Bulk Manufacturer of Controlled Substances Application: Benuvia Manufacturing, Inc., 64251-64252 [2022-23056]
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
does not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(API) for product development and
distribution to DEA registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on September 1, 2022, Rocky Mountain
Biotech, LLC, 4740 Dillon Drive, Pueblo,
Colorado 81008–2112, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
Controlled substance
Drug code
Marihuana .........
7360
Schedule
I
Kristi O’Malley,
Assistant Administrator.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 19, 2022,
10300 128th Avenue, Pleasant Prairie,
Wisconsin 53158–7336, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1104]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Drug
code
Controlled substance
Importer of Controlled Substances
Application: Nexus Pharmaceuticals,
Inc.
Nexus Pharmaceuticals, Inc.
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:
19:12 Oct 21, 2022
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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2022–23050 Filed 10–21–22; 8:45 am]
VerDate Sep<11>2014
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 23, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 23, 2022.
DATES:
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Schedule
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The company plans to import the
listed controlled substance for research
and analytical testing purposes.
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-
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Sfmt 4703
64251
approved finished dosage forms for
commercial sale.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–23052 Filed 10–21–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1105]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Manufacturing, Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Benuvia Manufacturing 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.
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 December 23, 2022. Such
persons may also file a written request
for a hearing on the application on or
before December 23, 2022.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 12, 2022,
Benuvia Manufacturing Inc., 3950 North
Mays Street, Round Rock, Texas 78665,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
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64252
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
Controlled substance
Drug code
Tetrahydrocannabinols ........................................................................................................................................................
3,4-Methylenedioxyamphetamine ........................................................................................................................................
3,4-Methylenedioxymethamphetamine ................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .....................................................................................................................................
Dimethyltryptamine ..............................................................................................................................................................
Psilocybin .............................................................................................................................................................................
Psilocyn ...............................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for the internal use
intermediates or for sale to its
customers. In reference to drug codes
7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this
drug as synthetic. No other activities for
these drug codes are authorized for this
registration.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–23056 Filed 10–21–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; State
Training Provider Eligibility Collection
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting this Employment
and Training Administration (ETA)sponsored information collection
request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that the agency
receives on or before November 23,
2022.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
Comments are invited on: (1) whether
the collection of information is
necessary for the proper performance of
the functions of the Department,
including whether the information will
have practical utility; (2) if the
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ADDRESSES:
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
information will be processed and used
in a timely manner; (3) the accuracy of
the agency’s estimates of the burden and
cost of the collection of information,
including the validity of the
methodology and assumptions used; (4)
ways to enhance the quality, utility and
clarity of the information collection; and
(5) ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
automated collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT:
Mara Blumenthal by telephone at 202–
693–8538, or by email at DOL_PRA_
PUBLIC@dol.gov.
SUPPLEMENTARY INFORMATION: Section
122 of Public Law 113–128, the
Workforce Innovation and Opportunity
Act of 2014 (WIOA), requires training
providers to submit performance and
cost information in order to become
eligible to receive funds through WIOA
title 1–B and in order to maintain that
eligibility. The Governor or a designated
State agency (or State entity) is required
to collect this information in order to
determine eligibility of training
providers and to maintain and to
publicly disseminate the State eligible
training provider (ETP) list. For
additional substantive information
about this ICR, see the related notice
published in the Federal Register on
July 27, 2022 (87 FR 45133).
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
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 OMB Control Number.
See 5 CFR 1320.5(a) and 1320.6.
DOL seeks PRA authorization for this
information collection for three (3)
years. OMB authorization for an ICR
cannot be for more than three (3) years
without renewal. The DOL notes that
information collection requirements
submitted to the OMB for existing ICRs
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7370
7400
7405
7431
7435
7437
7438
7439
Schedule
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receive a month-to-month extension
while they undergo review.
Agency: DOL–ETA.
Title of Collection: State Training
Provider Eligibility Collection.
OMB Control Number: 1205–0523.
Affected Public: State, Local, and
Tribal Governments; Private Sector—
Businesses or other for-profits and notfor-profit institutions.
Total Estimated Number of
Respondents: 12,312.
Total Estimated Number of
Responses: 12,312.
Total Estimated Annual Time Burden:
8,906 hours.
Total Estimated Annual Other Costs
Burden: $0.
(Authority: 44 U.S.C. 3507(a)(1)(D)).
Dated: October 14, 2022.
Mara Blumenthal,
Senior PRA Analyst.
[FR Doc. 2022–23009 Filed 10–21–22; 8:45 am]
BILLING CODE 4510–FN–P
DEPARTMENT OF LABOR
Mine Safety and Health Administration
Petition for Modification of Application
of Existing Mandatory Safety
Standards
Mine Safety and Health
Administration, Labor.
ACTION: Notice.
AGENCY:
This notice is a summary of
a petition for modification submitted to
the Mine Safety and Health
Administration (MSHA) by the party
listed below.
DATES: All comments on the petition
must be received by MSHA’s Office of
Standards, Regulations, and Variances
on or before November 23, 2022.
ADDRESSES: You may submit comments
identified by Docket No. MSHA–2022–
052 by any of the following methods:
1. Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments
for MSHA–2022–052.
2. Fax: 202–693–9441.
3. Email: petitioncomments@dol.gov.
4. Regular Mail or Hand Delivery:
MSHA, Office of Standards,
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64251-64252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23056]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1105]
Bulk Manufacturer of Controlled Substances Application: Benuvia
Manufacturing, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Benuvia Manufacturing 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
December 23, 2022. Such persons may also file a written request for a
hearing on the application on or before December 23, 2022.
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 August 12, 2022, Benuvia Manufacturing Inc., 3950
North Mays Street, Round Rock, Texas 78665, applied to be registered as
a bulk manufacturer of the following basic class(es) of controlled
substance(s):
[[Page 64252]]
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols................ 7370 I
3,4-Methylenedioxyamphetamine........ 7400 I
3,4-Methylenedioxymethamphetamine.... 7405 I
5-Methoxy-N-N-dimethyltryptamine..... 7431 I
Dimethyltryptamine................... 7435 I
Psilocybin........................... 7437 I
Psilocyn............................. 7438 I
5-Methoxy-N,N-diisopropyltryptamine.. 7439 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for the internal use intermediates or for sale to its
customers. In reference to drug codes 7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture this drug as synthetic. No other
activities for these drug codes are authorized for this registration.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-23056 Filed 10-21-22; 8:45 am]
BILLING CODE 4410-09-P
