Importer of Controlled Substances Application: Novitium Pharma LLC, 58692-58693 [2021-23032]
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58692
Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
The company plans to import the
listed control substances for clinical
trials, research and development,
analytical purposes, and distribution to
its customers. 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.
Brian S. Besser,
Acting Assistant Administrator.
Controlled substance
Drug
code
Schedule
Marihuana Extract ............
Marihuana .........................
Tetrahydrocannabinols .....
7350
7360
7370
I
I
I
I
I
The company is federally authorized
to conduct cultivation activities in order
to bulk manufacture the listed
controlled substances for internal use
and for sale to federally registered
research investigators. No other
activities for these drug codes are
authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–23034 Filed 10–21–21; 8:45 am]
BILLING CODE P
[FR Doc. 2021–23036 Filed 10–21–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Controlled substance
Amphetamine ..................
Methylphenidate ..............
Nabilone ..........................
Codeine ...........................
Oxycodone ......................
Hydromorphone ...............
Hydrocodone ...................
Methadone ......................
Methadone intermediate ..
Morphine ..........................
Thebaine ..........................
Oxymorphone ..................
Fentanyl ...........................
Drug
code
Schedule
1100
1724
7379
9050
9143
9150
9193
9250
9254
9300
9333
9652
9801
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to bulk
manufacture small quantities of the
listed controlled substances for internal
use or for sale as analytical reference
standard materials to its customers. No
other activities for these drug codes are
authorized for this registration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Brian S. Besser,
Acting Assistant Administrator.
[Docket No. DEA–914]
[FR Doc. 2021–23038 Filed 10–21–21; 8:45 am]
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Bulk Manufacturer of Controlled
Substances Application: Organic
Consultants, LLC. DBA Cascade
Chemistry
[Docket No. DEA–912]
Bulk Manufacturer of Controlled
Substances Application: Groff NA
Hemplex LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Groff NA Hemplex 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.
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before December 21, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 21, 2021.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 16, 2021, Groff
NA Hemplex LLC, 100 Redco Avenue,
Suite A, Red Lion, Pennsylvania 17356–
1436, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
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SUPPLEMENTARY INFORMATION:
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17:47 Oct 21, 2021
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Organic Consultants, LLC.
DBA Cascade Chemistry, 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 file written
comments on or objections to the
issuance of the proposed registration on
or before December 21, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 21, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on September 9, 2021,
Organic Consultants, LLC. DBA Cascade
Chemistry, 90 North Polk Street, Suite
200, Eugene, Oregon 97402–4109,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00057
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Drug Enforcement Administration
[Docket No. DEA–911]
SUMMARY:
SUMMARY:
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Novitium Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Novitium Pharma LLC has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before November 22, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 22, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
SUMMARY:
E:\FR\FM\22OCN1.SGM
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Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on September 8, 2021,
Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Controlled substance
Drug
code
Schedule
Levorphanol ......................
9220
II
The company plans to import the
listed controlled substance Levorphanol
to develop the manufacturing process
for a drug product that will in turn be
used to produce a tablet equivalent to
the current brand product. 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 nonapproved finished dosage forms for
commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–23032 Filed 10–21–21; 8:45 am]
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DEPARTMENT OF JUSTICE
Service Contract Inventory; Notice of
Availability
Justice Management Division,
Department of Justice.
ACTION: Notice.
AGENCY:
The Department of Justice is
publishing this notice to advise the
public of the availability of its FY 2019
Service Contracts Inventory and
Inventory Supplement. The inventory
includes service contract actions over
$25,000 that were awarded in Fiscal
Year (FY) 2019. The inventory
supplement includes information
collected from contractors on the
amount invoiced and direct labor hours
expended for covered service contracts.
The Department of Justice analyzes this
data for the purpose of determining
whether its contract labor is being used
in an effective and appropriate manner
and if the mix of federal employees and
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SUMMARY:
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17:47 Oct 21, 2021
Jkt 256001
contractors in the agency is effectively
balanced. The inventory and
supplement do not include contractor
proprietary or sensitive information.
The FY 2019 Service Contract Inventory
and Inventory Supplements are
provided at the following link: https://
www.justice.gov/jmd/servicecontractinventory.
FOR FURTHER INFORMATION CONTACT:
Kevin Doss, Office of Acquisition
Management, Justice Management
Division, U.S. Department of Justice,
Washington, DC 20530; Phone: 202–
616–3758; Email: Kevin.Doss@usdoj.gov.
Authority: Section 743 of Division C
of the FY 2010 Consolidated
Appropriations Act, Pub. L. 111–117.
Dated: October 18, 2021.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2021–23014 Filed 10–21–21; 8:45 am]
BILLING CODE 4410–02–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2021–0010]
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Notice of reestablishment of the
Federal Advisory Council on
Occupational Safety and Health
(hereinafter FACOSH or Council) and
request for nominations to serve on
FACOSH.
AGENCY:
The Occupational Safety and
Health Administration (OSHA) hereby
announces that the Federal Advisory
Council on Occupational Safety and
Health (FACOSH) has been
reestablished for a two-year period
pursuant to the Federal Advisory
Committee Act (FACA) and in
accordance with the Committee
Management Secretariat, General
Services Administration. In addition,
the Secretary of Labor (Secretary)
requests nominations for membership
on FACOSH.
DATES: Submit (postmark, send,
transmit) nominations for FACOSH
membership by November 22, 2021.
ADDRESSES: You may submit
nominations and supporting materials
by one of the following methods:
Electronically: You may submit
nominations, including attachments,
electronically into Docket No. OSHA—
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
2021–0010 at https://
www.regulations.gov, which is the
Federal eRulemaking Portal. Follow the
online instructions for submissions.
Docket: To read or download
comments or other material in the
docket, go to https://
www.regulations.gov. Documents in the
docket are listed in the https://
www.regulations.gov index; however,
some information (e.g., copyrighted
material) is not publicly available to
read or download through the website.
All submissions, including copyrighted
material, are available for inspection
through the OSHA Docket Office.
Contact the OSHA Docket Office at (202)
693–2350 (TTY (877) 889–5627) for
assistance in locating docket
submissions.
Instructions: All submissions must
include the agency name and the OSHA
docket number for this Federal Register
notice (OSHA–2021–0010). OSHA will
place comments and requests to speak,
including personal information, in the
public docket, which may be available
online. Therefore, OSHA cautions
interested parties about submitting
personal information such as Social
Security numbers and birthdates.
FOR FURTHER INFORMATION CONTACT:
Federal Advisory Council on
Occupational Safety and Health
SUMMARY:
58693
Press inquiries: Mr. Frank Meilinger,
Director, OSHA Office of
Communications; telephone: (202) 693–
1999; email: meilinger.francis2@dol.gov.
General information: Mr. Francis
Yebesi, Director, OSHA Office of
Federal Agency Programs; telephone
(202) 693–2122; email ofap@dol.gov.
Copies of this Federal Register
document: Electronic copies of this
Federal Register document are available
at https://www.regulations.gov. This
document, as well as news releases and
other relevant information are also
available on the OSHA web page at
https://www.osha.gov.
On
September 30, 2021, President Joseph
Biden signed Executive Order (E.O.)
14048 continuing or reestablishing
certain federal advisory committees,
including FACOSH, until September 30,
2023 (86 FR 55465 (10/05/2021)). In
response, the Secretary reestablished
FACOSH and the Department of Labor
(DOL) filed the FACOSH charter on
October 14, 2021. FACOSH will
terminate on September 30, 2023, unless
continued by the President. The
FACOSH charter is available to read or
download at https://www.osha.gov/. In
addition, the Secretary invites interested
persons to submit nominations for
membership on FACOSH.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58692-58693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23032]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-911]
Importer of Controlled Substances Application: Novitium Pharma
LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Novitium Pharma LLC has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before November 22,
2021. Such persons may also file a written request for a hearing on the
application on or before November 22, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn:
[[Page 58693]]
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on September 8, 2021, Novitium Pharma LLC, 70 Lake
Drive, East Windsor, New Jersey 08520, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Levorphanol............................. 9220 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance
Levorphanol to develop the manufacturing process for a drug product
that will in turn be used to produce a tablet equivalent to the current
brand product. 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-23032 Filed 10-21-21; 8:45 am]
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