Importer of Controlled Substances Application: SpecGx LLC, 13927 [2020-04834]
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13927
Federal Register / Vol. 85, No. 47 / Tuesday, March 10, 2020 / Notices
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Business or other for-profit.
Other (if applicable): None.
Abstract: A person engaged in the
business of manufacturing explosives is
required to have a license under the
provisions of 18 U.S.C. 843. The Federal
Water Pollution Control Act, 33 U.S.C.
1341, authorizes the execution of the
Supplemental Information on Water
Quality Considerations—ATF 5000.30,
during the application process, in order
to ensure compliance with the Act.
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: An estimated 680 respondents
will utilize the form annually, and it
will take each respondent
approximately 30 minutes to complete
their responses.
6. An estimate of the total public
burden (in hours) associated with the
collection: The estimated annual public
burden associated with this collection is
340 hours, which is equal to 680 (# of
respondents) *.5 (30 minutes).
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: March 5, 2020.
Melody Braswell,
Department Clearance Officer for PRA,U.S.
Department of Justice.
[FR Doc. 2020–04889 Filed 3–9–20; 8:45 am]
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on September 6, 2019,
Caligor Coghlan Pharma Services, 1500
Business Park Drive, Unit B, Bastrop,
Texas 78602, applied to be registered as
an importer of the following basic
class(es) of controlled substance:
Controlled substance
Drug
code
Schedule
Tapentadol ................
9780
II
The company plans to import the
listed controlled substance in finished
dosage form to be used in pediatric
clinical trials. No other activity for this
drug code 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 be extended to the import of
FDA approved or non-approved
finished dosage forms for commercial
use.
Dated: February 11, 2020.
William T. McDermott,
Assistant Administrator.
BILLING CODE 4410–18–P
DEPARTMENT OF JUSTICE
[FR Doc. 2020–04835 Filed 3–9–20; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA 577]
DEPARTMENT OF JUSTICE
Importer of Controlled Substances
Application: Caligor Pharma Services
ACTION:
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. DEA–599]
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 April 9, 2020. Such persons
may also file a written request for a
hearing on the application on or before
April 9, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
DATES:
VerDate Sep<11>2014
17:20 Mar 09, 2020
Jkt 250001
Drug Enforcement Administration
Importer of Controlled Substances
Application: SpecGx 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 April 9, 2020. Such persons
may also file a written request for a
hearing on the application on or before
April 9, 2020.
DATES:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on December 30, 2019,
SpecGx LLC, 3600 North Second Street,
Saint Louis, Missouri 63147 applied to
be registered as an importer of the
following basic class(es) of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Marihuana .........
Phenylacetone ..
Coca Leaves ....
Thebaine ...........
Opium, raw .......
Poppy Straw
Concentrate.
Tapentadol ........
Schedule
7360
8501
9040
9333
9600
9670
I
II
II
II
II
II
9780
II
The company plans to import the
listed controlled substances for bulk
manufacture into Active Pharmaceutical
Ingredients (API) for distribution to its
customers. In reference to drug code
7360 (marihuana), the company plans to
import synthetic cannabinol. No other
activity for this drug is authorized for
this registration. Placement of these
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 the
import of FDA approved or nonapproved finished forms for commercial
sale.
Dated: February 27, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–04834 Filed 3–9–20; 8:45 am]
BILLING CODE 4410–09–P
E:\FR\FM\10MRN1.SGM
10MRN1
]]>Agencies
[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Page 13927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04834]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-599]
Importer of Controlled Substances Application: SpecGx 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 April 9, 2020.
Such persons may also file a written request for a hearing on the
application on or before April 9, 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 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 December 30, 2019, SpecGx LLC, 3600 North Second
Street, Saint Louis, Missouri 63147 applied to be registered as an
importer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana.......................... 7360 I
Phenylacetone...................... 8501 II
Coca Leaves........................ 9040 II
Thebaine........................... 9333 II
Opium, raw......................... 9600 II
Poppy Straw Concentrate............ 9670 II
Tapentadol......................... 9780 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
bulk manufacture into Active Pharmaceutical Ingredients (API) for
distribution to its customers. In reference to drug code 7360
(marihuana), the company plans to import synthetic cannabinol. No other
activity for this drug is authorized for this registration. Placement
of these 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 the import of FDA approved or non-
approved finished forms for commercial sale.
Dated: February 27, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-04834 Filed 3-9-20; 8:45 am]
BILLING CODE 4410-09-P
