Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: New Mexico Top Organics-Ultra Health, 55860-55861 [2021-21879]
Download as PDF
<![CDATA[
55860
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
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 May 19, 2021,
AndersonBrecon, Inc., 4545 Assembly
Drive, Rockford, Illonois 61109, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Tetrahydrocannabinols ...
Drug
code
Schedule
7370
I
The company plans to import the
listed controlled substance for clinical
trials only. 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–21876 Filed 10–6–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–906]
Importer of Controlled Substances
Application: Caligor Coghlan Pharma
Services
Drug
code
Controlled substance
Tapentadol ......................
I
9780
Schedule
III
The company plans to import the
listed controlled substance in finished
dosage form to be used in pediatric
clinical trials. 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.
Brian S. Besser,
Acting Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[FR Doc. 2021–21878 Filed 10–6–21; 8:45 am]
Caligor Coghlan Pharma
Services has applied to be registered as
an importer of basic class(es) of
controlled substance(s). Refer to
Supplemental 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 November 8, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 8, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
DEPARTMENT OF JUSTICE
AGENCY:
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
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 requests 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 August 16, 2021,
Caligor Coghlan Pharma Services, 1500
Business Park Drive, Unit B, Bastrop,
Texas 78602, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
VerDate Sep<11>2014
17:46 Oct 06, 2021
Jkt 256001
BILLING CODE P
Drug Enforcement Administration
[Docket No. DEA–907]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: New
Mexico Top Organics-Ultra Health
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
SUMMARY:
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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.
DATES: 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 December 6, 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–907 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
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). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
E:\FR\FM\07OCN1.SGM
07OCN1
Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Notices
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on August 27, 2021, New Mexico Top
Organics-Ultra Health, 225 Camino Don
Tomas, Bernalillo, New Mexico 87004,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled substance
Marihuana Extract ..........
Marihuana .......................
Drug
code
Schedule
7350
7360
I
I
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–21879 Filed 10–6–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Foreign Claims Settlement
Commission
[F.C.S.C. Meeting and Hearing Notice No.
04–21]
Sunshine Act Meetings
The Foreign Claims Settlement
Commission, pursuant to its regulations
(45 CFR part 503.25) and the
Government in the Sunshine Act (5
U.S.C. 552b), hereby gives notice in
regard to the scheduling of open
meetings as follows:
Thursday, October 21,
2021, at 1:00 p.m. EST.
TIME AND DATE:
This meeting will be held by
teleconference. There will be no
physical meeting place.
PLACE:
Open. Members of the public
who wish to observe the meeting via
teleconference should contact Patricia
M. Hall, Foreign Claims Settlement
Commission, Tele: (202) 616–6975, two
business days in advance of the
meeting. Individuals will be given callin information upon notice of
attendance to the Commission.
STATUS:
1:00 p.m.—
Issuance of Proposed Decisions under
the Guam World War II Loyalty
Recognition Act, Title XVII, Public Law
114–328.
lotter on DSK11XQN23PROD with NOTICES1
MATTERS TO BE CONSIDERED:
CONTACT PERSON FOR MORE INFORMATION:
Requests for information, advance
notices of intention to observe an open
meeting, and requests for teleconference
dial-in information may be directed to:
Patricia M. Hall, Foreign Claims
Settlement Commission, 441 G St. NW,
VerDate Sep<11>2014
17:46 Oct 06, 2021
Jkt 256001
Room 6234, Washington, DC 20579.
Telephone: (202) 616–6975.
Jeremy R. LaFrancois,
Chief Administrative Counsel.
[FR Doc. 2021–22009 Filed 10–5–21; 11:15 am]
BILLING CODE 4410–BA–P
Notice of Lodging of Proposed
Consent Decree Under The Clean Air
Act; The Comprehensive
Environmental Response,
Compensation, and Liability Act; and
The Emergency Planning and
Community Right-To-Know Act
On September 30, 2021, the
Department of Justice lodged a proposed
Consent Decree with the United States
District Court for the Western District of
Louisiana in the lawsuit entitled United
States et al. v. Firestone Polymers, LLC,
Case No. 2:21–cv–03464.
The proposed Consent Decree
resolves claims asserted in the
Complaint filed in the action that
Firestone Polymers, LLC (‘‘Defendant’’)
violated the Clean Air Act (‘‘CAA’’), and
other federal statutes, and related
Louisiana state air pollution control
laws applicable to the synthetic rubber
production facility located in Sulphur,
Calcasieu Parish near Lake Charles,
Louisiana. The Complaint alleges that
the CAA violations resulted in the
emission of illegal pollutants, including
nitrogen oxides, carbon monoxide,
volatile organic compounds, particulate
matter, and sulfur dioxide, and
hazardous air pollutants. Other claims
involve alleged violations of the
Comprehensive Environmental
Response, Compensation, and Liability
Act, the Emergency Planning and
Community Right-to-Know Act, and
Louisiana state air pollution control
requirements governed by the Louisiana
Environmental Quality Act and
implementing regulations. Under the
proposed Consent Decree, Defendant
has agreed to pay a civil penalty of
$3.35 million, implement a State of
Louisiana Beneficial Environmental
Project valued at $654,125 and
implement a mitigation project to
resolve the governments’ claims.
The publication of this notice opens
a period for public comment on the
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States et al. v. Firestone
Polymers, LLC, Case No. 2:21–cv–03464
and D.J. Ref. No. 90–5–2–1–11946. All
comments must be submitted no later
than thirty (30) days after the
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
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.
By mail .........
DEPARTMENT OF JUSTICE
55861
During the public comment period,
the Consent Decree may be examined
and downloaded at this Justice
Department website: https://
www.usdoj.gov/enrd/Consent_
Decrees.html. We will provide a paper
copy of the 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 $18.75 (25 cents per page
reproduction cost) without the Consent
Decree attachments or $29.50 with the
attachments, payable to the United
States Treasury.
Thomas Carroll,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2021–21910 Filed 10–6–21; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF LABOR
Office of the Workers’ Compensation
Programs
Agency Information Collection
Activities; Comment Request;
Rehabilitation Maintenance Certificate
(OWCP–17)
Office of Workers’
Compensations, DOL
ACTION: Notice.
AGENCY:
The Department of Labor
(DOL) is soliciting comments
concerning a proposed extension for the
authority to conduct the information
collection request (ICR) titled,
‘‘Rehabilitation Maintenance Certificate
(OWCP–17).’’ This comment request is
part of continuing Departmental efforts
to reduce paperwork and respondent
burden in accordance with the
Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
Consideration will be given to all
written comments received by
December 6, 2021.
DATES:
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55860-55861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21879]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-907]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: New Mexico Top Organics-Ultra Health
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: 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 December 6,
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-907 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 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). DEA will conduct this evaluation in the
manner described in the rule published at 85 FR 82333 on December 18,
2020, and
[[Page 55861]]
reflected in DEA regulations at 21 CFR part 1318.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on August 27, 2021, New Mexico Top Organics-Ultra Health, 225 Camino
Don Tomas, Bernalillo, New Mexico 87004, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
------------------------------------------------------------------------
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-21879 Filed 10-6-21; 8:45 am]
BILLING CODE P
