MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION, CENTER FOR DRUG EVALUATION AND RESEARCH
and the
NATIONAL INSTITUTES OF HEALTH

I. PURPOSE

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), and the National Institutes of Health (NIH), are both components of the Department of Health and Human Services (HHS), and hereinafter also referred to as the "Party" or "Parties."  The primary purpose of this Memorandum of Understanding (MOU) is to provide a framework for coordination, collaborative eff ort s, and information sharing between the Parties with respect to NIH' s participation in CD ER' s Drug Safety Oversight Board (DSOB). CDER's DSOB meets periodically to discuss selected emerging or ongoing drug safety and/or risk management issues, with the input and perspectives of experts within and outside the FDA, including NIH. These discussions may also cover potentially significant drug risks and safety issues that have broad policy implications or that would benefit from wider input than can be provided by internal discussion within CDER. This MOU provides principles and procedures by which the coordination, collaborative efforts, and information exchanges, in the context of CDER's DSOB, shall take place between FDA and any component of NIH with relevant expertise. In addition, this MOU outlines information-sharing procedures the parties may use generally to exchange information as well as procedures that may be used in a public health emergency.

II. BACKGROUND

Both FDA and NIH work to protect the public health but have different statutory mandates and responsibilities.

FDA is a regulatory agency responsible for protecting the public health through the regulation of food, cosmetics, and medical products, including drugs, biological products, animal drugs, and medical devices. FDA administers the Federal Food, Drug, and Cosmetic Act and relevant sections of the Public Health Service Act, among other statutes. Among its duties, FDA approves marketing applications, conducts inspections of manufacturing facilities, and monitors post-marketing adverse events. FDA also initiates civil and criminal litigation to enforce applicable laws and regulations. To accomplish its mission, FDA must stay abreast of the latest and emerging developments in research, leverage information from post-market data, and incorporate the patient perspective as part of the regulatory decision-making process.

The NIH mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. In support of this mission, NIH conducts pioneering biomedical research in its own laboratories and facilities, supports and funds the research of non-­Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad, trains the next generation of research investigators, and disseminates medical research information.

Each agency will coordinate and collaborate with the other agency to protect and improve the public health. To achieve this, each agency will utilize the expertise, resources, and relationships of the other agency to increase its own capability and readiness to respond to public health issues.

Ill.  SUBSTANCE OF AGREEMENT AND RESPONSIBILITY OF EACH AGENCY

A. Joint Responsibilities

Subject to compliance with applicable laws, regulations, policies, and privileges including those relating to conflict of interest, medical peer review, and the protection of patient data, it is agreed that the following are the responsibilities of both FDA/CDER and NIH:

1.    Establish a principal point of contact at each agency to facilitate any actions carried out under this MOU with respect to NIH's participation in the meetings of CDER's DSOB and related activities;

2.    Establish through email or other written communication the specific procedures and safeguards necessary to implement this MOU;

3.    Take part in periodic meetings of the DSOB and related discussions regarding selected emerging or ongoing drug-specific safety and risk management issues, or other potentially significant drug risks and safety issues that have broad policy implications or that would benefit from wider input than can be provided by internal discussion within CDER. Such participation by NIH may only occur if NIH is not a sponsor nor acts as a representative of the drugs or technologies being discussed. Such meetings and exchanges provide a forum for a mutual exchange of opinions and ideas and must avoid any actual incidence or appearance of conflict of interest;

4.    As necessary, outside of the formal DSOB meetings, the parties may discuss comparable issues, including, but not limited to, those that may require immediate attention in a public health emergency.

5.    Promptly notify the other Party when issues of mutual concern become evident;

6.    Collaborate, as appropriate, with the other Party in all investigations of mutual concern. Such collaboration may include providing alerts to the other agency when issues are identified; providing technical advice in areas of recognized expertise; providing results of analysis; and exchanging information;

7.    Consult with the other Party before issuing press or scientific releases or publications that may have a significant impact on the other Party.

This agreement does not preclude NIH or FDA/CDER from entering into other agreements which may set forth procedures for special programs which can be handled more efficiently and expertly by other agreements.

B. General Principles and Procedures for the Exchange of Non-Public Information

Subject to compliance with applicable laws, regulations, policies, and privileges, including those relating to conflict of interest, medical peer review, and the protection of patient data, FDA/CDER and NIH agree that the following principles and procedures will govern the exchange of nonpublic information between the two agencies.

As fellow agencies within HHS, FDA and NIH can generally share information in the possession of either agency with each other, recognizing that certain types of disclosures may be prohibited by law or may be contrary to agency policy. Both Parties recognize and acknowledge, however, that it is essential that any confidential information that is shared between FDA and NIH, whether in writing or orally, cannot be further shared unless authorized by law. See e.g., 21 U.S.C. § 331(j); 18 U.S.C. § 1905; 42 U.S.C. § 241(d); 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and Sb, and 46. Any such information exchanges must also be consistent with Appendices A and B, as applicable. Such safeguards are important to protect the interests of, among others, owners and submitters of trade secrets and confidential commercial information; patient identities and other personally identifiable information; privileged and/or pre-decisional agency records; and information protected for national security reasons. Such safeguards also help ensure FDA's and NIH's compliance with applicable laws, regulations, and policies. The sharing of identifiable patient information and national security information is not contemplated by this MOU.

C. Information Exchanges: DSOB Meetings

1.    In advance of any scheduled DSOB meeting, the FDA/CDER liaison will transmit to the NIH liaison a preview of the anticipated agenda items to be discussed. This preview will, among other things, if appropriate, identify the relevant drugs or technologies being discussed. The NIH liaison will ensure that any NIH representatives who may participate have reviewed the Conflict of Interest analysis outlined in Appendix C and take action as necessary.

2.    When CDER transmits its information for the upcoming meeting to NIH, it will clearly label the materials as follows: "This document may contain non-public information. Do not disclose without permission of FDA/ CDER."

3.    When CDER transmits information to a federal partner to the DSOB, CDER will identify the type of information being shared similar to the approach outlined in Appendix A.

D.  Other Non-Public Information Exchanges Between the Two Parties

To facilitate the sharing of non-public information between the Parties, both Parties are committed to responding to requests for information in a timely manner, consistent with budgetary and resource constraints, and in accordance with applicable laws, regulations, and agency policies and practices. Provisions for the sharing of non-public information, both written and oral, are set out below.

1.    The Requesting Party must specify, in writing, which may include informal written communication, e.g., email, the information requested and a brief statement of why the information is being requested. This written communication should include the following template language: 'This request is made pursuant to MOU No.225-22-004, between FDA/CDER and NIH." The Requesting Party should also state that it agrees not to further disclose any non-public information shared between the Parties.

2.    The Party that is considering sharing information {Sharing Party) will first determine what information, if any, should be shared, consistent with applicable laws, regulations, policies, and privileges, including those relating to conflict of interest, medical peer review, and/or the protection of patient data. The Sharing Party must specify in writing, which may include informal written communication, e.g., email, what agency information is being shared with the other Party to the MOU, indicating the type of information being shared (e.g., confidential commercial information, personal privacy, pre-decisional, etc.). A model transmittal communication from FDA to NIH is set forth in Appendix A. A model transmittal communication from NIH to FDA is set forth in Appendix B. Upon mutual agreement, the Parties may agree, in writing, including by email, to share non-public information over a specified period of time.

E. Non-Public Information Exchanges: Public Health Emergency or Required by Law

In cases where a Party to this MOU needs to obtain certain information as soon as possible due to emergency circumstances, such as an outbreak of an illness, or if required by law, the Requesting Agency shall so indicate orally or through informal written communication, e.g., email, to the other Party. The Requesting agency shall agree to protect any such information from unauthorized disclosure.

In the case of emergency circumstances or if required by law, as soon as is practicable, the Parties to this MOU shall document their sharing of any non-public information.

F. FOIA And Other Third-Party Requests for Shared Information

If any Party to this MOU receives a FOIA request for information shared by the other Party, it shall: (a) if the request implicates documents from the Sharing Party in their original form, refer the FOIA request to the Sharing Party for a response, without indicating to the FOIA requester whether the Sharing Party has responsive records or releasable records; or (b) if the request implicates documents received from the Sharing Party and then incorporated into document[s] by the Receiving Party, the Parties shall consult about how best to respond to the FOIA request. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25.

Any Party to this MOU shall promptly notify the other Party if there is any attempt by a third party, including requests by Congress, the Office of Inspector General, or the Government Accountability Office, to obtain shared non-public information by processes, including, but not limited to a voluntary request, subpoena, discovery request, or litigation complaint or motion. The Parties shall consult before complying with any request to obtain shared nonpublic information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action .

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

A.    FDA/CDER

Nancy Guan, PharmD
Public Health Analyst, Office of the Center Director Center for Drug Evaluation and Research
10903 New Hampshire Avenue Silver Spring, Maryland 20993

B.    NIH

Richard DeCederfelt, PharmD, CAPT, U.S. Public Health Service Acting Chief, Pharmacy Department
National Institutes of Health Clinical Center 1C240N
Bethesda, Maryland 20892-116

V. LIAISON OFFICERS

A.    Contact for FDA Nancy Guan, PharmD
Public Health Analyst, Office of the Center Director Center for Drug Evaluation and Research
10903 New Hampshire Avenue Silver Spring, Maryland 20993

B.    Contact for NIH

Marcus Ferrone, PharmD
Service Chief, Clinical Pharmacy and Investigational Drug Research National Institutes of Health Clinical Center
1C240E
Bethesda, Maryland 20892-116

VI. PERIOD OF AGREEMENT

This agreement becomes effective upon signature of both parties and shall remain in effect for five {S years) from the date of execution. It may be modified by mutual consent or terminated by either party upon 60 days written notice.

Appendix A- Model Transmittal from FDA/CDER to NIH
Appendix B - Model Transmittal from NIH to FDA/CDER
Appendix C - Guidelines for Conflict-of-Interest Considerations

APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION BY:

/s/
Patrizia Cavazzoni, M.D.
Director, Center for Drug Evaluation and Research Food and Drug Administration
10903 New Hampshire Ave Silver Spring, MD 20993
Date: 10/04/2021

APPROVED AND ACCEPTED FOR NIH BY:

/s/
James K. Gilman, MD
Chief Executive Officer, NIH Clinical Center
Date: 09/21/2021

Appendix A

Model Transmittal Communication from FDA/CDER to NIH

This [letter/email communication] accompanies agency records that the Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is sharing with the National Institutes of Health (NIH). These agency records contain one or more of the following categories of non-public information, which are prohibited from further disclosure by NIH:

[FDA/CDER checks applicable items below]

_trade secrets obtained from a third party and/or entity other than FDA;
_confidential commercial or financial information obtained from a third party and/or entity other than FDA;
_ personally identifiable information;
_ intra-agency records, e.g., documents commemorating FDA deliberative process;
_ records or information compiled for law enforcement purposes.

NIH shall notify FDA if there are any attempts by third parties, including Congress, the Office of the Inspector General, or the Government Accountability Office, to obtain shared information, including but not limited to Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions. NIH shall notify FDA before complying with any judicial order that compels the release of such information so that FDA/CDER may take appropriate measures, including filing a motion with the court or an appeal.

NIH has agreed not to further disclose this information without prior written approval from FDA/CDER, except as may be required by law. NIH acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See e.g., 21 U.S.C. §331(j) 360j(c); 18 U.S.C. §1905, 42 U.S.C. §241(d), 21 C.F.R. Parts 20 and 21, 45 C.F.R. Parts 5, Sb, and 46.

Appendix B

Model Transmittal Communication from NIH to FDA/CDER

This letter accompanies agency records that the National Institutes of Health (NIH) is sharing with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research. These agency records contain one or more of the following categories of non-public information, prohibited from further disclosure by FDA/CDER:

[NIH checks applicable items below]

_trade secrets obtained from a third party and/or entity other than FDA;
_confidential commercial or financial information obtained from a third party and/or entity other than FDA;
_personally identifiable information;
_ intra-agency records, e.g., documents commemorating FDA deliberative process;
_ records or information compiled for law enforcement purposes.

FDA shall notify NIH if there are any attempts by third parties, including Congress, the Office of the Inspector General, or the Government Accountability Office, to obtain shared information, including but not limited to Freedom of Information Act requests, subpoenas, discovery requests, and litigation complaints or motions. FDA shall notify NIH before complying with any judicial order that compels the release of such information so that NIH may take appropriate measures, including filing a motion with the court or an appeal.

FDA has agreed not to further disclose this information without prior written approval from NIH. FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See e.g., 21 U.S.C. §331(j) 360j(c); 18 U.S.C. §1905; 42 U.S.C. §241(d); 21 C.F.R. Parts 20 and 21, 45 C.F.R.
Parts 5, Sb, and 46.

Appendix C

Conflict-of- Interest Considerations

FDA and NIH have a unique relationship. When both agencies are acting in their capacity as public health agencies, they may broadly share information and expertise, subject to compliance with applicable laws, regulations, and policies, as both are components of the Department of Health and Human Services. However, in some circumstances, such as when NIH is conducting a clinical trial , FDA may regulate NIH and its formal or informal affiliates. In such circumstances, potential conflict-of­ interest issues arise.

The following questions are designed to help illustrate these issues for the Parties to this MOU.

• Does the designated NIH representative have any formal or informal affiliations, such as a Cooperative Research and Development Agreements (CRADA) or a research collaboration agreement, with FDA-regulated industry or academic institutions that have an interest in the relevant drugs or technologies being discussed? For example, is the NIH representative the principal investigator in a clinical trial where a member of FDA-regulated industry supplies the research agent?
• Does the designated NIH representative have any formal or informal affiliations, such as a CRADA or a research collaboration agreement, with FDA-regulated industry or academic institutions that have an interest in competitor products to relevant drugs or technologies being discussed?
• Does the designated NIH representative, or any of the members of his or her immediate family, have any intellectual property interest, such as a patent , or any financial interest , such as stock holdings, in any of the relevant drugs, technologies, or companies being discussed?

Affected NIH representatives are expected to exercise discretion, consult their NIH Ethics Office as appropriate or when required by NIH policy, and, if necessary, recuse themselves from the relevant portion of the DSOB discussion(s) or take other appropriate mitigation measures.