Bulk Manufacturer of Controlled Substances Application: Stepan Company, 13586-13587 [2021-04808]
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khammond on DSKJM1Z7X2PROD with NOTICES
13586
Federal Register / Vol. 86, No. 44 / Tuesday, March 9, 2021 / Notices
calendarpad/calendar.html. Interested
parties should check the Commission’s
website periodically for updates.
Requests to appear at the hearing should
be filed in writing with the Secretary to
the Commission on or before May 6,
2021. A nonparty who has testimony
that may aid the Commission’s
deliberations may request permission to
present a short statement at the hearing.
All parties and nonparties desiring to
appear at the hearing and make oral
presentations should attend a
prehearing conference to be held at 9:30
a.m. on May 7, 2021, if deemed
necessary. Oral testimony and written
materials to be submitted at the public
hearing are governed by sections
201.6(b)(2), 201.13(f), and 207.24 of the
Commission’s rules. Parties must submit
any request to present a portion of their
hearing testimony in camera no later
than 7 business days prior to the date of
the hearing.
Written submissions.—Each party
who is an interested party shall submit
a prehearing brief to the Commission.
Prehearing briefs must conform with the
provisions of § 207.23 of the
Commission’s rules; the deadline for
filing is May 4, 2021. Parties may also
file written testimony in connection
with their presentation at the hearing, as
provided in § 207.24 of the
Commission’s rules, and posthearing
briefs, which must conform with the
provisions of section 207.25 of the
Commission’s rules. The deadline for
filing posthearing briefs is May 17,
2021. In addition, any person who has
not entered an appearance as a party to
the investigations may submit a written
statement of information pertinent to
the subject of the investigations,
including statements of support or
opposition to the petition, on or before
May 17, 2021. On June 4, 2021, the
Commission will make available to
parties all information on which they
have not had an opportunity to
comment. Parties may submit final
comments on this information on or
before June 8, 2021, but such final
comments must not contain new factual
information and must otherwise comply
with § 207.30 of the Commission’s rules.
All written submissions must conform
with the provisions of § 201.8 of the
Commission’s rules; any submissions
that contain BPI must also conform with
the requirements of §§ 201.6, 207.3, and
207.7 of the Commission’s rules. The
Commission’s Handbook on Filing
Procedures, available on the
Commission’s website at https://
www.usitc.gov/documents/handbook_
on_filing_procedures.pdf, elaborates
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upon the Commission’s procedures with
respect to filings.
Additional written submissions to the
Commission, including requests
pursuant to § 201.12 of the
Commission’s rules, shall not be
accepted unless good cause is shown for
accepting such submissions, or unless
the submission is pursuant to a specific
request by a Commissioner or
Commission staff.
In accordance with §§ 201.16(c) and
207.3 of the Commission’s rules, each
document filed by a party to the
investigations must be served on all
other parties to the investigations (as
identified by either the public or BPI
service list), and a certificate of service
must be timely filed. The Secretary will
not accept a document for filing without
a certificate of service.
Authority: These investigations are being
conducted under authority of title VII of the
Tariff Act of 1930; this notice is published
pursuant to § 207.21 of the Commission’s
rules.
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 2, 2021,
Patheon Pharmaceuticals Inc, 2110 East
Galbraith Road, Cincinnati, Ohio
45237–1625, applied to be registered as
a bulk manufacturer of the following
basic class of controlled substance:
SUPPLEMENTARY INFORMATION:
Controlled substance
Gamma Hydroxybutyric
Acid.
Drug
code
Schedule
2010
I
The company plans to manufacture
the above-listed controlled substance as
Active Pharmaceutical Ingredient (API)
that will be further synthesized into
Food and Drug Administrationapproved dosage forms. No other
activities for this drug code are
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–04809 Filed 3–8–21; 8:45 am]
By order of the Commission.
Issued: March 4, 2021.
Lisa Barton,
Secretary to the Commission.
BILLING CODE 4410–09–P
[FR Doc. 2021–04860 Filed 3–8–21; 8:45 am]
Drug Enforcement Administration
DEPARTMENT OF JUSTICE
BILLING CODE 7020–02–P
[Docket No. DEA–804]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Patheon Pharmaceuticals Inc
has applied to be registered as a bulk
manufacturer 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 May 10, 2021. Such persons
may also file a written request for a
hearing on the application on or before
May 10, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
Frm 00068
Fmt 4703
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[Docket No. DEA–802]
PO 00000
Bulk Manufacturer of Controlled
Substances Application: Stepan
Company
Sfmt 4703
Stepan Company 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 file written
comments on or objections to the
issuance of the proposed registration on
or before May 10, 2021. Such persons
may also file a written request for a
hearing on the application on or before
May 10, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on February 8, 2021,
Stepan Company, 100 West Hunter
Avenue, Maywood, New Jersey 07607–
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 86, No. 44 / Tuesday, March 9, 2021 / Notices
1021, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Drug
code
Schedule
Cocaine ...........................
Ecgonine ..........................
9041
9180
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
No other activity for these drug codes is
authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–04808 Filed 3–8–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–803]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Groff NA
Hemplex 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
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.
SUMMARY:
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 10, 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–803 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
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DATES:
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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
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on December 29, 2020, Groff NA
Hemplex LLC, 100 Redco Avenue, Suite
A, Red Lion, Pennsylvania 17356–1436,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled substance
Marihuana Extract ...........
Drug
code
Schedule
7350
I
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–04810 Filed 3–8–21; 8:45 am]
BILLING CODE 4410–09–P
PO 00000
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Sfmt 4703
13587
DEPARTMENT OF JUSTICE
[OMB Number 1121–0197]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension
Without Change, of a Previously
Approved Collection; State Criminal
Alien Assistance Program (Section
241(i) of the Immigration and
Nationality Act (8 U.S.C. 1231(i))
Bureau of Justice Assistance,
Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Office of Justice Programs,
Bureau of Justice Assistance, will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted 60 days until May 10,
2021.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments on the
estimated burden to facilities covered by
the standards to comply with the
regulation’s reporting requirements,
suggestions, or need additional
information, please contact, Joseph
Husted, telephone number (202) 906–
0387, Policy Advisor, Bureau of Justice
Assistance, 810 Seventh Street NW,
Washington, DC 20531 or by email at
SCAAP@usdoj.gov.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions that
were used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information collected can be
enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including use of appropriate
automated, electronic, mechanical, or
other technological collection
techniques or other forms of
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 44 (Tuesday, March 9, 2021)]
[Notices]
[Pages 13586-13587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04808]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-804]
Bulk Manufacturer of Controlled Substances Application: Stepan
Company
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Stepan Company 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 file written comments on or objections to
the issuance of the proposed registration on or before May 10, 2021.
Such persons may also file a written request for a hearing on the
application on or before May 10, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on February 8, 2021, Stepan Company, 100 West Hunter
Avenue, Maywood, New Jersey 07607-
[[Page 13587]]
1021, applied to be registered as a bulk manufacturer of the following
basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Cocaine................................ 9041 II
Ecgonine............................... 9180 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers. No other activity
for these drug codes is authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-04808 Filed 3-8-21; 8:45 am]
BILLING CODE 4410-09-P
