MOU 225-22-001

MEMORANDUM OF UNDERSTANDING BETWEEN
THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FOOD AND DRUG ADMINISTRATION
AND
THE NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
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 on Deafness and Other Communication Disorders (NIDCD), 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 through the sharing of information and expertise with respect to the review and use of diagnostic, preventative, and therapeutic products for use in hearing, balance, taste, smell, voice, speech, and language disorders.

This MOU encourages the 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 regulatory science related to devices for use in hearing, balance, taste, smell, voice, speech, and language disorders. This MOU also provides the principles and procedures by which information exchanges between FDA and NIDCD 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. § 301 et seq.) and portions of the Public Health Service Act (42 U.S.C. § 201 et seq.), among other statutes. As part of its responsibilities, FDA approves premarket applications, conducts inspections of manufacturing facilities, and monitors postmarket adverse events. FDA, through the U.S. Department of Justice, 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 NIDCD will further support FDA’s mission.

The NIDCD is an agency that is part of the NIH (42 U.S.C. § 281). The NIH's mission is to uncover new knowledge that will lead to better health for everyone. Simply described, the goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability. The NIH is part of the U.S. Department of Health and Human Services. Established in 1988, the NIDCD is mandated to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. The institute also conducts and supports research and research training related to disease prevention and health promotion; addresses special biomedical and behavioral problems associated with people who have communication impairments or disorders; and supports efforts to create devices that assist individuals with hearing loss or other communication disorders.

III. Joint Responsibilities of the Parties

Subject to compliance with applicable laws, regulations and policies, it is agreed that the following are responsibilities of both the FDA/CDRH and NIH/NIDCD:

A. Establish a principal point of contact to facilitate actions carried out under this MOU.
B. Establish points of contact across NIH/NIDCD 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 this MOU becoming effective.
D. Take part in periodic joint meetings to promote better communication and understandingof 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 technical expertise; sharing data; coordinating public health communications to the public; providing results of analysis; 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.

This MOU does not preclude FDA/CDRH or NIH/NIDCD 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
(Ph) 301 796 6860
Email: Malvina.Eydelman@fda.hhs.gov

B. National Institute on Deafness and Other Communication Disorders

Roger L. Miller, Ph.D.
Program Director, Neural Prosthesis Development
National Institute on Deafness and Other Communication Disorders National Institutes of Health
6001 Executive Boulevard, MSC 9670
Bethesda, MD 20892-9670
(Ph) 301 402 3458 (Fax) 301 402 6251
E-mail: millerr@nidcd.nih.gov

V. Principles and Procedures for the Sharing of Non-Public Information

Subject to compliance with applicable laws, regulations and policies, FDA/CDRH and NIH/NIDCD 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/NIDCD, 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 important 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/NIDCD 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 model language for information request set forth in Appendix A and NIH/NIDCD will use the model language for information request 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 and regulations, are set out below:

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/NIDCD, dated [insert date of request]. [Insert name of requesting Party] agrees not to disclose any non-public information shared between FDA/CDRH and NIH/NIDCD whether orally or in writing, in any manner.’

The Party that is asked to share information (Sharing Party) will first determine: what information, if any, 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 provide in writing that it will not further disseminate the shared non-public information without permission of the Sharing Party or as required by law. This can be accomplished through written consent, e.g., email. Model letters providing as such are attached at Appendices A and B. Upon mutual agreement, FDA/CDRH and NIH/NIDCD may modify such a letter appropriately, e.g., to permit the sharing of related non-public information over a specified period of time.

The Parties shall also 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 Freedom of Information Act (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 the 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 incorporate 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 shared (e.g., confidential commercial information, personal privacy, pre-decisional). Model transmittal letters are attached in Appendices C and D. 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 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

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/NIDCD operate.

VII. Term, Termination and Modification

This MOU becomes effective upon the last signature and will remain in effect for five years, unless terminated. This MOU may be modified in writing by mutual 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.

Attachments

Appendix A – Model Language for Information Request from NIDCD to FDA
Appendix B – Model Language for Information Request from FDA to NIDCD
Appendix C – Model Transmittal Letter from NIDCD to FDA
Appendix D – Model Transmittal Letter from FDA to NIDCD

APPROVED AND ACCEPTED BY:
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Jeffrey Shuren, M.D., J.D. Director, CDRH
/s/
Date: 11/09/2021

APPROVED AND ACCEPTED BY:
NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Digitally signed by Timothy J. Wheeles Executive Officer, NIDCD
/s/
Date: 10/19/2021

Appendix A
Model Language for Information Request from NIDCD to FDA

Reference: MOU No. 225-22-001

The National Institute on Deafness and Other Communication Disorders (NIDCD), 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]

NIDCD hereby requests the following information from FDA for the following purposes: [Identify information and purpose]

NIDCD 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/NIDCD and FDA (MOU No. [insert number when known]). NIH/NIDCD 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.
§ 241(d).

NIDCD will limit dissemination of any shared information to the following NIDCD offices and/or employees, unless it identifies additional NIH/NIDCD 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 official with requisite responsibility and authority.]

Appendix B
Model Language for Information Request from FDA to NIDCD

Reference: MOU No. 225-22-001

The Food and Drug Administration (FDA) has requested the following information from the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) for the following purposes: [Identify information and purpose]

FDA hereby requests the following information from NIDCD for the following purposes: [Identify information and purpose]

FDA agrees that it will not further disclose any such information that NIDCD shares to any other party without prior written permission from NIDCD and that it will comply with the principles and procedures set forth in the Memorandum of Understanding on information sharing between NIH/NIDCD and FDA (MOU No. [insert number when known]). FDA 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.
§ 241(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/NIDCD official with requisite responsibility and authority.]

Appendix C
Model Transmittal Letter from NIDCD to FDA

Reference: MOU No. 225-22-001

This letter accompanies agency records that the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) is sharing with the Food and Drug Administration (FDA) in response to FDA's request, dated [insert date]. These agency records contain one or more of the following categories of nonpublic information (for some of these categories, further disclosure may be prohibited by law):

[NIDCD 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 [insert date], not to further disclose the above-described information without prior written permission of NIDCD. FDA acknowledges that applicable laws and regulations may prohibit the 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. § 241(d).

Name

Date

[Signature and Date by FDA official with requisite responsibility and authority.]

Appendix D
Model Transmittal Letter from FDA to NIDCD

Reference: MOU No. 225-22-001

This letter accompanies agency records that the FDA is sharing with NIH/NIDCD in response to NIDCD’s request, dated [insert date]. 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]

NIDCD 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/NIDCD has agreed, by this letter or e-mail and by a signed request letter dated [insert date], not to further disclose the above-described information without prior written permission of FDA. NIDCD acknowledges that applicable laws and regulations may prohibit the 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. § 241(d).

Name

Date

[Signature and Date by NIH/NIDCD official with requisite responsibility and authority.]