Importer of Controlled Substances Application: Novitium Pharma LLC, 56634 [2020-20161]
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56634
Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices
persons may also file a written request
for a hearing on the application on or
before November 13, 2020.
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 July 23, 2020,
Cambridge Isotype Lab 50 Frontage
Road, Andover, Massachusetts 01810–
5413, applied to be registered as an bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Tetrahydrocannabinols ...
Drug code
7370
Schedule
I
The company plans to synthetically
bulk manufacture the controlled
substance Tetrahydrocannabinols to
produce analytical standards for
distribution to its customers. No other
activity for this drug code is authorized
for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–20160 Filed 9–11–20; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–711]
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(s) 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 October 14, 2020. Such
persons may also file a written request
for a hearing on the application on or
before October 14, 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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:51 Sep 11, 2020
Jkt 250001
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 August 18, 2020,
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
Lisdexamfetamine ...
Levorphanol .............
1205
9220
Schedule
II
II
The company plans to import the
listed controlled substance
Lisdexamfetamine as a raw Active
Pharmaceutical Ingredients (API)
material for drug product development
and research purposes only. The
company may import Lisdexamfetamine
API for research purposes only but not
for the manufacturing of Food and Drug
Administration (FDA)-approved
products.
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.
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 FDA-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
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DEPARTMENT OF LABOR
Employment and Training
Administration
Notice of a Change in Status of the
Extended Benefit (EB) Program for
Nevada
Employment and Training
Administration, Labor.
AGENCY:
Frm 00063
Fmt 4703
Notice.
This notice announces a retroactive
change in benefit period eligibility
under the EB program for Nevada.
The following change has occurred
since the publication of the last notice
regarding the State’s EB status:
Based on Nevada’s State law, which
provides for the temporary adoption of
the optional TUR trigger during periods
of 100 percent Federal financing, and
data released by the Bureau of Labor
Statistics on May 22, 2020, the
seasonally-adjusted total unemployment
rate for Nevada rose to meet the 8.0
percent threshold to trigger ‘‘on’’ to a
high unemployment period in EB. The
payable period for Nevada under the
high unemployment period is
retroactive to June 7, 2020, and
eligibility for claimants has been
extended from a potential duration of
up to 13 weeks to a potential duration
of up to 20 weeks in the EB program.
The trigger notice covering state
eligibility for the EB program can be
found at: https://ows.doleta.gov/
unemploy/claims_arch.as
Information for Claimants
The duration of benefits payable in
the EB program, and the terms and
conditions on which they are payable,
are governed by the Federal-State
Extended Unemployment Compensation
Act of 1970, as amended, and the
operating instructions issued to the
states by the U.S. Department of Labor.
In the case of a state beginning an EB
period, the State Workforce Agency will
furnish a written notice of potential
entitlement to each individual who has
exhausted all rights to regular benefits
and is potentially eligible for EB (20
CFR 615.13(c)(1)).
Persons who believe they may be
entitled to EB, or who wish to inquire
about their rights under the program,
should contact their State Workforce
Agency.
U.S.
Department of Labor, Employment and
Training Administration, Office of
Unemployment Insurance Room S–
4524, Attn: Thomas Stengle, 200
Constitution Avenue NW, Washington,
DC 20210, telephone number (202)–
693–2991 (this is not a toll-free number)
or by email: Stengle.Thomas@dol.gov.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2020–20161 Filed 9–11–20; 8:45 am]
PO 00000
ACTION:
Sfmt 4703
Signed in Washington, DC.
John Pallasch,
Assistant Secretary for Employment and
Training.
[FR Doc. 2020–20192 Filed 9–11–20; 8:45 am]
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]]>Agencies
[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Page 56634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20161]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-711]
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(s) 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 October 14,
2020. Such persons may also file a written request for a hearing on the
application on or before October 14, 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 August 18, 2020, 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
------------------------------------------------------------------------
Lisdexamfetamine...................... 1205 II
Levorphanol........................... 9220 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance
Lisdexamfetamine as a raw Active Pharmaceutical Ingredients (API)
material for drug product development and research purposes only. The
company may import Lisdexamfetamine API for research purposes only but
not for the manufacturing of Food and Drug Administration (FDA)-
approved products.
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.
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 FDA-approved or non-approved finished dosage forms for commercial
sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-20161 Filed 9-11-20; 8:45 am]
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