Notice of Intent to Sole Source for the Modeling, simulation and demonstration capabilities to facilitate evaluation of smart design and manufacturing processes for shortage mitigation and supply chain resilience

As part of its regulatory science mission, The FDA Office of Counterterrorism and Emerging Threats (OCET) is tasked with supporting the development of safe and effective medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear agents and emerging threats, such as threats posed by the SARS-CoV-2 virus. This mission space includes preparing the agency to evaluate and foster use of new technologies that can help increase supply chain resilience and improve shortage mitigation.  The COVID-19 pandemic has exemplified the possibility that existing manufacturing supply chains and infrastructures can be disrupted by severe events, something that has also been demonstrated in the aftermath of hurricanes in recent years. This can and has elevated risks to public health and created shortages in the U.S.

To that end, there is a critical question about how advanced design and manufacturing technologies can increase US manufacturing capacity, increase supply chain resilience, or decrease time to market for medical diagnostics, therapies, and vaccines that are needed for public health emergency response. Moreover, smart and digital manufacturing technologies can help retrofit older manufacturing equipment to enable improvements in quality, efficiency, and reduce supply chain uncertainty. These solutions can also include automation, optimizing design and manufacturing computational modeling, and digital monitoring and analysis of production.  Applicable across the industries regulated by FDA, the Agency needs experience with and understanding of the processes and technologies to provide appropriate guidance to industry, develop the regulatory science to evaluate incoming submissions, and prepare for the potentially disruptive changes to design and production norms.  The FDA could become a stumbling block to implementing these technologies without increased experience, communication, and clarity.

An advanced digital design and manufacturing line from Siemens Industry Software Inc. (Siemens) was designed for use at a federal public private partnership called MxD was identified to meet FDA needs for a digital design and manufacturing platform for research and training.  Their system is already designed, built, and operational.  It includes both physical and virtual manufacturing lines along with simulations and optimization use cases.  This demonstration line is a functional manufacturing process assembled with hardware from multiple vendors, tied together with control and automation systems by Siemens and other automation vendors. It is also duplicated in virtual space with a “digital twin”.  This system can replicate digital uses cases similar to those provided by Siemens as part of a previous award to the Center for Devices and Radiological Health (CDRH).  In that project (FDA-RFQ-1230746), CDRH commissioned several computational modeling and simulation for several device-related use cases.  This proposal would leverage the work done in those use cases and the experience gained by CDRH.  It expands the research and training opportunities with a broader set of computational functions and access to a working miniature manufacturing line installed in an FDA Innovation laboratory.

This notice of intent is not a request for competitive quotes. Interested parties may identify in writing their interest and capability to respond, may submit a capability statement to Peter Lee, Contract Specialist, at peter.lee@fda.hhs.gov before June 25, 2021 at 4:00pm EST.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, negotiations with, and subsequent award shall be made to, Siemens Government Technologies, Inc.