Importer of Controlled Substances Application: Hybrid Pharma, 61364-61365 [2022-21946]
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61364
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
Determinations
Pursuant to NAGPRA and its
implementing regulations, and after
consultation with the appropriate
Indian Tribes and Native Hawaiian
organizations, NYU Dentistry has
determined that:
• The human remains described in
this notice represent the physical
remains of eight individuals of Native
American ancestry.
• There is a relationship of shared
group identity that can be reasonably
traced between the human remains and
the La Jolla Band of Luiseno Indians,
California (previously listed as La Jolla
Band of Luiseno Mission Indians of the
La Jolla Reservation); Pala Band of
Mission Indians (previously listed as
Pala Band of Luiseno Mission Indians of
the Pala Reservation, California); Pauma
Band of Luiseno Mission Indians of the
Pauma & Yuima Reservation, California;
Pechanga Band of Indians (previously
listed as Pechanga Band of Luiseno
Mission Indians of the Pechanga
Reservation, California); Rincon Band of
Luiseno Mission Indians of Rincon
Reservation, California; Santa Ynez
Band of Chumash Mission Indians of
the Santa Ynez Reservation, California;
and the Soboba Band of Luiseno
Indians, California.
Requests for Repatriation
Written requests for repatriation of the
human remains and associated funerary
objects in this notice must be sent to the
Responsible Official identified in
ADDRESSES. Requests for repatriation
may be submitted by:
1. Any one or more of the Indian
Tribes or Native Hawaiian organizations
identified in this notice.
2. Any lineal descendant, Indian
Tribe, or Native Hawaiian organization
not identified in this notice who shows,
by a preponderance of the evidence, that
the requestor is a lineal descendant or
a culturally affiliated Indian Tribe or
Native Hawaiian organization.
Repatriation of the human remains
and associated funerary objects in this
notice to a requestor may occur on or
after November 10, 2022. If competing
requests for repatriation are received,
NYU Dentistry must determine the most
appropriate requestor prior to
repatriation. Requests for joint
repatriation of the human remains and
associated funerary objects are
considered a single request and not
competing requests. NYU Dentistry is
responsible for sending a copy of this
notice to the Indian Tribes and Native
Hawaiian organizations identified in
this notice.
Authority: Native American Graves
Protection and Repatriation Act, 25
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
U.S.C. 3003, and the implementing
regulations, 43 CFR 10.9, § 10.10, and
§ 10.14.
Dated: September 27, 2022.
Melanie O’Brien,
Manager, National NAGPRA Program.
[FR Doc. 2022–22041 Filed 10–7–22; 8:45 am]
BILLING CODE 4312–52–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1088]
Bulk Manufacturer of Controlled
Substances Application: Eli-ElSohly
Laboratories
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Eli-ElSohly Laboratories, 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 12, 2022. Such
persons may also file a written request
for a hearing on the application on or
before December 12, 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 19, 2022, EliElSohly Laboratories, 5 Industrial Park
Drive, Oxford, Mississippi 38655–5343,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUMMARY:
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
Controlled substance
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
Dihydromorphine ..........
Amphetamine ...............
Methamphetamine ........
Cocaine ........................
Codeine ........................
Dihydrocodeine .............
Oxycodone ...................
Ecgonine .......................
Thebaine .......................
Drug
code
7350
7360
7370
9145
1100
1105
9041
9050
9120
9143
9180
9333
Schedule
I
I
I
I
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances for
product development and reference
standards. In reference to drug codes
7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to isolate these controlled
substances from procured 7350
(Marihuana Extract). In reference to
drug code 7360, no cultivation activities
are authorized for this registration. In
reference to drug code 9333 (Thebaine),
the company plans to manufacture a
Thebaine derivative. No other activities
for these drug codes are authorized for
this registration.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21945 Filed 10–7–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1089]
Importer of Controlled Substances
Application: Hybrid Pharma
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Hybrid Pharma 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 10, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 10, 2022.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
DATES:
E:\FR\FM\11OCN1.SGM
11OCN1
61365
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 2, 2022,
Hybrid Pharma, 1015 West Newport
Center Drive, Suite 106A, Deerfield
Beach, Florida 33442–7707, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
khammond on DSKJM1Z7X2PROD with NOTICES
Dimethyltryptamine .......
Drug
code
7435
Schedule
I
The company plans to import the
listed controlled substance to
manufacture dosage forms to support
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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21946 Filed 10–7–22; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
DEPARTMENT OF JUSTICE
Drug
code
Controlled substance
Schedule
Drug Enforcement Administration
[Docket No. DEA–1084]
Importer of Controlled Substances
Application: Groff NA Hemplex LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Groff NA Hemplex 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 November 10, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 10, 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. 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 August 18, 2022, Groff
NA Hemplex LLC, 100 Redco Avenue,
Suite A, Red Lion, Pennsylvania 17356–
1436, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUMMARY:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
I
7350
7360
7370
I
I
I
I
The company plans to import the
above listed controlled substance(s) as
bulk to manufacture research grade
material for clinical trial studies.
Several types of Marihuana Extract
compounds are listed under drug code
7350. No other activity 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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21939 Filed 10–7–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1080]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
High Point, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Cambrex High Point, 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 12, 2022. Such
persons may also file a written request
for a hearing on the application on or
before December 12, 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
SUMMARY:
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61364-61365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21946]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1089]
Importer of Controlled Substances Application: Hybrid Pharma
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Hybrid Pharma 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
November 10, 2022. Such persons may also file a written request for a
hearing on the application on or before November 10, 2022.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal,
[[Page 61365]]
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 September 2, 2022, Hybrid Pharma, 1015 West Newport
Center Drive, Suite 106A, Deerfield Beach, Florida 33442-7707, applied
to be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Dimethyltryptamine..................... 7435 I
------------------------------------------------------------------------
The company plans to import the listed controlled substance to
manufacture dosage forms to support 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 non-approved finished
dosage forms for commercial sale.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-21946 Filed 10-7-22; 8:45 am]
BILLING CODE P
