Importer of Controlled Substances Application: Caligor Coghlan Pharma Services, 55860 [2021-21878]
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55860
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / 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 May 19, 2021,
AndersonBrecon, Inc., 4545 Assembly
Drive, Rockford, Illonois 61109, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Tetrahydrocannabinols ...
Drug
code
Schedule
7370
I
The company plans to import the
listed controlled substance for clinical
trials only. 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 Food
and Drug Administration-approved or
non-approved finished dosage forms for
commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–21876 Filed 10–6–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–906]
Importer of Controlled Substances
Application: Caligor Coghlan Pharma
Services
Drug
code
Controlled substance
Tapentadol ......................
I
9780
Schedule
III
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 extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[FR Doc. 2021–21878 Filed 10–6–21; 8:45 am]
Caligor Coghlan Pharma
Services has applied to be registered as
an importer of basic class(es) of
controlled substance(s). Refer to
Supplemental Information listed below
for further drug information.
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 November 8, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 8, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
DEPARTMENT OF JUSTICE
AGENCY:
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on August 16, 2021,
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(s):
VerDate Sep<11>2014
17:46 Oct 06, 2021
Jkt 256001
BILLING CODE P
Drug Enforcement Administration
[Docket No. DEA–907]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: New
Mexico Top Organics-Ultra Health
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefor, may file written
comments on or objections to the
issuance of the proposed registration on
or before December 6, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW 8701
Morrissette Drive, Springfield, Virginia
22152. To ensure proper handling of
comments, please reference Docket
No—DEA–907 in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
file written comments on or objections
of the requested registration, as
provided in this notice. This notice does
not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA-registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Page 55860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21878]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-906]
Importer of Controlled Substances Application: Caligor Coghlan
Pharma Services
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Caligor Coghlan Pharma Services has applied to be registered
as an importer of basic class(es) of controlled substance(s). Refer to
Supplemental Information listed below for further drug information.
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 November 8,
2021. Such persons may also file a written request for a hearing on the
application on or before November 8, 2021.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on August 16, 2021, 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(s):
------------------------------------------------------------------------
Drug
Controlled substance 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 extend to the import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-21878 Filed 10-6-21; 8:45 am]
BILLING CODE P
