Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc, 71934-71935 [2024-19790]
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Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
application and Applicant has not
demonstrated that he can be entrusted
with the responsibility of registration.
Id. at 19. Accordingly, the Agency will
order that Applicant’s application be
denied.
Order
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2024–19731 Filed 9–3–24; 8:45 am]
BILLING CODE 4410–09–P
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C. 823,
I hereby deny the pending application
for a DEA Certificate of Registration,
Control No. W21057811C, submitted by
Samirkumar Shah, M.D., as well as any
other pending application of
Samirkumar Shah, M.D., for additional
registration in Pennsylvania. This Order
is effective October 4, 2024.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on August 19, 2024, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1419]
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 October 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before October 4, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
SUMMARY:
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 July 19, 2024, 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):
Controlled substance
Drug code
ddrumheller on DSK120RN23PROD with NOTICES1
Lysergic acid diethylamide ............................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine ...............................................................................................................................
Dimethyltryptamine ........................................................................................................................................................
Psilocyn ..........................................................................................................................................................................
The company plans to import the
listed controlled substances as finished
dosage units for use in 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 nonapproved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19785 Filed 9–3–24; 8:45 am]
BILLING CODE 4410–09–P
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21:26 Sep 03, 2024
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Drug Enforcement Administration
[Docket No. DEA–1421]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
High Point, Inc
Notice of application.
Cambrex High Point, 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.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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 November 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
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
ADDRESSES:
Drug Enforcement
Administration, Justice.
AGENCY:
SUMMARY:
I
I
I
I
DATES:
DEPARTMENT OF JUSTICE
ACTION:
7315
7431
7435
7438
Schedule
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71935
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
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 23, 2024, Cambrex
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
High Point, Inc., 4180 Mendenhall Oaks
Parkway, High Point, North Carolina
27265–8017, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Controlled substance
Drug code
Oxymorphone ................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
The company plans to manufacture
the above listed controlled substances in
bulk for use as an internal intermediates
and distribution to its customers. No
other activities for these drug codes are
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19790 Filed 9–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF LABOR
Office of Workers’ Compensation
Programs
Agency Information Collection
Activities; Comment Request; Request
for Earnings Information
ACTION:
Notice.
Division of Federal Employees’,
Longshore and Harbor Workers’
Compensation, Office of Workers’
Compensation Programs.
SUMMARY: The Department of Labor
(DOL) is soliciting comments
concerning a proposed extension for the
authority to conduct the information
collection request (ICR) titled, ‘‘Request
for Earnings Information’’. This
comment request is part of continuing
Departmental efforts to reduce
paperwork and respondent burden in
accordance with the Paperwork
Reduction Act of 1995 (PRA).
DATES: Consideration will be given to all
written comments received by October
31, 2024.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained for free by contacting
Anjanette Suggs by telephone at 202–
354–9660 or by email at
suggs.anjanette@dol.gov.
Submit written comments about this
ICR by mail or courier to the U.S.
Department of Labor, Office of Workers’
Compensation Programs, Room S3323,
200 Constitution Avenue NW,
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
VerDate Sep<11>2014
21:26 Sep 03, 2024
Jkt 262001
Washington, DC 20210; or by email at
suggs.anjanette@dol.gov. Please note
that comments submitted after the
comment period will not be considered.
FOR FURTHER INFORMATION CONTACT:
Anjanette Suggs by telephone at 202–
354–9660 or by email at
suggs.anjanette@dol.gov.
SUPPLEMENTARY INFORMATION: The DOL,
as part of continuing efforts to reduce
paperwork and respondent burden,
conducts a pre-clearance consultation
program to provide the general public
and Federal agencies an opportunity to
comment on proposed and/or
continuing collections of information
before submitting them to the OMB for
final approval. This program helps to
ensure requested data can be provided
in the desired format, reporting burden
(time and financial resources) is
minimized, collection instruments are
clearly understood, and the impact of
collection requirements can be properly
assessed.
The Office of Workers’ Compensation
Programs administers the Longshore
and Harbor Workers’ Compensation Act
(LHWCA). The Act provides benefits to
workers injured in maritime
employment on the navigable waters of
the United States or in an adjoining area
customarily used by an employer in
loading, unloading, repairing, or
building a vessel. In addition, several
acts extend the Longshore Act’s
coverage to certain other employees.
Pursuant to the LHWCA, injured
employees shall receive compensation
in an amount equal to 66–2/3 per
centum of their average weekly wage.
Form LS–426, Request for Earnings
Information, is used by district offices to
collect wage information from injured
workers to assure payment of
compensation benefits to injured
workers at the proper rate. This
information is needed for determination
of compensation benefits in accordance
with section 10 of the LHWCA. This
information collection is currently
approved for use through February 28,
2025.
Legal authority for this information
collection is found at 33 U.S.C. 910.
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Frm 00058
Fmt 4703
Sfmt 4703
9652
9668
Schedule
II
II
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless the OMB
under the PRA approves it and displays
a currently valid OMB Control Number.
In addition, notwithstanding any other
provisions of law, no person shall
generally be subject to penalty for
failing to comply with a collection of
information that does not display a
valid Control Number. See 5 CFR
1320.5(a) and 1320.6.
Interested parties are encouraged to
provide comments to the contact shown
in the ADDRESSES section. Written
comments will receive consideration,
and summarized and included in the
request for OMB approval of the final
ICR. In order to help ensure appropriate
consideration, comments should
mention OMB No. 1240–0025.
Submitted comments will also be a
matter of public record for this ICR and
posted on the internet, without
redaction. The DOL encourages
commenters not to include personally
identifiable information, confidential
business data, or other sensitive
statements/information in any
comments.
The DOL is particularly interested in
comments that:
• 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
• 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,
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]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71934-71935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19790]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1421]
Bulk Manufacturer of Controlled Substances Application: Cambrex
High Point, Inc
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Cambrex High Point, 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
November 4, 2024. Such persons may also file a written request for a
hearing on the application on or before November 4, 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
[[Page 71935]]
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 23, 2024, Cambrex High Point, Inc., 4180
Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017, applied
to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Oxymorphone......................... 9652 II
Noroxymorphone...................... 9668 II
------------------------------------------------------------------------
The company plans to manufacture the above listed controlled
substances in bulk for use as an internal intermediates and
distribution to its customers. No other activities for these drug codes
are authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19790 Filed 9-3-24; 8:45 am]
BILLING CODE P
