Importer of Controlled Substances Application: Alcami Carolinas Corporation

CourtDrug Enforcement Administration
Citation86 FR 36160
Record Number2021-14533
Publication Date08 Jul 2021
36160
Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–863]
Importer of Controlled Substances
Application: Alcami Carolinas
Corporation
AGENCY
: Drug Enforcement
Administration, Justice.
ACTION
: Notice of application.
SUMMARY
: Alcami Carolinas Corporation
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 August 9, 2021. Such persons
may also file a written request for a
hearing on the application on or before
August 9, 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 May 18, 2021, Alcami
Carolinas Corporation, 1726 North 23rd
Street, Wilmington, North Carolina
28405–1822, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Controlled substance Drug
code Schedule
Psilocybin ..................... 7437 I
Psilocyn ........................ 7438 I
Pentobarbital ................ 2270 II
Thebaine ....................... 9333 II
The company plans to import the
listed controlled substances in bulk for
the manufacturing of capsules/tablets
for Phase II clinical trials. The company
plans to import derivatives of Thebaine
that have been determined by DEA to be
captured under drug code (9333)
Thebaine. No other activity for these
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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–14533 Filed 7–7–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–862]
Importer of Controlled Substances
Application: Aspen API, Inc.
AGENCY
: Drug Enforcement
Administration, Justice.
ACTION
: Notice of application.
SUMMARY
: Aspen API, Inc. 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 August 9, 2021. Such persons
may also file a written request for a
hearing on the application on or before
August 9, 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 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 May 5, 2021, Aspen
API, Inc., 2136 Wolf Road, Des Plaines,
Illinois 60018, applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
Controlled substance Drug
code Schedule
Remifentanil .............. 9739 II
The company plans to import the
listed controlled substance as a bulk
active pharmaceutical ingredient (API)
for distribution to manufacturers of
finished dosage prescription drugs. No
other activity for these drug codes 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 the Food and Drug
Administration-approved or non-
approved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–14530 Filed 7–7–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Parole Commission
Certification of Meeting Closure
Pursuant to the Government in the
Sunshine Act (Pub. L. 94–409) [5 U.S.C.
Section 552b]
I, Helen H. Krapels, General Counsel
of the United States Parole Commission,
certify, pursuant to 5 U.S.C. Section
552b(f)(1):
In my opinion a meeting of the
Commission to be held on Tuesday, July
13, 2021 at approximately 2:00 p.m., at
the U.S. Parole Commission, 90 K Street
NE, Washington, DC 20530, could be
closed to the public in the event that a
majority of the Commissioners present
vote to close said meeting at the
beginning thereof, with the vote
properly recorded.
The exemptions of the Government in
the Sunshine Act that may allow closing
the meeting to the public 5 U.S.C.
552b(c)(10) and (d)(4) (for applicable
Parole Commission regulations see 28
CFR 16.203(a)(10), 16.205(a) and
16.205(b)(1)). In addition, the following
laws and regulations may apply to
exempt disclosure to the public portions
of the subject matter of this meeting: 5
U.S.C. 552b(c)(3), (6) and (7) and 28 CFR
16.203(a)(3), (6), and (7).
In witness whereof, I have signed this
document (and affixed the seal of the
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