Notice of Intent to Sole Source for Cardiomyocytes for the Food and Drug Administration

THIS IS A NOTICE OF INTENT TO SOLE SOURCE AN AWARD in accordance with 6.302-1 Only one responsible source and no other supplies or services will satisfy agencyrequirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1). The FDA intends to award a sole source Purchase Order to Fujifilm Cellular Dynamics, Inc., distributed by Fujifilm Irvine Scientific), FUJIFILM Irvine Scientific, Inc, 1830 East Warner Ave, Santa Ana, CA 92705, Duns#057475246/UEI: NCTEKH2J9293 ,Cage Code:0kDR5 (NAICS) Code Is 38206. This notice is not a request for competitive quotes; however, firms with expressed interest may respond. A determination by the Government not to compete this requirement is at the sole discretion of the Government. Information received as a result of this notice will be considered for the sole purpose of determining whether to conduct a competitive acquisition in the future. Description of Requirement The Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) has an active and important research program in Induced Pluripotent Stem Cell and Electrophysiology (iPSC&EP) that utilizes large quantities of human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). The hiPSC-CMs are used across multiple programs areas and linked to key program deliverables that OSEL is currently pursuing in its efforts to advance regulatory science. The experiments conducted support regulatory research projects on the development of in vitro pre-clinical assays for medical device safety and efficacy assessment. FDA is developing robust in vitro humanbased assays to elucidate mechanisms of current and novel cardiac medical devices including cardiac contractility modulation and irreversible electroporation. This will be achieved by scientific aims focused on hiPSC-CM model development, electrical stimulation, morphometry, and molecular profile. Toward this goal the FDA utilizes functional human cardiomyocytes derived from induced pluripotent stem cells (iPSCs) as a foundation to develop tools and test methods. These tools provide the first in vitro human cardiomyocyte model to enhance understanding of the safety and efficacy of cardiac medical devices. The hiPSC-CMs will provide the ability to reproducibly assess human cardiomyocyte health, and function in vitro. The ability to have continuous access to a consistent renewal hiPSC-CM source is critical to develop such tools and greatly improve the agency's ability to develop novel advanced methods and models that can be used to improve the development of cardiac medical devices. OBJECTIVES The FDA seeks terminally differentiated human induced pluripotent stem cell derived cardiomyocytes (hiPSC-CMs) in the hiPSC and Electrophysiology Lab.