BRAIN Initiative: Pre-Applications for Industry Partnerships to Provide Early Access to Devices for Stimulation and Recording in the Human Central Nervous System (X02)

Post Date

September 17th 2015

Application Due Date

November 18th 2015

Funding Opportunity Number

PAR-15-345

CFDA Number(s)

93.173
93.213
93.242
93.273
93.279
93.286
93.853
93.865
93.866
93.867

Funding Instrument Type(s)

Grant

Funding Activity Categories

Education
Health
Income Security and Social Services

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

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.

Funding

• Award Range:

  $None - $None

Grant Description

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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  National Institutes of Health

• Agency Contact:

  NIH OER Webmaster
  FBOWebmaster@OD.NIH.GOV
  

• Agency Mailing Address:

  If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

• Agency Email Address:

  FBOWebmaster@OD.NIH.GOV

• More Information:

  http://grants.nih.gov/grants/guide/pa-files/PAR-15-345.html