Description
This annoucement is not a Request for Proposal (RFP) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information in this notice. Proposals are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price order as a result of this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-07 dated August 11, 2021.The associated North American Industrial Classification System (NAICS) code for this procurement is 541380 –Testing Laboratories, with an associated size standard of 1,500 employees. This propose simplified acquisition combined synopsis/solicitation is for services; the Government is soliciting only to after exclusion of sources. A determination by the Government not to reissue and recompete this proposed simplified acquisition based upon responses to this notice, is solely within the discretion of the Government. IPublic information received will be considered solely for the purpose of determining whether to conduct another competitive requirement. No further solicitation is available. 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. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate 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.The Office of Science and Engineering Laboratories (OSEL) supports the CDRH’s mission of protecting and promoting public health. The OSEL undertakes the highest quality science to provide their customers with the best methods, tools and expertise to: • Ensure readiness for emerging and innovative medical technologies • Develop appropriate evaluation strategies and testing standards • Create accessible and understandable public health information and • Deliver timely and accurate decisions for products across their life cycle. Under OSEL, the Division of Biology, Chemistry, and Materials Science (DBCMS) within comprises wide-ranging expertise to address a host of issues stemming from molecular-level interactions between the human body and medical devices or radiation-emitting products. The technical disciplines of the Division’s staff include biology, biomaterials science, biomedical and chemicalengineering, chemical physics, materials science, pharmacology, physical chemistry, polymer science, and toxicology. The Division focuses on issues related to the following areas: • Analytical chemistry and electrochemistry • Biocompatibility, toxicology, and biological risk assessment • Biosensors and biomarkers • Extractables, leachables, and chemical contamination • Genomic and genetic technologies • Immune and cellular responses • Infection control, sterility, and biofilms • Materials characterization, processing, and materials degradation • Modeling of physiological processes • Multicomponent mass transfer and reaction kinetics, and • Nanotechnology. The CDRH/DBCMS is seeking a vendor to conduct metal ion release testing per ASTM F3306 on a range of stainless steel and nitinol test specimens. This testing is needed to support research efforts to establish in vitro to in vivo correlations for metal ion release. It is recognized that standard corrosion test methods, such as ASTM F3306, are not conducted under physiological conditions, and therefore, the implications of these test results for patient exposure and ultimately risk, are not yet established. The CDRH/DBCMS have acquired miniaturized devices and other test specimens that will be implanted in a murine model to assess corrosion behavior in vivo. This contract is needed to establish the response of these specimens to the standard in vitro testing for metal ion release, i.e. ASTM F3306. These data will be used to compare to metal ion release observed in vivo in the murine model and used to support modifications to the internationally recognized standard ASTM F3306 to improve the clinical relevance of the test method. For this procurement, the vendor will be responsible for providing the test reports detailing the protocols and results of the ASTM F3306 testing as well as the spike and recovery validation study and validation of the analytical instrumentation.