Importer of Controlled Substances Application: Unither Manufacturing LLC, 26715-26716 [2020-09514]
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26715
Federal Register / Vol. 85, No. 87 / Tuesday, May 5, 2020 / Notices
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–635]
Bulk Manufacturer of Controlled
Substances Application: Research
Triangle Institute
ACTION:
Notice of application.
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 July 6, 2020.
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 March 4, 2020,
Research Triangle Institute, 3040 East
Cornwallis Road, Hermann Building,
Room 106, Research Triangle Park,
North Carolina 27709, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
DATES:
Controlled substance
Drug code
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 21, 2020,
Patheon A PI Manufacturing, Inc, 309
Delaware Street, Greenville, South
Carolina 29605, applied to be registered
as a bulk manufacturer of the following
basic class(es) of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Gamma Hydroxybutyric
Acid.
Alpha-methyltryptamine
Thebaine .......................
Noroxymorphone ..........
Schedule
2010
I
7432
9333
9668
I
II
II
The company plans to bulk
manufacture the above-listed controlled
substances as an Active Pharmaceutical
Ingredient (API) for distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–09556 Filed 5–4–20; 8:45 am]
BILLING CODE 4410–09–P
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 March 13, 2020, Alcami
Carolinas Corporation, 1726 North 23rd
Street, Wilmington, North Carolina
28405–1822, applied to be registered as
an importer of the following basic
class(es) of controlled substances:
Controlled substance
Drug code
Psilocybin ......................
Psilocyn .........................
Thebaine .......................
Pentobarbital .................
7437
7438
9333
2270
Schedule
I
I
II
II
The company plans to import the
listed controlled substances in bulk for
the manufacturing of capsules/tablets
for Phase II clinical trials. Approval of
permit applications will occur only
when the registrant’s activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDAapproved or non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–09552 Filed 5–4–20; 8:45 am]
Schedule
BILLING CODE 4410–09–P
Tetrahydrocannabinols
7370
DEPARTMENT OF JUSTICE
I
The purpose for the bulk
manufacturing of the controlled
substance is for the preparation and the
sale of small quantities of
Tetrahydrocannabinols (7370), which
will be manufactured by synthesis for
use by customers as analytical reference
standards.
William T. McDermott,
Assistant Administrator.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–636]
khammond on DSKJM1Z7X2PROD with NOTICES
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Notice of application.
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 July 6, 2020.
DATES:
VerDate Sep<11>2014
19:16 May 04, 2020
[Docket No. DEA–626]
ACTION:
Jkt 250001
Notice of application.
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 June 4, 2020. Such persons
may also file a written request for a
hearing on the application on or before
June 4, 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 request for a hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
PO 00000
Frm 00060
Fmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances
Application: Alcami Carolinas
Corporation
DATES:
[FR Doc. 2020–09555 Filed 5–4–20; 8:45 am]
ACTION:
Drug Enforcement Administration
Sfmt 4703
[Docket No. DEA–611]
Importer of Controlled Substances
Application: Unither Manufacturing
LLC
ACTION:
Notice of application.
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 June 4, 2020. Such persons
may also file a written request for a
hearing on the application on or before
June 4, 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
DATES:
E:\FR\FM\05MYN1.SGM
05MYN1
26716
Federal Register / Vol. 85, No. 87 / Tuesday, May 5, 2020 / Notices
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 February 27, 2020,
Unither Manufacturing LLC, 331 Clay
Road, Rochester, New York 14623,
applied to be registered as an importer
of the following basic class(es) of a
controlled substance:
Controlled substance
Methylphenidate ............
Drug
code
1724
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–634]
Bulk Manufacturer of Controlled
Substances Application: Absolute
Standards, Inc.
Notice of application.
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 July 6, 2020.
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 March 12, 2020,
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
Pentobarbital .................
2270
Schedule
II
The company plans to bulk
manufacture the above-listed controlled
substance for distribution to customers.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–09553 Filed 5–4–20; 8:45 am]
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Principal Deputy Assistant Attorney General U.S. DOJ—
ENRD, P.O. Box 7611,
Washington, DC 20044–
7611.
By mail .........
DEPARTMENT OF JUSTICE
II
[FR Doc. 2020–09514 Filed 5–4–20; 8:45 am]
21:29 May 04, 2020
Drug Code
Schedule
William T. McDermott,
Assistant Administrator.
VerDate Sep<11>2014
Controlled Substance
Environment and Natural Resources
Division, and should refer to United
States v. American Zinc Recycling
Corp., D.J. Ref. No. 90–5–2–1–11205. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
BILLING CODE 4410–09–P
The company plans to import the
listed controlled substance solely for
updated analytical testing purposes for
European customer requirements. This
analysis is required to allow the
company to export domesticallymanufactured finished dosage forms to
foreign markets. Approval of permit
applications will occur only when the
registrant’s activity is consistent with
what is authorized under to 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.
ACTION:
Absolute Standards, Inc., 44 Rossotto
Drive, Hamden, Connecticut 06514–
1335, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Jkt 250001
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On April 29, 2020, the Department of
Justice lodged a proposed Consent
Decree with the United States District
Court for the Northern District of Illinois
in the lawsuit entitled United States v.
American Zinc Recycling Corp., Case
No. 1:20–cv–02582.
The United States filed a Complaint
seeking civil penalties and injunctive
relief from Defendant American Zinc
Recycling Corp. (‘‘AZR’’) for alleged
violations of the Clean Air Act, 42
U.S.C. 7401–7671q, at its electric arc
furnace flue dust recycling facility in
Chicago (the ‘‘Facility’’). Among other
things, the United States alleges that
AZR has violated statutory and
regulatory requirements limiting
particulate matter emissions from the
Facility, as well as corresponding
requirements in AZR’s Clean Air Act
permits for the Facility.
When the Complaint was filed, the
United States also lodged a proposed
Consent Decree that would settle the
claims asserted in the Complaint. The
proposed Consent Decree would require
that AZR implement appropriate
injunctive relief to control air pollutant
emissions from the Facility, including
upgrading multiple bag collectors that
filter and remove particulate matter
from air exhausted from the Facility.
The Consent Decree also assess a
$1,054,000 civil penalty. $654,000 of the
penalty assessment would be payable on
discounted basis under AZR’s 2016
Chapter 11 bankruptcy reorganization
plan. The remaining $400,000 would be
paid in full.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Principal
Deputy Assistant Attorney General,
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
During the public comment period,
the proposed Consent Decree may be
examined and downloaded at this
Justice Department website: https://
www.justice.gov/enrd/consent-decrees.
We will provide a paper copy of the
proposed Consent Decree upon written
request and payment of reproduction
costs. Please mail your request and
payment to: Consent Decree Library U.S.
DOJ—ENRD, P.O. Box 7611,
Washington, DC 20044–7611.
Please enclose a check or money order
for $18.00 (25 cents per page
reproduction cost) payable to the United
States Treasury.
Patricia A. McKenna,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2020–09595 Filed 5–4–20; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF LABOR
Bureau of Labor Statistics
Information Collection Activities;
Comment Request
Bureau of Labor Statistics,
Department of Labor.
ACTION: Notice of information collection;
request for comment.
AGENCY:
The Department of Labor, as
part of its continuing effort to reduce
paperwork and respondent burden,
conducts a pre-clearance consultation
program to provide the general public
and Federal agencies with an
opportunity to comment on proposed
and/or continuing collections of
information in accordance with the
Paperwork Reduction Act of 1995. This
program helps to ensure that requested
data can be provided in the desired
format, reporting burden (time and
SUMMARY:
E:\FR\FM\05MYN1.SGM
05MYN1
]]>Agencies
[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
[Notices]
[Pages 26715-26716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09514]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-611]
Importer of Controlled Substances Application: Unither
Manufacturing LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
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 June 4, 2020.
Such persons may also file a written request for a hearing on the
application on or before June 4, 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
[[Page 26716]]
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 February 27, 2020, Unither Manufacturing LLC, 331
Clay Road, Rochester, New York 14623, applied to be registered as an
importer of the following basic class(es) of a controlled substance:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance solely
for updated analytical testing purposes for European customer
requirements. This analysis is required to allow the company to export
domestically-manufactured finished dosage forms to foreign markets.
Approval of permit applications will occur only when the registrant's
activity is consistent with what is authorized under to 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. 2020-09514 Filed 5-4-20; 8:45 am]
BILLING CODE 4410-09-P
