Importer of Controlled Substances Application: R & D Systems, Inc., 15566 [2016-06542]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06542]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: R & D Systems, 
Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before April 22, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before April 22, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All request for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152. Comments and requests for hearing on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417 (January 25, 2007).

SUPPLEMENTARY INFORMATION:  The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on 
February 25, 2015, R & D Systems, Inc., 614 McKinley Place NE., 
Minneapolis, Minnesota 55413 applied to be registered as an importer of 
the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
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Mephedrone (4-Methyl-N-methylcathinone)       I
 (1248).
JWH-018 (also known as AM678) (1-Pentyl-3-(1- I
 naphthoyl)indole) (7118).
CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)- I
 3-hydroxycyclohexyl-phenol) (7297).
Marihuana (7360)............................  I
Tetrahydrocannabinols (7370)................  I
4-Bromo-2,5-dimethoxyamphetamine (7391).....  I
3,4-Methylenedioxymethamphetamine (7405)....  I
Dimethyltryptamine (7435)...................  I
Psilocyn (7438).............................  I
Amphetamine (1100)..........................  II
Methylphenidate (1724)......................  II
Pentobarbital (2270)........................  II
Phencyclidine (7471)........................  II
Cocaine (9041)..............................  II
Oxycodone (9143)............................  II
Morphine (9300).............................  II
Thebaine (9333).............................  II
Fentanyl (9801).............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
dosage form to distribute to researchers.
    In reference to drug codes 7360 and 7370, the company plans to 
import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No 
other activity for these drug codes is authorized for this 
registration.
    The import of the above listed basic classes of controlled 
substances would be granted only for analytical testing and clinical 
trials. This authorization does not extend to the import of a finished 
Food and Drug Administration approved or non-approved dosage form for 
commercial distribution in the United States.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06542 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P