Manufacturing Extension Partnership (MEP) National Network

Semiconductors, or chips, are tiny electronic devices that are integral to America’s economic and national security. These devices power tools as simple as a light switch and as complex as a fighter jet or a smartphone. Semiconductors power our consumer electronics, automobiles, data centers, critical infrastructure, and virtually all military systems. They are also essential building blocks of the technologies that will shape our future, including artificial intelligence, biotechnology, and clean energy.

While the United States remains a global leader in semiconductor design and research and development, it has fallen behind in manufacturing and now accounts for only about 10 percent of global commercial production. Today, none of the most advanced logic and memory chips—the chips that power PCs, smartphones, and supercomputers—are manufactured at commercial scale in the United States. In addition, many elements of the semiconductor supply chain are geographically concentrated, leaving them vulnerable to disruption and endangering the global economy and U.S. national security.

That’s why President Biden signed the bipartisan CHIPS and Science Act of 2022 into law. The law provides the Department of Commerce with $50 billion for a suite of programs to strengthen and revitalize the U.S. position in semiconductor research, development, and manufacturing—while also investing in American workers.

The MEP National Network^TM is a unique public-private partnership that delivers comprehensive, proven solutions to U.S. manufacturers, fueling growth and advancing U.S. manufacturing.  The Network comprises the National Institute of Standards and Technology’s Manufacturing Extension Partnership, the 51 MEP Centers located in all 50 states and Puerto Rico, the MEP Advisory Board, MEP Center boards, and the Foundation for Manufacturing Excellence, as well as over 1,440 trusted advisors and experts at approximately 460 MEP service locations. MEP Centers tailor services ranging from process improvement and workforce development to specialized business practices, including supply chain integration and technology transfer. Centers connect manufacturers with government agencies, trade associations, universities, research laboratories, state and federal initiatives, and other resources.

The NIST Office of Advanced Manufacturing (OAM) serves as the headquarters for the interagency Advanced Manufacturing National Program Office to coordinate Manufacturing USA, a network of manufacturing innovation institutes across the country that brings together industry, academia, and the public sector to advance American manufacturing. OAM is also responsible for the NIST-sponsored manufacturing innovation institute, NIIMBL, and other NIST-funded awards to Manufacturing USA.

This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.