[Federal Register Volume 64, Number 28 (Thursday, February 11, 1999)]
[Notices]
[Page 6913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3403]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated June 10, 1998, and published in the Federal 
Register on July 9, 1998, (63 FR 37137), Chiragene, Inc., 7 Powder Horn 
Drive, Warren, New Jersey 07509, made application to the Drug 
Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of the basic classes of controlled substances listed 
below:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
N-Ethylamphetamine (1475)..................  I
2,5-Dimethoxyamphetamine (7396)............  I
3,4-Methylenedioxyamphetamine (7400).......  I
4-Methoxyamphetamine) (7411)...............  I
Amphetamine (1100).........................  II
Methylphenidate (1724).....................  II
------------------------------------------------------------------------

    The firm plans to manufacture the listed controlled substances to 
supply their customers.
    A registered bulk manufacturer of methylphenidate filed written 
comments and an objection in response to the notice of application. 
Review of the Administrative Procedures Act's (APA) 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 Chiragene cannot prove its registration as 
a bulk manufacturer of methylphenidate is in the public interest, the 
Chiragene's registration is not required to produce an adequate and 
uninterrupted supply of methylphenidate, that there is sufficient 
competition with the present bulk manufacturers and that there would be 
a public interest impact on reported trends of over-prescribing, abuse 
and diversion of methylphenidate.
    The arguments of the objector were considered, however, DEA has 
reviewed the firm's safeguards to prevent the theft and diversion of 
methylphenidate and found that the firm has met the regulatory 
requirements and public interest factors of the Controlled Substances 
Act (CSA).
    Chiragene has been investigated by DEA to determine if the firm 
maintains effective controls against diversion which included, in part, 
inspection and testing of the firm's physical security, verification of 
compliance with State and local law and a review of the firm's 
background. The investigation has found Chiragene to be in compliance 
with the CSA and its implementing regulations.
    Under Title 21, Code of Federal Regulations, Section 1301.33(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 
Chiragene.
    After reviewing all the evidence, DEA has determined, pursuant to 
21 U.S.C., Section 823(a), that it is consistent with the public 
interest to grant Chiragene's application to manufacture 
methylphenidate and the other listed controlled substances at this 
time. Therefore, pursuant to 21 U.S.C., Section 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 classes of 
controlled substances listed above is granted.

    Dated: January 25, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 99-3403 Filed 2-10-99; 8:45 am]
BILLING CODE 4410-09-M