This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is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. 

The Bioenergy Technologies Office (BETO) within the U.S. Department of Energy’s (DOE’s) Office of Energy Efficiency and Renewable Energy (EERE) supports the research, development, and demonstration (RD&D) of technologies aimed at mobilizing domestic renewable carbon resources for the reduction of greenhouse gas (GHG) emissions across the U.S. economy. BETO funds work in collaboration with industry, academia, and DOE national laboratories to develop advanced technologies and innovative solutions to reduce the costs of biofuels. The R&D supported by BETO and its partners is creating cutting-edge technologies used in the processing of biomass and waste, from harvesting and preprocessing to conversion. BETO is focused on technologies to efficiently convert organic materials and biomass into affordable biofuels and bioproducts. 

A strong, committed partnership between industry and the federal government is vital when responding to a public health emergency. Through the work of its three programs, PCI partners with industry to strengthen and enhance the nation’s ability to manufacture, distribute, and administer life-saving vaccines and therapeutics during a public health emergency.

The Cybersecurity Manufacturing Innovation Institute (CyManII), a Manufacturing USA Institute, is an inclusive national research institute with major leading research universities in cybersecurity, smart and energy-efficient manufacturing, and deep expertise in research and development, supply chains, factory automation, and workforce development. Funded by the DOE, CyManII aggregates the most advanced research institutions in revolutionary manufacturing, securing automation and supply chains, workforce development, and cybersecurity. The research team brings to bear the most powerful expertise and infrastructure needed to ensure the digital transformation that will continue to propel the U.S. in innovative research in manufacturing for decades.

The Industrial Efficiency & Decarbonization Office (IEDO) accelerates the innovation and adoption of cost-effective technologies that eliminate industrial greenhouse gas emissions. IEDO provides planning, management, and direction necessary for a balanced national program of research, development, demonstration, technical assistance, and workforce development to drive energy, materials and production efficiency, and decarbonization across the industrial sector. 

The Industry–University Cooperative Research Centers (IUCRC) program accelerates the impact of basic research through close relationships between industry innovators, world-class academic teams, and government leaders. The IUCRC program provides a structure for academic researchers to conduct fundamental, pre-competitive research of shared interest to industry and government organizations. These organizations pay membership fees to a consortium so that they can collectively envision and fund research, with at least 90% of member funds allocated to the direct costs of these shared research projects.

The Institute for Advanced Composites Manufacturing Innovation (IACMI), a Manufacturing USA Institute, is a partnership of industry, academic and governmental organizations joining forces to benefit the nation’s energy and economic security. This is accomplished by bringing low-cost, energy-efficient advanced composites to commercial readiness through the collaborative and innovative work of our members. Researchers at IACMI are working to develop lower-cost, higher-speed, and more efficient manufacturing and recycling processes for advanced composite materials. 

The Materials Genome Initiative is a federal multi-agency initiative for discovering, manufacturing, and deploying advanced materials twice as fast and at a fraction of the cost compared to traditional methods. The initiative creates policy, resources, and infrastructure to support U.S. institutions in the adoption of methods for accelerating materials development. 

The Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium) supports the Biomedical Advanced Research and Development Authority (BARDA) and is comprised of industry partners across the drug and vaccine manufacturing supply chain, including manufacturers of required raw materials and consumables, developers of innovative manufacturing technologies, and suppliers of fill finish services. This consortium seeks to expand the industrial and manufacturing base for medical countermeasures to include the requisite capabilities, flexibilities, and strategies to secure needed medical supplies to meet the nation’s public health preparedness and response requirements.

The National Nanotechnology Initiative (NNI) is a U.S. Government research and development (R&D) initiative. Over thirty Federal departments, independent agencies, and commissions work together toward the shared vision of a future in which the ability to understand and control matter at the nanoscale leads to ongoing revolutions in technology and industry that benefit society. The NNI enhances interagency coordination of nanotechnology R&D, supports a shared infrastructure, enables leveraging of resources while avoiding duplication, and establishes shared goals, priorities, and strategies that complement agency-specific missions and activities.

The National Network for Manufacturing Innovation (NNMI) is an interagency initiative made up of public/private partnerships devoted to manufacturing excellence. Under the NNMI, each institute will bring together innovative manufacturers, university engineering schools, community colleges, federal agencies, non-profits, and regional and state organizations to invest in unique, but industrially relevant, manufacturing technologies with broad applications. Federal NNMI partners include the Departments of Energy, Defense, and Commerce, as well as NASA and the National Science Foundation. 

The Office of Energy Efficiency and Renewable Energy (EERE) is working to build a clean energy economy that benefits all Americans. EERE’s mission is to accelerate the research, development, demonstration, and deployment of technologies and solutions to equitably transition America to net-zero greenhouse gas emissions economy-wide

As a member of Manufacturing USA, PowerAmerica connects many of the world’s leading wide bandgap (WBG) semiconductor manufacturers and end-users with experts from research universities and government labs. PowerAmerica is a member-driven consortium of industry, academia, and national labs — managed by North Carolina State University and headquartered on its Centennial Campus — accelerating the commercialization of energy-efficient silicon carbide and gallium nitride power semiconductor chips and electronics.

The Clean Energy Manufacturing Innovation Institute for Reducing Embodied-energy And Decreasing Emissions (REMADE), a Manufacturing USA Institute, focuses on early stage applied research towards innovations that could dramatically reduce the energy required to manufacture key materials and improve overall manufacturing energy efficiency through increased material reuse, recycling, and remanufacturing. EMADE is the only national institute focused entirely on developing innovative technologies to accelerate the U.S.’s transition to a Circular Economy. In partnership with industry, academia, trade organizations, and national laboratories, REMADE enables early-stage applied research and development that will create jobs, dramatically reduce embodied energy and greenhouse gas emissions, and increase the supply and use of recycled materials.

The Department of Energy (DOE) Solid-State Lighting Program fosters U.S. scientific capabilities, leverages private funds, provides internationally trusted information, and drives innovation to create efficient and flexible lighting products that support health, productivity, and well-being. the Solid-State Lighting Program has acted as a catalyst, bringing together researchers, industry, universities, standards organizations, utilities, energy efficiency programs, building owners, lighting designers, and specifiers to drive SSL technology advances. The Energy Policy Act of 2005 (EPACT 2005) and the Energy Independence and Security Act of 2007 (EISA 2007) issued directives to the Secretary of Energy to carry out a Next Generation Lighting Initiative to support SSL research, development, demonstration, and commercial application activities. In order to effectively fulfill the directives in EPACT 2005 and EISA 2007, DOE developed a comprehensive national strategy to build collaborative efforts with lighting industry and research partners to guide SSL technology innovation. 

The Building Technologies Office (BTO) develops, demonstrates, and accelerates the adoption of cost-effective technologies, techniques, tools and services that enable high-performing, energy-efficient and demand-flexible residential and commercial buildings in both the new and existing buildings markets. Moving scientific discoveries from research and development (R&D) concepts to commercially viable and available products to transforming the market via broad adoption is imperative for America to meet its climate goals while growing our economy. Technology-to-market (T2M) activities are designed to accelerate innovative R&D concepts to become commercially viable and available products. These activities then dovetail with market transformation efforts.