BRAIN Initiative: Pre-Applications for Industry Partnerships to Provide Early Access to Devices for Stimulation and Recording in the Human Central Nervous System (X02)
This FOA is intended to facilitate partnerships between clinical investigators and manufacturers of latest-generation stimulating and/or recording devices that are FDA-designated as Class III (invasive, posing significant risk of harm), to conduct clinical research in the central nervous system.As part of The BRAIN InitiativeSM, NIH has initiated a Public-Private Partnership program (BRAIN PPP) to reduce barriers to negotiating such partnerships, and to ensure that new clinical studies leverage manufacturers existing data demonstrating safety and utility of these devices.Safety and utility data for invasive devices are costly to obtain, yet they are necessary for regulatory approval of human research, and therefore pose a substantial barrier to research progress.For this program, NIH has entered into agreements with a number of manufacturers to make available next generation devices that can stimulate and/or record from the central nervous system and have sufficient data to enable new Non-Significant Risk (NSR) or Investigational Device Exemption (IDE) without the need for significant additional testing.
General information about this opportunity
Last Known Status
Deleted 12/19/2015 (Archived.)
Program Number
PAR-15-345
Federal Agency/Office
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Grant
Who is eligible to apply/benefit from this assistance?
Applicant 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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
What is the process for applying and being award this assistance?
Deadlines
11/18/2015
Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements.
Who do I contact about this opportunity?
Headquarters Office
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV
Website Address
http://grants.nih.gov/grants/guide/pa-files/PAR-15-345.html
E-mail Address
FBOWebmaster@OD.NIH.GOV
Financial Information
Obligations
$0.00
