NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (U44)

The summary for the NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (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 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 on the Path to 510(k) (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 the immediate next steps upon completion of the clinical study will be a 510(k)/510(k) De Novo submission or a larger clinical trial that will lead directly to a 510(k)/510(k) De Novo submission. 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 on the Path to 510(k) (U44)
Federal Agency Name: National Institutes of Health
Grant Categories: Health
Type of Opportunity: Discretionary
Funding Opportunity Number: PAR-14-296
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
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
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

National Institutes of Health 301-496-3405
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