Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Groff NA Hemplex LLC, 21889-21890 [2020-08334]
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21889
Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices
Controlled substance
Drug code
Desomorphine .................................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Heroin ..............................................................................................................................................................................
Morphine-N-oxide ............................................................................................................................................................
Normorphine ....................................................................................................................................................................
Tilidine .............................................................................................................................................................................
Alpha-methylfentanyl .......................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...............................................................................
Methamphetamine ...........................................................................................................................................................
Phenmetrazine .................................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Amobarbital ......................................................................................................................................................................
Pentobarbital ....................................................................................................................................................................
Secobarbital .....................................................................................................................................................................
Glutethimide .....................................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
Phenylacetone .................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Ethylmorphine ..................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Meperidine intermediate-B ..............................................................................................................................................
Meperidine intermediate-C ..............................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
14-Hydroxmorphone ........................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis. In reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols) the company
plans to import a synthetic cannabidiol
and a synthetic tetrahydrocannabinols.
No other activities for these drug codes
are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–08328 Filed 4–17–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–621]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Groff NA
Hemplex LLC
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
Notice of application.
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
SUMMARY:
VerDate Sep<11>2014
18:34 Apr 17, 2020
Jkt 250001
pending applications according to
proposed regulations that, if finalized,
would govern 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
comments on or objections to the
issuance of the proposed registration on
or before June 19, 2020.
ADDRESSES: 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–621 in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: 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
PO 00000
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Fmt 4703
Sfmt 4703
9055
9145
9200
9307
9313
9750
9814
9821
1105
1631
1724
2125
2270
2315
2550
7471
8501
9050
9120
9170
9180
9190
9193
9220
9230
9233
9234
9273
9665
9668
9740
9801
Schedule
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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II
of the requested registration, as
provided in this notice. This notice does
not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA-registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA
proposes to conduct this evaluation in
the manner described in the rule
proposed at 85 FR 16292, published on
March 23, 2020, if finalized.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on February 28, 2020, Groff NA
Hemplex LLC, 100 Redco Avenue, Suite
E:\FR\FM\20APN1.SGM
20APN1
21890
Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices
A, Red Lion, Pennsylvania 17356–1436,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled substance
marihuana ........................
tetrahydrocannabinols .....
Drug
code
Schedule
7360
7370
I
I
The applicant’s notice above applied
to become registered with DEA to grow
marihuana as a bulk manufacturer
subsequent to a 2016 DEA policy
statement that provided information on
how it intended to expand the number
of registrations, and described in general
terms the way it would oversee those
additional growers. In order to complete
the evaluation and registration process
for applicants to grow marihuana, DEA
has proposed regulations that, if
finalized, would supersede the 2016
policy statement and govern persons
seeking to become registered with DEA
to grow marihuana as a bulk
manufacturer, consistent with
applicable law. The proposed
regulations are available at 85 FR 16292.
William T. McDermott,
Assistant Administrator.
Controlled substance
Marihuana ........................
Tetrahydrocannabinols ....
Amphetamine ..................
Lisdexamfetamine ...........
Pentobarbital ...................
ANPP (4-Anilino-Nphenethyl-4-piperidine).
Codeine ...........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Meperidine .......................
Morphine ..........................
Fentanyl ...........................
Drug
code
Schedule
7360
7370
1100
1205
2270
8333
I
I
II
II
II
II
9050
9143
9150
9193
9230
9300
9801
II
II
II
II
II
II
II
The company plans to manufacture
the above controlled substances as bulk
active pharmaceutical ingredients (APIs)
for use in product development and for
distribution to its customers. In
reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetics. No other activities for
these drug codes are authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–08330 Filed 4–17–20; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2020–08334 Filed 4–17–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–609]
[Docket No. DEA–622]
Importer of Controlled Substances
Application: Purisys, LLC
Bulk Manufacturer of Controlled
Substances Application: AMRI
Rensselaer, Inc.
ACTION:
ACTION:
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 June 19, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 9, 2020, AMRI
Rensselaer, Inc., 33 Riverside Avenue,
Rensselaer, New York 12144–2951,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
jbell on DSKJLSW7X2PROD with NOTICES
VerDate Sep<11>2014
18:34 Apr 17, 2020
Jkt 250001
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 May 20, 2020. Such persons
may also file a written request for a
hearing on the application on or before
May 20, 2020.
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,
DATES:
Notice of application.
SUPPLEMENTARY INFORMATION:
Notice of application.
PO 00000
Frm 00069
Fmt 4703
Sfmt 9990
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on January 30, 2020,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602 applied to
be registered as an importer of the
following basic class(es) of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Nabilone .........................
Phenylacetone ................
Levorphanol ....................
Thebaine .........................
Poppy Straw Concentrate.
Tapentadol ......................
Drug
code
Schedule
7350
7360
7370
7379
8501
9220
9333
9670
I
I
I
II
II
II
II
II
9780
II
The company plans to import drug
code 8501, Phenylacetone and drug
code 9670, Poppy Straw Concentrate to
bulk manufacture other controlled
substances for distribution to its
customers. The company plans to
import impurities of buprenorphine that
have been determined by DEA to be
captured under drug code 9333,
Thebaine. In reference to drug codes
7360, Marihuana and 7370,
Tetrahydrocannabinols the company
plans to import a Synthetic Cannabidiol
and a Synthetic Tetrahydrocannabinol.
No other activity for these drug codes is
authorized for this registration.
Placement of these drugs codes on the
company’s registration does not
translate into automatic approval of
subsequent permit applications to
import controlled substances. 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 FDAapproved or non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–08270 Filed 4–17–20; 8:45 am]
BILLING CODE 4410–09–P
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20APN1
]]>Agencies
[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Pages 21889-21890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08334]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-621]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Groff NA Hemplex LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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 proposed regulations that, if
finalized, would govern 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 comments on or objections to
the issuance of the proposed registration on or before June 19, 2020.
ADDRESSES: 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-621 in all
correspondence, including attachments.
SUPPLEMENTARY INFORMATION: 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 provided in this
notice. This notice does not constitute any evaluation or determination
of the merits of the application submitted.
The applicant plans to manufacture bulk active pharmaceutical
ingredients (APIs) for product development and distribution to DEA-
registered researchers. If the application for registration is granted,
the registrant would not be authorized to conduct other activity under
this registration aside from those coincident activities specifically
authorized by DEA regulations. DEA will evaluate the application for
registration as a bulk manufacturer for compliance with all applicable
laws, treaties, and regulations and to ensure adequate safeguards
against diversion are in place.
As this applicant has applied to become registered as a bulk
manufacturer of marihuana, the application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA proposes to conduct this evaluation
in the manner described in the rule proposed at 85 FR 16292, published
on March 23, 2020, if finalized.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on February 28, 2020, Groff NA Hemplex LLC, 100 Redco Avenue, Suite
[[Page 21890]]
A, Red Lion, Pennsylvania 17356-1436, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
marihuana............................... 7360 I
tetrahydrocannabinols................... 7370 I
------------------------------------------------------------------------
The applicant's notice above applied to become registered with DEA
to grow marihuana as a bulk manufacturer subsequent to a 2016 DEA
policy statement that provided information on how it intended to expand
the number of registrations, and described in general terms the way it
would oversee those additional growers. In order to complete the
evaluation and registration process for applicants to grow marihuana,
DEA has proposed regulations that, if finalized, would supersede the
2016 policy statement and govern persons seeking to become registered
with DEA to grow marihuana as a bulk manufacturer, consistent with
applicable law. The proposed regulations are available at 85 FR 16292.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-08334 Filed 4-17-20; 8:45 am]
BILLING CODE 4410-09-P
