Bulk Manufacturer of Controlled Substances Application: Novitium Pharma, LLC, 40211 [2021-15920]
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40211
Federal Register / Vol. 86, No. 141 / Tuesday, July 27, 2021 / Notices
EARLY TERMINATION GRANTED
[07/21/2021]
20211736 ........
G
Green Dot Corporation; Republic Bancorp, Inc.; Republic Bank & Trust Company.
Suzanne Morris,
Chief, Premerger and Division Statistics,
Antitrust Division, Department of Justice.
Controlled substance
Gamma Hydroxybutyric Acid ....
Lysergic Acid Diethylamide ......
[FR Doc. 2021–15904 Filed 7–26–21; 8:45 am]
Drug
code
Schedule
2010
7315
I
I
BILLING CODE 4410–11–P
The company plans to import the
above controlled substances as finished
dosage unit products for clinical trials,
research, and analytical activities. 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.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–866]
Importer of Controlled Substances
Application: Catalent Pharma
Solutions, LLC.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Catalent Pharma Solutions,
LLC. 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 file written
comments on or objections to the
issuance of the proposed registration on
or before August 26, 2021. Such persons
may also file a written request for a
hearing on the application on or before
August 26, 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 request 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 June 2, 2021, Catalent
Pharma Solutions, LLC., 3031 Red Lion
Road, Philadelphia, Pennsylvania
19114, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:07 Jul 26, 2021
Jkt 253001
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–15919 Filed 7–26–21; 8:45 am]
BILLING CODE P
In
accordance with 21 CFR 1301.33(a), this
is notice that on June 17, 2021,
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 substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Psilocybin ..................................
Psilocyn .....................................
Drug
code
Schedule
7347
7348
I
I
The company plans to bulk
manufacture the above controlled
substances to produce Active
Pharmaceutical Ingredient (API) and
finished dosage forms for clinical trial
purposes. No other activities for these
drug codes are authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–15920 Filed 7–26–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
[Docket No. DEA–867]
Notice of Lodging of Proposed
Consent Decree Under the Clean Water
Act
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
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 September 27, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 27, 2021.
ADDRESS: Written comments should be
sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
On July 16, 2021, the U.S. Department
of Justice (DOJ) lodged a proposed
Amendment to Consent Decree with the
United States District Court for the
Northern District of Indiana in United
States and State of Indiana v. City of
Elkhart, Indiana, Civil Action No.
2:11CV328. The lodging of the proposed
Amendment to Consent Decree, by the
United States on behalf of the U.S.
Environmental Protection Agency, with
the concurrence of the State of Indiana
on behalf of the Indiana Department of
Environmental Management, modifies
the Consent Decree in this action that
was entered by the Court on November
30, 2011.
The 2011 Consent Decree resolved
claims for civil penalties as well as
injunctive relief in the form of a Long
Term Control Plan (LTCP) for violations
of the Clean Water Act and related State
law claims in connection with the City
of Elkhart’s operation of its municipal
wastewater and sewer system. The
proposed Amendment to Consent
Decree modifies the LTCP by allowing
the City to change the technology
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 86, Number 141 (Tuesday, July 27, 2021)]
[Notices]
[Page 40211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15920]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-867]
Bulk Manufacturer 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 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 September 27,
2021. Such persons may also file a written request for a hearing on the
application on or before September 27, 2021.
ADDRESS: 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 June 17, 2021, 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
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Psilocybin.............................. 7347 I
Psilocyn................................ 7348 I
------------------------------------------------------------------------
The company plans to bulk manufacture the above controlled
substances to produce Active Pharmaceutical Ingredient (API) and
finished dosage forms for clinical trial purposes. No other activities
for these drug codes are authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-15920 Filed 7-26-21; 8:45 am]
BILLING CODE 4410-09-P
