OpportunityTitle: Bioreactors for Reparative Medicine (R43/R44)
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. (i) SBIR and STTR.  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.  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.  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.  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 &#167; 121.705(b) concerning registration and proposal requirements.  4.  Has, including its affiliates, not more than 500 employees.
Description: Major obstacles to the generation of functional tissues and their widespread use are limited by rudimentary tissue growth technologies. The purpose of this funding opportunity is to encourage small businesses to develop sophisticated and complex biomimetic culture systems that are capable of precise control of the cellular and 3-dimensional organ microenvironment, and which address the unique physiological dynamics of heart, lung and blood tissues. Projects awarded under this announcement should show evidence of developing or using good laboratory practice (GLP) standards and/or good manufacturing practices (GMP) standards, which play an important role in the adoption of many technologies used for pre-clinical research. Additionally, sources of cell variability should be discussed in the context of potential elements of measurement assurance and use of reference materials. For projects proposing clinical grade bioreactors and clinical investigations, an applicant must provide evidence that they have contacted the Food and Drug Administration (FDA) for guidance concerning the development of their bioreactor device, such as correspondence regarding Investigational New Drug (IND) Application and status of their project in a timeline related to Federal regulatory approval processes.
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