83 FR 64158 - Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 239 (December 13, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 239 (December 13, 2018)
| Page Range | 64158-64159 | |
| FR Document | 2018-27036 |
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)] [Notices] [Pages 64158-64159] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-27036] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Mylan Pharmaceuticals 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 January 14, 2019. Such persons may also file a written request for a hearing on the application on or before January 14, 2019. 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 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/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: 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 October 10, 2018, Mylan Pharmaceuticals Inc., 2898 Manufacturers Road, Greensboro, North Carolina 27406-4600 applied to be registered as an importer of the following basic class of controlled substance: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Nabilone............................... 7379 II ------------------------------------------------------------------------ The company plans to import the FDA approved drug product in finished dosage form for 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). [[Page 64159]] Dated: December 3, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-27036 Filed 12-12-18; 8:45 am] BILLING CODE 4410-09-P
![64158 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices
ACTION: Notice. 8701 Morrissette Drive, Springfield, DATES: Registered bulk manufacturers of
Virginia 22152. All requests for hearing the affected basic classes, and
DATES: December 7, 2018. should also be sent to: (1) Drug applicants therefore, may file written
FOR FURTHER INFORMATION CONTACT: Eric Enforcement Administration, Attn: comments on or objections to the
Mozie, Director of Human Resources, or Hearing Clerk/OALJ, 8701 Morrissette issuance of the proposed registration on
Ronald Johnson, Senior Human Drive, Springfield, Virginia 22152; and or before January 14, 2019. Such
Resources Specialist, U.S. International (2) Drug Enforcement Administration, persons may also file a written request
Trade Commission (202) 205–2651. Attn: DEA Federal Register for a hearing on the application on or
SUPPLEMENTARY INFORMATION: The Representative/DPW, 8701 Morrissette before January 14, 2019.
Chairman of the U.S. International Drive, Springfield, Virginia 22152. ADDRESSES: Written comments should
Trade Commission has appointed the SUPPLEMENTARY INFORMATION: The be sent to: Drug Enforcement
following individuals to serve on the Attorney General has delegated his Administration, Attention: DEA Federal
Commission’s Performance Review authority under the Controlled Register Representative/DPW, 8701
Board (PRB): Substances Act to the Administrator of Morrissette Drive, Springfield, Virginia
the Drug Enforcement Administration 22152. All requests for hearing must be
Chair of the PRB: Commissioner Irving sent to: Drug Enforcement
(DEA), 28 CFR 0.100(b). Authority to
A. Williamson Administration, Attn: Administrator,
Vice-Chair of the PRB: Commissioner exercise all necessary functions with
respect to the promulgation and 8701 Morrissette Drive, Springfield,
Meredith Broadbent Virginia 22152. All requests for hearing
Member—John Ascienzo implementation of 21 CFR part 1301,
incident to the registration of should also be sent to: (1) Drug
Member—Dominic Bianchi Enforcement Administration, Attn:
Member—Nannette Christ manufacturers, distributors, dispensers,
importers, and exporters of controlled Hearing Clerk/OALJ, 8701 Morrissette
Member—Catherine DeFilippo Drive, Springfield, Virginia 22152; and
Member—James Holbein substances (other than final orders in
connection with suspension, denial, or (2) Drug Enforcement Administration,
Member—Margaret Macdonald Attn: DEA Federal Register
Member—Stephen A. McLaughlin revocation of registration) has been
redelegated to the Assistant Representative/DPW, 8701 Morrissette
Member—William Powers Drive, Springfield, Virginia 22152.
Administrator of the DEA Diversion
Authority: This notice is published in the Control Division (‘‘Assistant SUPPLEMENTARY INFORMATION: The
Federal Register pursuant to the requirement Attorney General has delegated his
Administrator’’) pursuant to section 7 of
of 5 U.S.C. 4314(c)(4). Hearing impaired authority under the Controlled
individuals are advised that information on 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR Substances Act to the Administrator of
this matter can be obtained by contacting our
TDD terminal on (202) 205–1810. 1301.34(a), this is notice that on the Drug Enforcement Administration
November 05, 2018, Siegfried USA, (DEA), 28 CFR 0.100(b). Authority to
By order of the Commission. exercise all necessary functions with
LLC, 33 Industrial Park Road,
Issued: December 4, 2018. respect to the promulgation and
Pennsville, New Jersey 08070 applied to
Lisa Barton, be registered as an importer of the implementation of 21 CFR part 1301,
Secretary to the Commission. following basic classes of controlled incident to the registration of
[FR Doc. 2018–26742 Filed 12–12–18; 8:45 am] substances: manufacturers, distributors, dispensers,
BILLING CODE 7020–02–P importers, and exporters of controlled
Controlled Drug substances (other than final orders in
Schedule
substance code connection with suspension, denial, or
DEPARTMENT OF JUSTICE revocation of registration) has been
Opium, raw ....................... 9600 II redelegated to the Assistant
Poppy Straw Concentrate 9670 II
Drug Enforcement Administration Administrator of the DEA Diversion
Control Division (‘‘Assistant
[Docket No. DEA–392] The company plans to import the
Administrator’’) pursuant to section 7 of
listed controlled substances to
Importer of Controlled Substances 28 CFR part 0, appendix to subpart R.
manufacture bulk active pharmaceutical In accordance with 21 CFR
Application: Siegfried USA, LLC ingredients (API) for distribution to its 1301.34(a), this is notice that on October
customers. 10, 2018, Mylan Pharmaceuticals Inc.,
ACTION: Notice of application.
Dated: December 3, 2018. 2898 Manufacturers Road, Greensboro,
DATES: Registered bulk manufacturers of John J. Martin, North Carolina 27406–4600 applied to
the affected basic classes, and Assistant Administrator. be registered as an importer of the
applicants therefore, may file written [FR Doc. 2018–27032 Filed 12–12–18; 8:45 am] following basic class of controlled
comments on or objections to the BILLING CODE 4410–09–P substance:
issuance of the proposed registration on
or before January 14, 2019. Such Drug
Controlled substance Schedule
code
persons may also file a written request DEPARTMENT OF JUSTICE
for a hearing on the application on or Nabilone ........................ 7379 II
before January 14, 2019. Drug Enforcement Administration
ADDRESSES: Written comments should The company plans to import the
amozie on DSK3GDR082PROD with NOTICES1
be sent to: Drug Enforcement [Docket No. DEA–392] FDA approved drug product in finished
Administration, Attention: DEA Federal dosage form for distribution to its
Register Representative/DPW, 8701 Importer of Controlled Substances customers. Approval of permit
Morrissette Drive, Springfield, Virginia Application: Mylan Pharmaceuticals applications will occur only when the
22152. All requests for hearing must be Inc. registrant’s business activity is
sent to: Drug Enforcement consistent with what is authorized
ACTION: Notice of application.
Administration, Attn: Administrator, under 21 U.S.C. 952(a)(2).
VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1](https://thefederalregister.org/doc/83_FR_64397/page/1.svg)
![Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Notices 64159
Dated: December 3, 2018. Drug connection with suspension, denial, or
Controlled substance Schedule
John J. Martin, code revocation of registration) has been
Assistant Administrator. redelegated to the Assistant
Cocaine ......................... 9041 II Administrator of the DEA Diversion
[FR Doc. 2018–27036 Filed 12–12–18; 8:45 am]
Codeine ......................... 9050 II Control Division (‘‘Assistant
BILLING CODE 4410–09–P Dihydrocodeine .............. 9120 II
Oxycodone .................... 9143 II Administrator’’) pursuant to section 7 of
Hydromorphone ............. 9150 II 28 CFR part 0, appendix to subpart R.
DEPARTMENT OF JUSTICE Ecgonine ........................ 9180 II In accordance with 21 CFR
Hydrocodone ................. 9193 II 1301.33(a), this is notice that on July 16,
Drug Enforcement Administration Morphine ........................ 9300 II 2018, Cambrex High Point Inc., 4180
Thebaine ........................ 9333 II Mendenhall Oaks Parkway, High Point,
[Docket No. DEA–392]
North Carolina 27265 applied to be
The company plans to manufacture registered as a bulk manufacturer of the
Bulk Manufacturer of Controlled
the listed controlled substances for following basic classes of controlled
Substances Application: Eli-Elsohly
product development and reference substances:
Laboratories
standards. In reference to drug codes
ACTION: Notice of application. 7360 (marihuana) and 7370 (THC), the Controlled Drug Schedule
company plans to isolate these substances code
DATES: Registered bulk manufacturers of controlled substances from procured
7350 (marihuana extract). In reference to Oxymorphone ................ 9652 II
the affected basic classes, and Noroxymorphone ........... 9668 II
applicants therefore, may file written drug code 7360 (marihuana), no
comments on or objections to the cultivation activities are authorized for The company plans to manufacture
issuance of the proposed registration on this registration. No other activities for the above listed controlled substances in
or before February 11, 2019. these drug codes are authorized for this bulk for distribution to its customers.
ADDRESSES: Written comments should registration.
Dated: December 3, 2018.
be sent to: Drug Enforcement Dated: December 3, 2018.
John J. Martin,
Administration, Attention: DEA Federal John J. Martin,
Assistant Administrator.
Register Representative/DPW, 8701 Assistant Administrator.
Morrissette Drive, Springfield, Virginia [FR Doc. 2018–27039 Filed 12–12–18; 8:45 am]
[FR Doc. 2018–27029 Filed 12–12–18; 8:45 am]
22152. BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his DEPARTMENT OF JUSTICE
authority under the Controlled DEPARTMENT OF JUSTICE
Substances Act to the Administrator of Drug Enforcement Administration
the Drug Enforcement Administration Drug Enforcement Administration
[Docket No. DEA–392]
(DEA), 28 CFR 0.100(b). Authority to [Docket No. DEA–392]
exercise all necessary functions with Importer of Controlled Substances
respect to the promulgation and Bulk Manufacturer of Controlled Application: Noramco Inc.
implementation of 21 CFR part 1301, Substances Application: Cambrex
incident to the registration of High Point, Inc. ACTION: Notice of application.
manufacturers, distributors, dispensers,
importers, and exporters of controlled ACTION: Notice of application. DATES: Registered bulk manufacturers of
substances (other than final orders in the affected basic classes, and
DATES: Registered bulk manufacturers of applicants therefore, may file written
connection with suspension, denial, or the affected basic classes, and
revocation of registration) has been comments on or objections to the
applicants therefore, may file written issuance of the proposed registration on
redelegated to the Assistant comments on or objections to the
Administrator of the DEA Diversion or before January 14, 2019. Such
issuance of the proposed registration on persons may also file a written request
Control Division (‘‘Assistant or before February 11, 2019.
Administrator’’) pursuant to section 7 of for a hearing on the application on or
ADDRESSES: Written comments should before January 14, 2019.
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR be sent to: Drug Enforcement ADDRESSES: Written comments should
1301.33(a), this is notice that on Administration, Attention: DEA Federal be sent to: Drug Enforcement
November 22, 2017, Eli-Elsohly Register Representative/DPW, 8701 Administration, Attention: DEA Federal
Laboratories, Mahmoud A. Elsohly Morrissette Drive, Springfield, Virginia Register Representative/DPW, 8701
Ph.D., 5 Industrial Park Drive, Oxford, 22152. Morrissette Drive, Springfield, Virginia
Mississippi 38655 applied to be SUPPLEMENTARY INFORMATION: The 22152. All requests for hearing must be
registered as a bulk manufacturer of the Attorney General has delegated his sent to: Drug Enforcement
following basic classes of controlled authority under the Controlled Administration, Attn: Administrator,
substances: Substances Act to the Administrator of 8701 Morrissette Drive, Springfield,
the Drug Enforcement Administration Virginia 22152. All requests for hearing
Drug (DEA), 28 CFR 0.100(b). Authority to should also be sent to: (1) Drug
amozie on DSK3GDR082PROD with NOTICES1
Controlled substance Schedule
code exercise all necessary functions with Enforcement Administration, Attn:
respect to the promulgation and Hearing Clerk/OALJ, 8701 Morrissette
Marihuana Extract ......... 7350 I
Marihuana ...................... 7360 I
implementation of 21 CFR part 1301, Drive, Springfield, Virginia 22152; and
Tetrahydrocannabinols .. 7370 I incident to the registration of (2) Drug Enforcement Administration,
Dihydromorphine ........... 9145 I manufacturers, distributors, dispensers, Attn: DEA Federal Register
Amphetamine ................ 1100 II importers, and exporters of controlled Representative/DPW, 8701 Morrissette
Methamphetamine ......... 1105 II substances (other than final orders in Drive, Springfield, Virginia 22152.
VerDate Sep<11>2014 17:12 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1](https://thefederalregister.org/doc/83_FR_64397/page/2.svg)
Document Created: 2018-12-13 01:16:00
Document Modified: 2018-12-13 01:16:00
| 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 January 14, 2019. Such persons may also file a written request for a hearing on the application on or before January 14, 2019. | |
| FR Citation | 83 FR 64158 |
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