Importer of Controlled Substances Application: Mycrodose Therapeutics, 58691-58692 [2021-23036]
Download as PDF
58691
Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
DEPARTMENT OF JUSTICE
Antitrust Division
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—Electrified Vehicle and
Energy Storage Evaluation
Notice is hereby given that, on
September 21, 2021, pursuant to Section
6(a) of the National Cooperative
Research and Production Act of 1993,
15 U.S.C. 4301 et seq. (‘‘the Act’’),
Electrified Vehicle and Energy Storage
Evaluation (‘‘EVESE’’) has filed written
notifications simultaneously with the
Attorney General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, LG Energy Solution, Ltd.,
Seoul, KOREA, has been added as a
party to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and EVESE
intends to file additional written
notifications disclosing all changes in
membership.
On September 24, 2020, EVESE filed
its original notification pursuant to
Section 6(a) of the Act. The Department
of Justice published a notice in the
Federal Register pursuant to Section
6(b) of the Act on October 15, 2020 (85
FR 65423).
The last notification was filed with
the Department on July 27, 2021. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
Act on August 23, 2021 (86 FR 47157).
Suzanne Morris,
Chief, Premerger and Division Statistics,
Antitrust Division.
[FR Doc. 2021–23098 Filed 10–21–21; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
lotter on DSK11XQN23PROD with NOTICES1
[Docket No. DEA–913]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Chattem Chemicals has
applied to be registered as a bulk
SUMMARY:
VerDate Sep<11>2014
17:47 Oct 21, 2021
Jkt 256001
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY 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 December 21, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 21, 2021.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on July 23, 2021, Chattem
Chemicals, 3801 Saint Elmo Avenue,
Chattanooga, Tennessee 37409–1237,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Gamma Hydroxybutyric Acid ....
Marihuana .................................
Tetrahydrocannabinols .............
4-Methoxyamphetamine ...........
Noroxymorphone ......................
Amphetamine ............................
Methamphetamine ....................
Lisdexamfetamine .....................
Methylphenidate ........................
Cocaine .....................................
Codeine .....................................
Dihydrocodeine .........................
Oxycodone ................................
Hydromorphone ........................
Ecgonine ...................................
Hydrocodone .............................
Levorphanol ..............................
Methadone ................................
Methadone intermediate ...........
Morphine ...................................
Oripavine ...................................
Thebaine ...................................
Oxymorphone ...........................
Noroxymorphone ......................
Alfentanil ...................................
Remifentanil ..............................
Sufentanil ..................................
Tapentadol ................................
Fentanyl ....................................
Drug
code
Schedule
2010
7360
7370
7411
9145
1100
1105
1205
1724
9041
9050
9120
9143
9150
9180
9193
9220
9250
9254
9300
9330
9333
9652
9668
9737
9739
9740
9780
9801
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
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers. In reference to drug code
7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as a synthetic.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
No other activities for this drug code
are authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–23037 Filed 10–21–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–919]
Importer of Controlled Substances
Application: Mycrodose Therapeutics
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mycrodose Therapeutics has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplementary
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 November 22, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 22, 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 September 17, 2021,
Mycrodose Therapeutics, 5940 Pacific
Mesa Court, Suite 210, San Diego,
California 92121–4317 applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUMMARY:
Controlled substance
Psilocybin ........................
Psilocyn ...........................
E:\FR\FM\22OCN1.SGM
22OCN1
I
Drug
code
Schedule
7437
7438
I
I
I
58692
Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
The company plans to import the
listed control substances for clinical
trials, research and development,
analytical purposes, and distribution to
its customers. 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
Controlled substance
Drug
code
Schedule
Marihuana Extract ............
Marihuana .........................
Tetrahydrocannabinols .....
7350
7360
7370
I
I
I
I
I
The company is federally authorized
to conduct cultivation activities in order
to bulk manufacture the listed
controlled substances for internal use
and for sale to federally registered
research investigators. No other
activities for these drug codes are
authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–23034 Filed 10–21–21; 8:45 am]
BILLING CODE P
[FR Doc. 2021–23036 Filed 10–21–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Controlled substance
Amphetamine ..................
Methylphenidate ..............
Nabilone ..........................
Codeine ...........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Methadone ......................
Methadone intermediate ..
Morphine ..........................
Thebaine ..........................
Oxymorphone ..................
Fentanyl ...........................
Drug
code
Schedule
1100
1724
7379
9050
9143
9150
9193
9250
9254
9300
9333
9652
9801
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to bulk
manufacture small quantities of the
listed controlled substances for internal
use or for sale as analytical reference
standard materials to its customers. No
other activities for these drug codes are
authorized for this registration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Brian S. Besser,
Acting Assistant Administrator.
[Docket No. DEA–914]
[FR Doc. 2021–23038 Filed 10–21–21; 8:45 am]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: Organic
Consultants, LLC. DBA Cascade
Chemistry
[Docket No. DEA–912]
Bulk Manufacturer of Controlled
Substances Application: Groff NA
Hemplex LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Groff NA Hemplex LLC has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY 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 December 21, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 21, 2021.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 16, 2021, Groff
NA Hemplex LLC, 100 Redco Avenue,
Suite A, Red Lion, Pennsylvania 17356–
1436, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:47 Oct 21, 2021
Jkt 256001
Organic Consultants, LLC.
DBA Cascade Chemistry, has applied to
be registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplementary
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 December 21, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 21, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on September 9, 2021,
Organic Consultants, LLC. DBA Cascade
Chemistry, 90 North Polk Street, Suite
200, Eugene, Oregon 97402–4109,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–911]
SUMMARY:
SUMMARY:
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Novitium Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Novitium Pharma 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.
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 November 22, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 22, 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 requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
SUMMARY:
E:\FR\FM\22OCN1.SGM
22OCN1
Agencies
[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58691-58692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23036]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-919]
Importer of Controlled Substances Application: Mycrodose
Therapeutics
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mycrodose Therapeutics has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplementary 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 November 22,
2021. Such persons may also file a written request for a hearing on the
application on or before November 22, 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 September 17, 2021, Mycrodose Therapeutics, 5940
Pacific Mesa Court, Suite 210, San Diego, California 92121-4317 applied
to be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
[[Page 58692]]
The company plans to import the listed control substances for
clinical trials, research and development, analytical purposes, and
distribution to its customers. 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-23036 Filed 10-21-21; 8:45 am]
BILLING CODE P