[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:
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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
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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