Importer of Controlled Substances Application: AndersonBrecon Inc. dba PCI Pharma Services, 16029-16030 [2024-04753]
Download as PDF
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
consider will help the Commission in
understanding your views. You should
file a prehearing brief particularly if you
plan to testify at the hearing on behalf
of an industry group, company, or other
organization, and wish to provide
detailed views or information that will
support or supplement your testimony.
(2) Oral hearing statements
(testimony) refers to the actual oral
statement that you intend to present at
the hearing. Do not include any
confidential business information (CBI)
in that statement. If you plan to testify,
you must file a copy of your oral
statement by the date specified in this
notice. This statement will allow
Commissioners to understand your
position in advance of the hearing and
will also assist the court reporter in
preparing an accurate transcript of the
hearing (e.g., names spelled correctly).
(3) Posthearing briefs refers to
submissions filed after the hearing by
persons who appeared at the hearing.
Such briefs: (a) should be limited to
matters that arose during the hearing; (b)
should respond to any Commissioner
and staff questions addressed to you at
the hearing; (c) should clarify, amplify,
or correct any statements you made at
the hearing; and (d) may, at your option,
address or rebut statements made by
other participants in the hearing.
(4) Other written submissions refers to
any other written submissions that
interested persons wish to make,
regardless of whether they appeared at
the hearing, and may include new
information or updates of information
previously provided.
In accordance with the provisions of
section 201.8 of the Commission’s Rules
of Practice and Procedure (19 CFR
201.8) the document must identify on
its cover (1) the investigation number
and title and the type of document filed
(i.e., prehearing brief, oral statement of
(name), posthearing brief, or written
submission), (2) the name and signature
of the person filing it, (3) the name of
the organization that the submission is
filed on behalf of, and (4) whether it
contains CBI. If it contains CBI, it must
comply with the marking and other
requirements set out below in this
notice relating to CBI. Submitters of
written documents (other than oral
hearing statements) are encouraged to
include a short summary of their
position or interest at the beginning of
the document, and a table of contents
when the document addresses multiple
issues.
Confidential business information:
Any submissions that contain CBI must
also conform to the requirements of
section 201.6 of the Commission’s Rules
of Practice and Procedure (19 CFR
VerDate Sep<11>2014
16:57 Mar 05, 2024
Jkt 262001
201.6). Section 201.6 of the rules
requires that the cover of the document
and the individual pages be clearly
marked as to whether they are the
‘‘confidential’’ or ‘‘nonconfidential’’
version, and that the CBI is clearly
identified by means of brackets. All
written submissions, except for CBI,
will be made available for inspection by
interested persons.
As requested by the Committee, the
Commission will not include any CBI in
its report. However, all information,
including CBI, submitted in this
investigation may be disclosed to and
used by: (i) the Commission, its
employees and offices, and contract
personnel (a) for developing or
maintaining the records of this or a
related proceeding, or (b) in internal
investigations, audits, reviews, and
evaluations relating to the programs,
personnel, and operations of the
Commission, including under 5 U.S.C.
Appendix 3; or (ii) U.S. Government
employees and contract personnel for
cybersecurity purposes. The
Commission will not otherwise disclose
any CBI in a way that would reveal the
operations of the firm supplying the
information.
Summaries of written submissions:
Persons wishing to have a summary of
their position included in the report
should include a summary with their
written submission on or before July 12,
2024, and should mark the summary as
having been provided for that purpose.
The summary should be clearly marked
as ‘‘summary for inclusion in the
report’’ at the top of the page. The
summary may not exceed 500 words
and should not include any CBI. The
summary will be published as provided
if it meets these requirements and is
germane to the subject matter of the
investigation. The Commission will list
the name of the organization furnishing
the summary and will include a link
where the written submission can be
found.
By order of the Commission.
Issued: February 29, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024–04649 Filed 3–5–24; 8:45 am]
BILLING CODE 7020–02–P
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
16029
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1324]
Importer of Controlled Substances
Application: AndersonBrecon Inc. dba
PCI Pharma Services
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
AndersonBrecon Inc. dba PCI
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.
SUMMARY:
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 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
April 5, 2024.
ADDRESSES: The Drug Enforcement
Administration 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
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 September 29, 2023,
AndersonBrecon Inc. dba PCI Pharma
Services, 5775 Logistics Parkway,
Rockford, Illinois 61109–3608, applied
DATES:
E:\FR\FM\06MRN1.SGM
06MRN1
16030
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Dimethyltryptamine ..........
Cocaine ...........................
Methadone ......................
I
Drug
code
Schedule
7435
9041
9250
I
II
II
I
The company plans to import the
listed controlled substances for clinical
trials. No other activities 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
and Drug Administration-approved or
non-approved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–04753 Filed 3–5–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on February 7, 2024,
Sigma Aldrich Company LLC, 3500
Dekalb Street, Saint Louis, Missouri
63118–4103, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
[Docket No. DEA–1332]
Importer of Controlled Substances
Application: Sigma Aldrich Company
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sigma Aldrich Company 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 5, 2024. Such persons
may also file a written request for a
hearing on the application on or before
April 5, 2024.
ADDRESSES: The Drug Enforcement
Administration 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:57 Mar 05, 2024
Jkt 262001
Cathinone ........................
Methcathinone .................
Mephedrone (4-Methyl-Nmethylcathinone).
Gamma Hydroxybutyric
Acid.
Tetrahydrocannabinols ....
4-Bromo-2,5dimethoxyamphetamine.
4-Bromo-2,5dimethoxyphenethylamine.
2,5Dimethoxyamphetamine.
3,4Methylenedioxyamphetamine.
3,4-Methylenedioxy-Nethylamphetamine.
3,4Methylenedioxymethamphetamine.
4-Methoxyamphetamine ..
Dimethyltryptamine ..........
N-Benzylpiperazine .........
Heroin ..............................
Normorphine ....................
Amobarbital .....................
Secobarbital .....................
Nabilone ..........................
Phencyclidine ..................
Ecgonine ..........................
Ethylmorphine ..................
Levorphanol .....................
Meperidine .......................
Thebaine ..........................
Opium, powdered ............
PO 00000
Frm 00062
Fmt 4703
Drug
code
Schedule
1235
1237
1248
I
I
I
2010
I
7370
7391
I
I
7392
I
7396
I
7400
I
7404
I
7405
I
7411
7435
7493
9200
9313
2125
2315
7379
7471
9180
9190
9220
9230
9333
9639
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
Sfmt 4703
Controlled substance
Levo-alphacetylmethadol
Drug
code
Schedule
I 9648 III
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis. In reference to drug code 7370
(Tetrahydrocannabinols) the company
plans to import synthetic
Tetrahydrocannabinols. No other
activities 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 and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–04756 Filed 3–5–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1328]
Bulk Manufacturer of Controlled
Substances Application: Sterling
Pharma USA LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sterling Pharma USA LLC has
applied to be registered as a bulk
manufacturer 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 May 6, 2024. Such persons
may also file a written request for a
hearing on the application on or before
May 6, 2024.
ADDRESSES: The Drug Enforcement
Administration 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
SUMMARY:
E:\FR\FM\06MRN1.SGM
06MRN1
Agencies
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16029-16030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04753]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1324]
Importer of Controlled Substances Application: AndersonBrecon
Inc. dba PCI Pharma Services
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: AndersonBrecon Inc. dba PCI 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 5, 2024. Such persons may also file a written request for a
hearing on the application on or before April 5, 2024.
ADDRESSES: The Drug Enforcement Administration 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 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 September 29, 2023, AndersonBrecon Inc. dba PCI
Pharma Services, 5775 Logistics Parkway, Rockford, Illinois 61109-3608,
applied
[[Page 16030]]
to be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Dimethyltryptamine...................... 7435 I
Cocaine................................. 9041 II
Methadone............................... 9250 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
clinical trials. No other activities 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 and Drug Administration-approved or non-
approved finished dosage forms for commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-04753 Filed 3-5-24; 8:45 am]
BILLING CODE P