DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
MEMORANDUM OF UNDERSTANDING
Division of Program Coordination, Planning and Strategic Initiatives,
National Institutes of Health
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
This Memorandum of Understanding (MOU) details the joint objectives of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). These agencies share a common interest and goal in developing 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.
FDA has authority to enter into this agreement pursuant to sections 1003(b) and (c) of the Federal Food, Drug, and Cosmetic Act. NIH has authority to enter into this agreement pursuant to sections 301 and 402 of the Public Health Service Act
Advances in bioengineering, such as in materials science, microfabrication, and microfluidics technologies have allowed the manufacture of microsystems representing functional units of an organ that replicate physiologically the spatiotemporal, mechanical and biochemical cues inherent in those tissues. In parallel, recent developments in stem cell technology now make it possible to obtain tissues from humans with specific genotypes and/or disease phenotypes. The NIH has issued Funding Opportunity Announcements (FOA), RFA-RM-11-022 http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-11-022.html and RFA-RM-12-001 http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-12-001.html in order to support research, development and deployment of human microphysiological systems. Interagency cooperation provides an excellent opportunity to bolster individual agency efforts, achieve program benefits, and facilitate program operations.
NIH and FDA intend to collaborate and coordinate efforts towards development of human microphysiological systems. 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 FOA. 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 NIH and FDA intend to assume their respective roles and responsibilities as follows:
- 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 NIH and/or Principal Investigator who receives an award under this FOA, as needed in areas of FDA purview.
- NIH will hold program reviews for all award recipients of the FOA 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.
- On a need-to-know basis, and with the written permission of the Scientific Review Officer running the review, FDA personnel may attend the review meeting as observers.Each party may utilize the expertise and relationships of the other in order to increase its own capability and responsiveness.
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 NIH and FDA staff listed below represent the current persons in these assigned roles at the date of signing of this MOU. Additional NIH and FDA staff may be drawn to provide scientific expertise on organ/tissue physiology as needed.
A. Scientific / Research Contacts for NIH:
1. Danilo A. Tagle, Ph.D.
Phone: (301) 208-1177
NIH intends for the NIH Program Official (PO) to be responsible for the scientific, programmatic, and technical aspects of the Advancing Regulatory Science Initiative which may entail, in part, the programmatic review of the milestones and non-competing renewal applications for the cooperative agreements awarded in response to RFA-RM-11-022 and RFA-RM-12-001. NIH intends for the PO to have substantial scientific involvement during the conduct of the program through technical assistance, advice, and coordination.
2. Scientific / Research Contact for NIH/DPCPSI/OSC:
Elizabeth Wilder, Ph.D.
Phone: (301) 402-7617
The DPCPSI Scientific Contact represents DPCPSI in overseeing the use of the NIH Common Fund, providing logistical and programmatic guidance for funding announcement(s), funding plans and reports on progress to NIH Leadership.
B. Scientific/Research Contact for FDA:
Suzanne C. Fitzpatrick, Ph.D., DABT
Senior Science Advisor
Office of the Commissioner
Phone (301) 796-8527
The FDA Scientific Contact will coordinate technical assistance, including guidance on the milestones and progress reports, providing advice and plans for the integration of the findings into practice and guidance.
It is anticipated that there will be semi-annual meetings with award recipients and experts from NIH and FDA. NIH will request that awardees, in their discretion, share progress reports with the FDA. The meeting schedule can be unilaterally changed at any time by NIH or FDA.
Both agencies efforts will be Unclassified.
X. PUBLIC RELEASE OF INFORMATION
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.
NIH and FDA agree that there should be a presumption in favor of full and free sharing of information as relates to the Regulatory Science Initiative, consistent with applicable law and agency policy. Both parties recognize and acknowledge, however, that all non-public information shared between 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, 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., Freedom of Information Act (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 this 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 will forward all such requests to the respective FOIA offices for NIH and FDA for disposition.
XI. PERIOD OF AGREEMENT
This MOU becomes effective following the signature of both parties and remains effective for five 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. At the conclusion of 5 years, the parties may consider the extension of this MOU or the development of a new MOU as needed.
Signed by: James M. Anderson, M.D., Ph.D. Director Division of Program Coordination, Planning, and Strategic Initiatives Date: 11/28/2011 Signed by: Jesse L. Goodman, M.D., M.P.H. Chief Scientist and Deputy Commissioner for Science & Public Health Office of the Chief Scientist Food and Drug Administration Date: 11/28/2011
APPROVED AND ACCEPTED FOR THE NATIONAL INSTITUTE OF HEALTH
APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION
Signed by: James M. Anderson, M.D., Ph.D.
Director Division of Program Coordination, Planning, and Strategic Initiatives
Signed by: Jesse L. Goodman, M.D., M.P.H.
Chief Scientist and Deputy Commissioner for Science & Public Health Office of the Chief Scientist Food and Drug Administration