MOU 225-19-017
MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
and the
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE ON DRUG ABUSE
I. PURPOSE
This Memorandum of Understanding (MOU) between the Food and Drug Administration/Center for Devices and Radiological Health (FDA/CDRH) and the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) (individually referred to as a “Participant” and collectively referred to as the “Participants”) provides a framework for coordination and collaborative efforts between these two entities, which are both components of the United States Department of Health and Human Services (HHS). This MOU also provides the principles and procedures by which information sharing between FDA/CDRH and NIH/NIDA under this MOU shall take place.
II. AUTHORITY
FDA has authority to enter into this agreement pursuant to section 11003(b) and (c) of the Federal Food, Drug, and Cosmetic Act. NIH has authority to enter into this agreement pursuant to sections 301 and 402 of the Public Health Service (PHS) Act.
III. BACKGROUND
FDA and NIH are agencies within HHS. 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 responsible for protecting the public health through the regulation of food, cosmetics, and medical products, including human 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 reviews and monitors the use of investigative articles in clinical studies, conducts on-site inspections of biomedical research, approves pre-market applications, conducts regulatory research, conducts inspections of manufacturing facilities, and monitors post-marketing adverse events. FDA also refers civil and criminal cases to the Department of Justice to enforce applicable laws and regulations. Within FDA, CDRH’s mission is to protect and promote the public health by assuring that patients and providers have timely and continuous access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products CDRH oversees. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
The NIH is the Federal focal point for biomedical research in the United States. The NIH mission is to uncover new knowledge that will lead to better health for everyone. The NIH works toward this 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, facilitating the training of research investigators, and fostering communication of medical information and research discoveries. Within the NIH, NIDA is the lead federal agency supporting scientific research on drug use and its consequences. The mission of NIDA is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. Toward this end, NIDA conducts, fosters, coordinates and guides research on the causes, prevention, diagnosis and treatment of Substance Use Disorders (SUDs).
The respective missions of NIH and FDA 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/CDRH or NIH/NIDA may have information that could be useful to the other Participant in that Participant’s performance of its responsibilities. Timely sharing of information between NIH/NIDA and FDA/CDRH is therefore critical in achieving the shared goals of protecting and improving the public health.
IV. SUBSTANCE OF MOU AND RESPONSIBILITIES OF EACH AGENCY
A. Coordination and Collaboration Relative to Public Health Activities
Subject to compliance with applicable laws, regulations and policies, it is mutually agreed that:
1. FDA/CDRH and NIH/NIDA will coordinate and collaborate with each other to protect and improve the public health. To achieve this, each Participant will utilize the expertise, resources, and relationships of the other to increase its own capability and readiness to respond to situations. In addition, each Participant will designate central contact points to coordinate communications from the other, dealing with matters covered by this MOU.
2. Each Participant will take part in periodic joint 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. Each Participant will 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. The Participants will present, as appropriate, reciprocal in-house presentations to their corresponding staff on topics of common interest such as FDA’s regulatory review process and NIH/NIDA’s extramural, federally-funded translational research initiatives and programs, specifically those applicable to research and development of medical devices and digital therapeutics for SUDs.
5. Where appropriate, FDA/CDRH will provide relevant reference documents that describe the investigational product review process and marketing approval processes for use by NIH/NIDA staff involved in conferring with prospective translational research grantees to assist in the design and implementation of clinical studies that comply with FDA/CDRH guidance and regulations.
6. The Participants will take advantage of opportunities to work collaboratively together to improve generally the efficiency of the submission and review process for clinical investigator applications that request funding from NIH/NIDA and may require submission of an Investigational Device Exemption (IDE) application to FDA/CDRH.
7. Under this MOU, Participants will promote communication and consultation on select policy issues and guidance documents of particular interest and relevance to researchers, consumers and/or health care professionals pertaining to novel devices. This cooperative interaction will target possible health risks posed to the public as well as address research and regulatory processes affecting the pace of bench top to bedside research translation.
8. NIH/NIDA will invite FDA/CDRH input and recommendations during development of Funding Opportunity Announcements targeting relevant, essential research areas in order to foster and support the development of devices and digital therapeutics for SUDs.
9. As appropriate, FDA/CDRH will invite NIH/NIDA input and recommendations on selected applications that seek FDA/CDRH permission to initiate clinical studies involving novel medical devices or digital therapeutics in which the scientific and clinical aspects may be complex and non-conventional, and where NIH/NIDA may have expertise.
10. FDA/CDRH staff will have the opportunity to participate in NIH/NIDA-sponsored conferences that pertain to development of devices and digital therapeutics. FDA/CDRH contributions may include: (1) participation in workshops, (2) individual presentations, (3) use of existing videotaped FDA conferences/workshops on select regulatory policy and process issues.
11. This MOU does not preclude NIH/NIDA or FDA/CDRH 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. Principles and Procedures for the Sharing of Non-Public Information
Subject to compliance with applicable laws, regulations and policies, FDA/CDRH and NIH/NIDA agree that the following principles and procedures will govern the sharing of non-public information, as resources permit, between the two Participants.
As fellow agencies within HHS, FDA and NIH can generally share information in the possession of either agency with each other. Both Participants recognize and acknowledge it is essential that any non-public information that is shared between FDA/CDRH and NIH/NIDA whether written or oral cannot be further shared unless authorized by law. See, e.g., 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), 18 U.S.C. § 1905, 21 CFR Parts 20 and 21, 45 CFR Parts 5 and 5b, and 42 U.S.C. § 241(d). Safeguards are needed to protect shared non-public information, both written and oral, such as trade secrets, confidential commercial information and intellectual property 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. The sharing of national security information is not contemplated by this MOU. Such safeguards also help ensure FDA/CDRH’s and NIH/NIDA’s compliance with applicable laws and regulations.
To facilitate the sharing of non-public information, written or oral, FDA/CDRH and NIH/NIDA will implement procedures to ensure that such sharing is appropriate and that the Participant receiving shared non-public information (Receiving Participant) will guard the confidentiality of all non-public information received1. Both Participants 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 or agency policy and practice. 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 Participant must specify, in writing, 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/CDRH and NIH/NIDA, dated [insert date]. [insert name of requesting Participant] agrees not to disclose any non-public information shared between FDA/CDRH and NIH/NIDA whether orally or in writing, in any manner.’ This request shall state which internal Participant offices and/or individuals are requesting the information.
2. In response to a request for information from the Receiving Participant, the Participant that is considering sharing information (Sharing Participant) will first determine what should be shared. The Sharing Participant will review the information to be shared and identify whether any of this information is non-public. If non-public information has been identified, the Sharing Participant will clearly label the relevant materials as follows: “This document contains non-public information. Do not disclose without permission of [insert name of Sharing Participant].”
3. The Sharing Participant will tell the Receiving Participant that the information that it intends to share contains non-public information. At this time the Receiving Participant, must promise in writing that it will not further disseminate the shared non-public information without permission of the Sharing Participant or as required by law. The promise can be accomplished through a written letter, e.g. email. A model promise letter is attached. Upon mutual agreement, FDA/CDRH and NIH/NIDA may modify the request letter appropriately, e.g., to permit the sharing of related non-public information over a specified period of time.
4. The Receiving Participant shall comply with the following conditions:
a. The Receiving Participant shall limit the dissemination of shared non-public information it receives to internal unit offices and/or employees that have been identified in its written request and/or have a need to know. The Participant official who signs the promise letter shall be responsible for ensuring that there are no inappropriate recipients of the information.
b. If the Receiving Participant receives a Freedom of Information Act (FOIA) request for the shared information, it shall: (a) if the request implicates documents from the Sharing Participant in their original form, refer the request to the Sharing Participant for that Participant to respond directly to the requester, and notify the FOIA requester of the referral and that a response will issue directly from the Sharing Participant regarding the releaseability of the information; and (b) if the request implicates documents authored by the Receiving Participant that incorporates information from shared documents, consult with the Sharing Participant about how to respond to the FOIA request. The Receiving Participant will not indicate to the FOIA requester whether the Sharing Participant has responsive or releasable records.
c. The Sharing Participant shall include a transmittal letter along with any agency non-public information shared. The transmittal letter shall indicate the type of non-public information contained in the shared materials (e.g., confidential commercial information, personal privacy, or pre-decisional). A model transmittal letter is attached. As stated above, the shared documents containing non-public information should be stamped “This document contains non-public information. Do not disclose without permission of [insert name of Sharing Participant]” as is applicable.
d. The Receiving Participant shall promptly notify the contact person or designee of the Sharing Participant when there is any attempt by a third party to obtain shared non-public information by compulsory process, including, but not limited to, a FOIA request, judicial order, subpoena, discovery request, or litigation complaint or motion.
e. The Receiving Participant will notify the Sharing Participant before complying with any judicial order that compels the release of shared non-public information, so that the Participants may determine the appropriate measures to take, including, where appropriate, legal action.
V. RESOURCE OBLIGATIONS
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 between the Participants and does not affect the ability of the Participants to enter into other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NIH/NIDA operate.
VI. LIASON OFFICERS
Liaison Officers will participate in the management, coordination and oversight of this MOU. The Liaison Officers will constitute a Steering Committee comprised of an equal number of member representatives from the FDA/CDRH and the NIH/NIDA. Two Liaison Officers, one designate from each participating agency, will serve as co-chairs of the Steering Committee.
Member appointments shall be authorized by the signatories to this MOU. The Liaison Officer Steering Committee shall meet at least once every six months for the first year of this MOU and then once annually thereafter to review the progress of this MOU, resolve any issues and disputes that may arise, and oversee necessary modifications to the MOU.
A. For FDA/CDRH
Carlos Pena, Ph.D.
Director
Division of Neurological and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: 301-796-6610
Email: [email protected]
John Marler, M.D. (Alternate)
Acting Clinical Deputy Director
Division of Neurological and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Telephone: 301-796-4221
Email: [email protected]
B. For NIH/NIDA
Will M. Aklin, Ph.D.
Director, Behavioral Therapy Development Program (BTDP)
Clinical Research Grants Branch
Division of Therapeutics and Medical Consequences (DTMC)
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard, Rm. 4127, MSC 9593
Bethesda, Maryland 20892-9551
Telephone: 301-827-5909 (Phone)
Email: [email protected]
Kevin Walton, PhD (Alternate)
Chief, Clinical Research Grants Branch
Division of Therapeutics and Medical Consequences
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd, Rm 4111
Bethesda MD 20892
[email protected]
Telephone: 301-827-5980
Email: [email protected]
VII. PERIOD OF AGREEMENT
This MOU becomes effective on date of latest signature, and shall continue in effect for a period of five years, or until terminated by either Participant upon a ninety (90) day advance written notice to the other Participant. Not later than 120 days prior to the expiration of this MOU, each Participant will provide a recommendation regarding the extension of the MOU, including modifications if any.
AUTHORIZED SIGNATURES
APPROVED AND ACCEPTED FOR NATIONAL INSTITUTES OF HEALTH
National Institute on Drug Abuse
By:
/S/
Nora Volkow, M.D.
Director
National Institute on Drug Abuse
National Institutes of Health
Date: 5/20/2019
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Center for Devices and Radiological Health
By:
/S/
Jeffrey Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Date: 5/30/2019
[1] Each Participant has implemented or will implement their respective agency’s data and information security statutory, regulatory, policy, or procedural requirements and has implemented or will implement, to the extent necessary and practicable, all data and information security recommendations suggested by the other agency.
Model Language for Promise Not to Disclose Letter from FDA/CDRH
The Food and Drug Administration/Center for Devices and Radiological Health (FDA/CDRH) requests the following information from the National Institutes of Health, National Institute on Drug Abuse (NIH/NIDA) for the following purpose(s): [Identify information and purpose]
FDA/CDRH agrees that it will not disclose any information that NIH/NIDA shares with it and designates non-public to any other party without prior written permission from NIH/NIDA and that FDA/CDRH will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/CDRH and NIH/NIDA (MOU no. [Insert MOU number]). FDA/CDRH acknowledges that applicable statutes and regulations may govern the disclosure of such information. See, e.g., 5 U.S.C. § 552; 5 U.S.C. § 552a; 18 U.S.C. § 1905; 21 U.S.C. § 331(j) and 360j(c); 21 C.F.R. Parts 20 and 21; 45 CFR Parts 5 and 5b; and 42 U.S.C. § 241(d).
FDA/CDRH will limit dissemination of any shared non-public information to the following FDA/CDRH offices and/or employees, unless it identifies additional FDA/CDRH employees who have a need to know the non-public information: [Identify office(s) and/or employee(s)]
________________________ _____________
Name Date
[Signature and Date by FDA/CDRH official with requisite responsibility and authority.]
Model Language for Promise Not to Disclose Letter from NIH/NIDA
The National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) requests the following information from the Food and Drug Administration/Center for Devices and Radiological Health (FDA/CDRH) for the following purpose(s): [Identify information and purpose]
NIH/NIDA agrees that it will not disclose any information that FDA/CDRH shares with it and designates non-public to any other party without prior written permission from FDA/CDRH and that NIH/NIDA will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NIDA and FDA/CDRH (MOU No. [Insert MOU number]). NIH/NIDA acknowledges that applicable laws and regulations may govern the disclosure of such information. See, e.g., 5 U.S.C. § 552; 5 U.S.C. § 552a; 18 U.S.C. § 1905; 21 U.S.C. § 331(j) and 360j(c); 21 C.F.R. Parts 20 and 21; 45 CFR Parts 5 and 5b; and 42 U.S.C. § 241(d).
NIH/NIDA will limit dissemination of any shared information to the following NIH/NIDA offices and/or employees, unless it identifies additional NIH/NIDA employees who have a need to know the non-public information: [Identify office(s) and/or employee(s)]
________________________ _____________
Name Date
[Signature and Date by NIH/NIDA official with requisite responsibility and authority.]
Model Transmittal Letter from NIH/NIDA to FDA/CDRH
This letter accompanies information that the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) is sharing with the Food and Drug Administration/Center for Devices and Radiological Health (FDA/CDRH) in response to FDA/CDRH’s request, dated. This information contains one or more of the following categories of non-public information, which include information the disclosure of which may be prohibited by law:
[NIH/NIDA checks applicable categories below]
___ confidential research proposals, progress reports, and/or unpublished data
___ privileged or pre-decisional agency information
___ trade secrets
___ confidential commercial or financial information
___ information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy
___ information contained in records subject to the Privacy Act
___ information contained in the inter-agency or intra-agency memoranda
___ records or information compiled for law enforcement purposes
___ other (explain)
FDA/CDRH shall notify the contact person or designee of NIH/NIDA if there are any attempts to obtain such shared non-public information by compulsory process, including, but not limited to, Freedom of Information Act requests, subpoenas, judicial orders, discovery requests, and litigation complaints or motions.
By a signed request letter dated , FDA/CDRH has agreed not to disclose the above-described shared non-public information without prior written permission of NIH/NIDA. FDA/CDRH has acknowledged that applicable laws and regulations may govern the disclosure of such information. See, e.g., 5 U.S.C. § 552; 5 U.S.C. § 552a; 18 U.S.C. § 1905; 21 U.S.C. § 331(j) and 360j(c); 21 C.F.R. Parts 20 and 21; 45 CFR Parts 5 and 5b; and 42 U.S.C. § 241(d).
FDA/CDRH has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between FDA/CDRH and NIH/NIDA, (MOU no. [Insert number here]).
Model Transmittal letter from FDA/CDRH to NIH/NIDA
This letter accompanies information that the Food and Drug Administration/Center for Devices and Radiological Health (FDA/CDRH) is sharing with the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) in response to NIH/NIDA’s request, dated . This information contains one or more of the following categories of non-public information, including information the disclosure of which may be prohibited by law:
[FDA/CDRH checks applicable categories below]
___ trade secrets
___ confidential commercial or financial information
___ information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy
___ information contained in records subject to the Privacy Act
___ information contained in inter-agency or intra-agency memoranda
___ records or information compiled for law enforcement purposes
___ other (explain)
NIH/NIDA shall notify the contact person or designee of FDA/CDRH if there are any attempts to obtain such shared non-public information by compulsory process, including, but not limited to, Freedom of Information Act requests, subpoenas, judicial orders, discovery requests, and litigation complaints or motions.
By a signed request letter dated , NIH/NIDA has agreed not to disclose the above-described shared non-public information without prior written permission of FDA/CDRH. NIH/NIDA has acknowledged that applicable laws and regulations may govern the disclosure of such information. See, e.g., 5 U.S.C. § 552; 5 U.S.C. § 552a; 18 U.S.C. § 1905; 21 U.S.C. § 331(j) and 360j(c); 21 C.F.R. Parts 20 and 21; 45 CFR Parts 5 and 5b; and 42 U.S.C. § 241(d). NIH/NIDA has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information between FDA/CDRH and NIH/NIDA (MOU no. [Insert number here]).