Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 22516-22517 [2018-10303]
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Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
Secretary, U.S. International Trade
Commission, 500 E Street SW, Room
112, Washington, DC 20436, telephone
(202) 205–2000. 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. The public
record for this investigation may be
viewed on the Commission’s electronic
docket (EDIS) at https://edis.usitc.gov.
FOR FURTHER INFORMATION CONTACT:
Katherine Hiner, Office of the Secretary,
Docket Services Division, U.S.
International Trade Commission,
telephone (202) 205–1802.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
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 (2017).
Scope of Investigation: Having
considered the complaint, the U.S.
International Trade Commission, on
May 9, 2018, Ordered that—
(1) Pursuant to subsection (b) of
section 337 of the Tariff Act of 1930, as
amended, an investigation be instituted
to determine whether there is a
violation of subsection (a)(1)(B) 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 radio frequency
micro-needle dermatological treatment
devices and components thereof by
reason of infringement of one or more of
claims 1, 2, 4, 9–11, 15, 20, and 21 of
the ’899 patent and claims 1, 2, 4, 9–12,
17, and 18 of the ’357 patent, and
whether an industry in the United
States exists as required by subsection
(a)(2) of section 337;
(2) 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 complainants are:
Syneron Medical Ltd., Tavor Building,
Industrial Zone, Yokneam lllit, 20692,
Israel
Candela Corporation, 530 Boston Post
Road, Wayland, MA 01778
General Hospital Corporation d/b/a,
Massachusetts General Hospital, 55
Fruit Street, Boston, MA 02114
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20:27 May 14, 2018
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(b) The respondents are the following
entities alleged to be in violation of
section 337, and are the parties upon
which the complaint is to be served:
Invasix, Inc., 21084 Bake Parkway, Suite
106, Lake Forest, CA 92618
Invasix, Ltd., Apolo Building, Shaar
Yokneam, Yokneam, 20692, Israel
Inmode Md, Ltd., 20996 Bake Parkway,
Suite 106, Lake Forest, CA 92630
Ilooda Co., Ltd., 37–1 Imok-dong, Imokdong, Jangan-gu, Suwon-si, Gyeonggido, Republic of Korea
Cutera, Inc., 3240 Bayshore Boulevard,
Brisbane, CA 94005
Emvera Technologies, LLC, 641 10th
Street, Cedartown, GA 30125
Rohrer Aesthetics, LLC, 105 Citation
Court, Homewood, AL 35209
Lutronic, Corp., Lutronic Center, 219
Sowon-ro, Deogyang-gu, Goyang-si,
Geonggi-do, Republic of Korea
Lutronic, Inc., 19 Fortune Drive,
Billerica, MA 01821
Endymed Medical Inc., 790 Madison
Avenue, Suite 402, New York, NY
10065
Endymed Medical Ltd., 12 Leshem
Street, North Industrial Park,
Caesarea, 30889 Israel
Sung Hwan E&B Co., Ltd. d/b/a SHEnB
Co., Ltd., 148 Seongsui-Ro,
Soengdong-Gu, Seoul 04796, Republic
of Korea
Aesthetics Biomedical, Inc., 4602 N
16th Street, Suite 300, Phoenix, AZ
85016
Cartessa Aesthetics, 210 Peoples Way,
Hockessin, DE 19707–1904
Jeisys Medical, Inc., 307 Daeryung
Techno Town 8th, Gamasan-ro 96,
Geumcheon-Gu, Seoul, 153–775,
Republic of Korea
Perigee Medical LLC, 2227 N Macarthur
Dr., Tracy, CA 95376–2830
Lumenis Ltd., Yokneam Industrial Park,
Hakidma 6, Yokneam 2069204, Israel
Pollogen Ltd., 6 Kaufman Yehezkel, Tel
Aviv-Jaffa, 6801298, Israel
(3) For the investigation so instituted,
the Chief Administrative Law Judge,
U.S. International Trade Commission,
shall designate the presiding
Administrative Law Judge.
The Office of Unfair Import
Investigations will not participate as a
party in this investigation.
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), such
responses will be considered by the
Commission if received not later than 20
days after the date of service by the
Commission of the complaint and the
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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
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: May 9, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018–10240 Filed 5–14–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before July 16, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
SUPPLEMENTARY INFORMATION:
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22517
Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on April
5, 2017, Patheon API Manufacturing,
Inc., 309 Delaware Street, Building
1106, Greenville, South Carolina 29605
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Thebaine .................................
Noroxymorphone ....................
9333
9668
II
II
The company plans to manufacture
the above-listed controlled substances
as Active Pharmaceutical Ingredient
(API) for supply to its customers.
Dated: May 1, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10303 Filed 5–14–18; 8:45 am]
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on April
18, 2018, Mylan Pharmaceuticals, Inc.,
3711 Collins Ferry Road, Morgantown,
West Virginia 26505 applied to be
registered as an importer of the
following basic classes of controlled
substances:
BILLING CODE 4410–09–P
Amphetamine ..........................
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Methadone ..............................
Morphine .................................
Fentanyl ..................................
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Pharmaceuticals,
Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before June 14, 2018. Such persons
may also file a written request for a
hearing on the application on or before
June 14, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
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DATES:
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20:27 May 14, 2018
Jkt 244001
1100
1724
9143
9150
9250
9300
9801
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF.
This analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Dated: April 25, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–10301 Filed 5–14–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Rhodes Technologies
ACTION:
Tetrahydrocannabinols ...........
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Hydrocodone ...........................
Morphine .................................
Opium, raw .............................
Oxymorphone .........................
Poppy Straw Concentrate .......
7370
1724
9143
9150
9193
9300
9600
9652
9670
I
II
II
II
II
II
II
II
II
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before June 14, 2018. Such persons
may also file a written request for a
DATES:
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hearing on the application on or before
June 14, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007).
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on April
6, 2018, Rhodes Technologies, 498
Washington Street, Coventry, Rhode
Island 02816 applied to be registered as
an importer of the following basic
classes of controlled substances:
Frm 00077
Fmt 4703
Sfmt 4703
The company plans to import opium,
raw (9600) and poppy straw concentrate
(9670) in order to bulk manufacture
controlled substances in Active
Pharmaceutical Ingredient (API) form.
The company distributes the
manufactured APIs in bulk to its
customers.
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[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22516-22517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10303]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Manufacturing, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before July 16, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or
[[Page 22517]]
revocation of registration) has been redelegated to the Assistant
Administrator of the DEA Diversion Control Division (``Assistant
Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to
subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on April
5, 2017, Patheon API Manufacturing, Inc., 309 Delaware Street, Building
1106, Greenville, South Carolina 29605 applied to be registered as a
bulk manufacturer of the following basic classes of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Thebaine............................... 9333 II
Noroxymorphone......................... 9668 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances as Active Pharmaceutical Ingredient (API) for supply to its
customers.
Dated: May 1, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-10303 Filed 5-14-18; 8:45 am]
BILLING CODE 4410-09-P
