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  1. Domestic MOUs

 

MEMORANDUM OF UNDERSTANDING
Between the
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
and the
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
 
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 of Neurological Disorders and Stroke (NIH/ NINDS) 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/CDRH and NIH/NINDS 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 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, the NINDS is the nation’s leading supporter of biomedical research on disorders of the brain and nervous system. The mission of the NINDS is to reduce the burden of neurological disease. To achieve this mission, the NINDS conducts, fosters, coordinates and guides research on the causes, prevention, diagnosis and treatment of neurological disorders and stroke, including basic research in related scientific areas.   
 
The 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/CDRH or NIH/NINDS may have information that could be useful to the other unit in that unit’s performance of its responsibilities. Timely sharing of information between NIH/NINDS and FDA/CDRH is therefore critical in achieving the shared goals of protecting and improving 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.      FDA/CDRH and NIH/NINDS will coordinate and collaborate with each other to protect and improve the public health. To achieve this, each unit will utilize the expertise, resources, and relationships of the other in order to increase its own capability and readiness to respond to situations. In addition, each unit will designate central contact points to coordinate communications from the other, dealing with matters covered by this agreement.
 
2.      Each unit will participate 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 unit 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.      Parties will present reciprocal in-house presentations to their corresponding staff on topics of common interest such as FDA’s managed regulatory review process and NIH/NINDS’s extramural, federally-funded translational research initiatives and programs, specifically those applicable to development of medical devices for treatment of neurologic diseases, conditions and disorders.
 
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/NINDS 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.      FDA/CDRH and NIH/NINDS MOU Parties will seek opportunities to work collaboratively together in order to improve efficiency of the submission and review process for clinical investigator applications requesting funding from NIH/NINDS and require submission of an Investigational Device Exemption (IDE) application to FDA/CDRH.
 
7.      Under this MOU, Parties 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 risk posed to the public as well as address research and regulatory processes affecting the pace of bench top to bedside research translation.
 
8.      NIH/NINDS 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 device therapies for treating neurologic disease and stroke.
 
9.      As appropriate, FDA/CDRH will invite participation of NIH/NINDS experts in pre-decisional evaluation of selected IDEs that seek FDA/CDRH permission to initiate clinical studies involving novel medical devices whose scientific and clinical aspects may be complex and non-conventional.
 
10. This MOU will provide opportunity for FDA/CDRH staff to participate in NIH/NINDS-sponsored conferences that pertain to development of devices FDA/CDRH 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. This agreement does not preclude NIH/NINDS 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
 
FDA/CDRH and NIH/NINDS agree that the following principles and procedures will govern the sharing of non-public information, as resources permit, between the two parties.
 
Although there is no legal requirement that FDA/CDRH and NIH/NINDS 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/CDRH and NIH/NINDS. As public health agencies, there are no legal prohibitions that preclude the FDA or the NIH from sharing with each other most information in the possession of either agency. Both parties recognize and acknowledge it is essential that any non-public information that is shared between FDA/CDRH and NIH/NINDS 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, 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/CDRH's and NIH/NINDS's compliance with applicable laws and regulations. 
 
To facilitate the sharing of non-public information, written or oral, FDA/CDRH and NIH/NINDS will implement procedures to ensure that such sharing is appropriate and that the recipient party will guard the confidentiality of all information received.[1] 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 or agency policy and practice. 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 unit must specify, in writing, [2] the information requested (to facilitate identification of relevant information) and provide a brief statement of why the information is needed. This request shall state which internal unit offices and/or individuals are requesting the information. A model request letter is attached. Upon mutual agreement, FDA/CDRH and NIH/NINDS may modify the request letter appropriately, e.g., to permit the sharing of related non-public information over a specified period of time.
 
2.       The unit receiving the request shall, based upon the request described in section III.B.1. above, determine whether it is appropriate to share the requested non-public information. For example, a unit should decide not to share information if it has credible information and a reasonable belief that the requesting unit may not be able to comply with applicable laws or regulations governing the protection of non-public information or with the principles or procedures set forth in this MOU. If a unit decides not to share information, it shall describe to the requesting unit the reasons for such decision.  
 
3.       The requesting unit shall comply with the following conditions: 
 
a.       The requesting unit 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 unit official who signs the request letter shall be responsible for ensuring that there are no inappropriate recipients of the information.
 
b.      The requesting unit shall agree in writing, by using the model request letter (or a reasonable, mutually agreed upon facsimile), not to disclose any shared non-public information in any manner not authorized by law or regulation, including disclosure in publications and public meetings. If the requesting unit wishes to disclose shared information that the sharing unit has designated as nonpublic, it shall first obtain the written permission of the sharing unit. If the requesting unit receives a Freedom of Information Act (FOIA) request for the shared information, it shall: (a) refer the request to the information-sharing unit for that unit to respond directly to the requester regarding the releaseability of the information, and (b) notify the requester of the referral that a response will issue directly from the other unit.
 
c.       The unit that shares non-public information shall include a transmittal letter along with any agency information shared. The transmittal letter shall indicate the type of information (e.g., confidential commercial information, personal privacy, or pre-decisional). A model transmittal letter is attached. The shared documents containing non-public information should be stamped “Do not disclose without permission of CDRH/FDA or NIH/NINDS” as is applicable. 
 
d.      The requesting unit shall promptly notify the contact person or designee of the information-sharing unit 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, subpoena, discovery request, or litigation complaint or motion.
       
e.      The requesting unit shall notify the information-sharing unit before complying with any judicial order that compels the release of shared non-public information, so that the unit may determine the appropriate measures to take, including, where appropriate, the filing of a motion or an appeal within court.
 
V. LIASON OFFICERS
 
Liaison Officers will participate in the management, coordination and oversight of this agreement. The Liaison Officers will constitute a Steering Committee comprised of an equal number of member representatives from the FDA/CDRH and the NIH/NINDS. 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 agreement. The Liaison Officer Steering Committee shall meet at least once every six months for the first year of this agreement and then once annually thereafter to review the progress of this agreement, resolve any issues and disputes that may arise, and oversee necessary modifications to the agreement.
 
A.       For FDA/CDRH
 
Kristen A. Bowsher, Ph.D.
Scientific Reviewer – Biomedical and Electrical Engineer
Division of Neurological and Physical Medicine Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration
White Oak 66, Room 2454
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Telephone: 301-796-6448
 
Cristin G. Welle, Ph.D. (alternate)
Staff Fellow
Division of Physics
Office of Science and Engineering Laboratories
Center for Devices and Radiological Health
Food and Drug Administration
White Oak 62, Room 1208
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Telephone: 301-796-2492
 
B.       For NIH/NINDS 
 
Kip Ludwig, Ph.D.
Program Director for Neural Engineering
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Neuroscience Center, 6001 Executive Blvd. Room 2207
Bethesda, MD 20892
Telephone: (301) 496-1447
Fax: (301) 480-1080
 
Stephanie Fertig, M.B.A. (Alternate)
Small Business Project Manager
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Neuroscience Center, Room 2142
6001 Executive Blvd.
Bethesda, MD 20892-9521
Tel: (301) 496-1779
 
VI. PERIOD OF AGREEMENT
  
This agreement becomes effective on date of latest signature, and shall continue in effect for a period of five years, or until 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 agreement, each party will provide a recommendation regarding the extension of the agreement, including modifications if any.
 
 
AUTHORIZED SIGNATURES
 
APPROVED AND ACCEPTED FOR                APPROVED ANDACCEPTED FOR
NATIONAL INSTITUTES OF HEALTH           THE FOOD AND DRUG ADMINISTRATION
National Institute of Neurological                            Center for Devices and Radiological Health
Disorders and Stroke
 
 
By: ______________________________        By: _____________________________
 
Story Landis, Ph.D.                                                                Jeffrey Shuren, M.D., J.D.
Director                                                                                      Director
National Institute of                                                              Center for Devices and Radiological health
Neurological Disorders and Stroke                                                  Food and Drug Administration
National Institutes of Health                                              
 
 
Date: _____________________________       Date: ______________________________
 
 
MODEL LANGUAGE FOR REQUEST FROM FD/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 of Neurological Disorders and Stroke (NIH/NINDS) for the following purposes: [Identify information and purpose]
 
 
FDA/CDRH agrees that it will not disclose any information that NIH/NINDS shares with it and designates non-public without prior written permission from NIH/NINDS 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/NINDS dated [Insert date MOU between FDA/CDRH and NIH/NINDS initiated]. FDA/CDRH 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); 21 C.F.R. Parts 20 and 21. 
 
FDA/CDRH will limit dissemination of any shared 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 REQUEST FROM NIH/NINDS
  
The National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) requests the following information from the Food and Drug Administration/Center for Devices and Radiological Health (FDA/CDRH) for the following purposes: [Identify information and purpose]
 
 
 
NIH/NINDS agrees that it will not disclose any information that FDA/CDRH shares with it and designates non-public without prior written permission from FDA/CDRH and that NIH/NINDS will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NINDS and FDA/CDRH MOU No. [Insert MOU number]. NIH/NINDS 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); 21 C.F.R. Parts 20 and 21. 
 
NIH/NINDS will limit dissemination of any shared information to the following NIH/NINDS offices and/or employees, unless it identifies additional NIH/NINDS 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/NINDS official with requisite responsibility and authority.]
 
 
Model Transmittal Letter from NIH/NINDS to FDA/CDRH
 
 
This letter accompanies information that the National Institutes of Health/National Institute for Neurological Disorders and Stroke (NIH/NINDS) 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, including information the disclosure of which may be prohibited by law:
 
[NIH/NINDS checks applicable numbers 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;
__ information protected for national security reasons; or
__ other (explain).
 
FDA/CDRH shall notify the contact person or designee of NIH/NINDS 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, discovery requests, and litigation complaints or motions.
 
FDA/CDRH shall notify NIH/NINDS before complying with any judicial order that compels the release of such shared non-public information so that FDA/CDRH and/or NIH/NINDS may take appropriate measures, including filing a motion with the court or an appeal.
 
By a signed request letter dated                    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); 21 C.F.R. Parts 20 and 21. , FDA/CDRH has agreed not to disclose the above-described shared non-public information without prior written permission of NIH/NINDS. FDA/CDRH has acknowledged that applicable laws and regulations may
 
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/NINDS, dated __________________.
 
Model Transmittal letter from FDA/CDRH to NIH/NINDS
 
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 for Neurological Disorders and Stroke (NIH/NINDS) in response to NIH/NINDS’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 numbers 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;
__    information protected for national security reasons; or
__    other (explain).
 
NIH/NINDS 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, discovery requests, and litigation complaints or motions.
 
NIH/NINDS shall notify FDA/CDRH before complying with any judicial order that compels the release of such shared non-public information, so that FDA/CDRH and/or NIH/NINDS may take appropriate measures, including filing a motion with the court or an appeal.
 
By a signed request letter dated                     ,§ 552; 5 U.S.C. § 552a; 18 U.S.C. § 1905; 21 U.S.C. § 331(j); 21 C.F.R. Parts 20 and 21.   NIH/NINDS has also agreed to comply with the principles and procedures set forth in the Memorandum of Understanding on information between FDA/CDRH and NIH/NINDS, dated ______________________. NIH/NINDS has agreed not to disclose the above-described shared non-public information without prior written permission of FDA/CDRH. NIH/NINDS has acknowledged that applicable laws and regulations may govern the disclosure of such information. See, e.g., 5 U.S.C.
 

[1] 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 and practicable, all data and information security recommendations suggested by the other agency.
[2]The term “writing” used throughout this MOU includes a writing by electronic means.