Center for Drug Evaluation and Research (CDER) Office of Executive Programs (OEP) Division of Learning and Organizational Development (DLOD) Drug Development and Regulatory Sciences Course

FDA-1236402 Notice of Intent to Sole Source to the University of California, San Francisco (UCSF) Title: Center for Drug Evaluation and Research (CDER) Office of Executive Programs (OEP) Division of Learning and Organizational Development (DLOD) Drug Development and Regulatory Sciences Course The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), intends to award a Sole Source firm-fixed price purchase order to the University of California, San Francisco, 3333 California Street Rm 218 San Francisco, CA, in accordance with the authority under FAR Part 13. This procurement is being conducted under simplified acquisition procedures in accordance with FAR Parts 12 and 13. The NAICS code is 611430 – Professional and Management Development Training. The PSC Code is U001- Education Lectures. The Government intends to solicit and negotiate directly with UCSF and no solicitation will be issued. The Food and Drug Administration intends to make a sole source award to UCSF to provide American Course training on Drug Development and Regulatory Sciences (ACDRS). UCSF provides a unique training and expertise course in medical product discovery and development, collaborating on best practices in rapid development of new products, team-oriented case studies, and building an international network of colleagues – all of which provides a perspective from multiple viewpoints: academia, industry, and regulatory regarding the development and regulation of medical products contained in the ACDRS. It is the only known course of its kind available for serving CDER’s need. The period of performance will be twelve (12) months. The course objectives/performance requirements are as follows: Present a foundation of integrated knowledge in science-based medical product development and regulation. Enable application of innovative methods, tools, and strategies that best utilize recent scientific advances and technologies to medical product design, development, and regulatory review. Address real-world challenges encountered during the development, manufacturing, review, and commercialization of FDA-regulated medical products Cover the entire medical product lifecycle – from molecule or devise concept to marketplace. Train the leaders and the integrators for medical product development. Understand future directions in global pharmaceutical and health economics and business environments and implications for product development and evaluation. Provide an understanding of the consumer protection culture and changing approaches taken by regulatory bodies. This notice is not a request for competitive quotes. However, all responsible parties that believe they have the capability of meeting the requirements as stated herein may submit a written response (i.e., capability statement), which clearly supports and demonstrates its ability to perform the requirements. Any response shall be received within five (5) days after the publication of this synopsis, which will be considered by the agency. Responses received after the response date or without the required information may not be considered. Any response will undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government. Response Date: 10:00 AM, Eastern Time, on December 4, 2020. Responses must be emailed to Kimberly Davis at [email protected]. Ref. #1236402.