Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Denco, LLC, 21268-21269 [2020-07999]
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21268
Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
at https://edis.usitc.gov. For help
accessing EDIS, please email
EDIS3Help@usitc.gov. Hearing impaired
individuals are advised that information
on this matter can be obtained by
contacting the Commission’s TDD
terminal on (202) 205–1810. Persons
with mobility impairments who will
need special assistance in gaining access
to the Commission should contact the
Office of the Secretary at (202) 205–
2000. General information concerning
the Commission may also be obtained
by accessing its internet server at
https://www.usitc.gov.
FOR FURTHER INFORMATION CONTACT:
Pathenia M. Proctor, The Office of
Unfair Import Investigations, U.S.
International Trade Commission,
telephone (202) 205–2560 or (202) 205–
1802.
SUPPLEMENTARY INFORMATION: Authority:
The authority for institution of this
investigation is contained in section 337
of the Tariff Act of 1930, as amended,
19 U.S.C. 1337, and in section 210.10 of
the Commission’s Rules of Practice and
Procedure, 19 CFR 210.10 (2019).
Scope of Investigation: Having
considered the complaint, the U.S.
International Trade Commission, on
April 10, 2020, ordered that—
(1) Pursuant to subsection (b) of
section 337 of the Tariff Act of 1930, as
amended, an investigation be instituted
to determine:
(a) whether there is a violation of
subsection (a)(1)(C) of section 337 in the
importation into the United States, the
sale for importation, or the sale within
the United States after importation of
certain products identified in paragraph
(2) by reason of infringement of one or
more of the Registered Marks and
whether an industry in the United
States exists as required by subsection
(a)(2) of section 337;
(b) whether there is a violation of
subsection (a)(1)(A) of section 337 in the
unfair methods of competition and
unfair acts in the importation and sale
of the Gray Market IVF Products
through the false designation as to
source, the threat or effect of which is
to destroy or substantially injure an
industry in the United States; and
(c) whether there is a violation of
subsection (a)(1)(A) of section 337 in the
unfair methods of competition and
unfair acts in the importation and sale
of the Gray Market IVF Products
through false advertising, the threat or
effect of which is to destroy or
substantially injure an industry in the
United States;
(2) Pursuant to section 210.10(b)(1) of
the Commission’s Rules of Practice and
Procedure, 19 CFR 210.10(b)(1), the
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plain language description of the
accused products or category of accused
products, which defines the scope of the
investigation, is ‘‘prescription in vitro
fertilization drugs, components thereof,
and products containing the same
labeled, in whole or in part, Gonal-f,
Ovidrel, or Ovitrelle;’’
(3) For the purpose of the
investigation so instituted, the following
are hereby named as parties upon which
this notice of investigation shall be
served:
(a) The complainant is:
EMD Serono, Inc., One Technology
Place, Rockland, MA 02370
(b) The respondents are the following
entities alleged to be in violation of
section 337, and is/are the parties upon
which the complaint is to be served
FastIVF c/o Domains by Proxy LLC,
14455 N Hayden Road, Scottsdale, AZ
85260
Hermes Eczanesi, Eski Bu¨yu¨kdere Cad.,
Windowist Tower No. 26/2, MaslakSariyer, Istanbul, Turkey
General Plastik Drug Stores, Buyuk
Hanli Konut B2, Suadiye, 34740
Istanbul Suadiye, Turkey
(c) The Office of Unfair Import
Investigations, U.S. International Trade
Commission, 500 E Street SW, Suite
401, Washington, DC 20436; and
(4) For the investigation so instituted,
the Chief Administrative Law Judge,
U.S. International Trade Commission,
shall designate the presiding
Administrative Law Judge.
Responses to the complaint and the
notice of investigation must be
submitted by the named respondents in
accordance with section 210.13 of the
Commission’s Rules of Practice and
Procedure, 19 CFR 210.13. Pursuant to
19 CFR 201.16(e) and 210.13(a), as
amended in 85 FR 15798 (March 19,
2020), such responses will be
considered by the Commission if
received not later than 20 days after the
date of service by the complainant of the
complaint and the notice of
investigation. Extensions of time for
submitting responses to the complaint
and the notice of investigation will not
be granted unless good cause therefor is
shown.
Failure of a respondent to file a timely
response to each allegation in the
complaint and in this notice may be
deemed to constitute a waiver of the
right to appear and contest the
allegations of the complaint and this
notice, and to authorize the
administrative law judge and the
Commission, without further notice to
the respondent, to find the facts to be as
alleged in the complaint and this notice
and to enter an initial determination
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and a final determination containing
such findings, and may result in the
issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
By order of the Commission.
Issued: April 13, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–08062 Filed 4–15–20; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–616]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Denco,
LLC
ACTION:
Notice of application.
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 June 15, 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–616 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
SUMMARY:
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Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
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.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on March 2, 2020, Denco, LLC, 5155
East 46th Avenue, Denver, Colorado
80216, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled
substance
jbell on DSKJLSW7X2PROD with NOTICES
Marihuana .................
Tetrahydrocannabinols.
Drug
code
Schedule
7360
7370
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[OMB Number 1121–0094]
[Docket No. DEA–629]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals
Inc.
ACTION:
Notice of application.
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:
In
accordance with 21 CFR 1301.34(a), this
is notice that on March 31, 2020, Mylan
Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, North
Carolina 27406, applied to be registered
as an importer of the following basic
class(es) of controlled substances:
The applicant’s notice above applied
to become registered with DEA to grow
marihuana as a bulk manufacturer
subsequent to a 2016 DEA policy
statement that provided information on
how it intended to expand the number
of registrations, and described in general
terms the way it would oversee those
additional growers. In order to complete
the evaluation and registration process
for applicants to grow marihuana, DEA
has proposed regulations that, if
finalized, would supersede the 2016
policy statement and govern persons
seeking to become registered with DEA
to grow marihuana as a bulk
manufacturer, consistent with
applicable law. The proposed
regulations are available at 85 FR 16292.
The company plans to import the
above-controlled substance as the FDAapproved drug product in finished
dosage form for commercial distribution
to its customers. 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).
William T. McDermott,
Assistant Administrator.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–07999 Filed 4–15–20; 8:45 am]
[FR Doc. 2020–08001 Filed 4–15–20; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
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Controlled Substance
Drug
code
Schedule
Remifentanil ..............
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II
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Agency Information Collection
Activities; Proposed eCollection
eComments Requested;
Reinstatement, With Change, of a
Previously Approved Collection for
Which Approval Has Expired: 2019
Census of Jails
Bureau of Justice Statistics,
Department of Justice.
ACTION: 30-Day notice.
AGENCY:
Registered bulk manufacturer 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 18, 2020. Such persons
may also file a written request for a
hearing on the application on or before
May 18, 2020.
DATES:
SUPPLEMENTARY INFORMATION:
I
I
21269
The Department of Justice
(DOJ), Office of Justice Programs,
Bureau of Justice Statistics, 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 May
18, 2020.
FOR FURTHER INFORMATION CONTACT:
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
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.
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21268-21269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07999]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-616]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Denco, LLC
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 June 15, 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-616 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
[[Page 21269]]
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.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on March 2, 2020, Denco, LLC, 5155 East 46th Avenue, Denver, Colorado
80216, applied to be registered as a bulk manufacturer of the following
basic class(es) of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana............................. 7360 I
Tetrahydrocannabinols................. 7370 I
------------------------------------------------------------------------
The applicant's notice above applied to become registered with DEA
to grow marihuana as a bulk manufacturer subsequent to a 2016 DEA
policy statement that provided information on how it intended to expand
the number of registrations, and described in general terms the way it
would oversee those additional growers. In order to complete the
evaluation and registration process for applicants to grow marihuana,
DEA has proposed regulations that, if finalized, would supersede the
2016 policy statement and govern persons seeking to become registered
with DEA to grow marihuana as a bulk manufacturer, consistent with
applicable law. The proposed regulations are available at 85 FR 16292.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-07999 Filed 4-15-20; 8:45 am]
BILLING CODE 4410-09-P
