MEMORANDUM  OF UNDERSTANDING
BETWEEN THE FOOD AND DRUG ADMINISTRATION AND
THE DEFENSE  ADVANCED  RESEARCH PROJECTS AGENCY
FOR DEVELOPMENT AND ASSESSMENT OF INNOVATIVE MEDICAL PRODUCTS

 

I. PURPOSE

 

The Food and Drug Administration (FDA) and the Defense Advanced Research Projects Agency (DARPA) agree to work together to facilitate innovation that may result in medical products, including medical countermeasures and new enabling technologies that advance the regulatory sciences.

 

II. BACKGROUND

 

FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and the safety and security of our nation’s food supply, 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. Except under extraordinary circumstances, it is the policy of the Department of Defense (DoD) to administer and use only FDA-approved products. As a result, FDA and DARPA have a common interest in modernizing regulatory science to support the development of useful medical products prior to their use in humans.

 

The DARPA Biological Technologies Office (BTO) identifies and advances radically new technologies that promise to revolutionize military capabilities. BTO programs harness cutting-edge biological sciences to advance Warfighter combat performance, tactical and restorative biomedical technologies, and leverage advances in engineering and life sciences to drive and reshape biotechnology for technological advantage that may include medical countermeasure development.

 

III. AUTHORITY

 

FDA has authority to enter into this agreement pursuant to Section 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act.  DARPA has authority to enter into this agreement pursuant to DoD Directive 5134.10, "Defense Advanced Research Projects Agency," May 7, 2013.

 

IV. PROPOSED EFFORT/OBJECTIVES

 

The purpose of this memorandum of understanding (MOU) is to promote collaboration between FDA and DARPA, and to provide a mechanism for the sharing of certain nonpublic information to facilitate:

• Development of tools of regulatory science.  For the purposes of this MOU, regulatory science includes the development and qualification/validation  of new test methods, reference materials, or reagents for preclinical and clinical safety/ toxicology assessments and assessments of product efficacy and quality, post­ market safety, and effectiveness methods development.

 

• Development of enabling technologies that could support the ultimate development of useful medical products or medical countermeasures.  FDA and DARPA will seek to collaborate, as appropriate, on research concerning enabling technologies that will facilitate the development of innovative medical products, including medical countermeasures.

 

• Identification of product development targets of greatest potential value to the public. FDA and DARPA recognize that they have different roles with respect to innovative medical products, including medical countermeasures.  FDA is ultimately responsible for reviewing data supporting the safety and effectiveness of such products and for deciding whether the products can be approved, licensed, or cleared, or authorized for emergency use.  DARPA funds and nurtures the development of certain types of products.  Consistent with these different roles, FDA and DARPA will seek to collaborate, where possible, in identifying product development targets that would, if developed successfully, be most valuable to the public.

 

V. WORKPLAN AND RESPONSIBILITIES OF EACH AGENCY

 

FDA and DARPA will originate and manage separate and independent programs as befitting their agency roles. There will be no exchange or transfer of funds under this MOU.

 

FDA personnel may participate in DARPA program development discussions, scientific review of abstracts and proposals, program reviews as subject matter experts, and performer milestone and progress reviews.

 

FDA personnel may offer regulatory or regulatory science perspectives to DARPA program managers as new technologies and products are planned, developed, and transitioned to end users.

 

FDA and DARPA will seek to collaborate on issues common to product classes, rather than focus on individual products.
 

VI. PERSONNEL

 

Each party is responsible for all costs of its personnel, including pay and benefits, support, and travel. Each party is responsible for supervision and management of its personnel.

 

VII. GENERAL PROVISIONS

 

POINTS OF CONTACT (POCs)

 

The names of FDA and DARPA staff listed below represent the current persons in these assigned roles at the date of signing of this MOU. Each party may change its POC upon reasonable written notice to the other party. Additional FDA staff may be drawn to provide scientific expertise, including on organ/tissue physiology, as needed.

• For FDA:

 

RADM Carmen T. Maher, MA, BSN, RN, RAC
Acting Assistant Commissioner for Counterterrorism Policy and Acting Director, Office of Counterterrorism and Emerging Threats, Office of the Commissioner 301-796-8513
carmen.maher @fda.hhs.gov

 

• For DARPA:

 

Bradley R. Ringeisen, Ph.D.
Deputy Director, Biological Technologies Office 703-526-1576
[email protected]

 

This is an internal Government agreement between FDA and DARPA and does not confer any rights or benefits to any person or party.

This MOU does not affect or supersede any existing or future agreements or arrangements between the parties.  This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which the parties operate.

 

DISPUTES

 

Any disputes relating to this MOU will, subject to any applicable law, executive order, directive or instruction, be resolved by consultation between the Parties or in accordance with DoD Instruction 4000.19, "Support Agreements.”

 

SCHEDULE MILESTONES

 

The provisions of this MOU will be regularly reviewed by both parties and amended as necessary.
 

SECURITY

 

The planned program efforts associated with this MOU will be conducted at the unclassified level.  In the event an exchange of classified information is necessary, FDA and DARPA will coordinate their efforts and involve DARPA Security and Intelligence Directorate (SID) to properly safeguard the information.  DARPA SID is responsible for foreign disclosure decisions related to DARPA efforts associated with this MOU.

 

VIII.   PUBLIC RELEASE OF INFORMATION

 

FDA and DARPA intend for the following principles and procedures to govern the sharing of nonpublic information, as resources permit, between the two parties.

 

FDA and DARPA anticipate the activities covered by this MOU will involve workshops, meetings, and other communications among officials of FDA and DARPA in which the information discussed generally will not involve FDA disclosing to DARPA "confidential commercial or financial information" (21 CFR 20.61) or trade secret information obtained by or provided directly to FDA from a third party (such as an applicant for product approval).  FDA will not reveal information entitled to protection as a trade secret unless there is in place a written authorization, from the owner of that information who permits FDA to reveal such information.

 

Both parties recognize and acknowledge that all other nonpublic information shared between FDA and DARPA, whether written or oral, must be protected from any further disclosures or use not authorized by law or regulation. Both parties will establish safeguards to ensure that any nonpublic information shared under this MOU is protected from unauthorized disclosure or use including: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(C) of the FOIA; and (3) privileged and/or predecisional agency information , research proposals , progress reports, and unpublished data, confidential commercial and trade secret information, or information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., FOIA, Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.)), and the Health Insurance Portability and Accountability Act, Pub. L. 104 191). Such safeguards help ensure compliance with other applicable laws and regulations and should include the marking of any materials as "confidential or financial” prior to disclosure or the use of encryption technologies when appropriate.

 

Access to nonpublic information shared under this MOU shall be restricted to authorized employees, agents, and officials of FDA and DARPA who require access to perform their official duties in accordance with the uses of information as authorized by this MOU. Such personnel shall be advised of the confidential nature of the information; safeguards required to protect the information; and the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. Each party agrees to promptly notify the other of any actual or suspected unauthorized disclosure of information shared under this MOU.

Contractors, their subcontractors, and/or agents of parties participating in discussions covered by this MOU will be permitted to participate in discussions and to receive information under this MOU only if they have signed an agreement by which they will commit to keep the information confidential.

 

FDA and DARPA agree that either party may decide not to share information or expertise in response to a particular request for information or to limit the scope of information and expertise shared in response to a particular request. A decision not to share information in response to a specific request may be based on several factors including, the amount of resources necessary to fulfill the request, the reasonableness of the request, the responding party’s priorities, or legal restrictions. There is, however, a presumption in favor of sharing information in furtherance of the purposes of this MOU. The parties further agree that a party may, on its own initiative, elect to share information pursuant to this MOU to further the purposes of this MOU.  In the event the parties cannot reach consensus on a decision to share or not share information, the issue will be referred to the signatories, or their successors, of this MOU for resolution.

 

If records provided by either party under this MOU are the subject of a FOIA request submitted to the party that received the records, that party will refer the FOIA request and relevant records to the party that provided the records for the latter agency to respond directly to the requestor regarding the releaseability of the information at issue. This also applies to a request that seeks both parties' records or if the request is for records created by one party that incorporates information provided by the other party. In such cases, the party making the referral will notify the FOIA requestor that a referral has been made and that a response will be issued directly from the other agency. Requests may be referred to the relevant Freedom of lnformation Office(s) for disposition for FDA and to DARPA.

 

DARPA and FDA will each maintain primary responsibility for other external relations (e.g., public and congressional affairs) pertaining to their respective efforts related to this MOU. DARPA and FDA will consult on the public release of technical documents that are shared or developed pursuant to this MOU in instances where both DARPA and FDA have an interest pertaining to the release of such information. Except where otherwise required or prohibited by law, consistent with DoD Directive 5230.24, "Technical Data," "Technical Information," and "Technical Documentation," shared or developed within the scope of this MOU and intended for external (public) release must be submitted to the DARPA Public Release Center for "Distribution Statement A" approval.

 

FDA and DARPA further agree that nothing in this MOU shall be construed to prevent a disclosure required by law or legal process. Notwithstanding this provision, should information shared pursuant to this MOU be subpoenaed or otherwise ordered through a legal process, the party to whom the subpoena or order is directed will notify an authorized official of the party that shared the information immediately to provide an opportunity to seek to intervene and block the disclosure, and DARPA and FDA will consult on an appropriate response.

 

Both parties agree that termination of this MOU does not relieve them of their confidentiality obligations established under this MOU, including their obligations to safeguard and limit access to all information provided pursuant to this MOU.

 

IX. EFFECTIVE DATE, DURATION, TERMINATION

 

This MOU becomes effective upon the signature of authorized representatives of both parties and remains in effect, unless otherwise terminated.  This MOU may be modified by mutual consent or terminated by either 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 either party that materially affects this MOU. The parties may consider the development of a new MOU as needed.  The FDA and DARPA agree to take actions under this collaboration that are consistent with existing laws and regulations, and that nothing in this MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by the parties including, but not limited, to the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.  Further, nothing contained in this MOU constitutes a mandate or a requirement imposed on either partner that is in addition to the mandates or requirements imposed on the FDA and DARPA by Federal statutes and regulations.

 

X. APPROVAL

 

 

Luciana Borio, M.D., Acting Chief Scientist, Office of the Chief Scientist

 

June 1, 2017

 

 

Justin C. Sanchez, Ph.D., Director, Biological Technologies Office

 

March 30, 2017