[Federal Register: November 2, 1999 (Volume 64, Number 211)]
[Notices]               
[Page 59214-59215]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no99-77]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 
Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated August 5, 1999, and published in the Federal 
Register on August 20, 1999 (64 FR 45565), ISP Freetown Acquisition 
Corp., 238 South Main Street, Freetown, Massachusetts 02702 which has 
changed its name to ISP Freetown Fine Chemicals Inc. made application 
to the Drug Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of 2,5-Dimethoxyamphetamine (7396), a basis class of 
controlled substance listed in Schedule I.
    This firm plans to manufacture bulk 2,5-Dimethoxyamphetamine of 
conversion into a noncontrolled substance.
    A registered bulk manufacturer of 2,5-Dimethoxyamphetamine filed 
written comments requesting that DEA not grant a registration because 
of the already existing adequate competition and supply in the domestic 
market, and

[[Page 59215]]

significant diversion risks. 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.
    DEA has considered the factors in Title 21, United States Code, 
Section 823 (a) and the objector's arguments, and determined that the 
registration of the ISP Freetown Fine Chemicals Inc. to manufacture 
2,5-Dimethoxyamphetamine is consistent with the public interest at this 
time. DEA has investigated the firm to ensure that the company's 
continued registration is consistent with the public interest. These 
investigations have included inspection and testing of the applicant's 
physical security systems, verification of the applicants compliance 
with state and local laws, and review of the firm's background and 
history.
    Under Title 21, Code of Federal Regulations, Section 1301.33b, 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 ISP 
Freetown Fine Chemicals Inc.
    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 2,5-Dimethoxyamphetamine is 
granted.

    Dated: October 27, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 99-28604 Filed 11-1-99; 8:45 am]
BILLING CODE 4410-09-M