Importer of Controlled Substances Application: Myoderm, 13134-13135 [2017-04646]
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
13134
Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
3. Please explain how ‘‘antitrust
injury’’ standing, as required for private
litigants in federal district courts
asserting antitrust claims, see, e.g., Atl.
Richfield Co. v. USA Petroleum Co., 495
U.S. 328, 335 (1990), compares to, or
differs from, the injury requirement
under Section 337(a)(1)(A). Please
include an analysis of any relevant
statutory language, legislative history,
Commission determinations, case law,
or other authority. In discussing this
question, please explain the chronology
of the adoption of the ‘‘antitrust injury’’
standing requirement in relation to the
injury requirement under Section
337(a)(1)(A).
4. Please explain whether ‘‘antitrust
injury’’ standing is, or should be,
required for establishing a Section 337
violation based on a claim alleging a
conspiracy to fix prices and control
output and export volumes as a matter
of law and/or policy. Please include an
analysis of any relevant statutory
language, legislative history,
Commission determinations, case law,
or other authority.
The parties to this investigation,
including the Office of Unfair Import
Investigations, may file submissions in
response to any written submission(s)
that are submitted by the public or any
interested government agencies. No
further submissions on any of these
issues will be permitted unless
otherwise ordered by the Commission.
Written Submissions: Written
submissions from entities other than the
parties and/or government agencies
shall include a Statement of Interest
including: (1) A concise statement of the
identity of the entity filing the written
submission, its interest in the case, and
the reasons why the written submission
is relevant to the disposition of the
issues in dispute; and (2) a statement
indicating whether: (i) A party’s counsel
authored the written submission in
whole or in part; (ii) a party or party’s
counsel contributed money that was
intended to fund preparing or
submitting the written submission; and
(iii) a person—other than the entity, its
members, or its counsel—contributed
money that was specifically intended to
fund preparing or submitting the written
submission and, if so, each such person
shall be identified. Written submissions
from individuals shall also include a
curriculum vitae (‘‘CV’’). Written
submissions must be filed no later than
close of business on March 27, 2017,
may not exceed 20 pages in length,
exclusive of any exhibits, Statement of
Interest, and CV, and shall be doublespaced. Responsive submissions from
the parties must be filed no later than
the close of business on April 3, 2017,
VerDate Sep<11>2014
17:43 Mar 08, 2017
Jkt 241001
may not exceed 20 pages in length,
exclusive of any exhibits, and shall be
double-spaced. 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 (8) 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–1002’’) in a prominent place on
the cover page and/or the first page. (See
Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
secretary/documents/handbook_on_
filing_procedures.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
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.
Commission Oral Argument: The
Commission has also determined to
reschedule the oral argument to April
20, 2017, in order to provide sufficient
time for the Commission to receive and
review any written submissions and any
responses thereto. The Commission will
hold the public oral argument in the
Commission’s Main Hearing Room
1 All contract personnel will sign appropriate
nondisclosure agreements.
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Frm 00046
Fmt 4703
Sfmt 4703
(Room 101), 500 E Street SW.,
Washington, DC 20436, beginning at
9:30 a.m. While any member of the
public may attend the oral argument,
only counsel for the parties to the
investigation, including the Office of
Unfair Import Investigations, and
representatives of interested government
agencies may participate and/or argue at
the oral argument.
At the oral argument, counsel for each
party and representatives of interested
government agencies will be given an
opportunity to comment in opening
remarks for no more than 10 minutes,
and the Commissioners may ask
questions of those appearing. Details as
to the format of the hearing will be
provided at a later date. This is a public
proceeding; confidential business
information (‘‘CBI’’) shall not be
discussed. A party, however, can draw
the Commission’s attention to CBI, if
necessary, by pointing to where in the
record the information can be found.
The oral argument will be limited in
scope to the issues identified in the ID
(Order No. 38); the Commission’s
December 19, 2016, Notice; the present
Notice; and any related petition, written
submissions, and responses thereto.
After the conclusion of the oral
argument, no additional written
submissions or arguments will be
permitted.
Notice of Appearance: Counsel for the
parties to the investigation or any
representatives of interested government
agencies who wish to participate in the
oral argument must file a written
request to appear at the Commission
oral argument by April 6, 2017 and must
provide their email addresses as part of
their contact information.
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).
By order of the Commission.
Issued: March 3, 2017.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2017–04597 Filed 3–8–17; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Myoderm
ACTION:
E:\FR\FM\09MRN1.SGM
Notice of application.
09MRN1
13135
Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
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 April 10, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before April 10,
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,
DATES:
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
November 11, 2016, Myoderm, 48 East
Main Street, Norristown, Pennsylvania
19401 applied to be registered as an
importer of the following basic classes
of controlled substances:
Controlled substance
Drug code
Amphetamine .............................................................................................................................................................
Lisdexamfetamine ......................................................................................................................................................
Methylphenidate .........................................................................................................................................................
Nabilone .....................................................................................................................................................................
Oxycodone .................................................................................................................................................................
Hydromorphone ..........................................................................................................................................................
Hydrocodone ..............................................................................................................................................................
Morphine ....................................................................................................................................................................
Oxymorphone .............................................................................................................................................................
Fentanyl ......................................................................................................................................................................
The company plans to import the
listed controlled substances in finished
dosage form for clinical trials, research,
and analytical purposes.
The import of the above listed basic
classes of controlled substances will be
granted only for analytical testing,
research, and clinical trials. This
authorization does not extend to the
import of a finished FDA approved or
non-approved dosage form for
commercial sale.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017–04646 Filed 3–8–17; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Meridian Medical
Technologies
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
DATES:
VerDate Sep<11>2014
18:42 Mar 08, 2017
Jkt 241001
or before April 10, 2017. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before April 10,
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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
1100
1205
1724
7379
9143
9150
9193
9300
9652
9801
Schedule
II
II
II
II
II
II
II
II
II
II
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, 2016, Meridian Medical
Technologies, 2555 Hermelin Drive,
Saint Louis, Missouri 63144 applied to
be registered as an importer of morphine
(9300), a basic class of controlled
substance listed in schedule II.
The company manufactures a product
containing morphine in the United
States. The company exports this
product to customers around the world.
The company has been asked to ensure
that its product, which is sold to
European customers, meets the
standards established by the European
Pharmacopeia, administered by the
Directorate for the Quality of Medicines
(EDQM). In order to ensure that its
product will meet European
specifications, the company seeks to
import morphine supplied by EDQM for
use as reference standards.
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13134-13135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04646]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Myoderm
ACTION: Notice of application.
-----------------------------------------------------------------------
[[Page 13135]]
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 April 10, 2017. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before April 10, 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
November 11, 2016, Myoderm, 48 East Main Street, Norristown,
Pennsylvania 19401 applied to be registered as an importer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Amphetamine...................... 1100 II
Lisdexamfetamine................. 1205 II
Methylphenidate.................. 1724 II
Nabilone......................... 7379 II
Oxycodone........................ 9143 II
Hydromorphone.................... 9150 II
Hydrocodone...................... 9193 II
Morphine......................... 9300 II
Oxymorphone...................... 9652 II
Fentanyl......................... 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form for clinical trials, research, and analytical
purposes.
The import of the above listed basic classes of controlled
substances will be granted only for analytical testing, research, and
clinical trials. This authorization does not extend to the import of a
finished FDA approved or non-approved dosage form for commercial sale.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-04646 Filed 3-8-17; 8:45 am]
BILLING CODE 4410-09-P
