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  1. Domestic MOUs

MOU 225-16-011

I.                    Purpose
This Memorandum of Understanding (MOU) is between the Division of Clinical Innovation (DCI), part of the National Center for Advancing Translational Sciences (“NCATS”), which is a component of the National Institutes of Health (“NIH”), an agency of the U.S. Department of Health and Human Services having offices located at 6701 Democracy Blvd, Bethesda, MD 20892, and the Office of Translational Sciences (OTS) within the Center for Drug Evaluation and Research (“CDER”), which is a component of the Foodland Drug Administration (“FDA”), an agency of the U.S. Department of Health and Human Services also referred to as “Collaborator”, having a principal place of business located at 10903 New Hampshire Ave, White Oak, Bldg 21, Silver Spring, MD 20993 (collectively, the “Parties”). This MOU serves to confirm the mutual interest of the Parties to discuss and explore collaborative opportunities in supporting translational and regulatory science, including but not limited to joint financial support for applications submitted in response to the Clinical and Translational Science Awards (CTSA) Collaborative Innovation Awards program, or other scientific research funded by DCI, and training initiatives. This MOU is not exclusive and does not bind the parties to collaborate or provide funding on any specific project. Collaborations on any specific project will be governed by an individual collaboration agreement that would be executed when such projects are identified.
II.                  Background
FDA is authorized to implement and enforce the Federal Food, Drug, and Cosmetic act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling 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 drugs, and medical devices and the safety and security of foods, dietary supplements, radiological products, and cosmetics. 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. It is part of FDA’s mission to collaborate with other science-based agencies, and in particular the National Institutes of Health, to advance its objectives see, Section 1003(c)). To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships with the NCATS will greatly contribute to FDA’s mission.
NCATS, one of 27 Institutes and Centers (IC) at the National Institutes of Health (NIH) was established to transform the translational process so that new treatments and cures for disease can be delivered to patients faster. NCATS strives to develop innovations to reduce, remove, or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics, and medical devices top patients. Part of NCATS’ statutory purpose includes “coordinating and developing resources that leverage basic research in support of translational science” and “developing partnerships and working cooperatively to foster synergy,” Section 479(a) of the Public Health Service Act (42 U.S.C. 287(a)). Increased development of research, education, and outreach partnerships with the FDA will greatly contribute to NCATS’ mission.
III.                Substance of Agreement
NCATs and FDA want to explore areas to collaborate in the general area of translational and regulatory science, develop training partnerships, and educational initiatives. Under this MOU, FDA and NCATS will seek opportunities to participate together in translational science and training partnerships as permitted under appropriate statutory authority. Before any specific training opportunity is initiated or implemented, the Parties shall identify priorities and topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. NCATS and FDA want to exchange, during the term of any independent collaboration agreement subject to this MOU, confidential documents that may facilitate progress in their areas of common interest, and lead to specific collaboration opportunities.
IV.                Potential Areas of Collaboration
A.      Sharing applications submitted in response to funding opportunities published by DCI, including but not limited to NIH PAR-15-172 and 173, without compromising the Confidential Information obtained from third parties.
B.      Jointly reviewing applications to support promising approaches to translational and regulatory science, while ensuring that third party Confidential Information will be protected.
C.      Providing advice and guidance on ongoing projects that are supported by either Party, by serving on joint project review or advisory committees.
D.     Co-development of funding opportunities to support research to address translational and regulatory science roadblocks.
E.      Co-development of educational and training opportunities for scientists and medical professionals in translational and regulatory science.
V.                  General Provisions
A.                  Treatment of confidential information
As public health agencies within the Department of Health and Human Services, there are no legal prohibitions that preclude FDA or NCATS from sharing with each other most information in the possession of either party where necessary to engage in the types of collaborations contemplated by the parties pursuant to this MOU. Both parties recognize and acknowledge however, that all non-public information shared between FDA and NCATS whether in writing or orally, must be protected from any disclosure not authorized by law or regulation. See e.g., 18 U.S.C. section 1095; 5 U.S.C. section 552a; 21 U.S.C. section 331(j); 21 CFR Parts 20 and 21; 42 U.S.C. Section 241(d); 42 CFR arts 5 and 5b. If any information is shared pursuant to an individual collaboration agreement subject to this MOU, safeguards are needed to protect shared non-public information, such as trade secrets and confidential commercial information; identities of study participants and other personal privacy information; privileged and/or pre-decisional agency information; research proposals, progress reports, and/or unpublished data; or national security information. Such safeguards also help ensure compliance by FDA and NCATS with other applicable laws and regulations. For the purposes of the MOU, all NIH or FDA grant applications, grant supplements, and information related to the grant application are considered confidential information.
Before FDA and NCATS share any non-public information for the purposes of furthering an area of collaboration discussed in this MOU, the parties will execute an individual collaboration agreement that incorporates the terms of this section V.A. FDA and NCATS will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all information received. Both parties are committed to responding to requests from each other for information in a complete and timely manner, consistent with budgetary and resource constraints, and to the extent permitted by law, regulation, and agency policy and practice. The party receiving shared non-public information (requesting party) will be responsible for protecting that information from any unauthorized disclosure. Provisions for sharing of non-public information in accordance with applicable statutes or regulations are set out below:
The requesting party will comply with the following conditions:
1.      The requesting party will limit the dissemination of share non-public information it receives pursuant to an individual collaboration agreement subject to this MOU to internal unit offices and/or employees other than those identified in the original request have a need to know the requested information, then 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.
2.      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 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 conformation and permission for the sharing arty before disclosing that information. If the requesting party receives a Freedom of Information Act (FOIA) request for shared information, the requesting party will:
(a)   Refer the FOIA request to the information-sharing contact person or designee for the sharing party to respond directly to the FOIA requester regarding the releaseability of the information, land
(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 arty has responsive records or releasable records.
3.      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 the permission of [FDAS or NCATS]” whichever is applicable.
4.      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, and FOIA request, subpoena, discovery request, or litigation complaint or motion.
5.      The requesting party will notify the sharing party before complying with any judicial order that compels the release of shared non-public information, so that the parties may determine the appropriate measures to take, including, where appropriate, legal action.
6.      The confidentiality provision of this MOU will survive expiration or earlier termination of this MOU and the relevant individual collaboration agreements pursuant to which it is necessary to exchange confidential information.
B.      Resource Obligations
This MOU represents the broad outline of the Parties present intent to enter specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and NCATS. None of the activities outlined in this memorandum currently requires the exchange of funds between NCATS and FDA. If joint financial support for an activity is deemed to be required in the future, the Partner(s) may execute any necessary documents such as an intra-Departmental Delegation of Authority (IDDA). All activities undertaken by this MOU are subject to available personnel, resources and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the partner(s). 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 the participating Partner(s) operate.
C.      Liaison Officers
a.      For the National Center for Advancing Translational Sciences
Philip J. Brooks, Ph.D.
Program Director
National Center for Advancing Translational Sciences (NCATS)
6701 Democracy Boulevard Rm 924 Bethesda, MD 20892
Joan Davis Nagel, M.D., M.P.H.
Medical Officer
National Center for Advancing Translational Sciences (NCATS)
6701 Democracy Boulevard Rm 928 Bethesda, MD 20892
b.      For the Food and Drug Administration
Chekesha S. Clingman, Ph.D., M.B.A.
CDER Office of Translational Sciences
Special Assistant to the Director
10903 New Hampshire Ave, WO21 4607
Ruth Barratt, Ph.D., D.V.M.
CDER Office of Translational Sciences
Science Advisor
10903 New Hampshire Ave WO21 4607
Each Party may designate new liaisons at any time by notifying the other Party’s administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a news liaison within 2 weeks and notify the other Party through the designated administrative liaison.
VI.                Terms, Termination and Modification
This MOU may be executed by the parties in counterparts by facsimile or electronically, each of which who so executed or delivered will be deemed to be an original and all will constitute one MOU.
This MOU will be effective on the date of the last authorized signature below. The Agreement may not be superseded, amended or modified except by written agreement between the Parties hereto. This MOU will terminate immediately upon the mutual agreement of the Partied in writing. This MOU is to be made under and shall be construed in accordance with Federal laws as applied by the Federal Courts in the District of Columbia and constitutes the entire understanding between the Parties hereto with respect to the subject matter hereof and merges any and all prior agreements, understandings and representation.
Christopher P. Austin, M.D., Director, NCATS
April 12, 2016
Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
April 13, 2016

ATTACHMENT A1 -- Model Language for Information Sharing Request for Participating Partner(s) to FDA 

Attachment A1 -- Model Language for Information Sharing Request from Participating Partner(s) to FDA
MOU Control No. (Insert number)
Process for Information Sharing
Pursuant to Section __of the Memorandum of Understand (MOU) entered by the Food and Drug Administration (FDA) and the ________________________________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 __.
When, under the current MOU, staff at the FDA or ______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 agreement will be under the FDA _________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 ________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 A2 -- Model Language for Information Sharing Request from Participating Partner(s) to FDA
MOU Control No. (Insert number)
This letter accompanies agency records the (Participating Partner(s)) 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 b law.
(Participating Partner(s)) checks applicable items below]
____ Trade secrets
____ Confidential commercial or financial information
____ Information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy
____ Information subject to the Privacy Act
____ Intra-agency records
____ Records or information compiled for law enforcement purposes
____ Information protected for national security reasons; or
____ Other
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 Partner(s) may take appropriate measures, including filing a motion with the court or an appeal.
FDA has agreed, by this letter or e-mail and by a signed request letter dated ___________________, not to disclose the above-described information without prior written permission of the (Partner(s). FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. section 331(j); 18 U.S.C. section 1095, 21 C.F.R. Parts 20 and 21, 45 CF.R. Parts 5 and 5b and 42 U.S.C. Section 241(d).


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