Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing, LLC, 23066-23067 [2017-10230]
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
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Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
21, 2005. 70 FR 43251 (July 26, 2005).
During this period, the subject articles
would be entitled to enter the United
States under bond, in an amount
determined by the Commission and
prescribed by the Secretary of the
Treasury. The Commission is therefore
interested in receiving submissions
concerning the amount of the bond that
should be imposed if a remedy is
ordered.
Written Submissions: The parties to
the investigation are requested to file
written submissions on the issues
identified in this notice. Parties to the
investigation, interested government
agencies, and any other interested
parties are encouraged to file written
submissions on the issues of remedy,
the public interest, and bonding. Such
submissions should address the
recommended determination by the ALJ
on remedy and bonding. Complainants
are requested to submit proposed
remedial orders for the Commission’s
consideration. Complainants are also
requested to state the date that the
patent expires and the HTSUS numbers
under which the accused products are
imported. Complainants are further
requested to supply the names of known
importers of the Nautilus products at
issue in this investigation. The written
submissions and proposed remedial
orders must be filed no later than close
of business on May 25, 2017. Reply
submissions must be filed no later than
the close of business on June 1, 2017.
Opening submissions are limited to 50
pages. Reply submissions are limited to
25 pages. Such submissions should
address the ALJ’s recommended
determinations on remedy and bonding.
No further submissions on any of these
issues will be permitted unless
otherwise ordered by the Commission.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above and submit eight true paper
copies to the Office of the Secretary by
noon the next day pursuant to section
210.4(f) of the Commission’s Rules of
Practice and Procedure (19 CFR
210.4(f)). Submissions should refer to
the investigation number (‘‘Inv. No.
337–TA–989’’) in a prominent place on
the cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
secretary/fed_reg_notices/rules/
handbook_on_electronic_filing.pdf).
Persons with questions regarding filing
should contact the Secretary (202–205–
2000).
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment. All such requests should be
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19:15 May 18, 2017
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directed to the Secretary to the
Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this Investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel,1 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in Part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
rules-policies/records-and-archivesrules-committees/agenda-books.
DATES: June 12–13, 2017.
TIME:
June 12—1:30 p.m.–5:00 p.m.
June 13—8:30 a.m.–3:00 p.m.
ADDRESSES: Thurgood Marshall Federal
Judiciary Building, Mecham Conference
Center, Administrative Office of the
United States Courts, One Columbus
Circle NE., Washington, DC 20544.
FOR FURTHER INFORMATION CONTACT:
Rebecca A. Womeldorf, Rules
Committee Secretary, Rules Committee
Support Office, Administrative Office of
the United States Courts, Washington,
DC 20544, telephone (202) 502–1820.
By order of the Commission.
Issued: May 15, 2017.
William R. Bishop,
Supervisory Hearings and Information
Officer.
DATES:
[FR Doc. 2017–10144 Filed 5–18–17; 8:45 am]
BILLING CODE 7020–02–P
JUDICIAL CONFERENCE OF THE
UNITED STATES
Meeting of the Judicial Conference;
Committee on Rules of Practice and
Procedure
Committee on Rules of Practice
and Procedure, Judicial Conference of
the United States.
ACTION: Notice of open meeting.
AGENCY:
The Committee on Rules of
Practice and Procedure will hold a
meeting on June 12–13, 2017. The
meeting will be open to public
observation but not participation. An
agenda and supporting materials will be
posted at least 7 days in advance of the
meeting at: https://www.uscourts.gov/
SUMMARY:
1 All contract personnel will sign appropriate
nondisclosure agreements.
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Fmt 4703
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Dated: May 15, 2017.
Rebecca A. Womeldorf,
Rules Committee Secretary.
[FR Doc. 2017–10151 Filed 5–18–17; 8:45 am]
BILLING CODE 2210–55–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Insys
Manufacturing, 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 1301.33(a) on
or before July 18, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19MYN1.SGM
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Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
[Docket No. DEA–392]
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 2, 2016, Patheon
Pharmaceuticals, Inc., 2110 E. Galbraith
Road, Cincinnati, Ohio 45237 applied to
be registered as a bulk manufacturer of
gamma hydroxybutyric acid (2010) a
basic class of controlled substance listed
in schedule I.
The company plans to manufacture
the listed controlled substance for
product development.
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals, Inc.
Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
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 March
21, 2017, Insys Manufacturing, LLC,
2700 Oakmont Drive, Round Rock,
Texas 78665 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Schedule
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
I
I
The company plans to manufacture
bulk synthetic active pharmaceutical
ingredients (APIs) for product
development and distribution to its
customers. No other activity for these
drug codes is authorized for this
registration.
Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017–10230 Filed 5–18–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[FR Doc. 2017–10238 Filed 5–18–17; 8:45 am]
ACTION:
Notice of application.
BILLING CODE 4410–09–P
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.33(a) on or before July
18, 2017.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW 8701
DATES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.33(a) on or before July
18, 2017.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: 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
1301.33(a), this is notice that on March
3, 2017, Eli-Elsohly Laboratories,
Mahmoud A. Elsohly Ph. D., 5
Industrial Park Drive, Oxford,
Mississippi 38655 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Bulk Manufacturer of Controlled
Substances Application: Eli-Elsohly
Laboratories
ACTION:
Notice of application.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Controlled substance
Drug code
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
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E:\FR\FM\19MYN1.SGM
19MYN1
7350
7360
7370
9145
1100
1105
9041
9050
9120
9143
9150
9180
9193
9300
9333
Schedule
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
]]>Agencies
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23066-23067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10230]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Insys
Manufacturing, LLC
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
1301.33(a) on or before July 18, 2017.
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
[[Page 23067]]
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 March
21, 2017, Insys Manufacturing, LLC, 2700 Oakmont Drive, Round Rock,
Texas 78665 applied to be registered as a bulk manufacturer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
------------------------------------------------------------------------
The company plans to manufacture bulk synthetic active
pharmaceutical ingredients (APIs) for product development and
distribution to its customers. No other activity for these drug codes
is authorized for this registration.
Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10230 Filed 5-18-17; 8:45 am]
BILLING CODE 4410-09-P
