Bulk Manufacturer of Controlled Substances Application: SpecGx LLC, 26447-26448 [2019-11877]
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26447
Federal Register / Vol. 84, No. 109 / Thursday, June 6, 2019 / Notices
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on
February 25, 2019, Shertech
Laboratories, LLC, 1185 Woods Chapel
Road, Duncan, South Carolina 29334
applied to be registered as an importer
of the following basic class of controlled
substance:
controlled substance in bulk form to
conduct clinical trials.
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.
Dated: May 17, 2019.
John J. Martin,
Assistant Administrator.
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[FR Doc. 2019–11876 Filed 6–5–19; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
Cocaine ........................
Drug
code
9041
Schedule
[Docket No. DEA–392]
II
Bulk Manufacturer of Controlled
Substances Application: SpecGx LLC
The company plans to import
synthetic derivatives of the listed
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 August 5, 2019.
DATES:
ACTION:
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 1, 2019,
SpecGx LLC, 3600 North 2nd Street,
Saint Louis, Missouri 63147 applied to
be registered as a bulk manufacturer of
the following basic class of controlled
substances:
Notice of application.
khammond on DSKBBV9HB2PROD with NOTICES
Controlled substance
Drug code
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Codeine-N-oxide ..............................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Difenoxin ..........................................................................................................................................................................
Morphine-N-oxide ............................................................................................................................................................
Normorphine ....................................................................................................................................................................
Norlevorphanol ................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...............................................................................
Butyryl Fentanyl ...............................................................................................................................................................
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) .....................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Nabilone ...........................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Oripavine .........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Opium tincture .................................................................................................................................................................
Opium, powdered ............................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
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9168
9307
9313
9634
9821
9822
9850
1100
1105
1205
1724
7379
8333
9050
9120
9143
9150
9170
9180
9193
9220
9230
9250
9254
9273
9300
9330
9333
9630
9639
9652
9668
9737
9739
9740
9780
9801
Schedule
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26448
Federal Register / Vol. 84, No. 109 / Thursday, June 6, 2019 / Notices
The company plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for distribution to its customers.
Dated: May 23, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–11877 Filed 6–5–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
The registrant listed below
has applied for and been granted a
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of various classes of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as a bulk manufacturer of
various basic classes of controlled
substances. Information on a previously
published notice is listed below. No
comments or objections were submitted
for the notice.
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
Company
FR
docket
Published
Noramco, Inc ....
84 FR
5499.
February 21,
2019.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this registrant to
manufacture the applicable basic classes
of 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 the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed company.
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On May 22, 2019, the Department of
Justice lodged a proposed Consent
Decree (‘‘Consent Decree’’) with the
United States District Court for the
District of Connecticut in the lawsuit
entitled United States and the State of
New Jersey, Department of
Environmental Protection v. Gloucester
County Utilities Authority, Civil Action
No. 2:19–cv–12818.
In a Complaint, the United States, on
behalf of the U.S. Environmental
Protection Agency (‘‘EPA’’) and the
State of New Jersey, on behalf of the
Department of Environmental
Protection, alleges that the Gloucester
County Utilities Authority (‘‘GCUA’’)
violated the Clean Air Act (the ‘‘Act’’),
42 U.S.C. 7413, by violating: (1) The
Solid Waste Combustion provisions in
Section 129 of the Clean Air Act, 42
U.S.C. 7429, and (2) the Federal Plan
Requirements for Sewage Sludge
Incineration Units Constructed on or
Before October 14, 2010, 40 CFR part 62,
subpart LLL (‘‘Subpart LLL’’). The
proposed Consent Decree in this case,
among other things, requires that GCUA
pay a civil penalty of $132,500 in two
installments. In addition, the Consent
Decree requires a New Jersey-sponsored
supplemental project, to be overseen by
the state, involving the purchase and
installation of four electric vehiclecharging stations within Gloucester
County by September 31, 2019.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States and the State of
New Jersey, Department of
Environmental Protection v. Gloucester
County Utilities Authority, D.J. Ref. No.
90–5–2–1–11877. 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:
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 .........
Dated: May 21, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019–11881 Filed 6–5–19; 8:45 am]
BILLING CODE 4410–09–P
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During the public comment period,
the proposed Consent Decree may be
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Sfmt 4703
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 $10.00 (25 cents per page
reproduction cost), payable to the
United States Treasury.
Jeffrey Sands,
Assistant Chief, Environmental Enforcement
Section, Environment & Natural Resources
Division.
[FR Doc. 2019–11863 Filed 6–5–19; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
196th Meeting of the Advisory Council
on Employee Welfare and Pension
Benefit Plans; Notice of Meeting
Pursuant to the authority contained in
Section 512 of the Employee Retirement
Income Security Act of 1974 (ERISA), 29
U.S.C. 1142, the 196th meeting of the
Advisory Council on Employee Welfare
and Pension Benefit Plans (also known
as the ERISA Advisory Council) will be
held on June 25–27, 2019.
The three-day meeting will take place
at the U.S. Department of Labor, 200
Constitution Avenue NW, Washington,
DC 20210 in N5437 A–C. The meeting
will run from 9:00 a.m. to
approximately 5:30 p.m. on June 25 and
26 with a one hour break for lunch, and
from 8:30 a.m. to 11:00 a.m. on June 27.
The purpose of the open meeting is for
Advisory Council members to hear
testimony from invited witnesses and to
receive an update from the Employee
Benefits Security Administration
(EBSA). The EBSA update is scheduled
for the morning of June 25, subject to
change.
The Advisory Council will study the
following topics: (1) Beyond Plan Audit
Compliance: Improving the Financial
Statement Audit Process (on June 25);
and, (2) Permissive Transfers of
Uncashed Checks from ERISA Plans to
State Unclaimed Property Funds (on
June 26). The Advisory Council will
continue with discussions of its topics
on June 27. Descriptions of these topics
are available on the Advisory Council
page of the EBSA website, at https://
www.dol.gov/agencies/ebsa/about-ebsa/
about-us/erisa-advisory-council.
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]]>Agencies
[Federal Register Volume 84, Number 109 (Thursday, June 6, 2019)]
[Notices]
[Pages 26447-26448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11877]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: SpecGx
LLC
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 August 5, 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 February 1, 2019, SpecGx LLC, 3600 North 2nd Street,
Saint Louis, Missouri 63147 applied to be registered as a bulk
manufacturer of the following basic class of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.......... 2010 I
Tetrahydrocannabinols.............. 7370 I
Codeine-N-oxide.................... 9053 I
Dihydromorphine.................... 9145 I
Difenoxin.......................... 9168 I
Morphine-N-oxide................... 9307 I
Normorphine........................ 9313 I
Norlevorphanol..................... 9634 I
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Butyryl Fentanyl................... 9822 I
Fentanyl related-compounds as 9850 I
defined in 21 CFR 1308.11(h).
Amphetamine........................ 1100 II
Methamphetamine.................... 1105 II
Lisdexamfetamine................... 1205 II
Methylphenidate.................... 1724 II
Nabilone........................... 7379 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Codeine............................ 9050 II
Dihydrocodeine..................... 9120 II
Oxycodone.......................... 9143 II
Hydromorphone...................... 9150 II
Diphenoxylate...................... 9170 II
Ecgonine........................... 9180 II
Hydrocodone........................ 9193 II
Levorphanol........................ 9220 II
Meperidine......................... 9230 II
Methadone.......................... 9250 II
Methadone intermediate............. 9254 II
Dextropropoxyphene, bulk (non- 9273 II
dosage forms).
Morphine........................... 9300 II
Oripavine.......................... 9330 II
Thebaine........................... 9333 II
Opium tincture..................... 9630 II
Opium, powdered.................... 9639 II
Oxymorphone........................ 9652 II
Noroxymorphone..................... 9668 II
Alfentanil......................... 9737 II
Remifentanil....................... 9739 II
Sufentanil......................... 9740 II
Tapentadol......................... 9780 II
Fentanyl........................... 9801 II
------------------------------------------------------------------------
[[Page 26448]]
The company plans to manufacture bulk active pharmaceutical
ingredients (APIs) for distribution to its customers.
Dated: May 23, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-11877 Filed 6-5-19; 8:45 am]
BILLING CODE 4410-09-P
