Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics Inc., 5812 [2018-02642]
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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
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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]
[Page 5812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02642]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Siemens
Healthcare Diagnostics 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 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.
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 1301.33(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:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Ecgonine............................... 9180 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