Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: API GLOBAL LLC, 68090-68091 [2020-23767]
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Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Notices
notice in the Federal Register on May
13, 2020 (85 FR 28663). In light of the
restrictions on access to the Commission
building due to the COVID–19
pandemic, the Commission conducted
its hearing through written testimony
and video conference on August 25,
2020. All persons who requested the
opportunity were permitted to
participate.
The Commission made these
determinations pursuant to section
751(c) of the Act (19 U.S.C. 1675(c)).
The Commission determined that these
reviews were extraordinarily
complicated and extended the review
period by up to 90 days. It completed
and filed its determinations in these
reviews on October 21, 2020. The views
of the Commission are contained in
USITC Publication 5127 (October 2020),
entitled Monosodium Glutamate from
China and Indonesia: Investigation Nos.
731–TA–1229–1230 (Review).
By order of the Commission.
Issued: October 21, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–23696 Filed 10–26–20; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–736]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Pharmaceuticals has
applied to be registered as an importer
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 November 27, 2020. Such
persons may also file a written request
for a hearing on the application on or
before November 27, 2020.
ADDRESSES: 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,
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Controlled substance
Drug
code
Schedule
Amphetamine ...................
Methylphenidate ...............
Oxycodone .......................
Hydromorphone ................
Methadone ........................
Morphine ...........................
Fentanyl ............................
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import finished
dosage forms for analytical testing and
distribution for clinical trials. 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.
BILLING CODE 7020–02–P
SUMMARY:
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on October 7, 2020, Mylan
Pharmaceuticals, Incorporated, 3711
Collins Ferry Road, Morgantown, West
Virginia 26505–2362, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–23766 Filed 10–26–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–738]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: API
GLOBAL 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
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to
proposed regulations that, if finalized,
would govern 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 December 28, 2020.
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–738 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
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
proposes to conduct this evaluation in
the manner described in the rule
proposed at 85 FR 16292, published on
March 23, 2020, if finalized.
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Federal Register / Vol. 85, No. 208 / Tuesday, October 27, 2020 / Notices
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on September 15, 2020, API Global LLC,
30 Hillview Road, Lincoln Park, New
Jersey 07035, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled substances:
Controlled substance
Drug
code
Schedule
Tetrahydrocannabinols .....
Marihuana Extract ............
Marihuana .........................
7370
7350
7360
I
I
I
The applicant noticed above applied
to become registered with DEA to grow
marihuana as a bulk manufacturer
subsequent to a 2020 DEA notice of
proposed rulemaking that provided
information on how DEA intends to
expand the number of registrations and
described the way it would oversee
those additional growers. If finalized,
the proposed rule would govern persons
seeking to become registered with DEA
to grow marihuana as a bulk
manufacturer, consistent with
applicable law. The notice of proposed
rulemaking is available at 85 FR 16292.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–23767 Filed 10–26–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–0072]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension of a
Currently Approved Collection;
Address Verification/Change Request
Form (1–797)
Criminal Justice Information
Services Division, Department of
Justice.
ACTION: 60-Day notice.
AGENCY:
Department of Justice (DOJ),
Federal Bureau of Investigation,
Criminal Justice Information Services
Division 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 for 60 days until
December 28, 2020.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
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SUMMARY:
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Jkt 253001
instrument with instructions or
additional information, please contact
Gerry Lynn Brovey, Supervisory
Information Liaison Specialist, Federal
Bureau of Investigation, Criminal Justice
Information Services Division, 1000
Custer Hollow Road, Clarksburg, WV
26306; phone: 304–625–4320 or email
glbrovey@fbi.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 Bureau of Justice
Statistics, 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 used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms
of information technology, e.g.,
permitting electronic submission of
responses.
Overview of This Information
Collection
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Fmt 4703
Sfmt 4703
respond: It is estimated that 780
respondents will complete each form
within approximately 2 minutes.
6. An estimate of the total public
burden (in hours) associated with the
collection: There are an estimated 26
total annual burden hours associated
with this collection.
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: October 20, 2020.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2020–23772 Filed 10–26–20; 8:45 am]
BILLING CODE 4410–14–P
DEPARTMENT OF JUSTICE
[OMB Number 1117–0046]
Agency Information Collection
Activities; Proposed eCollection,
eComments Requested; Extension
Without Change of a Previously
Approved Collection; Self-Certification,
Training, and Logbooks for Regulated
Sellers and Mail-Order Distributors of
Scheduled Listed Chemical Products;
DEA Form 597
Drug Enforcement
Administration, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ), Drug Enforcement
Administration (DEA), 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 for 30 days until
November 27, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
SUMMARY:
1. Type of Information Collection:
Extension of a currently approved
collection.
2. The Title of the Form/Collection:
Address Verification/Change Request
Form (1–797).
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
The form number is 1–797. The
applicable component within the
Sponsoring component: Department of
Justice, Federal Bureau of Investigation,
Criminal Justice Information Services
Division.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract: Individuals or households. The
form can be used by any requester who
wishes to correct or verify the address
submitted on their Departmental Order
556–73 request.
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
68091
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]]>Agencies
[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Notices]
[Pages 68090-68091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23767]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-738]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: API GLOBAL LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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 proposed regulations that, if
finalized, would govern 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 December 28,
2020.
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-738 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 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 proposes to conduct this evaluation
in the manner described in the rule proposed at 85 FR 16292, published
on March 23, 2020, if finalized.
[[Page 68091]]
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on September 15, 2020, API Global LLC, 30 Hillview Road, Lincoln Park,
New Jersey 07035, applied to be registered as a bulk manufacturer of
the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols................... 7370 I
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
------------------------------------------------------------------------
The applicant noticed above applied to become registered with DEA
to grow marihuana as a bulk manufacturer subsequent to a 2020 DEA
notice of proposed rulemaking that provided information on how DEA
intends to expand the number of registrations and described the way it
would oversee those additional growers. If finalized, the proposed rule
would govern persons seeking to become registered with DEA to grow
marihuana as a bulk manufacturer, consistent with applicable law. The
notice of proposed rulemaking is available at 85 FR 16292.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-23767 Filed 10-26-20; 8:45 am]
BILLING CODE 4410-09-P
