82 FR 42120 - Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 171 (September 6, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 171 (September 6, 2017)
| Page Range | 42120-42121 | |
| FR Document | 2017-18801 |
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)] [Notices] [Pages 42120-42121] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18801] ----------------------------------------------------------------------- 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 in accordance with 21 CFR 1301.34(a) on or before October 6, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 6, 2017. 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 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 December 9, 2016, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Amphetamine............................ 1100 II Methylphenidate........................ 1724 II Oxycodone.............................. 9143 II Hydromorphone.......................... 9150 II Methadone.............................. 9250 II Morphine............................... 9300 II Fentanyl............................... 9801 II ------------------------------------------------------------------------ The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials [[Page 42121]] 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 domestically-manufactured FDF to foreign markets. Authorization will not extend to the import of FDA approved or non- approved finished dosage forms for commercial sale. Dated: August 28, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-18801 Filed 9-5-17; 8:45 am] BILLING CODE 4410-09-P
![42120 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
revocation of registration) has been (2) Drug Enforcement Administration, applicants therefore, may file written
redelegated to the Assistant Attn: DEA Federal Register comments on or objections to the
Administrator of the DEA Diversion Representative/DRW, 8701 Morrissette issuance of the proposed registration in
Control Division (‘‘Assistant Drive, Springfield, Virginia 22152. accordance with 21 CFR 1301.34(a) on
Administrator’’) pursuant to section 7 of SUPPLEMENTARY INFORMATION: The or before October 6, 2017. Such persons
28 CFR part 0, appendix to subpart R. Attorney General has delegated his may also file a written request for a
In accordance with 21 CFR authority under the Controlled hearing on the application pursuant to
1301.34(a), this is notice that on July 18, Substances Act to the Administrator of 21 CFR 1301.43 on or before October 6,
2016, KVK–Tech, Inc., 110 Terry Drive, the Drug Enforcement Administration 2017.
Newtown, Pennsylvania 18940 applied (DEA), 28 CFR 0.100(b). Authority to ADDRESSES: Written comments should
to be registered as an importer of exercise all necessary functions with be sent to: Drug Enforcement
Lisdexamfetamine (1205), a basic class respect to the promulgation and Administration, Attention: DEA Federal
of controlled substance listed in implementation of 21 CFR part 1301, Register Representative/DRW, 8701
schedule II. incident to the registration of Morrissette Drive, Springfield, Virginia
The company plans to import the manufacturers, distributors, dispensers, 22152. All requests for hearing must be
listed controlled substance in finished importers, and exporters of controlled sent to: Drug Enforcement
dosage form for clinical trials, research, substances (other than final orders in Administration, Attn: Administrator,
and analytical purposes. Approval of connection with suspension, denial, or 8701 Morrissette Drive, Springfield,
permit applications will occur only revocation of registration) has been Virginia 22152. All requests for hearing
when the registrant’s business activity is redelegated to the Assistant should also be sent to: (1) Drug
consistent with what is authorized Administrator of the DEA Diversion Enforcement Administration, Attn:
under 21 U.S.C. 952(a)(2). Authorization Control Division (‘‘Assistant Hearing Clerk/LJ, 8701 Morrissette
will not extend to the import of FDA Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152; and
approved or non-approved finished 28 CFR part 0, appendix of subpart R. (2) Drug Enforcement Administration,
dosage forms for commercial sale. In accordance with 21 CFR Attn: DEA Federal Register
Dated: August 28, 2017. 1301.34(a), this is notice that on October Representative/DRW, 8701 Morrissette
Demetra Ashley, 31, 2016, Spex Certiprep Group, LLC, Drive, Springfield, Virginia 22152.
203 Norcross Avenue, Metuchen, New SUPPLEMENTARY INFORMATION: The
Acting Assistant Administrator.
Jersey 08840 applied to be registered as Attorney General has delegated his
[FR Doc. 2017–18787 Filed 9–5–17; 8:45 am]
an importer of the following basic authority under the Controlled
BILLING CODE 4410–09–P
classes of controlled substances: Substances Act to the Administrator of
the Drug Enforcement Administration
Controlled substance Drug Schedule (DEA), 28 CFR 0.100(b). Authority to
DEPARTMENT OF JUSTICE code
exercise all necessary functions with
Drug Enforcement Administration Marihuana ............................... 7360 I respect to the promulgation and
Tetrahydrocannabinols ........... 7370 I implementation of 21 CFR part 1301,
[Docket No. DEA–392] incident to the registration of
The company plans to import the manufacturers, distributors, dispensers,
Importer of Controlled Substances listed controlled substances for sale to importers, and exporters of controlled
Application: Spex Certiprep Group, research facilities for drug testing and substances (other than final orders in
LLC analysis. connection with suspension, denial, or
ACTION: Notice of application. In reference to drug codes 7360 revocation of registration) has been
(marihuana) and 7370 (THC), the redelegated to the Assistant
DATES: Registered bulk manufacturers of company plans to import a synthetic Administrator of the DEA Diversion
the affected basic classes, and cannabidiol and a synthetic Control Division (‘‘Assistant
applicants therefore, may file written tetrahydrocannabinol. No other activity Administrator’’) pursuant to section 7 of
comments on or objections to the for these drug codes is authorized for 28 CFR part 0, appendix to subpart R.
issuance of the proposed registration in this registration. In accordance with 21 CFR
accordance with 21 CFR 1301.34(a) on Dated: August 28, 2017. 1301.34(a), this is notice that on
or before October 6, 2017. Such persons Demetra Ashley, December 9, 2016, Mylan
may also file a written request for a Pharmaceuticals, Inc., 781 Chestnut
Acting Assistant Administrator.
hearing on the application pursuant to Ridge Road, Morgantown, West Virginia
[FR Doc. 2017–18788 Filed 9–5–17; 8:45 am]
21 CFR 1301.43 on or before October 6, 26505 applied to be registered as an
BILLING CODE 4410–09–P
2017. importer of the following basic classes
ADDRESSES: Written comments should
of controlled substances:
be sent to: Drug Enforcement DEPARTMENT OF JUSTICE Drug
Controlled substance Schedule
Administration, Attention: DEA Federal code
Register Representative/DRW, 8701 Drug Enforcement Administration
Amphetamine .......................... 1100 II
Morrissette Drive, Springfield, Virginia [Docket No. DEA–392] Methylphenidate ...................... 1724 II
asabaliauskas on DSKBBXCHB2PROD with NOTICES
22152. All requests for hearing must be Oxycodone .............................. 9143 II
sent to: Drug Enforcement Hydromorphone ...................... 9150 II
Importer of Controlled Substances Methadone .............................. 9250 II
Administration, Attn: Administrator, Application: Mylan Pharmaceuticals, Morphine ................................. 9300 II
8701 Morrissette Drive, Springfield, Inc. Fentanyl .................................. 9801 II
Virginia 22152. All request for hearing
should also be sent to: (1) Drug ACTION: Notice of application. The company plans to import the
Enforcement Administration, Attn: listed controlled substances in finished
Hearing Clerk/LJ, 8701 Morrissette DATES: Registered bulk manufacturers of dosage form (FDF) from foreign sources
Drive, Springfield, Virginia 22152; and the affected basic classes, and for analytical testing and clinical trials
VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1](https://thefederalregister.org/doc/82_FR_42291/page/1.svg)
![Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42121
in which the foreign FDF will be importers, and exporters of controlled Government in the Sunshine Act (5
compared to the company’s own substances (other than final orders in U.S.C. 552b), hereby gives notice in
domestically-manufactured FDF. This connection with suspension, denial, or regard to the scheduling of open
analysis is required to allow the revocation of registration) has been meetings as follows:
company to export domestically- redelegated to the Assistant DATES: THURSDAY, SEPTEMBER 14, 2017:
manufactured FDF to foreign markets. Administrator of the DEA Diversion 10:00 a.m.—Issuance of Proposed
Authorization will not extend to the Control Division (‘‘Assistant Decisions in claims against Iraq.
import of FDA approved or non- Administrator’’) pursuant to section 7 of STATUS: Open.
approved finished dosage forms for 28 CFR part 0, appendix to subpart R. All meetings are held at the Foreign
commercial sale. In accordance with 21 CFR Claims Settlement Commission, 600 E
Dated: August 28, 2017. 1301.34(a), this is notice that on May 5, Street NW., Washington, DC. Requests
Demetra Ashley, 2017, Fisher Clinical Services, Inc., for information, or advance notices of
7554 Schantz Road, Allentown, intention to observe an open meeting,
Acting Assistant Administrator.
Pennsylvania 18106 applied to be may be directed to: Patricia M. Hall,
[FR Doc. 2017–18801 Filed 9–5–17; 8:45 am]
registered as an importer of the Foreign Claims Settlement Commission,
BILLING CODE 4410–09–P
following basic classes of controlled 600 E Street NW., Suite 6002,
substances: Washington, DC 20579. Telephone:
DEPARTMENT OF JUSTICE Drug (202) 616–6975.
Controlled substance Schedule
code
Brian M. Simkin,
Drug Enforcement Administration
Methylphenidate ...................... 1724 II Chief Counsel.
[Docket No. DEA–392] Levorphanol ............................ 9220 II [FR Doc. 2017–18962 Filed 9–1–17; 11:15 am]
Noroxymorphone .................... 9668 II
Tapentadol .............................. 9780 II BILLING CODE 4410–BA–P
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc. The company plans to import the
listed controlled substances for DEPARTMENT OF JUSTICE
ACTION: Notice of application. analytical research, testing, and clinical [OMB Number 1122–0011]
trials. This authorization does not
DATES: Registered bulk manufacturers of extend to the import of a finished FDA Agency Information Collection
the affected basic classes, and approved or non-approved dosage form Activities; Proposed eCollection
applicants therefore, may file written for commercial distribution in the eComments Requested; Extension of a
comments on or objections to the United States. Currently Approved Collection
issuance of the proposed registration in The company plans to import an
accordance with 21 CFR 1301.34(a) on intermediate form of tapentadol (9780) AGENCY: Office on Violence Against
or before October 6, 2017. Such persons to bulk manufacture tapentadol for Women, Department of Justice.
may also file a written request for a distribution to its customers. Placement ACTION: 60-Day notice.
hearing on the application pursuant to of these (this) drug code(s) onto the
21 CFR 1301.43 on or before October 6, SUMMARY: The Department of Justice,
company’s registration does not
2017. Office on Violence Against Women
translate into automatic approval of
(OVW) will be submitting the following
ADDRESSES: Written comments should subsequent permit applications to
information collection request to the
be sent to: Drug Enforcement import controlled substances. Approval
Office of Management and Budget
Administration, Attention: DEA Federal of permit applications will occur only
(OMB) for review and approval in
Register Representative/DRW, 8701 when the registrant’s business activity is
accordance with the Paperwork
Morrissette Drive, Springfield, Virginia consistent with what is authorized
Reduction Act of 1995.
22152. All requests for hearing must be under to 21 U.S.C. 952(a)(2).
sent to: Drug Enforcement DATES: Comments are encouraged and
Authorization will not extend to the
Administration, Attn: Administrator, import of FDA approved or non- will be accepted for 60 days until
8701 Morrissette Drive, Springfield, approved finished dosage forms for November 6, 2017.
Virginia 22152. All request for hearing commercial sale. FOR FURTHER INFORMATION CONTACT:
should also be sent to: (1) Drug Written comments and/or suggestion
Dated: August 28, 2017.
Enforcement Administration, Attn: regarding the items contained in this
Demetra Ashley, notice, especially the estimated public
Hearing Clerk/LJ, 8701 Morrissette
Acting Assistant Administrator. burden and associated response time,
Drive, Springfield, Virginia 22152; and
[FR Doc. 2017–18785 Filed 9–5–17; 8:45 am] should be directed to Cathy Poston,
(2) Drug Enforcement Administration,
Attn: DEA Federal Register BILLING CODE 4410–09–P Office on Violence Against Women, at
Representative/DRW, 8701 Morrissette 202–514–5430 or Catherine.poston@
Drive, Springfield, Virginia 22152. usdoj.gov.
DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION: Written
Attorney General has delegated his Foreign Claims Settlement comments and suggestions from the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
authority under the Controlled Commission public and affected agencies concerning
Substances Act to the Administrator of the proposed collection of information
the Drug Enforcement Administration [F.C.S.C. Meeting and Hearing Notice No. are encouraged. Your comments should
8–17]
(DEA), 28 CFR 0.100(b). Authority to address one or more of the following
exercise all necessary functions with Sunshine Act Meeting four points:
respect to the promulgation and (1) Evaluate whether the proposed
implementation of 21 CFR part 1301, The Foreign Claims Settlement collection of information is necessary
incident to the registration of Commission, pursuant to its regulations for the proper performance of the
manufacturers, distributors, dispensers, (45 CFR part 503.25) and the functions of the agency, including
VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\06SEN1.SGM 06SEN1](https://thefederalregister.org/doc/82_FR_42291/page/2.svg)
Document Created: 2017-09-06 00:56:56
Document Modified: 2017-09-06 00:56:56
| 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 in accordance with 21 CFR 1301.34(a) on or before October 6, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 6, 2017. | |
| FR Citation | 82 FR 42120 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR