Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 42120-42121 [2017-18801]
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42120
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / 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
1301.34(a), this is notice that on July 18,
2016, KVK–Tech, Inc., 110 Terry Drive,
Newtown, Pennsylvania 18940 applied
to be registered as an importer of
Lisdexamfetamine (1205), a basic class
of controlled substance listed in
schedule II.
The company plans to import the
listed controlled substance in finished
dosage form for clinical trials, research,
and analytical purposes. 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). 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. 2017–18787 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
(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 of subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on October
31, 2016, Spex Certiprep Group, LLC,
203 Norcross Avenue, Metuchen, New
Jersey 08840 applied to be registered as
an importer of the following basic
classes of controlled substances:
Drug
code
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Marihuana ...............................
Tetrahydrocannabinols ...........
7360
7370
Schedule
I
I
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Spex Certiprep Group,
LLC
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 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 request for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:37 Sep 05, 2017
Jkt 241001
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis.
In reference to drug codes 7360
(marihuana) and 7370 (THC), the
company plans to import a synthetic
cannabidiol and a synthetic
tetrahydrocannabinol. No other activity
for these drug codes is authorized for
this registration.
Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–18788 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Controlled substance
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
DATES:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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:
Amphetamine ..........................
Methylphenidate ......................
Oxycodone ..............................
Hydromorphone ......................
Methadone ..............................
Morphine .................................
Fentanyl ..................................
Drug
code
1100
1724
9143
9150
9250
9300
9801
Schedule
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
E:\FR\FM\06SEN1.SGM
06SEN1
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
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 May 5,
2017, Fisher Clinical Services, Inc.,
7554 Schantz Road, Allentown,
Pennsylvania 18106 applied to be
registered as an importer of the
following basic classes of controlled
substances:
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.
Authorization will not extend to the
import of FDA approved or nonapproved 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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Fisher Clinical Services,
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 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 request 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,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:37 Sep 05, 2017
Drug
code
Controlled substance
Jkt 241001
Methylphenidate ......................
Levorphanol ............................
Noroxymorphone ....................
Tapentadol ..............................
1724
9220
9668
9780
Schedule
II
II
II
II
The company plans to import the
listed controlled substances for
analytical research, testing, and clinical
trials. This authorization does not
extend to the import of a finished FDA
approved or non-approved dosage form
for commercial distribution in the
United States.
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers. Placement
of these (this) drug code(s) onto the
company’s registration does not
translate into automatic approval of
subsequent permit applications to
import controlled substances. Approval
of permit applications will occur only
when the registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: August 28, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–18785 Filed 9–5–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[F.C.S.C. Meeting and Hearing Notice No.
8–17]
Sunshine Act Meeting
The Foreign Claims Settlement
Commission, pursuant to its regulations
(45 CFR part 503.25) and the
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
Government in the Sunshine Act (5
U.S.C. 552b), hereby gives notice in
regard to the scheduling of open
meetings as follows:
DATES: THURSDAY, SEPTEMBER 14, 2017:
10:00 a.m.—Issuance of Proposed
Decisions in claims against Iraq.
STATUS: Open.
All meetings are held at the Foreign
Claims Settlement Commission, 600 E
Street NW., Washington, DC. Requests
for information, or advance notices of
intention to observe an open meeting,
may be directed to: Patricia M. Hall,
Foreign Claims Settlement Commission,
600 E Street NW., Suite 6002,
Washington, DC 20579. Telephone:
(202) 616–6975.
Brian M. Simkin,
Chief Counsel.
[FR Doc. 2017–18962 Filed 9–1–17; 11:15 am]
BILLING CODE 4410–BA–P
DEPARTMENT OF JUSTICE
[OMB Number 1122–0011]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension of a
Currently Approved Collection
Office on Violence Against
Women, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice,
Office on Violence Against Women
(OVW) 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 60 days until
November 6, 2017.
FOR FURTHER INFORMATION CONTACT:
Written comments and/or suggestion
regarding the items contained in this
notice, especially the estimated public
burden and associated response time,
should be directed to Cathy Poston,
Office on Violence Against Women, at
202–514–5430 or Catherine.poston@
usdoj.gov.
SUMMARY:
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:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
SUPPLEMENTARY INFORMATION:
Foreign Claims Settlement
Commission
42121
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42120-42121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
