The NIH BRAIN Initiative is offering grants for clinical investigators to partner with manufacturers of Class III stimulating/recording devices for research in the central nervous system. This program aims to reduce barriers to partnerships, utilizing existing safety and utility data to expedite research progress. Through the BRAIN PPP, next-generation devices will be provided for new studies without requiring extensive additional testing, advancing research in this critical area. Closing date for pre-applications is November 18, 2015.
Opportunity ID: 279049
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-15-345 |
| Funding Opportunity Title: | BRAIN Initiative: Pre-Applications for Industry Partnerships to Provide Early Access to Devices for Stimulation and Recording in the Human Central Nervous System (X02) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Education Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.173 — Research Related to Deafness and Communication Disorders |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Sep 17, 2015 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Nov 18, 2015 |
| Current Closing Date for Applications: | Nov 18, 2015 |
| Archive Date: | Dec 19, 2015 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Independent school districts Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Public and State controlled institutions of higher education Special district governments County governments For profit organizations other than small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-15-345.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-C | FORMS-C | PKG00218565 | Oct 18, 2015 | Nov 18, 2015 | View |
Package 1
Mandatory forms
279049 RR_SF424_2_0-2.0.pdf
279049 PHS398_ResearchPlan_2_0-2.0.pdf
279049 PHS398_CoverPageSupplement_2_0-2.0.pdf
279049 RR_KeyPersonExpanded_2_0-2.0.pdf
279049 RR_OtherProjectInfo_1_3-1.3.pdf
279049 PerformanceSite_2_0-2.0.pdf
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