[Federal Register: September 29, 1999 (Volume 64, Number 188)]
[Notices]               
[Page 52538]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se99-102]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 
Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated February 23, 1999, and published in the Federal 
Register on March 5, 1999 (64 FR 10725), Sigma Aldrich Research 
Biochemicals, Inc., Attn: Richard Miliius, 1-3 Strathmore Road, Natick, 
Massachusetts 01760 made application to the Drug Enforcement 
Administration (DEA) by letter to be registered as a bulk manufacturer 
of fentanyl (9801).
    A registered bulk manufacturer of fentanyl filed written comments 
and an objection in response to the notice of application. Review of 
the APA's definitions of license and licensing reveals that the 
granting or denial of a manufacturer's registration is a licensing 
action, not a rulemaking. Courts have frequently distinguished between 
agency licensing actions and rulemaking proceedings. See, e.g. Gateway 
Transp. Co. v. United States, 173 F. Supp. 822, 828 (D.C. Wis. 1959); 
Underwater Exotics, Ltd. v. Secretary of the Interior, 1994 U.S. Dist. 
LEXIS 2262 (1994). Courts have interpreted agency action relating to 
licensing as not falling within the APA's rulemaking provisions.
    The objector argues that Sigma Aldrich Research Biochemicals, Inc. 
cannot prove its registration as a bulk manufacturer of fentanyl is in 
the public interest, that Sigma Aldrich Research Biochemicals, Inc.'s 
registration is not required to produce an adequate and uninterrupted 
supply of fentanyl, that there is sufficient competition with the 
present bulk manufacturers.
    The arguments of the objector were considered, however, DEA has 
reviewed the firm's safeguards to prevent that theft and diversion of 
fentanyl and found that the firm has met the regulatory requirements 
and public interest factors of the Controlled Substances Act.
    Sigma Aldrich Research Biochemicals, Inc. has been and is currently 
registered with DEA as a manufacturer of other Schedule II controlled 
substances. Sigma Aldrich Research Biochemicals, Inc.'s application is 
based on the firm's request to add fentanyl to its existing 
registration as a bulk manufacturer. The firm has been investigated by 
DEA on a regular basis to determine if the firm maintains effective 
controls against diversion and if its continued registration is 
consistent with the public interest. These investigations have 
included, in part, inspection and testing of the firm's physical 
security, audits of the firm's records, verification of compliance with 
state and local law and a review of the firm's background and history. 
These investigations have found Sigma Aldrich Research Biochemicals, 
Inc. to be in compliance with the Controlled Substances Act (C.S.A.) 
and its implementing regulations in recent years.
    Under Title 21, Code of Federal Regulations, Sec. 1301.43(b), DEA 
is not required to limit the number of manufacturers solely because a 
smaller number is capable of producing an adequate supply provided 
effective controls against diversion are maintained. DEA has determined 
that effective controls against diversion will be maintained by Sigma 
Aldrich Research Biochemicals, Inc.
    After reviewing all the evidence, DEA has determined, pursuant to 
21 U.S.C. 823(a), that it is consistent with the public interest to 
grant Sigma Aldrich Research Biochemicals, Inc.'s application to 
manufacture fentanyl at this time. Therefore, pursuant to 21 U.S.C. 823 
and 28 CFR 0.100 and 0.104, the Deputy Assistant Administrator, Office 
of Diversion Control, hereby orders that the application submitted by 
the above firm for registration as a bulk manufacturer of the basic 
class of controlled substance listed above is granted.

    Dated: September 16, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 99-25358 Filed 9-28-99; 8:45 am]
BILLING CODE 4410-09-M