Importer of Controlled Substances Application: S&B Pharma LLC, 12980 [2022-04805]
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12980
Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices
inspection at the Office of the Secretary
and on EDIS.3
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of §§ 201.10 and 210.8(c) of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Issued: March 2, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022–04835 Filed 3–7–22; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
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 24, 2021,
S&B Pharma LLC, 405 South Motor
Avenue, Azusa, California 91702,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Drug Enforcement Administration
4-Anilino-N-Phenethyl4-Piperdine (ANPP).
Tapentadol ....................
Importer of Controlled Substances
Application: S&B Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
S&B 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 April 7, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
VerDate Sep<11>2014
17:25 Mar 07, 2022
Drug
code
Controlled substance
[Docket No. DEA–969]
Jkt 256001
I
Schedule
8333
II
9780
I II
The company plans to import
intermediate forms of Tapentadol (9780)
for further manufacturing prior to
distribution to its customers. The
company plans to import ANPP (8333)
to bulk manufacture other controlled
substances for distribution to its
customers. 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. 2022–04805 Filed 3–7–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–973]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Tikun
Olam Adelanto 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
SUMMARY:
PO 00000
Frm 00057
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 May 9, 2022.
ADDRESSES: 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.’’
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
E:\FR\FM\08MRN1.SGM
08MRN1
]]>Agencies
[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Page 12980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04805]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-969]
Importer of Controlled Substances Application: S&B Pharma LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: S&B 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
April 7, 2022. Such persons may also file a written request for a
hearing on the application on or before April 7, 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 24, 2021, S&B Pharma LLC, 405 South Motor
Avenue, Azusa, California 91702, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
4-Anilino-N-Phenethyl-4-Piperdine 8333 II
(ANPP).
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The company plans to import intermediate forms of Tapentadol (9780)
for further manufacturing prior to distribution to its customers. The
company plans to import ANPP (8333) to bulk manufacture other
controlled substances for distribution to its customers. 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 non-approved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04805 Filed 3-7-22; 8:45 am]
BILLING CODE P
