Importer of Controlled Substances Application: SpecGX LLC, 19988-19989 [2023-06953]
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<![CDATA[
19988
Federal Register / Vol. 88, No. 64 / Tuesday, April 4, 2023 / Notices
Dated: March 30, 2023.
Thomas V. Curtin, Jr.,
Executive Director, Joint Board for the
Enrollment of Actuaries.
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on February 8, 2023, Sharp
Clinical Services, LLC, 2400 Baglyos
Circle, Bethlehem, Pennsylvania 18020–
8024, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
[FR Doc. 2023–06977 Filed 4–3–23; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug
code
Controlled substance
[Docket No. DEA–1160]
Importer of Controlled Substances
Application: Sharp Clinical Services,
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Gamma Hydroxybutyric Acid
3,4Methylenedioxymethamphetamine.
5-Methoxy-N-Ndimethyltryptamine.
Schedule
2010
7405
I
I
7431
I
AGENCY:
Sharp Clinical Services, LLC
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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 4, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 4, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:41 Apr 03, 2023
Jkt 259001
The company plans to import the
listed controlled substances for
distribution and clinical trials. No other
activities for these drug codes are
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06948 Filed 4–3–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on January 28, 2023,
SpecGX LLC, 3600 North 2nd Street,
Saint Louis, Missouri 63147, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1177]
Importer of Controlled Substances
Application: SpecGX LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
SpecGX, 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 4, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 4, 2023.
ADDRESSES: The Drug Enforcement
Administration (DEA) requires that all
SUMMARY:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
Marihuana .....................
Phenylacetone ..............
Coca Leaves ................
Thebaine .......................
Opium, Raw ..................
Poppy Straw Concentrate.
Tapentadol ....................
Drug
code
Schedule
7360
8501
9040
9333
9600
9670
I
II
II
II
II
II
9780
II
The company plans to import the
listed controlled substances for bulk
manufacture into Active Pharmaceutical
Ingredients (API) for distribution to its
customers. In reference to Tapentadol
(9780) and Thebaine (9333), the
company plans to import intermediate
forms of these controlled substances for
further manufacturing prior to
distribution to its customers. In
reference to drug code 7360
(Marihuana), the company plans to
import synthetic cannabinol. No other
activity for this drug is authorized for
this registration. Placement of these
codes onto the company’s registration
does not translate into automatic
approval of subsequent permit
E:\FR\FM\04APN1.SGM
04APN1
19989
Federal Register / Vol. 88, No. 64 / Tuesday, April 4, 2023 / Notices
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 Food
and Drug Administration-approved or
non-approved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06953 Filed 4–3–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Controlled
substance
Drug Enforcement Administration
Importer of Controlled Substances
Application: ANI Pharmaceuticals, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
ANI Pharmaceuticals, Inc. 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 4, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 4, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
19:41 Apr 03, 2023
Drug
code
Psilocybin ...
Levorphanol
[Docket No. DEA–1178]
VerDate Sep<11>2014
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on March 3, 2023, ANI
Pharmaceuticals, Inc., 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Jkt 259001
Schedule
7437
9220
I
II
Psilocybin (7437) will be imported to
support research, formulation
development, and clinical trials of an
experimental drug product for the
United States market. Levorphanol
(9220) will be imported as bulk active
pharmaceutical ingredient (API) to
support the manufacturing of Food and
Drug Administration-approved dosage
forms for distribution in the United
States. No other activities for these drug
codes are 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.
Matthew Strait,
Deputy Assistant Administrator.
Supplementary Information listed below
for further drug information.
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before June 5, 2023. Such persons
may also file a written request for a
hearing on the application on or before
June 5, 2023.
DATES:
The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 14, 2023,
Research Triangle Institute, 3040 East
Cornwallis Road, Hermann Building,
Room 106, Research Triangle Park,
North Carolina 27709, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
[FR Doc. 2023–06949 Filed 4–3–23; 8:45 am]
Tetrahydrocannabinols .........
Drug
code
7370
Schedule
I
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1175]
Bulk Manufacturer of Controlled
Substances Application: Research
Triangle Institute
The company plans to bulk
manufacture the listed controlled
substance synthetically for distribution
to its customers for research and as
analytical reference standards. No other
activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06951 Filed 4–3–23; 8:45 am]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
BILLING CODE 4410–09–P
Research Triangle Institute
has applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
PO 00000
Frm 00087
Fmt 4703
Sfmt 9990
E:\FR\FM\04APN1.SGM
04APN1
]]>Agencies
[Federal Register Volume 88, Number 64 (Tuesday, April 4, 2023)]
[Notices]
[Pages 19988-19989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06953]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1177]
Importer of Controlled Substances Application: SpecGX LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: SpecGX, 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
May 4, 2023. Such persons may also file a written request for a hearing
on the application on or before May 4, 2023.
ADDRESSES: The Drug Enforcement Administration (DEA) requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on January 28, 2023, SpecGX LLC, 3600 North 2nd Street,
Saint Louis, Missouri 63147, applied to be registered as an importer of
the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Phenylacetone.......................... 8501 II
Coca Leaves............................ 9040 II
Thebaine............................... 9333 II
Opium, Raw............................. 9600 II
Poppy Straw Concentrate................ 9670 II
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
bulk manufacture into Active Pharmaceutical Ingredients (API) for
distribution to its customers. In reference to Tapentadol (9780) and
Thebaine (9333), the company plans to import intermediate forms of
these controlled substances for further manufacturing prior to
distribution to its customers. In reference to drug code 7360
(Marihuana), the company plans to import synthetic cannabinol. No other
activity for this drug is authorized for this registration. Placement
of these codes onto the company's registration does not translate into
automatic approval of subsequent permit
[[Page 19989]]
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 Food and Drug
Administration-approved or non-approved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06953 Filed 4-3-23; 8:45 am]
BILLING CODE P
