Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc., 71021-71022 [2023-22627]
Download as PDF
71021
Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices
All written submissions must conform
with the provisions of § 201.8 of the
Commission’s rules; any submissions
that contain BPI must also conform with
the requirements of §§ 201.6, 207.3, and
207.7 of the Commission’s rules. The
Commission’s Handbook on Filing
Procedures, available on the
Commission’s website at https://
www.usitc.gov/documents/handbook_
on_filing_procedures.pdf, elaborates
upon the Commission’s procedures with
respect to filings.
In accordance with §§ 201.16(c) and
207.3 of the rules, each document filed
by a party to the investigations must be
served on all other parties to the
investigations (as identified by either
the public or BPI service list), and a
certificate of service must be timely
filed. The Secretary will not accept a
document for filing without a certificate
of service.
Certification.—Pursuant to § 207.3 of
the Commission’s rules, any person
submitting information to the
Commission in connection with these
investigations must certify that the
information is accurate and complete to
the best of the submitter’s knowledge. In
making the certification, the submitter
will acknowledge that any information
that it submits to the Commission
during these investigations 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 these or related investigations or
reviews, 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. government employees and
contract personnel, solely for
cybersecurity purposes. All contract
personnel will sign appropriate
nondisclosure agreements.
Authority: These investigations are
being conducted under authority of title
VII of the Tariff Act of 1930; this notice
is published pursuant to § 207.12 of the
Commission’s rules.
By order of the Commission.
Issued: October 5, 2023.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2023–22519 Filed 10–12–23; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1280]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Chattem Chemicals, Inc., has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
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 December 12, 2023. Such
persons may also file a written request
for a hearing on the application on or
before December 12, 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 July 14, 2023, Chattem
Chemicals, Inc. 3801 Saint Elmo
Avenue, Chattanooga, Tennessee 37409,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
4-Methoxyamphetamine ..................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Morphine ..........................................................................................................................................................................
Oripavine .........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
VerDate Sep<11>2014
16:55 Oct 12, 2023
Jkt 262001
PO 00000
Frm 00102
Fmt 4703
Sfmt 4703
E:\FR\FM\13OCN1.SGM
13OCN1
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
Schedule
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
71022
Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices
Controlled substance
Drug code
Fentanyl ...........................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances in bulk for distribution and
sale to its customers. In reference to
drug codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as a synthetic. 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
manufacturing of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–22627 Filed 10–12–23; 8:45 am]
BILLING CODE P
[FR Doc. 2023–22623 Filed 10–12–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–1271]
Bulk Manufacturer of Controlled
Substances Application: Cambridge
Isotope Laboratories, Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Cambridge Isotope
Laboratories, 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.
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 December 12, 2023. Such
persons may also file a written request
for a hearing on the application on or
before December 12, 2023.
SUMMARY:
Drug code
lotter on DSK11XQN23PROD with NOTICES1
[Docket No. DEA–1273]
Bulk Manufacturer of Controlled
Substances Application: Curia New
York, Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Curia New York, Inc has
applied to be registered as a bulk
SUMMARY:
VerDate Sep<11>2014
16:55 Oct 12, 2023
Jkt 262001
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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before December 12, 2023. Such
persons may also file a written request
for a hearing on the application on or
before December 12, 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
ADDRESSES:
PO 00000
Frm 00103
Fmt 4703
Sfmt 4703
II
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 August 25, 2023,
Cambridge Isotope Laboratories, Inc 50
Frontage Road, Andover, Massachusetts
01810–5413, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Tetrahydrocannabinols ............................................................................................................................................
Claude Redd,
Acting Deputy Assistant Administrator.
9801
ADDRESSES:
DEPARTMENT OF JUSTICE
Controlled substance
The company plans to synthetically
bulk manufacture the controlled
substance Tetrahydrocannabinols to
produce analytical standards for
distribution to its customers. No other
activities for this drug code is
authorized for this registration.
Schedule
7370
Schedule
I
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 August 10, 2023, Curia
New York, Inc, 33 Riverside Avenue,
Rensselaer, New York 12144–2951,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Drug
code
Schedule
Marihuana ...................................
Tetrahydrocannabinols ...............
Amphetamine ..............................
Lisdexamfetamine .......................
Methylphenidate ..........................
Pentobarbital ...............................
Codeine .......................................
Dihydrocodeine ...........................
Oxycodone ..................................
Hydromorphone ..........................
Hydrocodone ...............................
Meperidine ..................................
Morphine .....................................
7360
7370
1100
1205
1724
2270
8333
9050
9143
9150
9193
9230
9300
I
I
II
II
II
II
II
II
II
II
II
II
II
E:\FR\FM\13OCN1.SGM
13OCN1
Agencies
[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 71021-71022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22627]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1280]
Bulk Manufacturer of Controlled Substances Application: Chattem
Chemicals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Chattem Chemicals, 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.
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
December 12, 2023. Such persons may also file a written request for a
hearing on the application on or before December 12, 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 July 14, 2023, Chattem Chemicals, Inc. 3801 Saint
Elmo Avenue, Chattanooga, Tennessee 37409, applied to be registered as
a bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.......... 2010 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
4-Methoxyamphetamine............... 7411 I
Dihydromorphine.................... 9145 I
Amphetamine........................ 1100 II
Methamphetamine.................... 1105 II
Lisdexamfetamine................... 1205 II
Methylphenidate.................... 1724 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
Methadone.......................... 9250 II
Methadone intermediate............. 9254 II
Morphine........................... 9300 II
Oripavine.......................... 9330 II
Thebaine........................... 9333 II
Oxymorphone........................ 9652 II
Noroxymorphone..................... 9668 II
Alfentanil......................... 9737 II
Remifentanil....................... 9739 II
Sufentanil......................... 9740 II
Tapentadol......................... 9780 II
[[Page 71022]]
Fentanyl........................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances in bulk for distribution and sale to its customers. In
reference to drug codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as a synthetic. 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
manufacturing of Food and Drug Administration-approved or non-approved
finished dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-22627 Filed 10-12-23; 8:45 am]
BILLING CODE P