Importer of Controlled Substances Application: Microgenics Corporation Thermo Fisher Scientific, 12033-12034 [2021-04147]
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12033
Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices
Groff NA Hemplex, LLC 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.
SUMMARY:
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.
DATES:
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 requests 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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on January 19, 2021, Groff
NA Hemplex, LLC, 100 Redco Avenue,
Suite A, Red Lion, Pennsylvania 17356–
1436, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Marihuana Extract ...................
Marihuana ...............................
Tetrahydrocannabinols ...........
7350
7360
7370
Schedule
I
I
I
The company plans to import finished
dosage unit products containing
Marihuana Extracts for clinical trial
studies. These Marihuana Extracts
compounds are listed under drug code
7350. No other activity for this drug
code 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–04181 Filed 2–26–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–799]
Importer of Controlled Substances
Application: Microgenics Corporation
Thermo Fisher Scientific
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Microgenics Corporation
Thermo Fisher Scientific has applied to
SUMMARY:
be registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplemental Information
listed below for further drug
information.
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.
DATES:
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.
ADDRESSES:
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:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Cathinone ........................................................................................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) ....................................................................................................................
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Methaqualone ..................................................................................................................................................................
Mecloqualone ..................................................................................................................................................................
2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3-methylbutanoate ............................................................................
AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .........................................
AB–CHMINACA (N-(1-amino-3-methyl-1-≤oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide ...............
MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) ........
5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ..............................................
ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .................................
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide ..............................................................
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) .......................................................................................................
Lysergic acid diethylamide ..............................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine .......................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C–I) ........................................................................................................
MDPV (3,4-Methylenedioxypyrovalerone) .......................................................................................................................
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I–NBOMe) .........................................................
Butylone ...........................................................................................................................................................................
Pentylone .........................................................................................................................................................................
alpha-pyrrolidinopentiophenone (a-PVP) ........................................................................................................................
Normorphine ....................................................................................................................................................................
VerDate Sep<11>2014
18:48 Feb 26, 2021
Jkt 253001
PO 00000
Frm 00115
Fmt 4703
Sfmt 4703
E:\FR\FM\01MRN1.SGM
01MRN1
1235
1248
2010
2565
2572
7021
7023
7031
7032
7033
7035
7048
7201
7315
7360
7370
7400
7404
7405
7518
7535
7538
7541
7542
7545
9313
Schedule
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
12034
Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Notices
Controlled substance
Drug code
AH–7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) ..................................................................
Acetylmethadol ................................................................................................................................................................
Alphamethadol .................................................................................................................................................................
Ketobemidone ..................................................................................................................................................................
Noracymethadol ...............................................................................................................................................................
Para-Fluorofentanyl .........................................................................................................................................................
3-Methylfentanyl ..............................................................................................................................................................
Alpha-methylfentanyl .......................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...............................................................................
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide .........................................................................................
3-Methylthiofentanyl .........................................................................................................................................................
Cyclopropyl Fentanyl .......................................................................................................................................................
Fentanyl related-compounds as defined in 21 CFR 1308.11&h) ...................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Amobarbital ......................................................................................................................................................................
Pentobarbital ....................................................................................................................................................................
Secobarbital .....................................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Meperidine intermediate-B ..............................................................................................................................................
Methadone .......................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Levo-alphacetylmethadol .................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
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 nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–04147 Filed 2–26–21; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014
18:48 Feb 26, 2021
Jkt 253001
9551
9601
9605
9628
9633
9812
9813
9814
9821
9825
9833
9845
9850
1100
1105
1724
2125
2270
2315
7471
9041
9050
9120
9143
9150
9180
9193
9220
9230
9233
9250
9273
9300
9333
9648
9652
9743
9780
9801
Schedule
I
I
I
I
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
Drug Enforcement Administration
comments on or objections to the
issuance of the proposed registration on
or before April 30, 2021.
[Docket No. DEA–781]
ADDRESSES:
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Cosmic
Light LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefor, may file written
SUMMARY:
PO 00000
Frm 00116
Fmt 4703
Sfmt 4703
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. To ensure proper handling of
comments, please reference Docket No–
DEA–XXX in all correspondence,
including attachments.
The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
file written comments on or objections
of the requested registration, as
SUPPLEMENTARY INFORMATION:
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE P
