[Federal Register Volume 60, Number 47 (Friday, March 10, 1995)]
[Notices]
[Pages 13171-13172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5833]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[Docket No. 94-50]


Michael Schumacher; Denial of Registration

    On May 18, 1994, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Michael Schumacher, General Television 
(Respondent), of Urbana, Illinois, proposing to deny his application 
for a DEA Certificate of Registration as a manufacturer. 21 U.S.C. 
823(a) (1992). The statutory basis for the Order to Show Cause was 
Respondent's lack of authorization to manufacture controlled substances 
in the State of Illinois. 21 U.S.C. 824(a)(3). In addition, the Order 
to Show Cause alleged that Respondent's registration would be 
inconsistent with the public interest, as the term is used in 21 U.S.C. 
823(a) and 824(a)(4).
    The Order to Show Cause was sent to Respondent's registered 
location by registered mail on May 18, 1994, and on June 10, 1994, 
Respondent filed a request for hearing with the Office of 
Administrative Law Judges. The matter was docketed before 
Administrative Law Judge Mary Ellen Bittner. This case was then 
consolidated with Docket No. 94-37 wherein Normaco of Delaware, Inc. 
(Normaco) had requested a hearing pursuant to 21 CFR 1301.43(a) (1994), 
in response to a notice of Respondent's application for registration as 
a bulk manufacturer of various Schedule II controlled substances (58 FR 
60061 (1994)). On June 28, 1994, the administrative law judge granted 
Normaco's request to withdraw from this matter.
    Counsel for the Government filed a motion for summary disposition 
on July 18, 1994, based on an order of the Illinois Department of 
Professional Regulation (DPR), dated July 10, 1992, denying 
Respondent's application for a state license to manufacture and conduct 
medical research under the Illinois Controlled Substances Act. 
Respondent did not file a response to the Government's motion.
    On September 29, 1994, the administrative law judge issued her 
opinion and recommended decision. The administrative law judge granted 
the Government's motion for summary disposition finding that Respondent 
is not eligible for a DEA registration as a bulk manufacturer of 
Schedule I and II controlled substances and therefore a hearing would 
serve no purpose. The administrative law judge found that Respondent 
currently lacks state authorization to handle controlled substances in 
the State of Illinois because Respondent was denied a state license to 
manufacture controlled substances by the Illinois DPR on July 10, 1992. 
As the administrative law judge noted, DPR's denial was based on 
findings that Respondent was unaware what substances were controlled 
under Illinois law, that Respondent did not have a background in those 
sciences pertaining to controlled substances, and that Respondent 
failed to demonstrate that its application should be granted. The 
administrative law judge noted that 21 U.S.C. 823(a), the provision 
requiring registration of manufacturers of Schedule I and II controlled 
substances, contains no express threshold requirement of state 
authorization. Nonetheless, she concluded that where as here state law 
requires manufacturers of controlled substances to obtain a state 
[[Page 13172]] license, it would be pointless to grant a Federal 
registration when Respondent lacked state authority. The administrative 
law judge then recommended that in those cases where an applicant for a 
DEA registration as a manufacturer of controlled substances has had a 
state license or registration denied, suspended, revoked, or restricted 
by a state regulatory agency with jurisdiction to take that action, DEA 
should not grant greater authority to handle controlled substances than 
has been granted by the state. Consequently, the administrative law 
judge granted Government's motion for summary disposition and 
recommended that Respondent's application for a DEA Certificate of 
Registration be denied. Neither party filed exceptions to the opinion 
and recommended decision. On November 2, 1994, the administrative law 
judge transmitted the record to the Deputy Administrator.
    The Deputy Administrator has carefully considered the entire record 
in this matter and hereby adopts the administrative law judge's opinion 
and recommended decision. The Deputy Administrator, pursuant to 21 CFR 
1316.67, hereby issues his final order in this matter based upon 
findings of fact and conclusions of law as hereinafter set forth. It is 
undisputed that Respondent is not authorized to manufacture controlled 
substances in the State of Illinois. Because 21 U.S.C. 824(a)(3) 
provides that denial or revocation of a state license or registration 
constitutes grounds to revoke a DEA registration, if Respondent were 
granted a registration, DEA would immediately have grounds to revoke 
it. It is well-settled that the agency need not grant a license on one 
day only to revoke it the next. Kuen H. Chen, 58 FR 65401 (1993) 
(quoting Serling Drug Co. and Detroit Prescription Wholesaler, Inc., 40 
FR 1118, 11919 (1975). Further, inasmuch as DEA must consider 
``compliance with applicable State and local law'' when determining 
whether to grant a DEA registration to manufacture controlled 
substances, 21 U.S.C. 823(a)(2), DEA's grant of a registration to 
Respondent would put him in jeopardy of Illinois law. Finally, despite 
the lack of a state authority threshold for manufacturer registrations, 
the Deputy Administrator concludes that, inasmuch as Illinois had 
denied Respondent a state license, DEA cannot grant Respondent's 
application for a DEA Certificate of Registration. Cf. Nathaniel S. 
Lehrman, M.D., 59 FR 44780 (1994) (holding that DEA has consistently 
held that it cannot maintain the registration of a practitioner who is 
not authorized to handle controlled substances in the state in which he 
practices); accord Franz A. Arakaky MD., 59 FR 42074 (1994); Elliott 
Monroe, M.D., 57 FR 23246 (1992).
    The Deputy Administrator concurs with the administrative law 
judge's granting of the Government's motion for summary disposition. In 
the absence of a question of material fact, a plenary adversary 
administrative proceeding is not required. Philip E. Kirk, M.D., 48 FR 
32887 (1983), aff'd sub nom Kirk v. Mullen, 749 F.2d 297 (6th Cir. 
1984); Alfred Tennyson Smurthwaite, N.D., 43 FR 11873 (1978); see also 
NLRB v. International Association of Bridge, Structural and Ornamental 
Ironworkers, AFL-CIO, 549 F.2d 634 (9th Cir. 1977); U.S. v. 
Consolidated Mines and Smelting Co. Ltd., 44 F.2d 432, 453 (9th Cir. 
1971).
    Accordingly, the Deputy Administrator of the Drug Enforcement 
Administration, pursuant to the authority vested in him by 21 U.S.C. 
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the 
application for a DEA Certificate of Registration submitted by Michael 
Schumacher, General Television, be, and it hereby is, denied. This 
order is effective April 10, 1995.

    Dated: March 3, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-5833 Filed 3-9-95; 8:45 am]
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