[Federal Register Volume 60, Number 156 (Monday, August 14, 1995)]
[Notices]
[Page 41900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19956]



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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 95-3]


Habit Management Institute, Inc.; Denial of Application

    On October 31, 1994, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Habit Management Institute, Inc., of Manchester, 
New Hampshire (Respondent), proposing to deny its application for DEA 
registration as a Narcotic Treatment Program (NTP) under 21 U.S.C. 
823(g). The statutory basis for the Order to Show Cause was that 
Respondent was not authorized to dispense controlled substances in the 
State of New Hampshire, the state in which it proposed to operate.
    Respondent, through counsel, requested a hearing on the issues 
raised in the Order to Show Cause, and the matter was docketed before 
Administrative Law Judge Paul A. Tenney. On December 16, 1994, the 
Government filed a motion for summary disposition clarifying the Order 
to Show Cause and alleging, inter alia, that Respondent was not 
authorized to handle controlled substances in the State of New 
Hampshire, and, that Respondent lacked authority from the Food and Drug 
Administration of the Department of Health and Human Services (FDA), to 
operate an NTP. The Government's motion was supported by a letter from 
an FDA official informing Respondent that because the State of New 
Hampshire had denied its application to establish an NTP, the FDA was 
unable to approve its application. Respondent did not file a response 
to the Government's motion and did not deny that FDA has denied its 
application.
    On January 30, 1995, the administrative law judge issued his 
conclusions of law and recommended ruling, recommending that 
Respondent's application for a DEA Certificate of Registration as an 
NTP be denied. On March 9, 1995, the administrative law judge 
transmitted the record to the Deputy Administrator. After a careful 
consideration of the record in its entirety, the Deputy Administrator, 
pursuant to 21 CFR 1316.67, enters his final order in this matter, 
based on the conclusions of law set forth herein.
    Practitioners who dispense narcotic drugs as part of a maintenance 
treatment or detoxification treatment are required to obtain a separate 
DEA registration under 21 U.S.C. 823(g). Authorization from the FDA is 
a prerequisite to the granting of registration by DEA. 21 U.S.C. 
823(g)(1). The administrative law judge found that FDA notified 
Respondent, in writing, that the FDA had not approved Respondent's NTP.
    DEA does not have statutory authority under the Controlled 
Substances Act to register an NTP unless that entity is authorized by 
the FDA to dispense controlled substances. 21 U.S.C. 823(g). In a 
proceeding to obtain registration as an NTP, if the applicant does not 
possess the requisite FDA authorization to operate an NTP, a motion for 
summary disposition is properly entertained. Rosalind A. Cropper, Inc., 
60 FR 18143 (1995). It is well settled that where no question of fact 
exists, or where the material facts are agreed, a plenary 
administrative proceeding is not required. Phillip E. Kirk, M.D., 48 FR 
32887 (1983), aff'd sub nom, Kirk v. Mullen, 749 F.2d 297 (6th Cir. 
1984).
    Accordingly, the Deputy Administrator adopts the conclusions of law 
and recommended ruling of the administrative law judge in its entirety. 
Based on the foregoing, the Deputy Administrator of the Drug 
Enforcement Administration, pursuant to 21 U.S.C. 823 and 824 and 28 
CFR 0.100(b) and 0.104, hereby orders that Respondent's application for 
DEA Certificate of Registration as an NTP be, and it hereby is, denied. 
This order is effective September 13, 1995.

    Dated: August 7, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-19956 Filed 8-11-95; 8:45 am]
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