OpportunityTitle: NINDS Cooperative Program in Translational Research Small Business Awards (U44)
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 can be no more than 49 percent participation by foreign business entities in the joint venture;    3.  Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States,  or it must be a for-profit business concern that is at least 51 percent owned and controlled by another for-profit business concern that is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;    4.  Has, including its affiliates, not more than 500 employees.
Description: The goal of this funding opportunity announcement (FOA) is to support preclinical development and testing of new therapies for neurological disorders. The program will facilitate encouragementation, development, and review of therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. Phase II and Fast-Track SBIR cooperative agreements are supported under the program. Phase I, as part of a Fast-Track, supports preliminary steps in the process for the preclinical development of therapeutics. To be eligible for Phase II support, either based on a previously successful Phase I or as part of a Fast-Track, projects must include therapeutic leads and in vivo proof of concept on efficacy. Phase II supports preclinical optimization and testing of the leads, and projects must be sufficiently advanced that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) can be submitted by the end of the project period. Phase II cannot support early-stage therapeutic discovery activities such as screening. The program scope excludes clinical research, basic research, and studies of disease mechanism. The scope includes only therapy development activities, so development of diagnostics, biomarkers, or rehabilitation strategies cannot be supported. This is a milestone-driven SBIR cooperative agreement program involving participation of NINDS staff in the development of the project plan and monitoring of research progress.
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GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV &lt;br/&gt;