Bulk Manufacturer of Controlled Substances Application: Purisys, LLC, 19325-19327 [2023-06687]
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19325
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
suspension agreements took effect on
March 17, 2023. The antidumping duty
suspension agreement is based upon an
agreement between Commerce and
producers/exporters which account for
substantially all imports of white grape
juice concentrate from Argentina, in
which each signatory producer/exporter
has agreed to revise its prices to
eliminate completely the injurious
effects of exports of WGJC to the United
States. The countervailing duty
suspension agreement is based upon an
agreement between Commerce and the
Government of Argentina (‘‘GOA’’),
wherein the GOA has agreed not to
provide any new or additional export or
import substitution subsidies on the
subject merchandise and has agreed to
restrict the volume of direct or indirect
exports to the United States of WGJC
from all Argentine producers/exporters
in order to eliminate completely the
injurious effects of exports of this
merchandise to the United States.
Accordingly, the U.S. International
Trade Commission gives notice of the
suspension of its antidumping and
countervailing duty investigations
involving imports of WGJC from
Argentina, provided for in subheading
2009.69.00 of the Harmonized Tariff
Schedule of the United States.
DATES:
March 24, 2023.
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Ahdia Bavari (202–205–3191), Office of
Investigations, U.S. International Trade
Commission, 500 E Street SW,
Washington, DC 20436. Hearingimpaired individuals are advised that
information on this matter can be
obtained by contacting the
Commission’s TDD terminal on 202–
205–1810. Persons with mobility
impairments who will need special
assistance in gaining access to the
Commission should contact the Office
of the Secretary at 202–205–2000.
General information concerning the
Commission may also be obtained by
accessing its internet server (https://
www.usitc.gov). The public record for
these investigations may be viewed on
the Commission’s electronic docket
(EDIS) at https://edis.usitc.gov.
Authority: These investigations are
being suspended under authority of title
VII of the Tariff Act of 1930 and
pursuant to section 207.40(b) of the
Commission’s Rules of Practice and
Procedure (19 CFR 207.40(b)). This
notice is published pursuant to section
201.10 of the Commission’s rules (19
CFR 201.10).
By order of the Commission.
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
Issued: March 27, 2023.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2023–06669 Filed 3–30–23; 8:45 am]
BILLING CODE 7020–02–P
INTERNATIONAL TRADE
COMMISSION
[USITC SE–23–018]
Sunshine Act Meetings
United
States International Trade Commission.
TIME AND DATE: April 7, 2023 at 11:00
a.m.
PLACE: Room 101, 500 E Street SW,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. Nos. 701–
TA–552 and 731–TA–1308 (Review)
(Pneumatic Off-the-Road (OTR) Tires
from India). The Commission currently
is scheduled to complete and file its
determinations and views of the
Commission on April 27, 2023.
5. Outstanding action jackets: none.
CONTACT PERSON FOR MORE INFORMATION:
Sharon Bellamy, Acting Supervisory
Hearings and Information Officer, 202–
205–2000.
The Commission is holding the
meeting under the Government in the
Sunshine Act, 5 U.S.C. 552(b). In
accordance with Commission policy,
subject matter listed above, not disposed
of at the scheduled meeting, may be
carried over to the agenda of the
following meeting.
AGENCY HOLDING THE MEETING:
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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before May 30, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 30, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on March 3, 2023, Sterling
Pharma USA LLC., 1001 Sheldon Drive,
Suite 101, Cary, North Carolina 27513–
2078, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Dimethyltryptamine .......
By order of the Commission.
Issued: March 29, 2023.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2023–06864 Filed 3–29–23; 4:15 pm]
BILLING CODE 7020–02–P
Drug
code
7435
Schedule
I
The company plans to manufacture
the above-listed controlled substance(s)
to support clinical trials. No other
activities for this drug code is
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2023–06698 Filed 3–30–23; 8:45 am]
Drug Enforcement Administration
BILLING CODE P
[Docket No. DEA–1174]
Bulk Manufacturer of Controlled
Substances Application: Sterling
Pharma USA LLC
Bulk Manufacturer of Controlled
Substances Application: Purisys, LLC
Sterling Pharma USA LLC.
has applied to be registered as a bulk
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–1172]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
SUMMARY:
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
AGENCY:
E:\FR\FM\31MRN1.SGM
31MRN1
19326
ACTION:
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
Notice of application.
Purisys, 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.
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 30, 2023. Such persons
may also file a written request for a
SUMMARY:
hearing on the application on or before
May 30, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on February 16, 2023,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substance(s):
ddrumheller on DSK120RN23PROD with NOTICES1
Controlled substance
Drug code
Cathinone ........................................................................................................................................................................
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Ibogaine ...........................................................................................................................................................................
Lysergic acid diethylamide ..............................................................................................................................................
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
2,5-Dimethoxyamphetamine ............................................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine .......................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N,N-dimethyltryptamine .................................................................................................................................
Diethyltryptamine .............................................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
5-Methyoxy-N,N-diisopropyltryptamine ............................................................................................................................
Codeine-N-oxide ..............................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Heroin ..............................................................................................................................................................................
Hydromorphinol ...............................................................................................................................................................
Morphine-N-oxide ............................................................................................................................................................
Normorphine ....................................................................................................................................................................
Norlevorphanol ................................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Pentobarbital ....................................................................................................................................................................
Nabilone ...........................................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Meperidine intermediate-A ..............................................................................................................................................
Meperidine intermediate-B ..............................................................................................................................................
Meperidine intermediate-C ..............................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Morphine ..........................................................................................................................................................................
Oripavine .........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Opium tincture .................................................................................................................................................................
Opium, powdered ............................................................................................................................................................
Opium, granulated ...........................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
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Fmt 4703
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E:\FR\FM\31MRN1.SGM
31MRN1
1235
2010
7260
7315
7350
7360
7370
7396
7400
7404
7405
7431
7434
7435
7437
7438
7439
9053
9145
9200
9301
9307
9313
9634
1100
1205
1724
2270
7379
9041
9050
9120
9143
9150
9180
9193
9220
9230
9232
9233
9234
9250
9254
9300
9330
9333
9630
9639
9640
9652
9668
9737
9740
9743
9780
9801
Schedule
I
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19327
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
The company plans to bulk
manufacture the listed controlled
substances for the production of active
pharmaceutical ingredients (API) and
analytical reference standards for sale to
its customers. The company plans to
manufacture the above listed controlled
substances as clinical trial and starting
materials to make compounds for
distribution to its customers. No other
activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06687 Filed 3–30–23; 8:45 am]
BILLING CODE P
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 February 22, 2023,
PerkinElmer, Inc., 120 East Dedham
Street, Boston, Massachusetts 02118–
2852, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
Lysergic Acid
Diethylamide.
Thebaine .......................
[Docket No. DEA–1167]
Importer of Controlled Substances
Application: PerkinElmer, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PerkinElmer, 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 1, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 1, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
Drug
code
Schedule
7315
I
9333
II
The company plans to import the
listed controlled substances for bulk
manufacturing into radioactive
formulations for sale to its customers for
research purposes. Drug code 9333
(Thebaine) will be used to import the
Thebaine derivative Diprenorphine. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06696 Filed 3–30–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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 30, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 30, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(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 a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
DATES:
Controlled substance
Psilocybin .....................
Levorphanol ..................
Drug
code
7437
9220
Schedule
I
I
The company plans to bulk
manufacture the listed controlled
substances for the internal use or for
sale to its customers. No other activities
for these drug codes are authorized for
this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–06700 Filed 3–30–23; 8:45 am]
[Docket No. DEA–1173]
BILLING CODE P
Bulk Manufacturer of Controlled
Substances Application: ANI
Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Drug Enforcement Administration
ANI Pharmaceuticals, Inc. 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.
Importer of Controlled Substances
Application: Lyndra Therapeutics
AGENCY:
SUMMARY:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
[Docket No. DEA–1165]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
E:\FR\FM\31MRN1.SGM
31MRN1
Agencies
[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19325-19327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06687]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1172]
Bulk Manufacturer of Controlled Substances Application: Purisys,
LLC
AGENCY: Drug Enforcement Administration, Justice.
[[Page 19326]]
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Purisys, 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.
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 30, 2023. Such persons may also file a written request for a
hearing on the application on or before May 30, 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 16, 2023, Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601-1602, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone................................ 1235 I
Gamma Hydroxybutyric Acid................ 2010 I
Ibogaine................................. 7260 I
Lysergic acid diethylamide............... 7315 I
Marihuana Extract........................ 7350 I
Marihuana................................ 7360 I
Tetrahydrocannabinols.................... 7370 I
2,5-Dimethoxyamphetamine................. 7396 I
3,4-Methylenedioxyamphetamine............ 7400 I
3,4-Methylenedioxy-N-ethylamphetamine.... 7404 I
3,4-Methylenedioxymethamphetamine........ 7405 I
5-Methoxy-N,N-dimethyltryptamine......... 7431 I
Diethyltryptamine........................ 7434 I
Dimethyltryptamine....................... 7435 I
Psilocybin............................... 7437 I
Psilocyn................................. 7438 I
5-Methyoxy-N,N-diisopropyltryptamine..... 7439 I
Codeine-N-oxide.......................... 9053 I
Dihydromorphine.......................... 9145 I
Heroin................................... 9200 I
Hydromorphinol........................... 9301 I
Morphine-N-oxide......................... 9307 I
Normorphine.............................. 9313 I
Norlevorphanol........................... 9634 I
Amphetamine.............................. 1100 II
Lisdexamfetamine......................... 1205 II
Methylphenidate.......................... 1724 II
Pentobarbital............................ 2270 II
Nabilone................................. 7379 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-A................ 9232 II
Meperidine intermediate-B................ 9233 II
Meperidine intermediate-C................ 9234 II
Methadone intermediate................... 9250 II
Methadone intermediate................... 9254 II
Morphine................................. 9300 II
Oripavine................................ 9330 II
Thebaine................................. 9333 II
Opium tincture........................... 9630 II
Opium, powdered.......................... 9639 II
Opium, granulated........................ 9640 II
Oxymorphone.............................. 9652 II
Noroxymorphone........................... 9668 II
Alfentanil............................... 9737 II
Sufentanil............................... 9740 II
Carfentanil.............................. 9743 II
Tapentadol............................... 9780 II
Fentanyl................................. 9801 II
------------------------------------------------------------------------
[[Page 19327]]
The company plans to bulk manufacture the listed controlled
substances for the production of active pharmaceutical ingredients
(API) and analytical reference standards for sale to its customers. The
company plans to manufacture the above listed controlled substances as
clinical trial and starting materials to make compounds for
distribution to its customers. No other activities for these drug codes
are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06687 Filed 3-30-23; 8:45 am]
BILLING CODE P