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MOU 225-20-008

Memorandum of Understanding:
Rapid Response to Covid-19 Using 3d Printing
between
National Institutes of Health within U.S. Department of Health and Human Services
and
Food and Drug Administration, U.S. Department of Health and Human Services
and
Veterans Health Administration within the U.S. Department of Veterans Affairs


I. PURPOSE

This Memorandum of Understanding (MOU) between the National Institutes of Health (NIH), represented by the National Institute of Allergy and Infectious Diseases, and the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Veterans Health Administration Innovation Ecosystem (VHA IE) of the U.S. Department of Veterans Affairs (each a Party and collectively the Parties) provides a framework for collaboration intended to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19. The Parties anticipate that this collaboration will yield metrics, training, protocols, and programs for medical products that are manufactured close to the patient or at point of care. The Parties intend to jointly develop a response to COVID-19 that will ensure Veterans and civilians have access to the most innovative medical solutions and technologies to support their care.

II. AUTHORITIES & GOVERNING OFFICES

Department of Veterans Affairs (VA), Veterans Health Administration Innovation Ecosystem
(VHA IE):

(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.s

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

(1) FDA has authority to enter this MOU pursuant to section 1003 of the Federal Food, Drug, and Cosmetic Act (21 USC§ 393) (the Act)

The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH):

(1) NIH has authority to enter into this MOU pursuant to section 446 of the Public Health Service Act, 42 U.S.C. § 285f.

III. GOALS OF THE OVERALL COLLABORATION

This collaboration will help the Parties proactively work to promote treatment and prevent the spread of the virus known as SARS-CoV-2, the cause of COVID-19. The goal of this MOU is to provide a mechanism for the Parties to directly collaborate on 3D printing projects and share information, resources, and subject matter expertise to facilitate:

  • Development of 3D printed products including the production, qualification, and validation of new test methods, the identification and mitigation of risks, material standards, and suggested best and safest practices to promote COVID-19 response
  • Development of 3D printing educational training, meetings, outreach materials, and programs to facilitate the implementation and use of tools and best practices related to COVID-19

IV. RESPONSIBILITIES OF THE PARTIES

All Parties will:

  1. Help connect healthcare organizations seeking 3D printed supplies with manufacturers willing to 3D print parts
  2. Share lessons learned from 3D printing files, including information on prior success and failures
  3. Provide consultation on models, testing, and practices developed by the Parties

VHA will: 

  1. Share resources, instructions, and information with the Parties
  2. Host an external-facing website for individuals and healthcare entities to support 3D printed medical supplies or those with 3D printing capabilities wishing to provide those services
  3. Provide engineering support for designing and evaluating printable designs

NIH will:

  1. Provide a collection digital files on the NIH Print Exchange for fabrication of COVID response medical devices and products such as personal protective equipment (PPE) through 3D printing/additive manufacturing, or other methods as appropriate
  2. Share information and 3D models with the Parties
  3. Provide 3D printing and infectious disease expertise in evaluating printable designs and testing

FDA will:

  1. Provide an email point of contact for public to address questions about 3D printable medical devices and products such as PPE
  2. Provide data and models to the Parties for evaluation
  3. Provide engineering support and scientific expertise in evaluating, developing, and testing designs

V. ENDORSEMENT

The Parties may not, with limited exceptions, 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 3D printed products or manufacturers.  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 3D printed products or manufacturers. 

VI. 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 2 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.

VII. POINTS OF CONTACT

The Parties will utilize the following Points of Contact (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.

Role FDA Representative VHA Representative NIH Representative
Project Manager CDR James Coburn
Senior Advisor, Emerging Technologies
FDA – OCS/OCET
10903 New Hampshire Avenue
WO1 Room 4316
Silver Spring, MD 20903
(301) 796-0286
Dr. Beth Ripley
Chair, VHA 3D Printing Advisory Committee
Enterprise Lead, VHA 3D Printing Network
VHA Innovation Ecosystem
Radiologist, VA Puget Sound Health Care System
1660 South Columbian Way
Seattle, WA 98108
(206) 764-2444
Dr. Meghan McCarthy
Project Lead, NIH 3D Print Exchange
Bioinformatics and Computational Biosciences Branch
NIH/NIAID/OD/OSMO/OCICB
5601 Fishers Lane
Room 4A31
Rockville, MD 20852
(240) 507-6485
Program Manager CDR James Coburn Mr. Joshua Patterson
Director, Care & Transformational Initiatives
VHA Innovation Ecosystem
(303) 809-7870
Dr. Darrell Hurt
Branch Chief
Bioinformatics and Computational Biosciences Branch
NIH/NIAID/OD/OSMO/OCICB
5601 Fishers Lane
Room 4A50
Rockville, MD 20852
(240) 669-2741
Organizational Sponsor RADM Denise Hinton
Chief Scientist
FDA - OCS
10903 New Hampshire Avenue
WO1 Room 3317
Silver Spring, MD 20903
(301) 796-4880
Dr. Ryan Vega
Executive Director
VHA Innovation Ecosystem
810 Vermont Avenue, NW
Washington, DC 20420
(202) 461-9027
Dr. Jill R. Harper
Associate Director for Science Management
NIH/NIAID
5601 Fishers Lane, Room 5A23
Rockville, MD 20852

VIII. APPROVALS

Approved and accepted for Food and Drug Administration by:

RADM Denise Hinton 
Chief Scientist, Office of the Commissioner
Food and Drug Administration
   
Date: 03/25/2020

Approved and accepted for the Department of Veterans Affairs by:

Ryan Vega, MD 
Executive Director, VHA Innovation Ecosystem
Department of Veterans Affairs 

Date: 03/25/2020

Approved and accepted for the National Institutes of Health by:

Jill R. Harper, Ph.D.
Associate Director for Science Management, National Institute of Allergy and Infectious Diseases
National Institutes of Health

Date: 03/25/2020