MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
DIVISION OF MEDICAL IMAGING PRODUCTS
and the
NATIONAL CANCER INSTITUTE
DIVISION OF CANCER TREATMENT AND DIAGNOSIS
August 30, 2019

I. PURPOSE

This Memorandum of Understanding (MOU) between the Food and Drug Administration/Center for Drug Evaluation and Research Division of Medical imaging Products (referred to as FDA/CDER/DMIP) and the National Institutes of Health/National Cancer Institute/Division of Cancer Treatment and Diagnosis (NIH/NCI/DCTD), each a party and collectively the parties, provides a framework for coordination and collaborative efforts between these two entities, which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information sharing between FDA/CDER/DMIP and NIH/NCI/DCTD units shall take place.

II. BACKGROUND

FDA and NIH are sister agencies within the Department of Health and Human Services. Both FDA and NIH exist and work to protect the public health but have different statutory mandates and responsibilities.

FDA is a science-based regulatory agency authorized to 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 ensuring 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. 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. 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. Within FDA, CDER’s mission is to protect and enhance the public health through regulation of drug and combination products according to statutory authorities. The regulation of these products is founded on science and law to ensure their purity, potency, safety, and efficacy.

NIH is the primary U.S. Federal agency for biomedical research. The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical schools, hospitals and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of medical information. The NCI, a component of the NIH, is the nation’s leading supporter of biomedical research on cancer. The mission of the NCI is to lead, conduct, and support cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. To achieve its mission of reducing the public health burden associated with cancer, the NCI conducts, fosters, coordinates, and guides research on the causes, prevention, diagnosis, and treatment of cancers, including basic research in related scientific areas. NIH's and FDA's respective missions to protect the public health are complementary and may overlap depending upon the subject matter. The agencies work collaboratively to protect and improve public health. Sometimes FDA/CDER or NIH/NCI/DCTD may have information that could be useful to the other party in that party's performance of its responsibilities. Timely sharing of information between NIH/NCI/DCTD and FDA/CDER is therefore critical to protect and improve the public health.

III. SUBSTANCE OF AGREEMENT AND RESPONSIBILITIES OF EACH AGENCY

A. Coordination and Collaboration Relative to Public Health Activities

The parties mutually agree that, on an as needed basis, as resources permit, and in all cases subject to applicable statutes, regulations and policies they will seek opportunities to collaborate on the following public health activities:

1. Coordinate and collaborate with each other to protect and improve the public health. To achieve this, each party will capitalize on the expertise, resources, and relationships of the other to increase its own capability and readiness to respond to situations of mutual interest. In addition, each party will designate central liaisons (listed in Section V of this MOU) to coordinate communications from the other and in responding to matters covered by this MOU.
2. Participate in periodic meetings to promote better communication and understanding of regulations, policies, and statutory responsibilities, and to serve as a forum for questions and problems that may arise.
3. Notify the other when issues of mutual concern become evident to the extent such notification does not interfere with the public health, oversight, enforcement, or compliance responsibilities of the notifying agency.
4. Present reciprocal in-house presentations to their corresponding staff on topics of common interest such as FDA's managed regulatory review process and NIH/NCI/DCTD's extramural, federally-funded translational research initiatives and programs, specifically those applicable to development of imaging drugs and technologies for the treatment, diagnosis, and staging of cancer. Non-federal employee staff under appropriate confidentiality terms and as permitted by law, such as contractors and volunteers, can be included in these meetings.
5. Where appropriate, FDA/CDER/DMIP will provide relevant reference documents that describe the investigational product review process and marketing approval processes for use by NIH/NCI/DCTD staff involved in conferring with prospective translational research grantees to assist in the design and implementation of clinical studies that comply with FDA/CDER/DMIP guidance and regulations.
6. Improve efficiency of the submission and review process for institutional applicants requesting funding from NIH/NCI/DCTD where the anticipated clinical study contemplates the submission of an Investigational New Drug (IND) application to FDA/CDER/DMIP by sharing publicly available information about the submission and review process. NCI is not the sponsor for such INDs but often provides advice to potential outside sponsors.
7. Promote communication and consultation on policy issues and guidance documents of interest and relevance to researchers, consumers and/or health care professionals pertaining to novel imaging and oncology drugs and technologies. This cooperative interaction will target possible public health risks and research and regulatory processes affecting the pace of bench top to bedside research translation. For example, during drafting of policy documents such as FDA Guidance for Industry or NIH Points-to-Consider that apply to cancer drugs and technologies, each party is encouraged to seek input from its counterpart.
8. NIH/NCI/DCTD will invite FDA/CDER/DMIP input and recommendations, when appropriate, during development of Funding Opportunity Announcements targeting relevant, essential research areas to foster and support development of imaging drugs and technologies and products for treating cancer.
9. As appropriate, and in accordance with applicable conflict of interest laws, regulations, and policies, NIH/NCI/DCTD experts may, at the request of sponsors, participate in discussions of INDs that seek FDA/CDER permission to initiate clinical studies involving novel imaging and oncology drugs or technologies and products whose scientific and clinical aspects may be complex and non-conventional. Any such participation must be pursuant to appropriate confidentiality agreements between NIH/NCI/DCTD and FDA/CDER/DMIP under 21 C.F.R. § 20.85.¹ Such participation by NIH/NCI/DCTD may occur only if NIH/NCI/DCTD is not a sponsor nor acts as a representative of the drugs or technologies being discussed.
10. Provide opportunities for FDA/CDER/DMIP staff to participate in NIH/NCI/DCTD-sponsored conferences that pertain to development of imaging and oncology drugs and technologies. FDA/CDER/DMIP contributions may include: (1) participation in workshops, (2) individual presentations, (3) use of existing videotaped FDA conferences/workshops on selected regulatory policy and process issues.
11. FDA participation in meetings and conferences under this MOU is predicated on a mutual understanding that such meetings and conferences provide a forum for a mutual exchange of opinions and ideas. Such meetings and conferences must avoid any actual incidence or appearance that procurement or investment considerations may influence FDA regulatory decision-making concerning product approval or authorization. FDA employees generally will not participate in discussions or decision-making regarding the terms or procurement of or investment in a medical product. FDA representatives may participate in discussions under this MOU to provide FDA’s currently thinking on scientific or regulatory issues within FDA’s areas of responsibility and expertise.

B. Restrictions on Coordination

This MOU does not preclude NIH/NCI/DCTD or FDA/CDER/DMIP from entering into other agreements that may enable special programs to be handled more efficiently and expertly.

This MOU does not in any way modify the relationship between the parties or change the interactions when the NCI/DCTD is filing formal regulatory documents. The NCI/DCTD is subject to the laws, rules, and guidelines that govern IND and NDA filings.

C. Principles and Procedures for the Sharing of Non-Public Information

FDA/CDER/DMIP and NIH/NCI/DCTD agree that the following principles and procedures will govern the sharing of non-public information between the two parties.

Although there is no legal requirement that FDA/CDER/DMIP and NIH/NCI/DCTD exchange information in all areas, the parties agree that there should be a presumption in favor of full and free sharing of information between FDA/CDER/DMIP and NIH/NCI/DCTD. As public health agencies within the Department of Health and Human Services, there are no legal prohibitions that preclude FDA or the NIH from sharing with each other most information in the possession of either agency. Both parties recognize and acknowledge, however, that it is essential that any non-public information that is shared between FDA/CDER/DMIP and NIH/NCI/DCTD whether written or oral must be protected from any disclosure that is not authorized by law or regulation. See e.g., 21 U.S.C. § 331(j), 18 U.S.C. § 1905, 5 U.S.C. §§ 552 and 552a, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and 5b, and 42 U.S.C. § 241(d). Safeguards are needed to protect non-public information shared, both written and oral, 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 FDA/CDER/DMIP 's and NIH/NCI/DCTD's compliance with applicable laws and regulations.

To facilitate the sharing of non-public information, written or oral, FDA/CDER/DMIP and NIH/NCI/DCTD will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all non-public information received. Each party has implemented or will implement the agency’s data and information security statutory, regulatory, policy, or procedural requirements and has implemented or will implement, to the extent necessary, practicable, and consistent with its own laws, regulations, and policy and procedural requirements, all data and information security recommendations suggested by the other agency. Both parties are committed to responding to requests for information in a complete and timely manner, consistent with budgetary and resource constraints, and to the extent permitted by applicable laws, regulations or agency policies and practices. The party receiving shared non-public information (requesting party), whether written or oral, will be responsible for protecting that information from any unauthorized disclosure. Provisions for sharing of non-public information, both written and oral, in accordance with applicable statutes or regulations are set out below:

1. The requesting party must specify, in writing (as used herein, the term “writing” includes by electronic means) the information requested (to facilitate identification of relevant information), provide a brief statement of why the information is needed, and include the following requesting party template language: “This request is made pursuant to the Memorandum of Understanding for Sharing of non-public information between FDA/CDER/DMIP and NIH/NCI/DCTD, dated August 30, 2019. The requesting party agrees not to disclose any non-public information shared between FDA/CDER/DMIP and NIH/NCI/DCTD whether orally or in writing, in any manner without the prior written permission of the sharing party.” This request shall state which internal unit offices and/or individuals are requesting the information.
2. The party receiving the request (sharing party) will determine, based upon the request described in section III.B.l above, whether it is appropriate and practicable to share the requested non-public information. The sharing party will include a response in writing along with any agency information shared. The response will indicate the type of information (e.g., confidential commercial information, personal privacy, pre-decisional, etc.), and will include the following sharing party template language: “Pursuant to the Memorandum of Understanding for sharing of non-public information between the FDA/CDER/DMIP and NIH/NCI/DCTD, dated August 30, 2019, the non-public information provided in this communication may not be disclosed or shared in any manner without the prior written permission of the [sharing party].” Any shared documents containing non-public information should be stamped “Do not disclose or further distribute.”
3. The requesting party will comply with the following conditions:
   1. The requesting party will limit the dissemination of shared non-public information it receives to internal unit offices and/or individuals that have been identified in its written request and/or have a need to know. The unit official who signs the request letter shall be responsible for ensuring information is not distributed to inappropriate recipients. If the requesting party determines that internal unit offices or individuals other than 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 internal unit offices or individuals.
   2. The requesting party will agree in writing not to disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings, or in the context of other agency collaborations. If the requesting party wishes to disclose shared information that the sharing unit 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 Freedom of Information Act (FOIA) request for the shared information, it shall: (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 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.
   3. 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.
   4. The requesting party will promptly notify the sharing party of 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.
   5. Nothing in this Section III prevents a party from complying with either a legally valid and enforceable order of a court of the Unites States or an official request of the United States Congress, or any committee thereof.

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¹ Further guidance on completing confidentiality agreements (including sample letters or memorandum) can be found in the CDER Manual for Policies and Procedures on Sharing Nonpublic Information with Federal Government Officials (MAPP 4112.2) available at:
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM073028.pdf.

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

Food and Drug Administration
Center for Drug Evaluation and Research
Office of Drug Evaluation IV
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: (240) 402-8000

National Institutes of Health
National Cancer Institute
Division of Cancer Treatment and Diagnosis
Building 31, Room 3A44
31 Center Drive MSC 2440
Bethesda, MD 20892-2440
Telephone: (301) 496-4291
Fax: (301) 496-0826

V. LIAISON OFFICERS

Liaison Officers will participate in the management, coordination and oversight of this MOU and serve as points of contact.

A. For FDA/CDER/DMIP

Libero Marzella M.D., Ph.D.
Division of Medical Imaging Products
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-2002
Telephone: 301-796-1414
E-mail: [email protected]

B. For NIH/NCI/DCTD

Paula Jacobs, Ph.D.
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
9609 Medical Center Drive
Room 4W236, MSC 9729
Bethesda, MD 20892-9729
Telephone: (240) 276-5950
E-mail: [email protected]

Janet F. Eary, M.D.
Cancer Imaging Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
9609 Medical Center Drive
Room 4W338, MSC 9729
Bethesda, MD 20892-9729
Telephone: (240) 276-5135
E-mail: [email protected]

Jeffrey S. Abrams, MD
Division of Cancer Treatment and Diagnosis
National Cancer Institute
9609 Medical Center Drive
Room 4W536, MSC 9732
Bethesda, MD 20892-9732
E-mail: [email protected]
phone: 240-276-6515

VI. PERIOD OF MOU

This MOU will become effective when accepted by all participating parties, and shall continue in effect until September 1, 2027, unless terminated by either party upon a ninety (90) day advance written notice to the other party. Not later than 120 days prior to the expiration of this MOU, each party will provide a recommendation regarding the extension of the MOU, including modifications if any.

VII. MODIFICATION

This MOU may be modified upon the mutual written consent of the parties and such modification shall become effective when executed by both parties.

SIGNATURES

APPROVED AND ACCEPTED FOR NATIONAL CANCER INSTITUTE
Division of Cancer Treatment and Diagnosis

James H. Doroshow, MD
Director, Division of Cancer Treatment and Diagnosis
National Cancer Institute

Date: 8/28/19

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research

Charles Ganley, MD
Director, Office of Drug Evaluation IV
Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration

Date: 8/29/19