Bulk Manufacturer of Controlled Substances Application: CreaGen Inc., 52136-52137 [2019-21311]
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52136
Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices
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.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on July 18, 2019, Noramco
Inc., 1550 Olympic Drive, Athens,
Georgia 30601 applied to be registered
as an importer of the following basic
classes of controlled substances:
Controlled substance
Drug
code
Schedule
approved or non-approved finished
dosage forms for commercial sale.
Phenylacetone ..................
Thebaine ...........................
Poppy Straw Concentrate
Tapentadol ........................
8501
9333
9670
9780
II
II
II
II
Dated: September 23, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator Deputy
Assistant Administrator.
ADDRESSES:
Controlled substance
Drug
code
Schedule
Marihuana Extract ............
Marihuana .........................
Tetrahydrocannabinols .....
Nabilone ...........................
7350
7360
7370
7379
I
I
I
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 (9780)
for distribution to its customers.
The company plans to import
impurities of buprenorphine that have
been determined by DEA to be captured
under drug code (9333) thebaine.
In reference to drug codes 7360 and
7370, the company plans to import a
synthetic cannabidiol and a synthetic
tetrahydrocannabinol. No other activity
for these drug codes is authorized for
this registration. Placement of these
drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. 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
Companies
jbell on DSK3GLQ082PROD with NOTICES
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of the
listed registrants to import the
applicable various basic classes of
schedule I and II controlled substances
is consistent with the public interest
and with United States obligations
under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA investigated each
of the company’s maintenance of
effective controls against diversion by
inspecting and testing each company’s
physical security systems, verifying
each company’s compliance with state
and local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
18:10 Sep 30, 2019
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BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
SUMMARY: The registrants listed below
have applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as importers of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
companies listed below applied to be
registered as an importers of various
basic classes of schedule I and II
controlled substances. Information on
previously published notices is listed in
the table below. No comments or
objections were submitted and no
requests for a hearing were submitted
for these notices.
FR docket
Restek Corporation ....................................................................................
AMRI Rensselaer, Inc ................................................................................
Alcami Carolinas Corporation ....................................................................
Cambrex Charles City ................................................................................
Chattem Chemicals, Inc .............................................................................
VerDate Sep<11>2014
[FR Doc. 2019–21319 Filed 9–30–19; 8:45 am]
84
84
84
84
83
FR
FR
FR
FR
FR
35691
35692
36941
36945
39129
Published
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
granted a registration as an importer for
schedule I and II controlled substances
to the above listed companies.
Dated: September 23, 2019
Thomas W. Prevoznik,
Acting Assistant Administrator, Deputy
Assistant Administrator.
July 24, 2019.
July 24, 2019.
July 30, 2019.
July 30, 2019.
August 8, 2019.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before December 2, 2019.
DATES:
DEPARTMENT OF JUSTICE
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
Drug Enforcement Administration
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–21321 Filed 9–30–19; 8:45 am]
BILLING CODE 4410–09–P
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: CreaGen Inc.
ACTION:
PO 00000
Notice of application.
Frm 00077
Fmt 4703
Sfmt 4703
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 14, 2019,
CreaGen Inc., 299 Washington Street,
Unit A, Woburn, Massachusetts 01801–
2795 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
E:\FR\FM\01OCN1.SGM
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52137
Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices
Controlled substance
Drug code
4-Methyl-N-ethylcathinone (4-MEC) ................................................................................................................................
Aminorex ..........................................................................................................................................................................
APINACA and AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ............................................................
JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ..............................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .................................................................................................................................
Alpha-methyltryptamine ...................................................................................................................................................
N-Benzylpiperazine ..........................................................................................................................................................
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine) ......................................................................................................
25B-NBOMe (2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) .....................................................
alpha-pyrrolidinopentiophenone (a-PVP) ........................................................................................................................
AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) ..................................................................
Secobarbital .....................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to synthesize the
above controlled substances for
distribution to its research and forensic
customers.
Dated: September 23, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator, Deputy
Assistant Administrator.
[FR Doc. 2019–21311 Filed 9–30–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
jbell on DSK3GLQ082PROD with NOTICES
Notice of Lodging of Proposed
Consent Decree Under the Clean Water
Act
On September 23, 2019, the
Department of Justice filed a Complaint
and concurrently lodged a proposed
Consent Decree to resolve claims by the
United States against the Utah
Department of Transportation for
violations of the Clean Water Act,
specifically violations of the terms and
conditions of Defendant’s National
Pollutant Discharge Elimination System
Permit issued by the State of Utah under
Section 402(b) of the Clean Water Act,
33 U.S.C. 1342(b), for discharges of
stormwater from Defendant’s municipal
separate storm sewer system (‘‘MS4’’)
throughout the State of Utah. The
Complaint alleges that Defendant failed
to comply with permit procedures
related to wet and dry weather
monitoring of its MS4; implement a
program to detect and eliminate illicit
discharges and improper disposal into
the MS4; implement a program to
reduce pollutants in construction site
stormwater runoff; implement and
enforce a program to address postconstruction stormwater runoff in new
development and redevelopment; and
implement an operation and
maintenance program to reduce
polluted runoff from municipal
operations. The proposed Consent
Decree addresses the alleged violations
by requiring Defendant to update its
VerDate Sep<11>2014
18:10 Sep 30, 2019
Jkt 250001
MS4 plans and operating practices to
comply with its permit and to pay a
$325,000 civil penalty.
The publication of this notice opens
a period for public comment on the
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States v. the Utah Department of
Transportation, Civil Action No. 2:19–
cv–00677, DOJ number 90–5–1–1–
11614. All comments must be submitted
no later than 30 days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
By mail .........
During the public comment period,
the 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
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 $10.50 (25 cents per page
reproduction cost) payable to the United
States Treasury. For a paper copy
without the exhibits and signature
pages, the cost is $9.00.
Jeffrey Sands,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2019–21213 Filed 9–30–19; 8:45 am]
BILLING CODE 4410–15–P
PO 00000
Frm 00078
Fmt 4703
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1249
1585
7048
7118
7405
7431
7432
7493
7509
7536
7545
9551
2315
9801
Schedule
I
I
I
I
I
I
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I
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
On September 19, 2019, the
Department of Justice lodged a proposed
Consent Decree with the United States
District Court for the Northern District
of New York in the lawsuit entitled
United States v. Gaetano Associates LP
and Charles A. Gaetano Construction
Corporation, Civil Action No. 6:19-cv01162. In the filed Complaint, the
United States, on behalf of the U.S.
Environmental Protection Agency
(‘‘EPA’’), alleges that the Defendants are
liable under the Comprehensive
Environmental Response,
Compensation, and Liability Act, 42
U.S.C. 9607(a), for the response costs
EPA incurred to respond to the releases
and/or threatened releases of hazardous
substances into the environment from a
parcel of property where the former
Charlestown Mall outlet is located in
Utica, New York that the Defendants
owned and operated. The Consent
Decree requires the Defendants to pay
$1.85 million in a lump sum to the
United States for the settlement of the
allegations in the filed Complaint.
The publication of this notice opens
a period for public comment on the
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States v. Gaetano Associates LP
and Charles A. Gaetano Construction
Corporation, D.J. Ref. No. 90–11–3–
11061. 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:
E:\FR\FM\01OCN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52136-52137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21311]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: CreaGen
Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before December 2, 2019.
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 August 14, 2019, CreaGen Inc., 299 Washington Street,
Unit A, Woburn, Massachusetts 01801-2795 applied to be registered as a
bulk manufacturer of the following basic classes of controlled
substances:
[[Page 52137]]
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
4-Methyl-N-ethylcathinone (4-MEC).. 1249 I
Aminorex........................... 1585 I
APINACA and AKB48 (N-(1-Adamantyl)- 7048 I
1-pentyl-1H-indazole-3-
carboxamide).
JWH-018 (also known as AM678) (1- 7118 I
Pentyl-3-(1-naphthoyl)indole).
3,4-Methylenedioxymethamphetamine.. 7405 I
5-Methoxy-N-N-dimethyltryptamine... 7431 I
Alpha-methyltryptamine............. 7432 I
N-Benzylpiperazine................. 7493 I
2C-E (2-(2,5-Dimethoxy-4- 7509 I
ethylphenyl) ethanamine).
25B-NBOMe (2-(4-bromo-2,5- 7536 I
dimethoxyphenyl)-N-(2-
methoxybenzyl) ethanamine).
alpha-pyrrolidinopentiophenone 7545 I
([alpha]-PVP).
AH-7921 (3,4-dichloro-N-[(1- 9551 I
dimethylamino)cyclohexylmethyl]ben
zamide)).
Secobarbital....................... 2315 II
Fentanyl........................... 9801 II
------------------------------------------------------------------------
The company plans to synthesize the above controlled substances for
distribution to its research and forensic customers.
Dated: September 23, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator, Deputy Assistant Administrator.
[FR Doc. 2019-21311 Filed 9-30-19; 8:45 am]
BILLING CODE 4410-09-P
