NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (U44)

The summary for the NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (U44) 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 Clinical Studies to Inform Final Device Design (U44): The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications to pursue translational and clinical 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) or IRB approval for a Non-Significant Risk (NSR) study and the following clinical study. It is expected that the clinical study will inform a final device design that would have to go through most, if not all, of the preclinical testing on the path to more advanced clinical trials and market approval. This program also supports development of a device to test scientific hypotheses that are not feasible or practical to conduct in animal models, but are critical to enable next-generation devices. 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 a small clinical study.
Federal Grant Title: NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (U44)
Federal Agency Name: National Institutes of Health (HHS-NIH11)
Grant Categories: Health
Type of Opportunity: Discretionary
Funding Opportunity Number: PAR-14-300
Type of Funding: Cooperative Agreement
CFDA Numbers: 93.853
CFDA Descriptions: Information not provided
Current Application Deadline: May 7th, 2017
Original Application Deadline: May 7th, 2017
Posted Date: July 28th, 2014
Creation Date: July 28th, 2014
Archive Date: June 7th, 2017
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching: No
Last Updated: July 28th, 2014
Applicants Eligible for this Grant
Small businesses
Additional Information on Eligibility
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria: 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; 3. (i) SBIR and STTR. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR (ii) SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees.
Link to Full Grant Announcement
http://grants.nih.gov/grants/guide/pa-files/PAR-14-300.html
Grant Announcement Contact
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV

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