The Food and Drug Administration (FDA) intends to negotiate on a sole-source basis with EnvisionTEC Inc. for maintenance support services for a EnvisionTEC Bioplotter (Model EnvisionTEC 3D-Bioplotter Serial Number ET.B4.15.10.M061. Maintenance support services are required for a base period of one-year with four one-year option periods under the authority of 41 U.S.C. 1901. Background Information and Basis for Sole Source The Food and Drug Administration (FDA) is responsible for protecting the 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. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. It provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. It facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S. CDRH’s Office of Science and Engineering Laboratories (OSEL) conducts laboratory-based regulatory science research; participates in device review activities; develops reliable and standardized test methods; develops computational models to advance efficient regulatory pathways; provides scientific and educational programs and training for CDRH and its stakeholders; and participates in the development of regulatory guidance and consensus standards. A fundamental system that OSEL utilizes to fulfill its mission is an EnvisionTEC 3D-Bioplotter additive manufacturing printing system capable of depositing various materials (conductive materials, polymers, and biological materials) for professional engineering and research and development purposes. It has been determined that EnvisionTEC is the only source for the required service. EnvisionTEC has no authorized resellers capable of providing the required service. EnvisionTEC holds legal patents to the EnvisionTEC 3D-Bioplotter technology, which is not licensed for use by any other party. Subsequently, EnvisionTEC has proprietary knowledge of all up-to-date service practices and techniques required to keep the system operating in accordance with the manufacturer’s specifications. General The North American Classification System (NAICS) code for this acquisition is 811219 – Other Electronic and Precision Equipment Repair and Maintenance. The small business size standard is $22.0M. No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, responses received by 4:00 p.m. Eastern Time on July 23, 2021 will be considered by the Government. A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Interested parties that believe they could satisfy the requirements listed above for FDA may clearly and unambiguously identify their capability in writing on or before the response date for this notice. This notice of intent is not a solicitation. Any questions regarding this notice must be submitted in writing via email to Adam Powell at
[email protected]. All responses to this notice of intent must be submitted so that they are received at
[email protected] no later than the aforementioned due date.