Importer of Controlled Substances Application: Chattem Chemicals, 54353-54354 [2023-17139]
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54353
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
Controlled substance
Lysergic acid diethylamide ....
5-Methoxy-N,Ndimethyltryptamine.
Tapentadol ............................
Drug
code
Schedule
7315
7431
I
I
9780
II
The company plans to import the
listed controlled substances as finished
dosage units for use in 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17138 Filed 8–9–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1242]
Bulk Manufacturer of Controlled
Substances Application: Continuus
Pharmaceuticals
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 6, 2023, Continuus
Pharmaceuticals, 256 West Cummings
Park, Woburn, Massachusetts 01801,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Fentanyl ........................
Drug
code
9801
Schedule
II
The company plans to bulk
manufacture the above listed controlled
substance for research and development
purposes only. 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.
Claude Redd,
Acting Deputy Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[FR Doc. 2023–17136 Filed 8–9–23; 8:45 am]
BILLING CODE 4410–09–P
Continuus Pharmaceuticals
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 October 10, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 10, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:28 Aug 09, 2023
Jkt 259001
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1244]
Importer of Controlled Substances
Application: Chattem Chemicals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Chattem Chemicals 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 September 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 11, 2023.
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on July 14, 2023, Chattem
Chemicals, 3801 Saint Elmo Avenue,
Chattanooga, Tennessee 37409–1237,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
ADDRESSES:
Methamphetamine ........
4-Anilino-N-phenethyl-4piperidine (ANPP).
Phenylacetone ..............
Cocaine ........................
Poppy Straw Concentrate.
Tapentadol ....................
Drug
code
Schedule
1105
8333
II
II
8501
9041
9670
II
II
II
9780
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substances
for sale to its customers. The company
plans to import an intermediate of
Tapentadol (9780), to bulk manufacture
Tapentadol for distribution to its
customers. 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
E:\FR\FM\10AUN1.SGM
10AUN1
54354
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
Administration-approved or nonapproved finished dosage forms for
commercial sale.
CONTACT PERSON FOR MORE INFORMATION:
Claude Redd,
Acting Deputy Assistant Administrator.
Lakeyia Thompson,
Special Assistant.
[FR Doc. 2023–17139 Filed 8–9–23; 8:45 am]
[FR Doc. 2023–17215 Filed 8–8–23; 11:15 am]
BILLING CODE P
BILLING CODE 7570–02–P
NEIGHBORHOOD REINVESTMENT
CORPORATION
NUCLEAR REGULATORY
COMMISSION
Sunshine Act Meetings
[NRC–2023–0112]
2:00 p.m., Thursday,
August 17, 2023.
PLACE: 1255 Union Street NE, Fifth
Floor, Washington, DC 20002.
STATUS: Parts of this meeting will be
open to the public. The rest of the
meeting will be closed to the public.
MATTERS TO BE CONSIDERED: Regular
Board of Directors meeting.
The General Counsel of the
Corporation has certified that in his
opinion, one or more of the exemptions
set forth in the Government in the
Sunshine Act, 5 U.S.C. 552b(c)(2) and
(4) permit closure of the following
portion(s) of this meeting:
Discontinuation of the State of New
York’s Sealed Source and Device
Evaluation and Approval Authority
Lakeyia Thompson, Special Assistant,
(202) 524–9940; Lthompson@nw.org.
TIME AND DATE:
ddrumheller on DSK120RN23PROD with NOTICES1
• Executive Session
Agenda
I. CALL TO ORDER
II. Sunshine Act Approval of Executive
(Closed) Session
III. Executive Session: Report from CEO
IV. Executive Session: Report from CFO
V. Executive Session: GAO Workplan
VI. Executive Session: General Counsel
Report
VII. Executive Session: CIO Report
VIII. Executive Session: NeighborWorks
Compass Update
IX. Action Item Resolution of
Recognition of Service for Chairman
Gruenberg
X. Action Item Approval of Meeting
Minutes
XI. Action Item FY2024 Preliminary
Spend Plan
XII. Discussion Item August 3rd Special
Audit Committee Report
XIII. Discussion Item Annual Ethics
Review Follow Up
XIV. Discussion Item Professional
Learning and Event Management
Solution
XV. Discussion Item Atlanta Office
Lease
XVI. Management Program Background
and Updates
XVII. Adjournment
PORTIONS OPEN TO THE PUBLIC:
Everything except the Executive
Session.
PORTIONS CLOSED TO THE PUBLIC:
Executive Session.
VerDate Sep<11>2014
17:28 Aug 09, 2023
Jkt 259001
Nuclear Regulatory
Commission.
ACTION: Discontinuation of the State of
New York’s regulatory authority and
reassumption of U.S. Nuclear
Regulatory Commission’s authority.
AGENCY:
Notice is hereby given that
effective August 9, 2023, the U.S.
Nuclear Regulatory Commission (NRC)
has assumed regulatory authority to
evaluate and approve sealed source and
device (SS&D) applications in the State
of New York and approved the Governor
of the State of New York’s request to
relinquish this authority.
DATES: The NRC has assumed regulatory
authority for evaluating and approving
SS&D applications on August 9, 2023.
ADDRESSES: Please refer to Docket ID
NRC–2023–0112 when contacting the
NRC about the availability of
information regarding this document.
You may obtain publicly available
information related to this document
using any of the following methods:
• Federal Rulemaking Website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2023–0112. Address
questions about Docket IDs in
Regulations.gov to Stacy Schumann;
telephone: 301–415–0624; email:
Stacy.Schumann@nrc.gov. For technical
questions, contact the individuals listed
in the FOR FURTHER INFORMATION
CONTACT section of this document.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publicly
available documents online in the
ADAMS Public Documents collection at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘Begin Web-based ADAMS Search.’’ For
problems with ADAMS, please contact
the NRC’s Public Document Room (PDR)
reference staff at 1–800–397–4209, 301–
415–4737, or by email to
PDR.Resource@nrc.gov. The ADAMS
accession number for each document
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 9990
referenced (if it is available in ADAMS)
is provided the first time that it is
mentioned in this document.
• NRC’s PDR: The PDR, where you
may examine and order copies of
publicly available documents, is open
by appointment. To make an
appointment to visit the PDR, please
send an email to PDR.Resource@nrc.gov
or call 1–800–397–4209 or 301–415–
4737, between 8 a.m. and 4 p.m. eastern
time (ET), Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Robert Johnson, Office of Nuclear
Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, telephone:
301–415–7314, email: Robert.Johnson@
nrc.gov.
Section
274b. of the Atomic Energy Act (AEA)
of 1954, as amended, provides the
authority for NRC to enter into
agreements with States that allow the
States to assume, and the NRC to
discontinue, regulatory authority over
specified AEA radioactive materials and
activities. On October 15, 1962, New
York entered a section 274b. Agreement
with the Atomic Energy Commission
(the predecessor regulatory agency to
the NRC) to regulate source material,
byproduct material, and special nuclear
material in quantities not sufficient to
form a critical mass. This Agreement
also provides the State regulatory
authority to evaluate and approve SS&D
applications.
On May 9, 2023, the NRC received a
letter from New York Governor Kathy
Hochul (ADAMS Accession No.
ML23131A254) requesting
discontinuation of the State’s regulatory
authority to evaluate and approve SS&D
applications and for reassumption of
this authority by the NRC. The
Commission approved the request and
has notified the State of New York that
effective August 9, 2023, the NRC has
reassumed authority to evaluate and
approve SS&D applications within the
State (ADAMS Accession No.
ML23138A033). The State of New York
will retain authority to regulate the
manufacture and use of SS&Ds within
the State in accordance with its section
274b. Agreement with the NRC.
SUPPLEMENTARY INFORMATION:
Dated: August 3, 2023.
For the Nuclear Regulatory Commission.
Brooke P. Clark,
Secretary of the Commission.
[FR Doc. 2023–16932 Filed 8–9–23; 8:45 am]
BILLING CODE 7590–01–P
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54353-54354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17139]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1244]
Importer of Controlled Substances Application: Chattem Chemicals
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Chattem Chemicals 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
September 11, 2023. Such persons may also file a written request for a
hearing on the application on or before September 11, 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, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on July 14, 2023, Chattem Chemicals, 3801 Saint Elmo
Avenue, Chattanooga, Tennessee 37409-1237, applied to be registered as
an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methamphetamine........................ 1105 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Phenylacetone.......................... 8501 II
Cocaine................................ 9041 II
Poppy Straw Concentrate................ 9670 II
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances to
manufacture bulk controlled substances for sale to its customers. The
company plans to import an intermediate of Tapentadol (9780), to bulk
manufacture Tapentadol for distribution to its customers. 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
[[Page 54354]]
Administration-approved or non-approved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17139 Filed 8-9-23; 8:45 am]
BILLING CODE P
