Importer of Controlled Substances Application: Janssen Pharmaceuticals, Inc., 11732 [2022-04321]
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11732
Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
other activities for these drug codes are
authorized for this registration.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04324 Filed 3–1–22; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–968]
Importer of Controlled Substances
Application: Janssen Pharmaceuticals,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Janssen 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.
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 April 1, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 1, 2022.
ADDRESSES: The DEA 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
19:14 Mar 01, 2022
Jkt 256001
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 10, 2021,
Janssen Pharmaceuticals Inc, 1440
Olympic Drive, Buildings 1–5 and 7–14,
Athens, Georgia 30601–1645, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Thebaine ...................................
Poppy Straw Concentrate .........
Tapentadol ................................
Drug
code
Schedule
9333
9670
9780
II
II
II
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 April 1, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 1, 2022.
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 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.
ADDRESSES:
The company plans to import
intermediates classified under
Tapentadol (9780) and Thebaine (9333)
for further manufacturing to the
controlled substances tapentadol and
buprenorpine, respectively, prior to
distribution to customers. The company
plans to import Poppy Straw
Concentrate (9670) to bulk manufacture
other controlled substances. 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.
SUPPLEMENTARY INFORMATION:
Matthew J. Strait,
Deputy Assistant Administrator.
Cocaine .....................................
Ecgonine ...................................
In
accordance with 21 CFR 1301.34(a), this
is notice that on December 16, 2021,
Medi-Physics Inc. dba GE Healthcare,
3350 North Ridge Avenue, Arlington
Heights, Illinois 60004–1412, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Controlled substance
[FR Doc. 2022–04321 Filed 3–1–22; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–959]
Importer of Controlled Substances
Application: Medi-Physics Inc. dba GE
Healthcare
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Medi-Physics Inc. dba GE
Healthcare 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:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Drug
code
Schedule
9041
II
I 9180 III
The company plans to import
derivatives of the listed controlled
substances to be used for the
manufacture of a diagnostic product and
reference standards. 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04371 Filed 3–1–22; 8:45 am]
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E:\FR\FM\02MRN1.SGM
02MRN1
]]>Agencies
[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Page 11732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04321]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-968]
Importer of Controlled Substances Application: Janssen
Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Janssen 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.
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
April 1, 2022. Such persons may also file a written request for a
hearing on the application on or before April 1, 2022.
ADDRESSES: The DEA 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 December 10, 2021, Janssen Pharmaceuticals Inc, 1440
Olympic Drive, Buildings 1-5 and 7-14, Athens, Georgia 30601-1645,
applied to be registered as an importer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Thebaine................................ 9333 II
Poppy Straw Concentrate................. 9670 II
Tapentadol.............................. 9780 II
------------------------------------------------------------------------
The company plans to import intermediates classified under
Tapentadol (9780) and Thebaine (9333) for further manufacturing to the
controlled substances tapentadol and buprenorpine, respectively, prior
to distribution to customers. The company plans to import Poppy Straw
Concentrate (9670) to bulk manufacture other controlled substances. 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.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04321 Filed 3-1-22; 8:45 am]
BILLING CODE P
