Importer of Controlled Substances Application: VA Cooperative Studies Program, 48693 [2022-17177]
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48693
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
Controlled substance
Thebaine .......................
Opium extracts .............
Opium fluid extract .......
Opium tincture ..............
Opium, powdered .........
Oxymorphone ...............
Noroxymorphone ..........
Fentanyl ........................
Drug
code
Schedule
9333
9610
9620
9630
9639
9652
9668
9801
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for conversion to other controlled
substances and sales to its customers for
dosage form development, clinical trials
and use in stability qualification
studies.
In reference to drug codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–17175 Filed 8–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[Docket No. DEA–1057]
Tetrahydrocannabinols
Importer of Controlled Substances
Application: VA Cooperative Studies
Program
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VA Cooperative Studies
Program 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 9, 2022. Such
persons may also file a written request
for a hearing on the application on or
before September 9, 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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
17:26 Aug 09, 2022
Jkt 256001
Drug
code
Controlled substance
Drug Enforcement Administration
VerDate Sep<11>2014
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 June 9, 2022, VA
Cooperative Studies Program, 2401
Centre Avenue SE, Albuquerque, New
Mexico 87106, applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
I
7370
Schedule
II
The company plans to import finished
dosage unit products containing
Tetrahydrocannabinols drug code (7370)
for research and clinical trial studies.
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. 2022–17177 Filed 8–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
ACTION:
Notice of application.
Epic Pharma, 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 9, 2022. Such
persons may also file a written request
for a hearing on the application on or
before September 9, 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 July 19, 2022, Epic
Pharma, LLC, 22715 North Conduit
Avenue, Laurelton, New York 11413–
3134, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUMMARY:
Controlled substance
Drug
code
Schedule
Drug Enforcement Administration
Methadone ....................
[Docket No. DEA–1066]
Importer of Controlled Substances
Application: Epic Pharma, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
9250
II
The company plans to import the
listed controlled substance for research
and development purposes. No other
activity for this drug code is authorized
for this registration.
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Page 48693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17177]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1057]
Importer of Controlled Substances Application: VA Cooperative
Studies Program
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: VA Cooperative Studies Program 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 9, 2022. Such persons may also file a written request for a
hearing on the application on or before September 9, 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 June 9, 2022, VA Cooperative Studies Program, 2401
Centre Avenue SE, Albuquerque, New Mexico 87106, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products
containing Tetrahydrocannabinols drug code (7370) for research and
clinical trial studies. 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. 2022-17177 Filed 8-9-22; 8:45 am]
BILLING CODE P
