Importer of Controlled Substances Application: Aspen API, Inc., 36160 [2021-14530]
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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
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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):
SUMMARY:
Controlled substance
lotter on DSK11XQN23PROD with NOTICES1
Psilocybin .....................
Psilocyn ........................
Pentobarbital ................
Thebaine .......................
Drug
code
7437
7438
2270
9333
Schedule
I
I
II
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
VerDate Sep<11>2014
16:47 Jul 07, 2021
Jkt 253001
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 nonapproved 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.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
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 nonapproved 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
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,
SUMMARY:
Illinois 60018, applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
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
E:\FR\FM\08JYN1.SGM
08JYN1
]]>Agencies
[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Notices]
[Page 36160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14530]
-----------------------------------------------------------------------
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
