MOU 225-24-019

MEMORANDUM OF UNDERSTANDING
BETWEEN
THE DRUG ENFORCEMENT ADMINISTRATION,
THE DEPARTMENT OF HOMELAND SECURITY,
U.S. CUSTOMS AND BORDER PROTECTION
AND
THE FOOD AND DRUG ADMINISTRATION
REGARDING THE JOINT RESEARCH CONSORTIUM

1. PARTIES

The Parties to this Memorandum of Understanding (MOU) are the Drug Enforcement Administration (DEA); the Department of Homeland Security (DHS), through U.S. Customs and Border Protection (CBP); and the Food and Drug Administration (FDA) Forensic Chemistry Center (FDA-FCC), collectively referred to as "the Parties." The terms and conditions of this MOU are intended to apply to future MOUs and/or applicable Addendums, or agreements between the Parties, regarding this collaboration.

2. PURPOSE

On August 24, 2023, the Parties entered into a Letter of Intent creating a joint research consortium (JRC) among the Parties, to perform analysis at the DEA Special Testing and Research Laboratory, which is to move to the DEA El Paso Intelligence Center (EPIC). This MOU serves as the framework within which any future implementing arrangements relevant to the JRC may be entered into.

3. AUTHORITIES

The DEA is authorized to enter into this MOU pursuant to the Comprehensive Drug Abuse and Prevention and Control Act of 1970, as amended, 21 U.S.C. § 801, et seq. The specific authority for DEA to enter into cooperative agreements for the exchange of information between governmental officials concerning the use and abuse of controlled substances is 21 U.S.C. § 873.

DHS/CBP is authorized to enter into this MOU pursuant to Sections 101, 102,202, and 411 of the Homeland Security Act of 2002, Public L. No. 107-296, as amended by the Trade Facilitation and Trade Enforcement Act of 2015, Pub. L. No. 114-125, codified at 6 U.S.C. §§ 111, 112, 122, and 211; The Tariff Act of 1930, Pub. L. No 71-361, codified at 19 U.S.C. Chapter 4, et seq., as amended.

FDA-FCC is authorized to enter into this MOU pursuant to sections 1003(b) and 1003(c) of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. §§ 393(b)-393(c).

4. SCOPE OF WORK

This MOU applies to research conducted by the Parties through the JRC.

In addition to collaborating in the field of scientific research through the JRC, the Parties understand that their collaboration and resultant analysis may culminate in the creation of law enforcement intelligence products which may be further shared with other federal, state, and local law enforcement personnel to support enforcement efforts, consistent with the terms of this MOU.

5. RESPONSIBILITIES

5.1. Definitions

5.1.1. "Host Agency" refers to the Party that provides the facility space at which a collaboration session is carried out.
5.1.2. "Guest Agency" refers to a Party that provides personnel, equipment, and other necessary resources to support or participate in collaboration at the Host Agency's facilities.

5.2. Each Party will be responsible for providing their respective expertise and resources toward the research efforts, consistent with their applicable authorities. The Parties will work together to develop a collaborative research plan, and each agency will be responsible for carrying out its assigned tasks within the plan.

5.3. Activities. Project-based collaborative advanced research and development of a fentanyl attribution program to establish a mechanism for:

5.3.1. Identifying geolocation of illicit fentanyl synthesis.
5.3.2. Determining illicit fentanyl synthetic routes and in-depth chemical analysis.
5.3.3. Identifying advanced physical and chemical characteristics of fake pills.
5.3.4.  Establishing, at a minimum, a database of illicit fentanyl markers and adulterants, diluents, coloring dyes, solvents, and other associated relevant information (such as physical and chemical data, chemical peaks, and chain of custody information), based on information from samples of illicit fentanyl. The database will be administered by DEA and accessible to employees of the Parties with a need-to­ know. The information inputted into the database will exclude any potential trade­ secret information regarding authentic drugs from legitimate manufacturers. The Parties shall mutually set forth in an additional written addendum the specifics of such a database, including but not limited to, administration responsibilities, access parameters, and any potential interconnectivity of systems.
5.3.5. Identifying additional aspects of analysis, including but not limited to packaging, imprints, friction ridge.

5.4. Samples

5.4.1. Each Party will provide samples of illicit products pulled from bulk seizures to be used by the JRC (writ large) for research and analysis using their respective evidence procedures. Sample storage, maintenance, and disposition will be maintained by the sample's originating Party.
5.4.2. Each Party will make samples of illicit products for research, development, and analysis purposes available to the other Parties, as appropriate and consistent with applicable law.
5.4.3. Samples that are part of active criminal investigations and/or prosecutions will be inventoried and tracked to ensure compliance with all criminal discovery requirements that may become applicable.

5.5. Data & Reports
The Parties agree to co-author any JRC publications and will coordinate publication approvals through each Party, consistent with their respective policies. Information that is identified by any Party as law-enforcement sensitive or otherwise sensitive will not be included in publicly available publications; instead, intelligence or law enforcement bulletins will be prepared for sensitive information and marked appropriately. The Parties agree that prior to designating any publication as "final," each Party's representative must confirm in writing that that Party's disclosure requirements have been satisfied. Formal issuance of any end-product or publication following the above procedures shall constitute release approval from all Parties.

5.6. Information Sharing

5.6.1.  Except as in 5.5 above, underlying data related to the project may not be shared outside of DEA, DHS/CBP, or FDA without prior written authorization of all Parties. However, the joint issuance of any end product or law enforcement intelligence-based product shall constitute release authorization of all Parties.
5.6.2. Timely Information Sharing. Each Party will respond, to the extent practicable, in a timely manner to requests from each other for information pursuant to this MOU. The Parties acknowledge that each Party may be limited in its ability to share information or expertise in response to a particular request due to agency priorities, resources, and statutory, regulatory or policy restrictions.
5.6.3.  Methods of Sharing Information. The Parties may share information in writing (including electronic form and e-mail) and verbally (including in meetings, by telephone, and by videoconference), consistent with the terms of this MOU. Specifically, the Parties agree not to further disclose the shared information without prior written authorization of the originating Party.
5.6.4. Safeguarding and Limiting Access to Shared Information. The Parties recognize that information shared pursuant to this MOU may contain information that must be protected from disclosure in accordance with to the Freedom of Information Act (FOIA) (5 U.S.C. § 552), the Privacy Act (5 U.S.C. § 552a), the Trade Secrets Act (18 U.S.C. § 1905), the Health Insurance· Portability and Accountability Act (Pub. L. 104-191), relevant portions of the Food, Drug, and Cosmetic Act, including, but not limited to, 21 U.S.C. § 3310), and/or other applicable statutes and regulations. The Parties will ensure that information shared under this MOU shall be properly marked for handling (as applicable), used, and disclosed in accordance with this MOU and applicable laws, regulations, and policies.

To the extent any non-public FDA information will be shared pursuant to this MOU, then any such written request submitted to FDA for this information must contain all substantive requirements of 21 C.F.R. § 20.85. Thus, the Parties agree that requests for information, subject to this MOU, and responses to such requests, will be submitted electronically in writing (or conveyed orally in an emergency) with the appropriate disclosure statements, as in Annex 1 to this MOU.

Access to the information shared under this MOU will be restricted to authorized employees of the Parties who have a need to know in the performance of their official duties, consistent with the terms of 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. For purposes of this MOU, the Parties understand that the
U.S. Department of Homeland Security is a Party to this MOU.

The information being shared pursuant to this MOU is generally considered sensitive but unclassified in nature. It is the intent of the Parties that the sharing of information will be conducted at the unclassified level and will be deemed "Controlled But Unclassified." The Parties agree to maintain administrative, technical, and physical safeguards appropriate to the sensitivity of, and designed to appropriately protect, the information shared under this MOU against loss, theft, and misuse and unauthorized access, disclosure, copying, use, modification, storage, and deletion in accordance with the Federal Information Security Modernization Act, and any applicable Privacy Act system of records notice.

5.6.5. Disclosure to Third Parties. The Parties recognize that information that the sharing Party considers sensitive may be shared among the Parties during the course of the research.

If any Party receives a request for information that has been shared with it pursuant to this MOU, including but not limited to requests under the FOIA or other legal process, that Party will promptly advise the originating Party. The originating Party will have the opportunity to approve any disclosure, including the opportunity to assert any privileges or FOIA exemptions as appropriate. In the case of a FOIA, the Parties will agree as to whether a consultation or a referral of the relevant information is appropriate. Termination of this MOU does not relieve any Party of its obligations to safeguard, protect, and limit access to shared information under this MOU, including that Party's obligation to notify the originating Party of outside requests for information.

5.7. Nothing in this MOU shall be construed to prevent a disclosure required by law or legal process. Notwithstanding this provision the Party required to disclose information it received under this MOU must notify an Authorized Official of the originating Party immediately to provide an opportunity to seek to intervene and block the disclosure.

5.8. The Parties will collaboratively develop and execute an implementation plan to achieve the purpose and responsibilities of this agreement.

6. ADMINISTRATIVE

6.1.  Locations. As Host Agency, DEA will hold meetings and collaborative research sessions at the following locations.

6.1.1. Special Testing & Research Laboratory - at start of the project, to begin meetings and collaborations around the methods, techniques and shared data to enhance the attribution of fentanyl.
6.1.2. EPIC - upon availability of laboratory space at the DEA-owned EPIC building.
Guest Parties must follow safety and security guidelines set forth at the EPIC laboratory.
6.1.2.1.  Space and Administrative Arrangements at EPIC. The Parties acknowledge that in order to effectively carry out the goals and objectives of this collaborative effort, certain administrative issues will need to be addressed, such as space allocation at EPIC, personnel matters, equipment, alterations or renovations to existing space, and other related matters. Therefore, prior to implementation of this MOU, the Parties agree to separately set forth in writing the specific terms and conditions for addressing these administrative matters related to activities undertaken pursuant to the overarching LOI and this MOU at the Host Agency.

6.2.  Personnel. Each Party is responsible for all costs of its personnel, including, but not limited to, pay and benefits, training, temporary duty (TOY), travel, and administrative support. Each Party is responsible for the supervision, management, and administrative control of its personnel.

7. EFFECT ON OTHER AUTHORITY

Nothing in this MOU is intended to restrict the authority of any Party to act as permitted by law, or to restrict any Party from administering or enforcing any law.

8. MODIFICATION

This MOU may only be modified or amended by the mutual written consent of all Parties.

9. TERMINATION

This MOU may be reviewed, amended, or terminated in writing, duly signed by authorized representatives, at any time by mutual decision of the Parties or if any Party fails to fulfill its obligations. The MOU may also be terminated at any time upon the mutual written consent of the Parties. Additionally, any Party may terminate its own participation in this via a 90- day written advance notice to the other Parties. In which case, collaboration between the remaining Parties will continue. In the event of termination, the Parties will work together to ensure an orderly transition of any ongoing research efforts. This MOU is not transferable except with the written consent of the Parties.

10. NO PRIVATE RIGHT CREATED

The Parties agree and understand that this MOU is non-binding. This MOU does not create any right or benefit, substantive or procedural, enforceable in law or in equity, against the United States or any state, against any department, agency, officer, or employee of the United States or any state, against any entity, or against any other person. If differences in understanding arise regarding this MOU, the Parties intend to resolve such differences by mutual consultation.

11. FINANCING AND FUNDS MANAGEMENT

This MOU defines in general terms the basis on which the Parties will collaborate and does not constitute a financial obligation or serve as a basis for expenditures. Each Party will handle and expend its own funds. Any and all expenditures from Federal funds by the Parties made in conformity with the activities conducted under this MOU must be in accord with law and each Party's policies, and in each instance based upon appropriate financial documentation. Expenditures made by DEA, CBP, and FDA will be in accord with their respective governing laws and regulations and/ r in furtherance of each respective agencies' illicit-drug interdiction and public-health missions.

The responsibilities assumed by each of the Parties under this MOU are contingent upon funds being available from which expenditures legally may be made.

Collaborative activities that may result in exchange, transfer, reimbursement, off-setting, or any other means of moving funds from one Party to the others are not authorized under the terms of this MOU. All such activities shall be documented and supported by separate financial documentation in compliance with all applicable Federal laws and regulations.

12. EFFECTIVE DATE AND REVIEW

This MOU will take effect upon the date of the last signature of the approving officials appearing below. This agreement will be reviewed every three years.

13. POINTS OF CONTACT

Below are the designated points of contact (POCs) selected by the Parties for the purpose of implementing the MOU and any associated agreements, addenda, and/or appendices. Each Party is expected to separately provide the other Parties with specific contact information for their POCs at the time of signature of this MOU, and promptly update the other Parties should these POCs change.

For the purposes of this MOU, the POCs are as follows:

For the DEA: Program Manager, Laboratory Management and Operations Section, SFMLabMOS@dea.gov.
 
For CBP, Laboratory Director, LSS INTERDICT Science Center Lab-interdict@cbp.gov.

For FDA: Satellite Lab Branch Director, Forensic Chemistry Center

APPROVED BY:

/s/
Scott Oulton
Deputy Assistant Administrator
Office of Forensic Sciences
U.S. Drug Enforcement Agency
Date: 07/30/2024
 
/s/
L. Dave Fluty
Assistant Commissioner
Laboratories and Scientific Services
U.S. Customs and Border Protection
Date: 07/25/2024

/s/
Paul Norris, DVM, MPA
Director, Office of Regulatory Science
U.S. Food and Drug Administration
Date: 07/30/2024

ANNEX l

YOUR AGENCY'S LETTERHEAD
Please copy and paste onto your agency's letterhead

Attn: Testimony Specialist
Division of Information Disclosure Programs
Office of Partnerships
Office of Regulatory Affairs
Food and Drug Administration
12420 Parklawn Drive
Element Building, 4th Floor
Rockville, Maryland 20857
ORAinfoShare@fda.hhs.gov

Dear Testimony Specialist,

The Drug Enforcement Administration (DEA) and U.S. Customs and Border Protection request access to the following non-public information pursuant to 21 C.F.R. § 20.85:

Results and underlying data regarding lab testing by FDA-FCC personnel of illicit drugs, excluding any potential trade-secret information regarding authentic drugs from legitimate manufacturers.

The purpose for which the information is requested is to assist in the activities described in sections 5.3-5.5 of the MOU between DEA, DHS/CBP, and FDA regarding the Joint Research Consortium.

The records will only be used for those authorized activities.

I certify that these activities are authorized by law, that the records or information will be used only for the stated purpose and will not be disclosed outside DEA and CBP without the prior written permission of the Food and Drug Administration. I also certify that disclosure within DEA and CBP will be limited to the specific purposes stated above, and that I will provide a copy of this letter to any person(s) with whom I share the non-public information.

I understand that 21 U.S.C. § 331 of the Federal Food, Drug, and Cosmetic Act prohibits disclosure of trade secrets information outside the Department of Health and Human Services. If you have any questions, please contact PROVIDE NAME AND CONTACT INFORMATION.

Sincerely,
YOUR SIGNATURE LINE #I

YOUR SIGNATURE LINE #2

cc: RECOMMEND INSERTING NAME OF YOUR FDA CONTACTS, IF ANY.