[Federal Register Volume 64, Number 213 (Thursday, November 4, 1999)]
[Notices]
[Page 60227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28867]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated August 14, 1998, and published in the Federal 
Register on August 25, 1998 (63 FR 45259), the National Center for 
Development of Natural Products, The University of Mississippi, 135 Cox 
Waller Comlex, University, Mississippi 38677, made application to the 
Drug Enforcement Administration (DEA) to be registered as a bulk 
manufacturer of the controlled substances listed below:

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                    Drug                               Schedule
------------------------------------------------------------------------
Marihuana...................................  I
Tetrahydrocannabinols.......................  I
------------------------------------------------------------------------

    Two registered bulk manufacturers of tetrahydrocannabinols filed 
written comments requesting that DEA ascertain whether the National 
Center for Development of Natural Products' application to bulk 
manufacturer tetrahydrocannabinols met the public interest factors of 
the Controlled Substances Act before registration is granted. 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 determined that the registration of the National 
Center for Development of Natural Products to manufacture the listed 
products is consistent with the public interest at this time. This 
determination was based on, among things, DEA's on-site investigation 
of the National Center for Development of Natural Products. The 
investigation included inspection and testing of the applicant's 
physical security systems, verification of the applicant's 
qualifications and experience, verification of the applicants 
compliance with state and local laws, and review of the firm's 
background and history. DEA has further determined that the 
registration will be consistent with United States obligations under 
international treaties. Therefore, pursuant to 21 U.S.C. Sec. 823 and 
28 CFR 0.100 and 0.104, the Deputy Assistant Administrator, Office of 
Division 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: October 20, 1999.
John H. King,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 99-28867 Filed 11-3-99; 8:45 am]
BILLING CODE 4410-09-M