MOU 225-15-11
MEMORANDUM OF UNDERSTANDING
Between the
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
And the
U.S. DEPARTMENT OF JUSTICE
DRUG ENFORCEMENT ADMINISTRATION
For the
SHARING OF INFORMATION
I. PREAMBLE
Pursuant to this Memorandum of Understanding (“MOU” or “Agreement”), the Center for Drug Evaluation and Research (“CDER”), 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”), both United States Federal Government entities agree that CDER and the DEA Office of Diversion Control (“OD”) may share information in areas of mutual concern, consistent with their 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. CDER and OD will hereinafter jointly be referred to as the “Federal Partners.”
FDA and DEA are federal agencies within two different departments, DHHS and DOJ, with related statutory mandates and responsibilities.
FDA is a regulatory agency responsible for promoting and protecting the public health by ensuring the safety of drugs. FDA administers the Federal Food, Drug, and Cosmetic Act and relevant sections of the Controlled Substances Act. Among its responsibilities, FDA approves new drug applications (“NDAs”) and abbreviated new drug applications (“ANDAs”), conducts inspections of manufacturing facilities, and monitors post-marketing data to identify and evaluate adverse events and mitigate and help prevent drug shortages. FDA also has responsibilities that specifically relate to controlled substances and require collaboration with DEA including the following: evaluating schedule I research protocols for scientific merit; providing scientific and medical evaluation and scheduling recommendations for 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.
DEA is a federal agency responsible for enforcing the controlled substance laws and regulations of the United States. Among its responsibilities, DEA coordinates and cooperates with federal, state, and local law enforcement officials on mutual drug enforcement efforts and investigates and prepares for the prosecution of major violators of controlled substance laws. Among its regulatory roles, DEA is responsible for domestic drug and chemical control, setting and implementing quotas for schedule I and II substances and certain listed chemicals, issuing DEA registrations to handle controlled substances, and preventing the diversion of controlled substances from the legitimate market. Under 21 U.S.C. § 873(a), the Attorney General is directed to cooperate with “local, State, tribal, and Federal agencies concerning traffic in controlled substances and in suppressing the abuse of controlled substances,” including through the exchange of information between government officials. This responsibility has been delegated to the Administrator of DEA in 28 C.F.R. § 0.100(b). Additionally, 28 C.F.R. § 0.103(a)(1) authorizes the Administrator of DEA “[t]o release information obtained by DEA and DEA investigative reports to Federal . . . officials engaged in the enforcement of laws related to controlled substances.” Accordingly, DEA has clear regulatory authority to share information with FDA and other Federal entities, although DEA understands that nothing in this regulatory authority should be construed to contravene DEA’s agreement in this MOU section IV.A that it will not disclose information provided to it by CDER.
II. PURPOSE AND GOALS
As described above, the FDA and DEA missions are related in a variety of ways. This MOU is intended to create a mechanism to facilitate timely sharing of information, and to build upon and establish additional collaborative efforts between the Federal Partners.
III. SUBSTANCE OF MOU
A. Procedure Governing Information Exchanges
In an effort to achieve the goals described above, the undersigned agree to the following procedure for exchanging information:
1. Periodic Meetings: The Federal Partners will meet periodically for the purpose of discussing information exchanges between the Federal Partners. These meetings will be attended by at least one Authorized Official (as defined in section III.A.2 below) representing each Federal Partner. For the first year after the approval of this MOU, as described in section IX below, the meetings will be held quarterly, and thereafter on a biannual basis. Consistent with the waiver and amendment provision of this MOU in section VIII below, the frequency of these meetings may be increased or decreased.
2. Authorized Officials: The Director of CDER or his or her designee shall designate one or more Authorized Officials for CDER. The Deputy Assistant Administrator, OD, shall appoint one or more Authorized Officials for OD. The Authorized Officials shall be authorized to discuss and approve the procedures for information exchanges pursuant to this MOU, including the approval of Workplans, as discussed in section III.A.3 below. Each Federal Partner will provide a list of its Authorized Officials to the other Federal Partner and will update such list whenever Authorized Officials change.
3. Workplans of Organizational Components within FDA/CDER and DEA/OD: Any exchange of information between the Federal Partners or their organizational components, except as authorized by sections VI and VII below, shall be consistent with a written, approved workplan that describes specific information exchanges and procedures for implementing such exchanges (“Workplan”). The Federal Partners may approve Workplans at the periodic meetings referred to in section III.A.1 by agreement of an Authorized Official of each Federal Partner or by another method mutually agreed to by an Authorized Official of each Federal Partner. All Workplans must comply with applicable law as well as the terms and conditions of this MOU. Once a Workplan is approved by an Authorized Official of Each Federal Partner, as documented by their signatures on the original Workplan, the Federal Partners may begin sharing information pursuant to that Workplan immediately.
4. Persons Authorized to Exchange Information: Workplans will include the designation of one or more Authorized Contact Persons who will serve as primary points of contact for information exchanges between the Federal Partners. The names of all Authorized Contact Persons, along with their contact information, must be identified in the Workplan or as an Addendum to it and the names and contact information must be kept up-to-date at all times.
5. Timely Sharing of Information: Information exchanged pursuant to this MOU (including under accepted Workplans) will be exchanged in a timely manner, considering agency priorities and resources. Any instances of undue delay may be reported to an Authorized Official of each Federal Partner.
However, 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 within one of the Federal Partners determines that he/she cannot share certain information sought by the other Federal Partner, the Authorized Contact Person may refer the issue to Authorized Officials of CDER and OD, if necessary. If the Authorized Officials are unable to reach an understanding, then the matter may be escalated to the Director of CDER and the Deputy Assistant Administrator, OD.
6. Methods of Sharing Information: The Federal Partners may share information in the following ways: in writing (including in electronic form and e-mail) and verbally (whether in in-person meetings or by telephone, video-conferencing or other electronic means).
a. 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 2015 CDER-DEA 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 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 2015 CDER-DEA 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.
b. Exchanges of Information in Meetings and other Verbal Communications
The Federal Partners may exchange information at meetings of the Federal Partners (whether in person or by telephone, videoconference or other electronic means). Approved Workplans will address such situations.
Meeting notices, announcements, and any agendas for such meetings will include the following language:
"Information shared during this meeting will be pursuant to the 2015 CDER-DEA 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 of the Federal Partners made pursuant to the MOU will be prefaced by the language above.
7. Tracking of Information Exchanges: The Federal Partners will allow for tracking of information exchanges between them. To this end, the CDER Authorized Official will ensure that CDER’s Executive Operations Staff (“CDER EXECSEC”) (or its successor, designee, or other FDA office designated by CDER’s Director) is made aware of all written requests for information received from DEA and all written information provided to DEA by any of FDA’s organizational components pursuant to this MOU (including under approved Workplans). CDER EXECSEC’s tracking may include the establishment of a mailbox or electronic notification system. Workplans must provide a procedure for verbal exchanges to be documented by CDER.
DEA will establish a specific mailbox for DEA to track information exchanges between the Federal Partners.
8. Prohibited Exchange of Information Between the Federal Partners: All information exchanges between the Federal Partners must be made in accordance with applicable laws, regulations, and policies, this MOU and, except in the circumstances discussed in sections VI and VII below, in accordance with a Workplan. Any information exchanges that are not made in accordance with applicable laws, regulations, and policies, this MOU and any relevant Workplan are not permitted and are considered prohibited exchanges. Any information exchanged in such prohibited exchanges must still be safeguarded and protected as discussed in section IV.A of this MOU.
Each Federal Partner has an affirmative obligation to notify affected personnel of their responsibilities and obligations under this MOU and any related Workplan in order to prevent prohibited exchanges.
9. Mitigation of Prohibited Exchanges & Disclosures: The undersigned agree that 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, this MOU, and any relevant Workplan (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.
10. This MOU supersedes in its entirety the Memorandum of Understanding Between the Drug Enforcement Administration and the Food and Drug Administration dated July 1, 1974.
B. Substance of Information to be Exchanged Under this Agreement
The undersigned agree that information exchanges between the Federal Partners are important to their ability to successfully carry out their statutory and regulatory responsibilities. Toward that end, this MOU is intended to provide a means for establishing and defining procedures by which information is to be exchanged between the Federal Partners and to enhance the Federal Partners’ collaboration. Each Workplan will detail the specific information that may be exchanged.
IV. GENERAL PROVISIONS
A. 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 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 USC 1905), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5 USC 552(b)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).
Pursuant to Federal Food, Drug, and Cosmetic Act section 301(j) (21 USC 331(j)), FDA will not reveal to DEA any method or process which is 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 and any related Workplan. 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.
If either Federal Partner receives a FOIA request for information provided by the other Federal Partner pursuant to this MOU or a related Workplan, 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.
Nothing in this MOU shall be construed to prevent a disclosure required by law or legal process. Notwithstanding this provision, should information shared pursuant to this MOU (including under approved Workplans) 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.
Termination of this MOU or any related Workplans does not relieve either of the Federal Partners of their obligation to safeguard, protect, and limit access to the shared information established under section IV of this MOU or any related Workplan.
B. 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.
V. RESOURCE OBLIGATIONS
This MOU represents the broad outline of the intent that the Federal Partners will enter into specific agreements for collaborative efforts in intellectual areas of mutual interest to them. It does not create binding, enforceable obligations against any party. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect the ability of the Federal Partners 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 the Federal Partners operate.
VI. EMERGENCY CIRCUMSTANCES
In certain emergency circumstances, as that term is understood and agreed upon by the Director of CDER and the Deputy Assistant Administrator, OD, information can be exchanged between the Federal Partners without the need for a Workplan governing the information exchange if the exchange is mutually agreed upon by the Director of CDER and the Deputy Assistant Administrator, OD. However, even in such emergency circumstances, the General Provisions under section IV and the limitations on information sharing in section III.A.6 remain applicable.
VII. EXCHANGES PRIOR TO THE DEVELOPMENT OF WORKPLANS
The undersigned acknowledge that after the execution of this MOU it may take some time to develop the Workplans required pursuant to section III.A.3. While the Federal Partners agree to work expeditiously toward the completion of those Workplans, the undersigned also agree that, until such Workplans are established, information exchanges that are necessary and appropriate to the respective missions of the Federal Partners may take place pursuant to 21 CFR 20.85 and 21 U.S.C. § 873(a).
VIII. WAIVER AND AMENDMENT
The requirements of this MOU including, but not limited to, the number and frequency of meetings required by section III.A.1 and the obligation to safeguard and protect the information required by section IV, may be waived or amended by the mutual written agreement of the Director of CDER and the DEA Administrator, but neither Federal Partner can waive requirements or restrictions imposed by Federal law. The requirements of any related Workplans may be waived or amended by the mutual written agreement of the Director of CDER and the Deputy Assistant Administrator, OD, or by Authorized Officials, pursuant to the same limitations. The Federal Partners’ failure to enforce or abide by any requirement of this MOU (or any requirement of any Workplan approved hereunder), whether once or repeatedly, is not to be construed as a waiver of the requirement and cannot be deemed to alter or amend the MOU (or any Workplan approved hereunder).
IX. TERM, TERMINATION AND MODIFICATION
This agreement, when accepted by the undersigned, will have an effective period of performance from the date of the latest signature until three years from that date and may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a thirty day advance written notice to the other.
Approved for the Drug Enforcement Administration
/s/
By: Michele M. Leonhart
Administrator
Drug Enforcement Administration
2/27/15
Date
Approved for the Food and Drug Administration
/s/
By: Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research
3/24/15
Date
Amendment 1
MOU 225-15-11 Amendment Number 1
MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
AND THE
U.S. DEPARTMENT OF JUSTICE
DRUG ENFORCEMENT ADMINISTRATION
This is amendment number one (1) to the Memorandum of Understanding (MOU) 225-15-11 between the Food and Drug Administration, Center for Drug Evaluation and Research, U.S. Department of Health and Human Services, and the Drug Enforcement Administration, U.S. Department of Justice.
The purpose of this amendment is to extend the termination date from March 25, 2018. This is permissible under Section IX. Term, Termination, and Modification. Execution of this amendment provides continuity in the collaboration to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information of mutual concern between the Federal partners. All other content, terms, and conditions stated in MOU Number 225-15-11, executed on March 24, 2015, will remain unchanged.
This agreement, when accepted by the undersigned, will have an effective period of performance from the date of the latest signature until three years from that date and may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a thirty-day advance written notice to the other.
APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION
Janet Woodcock
/s/
Janet Woodcock, MD, Director
Center for Drug Evaluation and Research
March 14, 2018
Date
APPROVED AND ACCEPTED BY
DRUG ENFORCEMENT ADMINISTRATION
Robert W. Patterson
/s/
Robert W. Patterson, Acting Administrator
March 14, 2018
Date
Amendment 2
MOU 225-15-11 Amendment Number 2
MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
AND THE
U.S. DEPARTMENT OF JUSTICE
DRUG ENFORCEMENT ADMINISTRATION
This is amendment number two (2) to the Memorandum of Understanding (MOU) 225-15-11 between the Food and Drug Administration, Center for Drug Evaluation and Research, U.S. Department of Health and Human Services, and the Drug Enforcement Administration, U.S. Department of Justice.
The purpose of this amendment is to extend the termination date from March 25, 2021. This is permissible under Section IX. Term, Termination, and Modification. Execution of this amendment provides continuity in the collaboration to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information of mutual concern between the Federal partners. All other content, terms, and conditions stated in MOU Number 225-15-11, executed on March 24, 2015, will remain unchanged.
This agreement, when accepted by the undersigned, will have an effective period of performance from the date of the latest signature until five years from that date and may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a thirty-day advance written notice to the other.
APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION
Patrizia A. Cavazzoni
/s/
Patrizia Cavazzoni, MD, Acting Director
Center for Drug Evaluation and Research
March 2, 2021
Date
APPROVED AND ACCEPTED BY
DRUG ENFORCEMENT ADMINISTRATION
Darrell Evans
/s/
D. Christopher Evans, Acting Administrator
March 16, 2021
Date
APPENDIX A
Non-Disclosure Agreement for Contractors
Access to information shared under to the Memorandum of Understanding (“MOU” or “Agreement”), the Center for Drug Evaluation and Research (“CDER”), 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 and any related Workplan. 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 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 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 USC 1905), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5 USC 552(b)), the Federal Food, Drug, and Cosmetic Act (21 USC 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:
Type or Print Name: