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  1. Domestic MOUs

MOU 225-18-027

Memorandum of Understanding Between the Food and Drug Administration and the National Aeronautics And Space Administration

I. Purpose

The Food and Drug Administration (FDA) and the National Aeronautics and Space Administration (NASA) (each a “Party” and collectively “the Parties”) agree to provide mutual support to biomedical research and advanced development efforts related to the use of drugs, biologics, and medical devices for space exploration missions as well as chemical, biological, radiological, and nuclear (CBRN) medical countermeasure (MCM) development. This memorandum of understanding (MOU) establishes a framework for collaboration between FDA and NASA to facilitate information-sharing activities related to relevant CBRN MCMs, and drug, biologic, and medical device product development.

II. Authority

FDA has authority to enter into this MOU pursuant to section 1003(c) of the Food, Drug and Cosmetic Act (“the Act”) (21 USC 393(c)).

NASA has authority to enter into this MOU pursuant to the National Aeronautics and Space Act, 51 U.S.C. § 20113(e).

III. Background

FDA is responsible for protecting the 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 the 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.  FDA also advances the public health by supporting the development of innovative technologies which help to make medical products safer and more effective and available to more patients.  As a part of the goal of speeding innovation, FDA seeks to identify and address scientific and technical challenges to the optimum development of safe and effective medical products and technologies.

NASA is tasked with addressing its exploration biomedical goals using space-related health research to support astronaut crew health and also increase medical knowledge for health benefits on Earth.

FDA and NASA have a common interest in advancing the development of drugs, biologics, and medical devices related to space exploration missions as well as medical countermeasures for radiation-induced human health risks.

IV. Substance of Agreement

Under this MOU, the Parties may seek opportunities to participate in collaborative efforts, in furtherance of their respective objectives and as permitted under appropriate statutory authority and applicable law, as resources permit, to:

  • Look for potential collaborative studies on the utilization of already-funded FDA projects that would enhance NASA’s medical risk reduction exploration research.
  • Encourage space-related health research through the exchange of expertise, scientific and technical information, data, and publications.
  • Discuss providing technical expertise for planning, performance, or review in areas of mutual interest, subject to program priorities and availability of funds and personnel.
  • Facilitate and enhance research and development activities by either agency, including distributing information on research opportunities, such as NASA Research Announcements.
  • Coordinate publicity of mutually reinforcing activities, publications, and research results.
  • Include representatives from FDA and NASA in workshops, including NASA’s Human Research Program Investigator’s Workshop, working groups, seminars, and other related activities.

V. Public Release of Information

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

NASA recognizes and acknowledges that information exchanged with FDA that contains any of the following types of information must be protected from unauthorized use and disclosure: (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; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905)), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5 USC 552(b)), the FDCA (21 USC 301 et seq.), the Health Insurance Portability and Accountability Act (HIPAA), Pub.L. 104-191), Section 319L(e) of the PHS Act (42 U.S.C. § 247d-7e(e)), and disclosure restrictions subject to 41 USC 2101- 2107 (Procurement Integrity Act) and 48 CFR 3.104 (Federal Acquisition Regulation).  Additionally, all federal agencies and contractors supporting FDA and NASA are under the Federal Information Security Management Act (FISMA), E-Government Act of 2002 (Pub. L. 107-347, 116 Stat. 2899, 44 USC §3541 et seq.  Pursuant to section 301(j) of the FDCA (21 USC 331(j)), FDA will not reveal to any NASA representatives any information entitled to protection as a trade secret unless there is in place a written authorization, from the owner of that information, that permits FDA to reveal such information to representatives of NASA. Such authorization may be obtained in the form attached as Exhibit A to this MOU.

The Parties will establish proper safeguards to ensure that information shared under this MOU shall be used and disclosed solely in accordance with applicable laws and regulations. Access to such information shared under this MOU shall be restricted to authorized employees, agents, and officials of FDA and NASA 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; and (3) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws.

Contractors, their subcontractors, and/or agents requiring access to the information shared under this MOU will be required to sign an agreement by which they will commit to keep the information confidential.

The Parties agree to promptly notify each other of any actual or suspected unauthorized disclosure of information shared under this MOU.

If a Party that has received information shared under this MOU receives a FOIA request for information shared by another Party pursuant to this MOU, the receiving Party will refer the request to the information-sharing Party for that latter agency to respond directly to the requestor regarding whether or not the release of the information at issue is permissible. In such cases, the Party making the referral will notify the requestor that a referral has been made and that a response will be issued directly from the other agency.

Each Party agrees that a Party may decide not to share information or expertise in response to a particular request made to or by the other Party 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, for example, 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, agreement to share information to the maximum extent possible 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 procedures established above, 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 information is not required to be shared under this MOU.

The Parties 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 other Party that shared the information immediately to provide an opportunity to seek to intervene and block the disclosure. This MOU does not prohibit disclosure of information that is available publicly or when authorized in writing by the information owner.

The 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.

This MOU does not address and has no effect on the application of, or compliance with any requirement or restriction on disclosure for national security purposes.  Any national security clearance requirements or restrictions applicable to classified information (e.g., “Confidential,” “Secret,” “Top Secret”) that may be shared by or among the Parties must be satisfied independent of this MOU.

VI. General Provisions

1. This is an MOU between the FDA and NASA wherein the Parties agree and understand that this MOU is non-binding and shall not create or give rise to any legally binding obligations upon the Parties to perform any activities or provide any funding. 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.

2. FDA and NASA anticipate the activities covered by this MOU will involve meetings, workshops, scientific collaborations, and other communications between officials of FDA and NASA.

VII. Resources

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.

VIII. Points of Contact

The names of FDA and NASA staff listed below represent the current persons in these assigned roles at the date of signing of this MOU. Each Party may change its point of contact upon reasonable written notice to the other Party.

Management point of contact for FDA:

Michael Mair, M.P.H. Acting Assistant Commissioner for Counterterrorism Policy, and Acting Director, Office of Counterterrorism & Emerging Threats (OCET) Food and Drug Administration (FDA)
Michael.Mair@fda.hhs.gov

Management point of contact for NASA:

William Paloski, Ph.D. Program Manager
NASA Human Research Program Johnson Space Center
National Aeronautics and Space Administration (NASA)
william.h.paloski@nasa.gov

Technical point of contact for FDA:

Susan McDermott, M.D. Medical Officer/Team Leader
Counter-Terrorism and Emergency Coordination Staff /Office of the Center Director/Center for Drug Evaluation and Research
Food and Drug Administration (FDA)
Susan.McDermott@fda.hhs.gov

Technical point of contact for NASA:

Kris Lehnhardt, M.D.
Element Scientist Johnson Space Center
National Aeronautics and Space Administration (NASA) kris.lehnhardt@nasa.gov

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 90 calendar days written notice.

X. Approval

Approved and Accepted tor the Food and Drug Administration

RADM Denise M. Hinton
Chief Scientist
Office of the Chief Scientist
Office of the Commission
Food and Drug Administration (FDA)
/s/
September 26, 2018

Approved and Accepted For NASA
Craig Kundrot, Ph.D.
Director, Space Life and Physical Sciences Research & Applications Division
National Aeronautics and Space Administration (NASA)
/s/
September 26, 2018

Exhibit A
Model Authorization for FDA to Share Non-Public Information with NASA

[To be completed on sponsor/information- owner letterhead]

[FDA Center Official – e.g., Center or Office Director]
United States Food and Drug Administration
10903 New Hampshire Avenue
Building __, Room ____
Silver Spring, MD 20993

[Identify relevant FDA file number – e.g., NDA/ANDA/BLA, EUA/Pre-EUA, etc)]
Re: FDA Sharing of Non-Public Information Concerning [insert name of regulated product(s)]
with the National Aeronautics and Space Administration (NASA)

On behalf of [insert name of information owner], I authorize the United States Food and Drug
Administration (FDA) to share with NASA, and with contractors to NASA, all information concerning the above described product(s) that [insert name of information owner] has provided or will provide to FDA or to NASA. I understand that NASA has committed to use such information only for the purposes of information-sharing activities related to relevant chemical, biological, radiological and nuclear medical countermeasures, and drug, biologic, and medical device product development related to astronaut crew health and have committed or are otherwise legally required to maintain the confidentiality of such information (or both), and that contractors to NASA are bound by their contracts to maintain the confidentiality of the information. I understand that the information may contain confidential commercial or financial information or trade secrets within the meaning of 18 U.S.C. § 1905, 21 U.S.C. § 331(j), and 5 U.S.C. § 552(b)(4), that is exempt from public disclosure. I agree to hold FDA harmless for any injury caused by FDA's disclosure of this information.

Authorization is given to FDA to share this information without deleting confidential commercial or financial or trade secret information. This authorization shall remain valid unless revoked in writing. As indicated by my signature, I am authorized to provide this consent on behalf of [insert name of information owner] and my full name, title, address, telephone number, and facsimile number are set out below for verification.

Sincerely,

(Signature)
(Printed name)
(Title)
(Telephone & Facsimile Numbers)

cc: Office of Counterterrorism and Emerging Threats (OCET), Office of the Chief Scientist, FDA