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Phase IIB Competing Renewal Awards

Description:

NIGMS will accept Phase IIB SBIR-only Competing Renewal grant applications to continue the process of developing products that ultimately require 1) clinical evaluation, 2) approval by a Federal regulatory agency, and 3) continuing refinements to durable medical equipment (DME) designs such as cost reduction, testing for safety, durability, and reliability, and meeting or establishing standards. This renewal grant should allow small businesses to get to reach a stage where interest and investment by third parties is more likely. Such products include, but are not limited to biological products, devices, drugs, medical implants, etc. related to the mission of the NIGMS. The previously funded Phase II SBIR grant need not have been submitted in response to a particular solicitation, as long as the research is appropriate to the purpose of this solicitation. Budgets up to $750,000 total costs per year and time periods up to 2 years may be requested for this Phase IIB Competing Renewal opportunity. These awards are intended to support completion of research needed to obtain an IND or IDE. Applicants must provide evidence that they have consulted formally with the FDA concerning the research needed for the development of a drug, biologic or medical device and that the proposed research will address these regulatory requirements. Such evidence should include FDA correspondence from a pre-IND meeting for an IND application or a pre-IDE meeting for an IDE application, and the status of the project in a timeline related to Federal regulatory approval processes.

Prospective applicants are strongly encouraged to contact NIH staff listed at the end of this NIGMS topics announcement prior to submission of a Phase IIB Competing Renewal application. Prospective applicants are strongly encouraged to submit to the program contact a letter of intent that includes the following information:

·       Descriptive title of the proposed research

·       Name, address, and telephone number of the Principal Investigator

·       Names of other key personnel

·       Participating institutions

·       Funding Opportunity Announcement Number (e.g., PA-12-XXX)

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