Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC, 67723-67725 [2021-25954]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
with an explicit carveout to exempt the
products of terminated respondents
Benepuri LLC and Nukun Technology
Co., Ltd. In the alternative, the ALJ
recommended the issuance of a limited
exclusion order (‘‘LEO’’) as to subject
products imported, sold for importation,
and/or sold after importation by each
defaulting respondent: (1) Suzhou
Kaidiya Garments Trading Co., Ltd.; (2)
Yiwu City Qiaoyu Trading Co., Ltd.
(‘‘Yiwu City’’); (3) Wenzhou Wending
Electric Appliance Co., Ltd.; (4)
Shenzhen Aiweilai Trading Co., Ltd.; (5)
Shenzhen Junmao International
Technology Co., Ltd.; (6) Shenzhen
Wantong Information Technology Co.,
Ltd.; (7) Yiwu Xingye Network
Technology Co., Ltd. (‘‘Yiwu Xingye’’);
and (8) Bald Shaver Inc. (‘‘Bald
Shaver’’).1 Regardless of whether a GEO
or LEO issues, the ALJ also
recommended the issuance of cease and
desist orders as to defaulting
respondents Yiwu City and Yiwu
Xingye, based on findings that they, and
not the other defaulting respondents,
maintain a commercially significant
inventory of subject products in the
United States. The ALJ further
recommended that bond during the
Presidential review period be set at one
hundred percent (100%) of the entered
value of subject products. Parties are to
file public interest submissions
pursuant to 19 CFR 210.50(a)(4).
The Commission is interested in
further development of the record on
the public interest in this investigation.
Accordingly, members of the public are
invited to file submissions of no more
than five (5) pages, inclusive of
attachments, concerning the public
interest in light of the ALJ’s ID/RD.
Comments should address whether
issuance of the recommended remedial
orders in this investigation, should the
Commission find a violation, would
affect the public health and welfare in
the United States, competitive
conditions in the United States
economy, the production of like or
directly competitive articles in the
United States, or United States
consumers.
In particular, the Commission is
interested in comments that:
(i) Explain how the articles
potentially subject to the recommended
remedial orders are used in the United
States;
(ii) identify any public health, safety,
or welfare concerns in the United States
relating to the recommended orders;
1 The ALJ’s initial determination finding Bald
Shaver in default, Order No. 32 (Nov. 18, 2021), is
currently pending before the Commission.
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16:55 Nov 26, 2021
Jkt 256001
(iii) identify like or directly
competitive articles that complainant,
its licensees, or third parties make in the
United States which could replace the
subject articles if they were to be
excluded;
(iv) indicate whether complainant,
complainant’s licensees, and/or thirdparty suppliers have the capacity to
replace the volume of articles
potentially subject to the recommended
orders within a commercially
reasonable time; and
(v) explain how the recommended
orders would impact consumers in the
United States.
Written submissions must be filed no
later than by close of business on
December 18, 2021.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above. The Commission’s paper
filing requirements in 19 CFR 210.4(f)
are currently waived. 85 FR 15798 (Mar.
19, 2020). Submissions should refer to
the investigation number (‘‘Inv. No.
337–TA–1230’’) in a prominent place on
the cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
documents/handbook_on_filing_
procedures.pdf.) Persons with questions
regarding filing should contact the
Secretary (202–205–2000).
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment by marking each document
with a header indicating that the
document contains confidential
information. This marking will be
deemed to satisfy the request procedure
set forth in Rules 201.6(b) and
210.5(e)(2) (19 CFR 201.6(b) &
210.5(e)(2)). Documents for which
confidential treatment by the
Commission is properly sought will be
treated accordingly. A redacted nonconfidential version of the document
must also be filed simultaneously with
any confidential filing. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
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67723
government employees and contract
personnel, solely for cybersecurity
purposes. All contract personnel will
sign appropriate nondisclosure
agreements. All nonconfidential written
submissions will be available for public
inspection on EDIS.
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and in Part 210 of the Commission’s
Rules of Practice and Procedure (19 CFR
part 210).
By order of the Commission.
Issued: November 22, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–25866 Filed 11–26–21; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–931]
Bulk Manufacturer of Controlled
Substances Application: IsoSciences,
LLC
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
IsoSciences, 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.
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 January 28, 2022. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2022.
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 November 4, 2021,
IsoSciences, LLC, 340 Mathers Road,
Ambler, Pennsylvania 19002–3420,
applied to be registered as a bulk
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29NON1.SGM
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67724
Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
manufacturer of the following basic
class(es) of controlled substance(s):
khammond on DSKJM1Z7X2PROD with NOTICES
Controlled substance
Cathinone .......................................................................................................................................................................................
Methcathinone ...............................................................................................................................................................................
Lysergic acid diethylamide ............................................................................................................................................................
Marihuana ......................................................................................................................................................................................
Tetrahydrocannabinols ..................................................................................................................................................................
3,4-Methylenedioxyamphetamine ..................................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine .....................................................................................................................................
3,4-Methylenedioxymethamphetamine ..........................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine ...............................................................................................................................................
Alpha-methyltryptamine .................................................................................................................................................................
Bufotenine ......................................................................................................................................................................................
Diethyltryptamine ...........................................................................................................................................................................
Dimethyltryptamine ........................................................................................................................................................................
Psilocybin .......................................................................................................................................................................................
Psilocyn ..........................................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................
Dihydromorphine ............................................................................................................................................................................
Heroin ............................................................................................................................................................................................
Nicocodeine ...................................................................................................................................................................................
Nicomorphine .................................................................................................................................................................................
Normorphine ..................................................................................................................................................................................
Thebacon .......................................................................................................................................................................................
Normethadone ...............................................................................................................................................................................
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) ...............................................................................................
Para-Fluorofentanyl .......................................................................................................................................................................
3-Methylfentanyl .............................................................................................................................................................................
Alpha-methylfentanyl .....................................................................................................................................................................
Acetyl-alpha-methylfentanyl ...........................................................................................................................................................
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide .....................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) .............................................................................................
Butyryl Fentanyl .............................................................................................................................................................................
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) .......................................................
2-Methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide .......................................................................................................
Beta-hydroxyfentanyl .....................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ......................................................................................................................................................
Alpha-methylthiofentanyl ................................................................................................................................................................
3-Methylthiofentanyl .......................................................................................................................................................................
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) ...........................................................................
Thiofentanyl ...................................................................................................................................................................................
Beta-hydroxythiofentanyl ...............................................................................................................................................................
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide ........................................................................................
Amphetamine .................................................................................................................................................................................
Methamphetamine .........................................................................................................................................................................
Codeine ..........................................................................................................................................................................................
Dihydrocodeine ..............................................................................................................................................................................
Oxycodone .....................................................................................................................................................................................
Hydromorphone .............................................................................................................................................................................
Hydrocodone ..................................................................................................................................................................................
Isomethadone ................................................................................................................................................................................
Methadone .....................................................................................................................................................................................
Methadone intermediate ................................................................................................................................................................
Morphine ........................................................................................................................................................................................
Thebaine ........................................................................................................................................................................................
Levo-alphacetylmethadol ...............................................................................................................................................................
Oxymorphone ................................................................................................................................................................................
Thiafentanil ....................................................................................................................................................................................
Alfentanil ........................................................................................................................................................................................
Sufentanil .......................................................................................................................................................................................
Carfentanil ......................................................................................................................................................................................
Fentanyl .........................................................................................................................................................................................
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29NON1
Drug
code
Schedule
1235
1237
7315
7360
7370
7400
7404
7405
7431
7432
7433
7434
7435
7437
7438
7439
9145
9200
9309
9312
9313
9315
9635
9811
9812
9813
9814
9815
9816
9821
9822
9824
9825
9830
9831
9832
9833
9834
9835
9836
9843
1100
1105
9050
9120
9143
9150
9193
9226
9250
9254
9300
9333
9648
9652
9729
9737
9740
9743
9801
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Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
The company plans to manufacture
bulk controlled substances for use in
analytical testing. 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.
Brian S. Besser,
Acting Assistant Administrator.
Ingredient (API) for distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
BILLING CODE 4410–09–P
[FR Doc. 2021–25950 Filed 11–26–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed First
Amendment to Consent Decree
[Docket No. DEA–929]
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Pisgah
Laboratories Inc.
Drug Enforcement Administration
[Docket No. DEA–930]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Patheon API Manufacturing,
Inc., has applied to be registered as a
bulk manufacturer 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 January 28, 2022. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 3, 2021,
Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South
Carolina 29605–5420, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Drug
code
Schedule
7435
7438
I
I
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
VerDate Sep<11>2014
16:55 Nov 26, 2021
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Pisgah Laboratories Inc. has
applied to be registered as a bulk
manufacturer 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 January 28, 2022. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Dimethyltryptamine .........
Psilocyn ..........................
Jkt 256001
Brian S. Besser,
Acting Assistant Administrator.
Drug Enforcement Administration
BILLING CODE P
Controlled substance
No other activities for these drug codes
are authorized for this registration.
[FR Doc. 2021–25949 Filed 11–26–21; 8:45 am]
DEPARTMENT OF JUSTICE
[FR Doc. 2021–25954 Filed 11–26–21; 8:45 am]
67725
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 30, 2021, Pisgah
Laboratories Inc., 3222 Old
Hendersonville Highway, Pisgah Forest,
North Carolina 28768, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Difenoxin .........................
Methylphenidate .............
Diphenoxylate .................
Levorphanol ....................
Remifentanil ....................
Tapentadol ......................
Drug
code
Schedule
9168
1724
9170
9220
9739
9780
I
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
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On November 19, 2021, the
Department of Justice lodged a proposed
First Amendment to Consent Decree
with the United States District Court for
the Western District of Louisiana in the
lawsuit entitled United States et al. v.
Sid Richardson Carbon, Ltd (M.D. La.),
Civil Action No. 3:17–cv–01792.
The Consent Decree, entered by the
Court on August 14, 2018, resolved
claims by the United States, the State of
Texas, and the State of Louisiana
alleging violations of certain Clean Air
Act provisions at three carbon black
manufacturing facilities owned and
operated by Sid Richardson (now
‘‘Tokai’’). The Consent Decree requires
Defendant to reduce harmful SO2, NOX,
and PM emissions through the
installation and operation of pollution
controls. Defendant also agreed to spend
$490,000 to fund environmental
mitigation projects that will further
reduce emissions and benefit
communities adversely affected by the
pollution from the facilities, and pay a
civil penalty of $999,000.
The proposed First Amendment to
Consent Decree would, if entered by the
Court, make modifications to the
Consent Decree to address and resolve
claims by Defendant that force majeure
events caused delays in meeting certain
compliance deadlines at Defendant’s
Borger, Texas facility. The modifications
extend certain deadlines in the Consent
Decree, while maintaining Defendant’s
ultimate obligation to install and
operate pollution controls at its
facilities.
The publication of this notice opens
a period for public comment on the
proposed First Amendment to Consent
Decree. Comments should be addressed
to the Assistant Attorney General,
Environment and Natural Resources
Division, and should refer to United
States et al. v. Sid Richardson Carbon,
Ltd. (M.D. La.), D.J. Ref. No. 90–5–2–1–
10663. All comments must be submitted
no later than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67723-67725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25954]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-931]
Bulk Manufacturer of Controlled Substances Application:
IsoSciences, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: IsoSciences, 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 file written comments on or objections to
the issuance of the proposed registration on or before January 28,
2022. Such persons may also file a written request for a hearing on the
application on or before January 28, 2022.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on November 4, 2021, IsoSciences, LLC, 340 Mathers Road,
Ambler, Pennsylvania 19002-3420, applied to be registered as a bulk
[[Page 67724]]
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Cathinone........................................... 1235 I
Methcathinone....................................... 1237 I
Lysergic acid diethylamide.......................... 7315 I
Marihuana........................................... 7360 I
Tetrahydrocannabinols............................... 7370 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
Alpha-methyltryptamine.............................. 7432 I
Bufotenine.......................................... 7433 I
Diethyltryptamine................................... 7434 I
Dimethyltryptamine.................................. 7435 I
Psilocybin.......................................... 7437 I
Psilocyn............................................ 7438 I
5-Methoxy-N,N-diisopropyltryptamine................. 7439 I
Dihydromorphine..................................... 9145 I
Heroin.............................................. 9200 I
Nicocodeine......................................... 9309 I
Nicomorphine........................................ 9312 I
Normorphine......................................... 9313 I
Thebacon............................................ 9315 I
Normethadone........................................ 9635 I
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9811 I
phenylacrylamide)..................................
Para-Fluorofentanyl................................. 9812 I
3-Methylfentanyl.................................... 9813 I
Alpha-methylfentanyl................................ 9814 I
Acetyl-alpha-methylfentanyl......................... 9815 I
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4- 9816 I
yl)propionamide....................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9821 I
phenylacetamide)...................................
Butyryl Fentanyl.................................... 9822 I
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1- 9824 I
phenethylpiperidin-4-yl)isobutyramide).............
2-Methoxy-N-(1-phenethylpiperidin-4-yl)-N- 9825 I
phenylacetamide....................................
Beta-hydroxyfentanyl................................ 9830 I
Beta-hydroxy-3-methylfentanyl....................... 9831 I
Alpha-methylthiofentanyl............................ 9832 I
3-Methylthiofentanyl................................ 9833 I
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9834 I
phenylfuran-2-carboxamide).........................
Thiofentanyl........................................ 9835 I
Beta-hydroxythiofentanyl............................ 9836 I
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-carboxamide................
Amphetamine......................................... 1100 II
Methamphetamine..................................... 1105 II
Codeine............................................. 9050 II
Dihydrocodeine...................................... 9120 II
Oxycodone........................................... 9143 II
Hydromorphone....................................... 9150 II
Hydrocodone......................................... 9193 II
Isomethadone........................................ 9226 II
Methadone........................................... 9250 II
Methadone intermediate.............................. 9254 II
Morphine............................................ 9300 II
Thebaine............................................ 9333 II
Levo-alphacetylmethadol............................. 9648 II
Oxymorphone......................................... 9652 II
Thiafentanil........................................ 9729 II
Alfentanil.......................................... 9737 II
Sufentanil.......................................... 9740 II
Carfentanil......................................... 9743 II
Fentanyl............................................ 9801 II
------------------------------------------------------------------------
[[Page 67725]]
The company plans to manufacture bulk controlled substances for use
in analytical testing. 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-25954 Filed 11-26-21; 8:45 am]
BILLING CODE P
