Importer of Controlled Substances Application: Vici Health Sciences, LLC, 56052 [2023-17719]
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56052
Federal Register / Vol. 88, No. 158 / Thursday, August 17, 2023 / Notices
DEPARTMENT OF JUSTICE
Controlled substance
Drug
code
Schedule
Ibogaine ........................
7260
I
Drug Enforcement Administration
[Docket No. DEA–1229]
Importer of Controlled Substances
Application: Vici Health Sciences, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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 September 18, 2023. Such
persons may also file a written request
for a hearing on the application on or
before September 18, 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 May 12, 2023, 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):
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
21:36 Aug 16, 2023
Jkt 259001
The company plans to import the
listed controlled substances for use in
clinical trials, research and analytical
testing as well as dosage formulation
development. 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. 2023–17719 Filed 8–16–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF LABOR
Mine Safety and Health Administration
Affirmative Decisions on Petitions for
Modification Granted in Whole or in
Part
Mine Safety and Health
Administration (MSHA), Labor.
ACTION: Notice.
AGENCY:
The Federal Mine Safety and
Health Act of 1977 and title 30 of the
Code of Federal Regulations govern the
application, processing, and disposition
of petitions for modification of
mandatory safety standards. Any mine
operator or representative of miners may
petition for an alternative method of
complying with an existing safety
standard. MSHA reviews the content of
each submitted petition, assesses the
mine in question, and ultimately issues
a decision on the petition. This notice
includes a list of petitions for
modification that were granted after
MSHA’s review and investigation,
between December 31, 2022, and June
30, 2023.
ADDRESSES: Copies of the final decisions
are posted on MSHA’s website at
https://www.msha.gov/regulations/
rulemaking/petitions-modification. The
public may inspect the petitions and
final decisions in person at MSHA,
Office of Standards, Regulations, and
Variances, 201 12th Street South,
Arlington, Virginia, between 9:00 a.m.
and 5:00 p.m. Monday through Friday,
except federal holidays. Before visiting
MSHA in person, call 202–693–9455 to
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
make an appointment, in keeping with
the Department of Labor’s COVID–19
policy. Special health precautions may
be required.
FOR FURTHER INFORMATION CONTACT: S.
Aromie Noe, Director, Office of
Standards, Regulations, and Variances
at 202–693–9440 (voice),
Petitionsformodification@dol.gov
(email), or 202–693–9441 (fax). [These
are not toll-free numbers.]
SUPPLEMENTARY INFORMATION:
I. Introduction
Under section 101(c) of the Federal
Mine Safety and Health Act of 1977, any
mine operator or representative of
miners may petition to use an
alternative approach to comply with a
mandatory safety standard. In response,
the Secretary of Labor (Secretary) or his
or her designee may modify the
application of a mandatory safety
standard to that mine if the Secretary
determines that: (1) An alternative
method exists that will guarantee no
less protection for the miners affected
than that provided by the standard; or
(2) the application of the standard will
result in a diminution of safety to the
affected miners.
MSHA bases the final decision on the
petitioner’s statements, any comments
and information submitted by interested
persons, and a field investigation of the
conditions at the mine. In some
instances, MSHA may approve a
petition for modification on the
condition that the mine operator
complies with other requirements noted
in the decision. In other instances,
MSHA may deny, dismiss, or revoke a
petition for modification. In accordance
with 30 CFR 44.5, MSHA publishes
every final action granting a petition for
modification.
II. Granted Petitions for Modification
On the basis of the findings of
MSHA’s investigation, and as designee
of the Secretary, MSHA granted or
partially granted the petitions for
modification below. Since the previous
Federal Register notice (88 FR 7468)
included petitions granted through
December 31, 2022, the following are
petitions granted between January 1,
2023, and June 30, 2023. The granted
petitions are shown in the order that
MSHA received them.
• Docket Number: M–2021–034–C.
FR Notice: 86 FR 71666 (12/17/2021).
Petitioner: Rosebud Mining Company,
301 Market Street, Kittanning,
Pennsylvania 16201.
Mine: Knob Creek Mine, MSHA ID
No. 36–09394, located in Indiana
County, Pennsylvania.
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Page 56052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17719]
[[Page 56052]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1229]
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
September 18, 2023. Such persons may also file a written request for a
hearing on the application on or before September 18, 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 May 12, 2023, 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 substances for
use in clinical trials, research and analytical testing as well as
dosage formulation development. 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. 2023-17719 Filed 8-16-23; 8:45 am]
BILLING CODE P
