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MOU 225-81-3000

Memorandum of Understanding

Between
The National Institute on Drug Abuse 

and

The Food and Drug Administration

 

FOOD AND DRUG ADMINISTRATION GUIDE 7155e.05
COMPLIANCE POLICY GUIDES

CHAPTER 55e-MOUs and IAGs-FEDERAL

 

SUBJECT: MOU with NIDA regarding mutual responsibilities in implementing the jointly published narcotic addict treatment regulations (FDA 225-81-3000)

 

I. PURPOSE

The purposes of this MOU are: (a) to describe the cooperative relationship and procedures to be followed by the National Institute on Drug Abuse(NIDA) and the Food and Drug Administration (FDA) in implementing the jointly published narcotic addict treatment regulations; (b) to input from NIDA to FDA about decisions on the operations of narcotic treatment programs under those regulations; and (c) to reduce the likelihood of inconsistent interpretations of those regulations. This agreement does not affect FDA's authority to make and issue all final decisions under the regulations.

 

II. BACKGROUND

In 1974 the Controlled Substance Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (CDAP&C Act), was amended by the Narcotic Addict Treatment Act (NATA). The NATA was intended primarily to establish the basis for more control of narcotic addict treatment programs by the Drug Enforcement Administration (DEA) and the Department of Heath and Human Services (HHS) to prevent diversion of narcotic drugs, and to ensure proper treatment of narcotic addicts. The NATA amended the CSA to provide for registration (through DEA) of practitioners conducting narcotic treatment programs. The fundamental purpose of the NATA, according to its legislative history, is to increase the Government's control over methadone and other narcotic drugs used in the treatment of narcotic addicts. This additional control would both ensure proper treatment and prevent diversion. The legislative history of the NATA further states that it is intended to complement the DEA and HHS controls in force at the time of enactment and to establish the basis for additional joint regulation of treatments programs by these two agencies.

The NATA, among other things, gives the Secretary of HHS authority to establish treatment standards for practitioners who use narcotic drugs for either maintenance or detoxification treatment of persons dependent upon narcotic drugs. Practitioners providing this treatment obtain a special registration which must be renewed annually from the Attorney General (through DEA) and, as a condition of registration, must comply with standards established by the Secretary. Under the NATA (21 U.S.C. 823 (g)), the Secretary must (a) determine if an applicant/ practitioner is qualified, and (b) determine if the applicant /practitioner will comply with the standards about the quantities of narcotic drugs which may be provided for unsupervised use by persons in such treatment and then report this determination to DEA. As noted above, HHS responsibilities under the NATA are carried out by FDA and NIDA.

 

In 1975 the Commissioner of Food and Drugs and the Director, National Institute on Drug Abuse agreed to jointly publish revisions to the methadone regulations. Accordingly, in 1977 they proposed a revision of the treatment standards. The final revised treatment standards were currently published in the FEDERAL REGISTER on Friday, September 19, 1980 ( 45 FR 62694). This revision of the methadone regulations includes the Secretary's treatment standards under the NATA.

 

III. SUBSTANCE OF AGREEMENT

A. FDA agrees to the following terms:

1. FDA will continue to inspect and monitor narcotic addict treatment programs forcompliance with jointly published treatment standards.

2. Before issuing a letter of noncompliance to a narcotic addict treatment program, FDA will provide NIDA with a draft copy of the letter, send to NIDA the supporting information upon which the action is based, and obtain NIDA's written recommendation as to whether the letter should issue.

3. Before notifying the DEA not to certify a treatment program under the jointly published standards, FDA will provide NIDA with a draft copy of the notice, send to NIDA the supporting information upon which the action is based, and obtain NIDA's written recommendation as to whether the notice should issue.

4. Before granting or denying an exemption section (d) (12) of the jointly published treatment standards, FDA will notify NIDA of the request for an exemption, send to NIDA the information supporting the request, and obtain NIDA's written recommendation as the whether to grant or deny the request. However, if the request involves a medical emergency or an exception for a specific patient, the notification may be made orally by telephone or in person.

5. FDA will notify NIDA in writing before taking action which is contrary to NIDA's recommendation under items 2, 3, and 4.above.

6. FDA will make final determination in matters which relate to safety and effectiveness of drugs or to the approval of new drugs to be used in the treatment of narcotic addicts.

 

B. NIDA agrees to the following terms:

1. Within seven (7) days of receipt of the information from FDA described in items 2 and 3 above, NIDA will give FDA its written recommendation and, in the event of disagreement with the proposed FDA action, state the reason(s) for disagreement including, when appropriate, a recommended alternative action.

2. Within ten (10) days of receipt of the information from FDA described in item 4 above, NIDA will give FDA its written recommendation.

3. In the event of disagreement with a proposed FDA action, NIDA will state the reasons for disagreement including, when appropriate, a recommended alternative action. However, if the request involves a medical emergency or an exception for a specific patient, the recommendation may be made orally by telephone in person.

 

C. NIDA and FDA agree to the following terms:

1. Jointly publish and future revisions of the methadone treatment regulations;

2. Consult each other before issuing interpretations and opinions under the treatment standards which would have broad policy implications; and

3. Consult each other on the need to update, develop, or revise the regulations and policy affecting narcotic addict treatment.

 

IV. NAME AND ADDRESS OF PARTICIPANTS

A. National Institute on Drug Abuse,
5600 Fishers Lane
Rockville, MD 20857.

B. Food and Drug Administration
5600 Fishers Lane,
Rockville, MD 20857.

 

V. LIAISON OFFICERS

A. Liaison Officer for NIDA:
Mr. Nathan M. Kight,
National Institute on Drug Abuse,
5600 Fishers Lane,
Rockville, MD 20857,
301-443-4877.

 

B. Liaison Officer for FDA:
Mr. Edwin V. Dutra, Jr.,
Food and Drug Administration (HFD-30)
5600 Fishers Lane,
Rockville, MD 20857,
301-443-1382.

 

VI. PERIOD OF MEMORANDUM OF UNDERSTANDING

 

This agreement becomes effective when signed by both parties and remains in effect until it is terminated. This agreement may be terminated by either agency upon 90 days' advance written notice to the other.

 

VII. REVISIONS

Revisions to this agreement may be made by mutual consent of the agencies.

Approved and Accepted
for the National Institute on Drug Abuse

Signed by: William Pollin
Director, National Institute on Drug Abuse

Date: October 30, 1980

Approved and Accepted
for the Food and Drug Administration

Signed by: Mark Wontley for
Jere E. Goyan, Commissioner of Food and Drugs

Date: November 20, 1980