Justia Regulation Tracker

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[Federal Register: June 20, 2008 (Volume 73, Number 120)]
[Notices]               
[Page 35152]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn08-80]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 
Importer of Controlled Substances; Notice of Registration

    By Notice dated April 17, 2006 and published in the Federal 
Register on April 21, 2006, (71 FR 20729), and as corrected by Notice 
dated May 15, 2006, and published in the Federal Register on May 22, 
2006, (71 FR 29354), Rhodes Technologies, 498 Washington Street, 
Coventry, Rhode Island 02816, made application to the Drug Enforcement 
Administration (DEA) to be registered as an importer of the basic 
classes of controlled substances in schedule II:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Raw Opium (9600)...........................  II
Concentrate of Poppy Straw (9670)..........  II
------------------------------------------------------------------------

    The company plans to import the basic classes of controlled 
substances to manufacture bulk active pharmaceutical ingredients. The 
company is registered with DEA as a manufacturer of several controlled 
substances that are manufactured from raw opium and concentrate of 
poppy straw.
    Comments, objections, and requests for a hearing were received. 
However, after a thorough review of this matter DEA has concluded that, 
per 21 CFR 1301.34(a), the objectors are not entitled to a hearing. As 
explained in the Correction to Notice of Application dated January 18, 
2007, pertaining to Rhodes Technologies et al., (72 FR 3417, January 
25, 2007), comments and requests for hearings on applications to import 
narcotic raw material are not appropriate.
    DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and 
determined that the registration of Rhodes Technologies to import the 
basic classes of controlled substances is consistent with the public 
interest and with United States obligations under international 
treaties, conventions, or protocols in effect on May 1, 1971. DEA 
investigated Rhodes Technologies to ensure that the company's 
registration would be consistent with the public interest. The 
investigation included inspection and testing of the company's physical 
security systems, verification of the company's compliance with state 
and local laws, and a review of the company's background and history. 
After investigating these and other matters, I have concluded that 
registering Rhodes Technologies to import raw opium and concentrate of 
poppy straw is consistent with the factors set forth in 21 U.S.C. 
823(a)(2)-(6), as incorporated in 21 U.S.C. 958(a).
    The DEA also considered whether the registration of Rhodes 
Technologies would be consistent with 21 U.S.C. 823(a)(1) that requires 
the DEA to limit the importation of certain controlled substances 
(including raw opium and concentrate of poppy straw) ``to a number of 
establishments which can produce an adequate and uninterrupted supply 
of these substances under adequately competitive conditions * * *.'' I 
find that the establishments currently registered with DEA to import 
raw opium and concentrate of poppy straw provide an adequate and 
uninterrupted supply of those substances. The DEA found no evidence 
that the supply of such substances was inadequate or interrupted in 
supplying the needs of the United States for legitimate medical, 
scientific, research, and industrial purposes.
    However, I find that the adequate and uninterrupted supply of these 
substances did not occur under adequately competitive conditions. 
Specifically, I find that Rhodes Technologies has demonstrated that the 
current importers of raw opium and concentrate of poppy straw have, in 
some cases, refused to sell these substances to Rhodes Technologies. 
Some of the current importers also use their position to demand 
restrictive contractual terms when selling narcotic raw material to 
Rhodes Technologies. Many of the current importers also manufacture 
active pharmaceutical ingredients or have corporate ties to firms that 
manufacture active pharmaceutical ingredients from raw opium and 
concentrate of poppy straw. These importers have a direct financial 
interest in refusing to sell narcotic raw material to Rhodes 
Technologies or in demanding significant contractual restrictions when 
selling narcotic raw material to Rhodes Technologies.
    Based on the information in the investigative file that is 
summarized herein, I find that the current importation of raw opium and 
concentrate of poppy straw is not being conducted under adequately 
competitive conditions. Therefore, under 21 U.S.C. 823(a)(1), DEA may 
grant the application of Rhodes Technologies to import raw opium and 
concentrate of poppy straw. Having already found that registering 
Rhodes Technologies to import raw opium and concentrate of poppy straw 
is consistent with the factors set forth in 21 U.S.C. 823(a)(2)-(6), I 
find that the statutory factor set forth in 21 U.S.C. 823(a)(1) also 
weighs in favor of granting the application.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above named company is granted 
registration as an importer of the basic classes of controlled 
substances listed.

    Dated: June 16, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E8-13912 Filed 6-19-08; 8:45 am]

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