Cancer Diagnostic and Therapeutic Agents Enabled by Nanotechnology (SBIR [U43/U44])

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Purpose. This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), National Institutes of Health (NIH), invites Small Business Innovation Research (SBIR) cooperative agreement applications from small business concerns (SBCs) that propose to develop new, or to improve existing application(s) of nanotechnology-based therapeutics or/and in vivo diagnostics. This FOA will specifically support pre-clinical optimization and testing of these cancer-relevant nanotechnology applications against the intended cancer type. The proposed projects must be milestone-driven and must be clearly directed toward development of an ultimate commercial product. The outcomes are expected to advance the discovery and pre-clinical optimization phase so that an Investigational New Drug (IND) or Investigational Device Exemptions (IDE) application could be submitted to the Food and Drug Administration (FDA) by the end or shortly after completion of the Phase II project period. To facilitate these steps, the NCI will assist the awardees in various ways, including the support through the NCI-sponsored Nanotechnology Characterization Laboratory. This FOA will NOT support basic research projects, studies on disease mechanisms, and clinical trials. Mechanism of Support. This FOA will utilize the SBIR (U43/U44) cooperative agreement mechanisms for Phase I and Phase II applications. Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.

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