Memorandum of Understanding:

Enabling Emergency Preparedness and Response with Distributed Manufacturing & Digital Stockpiles
between
Food and Drug Administration, U.S. Department of Health and Human Services 
and
Veterans Health Administration, the U.S. Department of Veterans Affairs

PURPOSE

This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Veterans Health Administration (VHA) VA Ventures, under the Office of Healthcare Innovation and Learning (OHIL) of the U.S. Department of Veterans Affairs (each a Party and collectively the Parties) provides a framework for collaboration to facilitate  the development of requirements for trusted networks needed to help enable the use of distributed manufacturing and digital stockpiles to protect public health by promoting supply chain resilience during emergencies, shortages, and pandemics. Distributed manufacturing is a set of technologies that allows products to be made at or near the point of use.  In this case, medical products such as personal protective equipment (PPE), nasal swabs, or even drugs and saline could be made near the point of care to help ameliorate or prevent shortages caused by supply chain disruptions.  A digital stockpile does not store physical goods and products.  Instead, it stores the electronic plans, instructions, and methods to make and test  medical products.  While primarily focused on medical devices, novel modalities for pharmaceutical fabrication may make it feasible to digitally stockpile drugs.  Using digital stockpiles relies on one or more trusted suppliers that can make the product from the digital information, either through methods like 3D printing or self-contained distributed manufacturing lines.  Ensuring the quality of these products and instilling trust in patients and clinicians is paramount to successful implementation of a digital stockpile.  The Parties anticipate that this collaboration will yield descriptive and functional frameworks for deploying digital stockpiles and for establishing distributed manufacturing locations.  The Parties also anticipate that metrics, validation tools, training, and standardized protocols and programs for medical products will be created to facilitate the safe and effective manufacture of certain medical products closer to the patient or at point of care. The Parties intend to jointly develop emergency preparedness and response tools and protocols that will help increase the flexibility of medical product manufacturing capacity and resilience of domestic supply chains.  The results of this collaboration will help ensure that Veterans and civilians have access to the most innovative medical solutions and technologies to support their care.

AUTHORITIES & GOVERNING OFFICES
Department of Veterans Affairs (VA), Veterans Health OHIL:

(1) The Secretary shall carry out a program of medical research in connection with the provision of medical care and treatment to Veterans under 38 U.S.C. § 7303., Title 38 United States Code § 523

The U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA):

(1) FDA has authority to enter into this MOU pursuant to sections 1003(b) and (c) of the FD&C Act (21 USC §§ 393(b) and (c)).

BACKGROUND

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices and by ensuring the safety of foods, cosmetics, and products that emit radiation. 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. 

VA’s mission is to fulfill President Lincoln's promise to care for those who have served in our nation's military and for their families, caregivers, and survivors. 

OHIL has identified three priorities in advancing this mission: 1) imbed innovation as a core fabric of VHA, 2) build a collaborative innovation community and, 3) deliver a repeatable process for scaling innovation. OHIL has identified these priorities to be the catalysts for the advancement of care delivery and service through mission-driven innovation. OHIL strives to address critical Veteran health imperatives through mutual collaboration

OHIL will benefit from collaboration with FDA to ensure the safety and efficacy of emerging techniques used to provide agile, comprehensive and scalable care to Veterans and, in turn, the FDA will benefit from the exercising the implementation of emerging technologies that may be adopted by industry or used during public health emergencies.

VA Ventures is part of OHIL VA Ventures’ vision is a future in which any Veteran can enter into any VA facility and receive health care solutions that are personalized and designed for Veterans. VA Ventures will achieve this by building the infrastructure necessary to bring prototyping and product development back within our hospital walls, where VHA health care providers, along with inter-agency governmental partners such as the FDA, can ensure that patients’ needs, safety and health outcomes are being addressed.VA Ventures supports the next generation of innovators and ideas by serving as the epicenter for medical device development and market release, collaborating across government, academia, the private sector and industry to accelerate medical device development. 

GOALS OF THE OVERALL COLLABORATION

This collaboration aims to help the Parties proactively work to increase medical product supply chain resilience and flexible manufacturing capacity for use in public health emergencies, disasters, and other emergent events.  The goal of this MOU is to provide a mechanism for the Parties to directly collaborate on digital stockpiles and distributed manufacturing frameworks, sharing information, resources, and subject matter expertise to facilitate:

• The definition of requirements, systems, and validation methods needed to create functional digital stockpiles that support the manufacture of medical products that are effective, trusted, certifiable, and meet regulatory standards of safety and effectiveness despite non-traditional manufacturing processes. 
• The establishment of distributed manufacturing capabilities that can be used to increase supply chain resilience and mitigate risk to patients during public health emergencies. 
• The development of educational training, meetings, outreach materials, and programs to facilitate the implementation and use of tools and best practices related to using various distributed and flexible manufacturing technologies.

RESPONSIBILITIES OF THE PARTIES

All Parties will:

1. Establish collaborative projects that facilitate the development and validation of a digital stockpile and associated distributed and flexible manufacturing technologies that are intended to improve supply chain resiliency for products for public health emergencies and other emergent events, and to ensure patient access to high quality medical products. 
2. Establish principal points of contact (POC) to facilitate the activities carried out under this MOU.
3. Provide engineering, research, and clinical support for testing methods, systems, frameworks, and practices developed by or being evaluated by the Parties
4. Share developments, data, and resources related to digital stockpiles and distributed manufacturing with the Parties
5. Provide subject matter expertise to analyze shared data
6. Plan and conduct meetings (intended to be quarterly or more frequently as needed) on collaborative projects and programs between the Parties’ leads and associated operational management. Such meetings are for the purpose of providing updates on progress, developing shared project goals, discussing scientific and clinical needs related to these topics, and updating each other about administrative, transactional, and operational needs. 

VHA will:

1. Provide Parties with access to OHIL technologies related to distributed manufacturing and digital stockpiles as needed to complete the goals of this MOU
2. Provide a pre-clinical and clinical (as needed) testbed for digital stockpiles and distributed manufacturing systems 
3. Provide clinical support for testing methods, systems, frameworks, and practices developed by or being evaluated by the Parties

FDA will:

1. Provide Parties with access to systems in the OCET Advanced Manufacturing Innovation Hub related to distributed manufacturing and digital stockpiles as needed to complete the goals of this MOU
2. Provide regulatory advice and guidance, and regulatory science expertise regarding testing methods, systems, frameworks, and practices developed by or being evaluated by the Parties

INFORMATION DISCLOSURE

To the extent any confidential or other non-public information will be shared pursuant to this MOU, then any such written request submitted to FDA for this information must contain all substantive requirements of 21 C.F.R. § 20.85. Access to the non-public information shared under this MOU shall be restricted to authorized FDA and VHA employees, agents, and officials who require access to perform their official duties in accordance with the uses of the information as authorized in this MOU, unless authorized in writing by the agency that provided the information or otherwise required by law. Such personnel shall be advised of (1) the confidential nature of the information; (2) safeguards against unauthorized disclosure of confidential information, and (3) the administrative, civil, and criminal penalties contained in applicable Federal laws for the unauthorized disclosure of confidential information.

VHA and FDA each agree to clearly identify any such confidential information disclosed in writing; and to clearly memorialize in writing, within a reasonable time, any confidential information initially disclosed orally. The Parties agree not to disclose, copy, reproduce or otherwise make available in any form whatsoever to any other person, firm, corporation, partnership, association or other entity information designated as proprietary or confidential information without consent of the other Party except as such information is subject to disclosure under the Freedom of Information Act (5 U.S.C. § 552) and FDA’s regulations at 21 C.F.R. Part 20, or as otherwise authorized or required by law.

If an agency that has received information under this MOU receives a Freedom of Information Act request for which there are responsive records that originated with the other agency, to the extent practicable, it will refer that request to the other agency for it to respond directly to the requestor regarding the releasability of the information. In such cases, the agency making the referral will notify the requestor that a referral has been made and that a response will issue directly from the other agency.

Proper safeguards shall include the adoption of policies and procedures to ensure that the information shared under this MOU shall be used consistent with the Trade Secrets Act [18 U.S.C. § 1905], the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. 301 et seq.], the Privacy Act of 1974, as amended [5 U.S.C. § 552a], the Freedom of Information Act [5 U.S.C. § 552], any other applicable Federal law and their implementing regulations. Pursuant to FDCA section 301(j) [21 U.S.C. 331(j)], FDA will not reveal to VHA any method or process which is entitled to protection as a trade secret.

ENDORSEMENT

The Parties may not endorse or promote products or services offered by or provided by any non-federal entity. Nothing in this MOU constitutes an endorsement by any of the Parties of distributed manufacturing or digital stockpile products.  The Parties agree not to make statements to the public at workshops and meetings, promotional literature, on their web sites or through any other means that imply that the Parties endorse any distributed manufacturing or digital stockpile products.

RESOURCE OBLIGATIONS

This MOU represents the broad outline of the Parties present intent to enter specific agreements for collaborative efforts in areas of mutual interest to FDA and VA. All activities undertaken through the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. 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 VA operate.

EFFECTIVE DATE, DURATION, TERMINATION, AND REVIEW

This MOU becomes effective upon the signature of authorized representatives of all Parties and remains in effect for a period of five [5] years. This MOU may be modified by mutual consent or terminated by any Party upon 60 days written notice. 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 any Party that materially affects this MOU. The Parties may consider the development of a new MOU as needed.

POINTS OF CONTACT

The Parties will utilize the following (POCs throughout the oversight, reporting, and analysis process of this collaboration. The names listed below represent the persons in these assigned roles at the date of signing this MOU. Each Party may change its POC upon reasonable written notice to the other Party. Additional staff may be drawn to subject matter expertise, as needed.

APPROVALS

Approved and accepted for Food and Drug Administration by:

/s/
Michael Mair
Assistant Commissioner for Counterterrorism Policy
Food and Drug Administration
Date:  05/10/2023

Approved and accepted for the Department of Veterans Affairs by:

/s/
Beth Ripley
Chief Officer (Acting), Office of Healthcare Innovation and Learning
Department of Veterans Affairs
Date: 05/10/2023