Importer of Controlled Substances Application: Caligor Coghlan Pharma Services, 54352-54353 [2023-17138]
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ddrumheller on DSK120RN23PROD with NOTICES1
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Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
institutions, and NGOs, including
outcomes of prior workshops and
planning bodies. BOEM has partnered
with the Blue World Research Institute
to implement the questionnaire. The
questionnaire comprises approximately
20 questions that ask respondents about:
(1) their organization; (2) information on
current monitoring and research
activities, such as objective, location,
scope, methods, timelines, outcomes
and challenges, and on contributions to
NARW conservation or impact
reduction; (3) related ancillary
information, such as type of study, next
steps, and suggestions for priority topics
for future funding ; and (4) additional
comments and discussion. The
questionnaire avoids sensitive topics or
matters that are commonly considered
private. The results will be summarized
as part of the NARW synthesis report.
Additionally, BOEM plans to conduct
directed interviews of participants who
indicate their willingness to provide
additional feedback on future research
priorities and management needs. This
feedback will be compiled in a final
report.
OMB Control Number: 1010–NEW.
Form Number: None.
Type of Review: New.
Respondents/Affected Public: State
(and Federal) government researchers,
academic institutions, and NGOs.
Total Estimated Number of Annual
Responses: 253 responses (213
questionnaire respondents and 40
interviewees).
Total Estimated Number of Annual
Burden Hours: 111 hours (40 annual
burden hours for interviews and 71
annual burden hours for questionnaire).
Respondent’s Obligation: Voluntary.
Frequency of Collection: On occasion.
Total Estimated Annual Non-hour
Burden Cost: There is no non-hour cost
burden associated with this collection.
A Federal Register notice with a 60day public comment period on this
proposed ICR was published on
February 24, 2023 (88 FR 11953). BOEM
received one public comment that
opposed offshore wind energy projects
and the use of sonar due to potential
impacts on whales and dolphins. BOEM
is committed to assessing and, to the
extent possible, reducing the effects of
potential environmental impacts on
marine life and their habitats. The
purpose of this strategy is to protect and
promote the recovery of the NARW
while responsibly developing offshore
wind energy. No change in the burden
was required as a result of the comment
received.
BOEM is again soliciting comments
on the proposed ICR. BOEM is
especially interested in public
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17:28 Aug 09, 2023
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comments addressing the following
issues: (1) is the collection necessary to
the proper functions of BOEM; (2) what
can BOEM do to ensure that this
information is processed and used in a
timely manner; (3) is the burden
estimate accurate; (4) how might BOEM
enhance the quality, utility, and clarity
of the information to be collected; and
(5) how might BOEM minimize the
burden of this collection on the
respondents, including minimizing the
burden through the use of information
technology?
Comments submitted in response to
this notice are a matter of public record
and will be available for public review
on www.reginfo.gov. You should be
aware that your entire comment—
including your address, phone number,
email address, or other personally
identifiable information included in
your comment—may be made publicly
available. Even if BOEM withholds your
information in the context of this ICR,
your comment is subject to the Freedom
of Information Act (FOIA). If your
comment is requested under FOIA, your
information will only be withheld if
BOEM determines that a FOIA
exemption to disclosure applies. BOEM
will make such a determination in
accordance with the Department of the
Interior’s (DOI’s) FOIA regulations and
applicable law.
In order for BOEM to consider
withholding from disclosure your
personally identifiable information, you
must identify, in a cover letter, any
information contained in your
comments that, if released, would
constitute a clearly unwarranted
invasion of your personal privacy. You
must also briefly describe any possible
harmful consequence of the disclosure
of information, such as embarrassment,
injury, or other harm.
BOEM protects proprietary
information in accordance with FOIA (5
U.S.C. 552) and DOI’s implementing
regulations (43 CFR part 2).
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number.
The authority for this action is the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Karen Thundiyil,
Chief, Office of Regulations, Bureau of Ocean
Energy Management.
[FR Doc. 2023–17126 Filed 8–9–23; 8:45 am]
BILLING CODE 4340–98–P
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1243]
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 September 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 11, 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. 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 11, 2023, 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):
SUMMARY:
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54353
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
Controlled substance
Lysergic acid diethylamide ....
5-Methoxy-N,Ndimethyltryptamine.
Tapentadol ............................
Drug
code
Schedule
7315
7431
I
I
9780
II
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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17138 Filed 8–9–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1242]
Bulk Manufacturer of Controlled
Substances Application: Continuus
Pharmaceuticals
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 6, 2023, Continuus
Pharmaceuticals, 256 West Cummings
Park, Woburn, Massachusetts 01801,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Fentanyl ........................
Drug
code
9801
Schedule
II
The company plans to bulk
manufacture the above listed controlled
substance for research and development
purposes only. 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.
Claude Redd,
Acting Deputy Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[FR Doc. 2023–17136 Filed 8–9–23; 8:45 am]
BILLING CODE 4410–09–P
Continuus Pharmaceuticals
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 10, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 10, 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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Jkt 259001
DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–1244]
Importer of Controlled Substances
Application: Chattem Chemicals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Chattem Chemicals 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 September 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 11, 2023.
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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 July 14, 2023, Chattem
Chemicals, 3801 Saint Elmo Avenue,
Chattanooga, Tennessee 37409–1237,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
ADDRESSES:
Methamphetamine ........
4-Anilino-N-phenethyl-4piperidine (ANPP).
Phenylacetone ..............
Cocaine ........................
Poppy Straw Concentrate.
Tapentadol ....................
Drug
code
Schedule
1105
8333
II
II
8501
9041
9670
II
II
II
9780
II
The company plans to import the
listed controlled substances to
manufacture bulk controlled substances
for sale to its customers. The company
plans to import an intermediate of
Tapentadol (9780), to bulk manufacture
Tapentadol for distribution to its
customers. 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
E:\FR\FM\10AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54352-54353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17138]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1243]
Importer of Controlled Substances Application: Caligor Coghlan
Pharma Services
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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
September 11, 2023. Such persons may also file a written request for a
hearing on the application on or before September 11, 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. 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 11, 2023, 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):
[[Page 54353]]
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Lysergic acid diethylamide............. 7315 I
5-Methoxy-N,N-dimethyltryptamine....... 7431 I
Tapentadol............................. 9780 II
------------------------------------------------------------------------
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 non-approved finished
dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17138 Filed 8-9-23; 8:45 am]
BILLING CODE 4410-09-P
