Importer of Controlled Substances Application: Noramco, Inc., 52135-52136 [2019-21319]
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52135
Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices
Dated: September 23, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator, Deputy
Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
[FR Doc. 2019–21320 Filed 9–30–19; 8:45 am]
Bulk Manufacturer of Controlled
Substances Registration
BILLING CODE 4410–09–P
ACTION:
Notice of registration.
SUMMARY: The registrants listed below
have applied for and been granted a
Company
FR docket
Absolute Standards, Inc .............................................................................
Pisgah Laboratories, Inc ............................................................................
84 FR 31620 .......................................................
84 FR 31622 .......................................................
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants 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 each company’s
physical security systems, verifying
each 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
[FR Doc. 2019–21312 Filed 9–30–19; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
18:10 Sep 30, 2019
Jkt 250001
The
companies listed below applied to be
registered as a bulk manufacturer of a
basic class of schedule I and II
controlled substances. Information on
previously published notices is listed
below. No comments or objections were
submitted for the notice.
Bulk Manufacturer of Controlled
Substances Registration; Siemens
Healthcare Diagnostics, Inc.
ACTION:
Notice of registration.
FR Docket
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each of the
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
July 2, 2019.
July 2, 2019.
Dated: September 24, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator, Deputy
Assistant Administrator.
Siegfried USA, LLC ....................................................................................
Patheon Pharmaceuticals, Inc ...................................................................
S & B Pharma Inc ......................................................................................
Siemens Healthcare Diagnostics, Inc ........................................................
Synthcon, LLC ...........................................................................................
VerDate Sep<11>2014
Published
SUMMARY: The registrants listed below
have 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.
registration as a bulk manufacturer to
the above listed companies.
Company
jbell on DSK3GLQ082PROD with NOTICES
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of a various classes of
schedule I and II controlled substances.
SUPPLEMENTARY INFORMATION: The
companies listed below applied to be
registered as a bulk manufacturer of
various classes of scheduled I and II
controlled substances. Information on a
previously published notices is listed
below. No comments or objections were
submitted for these notices.
84
84
84
84
84
FR
FR
FR
FR
FR
Published
7129 .........................................................
8114 .........................................................
8116 .........................................................
10534 .......................................................
13962 .......................................................
March 1, 2019.
March 6, 2019.
March 6, 2019.
March 21, 2019.
April 8, 2019.
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed companies.
DEPARTMENT OF JUSTICE
Dated: September 23, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator, Deputy
Assistant Administrator.
[Docket No. DEA–392]
[FR Doc. 2019–21313 Filed 9–30–19; 8:45 am]
ACTION:
Drug Enforcement Administration
Importer of Controlled Substances
Application: Noramco, Inc.
Notice of application.
BILLING CODE 4410–09–P
PO 00000
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 October 31, 2019. Such
persons may also file a written request
for a hearing on the application on or
before October 31, 2019.
DATES:
Frm 00076
Fmt 4703
Sfmt 4703
E:\FR\FM\01OCN1.SGM
01OCN1
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
Jkt 250001
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
01OCN1
]]>Agencies
[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52135-52136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21319]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Noramco, 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 October 31, 2019.
Such persons may also file a written request for a hearing on the
application on or before October 31, 2019.
[[Page 52136]]
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. 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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
Nabilone................................ 7379 II
Phenylacetone........................... 8501 II
Thebaine................................ 9333 II
Poppy Straw Concentrate................. 9670 II
Tapentadol.............................. 9780 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 approved or non-
approved finished dosage forms for commercial sale.
Dated: September 23, 2019.
Thomas W. Prevoznik,
Acting Assistant Administrator Deputy Assistant Administrator.
[FR Doc. 2019-21319 Filed 9-30-19; 8:45 am]
BILLING CODE 4410-09-P
