education
  • eligible_applicants:public_and_state_controlled_institutions_of_higher_education
  • eligible_applicants:public_housing_authoritiesindian_housing_authorities
  • eligible_applicants:small_businesses
  • eligible_applicants:special_district_governments
  • eligible_applicants:state_governments
  • funding_instrument_type:grant
  • opportunity_category:discretionary
  • status:forecasted
Description

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small 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 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 small clinical 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 NOFO 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.

Translational Neural Devices (R61/R33 - Clinical Trial Optional)
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage investigators to pursue translational activities and small 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 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 small clinical 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 NOFO 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.
[Forecasted] Translational Neural Devices (R61/R33 - Clinical Trial Optional)
Forecasted
National Institutes of Health
Health
Grant
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
2024-10-29