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MOU 225-74-8013

Memorandum of Understanding

Between
The Drug Enforcement Administration

and

The Food and Drug Administration

Purpose:

To outline the working arrangements for the operation and activities of the DEA/FDA Liaison Staff established for dealing with related objectives in carrying out DEA and FDA responsibilities under the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act.

 

I. Objectives and Structure.

The Drug Enforcement Administration and the Food and Drug Administration have established liaison staffs for dealing with related objectives in carrying out their responsibilities under the Controlled Substances Act and the Federal Food, Drug and Cosmetic Act. This Memorandum outlines the working arrangements being followed in the interest of the public so that each agency will discharge its responsibilities as effectively as possible.

The DEA/FDA Liaison Staffs will serve as a focal point for interagency coordinative management of investigative, consultant, scientific, compliance, and legal efforts, involving controlled substances or substances which are being investigated which may be controlled. The Liaison Staffs will also serve in assisting the Administrator and the Commissioner in the development and evaluation of policy.

DEA and FDA shall have the following type of representation on the liaison staff:

a. Liaison Officer,

b. Representative from legal office,

c. Compliance representative,

d. Science representative,

Other personnel may attend meetings on an as-needed basis.

 

II. Name and Address of Participating Agencies.

Drug Enforcement Administration
Department of Justice
Washington, DC 20537.

Food and Drug Administration
Department of Health, Education, and Welfare
5600 Fishers Lane
Rockville, MD 20857

 

III. Liaison Officers.

A. For DEA:

Mr. Ernest A. Carabillo, Jr.
Chief
Special Programs Division
Drug Enforcement Administration
14th and I St. N.W.
Washington, DC 20537
(202) 382-4344.

 

B. For FDA:

Mr. Thomas W. Brown
Director
Compliance Coordination and Policy Staff (HFC-13)
Office of the Associate Commissioner for Compliance
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
(301) 443-3470.


IV. Operations.

A. Meetings will be held every 2 months on the second Tuesday of the month. The Liaison Officers may reschedule the meeting or convene additional meetings as necessary. The host agency will prepare the minutes of meetings, which will be circulated to staff members by the Liaison Officer.

B. The Liaison Staff will limit its discussions to substantive matters in the area of controlled substances involving FDA (not HEW) and DEA.

C. Unresolved policy matters and problems will be referred for discussion at the periodic liaison meetings between the Administrator and the Commissioner.

D. Liaison Staff activities between agencies will be coordinated through the Offices of the Agency's Liaison Officer.

E. Important regulatory developments in both agencies will be promptly communicated to the Agency's Liaison Officer. Regular and frequent exchange of scientific, planning, and regulatory information should take place between officials and professional staffs.

F. The staff shall coordinate efforts to facilitate exchange of pertinent information necessary to controlled substances decisions.

G. The staff shall establish means to clarify and facilitate operating procedures necessary for controlled substances decisions, including, but not limited to, the following interagency cooperative efforts:

i. Transmittal of and access to necessary documents.

ii. Access to and knowledge of abuse information.

iii. Staff level working groups and informal exchanges between such groups.

iv. Location and production of expert witnesses.

v. A unified policy concerning publicity releases.

vi. Procedures to avoid duplication of efforts.

H. The agencies shall informally notify each other in advance of formal proposals to schedule drugs. Additionally, the agencies shall when possible, informally transmit data supporting scheduling decisions in advance of a formal transmittal.

 

V. Period of Agreement.

This agreement, when accepted by both parties, will have an indefinite period of performance, and may be modified by mutual consent of both parties or may be terminated by either party upon a thirty (30) day advance written notice to the other.

 

VI. Authority.

This agreement is entered into under the authority of the Economy Act approved June 30, 1932, as amended, 31 U.S.C. 686.

Approved and Accepted
for the Drug Enforcement Administration

Signed by: Frederick M. Garfield
Director of Research and Technology

Date: July 1, 1974

Approved and Accepted
for the Food and Drug Administration

Signed by: Sam D. Fine
Associate Commissiner for Compliance

Date: June 21, 1974