[Federal Register Volume 86, Number 38 (Monday, March 1, 2021)]
[Notices]
[Pages 12033-12034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04147]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-799]


Importer of Controlled Substances Application: Microgenics 
Corporation Thermo Fisher Scientific

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Microgenics Corporation Thermo Fisher Scientific has applied 
to be registered as an importer of basic class(es) of controlled 
substance(s). Refer to Supplemental Information listed below for 
further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before March 31, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before March 31, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on January 27, 2021, Microgenics Corporation Thermo 
Fisher Scientific, 46500 Kato Road Fremont, California 94538, has 
applied to be registered as an importer of the following basic classes 
of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Cathinone..........................            1235  I
Mephedrone (4-Methyl-N-                        1248  I
 methylcathinone).
Gamma Hydroxybutyric Acid..........            2010  I
Methaqualone.......................            2565  I
Mecloqualone.......................            2572  I
2-(1-(4-fluorobenzyl)-1Hindazole-3-            7021  I
 carboxamido)-3-methylbutanoate.
AB-PINACA (N-(1-amino-3-methyl-1-              7023  I
 oxobutan-2-yl)-1-pentyl-1H-
 indazole-3-carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-1-            7031  I
 <=oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide.
MAB-CHMINACA (N-(1-amino-                      7032  I
 3,3dimethyl-1-oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide).
5F-AMB (Methyl 2-(1-(5-                        7033  I
 fluoropentyl)-1H-indazole-3-
 carboxamido)-3-methylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl-           7035  I
 1-oxobutan-2-yl)-1-pentyl-1H-
 indazole-3-carboxamide).
APINACA and AKB48 N-(1-Adamantyl)-1-           7048  I
 pentyl-1H-indazole-3-carboxamide.
AM2201 (1-(5-Fluoropentyl)-3-(1-               7201  I
 naphthoyl) indole).
Lysergic acid diethylamide.........            7315  I
Marihuana..........................            7360  I
Tetrahydrocannabinols..............            7370  I
3,4-Methylenedioxyamphetamine......            7400  I
3,4-Methylenedioxy-N-                          7404  I
 ethylamphetamine.
3,4-Methylenedioxymethamphetamine..            7405  I
2-(4-iodo-2,5-dimethoxyphenyl)                 7518  I
 ethanamine (2C-I).
MDPV (3,4-                                     7535  I
 Methylenedioxypyrovalerone).
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-           7538  I
 methoxybenzyl) ethanamine (25I-
 NBOMe).
Butylone...........................            7541  I
Pentylone..........................            7542  I
alpha-pyrrolidinopentiophenone                 7545  I
 ([alpha]-PVP).
Normorphine........................            9313  I

[[Page 12034]]

 
AH-7921 (3,4-dichloro-N-[(1-                   9551  I
 dimethylamino)cyclohexylmethyl]ben
 zamide)).
Acetylmethadol.....................            9601  I
Alphamethadol......................            9605  I
Ketobemidone.......................            9628  I
Noracymethadol.....................            9633  I
Para-Fluorofentanyl................            9812  I
3-Methylfentanyl...................            9813  I
Alpha-methylfentanyl...............            9814  I
Acetyl Fentanyl (N-(1-                         9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
2-methoxy-N-(1-phenethylpiperidin-4-           9825  I
 yl)-N-phenylacetamide.
3-Methylthiofentanyl...............            9833  I
Cyclopropyl Fentanyl...............            9845  I
Fentanyl related-compounds as                  9850  I
 defined in 21 CFR 1308.11&h).
Amphetamine........................            1100  II
Methamphetamine....................            1105  II
Methylphenidate....................            1724  II
Amobarbital........................            2125  II
Pentobarbital......................            2270  II
Secobarbital.......................            2315  II
Phencyclidine......................            7471  II
Cocaine............................            9041  II
Codeine............................            9050  II
Dihydrocodeine.....................            9120  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Ecgonine...........................            9180  II
Hydrocodone........................            9193  II
Levorphanol........................            9220  II
Meperidine.........................            9230  II
Meperidine intermediate-B..........            9233  II
Methadone..........................            9250  II
Dextropropoxyphene, bulk (non-                 9273  II
 dosage forms).
Morphine...........................            9300  II
Thebaine...........................            9333  II
Levo-alphacetylmethadol............            9648  II
Oxymorphone........................            9652  II
Carfentanil........................            9743  II
Tapentadol.........................            9780  II
Fentanyl...........................            9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
feasibility studies for new products and cross reactivity studies for 
existing products. The products will serve as raw materials for In 
Vitro Diagnostic quantitative assay. No other activity for these drug 
codes is authorized for this registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of the Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-04147 Filed 2-26-21; 8:45 am]
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