I.                 Purpose

 

This Memorandum of Understanding (MOU or the agreement) establishes the framework and procedures to enhance collaborations and exchange of information between the Food and Drug Administration (FDA), Office of Women's Health (OWH) and the National Cancer Institute (NCI), Center for Cancer Research (CCR). FDA/OWH and NCI (each a Party, and together the Parties) seek to increase our scientific knowledge and understanding of cancer in women. FDA/OWH and NCI/CCR both recognize the need for a unified approach to advancing scientific knowledge related to cancer and women's health. This harmonized approach will aid in advancing the public health of all women through innovation in cancer research and medical therapies. This collaboration will serve to facilitate bi-directional communication between the two Agencies.

 

II.               Background

 

 FDA is 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, and medical devices and the safety and security of foods, cosmetics, and radiological products. 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. Increased development of research, education, and outreach partnerships with NCI/CCR will greatly contribute to FDA's mission. FDA's Office of Women's Health (OWH) was established to protect and advance the health of women through policy, science, and outreach, and to advocate for inclusion of women in clinical trials and for sex/gender analyses. OWH achieves its mission by supporting scientific research within FDA centers and collaborating with other government agencies and national organizations to sponsor scientific and consumer outreach efforts that address health issues affecting women across their lifespan. The OWH relies on partnerships with other Federal agencies, as well as public and private entities to help advance women's health research.

 

Pursuant to Sections 301, 401 and 463 of the Public Health Services Act [42 U.S.C. §241.28 and 285I]; The National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), is charged by Congress with leading the nation's efforts for National Cancer Program, which conducts and supports research, training, health information dissemination and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. The Center for Cancer Research is the basic and clinical intramural research program of the National Cancer Institute.

 

III.       Scope

 

This MOU establishes a collaborative framework in which FDA’s OWH and NIH’s NCI/CCR may engage in activities such as research and education for the mutual benefit of the parties, as well as benefits to the public health. Before any specific cooperative efforts are initiated or implemented, the parties will identify priorities, topics of mutual interests, and develop a separate written supplemental agreement for each cooperative effort that outlines each party’s commitments to collaboration and the terms to govern the cooperative effort. Where applicable, these agreements shall incorporate by reference the terms of this MOU. The terms and conditions of any agreement will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of FDA OWH and NIH NCI/CCR.

 

IV.      Other Provisions

 

Nothing in this MOU is intended to conflict with law, regulation, executive order or presidential directive, or the legislative mandates, regulations, or policies of the Department of Health and Human Services (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.

 

V.      Data Sharing Guidelines

 

As public health agencies within Department of Health and Human Services (DHHS), there are no legal prohibitions that preclude FDA or NCI/CCR from sharing with each other most information on in the possession of either agency. Both Parties recognize and acknowledge, however, that all non-public information shared between FDA and NCI/CCR, whether in writing or orally, must be protected from any disclosure not authorized by law or regulation. See e.g., 18 U.S.C. § 1905; 5 U.S.C. § 552; 5 U.S.C. § 552a; 21 U.S.C. § 3316; 21 CFR Parts 20 and 21; 42 U.S.C. § 241(d); 42 CFR Parts 5 and 5b. 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 NCI/CCR with other applicable laws and regulations.

 

To facilitate the sharing of non-public information, FDA and the NCI/CCR 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 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 and regulations are set out below:

 

The requesting Party will comply with the following conditions: 

VI.       Resource Obligations

 

This MOU represents the broad outline of the Parties' intent to enter into specific agreements for collaborative efforts in intellectual areas of mutual interests to FDA OWH and NCI/CCR. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to applicable policies, rules, regulations, and statutes under which FDA and NCl/CCR operate.

 

VII.       Liaison Officers

 

A.             For the National Cancer Institute

 

Melissa Bronez

Assistant Director for Clinical Affairs

Center for Cancer Research

National Cancer Institute

301-594-5958

 

B.             For the Food and Drug Administration, Office of Women's Health:

 

Dr. Pamela Scott

Director, Research and Development

10903 New Hampshire Avenue

Silver Spring, MD 20993

Telephone: 301-796-0530

FAX: 301-847-8604

 

VIII.      Term, Termination, and Modification

 

This agreement will be effective when accepted by all participating Parties. This agreement may be modified or terminated by mutual Written consent by both Parties or may be terminated by either Party upon a 60-day advance written notice to the other.

 

IX.     Approvals

 

 

August 10, 2015 

Center for Cancer Research

 

  

Attachment A1 -- Model Language for Information Sharing Request

 

MOU Control No.(Insert number) Process: for Information Sharing 

 

Pursuant to Section V of the Memorandum of Understanding (MOU) entered by the Food and Drug Administration (FDA) and National Cancer Institute (NCI) (FDA-NCI/CCR Memorandum of Understanding), either party 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 V. When, under the current MOU, staff at the FDA or NCI/CCR request for the other agency information 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 is 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-NCI/CCR 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 do 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 is not required for purposes of responding to a request. However, the following language should be included in the response:                                                

 

“Pursuant to the FDA-NCI/CCR 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

 

MOU Control No. (Insert number)

 

This letter accompanies agency records shared by one party (information-sharing Party) with the other (requesting Party) in response to requesting Party's request, dated _________. These agency records may contain one or more of the following categories of nonpublic information, including information the disclosure of which may be prohibited bylaw (including, limited to 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; interagency or intra-agency records which would not be available by law to a party other than an agency in litigation with the agency; records or information compiled for law · enforcement purposes; and information protected for national security reasons).

 

 The requesting Party 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.

 

The requesting· Party shall notify the information-sharing agency before complying with any judicial order that compels the release of such information that the Parties may take appropriate measures, including filing a motion with the court or an appeal.

 

Parties have agreed, by this letter or e-mail or by a signed request letter dated_____ not to publically disclose the above-described information without prior written permission of the Parties to the extent permitted by applicable law, regulation, and policy. Both Parties acknowledge that applicable laws and regulations may prohibit the disclosure of such information. See e.g., 21 U.S.C. Section 331(j); 5 U.S.C. Section 552; 5 U.S.C. Section 552a; 18 U.S.C. Section 1095; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b, and 42 U.S.C. Section 241(d).

 

 

Name                                                                Date