MOU 225-19-019
MEMORANDUM OF UNDERSTANDING BETWEEN
THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FOOD AND DRUG ADMINISTRATION
AND
THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH NATIONAL INSTITUTES OF HEALTH
I. Purpose
The Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA) and the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), are part of the Department of Health and Human Services (HHS), and hereinafter also referred to as “Party” or "Parties." The purpose of the MOU is to provide a framework for coordination and collaborative efforts between the Parties and enhance knowledge and efficiency sharing of information and expertise with respect to the review and use of diagnostic, preventative and therapeutic products for use in oral health care. This MOU encourages exchange of information on new and emerging technologies, and collaborations to support the advancement of biomedical research to clinical application and premarket approvals. In addition, this collaboration will also focus on sharing information to further enhance dental regulatory science. This MOU also provides the principles and procedures by which information exchanges between FDA and NIDCR will take place.
II. Background
FDA is a regulatory agency responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA administers the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321) and portions of the Public Health Service Act (42 U.S.C. 262), among other statutes. As part of their responsibilities, FDA approves premarket applications, conducts inspections of manufacturing facilities, and monitors postmarket 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 gleaned from postmarket data collection, and incorporate patient perspective as part of the regulatory decision-making process. Partnership and data sharing with NIDCR will further support FDA’s mission.
The NIDCR is an agency that is part of the NIH (42 U.S.C. 281). The NIDCR mission is to improve dental, oral, and craniofacial health through research, training, and the dissemination of health information and other programs related to the cause, prevention, and methods of diagnosis and treatment of dental and oral diseases and conditions. (42 U.S.C. 285h). NIDCR accomplishes this mission by: performing and supporting basic, translational and clinical research; supporting research training and career development programs to ensure an adequate number of talented, well-prepared and diverse investigators; coordinating and assisting relevant research and research-related activities among all sectors of the research community; and promoting the timely transfer of knowledge gained form research and its implications for health to the public, health professionals, researchers, and policy-makers.
III. Responsibilities of the Parties
A. Joint Responsibilities
Subject to compliance with applicable laws, regulations and policies, it is agreed that the following are responsibilities of both the FDA/CDRH and NIH/NIDCR:
A. Establish a principal point of contact to facilitate actions carried out under this MOU.
B. Establish point of contacts across NIH/NIDCR and FDA/CDRH to allow quick access/consultation on topics of mutual interest.
C. Take part in an initial meeting to establish specific procedures and safeguards necessary to implement this MOU. The initial meeting will take place within 90 days of signing and approval of this MOU.
D. Take part in periodic joint meetings to promote better communication and understanding of regulations, policies, and statutory responsibilities, to serve as a forum for questions and problems that may arise and to discuss new and ongoing collaborations.
E. Facilitate and encourage translation from discovery and nonclinical research, through clinical research, to clinical products on the market in the United States utilizing their respective authorities and implementation mechanisms.
F. Develop collaborative interagency efforts that help advance the translation of new science to clinical use and market entry.
G. Promptly notify the other Party as soon as possible when issues of significant mutual concern become evident.
H. Collaborate, as appropriate, including, but not limited to: providing alerts to the other Party when issues of mutual concern are identified; providing technical expertise; sharing data; and coordinating public health communications to the public. Such collaboration may include providing alerts to the other Party when issues are identified; providing technical expertise; providing results of analysis; coordinating health protection information and recommendations when provided to the public; and exchanging information.
I. Keep each other informed concerning press releases, scientific releases, and publications that may have a significant impact on the other Party.
J. Recognize that the non-public information transmitted between the Parties in any medium and from any source must be protected from unauthorized disclosure, as set forth in Section V of this MOU.
K. Promptly notify the other Party of any actual or suspected unauthorized disclosure of information shared under this MOU.
L. This MOU does not preclude FDA/CDRH or NIH/NIDCR from entering into other agreements which may set forth procedures for special programs which can be handled more efficiently and expertly by other agreements.
IV. Liaison Officers
A. Food and Drug Administration
Malvina Eydelman, MD
Director, Office of Health Technology 1
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20903
(301) 796-6860
Malvina.Eydelman@fda.hhs.gov
B. National Institute of Dental and Craniofacial Research
Lillian Shum, Ph.D.
Director, Division of Extramural Research
National Institute of Dental and Craniofacial Research
National Institutes of Health
Democracy One, Room 610
6701 Democracy Blvd
Bethesda, MD 20892
(301) 594-0618
V. Principles and Procedures for the Sharing of Non-Public Information
Subject to compliance with applicable laws, regulations and policies, FDA/CDRH and NIH/NIDCR agree that the following principles and procedures will govern the exchange of data and non-public 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, subject to applicable law and authorizations. Both Parties recognize and acknowledge it is essential that all non-public information that is shared between FDA/CDRH and NIH/NIDCR, whether in writing or orally, cannot be further shared unless authorized by law. See, e.g., 18 U.S.C. § 1905; 5 U.S.C. §§ 552 and 552a; 21
U.S.C. § 331(j); 21 CFR Parts 20 and 21; 42 U.S.C. § 241(d); 45 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/CDRH and NIH/NIDCR with other applicable laws and regulations. The sharing of identifiable patient information and national security information is not contemplated by this MOU.
To facilitate the sharing of non-public information, FDA/CDRH will use the processes set forth in Appendix A and NIH/NIDCR will use the processes set forth in Appendix B to ensure that such sharing is appropriate and that the Party receiving non-public information (Requesting Party) will guard the confidentiality of all non-public 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 in accordance with applicable laws, regulations, and 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 Party 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/NIDCR, dated [insert date of request]. [insert name of requesting Party] agrees not to disclose any non-public information shared between FDA/CDRH and NIH/NIDCR whether orally or in writing, in any manner.’
2. The Party that is considering sharing information (Sharing Party) will first determine what should be shared, review the information to be shared and identify whether any of this information is non-public. The Sharing Party will also determine whether sharing the information is consistent with all applicable laws, regulations, and policies. If non-public information has been identified, the Sharing Party will clearly label the relevant materials as follows: “This document contains non-public information. Do not disclose without permission of [insert name of Sharing Party].”
The Requesting Party must promise in writing that it will not further disseminate the shared non-public information without permission of the Sharing Party 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/NIDCR may modify the promise letter appropriately, e.g., to permit the sharing of related non-public information over a specified period of time.
The Requesting Party shall comply with the following conditions:
a. The Requesting Party shall limit the dissemination of shared non-public information it receives to internal Party offices and/or individuals that have been identified in its written request. If the Requesting Party determines that individuals other than those identified in the original request have a need to know the requested information, then an update to the request letter will be supplied to the sharing Party before the Requesting Party distributes the information to those individuals. The Party official who signs the request letter will be responsible for ensuring that there are no inappropriate recipients of the information.
b. If the Requesting Party receives a FOIA request for shared information, 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 that sharing Party to respond directly to the requester regarding the release of the information, and notify the FOIA requester of the referral and that a response will issue directly from the Sharing Party Regarding the releasability of the information; or (b) if the request implicates documents authored by the Requesting Party that incorporates information from the shared documents, consult with the Sharing Party about how to respond to the FOIA request. The Requesting Party will not indicate to the FOIA requester whether the Sharing Party has responsive records or releasable records. All actions taken under this paragraph must be in compliance with 45 C.F.R. 5.25.
c. The Sharing Party 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, pre-decisional, etc.). A model transmittal letter is attached in Appendix A. The shared documents containing non-public information should state "This document contains non-public information. Do not disclose without permission of [insert name of Sharing Party]"as is applicable.
d. The Requesting Party shall promptly notify the contact person or designee of the Sharing Party when there is any attempt by a third party to obtain shared non-public information by processes, including, but not limited to, a FOIA request, subpoena, discovery request, or litigation complaint or motion.
e. The Requesting Party shall notify the Sharing Party before complying with any request that compels the release of shared non-public information, so that the Parties may determine the appropriate measures to take, including, where appropriate, legal action.
VI. Resources
This MOU represents the broad outline of the Parties' intent to enter into this specific agreement in order to facilitate collaborating in efforts of mutual interest. 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 Parties. This MOU and all associated agreements will be subject to the applicable laws, regulations, rules, and policies under which FDA and NIH/NIDCR operate.
VII. Term, Termination and Modification
This MOU becomes effective upon the last signature and will remain in effect for 5 years, unless otherwise terminated. This MOU may be modified in writing by unanimous consent of the Parties and becomes effective when executed by both Parties. Either Party may terminate this MOU upon a 60-day advance written notice to the other Party.
APPROVED AND ACCEPTED BY:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
/s/
Jeffrey Shuren, M.D., J.D.
Director
Date: 03/30/2020
APPROVED AND ACCEPTED BY:
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
/s/
Jonathan Horsford, PhD
Acting Deputy Director, NIDCR
Date: 02/07/2020
Appendix A
Model Language for Information Request
Reference: MOU No. 225-19-019
The National Institute for Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH) has requested the following information from the Food and Drug Administration (FDA) for the following purposes: [Identify information and purpose]
Or
NIDCR hereby requests the following information from FDA for the following purposes: [Identify information and purpose]
NIDCR agrees that it will not further disclose any such information that FDA shares to any other party without prior written permission from FDA and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NIDCR and FDA (MOU No. 225-19-019). NIH/NIDCR acknowledges that applicable laws may prohibit the further disclosure of such information. See e.g., 21 U.S.C. §§ 331(j) and 360j(c); 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. § 24l(d).
NIDCR will limit dissemination of any shared information to the following NIDCR offices and/or employees, unless it identifies additional NIH/NIDCR employees who have a need to know the non-public information: [Identify office(s) and/or employee(s)]
Name: _
Date: _
Model Language for Information Request
Reference: MOU No. 225-19-019
The Food and Drug Administration (FDA) has requested the following information from the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH) for the following purposes: [Identify information and purpose]
Or
FDA hereby requests the following information from NIDCR for the following purposes: [Identify information and purpose]
FDA agrees that it will not further disclose any such information that NIDCR shares to any other party without prior written permission written permission from NIDCR and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NIDCR and FDA (MOU No. 225-13-0003). Applicable laws may prohibit the further disclosure of such information. Se e.g.,21 U.S.C. §§ 331(j) and 360j(c); 18 U.S.C. § 1905; 21 C.F.R. Parts 20 and 21; 45 C.F.R. Parts 5 and Sb; 42 U.S.C. §
24l(d).
FDA will limit dissemination of any shared information to the following FDA offices and/or employees, unless it identifies additional FDA 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/NIDCR official with requisite responsibility and authority.]
Model Transmittal Letter from NIDCR to FDA
Reference: MOU No. 225-19-019
This letter accompanies agency records that the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH) is sharing with the Food and Drug Administration (FDA) in response to FDA's request, dated _. These agency records contain one or more of the following categories of non- public information (for some of these categories, further disclosure may be prohibited by law):
[NIDCR checks applicable items below]
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;
Intra-agency records (including information protected by the deliberative process, attorney-client, and/or attorney work product privileges);
Records or information compiled for law enforcement purposes; Information protected for national security reasons; or
Other.
FDA will notify the appropriate office of the information-sharing agency if anyone seeks any of the shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, Congressional requests, judicial orders, and discovery requests.
FDA has agreed, by this letter or e-mail and by a signed request letter dated _, not to further disclose the above-described information without prior written permission of NIDCR. FDA acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. §§ 33l(j) and 360j(c); 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. § 241(d).
Name: _
Date: _
[Signature and Date by FDA official with requisite responsibility and authority.]
Model Transmittal Letter from FDA to NIDCR
Reference: MOU No. 225-19-019
This letter accompanies agency records that the FDA is sharing with NIH/NIDCR in response to NIDCR's request, dated _.These agency records contain one or more of the following categories of non-public information (for some of these categories, further disclosure may be prohibited by law):
[FDA checks applicable items below]
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;
Intra-agency records (including information protected by the deliberative process, attorney-client, and/or attorney work product privileges);
Records or information compiled for law enforcement purposes; Information protected for national security reasons; or
Other.
NIDCR will notify the appropriate office of the information-sharing agency if anyone seeks any of the shared information by compulsory process, including but not limited to, Freedom of Information Act requests, subpoenas, Congressional requests, judicial orders, discovery requests, and litigation complaints or motions.
NIH/NIDCR has agreed, by this letter or e-mail and by a signed request letter dated _, not to further disclose the above-described information without prior written permission of FDA. NIDCR acknowledges that applicable laws and regulations may prohibit the disclosure of such information. See, e.g., 21 U.S.C. §§ 33l(j) and 360j(c); 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. § 241(d).
Name: _
Date: _
[Signature and Date by NIH/NIDCR official with requisite responsibility and authority.]
Amendment 1
MEMORANDUM OF UNDERSTANDING BETWEEN THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FOOD AND DRUG ADMINISTRATION AND THE NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH NATIONAL INSTITUTES OF HEALTH
This is Amendment Number One (1) to the Memorandum of Understanding (MOU) 225-19--019 between the United States Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) and United States National Institutes of Health (NIH) National Institute of Dental and Craniofacial Research (NIDCR).
The purpose of this amendment is to extend the expiration date of the MOU from March 30, 2025, to March 30, 2030, and update the points of contact in Section IV. This is permissible under Section VII — Term, Termination and Modification. Execution of this amendment provides continuity for coordination and collaborative efforts between the Parties and enhance knowledge and efficiency sharing of information and expertise with respect to the review and use of diagnostic, preventative and therapeutic products for use in oral health care. All other content, terms, and conditions stated in MOU Number 225-19-019, executed on March 30, 2020, will remain unchanged.
IV. Liaison Officers
FDA/CDRH
Kesia Alexander, PhD
Acting Director, Office of Health Technology 1 Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20903
(301) 796-5620
Kesia.Alexander@fda.hhs.gov
NIH/NIDCR
Amanda Melillo, PhD
Acting Director, Division of Extramural Research
National Institute of Dental and Craniofacial Research National Institutes of Health amanda.melillo@nih.gov
Sanoj K. Suneja, Ph.D.
Acting Director, Division of Extramural Activities
National Institute of Dental and Craniofacial Research National Institutes of Health Email: sunejas@mail.nih.gov
This agreement, when accepted by the undersigned, will be effective from the date of the last signature and may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a sixty-day advance written notice to the other.
APPROVED AND ACCEPTED BY:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
/s/
Michelle Tarver, M.D., Ph.D.
Director, CDRH
Date: 10/10/2025
APPROVED AND ACCEPTED BY:
NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
/s/
Jennifer Webster-Cyriaque, D.D.S., Ph.D.
Acting Director, NIDCR
Date: 09/29/2025