Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 43572-43573 [2017-19832]
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43572
Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
October 18, 2017.
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.
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 April
19, 2017, Unither Manufacturing LLC,
331 Clay Road, Rochester, New York
14623 applied to be registered as an
importer of methylphenidate (1724), a
basic class of controlled substance listed
in schedule II.
The company plans to import the
listed substance solely for updated
analytical testing purposes for EU
customer requirements. This analysis is
required to allow the company to export
domestically-manufactured FDF to
foreign markets.
sradovich on DSKBBY8HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19830 Filed 9–15–17; 8:45 am]
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DEPARTMENT OF JUSTICE
Controlled substance
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Sharp 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 on
or before October 18, 2017. Such
persons may also file a written request
for a hearing on the application on or
before October 18, 2017.
DATES:
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.
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 August
23, 2017, Sharp Clinical Services, Inc.,
300 Kimberton Road, Phoenixville,
Pennsylvania 19460 applied to be
registered as an importer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
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Marihuana ................................
3,4-Methylenedioxymethamphetamine.
Psilocybin .................................
Drug
code
Schedule
7360
7405
I
I
7437
I
The company plans to import the
listed controlled substances for
analytical research, testing, and clinical
trials. No other activity for these drug
codes 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 nonapproved finished dosage forms for
commercial sale.
Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19836 Filed 9–15–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
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
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 18, 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 18, 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.
DATES:
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Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices
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 March
24, 2017, Mylan Pharmaceuticals, Inc.,
2898 Manufacturers Road, Greensboro,
North Carolina 27406 applied to be
registered as an importer of nabilone
(7379), a basic class of controlled
substance listed in schedule 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).
SUPPLEMENTARY INFORMATION:
Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017–19832 Filed 9–15–17; 8:45 am]
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DEPARTMENT OF JUSTICE
Overview of This Information
Collection
Federal Bureau of Investigation
[OMB Number 1110–NEW]
Agency Information Collection
Activities; Proposed eCollection,
eComments Requested; Crime Data
Explorer Feedback Survey
Federal Bureau of
Investigation, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Federal Bureau of Investigation
(FBI), Criminal Justice Information
Services Division (CJIS), 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 17, 2017.
sradovich on DSKBBY8HB2PROD with NOTICES
SUMMARY:
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All
comments, suggestions, or questions
regarding additional information, to
include obtaining a copy of the
proposed information collection
instrument with instructions, should be
directed to Mrs. Amy C. Blasher, Unit
Chief, Federal Bureau of Investigation,
Criminal Information Services Division,
Module E–3, 1000 Custer Hollow Road,
Clarksburg, West Virginia 26306;
facsimile (304) 625–3566.
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 Federal Bureau of
Investigation, 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;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms
of information technology, e.g.,
permitting electronic submission of
responses.
FOR FURTHER INFORMATION CONTACT:
1. Type of Information Collection:
New collection.
2. The Title of the Form/Collection:
Crime Data Explorer Feedback Survey.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
No form number. The applicable
component within the Department of
Justice is the Criminal Justice
Information Services Division, in the
Federal Bureau of Investigation.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Law enforcement,
academia and the general public.
Abstract: This survey is needed to
collect feedback on the functionality of
the CDE in order to make improvements
to the application.
5. An estimate of the total number of
respondents and the amount of time
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43573
estimated for an average respondent to
respond: UCR Crime Data Explorer
Burden Estimation: It is estimated the
CDE will generate 200 feedback
responses per year with an estimated
response time of 2 minutes per
response.
6. An estimate of the total public
burden (in hours) associated with the
collection: There are approximately 7
hours, annual burden, associated with
this information collection.
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE., 3E.405A,
Washington, DC 20530.
Dated: September 13, 2017.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2017–19814 Filed 9–15–17; 8:45 am]
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Water
Act, Clean Air Act, Emergency
Planning and Community Right-ToKnow Act, and Resource Conservation
and Recovery Act
On September 12, 2017, the
Department of Justice lodged a proposed
consent decree with the United States
District Court for the Western District of
Pennsylvania in the lawsuit entitled
United States v. StarKist Co. and
Starkist Samoa Co., Civil Action No.
2:17–cv–01190–DSC.
The United States filed this lawsuit
under the Clean Water Act (CWA),
Clean Air Act (CAA), Emergency
Planning and Community Right-toKnow Act (EPCRA), and the Resource
Conservation and Recovery Act (RCRA).
The complaint seeks injunctive relief
and civil penalties for violations of
these statutes and their implementing
regulations at defendants’ seafood
processing and canning facility in
American Samoa. Specifically, the
complaint alleges the following CWA
violations: (1) Unpermitted discharges
of wastewater through an outfall rupture
in 2014; (2) violations of terms and
conditions of the facility’s National
Pollutant Discharge Elimination System
Permit, including effluent limit
violations; and (3) violations of the
CWA’s Spill Prevention Control and
Countermeasures regulations related to
the facility’s oil storage tanks. The
complaint also alleges violations of the
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]]>Agencies
[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43572-43573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19832]
-----------------------------------------------------------------------
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 18, 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 18, 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.
[[Page 43573]]
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 March
24, 2017, Mylan Pharmaceuticals, Inc., 2898 Manufacturers Road,
Greensboro, North Carolina 27406 applied to be registered as an
importer of nabilone (7379), a basic class of controlled substance
listed in schedule 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).
Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-19832 Filed 9-15-17; 8:45 am]
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