Importer of Controlled Substances Application: Unither Manufacturing LLC, 48691 [2024-12562]
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48691
Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
In
accordance with 21 CFR 1301.33(a), this
is notice that on May 9, 2024, Veranova,
SUPPLEMENTARY INFORMATION:
L.P., 25 Patton Road, Pharmaceutical
Service, Devens, Massachusetts 01434–
3803, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Drug code
Amphetamine .................................................................................................................................................................
Methylphenidate .............................................................................................................................................................
Nabilone .........................................................................................................................................................................
Hydrocodone ..................................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Thebaine ........................................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances in order to support the
manufacturing and analytical testing
activities at its other Drug Enforcement
Administration-registered
manufacturing facility. No other
activities for these drug codes are
authorized for this registration.
Matthew J. Strait,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–12576 Filed 6–6–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1372]
Importer of Controlled Substances
Application: Unither Manufacturing
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Unither Manufacturing LLC
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before July 8, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 8, 2024.
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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:23 Jun 06, 2024
Jkt 262001
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 April 8, 2024, Unither
Manufacturing LLC, 331 Clay Road,
Rochester, New York 14623–3226,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Drug
code
Controlled substance
Methylphenidate .............
Schedule
I 1724 III
The company plans to import the
listed controlled substances solely for
updated analytical testing purposes to
meet European Union requirements for
their finished dosage form product. This
analysis is required to allow the
company to export domestically
manufactured finished dosage forms to
foreign markets. 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).
PO 00000
Frm 00142
Fmt 4703
Sfmt 4703
1100
1724
7379
9193
9220
9333
9737
9739
9740
Schedule
II
II
II
II
II
II
II
II
II
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–12562 Filed 6–6–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2012–0017]
Reports of Injuries to Employees
Operating Mechanical Power Presses;
Extension of the Office of Management
and Budget’s (OMB) Approval of
Information Collection (Paperwork)
Requirements
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Request for public comments.
AGENCY:
OSHA solicits public
comments concerning the proposal to
extend the Office of Management and
Budget’s (OMB) approval of the
information collection requirements
specified in the Reports of Injuries to
Employees Operating Mechanical Power
Presses.
DATES: Comments must be submitted
(postmarked, sent, or received) by
August 6, 2024.
ADDRESSES:
Electronically: You may submit
comments and attachments
electronically at https://
www.regulations.gov, which is the
Federal eRulemaking Portal. Follow the
instructions online for submitting
comments.
Docket: To read or download
comments or other material in the
docket, go to https://
www.regulations.gov. Documents in the
SUMMARY:
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Page 48691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12562]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1372]
Importer of Controlled Substances Application: Unither
Manufacturing LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Unither Manufacturing LLC has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
July 8, 2024. Such persons may also file a written request for a
hearing on the application on or before July 8, 2024.
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 April 8, 2024, Unither Manufacturing LLC, 331 Clay
Road, Rochester, New York 14623-3226, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances solely
for updated analytical testing purposes to meet European Union
requirements for their finished dosage form product. This analysis is
required to allow the company to export domestically manufactured
finished dosage forms to foreign markets. 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 non-approved finished
dosage forms for commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-12562 Filed 6-6-24; 8:45 am]
BILLING CODE 4410-09-P
