NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3)

The summary for the NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3): The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and Early Feasibility Studies for therapeutic devices to treat neurological disorders. The program will utilize a cooperative agreement mechanism to support the submission of an Investigational Device Exemption (IDE), with the option of also supporting the following Early Feasibility Study. It is expected the immediate next steps upon completion of the Early Feasibility Study will be a full Feasibility Study and a Pivotal Trial in support of a PMA (Pre-Market Approval) or HDE (Humanitarian Device Exemption). Activities supported in this program include implementation of clinical prototype devices, preclinical safety and efficacy testing, design verification and validation activities, pursuit of regulatory approval for the clinical study, and an Early Feasibility Study.

Federal Grant Title:	NINDS CREATE Devices: Translational and Early Feasibility Studies on the Path to Pre-Market Approval (PMA) or Humanitarian Device Exemption (HDE) (UH2/UH3)
Federal Agency Name:	National Institutes of Health
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	PAR-14-298
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.853
CFDA Descriptions:	Extramural Research Programs in the Neurosciences and Neurological Disorders
Current Application Deadline:	May 7, 2017
Original Application Deadline:	May 7, 2017
Posted Date:	Jul 28, 2014
Creation Date:	Jul 28, 2014
Archive Date:	Jun 7, 2017
Total Program Funding:
Maximum Federal Grant Award:	none
Minimum Federal Grant Award:	none
Expected Number of Awards:
Cost Sharing or Matching:	No

Applicants Eligible for this Grant: Public and State controlled institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Independent school districts
State governments
Small businesses
Native American tribal organizations (other than Federally recognized tribal governments)
For profit organizations other than small businesses
Native American tribal governments (Federally recognized)
County governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Special district governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
City or township governments
Public housing authorities/Indian housing authorities
Private 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); Non-domestic (non-U.S.) Entities (Foreign Organizations); 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 not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Link to Full Grant Announcement: http://grants.nih.gov/grants/guide/pa-files/PAR-14-298.html
Grant Announcement Contact: NIH OER Webmaster [email protected]
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

National Institutes of Health 301-496-3405
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