Importer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC, 83578 [2023-26342]
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83578
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices
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 January 29, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 29, 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on October 23, 2023,
Pharmaron Manufacturing Services (US)
LLC, 498 Washington Street, Coventry,
Rhode Island 02816, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
DATES:
Drug
code
Controlled substance
Dimethyltryptamine ........
I
7435
Schedule
II
The company plans to bulk
manufacture the listed controlled
substance for the purpose of producing
material for clinical trials. No other
activities for this drug code are
authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–26343 Filed 11–29–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
khammond on DSKJM1Z7X2PROD with NOTICES
Drug Enforcement Administration
Pharmaron Manufacturing
Services (US) 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.
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 January 2, 2024. Such
persons may also file a written request
for a hearing on the application on or
before January 2, 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 October 30, 2023,
Pharmaron Manufacturing Services (US)
LLC, 498 Washington Street, Conventry,
Rhode Island 02816, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
DATES:
[Docket No. DEA–1298]
Drug
code
Controlled substance
Schedule
Importer of Controlled Substances
Application: Pharmaron Manufacturing
Services (US) LLC
Dimethyltryptamine ..........
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
The company purpose of importing
Dimethyltryptamine (7435) is to
conduct process and analytical
technology transfer, further process, and
AGENCY:
VerDate Sep<11>2014
17:22 Nov 29, 2023
Jkt 262001
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Frm 00048
Fmt 4703
I
7435
Sfmt 4703
II
analytical development as needed and
subsequently manufacture/produce an
Active Pharmaceutical Ingredient under
Good Manufacturing Practices at the US
Pharmaron site (Pharmaron
Manufacturing Services (US) LLC in
Coventry, Rhode Island. 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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–26342 Filed 11–29–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–0057]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Uniform Crime
Reporting (UCR) Instrument Pretesting
and Burden Estimation Generic
Clearance
Federal Bureau of
Investigation, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Federal Bureau of
Investigation (FBI), 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
published in the Federal Register on
September 15, 2023, allowing a 60-day
comment period.
DATES: Comments are encouraged and
will be accepted for 30 days until
January 2, 2024.
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: Edward L. Abraham, Crime and
Law Enforcement Statistics Unit Chief,
FBI, CJIS Division, Module D–1, 1000
Custer Hollow Road, Clarksburg, West
Virginia 26306; telephone number: 304–
625–4830, email: elabraham@fbi.gov.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
SUMMARY:
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Page 83578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26342]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1298]
Importer of Controlled Substances Application: Pharmaron
Manufacturing Services (US) LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Pharmaron Manufacturing Services (US) 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
January 2, 2024. Such persons may also file a written request for a
hearing on the application on or before January 2, 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 October 30, 2023, Pharmaron Manufacturing Services
(US) LLC, 498 Washington Street, Conventry, Rhode Island 02816, applied
to be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Dimethyltryptamine...................... 7435 I
------------------------------------------------------------------------
The company purpose of importing Dimethyltryptamine (7435) is to
conduct process and analytical technology transfer, further process,
and analytical development as needed and subsequently manufacture/
produce an Active Pharmaceutical Ingredient under Good Manufacturing
Practices at the US Pharmaron site (Pharmaron Manufacturing Services
(US) LLC in Coventry, Rhode Island. 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 non-approved finished
dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-26342 Filed 11-29-23; 8:45 am]
BILLING CODE 4410-09-P
