MOU 225-14-017
MOU 225-14-017 has been amended, effective June 30, 2023.
MEMORANDUM OF UNDERSTANDING BETWEEN THE
FOOD AND DRUG ADMINISTRATION
AND THE
CENTERS FOR DISEASE CONTROL AND PREVENTION
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
I. PURPOSE
This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) provides a framework for coordination and collaborative efforts between all components of these two agencies, which are both operating divisions of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information, including data, exchanges between FDA and CDC should take place.
FDA and CDC agree that there should be a presumption in favor of full and free sharing of information between FDA and CDC. Federal law generally does not preclude FDA or CDC from sharing most agency records or data with each other. Both agencies recognize and acknowledge that any confidential data and other information shared between FDA and CDC must be protected from unauthorized disclosure.
This memorandum supersedes MOU 225-09-0002, dated June 25, 2009, MOU 225-140017, dated June 20, 2014, and the amendments dated July 9, 2021, and June 30, 2022, between the FDA and CDC regarding the exchange of information and coordination of actions.
II. BACKGROUND
FDA and CDC exist and work to protect the public health but operate under different statutory authorities and have different mandates and responsibilities.
FDA is responsible for protecting the public health through the regulation of food (including dietary supplements), cosmetics, tobacco, and medical products, including drugs, biological products, animal drugs, and medical devices. FDA enforces the Federal Food, Drug, and Cosmetic Act and relevant sections of the Public Health Service Act, among other statutes. Among its duties, FDA reviews pre-market applications, performs post-market surveillance including monitoring adverse events, conducts sampling and inspections, and, when appropriate, initiates civil and criminal proceedings to enforce applicable laws and regulations. As part of FDA’s mission to protect public health, FDA also responds to possible contamination events with state, local, territorial, tribal, federal, and regulated industry to help prevent additional illnesses and, when appropriate, take actions to remove the violative product from the marketplace.
CDC's mission as the nation’s health protection agency is to save lives and protect people from health threats. CDC seeks to accomplish its mission by working with partners, including state, tribal, local, and territorial health departments, throughout the nation and the world to monitor health; detect and investigate health problems, including illnesses and outbreaks; conduct research to enhance prevention; develop and advocate sound public health policies; implement prevention strategies; promote healthy behaviors; foster safe and healthful environments; and provide leadership, technical assistance, and training. CDC conducts its activities under the authority of the Public Health Service Act and other federal statutes.
CDC's and FDA's respective missions to protect the public health may intersect in a variety of ways depending upon the subject matter. Each agency has a responsibility to work collaboratively to protect and improve public health including working to advance health equity and reduce health disparities. FDA and CDC regularly possess information that is useful to each other to perform their responsibilities. Timely sharing of information between CDC and FDA in these circumstances is therefore critical to protecting the public health.
III. SUBSTANCE OF AGREEMENT AND RESPONSIBILITIES OF EACH AGENCY
A. Coordination and Collaboration Relative to Public Health Activities
It is mutually agreed that:
1. Each agency will coordinate and collaborate with the other agency to protect and improve the health of the public. To achieve this, each agency will use the expertise, resources, and relationships of the other agency to increase its own capability and readiness to respond to public health issues and emergency situations. In addition, each agency will designate central contact points to whom communications from the other agency dealing with matters covered by this agreement should be referred.
2. Each agency will participate in periodic joint meetings to promote better communication and understanding of statutory responsibilities, regulations, and policies. Additionally, meetings will serve as a forum for questions and issues that may arise as well as a review of this MOU.
3. Each agency will notify the other agency as soon as reasonably practicable when issues of mutual concern become evident.
4. Each agency will proactively collaborate with the other agency in all investigations of mutual concern and respond in a timely manner. Such collaboration may include providing advance alerts to the other agency when issues are identified; providing technical advice in areas of recognized expertise; sharing investigational findings, providing testing and results of analyses; coordinating health protection information and recommendations provided to other entities, such as public health and regulatory officials, industry, and the public; performing collaborative studies; making available expert witnesses; and exchanging information as described in section
III. B.
5. Each agency will consult with the other before publishing a report or journal article, or issuing a public advisory, press release, publication, or scientific communication that may have a significant impact on the other agency. Each agency will endeavor to provide sufficient time for the other agency to review and comment on communications recognizing there may be challenges during public health emergency situations. The intent is to foster a culture of communication and sharing, including credit on collaborative work such as publications and other scientific communications.
6. Each agency will refer its proposed communications, including regulations, guidance documents, policies, or recommendations that may have a significant impact on the other agency for review and comment by that agency before publication and with sufficient time—as agreed upon— to review and comment.
7. Each agency will endeavor to, whenever possible and appropriate, make their conclusions and public health recommendations concordant. This includes coordination and alignment between the agencies around health communication.
8. Each agency will work toward a mutually agreeable resolution when proposing analyses of public health problems based primarily on the other agency’s datasets to ensure accurate analysis, interpretation, and presentation of results. More in-depth discussions may be required to determine if the request is practicable. Discussions should also include roles and responsibilities, potential resources required, and strengths and limitations of the data.
9. This agreement does not preclude CDC or FDA from entering into other agreements with each other that may set forth procedures for special or specific programs in the interest of efficiency and expertise.
B. Principles and Procedures for the Exchange of Information that is Not Publicly Available
To facilitate the sharing of information with each other, it is necessary that FDA and CDC implement procedures to ensure, at a minimum, that such sharing of information is indeed appropriate, and that the recipient agency appropriately guards the confidentiality of all nonpublic information received.
FDA and CDC agree that the following principles and procedures will govern the exchange of nonpublic information between the two agencies.
Both agencies agree to protect non-public information that is shared between FDA and CDC from unauthorized disclosure. See e.g., 21 U.S.C. § 331;18 U.S.C. § 1905; 21 CFR Parts 20 and 21; 45 CFR Parts 5 and 5b; 42 U.S.C. § 242m (d), and 42 U.S.C. § 241(d). Safeguards are important to protect the interests of, among others, owners and submitters of trade secrets and confidential commercial information; patient identities and other personal privacy information; privileged and/or pre-decisional agency records; and information protected for national security reasons. Such safeguards also help ensure FDA's and CDC's compliance with applicable laws and regulations.
It is incumbent upon both agencies to respond to requests for information in a timely manner. Each agency should identify the level of urgency of any request. For example, requests related to emergencies such as investigations of FDA-regulated products possibly linked to illness or injury should be handled with a higher degree of urgency than routine requests for information needed to inform long-term policy.
1. Routine and Non-Routine Information Exchange
a. Routine information requests should be made in writing. Non-routine information requests that are necessary for responses to public health emergencies may be made orally, where those requests are preferably reduced to writing within 10 days. Communications such as those listed in A.4, A.5, or A.6 above are considered reduction to writing. Routine information requests should consist of a summary that describes, to the extent possible, the information requested (to facilitate identification of relevant records) and a brief statement of the purpose (e.g., reason for the need, intended use, and urgency) for which the information is needed. This request shall state which internal agency offices or individuals requested the information. For all requests, whether written or oral, the requesting agency agrees to abide by the confidentiality requirements established by the agency providing the information. Discussions should occur between agencies prior to making a request to ensure appropriate understanding of the issues, including potential resources involved, to facilitate efficient information exchange. A suggested model request is attached for routine requests.
b. Responses to routine information requests should be made in writing. The agency receiving the request for information shall assess whether it is appropriate to share the requested information with the requesting agency. The need-to-know threshold is a low one because there is a presumption in favor of information exchange between FDA and CDC. Each agency should have implemented, or will implement, to the extent necessary and practicable, all data and information security and confidentiality requirements. An agency should only decide not to share information in response to a request if it violates applicable laws and regulations or has credible information and a reasonable belief that the requesting agency may not be able to comply with applicable laws or regulations governing the protection of non-public information or with principles or procedures set forth in the MOU. Even if the process for information exchange is informal (e.g., oral), the agency receiving the request should indicate the level of confidentiality required to be maintained. If an agency decides that it is not appropriate to share information with the requesting agency, it shall describe to the requesting agency the reasons for such decision in a timely manner.
2. The agencies agree to comply with the following:
a. The requesting agency will limit the dissemination of shared information it receives to internal agency offices that have a need to know. The agency official who makes the request will be responsible for ensuring that there are no other recipients of the information. If the request is sent electronically, then the sender should have the requisite responsibility and authority. If the request is sent in a “letter” then there should be a signature and date provided. If biological materials are requested, it is the requester’s responsibility not to disseminate the materials to others without the sharing agency’s permission.
b. The requesting agency shall agree not to publicly disclose any shared information in any manner including in publications and at public meetings without approval. If the requesting agency wishes to disclose shared information, including information that it believes is publicly releasable, it shall obtain the permission of the agency that has shared the information. The requesting agency shall promptly notify the appropriate office of the information-sharing agency when there is any attempt to obtain shared information by compulsory process, including, but not limited to, a Freedom of Information Act request or judicial order.
c. The agency that shares information with the requesting agency will indicate (orally or in writing depending on whether it’s a routine or non-routine request) the type of information being shared is nonpublic (e.g. confidential commercial information, trade secret information, personal privacy, or pre-decisional) and indicate to the requesting agency the limitation on sharing (example text: “This information is nonpublic and shall not be further disclosed external to the agency without permission from [FDA or CDC]. (Whichever is the applicable sharing agency) Applicable laws and regulations may prohibit further disclosure of this information. See, e.g., 21 U.S.C. § 33l(j); 18 U.S.C. §1905; 21 CFR Parts 20 and 21; 45 CFR Parts 5 and 5b; 42 U.S.C. § 242m(d); and 42 U.S.C. § 241(d).” Suggested Model Language for Requests is attached
d. Any unauthorized disclosure of shared confidential information by the agency receiving the information shall be the responsibility of that agency, so long as the agency providing such information conveys the confidential nature of the information to the receiving agency, in accordance with the terms of this MOU, or the receiving agency otherwise has knowledge that such information is confidential.
e. When the information is needed due to possible emergency circumstances (e.g., an outbreak of serious illness), the responding agency should respond as soon as reasonably practicable.
IV. NAME AND ADDRESS OF PARTICIPATING PARTIES
A. FDA
Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
B. CDC
1600 Clifton Road
Atlanta, Georgia 30329-4027
V. LIAISON OFFICERS
A. Contact for FDA:
Susan Lance
FDA Liaison to CDC
Office of Coordinated Outbreak Response and Evaluation Network
60 8th St NE
Atlanta, Georgia 30309
Phone: (404) 639-3378
Email: susan.lance@fda.hhs.gov
B. Contact for CDC:
CDC Office of Science
1600 Clifton Road
Atlanta, Georgia 30329-4027
Phone: (404) 639-5994
Email:ScienceStrategy@cdc.gov
VI. PERIOD OF AGREEMENT
This agreement becomes effective upon signature of both parties and will continue for five years. It may be modified in writing by mutual consent or terminated by either party upon 120 days’ written notice.
Attachments:
- Model Request Correspondence
- Model Transmittal Correspondence
/s/
Robert M. Califf, MD,
Commissioner, FDA
Date: 06/30/2023
/s/
Rochelle P. Walensky, MD, MPH
Director, CDC
Date: 06/29/2023
Reference: Formerly 225-03-8001; 225-00-8000, 225-06-8401, 225-09-002 and 225-09-03
Model Language for Requests
The [Insert requesting Agency Name] has requested the following information from the [Insert other agency name] for the indicated purposes: [Identify information and purpose, and intended analysis if applicable]
or
[Insert requesting Agency name] requests the following information from [Insert other agency name] for the indicated purposes: [Identify information and purpose, and intended analysis if applicable]
[Insert requesting agency name] agrees that it will not publicly disclose any such information that [Insert other agency name] shares with it without prior written permission from [Inserting other agency name] and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between CDC and FDA. Applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. § 33l(j); 18 U.S.C. § 1905; 21 CFR Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; 42 U.S.C. § 242m(d); and 42 U.S.C. § 241(d).
[Model Language for Responses]
This communication accompanies agency records that the [Insert responding Agency name] is sharing in response to [Insert requesting agency name]'s request, dated [____________]. These agency records contain nonpublic information and may include information the public disclosure of which is prohibited by law (such as confidential commercial information, and Privacy Act information) and internal deliberative information such as information compiled for enforcement purposes.
The information contained in this transmission is not intended for public distribution and shall not be shared outside [insert the requesting Agency name] without the written permission of [insert responding Agency name].
[Insert requesting agency name] shall notify [insert 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.
[Insert requesting agency name] shall notify [insert the information-sharing agency] before complying with any judicial order that compels the release of such information so that FDA and/or CDC may take appropriate measures, including filing a motion with the court or an appeal. Further,
[Insert requesting agency name] has agreed, by this letter or e-mail and by a signed request letter dated not to publicly disclose the above-described information without the prior written permission of [Insert responding agency name]. [Insert requesting agency name] acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. §331(j); 18 U.S.C. §1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and 5b; 42 U.S.C. § 242m(d); and 42 U.S.C. §241(d).