OpportunityTitle: NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials
AdditionalInformationOnEligibility: Other Eligible Applicants include the following: 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.&#160;(i) SBIR and STTR.&#160;Be a concern which is more than 50 percent 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 percent 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.&#160;Be a concern which is more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.&#160;No single venture capital operating company, hedge fund, or private equity firm may own more than 50 percent of the concern OR  (iii) SBIR and STTR.&#160;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.&#160;Has, including its affiliates, not more than 500 employees.
Description: The purpose of this funding opportunity announcement (FOA) is to encourage exploratory clinical trial applications to the newly authorized Direct-to-Phase II SBIR grant mechanism.The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Applications are invited from eligible United States small business concerns (SBCs) that have demonstrated the scientific and technical merit and feasibility of the prototype stage of developing a biomedical technology that has commercial potential, RandD that is characteristic of Phase-I (R43) SBIR projects.The Direct-to-Phase II grant mechanism is intended to facilitate SBIR-type RandD, to expand RandD opportunities for applicant small business concerns (SBCs), and to enhance the pace of technology development and commercialization.
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GrantorContactText: NIH OER Webmaster&lt;br/&gt;FBOWebmaster@OD.NIH.GOV&lt;br/&gt;