Importer of Controlled Substances Application: Vici Health Sciences, LLC, 46904 [2024-11818]
Download as PDF
<![CDATA[
46904
Federal Register / Vol. 89, No. 105 / Thursday, May 30, 2024 / Notices
of the following basic class(es) of
controlled substance(s):
Controlled substance
Psilocybin ........................
Oxycodone ......................
Hydromorphone ...............
Morphine ..........................
Tapentadol ......................
Fentanyl ...........................
Drug
code
Schedule
7437
9143
9150
9300
9780
9801
I
II
II
II
II
II
The company plans to import the
listed controlled substances as finished
dosage form units for clinical trials
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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11817 Filed 5–29–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on April 16, 2024, Vici
Health Sciences, LLC, 6655 Amberton
Drive, Suite O, Elkridge, Maryland
21075–6202, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement Administration
I
II
Ibogaine ...........................
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
The company plans to import the
listed controlled substance for use in
clinical trials, research and analytical
testing as well as dosage formulation
development. 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.
Vici Health Sciences, 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 July 1, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 1, 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
SUMMARY:
VerDate Sep<11>2014
20:03 May 29, 2024
Jkt 262001
7260
Schedule
Importer of Controlled Substances
Application: Vici Health Sciences, LLC
AGENCY:
ddrumheller on DSK120RN23PROD with NOTICES1
Drug
code
Controlled substance
[Docket No. DEA–1376]
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–11818 Filed 5–29–24; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1374]
Importer of Controlled Substances
Application: VA Cooperative Studies
Program
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VA Cooperative Studies
Program 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 July 1, 2024. Such persons
may also file a written request for a
hearing on the application on or before
July 1, 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 April 12, 2024, VA
Cooperative Studies Program, 2401
Centre Avenue South East,
Albuquerque, New Mexico 87106,
applied to be registered as an importer
SUMMARY:
E:\FR\FM\30MYN1.SGM
30MYN1
]]>Agencies
[Federal Register Volume 89, Number 105 (Thursday, May 30, 2024)]
[Notices]
[Page 46904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11818]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1376]
Importer of Controlled Substances Application: Vici Health
Sciences, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Vici Health Sciences, 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
July 1, 2024. Such persons may also file a written request for a
hearing on the application on or before July 1, 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 April 16, 2024, Vici Health Sciences, LLC, 6655
Amberton Drive, Suite O, Elkridge, Maryland 21075-6202, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Ibogaine................................ 7260 I
------------------------------------------------------------------------
The company plans to import the listed controlled substance for use
in clinical trials, research and analytical testing as well as dosage
formulation development. 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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-11818 Filed 5-29-24; 8:45 am]
BILLING CODE 4410-09-P
