Bulk Manufacturer of Controlled Substances Application: Veranova, L.P., 48690-48691 [2024-12576]
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48690
Federal Register / Vol. 89, No. 111 / Friday, June 7, 2024 / Notices
Controlled substance
Drug code
Morphine ..............................................................................................................................................................................
Oripavine .............................................................................................................................................................................
Thebaine ..............................................................................................................................................................................
Oxymorphone ......................................................................................................................................................................
Phenazocine ........................................................................................................................................................................
Carfentanil ...........................................................................................................................................................................
Fentanyl ...............................................................................................................................................................................
Drug Enforcement Administration
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.
[Docket No. DEA–1383]
SUPPLEMENTARY INFORMATION:
The company plans to bulk
manufacture the listed controlled
substances for internal use as
intermediates or for sale to its
customers. The company plans to
manufacture small quantities of the
above listed controlled substances as
radiolabeled compounds for
biochemical research. In reference to
drug code 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–12567 Filed 6–6–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Usona Institute
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Usona Institute 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.
SUMMARY:
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
DATES:
VerDate Sep<11>2014
18:54 Jun 06, 2024
Jkt 262001
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 13, 2024, Usona
Institute, 2780 Woods Hollow Road,
Room 2412, Fitchburg, Wisconsin
53711–5370, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Controlled substance
5-Methoxy-N-Ndimethyltryptamine.
Dimethyltryptamine ..........
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7431
I
7435
7437
7438
I
I
I
The company plans to import the
listed controlled substances for research
and analytical purposes. The materials
will not be used for clinical trials or
human consumption. 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 non-
PO 00000
Frm 00141
Fmt 4703
Sfmt 4703
9300
9330
9333
9652
9715
9743
9801
Schedule
II
II
II
II
II
II
II
approved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–12575 Filed 6–6–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1384]
Bulk Manufacturer of Controlled
Substances Application: Veranova,
L.P.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Veranova, L.P., 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 August 6, 2024. Such
persons may also file a written request
for a hearing on the application on or
before August 6, 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.
SUMMARY:
E:\FR\FM\07JNN1.SGM
07JNN1
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]
[Pages 48690-48691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12576]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1384]
Bulk Manufacturer of Controlled Substances Application: Veranova,
L.P.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Veranova, L.P., 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
August 6, 2024. Such persons may also file a written request for a
hearing on the application on or before August 6, 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.
[[Page 48691]]
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on May 9, 2024, Veranova, 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 Schedule
------------------------------------------------------------------------
Amphetamine......................... 1100 II
Methylphenidate..................... 1724 II
Nabilone............................ 7379 II
Hydrocodone......................... 9193 II
Levorphanol......................... 9220 II
Thebaine............................ 9333 II
Alfentanil.......................... 9737 II
Remifentanil........................ 9739 II
Sufentanil.......................... 9740 II
------------------------------------------------------------------------
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