Importer of Controlled Substances Application: Veranova, L.P., 46906 [2024-11821]
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46906
Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
of the following basic class(es) of
controlled substance(s):
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1369]
Coca Leaves ...................
Thebaine ..........................
Opium, raw ......................
Noroxymorphone .............
Poppy Straw Concentrate
Fentanyl ...........................
Importer 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 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 1, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 1, 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,
Veranova, L.P., 2003 Nolte Drive, West
Deptford, New Jersey 08066–1727,
applied to be registered as an importer
ddrumheller on DSK120RN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
20:03 May 29, 2024
Jkt 262001
Drug
code
Schedule
9040
9333
9600
9668
9670
9801
II
II
II
II
II
II
The company plans to import Coca
Leaves (9040), Opium, raw (9600), and
Poppy Straw Concentrate (9670) in
order to bulk manufacture Active
Pharmaceutical Ingredients (API) for
distribution to its customers. The
company plans to also import Thebaine
(9333), Noroxymorphone (9668), and
Fentanyl (9801) to use as analytical
reference standards, both internally and
to be sold to their customers to support
testing of Veranova, L.P. APIs 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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11821 Filed 5–29–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
hearing on the application on or before
July 1, 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 9, 2024, ANI
Pharmaceuticals Inc., 70 Lake Drive,
East Windsor, New Jersey 08520–5321,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–1373]
Importer of Controlled Substances
Application: ANI Pharmaceuticals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
ANI Pharmaceuticals Inc.,
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 1, 2024. Such persons
may also file a written request for a
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Psilocybin ........................
Levorphanol .....................
Tapentadol ......................
I
Drug
code
Schedule
7437
9220
9780
I
II
II
I
Psilocybin (7437) will be imported for
use in dosage form development leading
to use in clinical trials. Levorphanol
(9220) will be imported for distribution
to customers. Tapentadol (9780) will be
used to import small quantities for
internal research and reference
standards purposes. 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-
E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Page 46906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11821]
[[Page 46906]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1369]
Importer 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 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 1, 2024. Such persons may also file a written request for a
hearing on the application on or before July 1, 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, Veranova, L.P., 2003 Nolte Drive, West
Deptford, New Jersey 08066-1727, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Coca Leaves............................. 9040 II
Thebaine................................ 9333 II
Opium, raw.............................. 9600 II
Noroxymorphone.......................... 9668 II
Poppy Straw Concentrate................. 9670 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to import Coca Leaves (9040), Opium, raw (9600),
and Poppy Straw Concentrate (9670) in order to bulk manufacture Active
Pharmaceutical Ingredients (API) for distribution to its customers. The
company plans to also import Thebaine (9333), Noroxymorphone (9668),
and Fentanyl (9801) to use as analytical reference standards, both
internally and to be sold to their customers to support testing of
Veranova, L.P. APIs 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 non-approved finished
dosage forms for commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-11821 Filed 5-29-24; 8:45 am]
BILLING CODE P
