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  1. Domestic MOUs

MOU 225-21-006

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I. Purpose

This Memorandum of Understanding (MOU) constitutes an agreement between the National Institute of Standards and Technology (NIST) of the United States (U.S.) Department of Commerce and the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (each a Party and collectively the Parties). 

This MOU defines an agreement through which both Parties intend to collaborate to increase U.S. medical supply chain resilience and advance domestic manufacturing of pharmaceuticals, biopharmaceuticals, and medical devices through adoption of 21st century manufacturing technologies including smart technologies, emerging manufacturing processes, and artificial intelligence and machine learning.  

AUTHORITIES. The authorities to enter this MOU are: 
NIST: 15 U.S.C. §272 (b)(1)(b)(3), and (c)(3) and 15 USC 278s and 278k 

FDA: 21 U.S.C. §§ 393(b) and (c) [Section 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act]

II. Background

The fourth industrial revolution is the ongoing modernization of traditional manufacturing with new capabilities, smart technologies, cutting-edge science, and digital technologies.  New technologies, better processes, improved sensors, greater connectivity, and computer modeling have changed both design and production of many consumer products.   These technologies, which can also facilitate increased production flexibility and better supply chain resilience to disruptions such as those observed during the COVID-19 pandemic are not widely deployed in the manufacture of pharmaceuticals, biopharmaceuticals, vaccines, and medical devices.  The successful transition to these 21st century technologies will require modernized regulatory structures, new standards, and measurement tools, and enhanced methods for data analysis and cybersecurity in order to encourage domestic production, increase efficiency, and build a resilient supply chain.  

A specific example of emerging technologies is artificial intelligence/machine learning (AI/ML), another pillar of the fourth industrial revolution.  Executive Order (EO) 13859 (Feb 11, 2019) emphasizes maintaining American leadership in AI.  In addition, on December 3, 2020, the President signed Executive Order 13960 on “Promoting the Use of Trustworthy Artificial Intelligence in the Federal Government”.

FDA is a science-based regulatory agency authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. § 301, et seq.), and certain sections of the Public Health Service Act (see, e.g., 42 U.S.C. § 262), among other statutes. In fulfilling its responsibilities, FDA, among other things, directs its activities toward promoting and protecting the public health by ensuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.  To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues.  Collaborating with NIST to encourage adoption of 21st century manufacturing technologies will further support FDA’s mission     

NIST, a partner to the U.S. manufacturing sector for more than a century, has a proven track record in delivering useful tools and technical assistance that existing manufacturers and aspiring start-ups need. NIST’s measurement research and manufacturing-focused programs provide a foundation that helps the nation’s manufacturers to invent, innovate and create new products and services more rapidly and more efficiently than their competitors around the world.  The NIST Laboratories provide industry with precision measurement technologies, tests, protocols, and world class scientific and engineering knowledge. The outputs of the NIST labs include scientific data and methods that are used in the processes, products and services of nearly every U.S. manufacturing industry, as well as the nation's service sector. NIST measurement research and services support advances and applications in the smallest of technologies—exceedingly tiny, but extremely promising nanoscale materials and devices—to the largest and most complex of human-made systems, from wide-bodied jets to globe-spanning information networks.  The Hollings Manufacturing Extension Partnership Program (MEP) a national network of technical assistance centers and offices located in every state helps small- and medium-sized manufacturers navigate economic, technological, and business challenges.  Finally, the National Advanced Manufacturing Program Office hosted by NIST provides leadership and coordination for Manufacturing USA and its network of 16 manufacturing innovation institutes sponsored by the Department of Defense, the Department of Energy, and NIST.   

III. Understanding of the Parties

The Parties intend to:

a. Establish cooperative projects between NIST and FDA that facilitate and enable the deployment of advanced manufacturing technologies in commercial manufacture of medical devices, pharmaceuticals, and biopharmaceuticals in order to ensure economic competitiveness and a robust, resilient supply of these products for the American Public. 

b. Establish principle points of contact (POC) within the Office of the Director for NIST and within the Office of the Commissioner for FDA respectively to facilitate the activities carried out under this MOU.  

c. Collaborate in interdisciplinary research in material, physical, and measurement sciences to develop and implement best practices in manufacturing process and quality control including advanced and innovative assays and measurements, modularization of unit operations, understanding appropriate uses of centralized and decentralized manufacturing trains, application of synthetic intelligence (e.g. neural networks, AI/ML), and adaptive process control strategies.

d. Plan and conduct meetings (intended to be semi-annual or more frequently as needed) between representatives from the Office of the Under Secretary of Commerce for Standards and Technology and representatives from the Office of the Commissioner of Food and Drugs, coordinated through their respective staffs, for the purpose of briefing on progress, hurdles, and enablers of this Interagency endeavor, obtaining approvals, responding to concerns, and requesting assistance.  Participation is intended to include the Directors of the Material Measurement Laboratory and Information Technology Laboratory at NIST or their designees, as well as the Directors of the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH), or their designees. Other participants will be included as appropriate (e.g., NIST and/or FDA subject matter experts, other development partners, such as BARDA or DARPA).  

e. Plan and conduct meetings (intended to be quarterly or more frequently as needed) on collaborative projects and programs between their leads and associated operational management.  Projects and programs executed fully within FDA Centers or NIST Laboratories will meet separately.  Such meetings are for the purpose of providing updates on progress, needs and opportunities at the administrative, transactional, and operational level.

f.  Facilitate NIST’s identification, development, and application of scientific tools, technologies, science approaches that can enable and support the evaluation of pharmaceuticals, biopharmaceuticals, and medical devices within the regulatory framework of the FDA.

g. Maintain appropriate, robust information and data security standards and practices while also assuring open communication on matters of shared technical interest.

IV. Limitations

This MOU represents the broad outline of the Parties’ intention to collaborate in areas of mutual interest.  All activities contemplated by this MOU are subject to the availability of personnel, resources, and funds.  This MOU does not affect or supersede any existing or future understandings or arrangements between the Parties and does not affect the ability of the Parties to enter into other understandings or arrangements related to this MOU.  This MOU does not create binding, enforceable obligations against any Party.    
This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NIST operate.

V. Data Sharing Guidelines

The Parties do not intend to exchange confidential, proprietary or other information subject to a restriction on disclosure, under this MOU.  If an exchange of such information becomes necessary, the Parties will enter into a separate written agreement covering that exchange of information.  

IX. Effective Date, Duration, Termination, and Review

This MOU may be modified by mutual written consent or terminated by either Party upon 60 days written notice. This MOU will expire five years after the date of the last authorizing signature; this term may be extended through written amendment signed by both Parties. This MOU may be terminated by any Party immediately upon written notice in the event that a Federal statute is enacted, or a regulation is issued by either Party that materially affects this MOU. The Parties may consider the development of a new MOU as needed. 

X. Points of Contact

Specific Points of Contact (POCs) will be assigned by the Under Secretary of Commerce for Standards and Technology and the Commissioner of Food and Drugs respectively and will engage in the oversight, reporting, and assessment of this collaboration. Each Party may change its POC upon written notice to the other Party. Additional FDA or NIST staff may be drawn to provide subject matter expertise, as needed. 

Jason Boehm, PhD
Director, Program Coordination Office

Henry Wixon, JD
Chief Counsel

CDR James Coburn, MSc
Senior Advisor for Emerging Technology
Office of Counterterrorism and Emerging Threats
Office of the Chief Scientist

Alice Welch, PhD
Director, Technology Transfer Program

XI. Approvals

Department of Commerce                
National Institute of Standards and Technology


Walter Copan, PhD                    
Under Secretary of Commerce for Standards        
and Technology and NIST Director
January 15, 2021

Department of Health and Human Services
Food and Drug Administration


Stephen M. Hahn, MD
Commissioner of Food and Drugs
January 15, 2021

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