Importer of Controlled Substances Application: Mylan Technologies Inc., 5811-5812 [2018-02641]
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5811
Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
issuance of the proposed registration on
or before March 12, 2018. Such persons
may also file a written request for a
hearing on the application March 12,
2018.
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.
Dated: January 31, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02647 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
Controlled substance
ADDRESSES:
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 29, 2017, Meridian Medical
Technologies Inc., 2555 Hermelin Drive,
Saint Louis, Missouri 63144 applied to
be registered as an importer of the
Schedule II control substance for
Morphine (9300) the basic class of
controlled substance.
The company plans to import the
listed controlled substance in finished
dosage form for internal analytical
purposes only. No other activity for this
drug code is authorized for this
registration. 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.
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:57 Feb 08, 2018
Jkt 244001
Nolte Drive, West Deptford, NJ 08066–
1742 applied to be registered as an
importer of the following basic classes
of controlled substances:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Johnson Matthey Inc.
ACTION:
Notice of application.
Registered importers 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
March 12, 2018. Such persons may also
file a written request for a hearing on
the application on or before March 12,
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 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,
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
November 9, 2017, Johnson Matthey
Inc., Pharmaceutical Materials, 2003
DATES:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Coca leaves ..................
Thebaine .......................
Opium, raw ...................
Noroxymorophone ........
Poppy Straw Concentrate.
Fentanyl ........................
Drug
code
Schedule
9040
9333
9600
9668
9670
II
II
II
II
II
9801
II
The company plans to import coca
leaves (9040), raw opium (9600), and
poppy straw concentrate (9670) in order
to bulk manufacture active
pharmaceutical ingredients (API) for
distribution to its customers. The
company plans to also import thebaine
(9333), noroxymorophone (9668), and
fentanyl (9801) to use as analytical
reference standards, both internally and
to be sold to their customers to support
testing of Johnson Matthey Inc.’s API’s
only.
Dated: January 31, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02639 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Mylan Technologies Inc.
ACTION:
Notice of application.
Registered bulk importers 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
March 12, 2018. Such persons may also
file a written request for a hearing on
the application on or before March 12,
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 request for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
DATES:
E:\FR\FM\09FEN1.SGM
09FEN1
5812
Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
(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).
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
November 10, 2017, Mylan
Technologies Inc., 110 Lake St., Saint
Albans, VT 05478 applied to be
registered as an importer of the
following basic classes of controlled
substances:
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[OMB Number 1103–0098]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Siemens
Healthcare Diagnostics Inc.
SUPPLEMENTARY INFORMATION:
Controlled substance
sradovich on DSK3GMQ082PROD with NOTICES
Methylphenidate ...........
Fentanyl ........................
Drug
code
Schedule
1724
9801
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 domestically
manufactured FDF to foreign markets.
Authorization will not extend to the
import of Food and Drug
Administration approved or nonapproved finish dosage forms for
commercial sale.
Dated: February 1, 2018.
Susan A Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02641 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
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 April 10, 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
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
December 13, 2017, Siemens Healthcare
Diagnostics Inc., 100 GBC Drive,
Mailstop 514, Newark, DE 19702
applied to be registered as a bulk
manufacturer of the following basic
class of controlled substance:
SUPPLEMENTARY INFORMATION:
Controlled substance
Ecgonine .......................
Drug
code
9180
16:57 Feb 08, 2018
II
The company plans to bulk
manufacture a material used in the
manufacture of reagents for a Cocaine in
vitro diagnostic test system.
Dated: February 1, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02642 Filed 2–8–18; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
Schedule
Jkt 244001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; COPS
Application Package
Community Oriented Policing
Services, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ) Office of Community Oriented
Policing Services (COPS) 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.
The proposed information collection
was previously published in the Federal
Register on December 1, 2017, to obtain
comments from the public and affected
agencies.
DATES: The purpose of this notice is to
allow for an additional 30 days for
public comment March 12, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have comments especially on the
estimated public burden or associated
response time, suggestions, or need a
copy of the proposed information
collection instrument with instructions
or additional information, please
contact Lashon M. Hilliard, Department
of Justice Office of Community Oriented
Policing Services, 145 N Street NE,
Washington, DC 20530 or at (202) 514–
6563. Written comments and/or
suggestions can also be directed to the
Office of Management and Budget,
Office of Information and Regulatory
Affairs, Attention Department of Justice
Desk Officer, Washington, DC 20530 or
sent to OIRA_submissions@
omb.eop.gov.
SUPPLEMENTARY INFORMATION: 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:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Enhance the quality, utility, and
clarity of the information to be
collected; and
SUMMARY:
E:\FR\FM\09FEN1.SGM
09FEN1
]]>Agencies
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5811-5812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02641]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Mylan Technologies
Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk importers 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 March 12, 2018. Such
persons may also file a written request for a hearing on the
application on or before March 12, 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
request for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and
[[Page 5812]]
(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
November 10, 2017, Mylan Technologies Inc., 110 Lake St., Saint Albans,
VT 05478 applied to be registered as an importer of the following basic
classes of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 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 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 Food and Drug
Administration approved or non-approved finish dosage forms for
commercial sale.
Dated: February 1, 2018.
Susan A Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02641 Filed 2-8-18; 8:45 am]
BILLING CODE 4410-09-P
