MEMORANDUM OF UNDERSTANDING
BETWEEN THE DEFENSE ADVANCEDRESEARCH PROJECTS AGENCY
AND THE FOOD AND DRUG ADMINISTRATION
This memorandum of understanding (MOU) is between the Defense Advanced Research Projects Agency (DARPA) and the Food and Drug Administration (FDA). Collectively, DARPA and FDA are referred to as the "Parties."
1. BACKGROUND: DARPA creates breakthrough technologies for national security and seeks to catalyze an advanced base in technologies emerging from the biological sciences. The mission of DARPA's Biological Technologies Office (BTO) is to foster, demonstrate, and transition breakthrough fundamental research at the intersection of traditional and emerging disciplines. The BTO research portfolio includes neuroscience programs aimed at developing a deeper understanding of ways to interface the human nervous system to enable restoration of lost function. DARPA recognizes that neuroscience efforts leveraging the latest methods and technologies will require close coordination with FDA to ensure adherence to regulatory requirements for safety and efficacy. Except under extraordinary circumstances, it is the policy of the Department of Defense (DoD) to administer and use only FDA-approved products.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In 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 drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. Among other things, FDA reviews data supporting the safety and effectiveness of medical devices and decides whether they may be approved, licensed, cleared, or authorized for emergency use.
The Parties have a common interest in modernizing regulatory science to support the development of useful medical products prior to their use in humans.
2. Authorities: The Parties agree to take actions under this collaboration that are consistent with existing Federal 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 those listed below.
2.1. DoD Directive 5134.10, "Defense Advanced Research Projects Agency," May 7, 2013
2.2. DoD Instruction 4000.19, "Support Agreements," April 25, 2013
2.3. DoD Instruction 6200.02, "Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs," February 27, 2008
2.4. Federal Food, Drug, Cosmetic Act, Title 21 U.S.C., § 301 et seq. 393 (b)(c), 2010 Edition. FDA has authority to enter into this MOU pursuant to Section 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act, Code of Federal Title 21
2.5. Freedom of lnformation Act (FOIA) (5 U.S.C. § 552)
2.6. Trade Secrets Act (18 U.S.C. § 1905)
2.7. Privacy Act (5 U.S.C. § 552a)
2.8. Health Insurance Portability and Accountability Act, Pub. L. 104-191
2.9. Public Health Service Act (42 U.S.C.)
2.10. International Traffic in Arms Regulations (ITAR)
2.11. 21 C.P.R. § 20.85
3. PURPOSE: This MOU documents a process for encouraging collaboration and information sharing between the Parties to facilitate innovation of medical products, including neurosensing, neuromodulation, and neurostimulation devices for the treatment of neurologic and psychiatric deficits and other neurological and physical medicine devices. Current DARPA efforts covered by the MOU include the Systems-Based Neurotechnology for Emerging Therapies (SUBNETS), Restoring Active Memory (RAM), Hand Proprioception and Touch Interfaces (HAPTIX), Electrical Prescriptions (ElectRx), and Revolutionizing Prosthetics (RP) programs. The Parties recognize the intent to include future relevant programs under the provisions of this MOU.
4. PROPOSED EFFORT/OBJECTIVES: The Parties will collaborate, where possible, in identifying product development targets that would, if developed successfully, be most valuable to the public. The Parties recognize they have different roles with respect to innovative medical products. The goal is to conduct quarterly regulatory review briefings to discuss scientific, regulatory, and programmatic developments. The Parties' objectives include:
4.1. Development of enabling technologies that will support the deployment of useful medical products, specifically, neurological and physical medicine devices, aided by the early establishment of clear regulatory pathways for various patient categories including military service personnel, veterans, their families, and consumers.
4.2. Identification of product development targets of greatest potential value to the public.
4.3. Exploration of new product areas, research funding, and regulatory requirements needed to realize emerging technologies.
5. UNDERSTANDING OF THE PARTIES
5.1. DARPA will:
5.1.1. Collaborate on issues common to product classes, rather than focus on individual products.
5.1.2. Participate in regulatory review briefings to occur no less than once per quarter in each fiscal year for the duration of this MOU. The purpose of this briefing will be to discuss scientific, regulatory, and programmatic developments as they pertain to topics identified in Sections 3 and 4 of this MOU.
5.2. FDA will:
5.2.1. Participate in DARPA program development discussions, scientific review of abstracts and proposals, program reviews as subject matter experts, and performer milestone and progress reviews.
5.2.2. Offer regulatory or regulatory science perspectives to DARPA program managers as new technologies and products are planned, developed, and transitioned to end users. FDA regulatory advice and perspectives to DARPA. It will not assist in the development of a marketable device.
5.2.3. Participate in regulatory review briefings no less than once per quarter in each fiscal year for the duration of this MOU. The purpose of this briefing will be to discuss scientific, regulatory, and programmatic developments as they pertain to topics identified in Sections 3 and 4 of this MOU.
6. DATA SHARING GUIDELINES: Any 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 sharing in response to a particular request.
Both Parties recognize that information exchanged that contains any of the following types of information must be protected from unauthorized use and disclosure: (1) confidential commercial information, such as 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; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (18 § 1905)), the Privacy Act (5 U.S.C. § 552a), other FOIA exemptions not mentioned above (5 U.S.C. § 552(c)), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191). Pursuant to Federal Food, Drug, and Cosmetic Act § 301(j) (21 U.S.C. § 331(j)), FDA will not reveal any method or process which is entitled to protection as a trade secret.
The Parties will establish proper safeguards to ensure that information shared under this MOU shall be used and disclosed solely in accordance with applicable Federal laws and regulations. Access to the information shared under this MOU shall be restricted to authorized FDA and DARPA employees, agents, and officials 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: (1) the confidential nature of the information; (2) safeguards required to protect the information;(3) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. Contractors, their subcontractors, and agents requiring access to the information shared under this MOU will be required to sign a business associate agreement by which they commit to keep the information confidential.
Provisions for sharing of non-public information in accordance with applicable Federal statutes or regulations are set out below:
The requesting party shall comply with conditions:
a. The requesting party will limit the dissemination of shared non-public information it receives to internal unit offices and/or employees that have been identified in its written request. If the requesting party determines that employees other those identified in the original request have a need to know the requested information, then an update to the request letter will be supplied to the sharing party before the requesting party distributes the information to those employees. The unit official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.
b. The requesting party will agree in writing, by using the model request letter (or a reasonable, mutually agreed upon variation), not to disclose any shared non-public information in any manner not authorized by Federal law or regulation, including disclosure in publications and public meetings. If the requesting party wishes to disclose shared information that the sharing party has designated as non-public, the requesting party will ask the sharing party whether the information's non-public status has changed, and if so, will first obtain written confirmation and permission from the sharing party before disclosing that information. If the requesting party receives a FOIA request for shared information, the requesting party will: (a) refer the FOIA request to information-sharing contact person or designee for the sharing party to respond directly the FOIA requester regarding the releasability of the information, and (b) notify the FOIA requester of the referral and that a response will issue directly from the sharing party. The requesting party will leave all final disclosure decisions up to the sharing party, including decisions on whether the records are responsive and whether they must be disclosed. Accordingly, the requesting party will not indicate to the FOIA requester whether the sharing party has responsive records or releasable records.
c. The sharing party will include a transmittal letter along with any agency information shared. The transmittal letter will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.) A model transmittal letter is attached. The shared documents containing non-public information should be stamped "Do not disclose without permission of FDA/ [or] DARPA" whichever is applicable.
d. The requesting party will promptly notify the contact person or designee of the sharing party of any attempt by a third party to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.
e. The requesting party will notify the sharing party before complying with any judicial order compels the release of shared non-public information, so that the parties may determine the appropriate measures to take, including, where appropriate, legal action."
DARPA will remain the office of primary responsibility for external relations (public and congressional affairs) for matters pertaining to DARPA current (initially SUBNETS, RAM, HAPTIX, ElectRx, and RP) and future programs. All external requests for information will be submitted to DARPA, which has sole responsibility for public release authorization determinations regarding DARPA programs while the programs are being managed by DARPA. All data, information, and documentation intended for external release must be submitted to DARPA Public Release Center. FDA will have a 10-day period to review and comment on material DARPA intends to externally release that contains FDA-provided information or that cites an FDA decision regarding DARPA programs covered under the terms of this MOU.
7. SECURITY: DARPA programs covered under this MOU (initially, SUBNETS, RAM, HAPTIX, ElectRx, and RP) will be protected under the guidance and oversight of the DARPA Security and Intelligence Directorate (SID). The planned efforts associated with this MOU will be conducted at the UNCLASSIFIED level. DARPA SID is responsible for foreign disclosure decisions related to DARPA programs to ensure compliance with the ITAR.
8. RESOURCE OBLIGATIONS: This MOU represents the broad outline of the Parties' intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and DARPA. All activities undertaken pursuant to 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 DARPA operate.
9. 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.
10. GENERAL PROVISIONS
10.1. POINTS OF CONTACT (POCs) AND CORRESPONDENCE: The following POCs will be used by the Parties to communicate during implementation of this MOU. Each Party may change its POC upon reasonable written notice to the other Party.
Justin C. Sanchez, Ph.D. (SUBNETS, RAM, RP); Justin.Sanchez@darpa.mil; (703) 526"2189
Acting Deputy Director, BTO
Douglas J. Weber, Ph.D. (HAPTIX, ElectRx) Douglas.Weber@darpamil; (703) 526-2856
Program Manager, BTO DARPA
675 North Randolph Street
Arlington, VA 22203
Carlos Pena, Ph.D., M.S.
Director, Division of Neurological and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993 (301) 796-6610
10.2. MODIFICATION OF MOU: This MOU may be modified only by the written agreement of the Parties, duly signed by their authorized representatives. This MOU will be reviewed annually on or around the anniversary of its effective date and triennially in its entirety. Each Party shall review the MOU independently. Coordination between the Parties is not required unless a change is needed. The signatories, or their successors, to this MOU will approve changes to or the termination of this MOU. Changes are effective only after both signatories, and their successors, agree to the changes in writing.
10.3. 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.
10.4. TERMINATION OF UNDERSTANDING: Subject to a reasonable determination that the effort of both Parties will not produce beneficial results commensurate with the expenditure of resources, DARPA and FDA may terminate this MOU by mutual written consent of the Parties or may be terminated by either Party upon a 30 day advance written notice to the other, provided such written notification is preceded by consultation between the signatories to the MOU.
10.5. EFFECTIVE DATE: This MOU takes effect the day after the last Party signs.
10.6. EXPIRATION DATE: This MOU expires 9 years from the date it is signed by both
APPROVED AND ACCEPTED BY DARPA
Barry P. Pallota
April 12, 2016
APPROVED AND ACCEPTED BY U.S. FOOD AND DRUG ADMINISTRATION
Jeffrey Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
April 13, 2016
Appendix 1- Model Language for Information Sharing Request from Participating Partner(s) to FDA
MOU Control No. (Insert number)
Process for Information Sharing
Pursuant to Section 6 of the Memorandum of Understanding (MOU) entered by the Food and Drug Administration (FDA) and DARPA, any Federal partner "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 sharing in response to a particular request." Nothing in the process described below changes Section 6.
When, under the current MOU, staff at the FDA or DARPA request for the other agency information that may contain confidential material, the request should be in writing, which includes an informal email, or need only identify the subject for which information is requested. Although a more specific description of the information asked for may be helpful, it would not be required for purposes of making a request. However, the following language should be included in the request:
"Information that is shared under this MOU will be under the FDA-DARPA Memorandum of Understanding. We agree not to disclose any shared information in any manner without your written permission or as required by law with advance notice to the originating agency. With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text.
A response to a request should also be in writing and can be an informal email that acknowledges transmission of information in response to the request. Although identifying each piece of information/document provided may be helpful, it would not be required for purposes of responding to a request. However, the following language should be included in the response:
"Pursuant to the FDA-DARPA Memorandum of Understanding, this communication may contain privileged and/or confidential information exempt from public disclosure. It may not be disclosed or shared in any manner without the express written consent or as required by law with advance notice to the originating agency.'' With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.
Appendix 2 - Model Language for Information Sharing Request from DARPA to FDA
MOU Control No. (Insert number)
This letter accompanies agency records that DARPA is sharing with the Food and Drug Administration (FDA) in response to FDA's request, dated_______________________ . These agency records contain one or more of the following categories of nonpublic information, including information the public disclosure of which may be prohibited by law.
[DARPA checks applicable items below]
_Confidential commercial or financial information
__Information the disclosure of which would constitute a clearly unwarranted invasion of personal Information subject to the Privacy Act
__Records or information compiled for law enforcement purposes
__Information protected for national security reasons; or
FDA shall notify the appropriate office of the information-sharing agency if there are any attempts to obtain shared information by compulsory process, including but not limited to, , Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions.
FDA shall notify the information-sharing agency before complying with any judicial order that compels the release of such information that FDA and DARPA may take appropriate measures, including filing a motion with the court or an appeal.
Appendix 3- Model Language for Information Sharing Request from Participating Partner(s) to FDA
FDA has agreed, by this letter or email and by a signed request letter dated___________, not to disclose the above-described information without prior written permission of DARPA. FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. § 331(j); 18 U.S.C. § 1905, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and 5b and 42 U.S.C. § 241(d).