Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 3763 [2023-01047]
Download as PDF
<![CDATA[
3763
Federal Register / Vol. 88, No. 13 / Friday, January 20, 2023 / Notices
DEPARTMENT OF JUSTICE
Controlled substance
Drug
code
Schedule
Drug Enforcement Administration
[Docket No. DEA–1116]
Importer of Controlled Substances
Application: Noramco
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Noramco 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 February 21, 2023. Such
persons may also file a written request
for a hearing on the application on or
before February 21, 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 October 19, 2022,
Noramco, 500 Swedes Landing Road,
Wilmington, Delaware 19801–4417,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
lotter on DSK11XQN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
17:29 Jan 19, 2023
Jkt 259001
Gamma Hydroxybutyric
Acid.
Marihuana .....................
Tetrahydrocannabinols
Nabilone .......................
Phenylacetone ..............
Opium, Raw ..................
Opium Extracts .............
Opium Fluid Extract ......
Opium Tincture .............
Opium Powdered ..........
Opium Granulated ........
Opium Poppy/Poppy
Straw.
Noroxymorphone ..........
Poppy Straw Concentrate.
Tapentadol ....................
2010
I
7360
7370
7379
8501
9600
9610
9620
9630
9639
9640
9650
I
I
II
II
II
II
II
II
II
II
II
9668
9670
II
II
9780
II
The company plans to import
Phenylacetone (8501), and Poppy Straw
Concentrate (9670) to bulk manufacture
other controlled substances for
distribution to its customers. The
company plans to import an
intermediate form of Tapentadol (9780)
to bulk manufacture Tapentadol for
distribution to its customers. In
reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to import a synthetic cannabidiol
and a synthetic Tetrahydrocannabinol.
No other activity for these drug codes 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 nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
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 March 21, 2023. Such
persons may also file a written request
for a hearing on the application on or
before March 21, 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
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on October 6, 2022,
Navinta LLC, 1499 Lower Ferry Road,
Ewing, New Jersey 08618–1414, applied
to be registered as a bulk manufacturer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Pentobarbital ................
Levomethorphan ...........
Levorphanol ..................
Remifentanil ..................
Drug
code
2270
9210
9220
9739
Schedule
II
II
II
II
[FR Doc. 2023–01033 Filed 1–19–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1127]
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The company plans to bulk
manufacture Active Pharmaceutical
Ingredients (API) quantities of the listed
controlled substances for validation
purpose and the Food and Drug
Administration approval. No other
activities for these drug codes are
authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–01047 Filed 1–19–23; 8:45 am]
BILLING CODE 4410–09–P
Navinta LLC 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.
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 9990
E:\FR\FM\20JAN1.SGM
20JAN1
]]>Agencies
[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Notices]
[Page 3763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01047]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1127]
Bulk Manufacturer of Controlled Substances Application: Navinta
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Navinta LLC 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
March 21, 2023. Such persons may also file a written request for a
hearing on the application on or before March 21, 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 October 6, 2022, Navinta LLC, 1499 Lower Ferry Road,
Ewing, New Jersey 08618-1414, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Pentobarbital.......................... 2270 II
Levomethorphan......................... 9210 II
Levorphanol............................ 9220 II
Remifentanil........................... 9739 II
------------------------------------------------------------------------
The company plans to bulk manufacture Active Pharmaceutical
Ingredients (API) quantities of the listed controlled substances for
validation purpose and the Food and Drug Administration approval. No
other activities for these drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01047 Filed 1-19-23; 8:45 am]
BILLING CODE 4410-09-P
