Importer of Controlled Substances Application: Siegfried USA, LLC, 12981-12982 [2022-04806]
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12981
Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices
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
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on September 30, 2021, Tikun Olam
Adelanto LLC, 16605 Koala Road,
Adelanto, California 92301–3925,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Drug
code
Controlled substance
Marihuana Extract ........
Marihuana .....................
I
Schedule
7350
7360
I
I
I
In
accordance with 21 CFR 1301.34(a), this
is notice that on December 21, 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):
SUPPLEMENTARY INFORMATION:
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04804 Filed 3–7–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances
Application: Caligor Coghlan Pharma
Services
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Caligor Coghlan Pharma
Services has applied to be registered as
an importer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed
below for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 7, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 2022.
ADDRESSES: The DEA requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
lotter on DSK11XQN23PROD with NOTICES1
VerDate Sep<11>2014
17:25 Mar 07, 2022
Jkt 256001
Drug
code
Controlled substance
[Docket No. DEA–971]
SUMMARY:
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
Lysergic acid
diethylamide.
Schedule
7315
I
I
I
The company plans to import drug
Lysergic acid diethylamide (7315) in
finished dosage forms for 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.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04807 Filed 3–7–22; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–970]
Importer of Controlled Substances
Application: Siegfried USA, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Siegfried USA, LLC has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
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 April 7, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 2022.
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 December 8, 2021,
Siegfried USA, LLC, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUMMARY:
Controlled substance
Phenylacetone ..............
Opium, raw ...................
Poppy Straw Concentrate.
Drug
code
8501
9600
9670
Schedule
II
II
II
BILLING CODE P
PO 00000
The company plans to import the
listed controlled substances to
manufacture bulk active
pharmaceuticals ingredients (API) for
distribution to its customers.
Phenylacetone will be used to
manufacture Amphetamine. No other
Frm 00058
Fmt 4703
Sfmt 4703
E:\FR\FM\08MRN1.SGM
08MRN1
12982
Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices
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.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04806 Filed 3–7–22; 8:45 am]
BILLING CODE P
Drug Enforcement Administration
Psilocybin .....................
Levorphanol ..................
[Docket No. DEA–961]
Importer of Controlled Substances
Application: ANI Pharmaceuticals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
ANI Pharmaceuticals Inc. has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 7, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 2022.
ADDRESSES: The DEA requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
20:36 Mar 07, 2022
Drug
code
Controlled substance
DEPARTMENT OF JUSTICE
VerDate Sep<11>2014
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on January 6, 2022, ANI
Pharmaceuticals Inc., 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Jkt 256001
I
7437
9220
Schedule
I
I
II
The substance Levorphanol (9220)
will be used to manufacture the Food
and Drug Administration-approved
dosage forms for distribution in the
United States. The substance Psilocybin
(7437) will be used to support
formulation development and clinical
trial research. No other activity for these
drug codes are 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 Drug Administrationapproved or non-approved finished
dosage forms for commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04803 Filed 3–7–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[OMB Number 1117–0006]
Agency Information Collection
Activities; Proposed eCollection,
eComments Requested; Extension
Without Change of a Previously
Approved Collection; Application for
Individual Manufacturing Quota for a
Basic Class of Controlled Substance
and for Ephedrine, Pseudoephedrine,
and Phenylpropanolamine; DEA Form
189
Drug Enforcement
Administration, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice,
Drug Enforcement Administration
(DEA), will be submitting the following
information collection request to the
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Office of Management and Budget for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
This information collection is also
associated with the proposed
rulemaking ‘‘Management of Quotas for
Controlled Substances and List I
Chemicals.’’ It is likely that the final
rule will not be published before this
information collection expires on June
30, 2022. If the final rule does publish
prior to the expiration, it will be
published as the 30-Day Notice.
DATES: Comments are encouraged and
will be accepted for 60 days until May
9, 2022.
FOR FURTHER INFORMATION CONTACT: If
you have comments, especially on the
estimated public burden or associated
response time, suggestions, or need a
copy of the proposed information
collection instrument with instructions
or additional information, please
contact Scott A. Brinks, Regulatory
Drafting and Policy Support Section
(DPW), Diversion Control Division, Drug
Enforcement Administration; Mailing
Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone:
(571) 776–2265.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information proposed to be collected
can be enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms
of information technology, e.g.,
permitting electronic submission of
responses.
Overview of This Information
Collection
1. Type of Information Collection:
Extension of a currently approved
collection.
E:\FR\FM\08MRN1.SGM
08MRN1
]]>Agencies
[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Pages 12981-12982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04806]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-970]
Importer of Controlled Substances Application: Siegfried USA, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Siegfried USA, LLC has applied to be registered as an importer
of basic class(es) of controlled substance(s). Refer to Supplementary
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 April 7, 2022.
Such persons may also file a written request for a hearing on the
application on or before April 7, 2022.
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 December 8, 2021, Siegfried USA, LLC, 33 Industrial
Park Road, Pennsville, New Jersey 08070, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Phenylacetone.......................... 8501 II
Opium, raw............................. 9600 II
Poppy Straw Concentrate................ 9670 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances to
manufacture bulk active pharmaceuticals ingredients (API) for
distribution to its customers. Phenylacetone will be used to
manufacture Amphetamine. No other
[[Page 12982]]
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.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04806 Filed 3-7-22; 8:45 am]
BILLING CODE P
