Importer of Controlled Substances Application: Lyndra Therapeutics, 76108-76109 [2020-26175]
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76108
Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
European customers, meets the
standards established by the European
Pharmacopeia, administered by the
Directorate for the quality of Medicines
(EDQM). In order to ensure that its
product will meet European
specifications, the company seeks to
import morphine supplied by EDQM for
use as reference standards. 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.
Levorphanol .....................
Drug
code
Schedule
9220
II
The company plans to bulk
manufacture the above-controlled
substance to support production of the
company’s Food and Drug
Administration approved drug product.
No other activity for this drug code is
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26171 Filed 11–25–20; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
William T. McDermott,
Assistant Administrator.
[Docket No. DEA–746]
[FR Doc. 2020–26172 Filed 11–25–20; 8:45 am]
Importer of Controlled Substances
Application: Noramco Inc.
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Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[Docket No. DEA–743]
SUMMARY:
AGENCY:
DEPARTMENT OF JUSTICE
Bulk Manufacturer 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 a bulk
manufacturer 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 January 26, 2021. Such
persons may also file a written request
for a hearing on the application on or
before January 26, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on November 2, 2020,
Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Controlled substance
VerDate Sep<11>2014
19:29 Nov 25, 2020
Jkt 253001
Noramco Inc. 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 December 28, 2020. Such
persons may also file a written request
for a hearing on the application on or
before December 28, 2020.
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:
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 October 23, 2020,
Noramco Inc., 500 Swedes Landing
Road, Wilmington, Delaware, 19801–
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
4417, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Marihuana ........................
Tetrahydrocannabinols ....
Nabilone ..........................
Phenylacetone .................
Opium, Raw .....................
Poppy Straw Concentrate
Tapentadol ......................
Drug
code
Schedule
7360
7370
7379
8501
9600
9670
9780
I
I
II
II
II
II
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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26174 Filed 11–25–20; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–742]
Importer of Controlled Substances
Application: Lyndra Therapeutics
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Lyndra Therapeutics 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
SUMMARY:
E:\FR\FM\27NON1.SGM
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76109
Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices
or before December 28, 2020. Such
persons may also file a written request
for a hearing on the application on or
before December 28, 2020.
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
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on October 22, 2020,
Lyndra Therapeutics, 65 Grove Street,
Suite 301, Watertown, Massachusetts
02472, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Controlled substance
Drug code
Schedule
Methadone ...............................................................................................................................................................
9250
II
The company plans to develop the
formulation and process, and then
manufacture the finished oral dosage
form for use in preclinical and human
clinical trials under a research grant
from National Institute on Drug Abuse.
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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–26175 Filed 11–25–20; 8:45 am]
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NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[Notice: (20–097)]
NASA Advisory Council; Science
Committee; Meeting
National Aeronautics and
Space Administration.
ACTION: Notice of revised dates for
meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, as
amended, the National Aeronautics and
Space Administration (NASA)
announces revised dates for the
upcoming meeting of the Science
Committee of the NASA Advisory
Council (NAC).
DATES: Tuesday, December 1, 2020, 1:00
p.m.–5:00 p.m., and Wednesday,
December 2, 2020, 1:00–5:15 p.m.,
Eastern Time.
FOR FURTHER INFORMATION CONTACT: Ms.
KarShelia Henderson, Science Mission
Directorate, NASA Headquarters,
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
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:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
VerDate Sep<11>2014
19:29 Nov 25, 2020
Jkt 253001
Washington, DC 20546, (202) 358–2355
or khenderson@nasa.gov.
scheduling priorities of the key
participants.
The
original meeting notice was published
in the Federal Register on Friday,
November 13, 2020 in Vol. 85, No. 220
on page 72703. This meeting will now
take place on two days (December 1–2,
2020), rather than on three days
(December 1–3, 2020). The Science
Committee reports to the NAC. The
meeting will be held for the purpose of
soliciting, from the scientific
community and other persons, scientific
and technical information relevant to
program planning. This meeting will be
open to the public via Webex and
telephonically. Webex connectivity
information for each day is provided
below. For audio, when you join the
Webex event, you may use your
computer or provide your phone
number to receive a call back,
otherwise, call the U.S. toll conference
number listed for each day. On Tuesday,
December 1, the event address for
attendees is: https://
nasaenterprise.webex.com/
nasaenterprise/onstage/g.php?MTID=
ec9f04af53099d097214a64cf178fc2ed.
The event number is 199 056 0375 and
the event password is wfSEe8uH5*3. If
needed, the U.S. toll conference number
is 1–415–527–5035 and access code is
199 056 0375. On Wednesday,
December 2, the event address for
attendees is: https://
nasaenterprise.webex.com/
nasaenterprise/onstage/g.php?MTID=
e51f38c7ac92a01577c5f697d7d1b4c5f.
The event number is 199 748 1916 and
the event password is EswGXYZ@742. If
needed, the U.S. toll conference number
is 1–415–527–5035 and access code is
199 748 1916.
The agenda for the meeting includes
the following topics:
Patricia Rausch,
Advisory Committee Management Officer,
National Aeronautics and Space
Administration.
SUPPLEMENTARY INFORMATION:
—Science Mission Directorate (SMD)
Missions, Programs and Activities
It is imperative that the meeting be
held on these dates due to the
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
[FR Doc. 2020–26244 Filed 11–25–20; 8:45 am]
BILLING CODE 7510–13–P
NATIONAL LABOR RELATIONS
BOARD
Privacy Act of 1974; System of
Records
National Labor Relations Board
(NLRB).
ACTION: Notice of a new privacy act
system of records.
AGENCY:
In accordance with the
Privacy Act of 1974, the National Labor
Relations Board proposes to issue a
National Labor Relations Board system
of records notice titled ‘‘NLRB iTrak and
Banned Entry List’’ (NLRB–34) to
support the protection of employees,
contractors, and property leased, or
occupied, by the National Labor
Relations Board. This system of records
includes the NLRB’s iTrak Incident &
Security Management Software System
(‘‘iTrak’’), which is used to manage
information on individuals who have
been reported to present a threat or
potential threat to NLRB employees,
contractors, and property, as well as a
Banned Entry List, which is a list of
individuals banned from entering NLRB
facilities based on information in iTrak.
The system allows the National Labor
Relations Board to collect and maintain
records on the results of law
enforcement activities concerning
individuals maintaining a presence at or
who have access to property leased or
occupied by the NLRB and who have
been reported to present a threat as
described above. The NLRB is issuing
this system of records notice in
compliance with the Privacy Act of
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76108-76109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26175]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-742]
Importer of Controlled Substances Application: Lyndra
Therapeutics
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Lyndra Therapeutics 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
[[Page 76109]]
or before December 28, 2020. Such persons may also file a written
request for a hearing on the application on or before December 28,
2020.
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: 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 October 22, 2020, Lyndra Therapeutics, 65 Grove
Street, Suite 301, Watertown, Massachusetts 02472, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Methadone............................. 9250 II
------------------------------------------------------------------------
The company plans to develop the formulation and process, and then
manufacture the finished oral dosage form for use in preclinical and
human clinical trials under a research grant from National Institute on
Drug Abuse. 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 non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-26175 Filed 11-25-20; 8:45 am]
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