Description

This is a Food and Drug Administration (FDA) Small Business Sources Sought Notice for Commercial Supplies. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition is 325414; Biological Product (except Diagnostic) Manufacturing, with a small business standard size of 1,250 employees. The Product Service Code (PSC) is 6505: Drugs and Biologicals. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code is still encouraged to submit a Capabilities Statement. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** BACKGROUND The United States Food and Drug Administration (FDA) has a mission to protect public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. In addition, FDA is responsible for facilitating innovations that make medicines more effective, safer, and more affordable. To accomplish these goals, FDA has stimulated advancement of regulatory science, which is defined as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA regulated products.” FDA's vision is to facilitate the integration of new science into the process of evaluating the safety and efficacy of proposed and marketed products and to close the gap between scientific innovation and this process of drug review. To achieve this vision, we perform mission-critical research to develop and evaluate tools, standards, and approaches to assess the safety, efficacy, quality, and performance of drugs. The Division of Applied Regulatory Science (DARS) is conducting a research project to examine the effect of female sex hormones on in vitro drug metabolism. DARS operates several labs that provide mission- critical research supporting review questions, translational science, and emerging public health issues for Center for Drug Evaluation and Research (CDER) and FDA. We develop and evaluate novel tools, standards, and approaches that increase the regulatory efficiency of developing and reviewing safe and effective CDER products. These operational supplies are essential for the continuance of these projects across our labs, and for continued preparedness to b…

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