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MOU 225-16-022

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE
MEMORANDOM OF UNDERSTANDING
between the
National Center for Advancing Translational Sciences,
National Institutes of Health and the
Office of the Chief Scientist,
U.S. Food and Drug Administration

Title of the Agreement: Coordinated Microphysiological Systems for Drug Efficacy and Toxicity Testing in Human Health and Disease

I. PURPOSE

This Memorandum of Understanding (MOU) details the joint objectives of the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA). These agencies share a common interest and goal in facilitating the development of in vitro microphysiological systems that represent major organs and tissues in the human body, for prediction of efficacy, bioavailability and toxicity. Each agency, operating under its own authority, intends to have specific roles in promoting this shared interest. This MOU provides a framework for coordination and collaborative efforts between the parties to maintain and enhance agency effectiveness while avoiding duplication of efforts to achieve this common goal. It also provides the principles and procedures by which the parties intend to manage and share expertise and information between the two agencies in order to increase interagency collaboration and strategic planning.

II. AUTHORITY

FDA has authority to enter into this agreement pursuant to sections 1003(b) and (c) of the Federal Food, drug, and Cosmetic Act. NCATS, as a component of the NIH, has the authority to enter into this agreement pursuant to sections 301 and 402 of the Public Health Service Act.

III. BACKGROUND

The tissues-on -chip s program ( http://www.ncats.nih.gov/research/reengineering/tissuc­chip/tissue-chip.html ) supports an innovative approach to preclinical toxicity testing on human tissue: development of in vitro, three-dimensional organ systems from human cells on bioengineered platforms that mimic in vivo tissue architecture and physiological conditions in order to facilitate and accurately monitor key organ-level functions. The platforms incorporate complex factors found in vivo, including extracellular scaffolding, three-dimensional structure, cellular interactions (including between different cell types), perfusion, biomechanical stresses (e.g., stretch and shear forces from fluid flow), electrical stimulation of excitable tissue, hormone responses, etc. Tissues-on-chips hold promise as tools for predicting toxicity and pharmacology of candidate therapeutics. Prior NCATS/NIH investments through RFA-RM-11-022 and RFA­ RM-12-001 supported the development and integration of bioengineered multi-organ systems, along with the generation of renewable human cell resources for predictive assessment of drug safety and toxicity. In 2011, NCATS/NIH and FDA entered into a five year partnership to collaborate and coordinate efforts towards development of human microphysiological systems.

IV. SCOPE

NCATS/NIH and FDA intend to continue to collaborate and coordinate efforts towards development of human microphysiological systems that will include new initiatives starting in 2016. These initiatives are detailed under RFA-TR-16-006 Tissue Chip Testing Centers: Validating Microphysiological Systems (U24); RFA-TR-16-017 Microphysiological Systems (MPS) for Disease Modeling and Efficacy Testing (UG3/UH3); and RFA-TR-16-019 NIH­ CASIS Coordinated Microphysiological Systems Program for Translational Research in Space (UH2/UH3).
Departmental and agency relationships identified in this MOU are intended to improve the efficiency and effectiveness of the solicitation process, review, award and programmatic management of research in conjunction with the above-stated RFAs. This MOU does not alter existing DHHS authorities, command relationships, or privacy, civil liberties, and other oversight relationships. In establishing a proposed framework to provide mutually beneficial logistical and operational support, this MOU is not intended to replicate or aggregate unnecessarily the diverse organizational structures of each agency in scientific research.

V. WORKPLAN AND RESPONSIBILITIES OF EACH AGENCY

The NCATS/NIH and FDA intend to assume their respective roles and responsibilities as follows:

  • NCATS/NIH will originate and manage separately its own program on microphysiological systems. There will be no exchange or transfer of funds.
  • FDA, to the extent feasible for the Agency, will provide expert advice and assistance to the NCATS/NIH and/or Principal Investigator who receives an NCATS/NIH award under these FOAs, as needed in areas of FDA purview.
  • On a need-to-know basis, and with the written permission of the NII-I' s Scientific Review Officer running the review, FDA personnel may attend, as observers, the meeting(s) reviewing the applications for the NCATS/NIH award under these RFAs. Each party may utilize the expertise and relationships of the other in order to increase its own capability and responsiveness.
  • NCATS/NIH will hold program reviews for all award recipients of the FOAs through a workshop held on a semi-annual basis. To the extent permissible under applicable law and agency policy, FDA staff may participate and contribute their expertise in these workshops.

VI. OTHER PROVISIONS

Nothing in this MOU is intended to conflict with law, regulation, executive order or presidential directive, or the directives of DHHS. If a term of this MOU is inconsistent with such authority, then that term shall be invalid, but the remaining terms and conditions of this MOU shall remain in full force and effect. This MOU shall be interpreted and implemented in a manner that respects and complies with (and does not abrogate) the statutory and regulatory responsibilities of each agency. This agreement does not obligate funds.

VII. POINTS OF CONTACT

The names of NCATS/NIH and FDA staff listed below represent the current persons in these assigned roles at the date of signing of this MOU. Additional NCATS/NIH and FDA staff may be drawn to provide scientific expertise on organ/tissue physiology as needed.
A. Scientific I Research Contacts for NCATS/NIH: Danilo A. Tagle, Ph.D.
Associate Director for Special Initiatives Office of the Director, NCATS, NIH Phone:(301)594-8064
Email: danilo.tagle@nih.gov

NCATS/NIH intends for its Program Official(s) (PO) to be responsible for the scientific, programmatic, and technical aspects of the Microphysiological Systems program which may entail, in part, the programmatic review of the milestones and non-competing renewal applications for the cooperative grants awarded in response to stated FOAs.
NCATS/NIH intends for the PO to have substantial scientific involvement during the conduct of the program through technical assistance, advice, and coordination.

B. Scientific/Research Contact for FDA: Carol D. Linden, Ph.D. Director, Office of Regulatory Science and Innovation Office of the Chief Scientist/Office of the Commissioner Food and Drug Administration
Phone:301-796-8527
Email: Carol.linden@fda.hhs.gov

The FDA Scientific Contact will coordinate technical assistance, including guidance on the milestones and progress reports.

VIII. SCHEDULE/MILESTONES

It is anticipated that there will be semi-annual review meetings with experts from NCATS/NIH and FDA meeting with award recipients. NCATS/NIH will request that awardees, at their discretion, share progress reports with the FDA. The meeting schedule can be unilaterally changed at any time by NCATS/NIH or FDA.

IX. SECURITY

Both agencies efforts will be Unclassified.

X. PUBLIC RELEASE OF INFORMATION

NCATS/NIH and FDA intend for the following principles and procedures to govern the sharing of non-public information, as resources permit, between the two parties.
NCATS/NIH and FDA agree that there should be a presumption in favor of full and free sharing of information as relates to the Microphysiological Systems program, consistent with applicable law and agency policy. Both parties recognize and acknowledge, however, that all non-public information shared between NCATS/NIH and FDA, whether written or oral, must be protected from any further disclosures not authorized by law or regulation. Both parties recognize that safeguards are needed to protect shared non-public information including, for example, identities of study participants and other personal privacy information; privileged and/or pre-decisional agency information; research proposals, progress reports, and unpublished data; confidential commercial and trade secret information; and 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) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)). Such safeguards help ensure compliance with other applicable laws and regulations and should include, for example, the marking of any materials as "confidential" prior to disclosure, the use of encryption technologies when appropriate. If records provided by either party under the agreement 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 processing. If the FOIA request seeks both parties' records or if the request is for records created by one party that incorporates information provided by the other party, in accordance with the Department of Health and Human Services' FOIA regulations at 45 C.F.R. 5, the party receiving the FOIA request wi11 forward all such requests to the respective FOIA offices for NCATS/NIH and FDA for disposition.

XI. PERIOD OF AGREEMENT

This MOU becomes effective following the signature of both parties and remains effective for six (6) years. It may be modified by mutual consent of the parties. The agreement may be terminated by any party upon a 90-day advance written notice to the other parties.

XI. APPROVAL

 
APPROVED AND ACCEPTED FOR THE NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES, NIH          
By: Christopher P. Austin, M.D.
Director
Date: 9-13-2016
     

APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION

By: Luciana Borio, M.D.
Acting Chief Scientist
Date: 6-13-2016