Importer of Controlled Substances Application: National Center for Natural Products Research, 30983-30984 [2021-12209]
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30983
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
import of the Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–12212 Filed 6–9–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–845]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Maridose,
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefor, may file written
comments on or objections to the
issuance of the proposed registration on
or before August 9, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW 8701
Morrissette Drive, Springfield, Virginia
22152. To ensure proper handling of
comments, please reference Docket
No—DEA–845 in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
file written comments on or objections
khammond on DSKJM1Z7X2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:15 Jun 09, 2021
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of the requested registration, as
provided in this notice. This notice does
not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) 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). In addition
to seeking to produce marihuana
extract, this applicant is separately
seeking to cultivate marihuana. See
Notice of Application, Bulk
Manufacturers of Marihuana, 84 FR
44920, 44922 (Aug. 27, 2019). DEA thus
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 May 6, 2021, Maridose, LLC., 74
Orion Street, Brunswick, Maine 04011,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Drug
code
Controlled substance
I
Marihuana Extract ........
7350
Schedule
II
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–12213 Filed 6–9–21; 8:45 am]
ACTION:
Notice of application.
National Center for Natural
Products Research 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 file written
comments on or objections to the
issuance of the proposed registration on
or before July 12, 2021. Such persons
may also file a written request for a
hearing on the application on or before
July 12, 2021.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a hearing
should also 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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on April 14, 2021,
National Center for Natural Products
Research, 806 Hathorn Road, 135 Coy
Waller Lab, University, Mississippi
38677–1848, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Drug
code
Schedule
7350
7360
7370
I
I
I
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–843]
Importer of Controlled Substances
Application: National Center for
Natural Products Research
Drug Enforcement
Administration, Justice.
AGENCY:
PO 00000
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Sfmt 4703
The company plans to acquire new
genetic materials with improved
Cannabinoids for research and
manufacturing purposes. No other
activity for these drug codes 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 FDA-approved or non-
E:\FR\FM\10JNN1.SGM
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30984
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
approved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–12209 Filed 6–9–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On June 2, 2021, the Department of
Justice lodged with the United States
District Court for the Southern District
of Indiana a Consent Decree in United
States and State of Indiana v. Lone Star
Industries, Inc. Civ. No. 2:21–cv–233–
JRS–MJD.
The proposed Consent Decree settles
claims brought by the United States and
State of Indiana against Lone Star for
violations of the Clean Air Act and Title
13 of the Indiana Code (including
regulations and permits issued
thereunder) at the cement
manufacturing facility it owns and
operates in Greencastle, Indiana. The
Consent Decree resolves these claims
and requires Lone Star to (1) pay a civil
penalty of $729,000 to be split evenly
between the state and United States; (2)
implement specified measures designed
to prevent the continuation or
reoccurrence of the violations alleged,
and (3) complete various mitigation
projects to offset harm caused by its past
violations.
The publication of this notice opens
a period for public comment on the
proposed Consent Decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division and should
refer to United States and State of
Indiana v. Lone Star Industries, Inc. D.J.
Ref. No. 90–5–2–1–09889/4. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
khammond on DSKJM1Z7X2PROD with NOTICES
By mail .........
During the public comment period,
the proposed Consent Decree may be
examined and downloaded at this
Justice Department website: https://
www.justice.gov/enrd/consent-decrees.
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
We will provide a paper copy of the
proposed Consent Decree upon written
request and payment of reproduction
costs. Please mail your request and
payment to: Consent Decree Library,
U.S. DOJ—ENRD, P.O. Box 7611,
Washington, DC 20044–7611.
Please enclose a check or money order
for $12.25 (25 cents per page
reproduction cost) payable to the United
States Treasury.
should contact their State Workforce
Agency.
FOR FURTHER INFORMATION CONTACT: U.S.
Department of Labor, Employment and
Training Administration, Office of
Unemployment Insurance Room S–
4524, Attn: Thomas Stengle, 200
Constitution Avenue NW, Washington,
DC 20210, telephone number (202) 693–
2991 (this is not a toll-free number) or
by email: Stengle.Thomas@dol.gov.
Patricia A. McKenna,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
Signed in Washington, DC.
Suzan G. LeVine,
Principal Deputy Assistant Secretary for
Employment and Training.
[FR Doc. 2021–12115 Filed 6–9–21; 8:45 am]
[FR Doc. 2021–12158 Filed 6–9–21; 8:45 am]
BILLING CODE 4410–15–P
BILLING CODE 4510–FW–P
DEPARTMENT OF LABOR
DEPARTMENT OF LABOR
Mine Safety and Health Administration
Employment and Training
Administration
Notice of a Change in Status of the
Extended Benefit (EB) Program for
Colorado
Employment and Training
Administration, Labor.
ACTION: Notice.
AGENCY:
This notice announces a change in
benefit period eligibility under the EB
program that has occurred since the
publication of the last notice regarding
the State’s EB status:
• Based on the data released by the
Bureau of Labor Statistics on May 21,
2021, the seasonally-adjusted TUR for
Colorado fell below the 6.5% threshold
necessary to remain ‘‘on’’ in EB.
Therefore the payable period in EB for
Colorado will end on June 12, 2021.
The trigger notice covering state
eligibility for the EB program can be
found at: https://ows.doleta.gov/
unemploy/claims_arch.as.
Information for Claimants
The duration of benefits payable in
the EB program, and the terms and
conditions on which they are payable,
are governed by the Federal-State
Extended Unemployment Compensation
Act of 1970, as amended, and the
operating instructions issued to the
states by the U.S. Department of Labor.
In the case of a state beginning an EB
period, the State Workforce Agency will
furnish a written notice of potential
entitlement to each individual who has
exhausted all rights to regular benefits
and is potentially eligible for EB (20
CFR 615.13(c)(1)).
Persons who believe they may be
entitled to EB, or who wish to inquire
about their rights under the program,
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Petitions for Modification of
Application of Existing Mandatory
Safety Standards
Mine Safety and Health
Administration, Labor.
ACTION: Notice.
AGENCY:
This notice includes the
summaries of three petitions for
modification submitted to the Mine
Safety and Health Administration
(MSHA) by the party listed below.
DATES: All comments on the petitions
must be received by MSHA’s Office of
Standards, Regulations, and Variances
on or before July 12, 2021.
ADDRESSES: You may submit your
comments including the docket number
of the petition by any of the following
methods:
1. Electronic Mail: zzMSHAcomments@dol.gov. Include the docket
number of the petition in the subject
line of the message.
2. Facsimile: 202–693–9441.
3. Regular Mail or Hand Delivery:
MSHA, Office of Standards,
Regulations, and Variances, 201 12th
Street South, Suite 4E401, Arlington,
Virginia 22202–5452, Attention: Jessica
D. Senk, Director, Office of Standards,
Regulations, and Variances. Persons
delivering documents are required to
check in at the receptionist’s desk in
Suite 4E401. Individuals may inspect
copies of the petition and comments
during normal business hours at the
address listed above.
MSHA will consider only comments
postmarked by the U.S. Postal Service or
proof of delivery from another delivery
service such as UPS or Federal Express
on or before the deadline for comments.
FOR FURTHER INFORMATION CONTACT:
Jessica Senk, Office of Standards,
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30983-30984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12209]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-843]
Importer of Controlled Substances Application: National Center
for Natural Products Research
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: National Center for Natural Products Research 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 file written comments on or objections to
the issuance of the proposed registration on or before July 12, 2021.
Such persons may also file a written request for a hearing on the
application on or before July 12, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
request for a hearing should also 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on April 14, 2021, National Center for Natural Products
Research, 806 Hathorn Road, 135 Coy Waller Lab, University, Mississippi
38677-1848, applied to be registered as an importer of the following
basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
The company plans to acquire new genetic materials with improved
Cannabinoids for research and manufacturing purposes. No other activity
for these drug codes 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 FDA-approved or non-
[[Page 30984]]
approved finished dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-12209 Filed 6-9-21; 8:45 am]
BILLING CODE 4410-09-P
