MEMORANDUM OF UNDERSTANDING
between the
FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE
and the
DRUG ENFORCEMENT ADMINISTRATION DIVERSION CONTROL DIVISION

I. Purpose.

This Memorandum of Understanding (MOU) establishes procedures to facilitate the exchange of information between the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) and the Drug Enforcement Administration (DEA), Diversion Control Division (DC) (herein after referred to as “Federal Partners”) consistent with the agencies’ mutual interest in ensuring an uninterrupted supply of animal drug products containing controlled substances for legitimate medical, scientific, and research needs; providing scientific and medical evaluation and scheduling recommendations for animal drugs under consideration for control; and providing information for DEA’s calculation of estimates of U.S. medical and scientific stock needs for schedule I and II substances. The Federal Partners will exchange information through the FDA CVM Office of Surveillance and Compliance (OSC) and the DEA DC United Nations Reporting and Quota Section (DRQ). All information exchanged between these Federal Partners will uphold distinct legislative mandates as defined by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., the Public Health Service Act, 42 U.S.C. §§ 201 et seq., and the Controlled Substances Act, 21 U.S.C. §§ 801 et seq.

II. Procedure Governing Information Exchanges.

A. Periodic Meetings.

Representatives of CVM and DRQ will meet periodically for the purpose of discussing pertinent information pertaining to the scheduling, manufacture, and distribution of controlled substances used in the manufacture of animal drugs.

The meetings will be attended by at least one Authorized Official representing each entity. The meetings will occur on a quarterly basis; however, the frequency can be increased or decreased as needed and agreed upon by both entities.

B. Authorized Officials.

The Director of CVM or his or her designee will designate one or more Authorized Officials for CVM. The Deputy Assistant Administrator-Regulatory, DC, or his or her designee, will appoint one or more Authorized Officials for DRQ.
 
The Authorized Officials will discuss and approve information exchanges pursuant to this MOU. Each Federal Partner will provide a list of its Authorized Officials to the other and will update such list whenever Authorized Officials change.

C. Persons Authorized to Exchange Information.

The Authorized Officials may designate one or more persons to serve as primary points of contact for information exchanges between the Federal Partners. The names of the authorized contact persons, along with their contact information, will be identified and kept up to date at all times.

D. Timely Sharing of Information.

Federal Partners will respond in a timely manner to requests for information pursuant to this MOU, considering agency priorities and resources. Any instances of undue delay may be reported to an Authorized Official of each Federal Partner.

The undersigned acknowledge that each Federal Partner may be limited in its ability to share information or expertise in response to a particular request for several reasons, for example: agency priorities, resources, and statutory or regulatory prohibitions.

In the event that an Authorized Contact Person determines that he or she cannot share certain information sought by the other Federal Partner, the Authorized Contact Person may refer the issue to the Authorized Official, as necessary.

If the Authorized Officials are unable to reach an understanding, then the matter may be referred to the Director of CVM and the Deputy Assistant Administrator, DC.

E. Methods of Sharing Information.

DRQ and CVM may share information in writing (including in electronic form and e-mail) and verbally (whether in in-person meetings or by telephone, videoconferencing or other electronic means).

F. Exchanges of Information in Written Form.

When an Authorized Contact Person requests information, documents, or data in written form, the request should be made in writing, which may include an informal email. The following language should be included in the request:

"Information that is shared under this request will be under the 2021 FDA CVM-DEA DC Memorandum of Understanding for the Sharing of Information. We agree not to further disclose any shared information in any manner without your written permission or, if such disclosure is required by law, without advance notice to the originating agency."
 
With the inclusion of this statement, requestors would not have to use a particular format or include other pre-specified text.

The response to such a request should also be in writing, but it, too, can be an informal e-mail that acknowledges transmission of information in response to the request. The following language should be included in the response:

"This communication acknowledges that information is being shared pursuant to the 2021 FDA CVM- DEA DC Memorandum of Understanding for the Sharing of Information. The shared information may not be further disclosed in any manner without our express written consent or, if such disclosure is required by law, without advance notice to the originating agency."

With the inclusion of this statement, responders would not have to use a particular format or include other pre-specified text.

G. Exchanges of Information in Meetings and other Verbal Communications.

DRQ and CVM may exchange information at meetings of the Federal Partners (whether in person or by telephone, videoconference or other electronic means).

Meeting notices, announcements, and any agendas for such meetings will include the following language:

"Information shared during this meeting will be pursuant to the 2021 FDA CVM-DEA DC Memorandum of Understanding for the Sharing of Information. Such information may not be further disclosed or shared in any manner without the express written consent of the originating agency or, if such disclosure is required by law, without advance notice to the originating agency."

Any verbal exchanges between DRQ and CVM made pursuant to the MOU will be prefaced by the language above.

The Federal partners will establish specific mailboxes for each agency to track information exchanges between the Federal Partners.

III. Information to be Exchanged Under this Agreement.

The undersigned agree that information exchanges between DRQ and CVM are important to their ability to successfully carry out their statutory and regulatory responsibilities.

Toward that end, this MOU establishes procedures to facilitate the exchange of information consistent with the agencies’ mutual interest in ensuring an uninterrupted supply of animal drug products containing controlled substances for legitimate medical, scientific, and research needs; providing scientific and medical evaluation and scheduling recommendations for animal drugs under consideration
 
for control; and providing information for DEA’s calculation of estimates of U.S. medical and scientific stock needs for schedule I and II substances.

Information may include but is not limited to company names of registered manufacturers of controlled substances, methods used to determine quota, quantities granted for production or in inventory, product recalls, product shortages, and any other identified manufacturing concerns that may halt or delay production.

IV. Disclosure to Third Parties.

A. Freedom of Information Act Requests.

If either Federal Partner receives a FOIA request for information provided by the other Federal Partner pursuant to this MOU, the Federal Partner receiving the FOIA request will refer the request to the Federal Partner that provided the information to respond directly to the requestor. The Federal Partner that refers the request will notify the requestor that a referral has been made to the other Federal Partner and that a response will issue directly from the other Federal Partner. In such cases where the Federal Partner has incorporated another Federal Partner’s information in a responsive record, the Federal Partner should consult with the Federal Partner whose information appears in the responsive records.

B. Disclosure Pursuant to Legal Process.

Should information shared pursuant to this MOU be subpoenaed or otherwise ordered through a legal process, the Federal Partner to whom the subpoena or order is directed will notify an Authorized Official of the other Federal Partner immediately to provide an opportunity to seek to intervene and block the disclosure. To the extent permitted by law, the receiving party will assert any privileges against disclosure if requested by the originating agency.

C. Continuing Obligation to Protect Information from Disclosure.

Termination of this MOU or any related agreement for exchange of information between the parties does not relieve either of the Federal Partners of their obligation to safeguard, protect, and limit access to the shared information under this MOU.

D. Mitigation of Prohibited Exchanges & Disclosures.

The undersigned agree that disclosure of confidential and other non-public information (directly or indirectly (i.e., through verbal or written communication, conduct or any other means)) that is not disclosed in accordance with applicable laws, regulations, policy, and this MOU (whether disclosed directly or indirectly (i.e., through verbal or written communication, conduct, or any other means)) may be detrimental to agency activities and may interfere with the Federal Partners’ ability to protect personal privacy, confidential, and/or trade secret information. Accordingly, if a Federal Partner becomes aware of a prohibited exchange or disclosure, whether made to the other Federal Partner or to a third party, it will immediately notify an Authorized Official of the other Federal Partner, providing the content of the prohibited exchange or disclosure, the identity of the person by whom it was made, the identity of the person to whom it was made, and the date on which it occurred. The Federal Partners will work with one another to develop and implement a plan to remedy the prohibited exchange or disclosure, taking into consideration the Federal Partners’ responsibility to preserve documents and records in accordance with applicable law or legal process.

E. Safeguarding & Limiting Access to Shared Information

The undersigned recognize that information exchanged that contains any of the following types of information must be protected from unauthorized use and disclosure:

(1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA);

(2) personal privacy information, such as the information that would be protected frompublic disclosure pursuant to Exemption 6 or 7(C) of the FOIA;

(3) information compiled for law enforcement purposes, such as information that wouldbe protected from public disclosure pursuant to Exemption 7 of the FOIA; or

(4) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), other Freedom of Information Act exemptions not mentioned above (5 U.S.C. § 552(b)), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).

Pursuant to section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 331(j)), FDA will not reveal to DEA any method or process which is entitled to protection as a trade secret. DEA will not disclose individual manufacturing and procurement quotas or other registrant information to FDA that DEA deems to be entitled to protection as a trade secret.

The Federal Partners will ensure that information shared under this MOU shall be used and disclosed solely in accordance with applicable laws, regulations, and policies. Access to the information shared under this MOU shall be restricted to authorized employees and contractors of the Federal Partners who require access to perform their official duties in accordance with the uses of information as authorized by this MOU. Such personnel shall be advised of (1) the necessity to safeguard and limit access to the information, and (2) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. Contractors of the Federal Partners who will receive access to the information shared under this MOU will sign the non-disclosure agreement included in Appendix A. Each Federal Partner will maintain on file non-disclosure agreements signed by its contractors.

V. Effect on Existing Statutes and Regulations.

Each Federal Partner will take actions under this collaboration that are consistent with existing laws, regulations, and policies, and nothing in the MOU shall be construed as changing the current requirements under the statutes and regulations administered and enforced by the Federal Partners including but not limited to: Titles 21 and 42 of the United States Code, the Public Health Service Act, and the Federal Food, Drug, and Cosmetic Act. Further, nothing contained in this MOU constitutes a mandate or a requirement that is additional to the mandates or requirements imposed on the Federal Partners by Federal statutes, regulations, and policies.

VI. Authorized Contacts.

A. For FDA:
Cindy L. Burnsteel, DVM
Deputy Director for Drugs and Devices Office of Surveillance and Compliance Center for Veterinary Medicine
Food and Drug Administration
(240) 402-0817.

B. For DEA:
Stacy Harper-Avilla
Chief United Nations Reporting and Quota Section Diversion Control Division
Drug Enforcement Administration
(571) 362-3998.

VII. Period of Agreement.

This agreement, when accepted by the undersigned, will have an effective period of performance from the date of the last signature until three years from that date and may be modified, extended, or terminated by mutual written consent by both parties or may be terminated by either party upon a 30- day advance written notice to the other.

APPROVED AND ACCEPTED FOR THE DRUG ENFORCEMENT AGENCY

Matthew J. Strait
/s/
Deputy Assistant Administrator Diversion Control Division
Drug Enforcement Administration
Date: 11/17/2021

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION

Dr. Steven Solomon
/s/
Director, Center for Veterinary Medicine
Date: 11/19/2021

APPENDIX A
Non-Disclosure Agreement for Contractors

Access to information shared under the 2021 FDA CVM-DEA DC Memorandum of Understanding ("MOU" or "Agreement"), the Center for Veterinary Medicine ("CVM"), as part of the Food and Drug Administration ("FDA") within the Department of Health and Human Services ("DHHS"), and the Drug Enforcement Administration ("DEA"), as part of the Department of Justice ("DOJ''), dated [insert date], is required to perform my official duties under the contractual agreement with my employer, in accordance with the uses of information as authorized by the MOU. I am an authorized contractor of FDA or DEA.

I recognize that information exchanged that contains any of the following types of information must be protected from unauthorized use and disclosure:

1. confidential commercial information, such as the information that would be protectedfrom public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA);
2. personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(C) of the FOIA;
3. information compiled for law enforcement purposes, such as information that would be protected from public disclosure pursuant to Exemption 7 of the FOIA; or
4. information that is otherwise protected from public disclosure by federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), other Freedom of Information Act exemptions not mentioned above (5 U.S.C. § 552(b)), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).

I have been advised of (1) the necessity to safeguard and limit access to the information, and (2) the administrative, civil, and criminal penalties for noncompliance contained in applicable Federal laws. I, on this  day of  _, 20 _, hereby agree that I shall not further release, publish, or disclose information shared under this MOU without the express written consent of the originating agency or, if such disclosure is required by law, without advance notice to the originating agency. I shall protect such information in accordance with applicable laws and regulations governing the confidentiality of non- public information.

Signature:   

Date:   

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