83 FR 22516 - Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 94 (May 15, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 94 (May 15, 2018)
| Page Range | 22516-22517 | |
| FR Document | 2018-10303 |
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)] [Notices] [Pages 22516-22517] From the Federal Register Online [www.thefederalregister.org] [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
![22516 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
Secretary, U.S. International Trade (b) The respondents are the following notice of investigation. Extensions of
Commission, 500 E Street SW, Room entities alleged to be in violation of time for submitting responses to the
112, Washington, DC 20436, telephone section 337, and are the parties upon complaint and the notice of
(202) 205–2000. Hearing impaired which the complaint is to be served: investigation will not be granted unless
individuals are advised that information Invasix, Inc., 21084 Bake Parkway, Suite good cause therefor is shown.
on this matter can be obtained by 106, Lake Forest, CA 92618 Failure of a respondent to file a timely
contacting the Commission’s TDD Invasix, Ltd., Apolo Building, Shaar response to each allegation in the
terminal on (202) 205–1810. Persons Yokneam, Yokneam, 20692, Israel complaint and in this notice may be
with mobility impairments who will Inmode Md, Ltd., 20996 Bake Parkway, deemed to constitute a waiver of the
need special assistance in gaining access Suite 106, Lake Forest, CA 92630 right to appear and contest the
to the Commission should contact the Ilooda Co., Ltd., 37–1 Imok-dong, Imok- allegations of the complaint and this
Office of the Secretary at (202) 205– dong, Jangan-gu, Suwon-si, Gyeonggi- notice, and to authorize the
2000. General information concerning do, Republic of Korea administrative law judge and the
the Commission may also be obtained Cutera, Inc., 3240 Bayshore Boulevard, Commission, without further notice to
by accessing its internet server at Brisbane, CA 94005 the respondent, to find the facts to be as
https://www.usitc.gov. The public Emvera Technologies, LLC, 641 10th alleged in the complaint and this notice
record for this investigation may be Street, Cedartown, GA 30125 and to enter an initial determination
viewed on the Commission’s electronic Rohrer Aesthetics, LLC, 105 Citation and a final determination containing
docket (EDIS) at https://edis.usitc.gov. Court, Homewood, AL 35209 such findings, and may result in the
FOR FURTHER INFORMATION CONTACT: Lutronic, Corp., Lutronic Center, 219 issuance of an exclusion order or a cease
Katherine Hiner, Office of the Secretary, Sowon-ro, Deogyang-gu, Goyang-si, and desist order or both directed against
Docket Services Division, U.S. Geonggi-do, Republic of Korea the respondent.
International Trade Commission, Lutronic, Inc., 19 Fortune Drive, By order of the Commission.
telephone (202) 205–1802. Billerica, MA 01821 Issued: May 9, 2018.
SUPPLEMENTARY INFORMATION:
Endymed Medical Inc., 790 Madison Lisa Barton,
Avenue, Suite 402, New York, NY
Authority: The authority for institution of Secretary to the Commission.
10065
this investigation is contained in section 337 Endymed Medical Ltd., 12 Leshem [FR Doc. 2018–10240 Filed 5–14–18; 8:45 am]
of the Tariff Act of 1930, as amended, 19 BILLING CODE 7020–02–P
U.S.C. 1337 and in section 210.10 of the
Street, North Industrial Park,
Commission’s Rules of Practice and Caesarea, 30889 Israel
Procedure, 19 CFR 210.10 (2017). Sung Hwan E&B Co., Ltd. d/b/a SHEnB
Co., Ltd., 148 Seongsui-Ro, DEPARTMENT OF JUSTICE
Scope of Investigation: Having Soengdong-Gu, Seoul 04796, Republic
considered the complaint, the U.S. of Korea Drug Enforcement Administration
International Trade Commission, on Aesthetics Biomedical, Inc., 4602 N [Docket No. DEA–392]
May 9, 2018, Ordered that— 16th Street, Suite 300, Phoenix, AZ
(1) Pursuant to subsection (b) of 85016 Bulk Manufacturer of Controlled
section 337 of the Tariff Act of 1930, as Cartessa Aesthetics, 210 Peoples Way, Substances Application: Patheon API
amended, an investigation be instituted Hockessin, DE 19707–1904 Manufacturing, Inc.
to determine whether there is a Jeisys Medical, Inc., 307 Daeryung
violation of subsection (a)(1)(B) of Techno Town 8th, Gamasan-ro 96, ACTION: Notice of application.
section 337 in the importation into the Geumcheon-Gu, Seoul, 153–775,
United States, the sale for importation, Republic of Korea DATES: Registered bulk manufacturers of
or the sale within the United States after Perigee Medical LLC, 2227 N Macarthur the affected basic classes, and
importation of certain radio frequency Dr., Tracy, CA 95376–2830 applicants therefore, may file written
micro-needle dermatological treatment Lumenis Ltd., Yokneam Industrial Park, comments on or objections to the
devices and components thereof by Hakidma 6, Yokneam 2069204, Israel issuance of the proposed registration on
reason of infringement of one or more of Pollogen Ltd., 6 Kaufman Yehezkel, Tel or before July 16, 2018.
claims 1, 2, 4, 9–11, 15, 20, and 21 of Aviv-Jaffa, 6801298, Israel ADDRESSES: Written comments should
the ’899 patent and claims 1, 2, 4, 9–12, (3) For the investigation so instituted, be sent to: Drug Enforcement
17, and 18 of the ’357 patent, and the Chief Administrative Law Judge, Administration, Attention: DEA Federal
whether an industry in the United U.S. International Trade Commission, Register Representative/DRW, 8701
States exists as required by subsection shall designate the presiding Morrissette Drive, Springfield, Virginia
(a)(2) of section 337; Administrative Law Judge. 22152.
(2) For the purpose of the The Office of Unfair Import SUPPLEMENTARY INFORMATION: The
investigation so instituted, the following Investigations will not participate as a Attorney General has delegated his
are hereby named as parties upon which party in this investigation. authority under the Controlled
this notice of investigation shall be Responses to the complaint and the Substances Act to the Administrator of
served: notice of investigation must be the Drug Enforcement Administration
(a) The complainants are: submitted by the named respondents in (DEA), 28 CFR 0.100(b). Authority to
Syneron Medical Ltd., Tavor Building, accordance with section 210.13 of the exercise all necessary functions with
daltland on DSKBBV9HB2PROD with NOTICES
Industrial Zone, Yokneam lllit, 20692, Commission’s Rules of Practice and respect to the promulgation and
Israel Procedure, 19 CFR 210.13. Pursuant to implementation of 21 CFR part 1301,
Candela Corporation, 530 Boston Post 19 CFR 201.16(e) and 210.13(a), such incident to the registration of
Road, Wayland, MA 01778 responses will be considered by the manufacturers, distributors, dispensers,
General Hospital Corporation d/b/a, Commission if received not later than 20 importers, and exporters of controlled
Massachusetts General Hospital, 55 days after the date of service by the substances (other than final orders in
Fruit Street, Boston, MA 02114 Commission of the complaint and the connection with suspension, denial, or
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![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22517
revocation of registration) has been authority under the Controlled hearing on the application on or before
redelegated to the Assistant Substances Act to the Administrator of June 14, 2018.
Administrator of the DEA Diversion the Drug Enforcement Administration ADDRESSES: Written comments should
Control Division (‘‘Assistant (DEA), 28 CFR 0.100(b). Authority to be sent to: Drug Enforcement
Administrator’’) pursuant to section 7 of exercise all necessary functions with Administration, Attention: DEA Federal
28 CFR part 0, appendix to subpart R. respect to the promulgation and Register Representative/DRW, 8701
In accordance with 21 CFR implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia
1301.33(a), this is notice that on April incident to the registration of 22152. All requests for hearing must be
5, 2017, Patheon API Manufacturing, manufacturers, distributors, dispensers, sent to: Drug Enforcement
Inc., 309 Delaware Street, Building importers, and exporters of controlled Administration, Attn: Administrator,
1106, Greenville, South Carolina 29605 substances (other than final orders in 8701 Morrissette Drive, Springfield,
applied to be registered as a bulk connection with suspension, denial, or Virginia 22152. All requests for hearing
manufacturer of the following basic revocation of registration) has been should also be sent to: (1) Drug
classes of controlled substances: redelegated to the Assistant Enforcement Administration, Attn:
Administrator of the DEA Diversion Hearing Clerk/LJ, 8701 Morrissette
Thebaine ................................. 9333 II
Noroxymorphone .................... 9668 II Control Division (‘‘Assistant Drive, Springfield, Virginia 22152; and
Administrator’’) pursuant to section 7 of (2) Drug Enforcement Administration,
The company plans to manufacture 28 CFR part 0, appendix to subpart R. Attn: DEA Federal Register
the above-listed controlled substances In accordance with 21 CFR Representative/DRW, 8701 Morrissette
as Active Pharmaceutical Ingredient 1301.34(a), this is notice that on April Drive, Springfield, Virginia 22152.
(API) for supply to its customers. 18, 2018, Mylan Pharmaceuticals, Inc., Comments and requests for hearings on
Dated: May 1, 2018. 3711 Collins Ferry Road, Morgantown, applications to import narcotic raw
West Virginia 26505 applied to be material are not appropriate. 72 FR
Susan A. Gibson,
registered as an importer of the 3417, (January 25, 2007).
Deputy Assistant Administrator.
following basic classes of controlled SUPPLEMENTARY INFORMATION: The
[FR Doc. 2018–10303 Filed 5–14–18; 8:45 am]
substances: Attorney General has delegated his
BILLING CODE 4410–09–P
authority under the Controlled
Amphetamine .......................... 1100 II
Methylphenidate ...................... 1724 II Substances Act to the Administrator of
DEPARTMENT OF JUSTICE Oxycodone .............................. 9143 II the Drug Enforcement Administration
Hydromorphone ...................... 9150 II (DEA), 28 CFR 0.100(b). Authority to
Methadone .............................. 9250 II exercise all necessary functions with
Drug Enforcement Administration Morphine ................................. 9300 II
Fentanyl .................................. 9801 II respect to the promulgation and
[Docket No. DEA–392]
implementation of 21 CFR part 1301,
Importer of Controlled Substances The company plans to import the incident to the registration of
Application: Mylan Pharmaceuticals, listed controlled substances in finished manufacturers, distributors, dispensers,
Inc. dosage form (FDF) from foreign sources importers, and exporters of controlled
for analytical testing and clinical trials substances (other than final orders in
ACTION: Notice of application. in which the foreign FDF will be connection with suspension, denial, or
compared to the company’s own revocation of registration) has been
DATES: Registered bulk manufacturers of domestically-manufactured FDF. redelegated to the Assistant
the affected basic classes, and This analysis is required to allow the Administrator of the DEA Diversion
applicants therefore, may file written company to export domestically- Control Division (‘‘Assistant
comments on or objections to the manufactured FDF to foreign markets. Administrator’’) pursuant to section 7 of
issuance of the proposed registration on 28 CFR part 0, appendix to subpart R.
or before June 14, 2018. Such persons Dated: April 25, 2018.
In accordance with 21 CFR
may also file a written request for a Susan A. Gibson, 1301.34(a), this is notice that on April
hearing on the application on or before Deputy Assistant Administrator. 6, 2018, Rhodes Technologies, 498
June 14, 2018. [FR Doc. 2018–10301 Filed 5–14–18; 8:45 am] Washington Street, Coventry, Rhode
ADDRESSES: Written comments should BILLING CODE 4410–09–P Island 02816 applied to be registered as
be sent to: Drug Enforcement an importer of the following basic
Administration, Attention: DEA Federal classes of controlled substances:
Register Representative/DRW, 8701 DEPARTMENT OF JUSTICE
Morrissette Drive, Springfield, Virginia Tetrahydrocannabinols ........... 7370 I
22152. All requests for hearing must be Drug Enforcement Administration Methylphenidate ...................... 1724 II
Oxycodone .............................. 9143 II
sent to: Drug Enforcement Hydromorphone ...................... 9150 II
[Docket No. DEA–392]
Administration, Attn: Administrator, Hydrocodone ........................... 9193 II
8701 Morrissette Drive, Springfield, Importer of Controlled Substances
Morphine ................................. 9300 II
Virginia 22152. All requests for hearing Opium, raw ............................. 9600 II
Application: Rhodes Technologies Oxymorphone ......................... 9652 II
should also be sent to: (1) Drug Poppy Straw Concentrate ....... 9670 II
Enforcement Administration, Attn: ACTION: Notice of application.
Hearing Clerk/LJ, 8701 Morrissette The company plans to import opium,
daltland on DSKBBV9HB2PROD with NOTICES
Drive, Springfield, Virginia 22152; and DATES: Registered bulk manufacturers of raw (9600) and poppy straw concentrate
(2) Drug Enforcement Administration, the affected basic classes, and (9670) in order to bulk manufacture
Attn: DEA Federal Register applicants therefore, may file written controlled substances in Active
Representative/DRW, 8701 Morrissette comments on or objections to the Pharmaceutical Ingredient (API) form.
Drive, Springfield, Virginia 22152. issuance of the proposed registration on The company distributes the
SUPPLEMENTARY INFORMATION: The or before June 14, 2018. Such persons manufactured APIs in bulk to its
Attorney General has delegated his may also file a written request for a customers.
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Document Created: 2018-05-15 00:33:38
Document Modified: 2018-05-15 00:33:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| FR Citation | 83 FR 22516 |
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