Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City, 57131-57132 [2023-18043]
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Federal Register / Vol. 88, No. 161 / Tuesday, August 22, 2023 / Notices
ACTION:
Notice of application.
DEPARTMENT OF JUSTICE
Pisgah Laboratories Inc. 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.
Drug Enforcement Administration
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 October 23, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 23, 2023.
AGENCY:
SUMMARY:
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on July 10, 2023, Pisgah
Laboratories Inc, 3222 Old
Hendersonville Highway, Pisgah Forest,
North Carolina 28768, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
lotter on DSK11XQN23PROD with NOTICES1
Ibogaine ........................
Tapentadol ....................
Drug
code
Schedule
7260
9780
I
II
The company plans to bulk
manufacture the above-listed controlled
substances in bulk for internal research
purposes and distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17971 Filed 8–21–23; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014
16:57 Aug 21, 2023
Jkt 259001
[Docket No. DEA–1249]
Bulk Manufacturer of Controlled
Substances Application: Irvine Labs
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Irvine Labs Inc. 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 October 23, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 23, 2023.
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on July 10, 2023, Irvine
Labs Inc., 7305 Murdy Circle,
Huntington Beach, California 92647–
3533, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Drug
code
Diethyltryptamine ....................
Dimethyltryptamine .................
Lysergic acid diethylamide .....
Mescaline ................................
Peyote .....................................
Psilocybin ................................
Psilocyn ...................................
7434
7435
7315
7381
7415
7437
7438
Schedule
I
I
I
I
I
I
I
The company plans to bulk
manufacture the above listed controlled
substances for research and
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
development purposes internally and
for distribution to its research
customers. No other activities for these
drug codes are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17984 Filed 8–21–23; 8:45 am]
BILLING CODE P
SUMMARY:
Controlled substance
57131
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1247]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
Charles City
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Cambrex Charles City 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 October 23, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 23, 2023.
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on July 3, 2023, Cambrex
Charles City, 1205 11th Street, Charles
City, Iowa 50616–3466, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUMMARY:
E:\FR\FM\22AUN1.SGM
22AUN1
57132
Federal Register / Vol. 88, No. 161 / Tuesday, August 22, 2023 / Notices
Controlled substance
Gamma Hydroxybutyric
Acid.
Tetrahydrocannabinols
Amphetamine ...............
Lisdexamfetamine ........
Methylphenidate ...........
ANPP (4-Anilino-Nphenethyl-4-piperidine).
Phenylacetone ..............
Codeine ........................
Oxycodone ...................
Hydromorphone ............
Hydrocodone ................
Methadone ....................
Morphine .......................
Oripavine ......................
Thebaine .......................
Opium extracts .............
Opium fluid extract .......
Opium tincture ..............
Opium, powdered .........
Oxymorphone ...............
Noroxymorphone ..........
Fentanyl ........................
Drug
code
Schedule
2010
I
7370
1100
1205
1724
8333
I
II
II
II
II
8501
9050
9143
9150
9193
9250
9300
9330
9333
9610
9620
9630
9639
9652
9668
9801
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for conversion to other controlled
substances and sales to its customers for
dosage form development, clinical trials
and use in stability qualification
studies.
In reference to drug codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–18043 Filed 8–21–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[OMB Number 1122–0003]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Annual
Progress Report for the STOP Formula
Grants Program
Office on Violence Against
Women, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Office on Violence
Against Women (OVW), Department of
Justice (DOJ), will be submitting the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The proposed
information collection was previously
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:57 Aug 21, 2023
Jkt 259001
published in the Federal Register on
June 30, 2023, allowing a 60-day
comment period.
DATES: Comments are encouraged and
will be accepted for 30 days until
September 21, 2023.
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 Catherine Poston, Office on
Violence Against Women, at 202–514–
5430 or Catherine.poston@usdoj.gov.
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;
—Enhance the quality, utility, and
clarity of the information to be
collected; and/or
—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.
Written comments and
recommendations for this information
collection should be submitted within
30 days of the publication of this notice
on the following website
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function and entering either the title of
the information collection or the OMB
Control Number 1122–0003. This
information collection request may be
viewed at www.reginfo.gov. Follow the
instructions to view Department of
Justice, information collections
currently under review by OMB.
DOJ seeks PRA authorization for this
information collection for three (3)
years. OMB authorization for an ICR
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
cannot be for more than three (3) years
without renewal. The DOJ notes that
information collection requirements
submitted to the OMB for existing ICRs
receive a month-to-month extension
while they undergo review.
Overview of This Information
Collection
1. Type of Information Collection:
Extension of a previously approved
collection.
Title of the Form/Collection: Annual
Progress Report for the STOP Formula
Grants Program.
Agency form number, if any, and the
applicable component of the
Department of Justice sponsoring the
collection: Form Number: 1122–0003.
U.S. Department of Justice, Office on
Violence Against Women.
2. Affected public who will be asked
or required to respond, as well as a brief
abstract: Affected Public: State, local
and tribal governments.
Abstract: The STOP Violence Against
Women Formula Grants Program was
authorized through the Violence Against
Women Act of 1994 (VAWA) and
amended and reauthorized in 2000,
2005, 2013 and 2022. The STOP
(Services, Training, Officers, and
Prosecutors) Violence Against Women
Formula Grant Program funding is
awarded to states and territories. It
enhances the capacity of local
communities to develop and strengthen
effective law enforcement and
prosecution strategies to combat
domestic violence, dating violence,
sexual assault and stalking and to
develop and strengthen comprehensive,
holistic victim services. The grant funds
must be distributed by STOP state
administrators to subgrantees according
to a statutory formula. The annual
progress reporting form is necessary for
the Attorney General and STOP
Formula Grant Program grantees and
subgrantees to comply with federal
statutory reporting requirements. The
information will be used for reports to
Congress on the use of appropriated
funds in support of the STOP Formula
Grant Program. There are two sets of
respondents—the STOP state
administrators who allocate the STOP
funds and the subgrantees who may
include law enforcement agencies,
prosecutors officers, courts, and victim
services organizations.
3. Obligation to Respond: Required to
obtain or retain a benefit.
4. Total Estimated Number of
Respondents: 2,556.
5. Estimated Time per Respondent:
One hour.
6. Frequency: Annual.
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 88, Number 161 (Tuesday, August 22, 2023)]
[Notices]
[Pages 57131-57132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18043]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1247]
Bulk Manufacturer of Controlled Substances Application: Cambrex
Charles City
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Cambrex Charles City 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
October 23, 2023. Such persons may also file a written request for a
hearing on the application on or before October 23, 2023.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on July 3, 2023, Cambrex Charles City, 1205 11th Street,
Charles City, Iowa 50616-3466, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
[[Page 57132]]
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Tetrahydrocannabinols.................. 7370 I
Amphetamine............................ 1100 II
Lisdexamfetamine....................... 1205 II
Methylphenidate........................ 1724 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
Phenylacetone.......................... 8501 II
Codeine................................ 9050 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Methadone.............................. 9250 II
Morphine............................... 9300 II
Oripavine.............................. 9330 II
Thebaine............................... 9333 II
Opium extracts......................... 9610 II
Opium fluid extract.................... 9620 II
Opium tincture......................... 9630 II
Opium, powdered........................ 9639 II
Oxymorphone............................ 9652 II
Noroxymorphone......................... 9668 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for conversion to other controlled substances and sales to its
customers for dosage form development, clinical trials and use in
stability qualification studies.
In reference to drug codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetic. No other activities for these drug codes are
authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-18043 Filed 8-21-23; 8:45 am]
BILLING CODE P
