Importer of Controlled Substances Application: Mylan Technologies Inc., 67567-67568 [2020-23511]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 206 / Friday, October 23, 2020 / Notices
subject to investigation, and (4) U.S.
consumers. The Commission is
therefore interested in receiving written
submissions that address the
aforementioned public interest factors
in the context of this investigation.
If the Commission orders some form
of remedy, the U.S. Trade
Representative, as delegated by the
President, has 60 days to approve,
disapprove, or take no action on the
Commission’s determination. See
Presidential Memorandum of July 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: 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.
In their initial submissions,
Complainants are also requested to
identify the remedy sought and
Complainants and OUII are requested to
submit proposed remedial orders for the
Commission’s consideration.
Complainants are further requested to
state the dates that the Asserted Patents
expire, to provide the HTSUS
subheadings under which the accused
products are imported, and to supply
the identification information for all
known importers of the products at
issue in this investigation. The initial
written submissions and proposed
remedial orders must be filed no later
than close of business on November 3,
2020. Reply submissions must be filed
no later than the close of business on
November 10, 2020. Opening
submissions are limited to 15 pages.
Reply submissions are limited to 10
pages. 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. The Commission’s paper
filing requirements in 19 CFR 210.4(f)
are currently waived. 85 FR 15798
(March 19, 2020). Submissions should
refer to the investigation number (Inv.
No. 337–TA–1203) in a prominent place
on the cover page and/or the first page.
(See Handbook for Electronic Filing
VerDate Sep<11>2014
18:09 Oct 22, 2020
Jkt 253001
Procedures, https://www.usitc.gov/
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. A redacted nonconfidential version of the document
must also be filed simultaneously with
any confidential filing. 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, solely for cybersecurity
purposes. All contract personnel will
sign appropriate nondisclosure
agreements. All nonconfidential written
submissions will be available for public
inspection on EDIS.
The Commission vote for this
determination took place on October 20,
2020.
While temporary remote operating
procedures are in place in response to
COVID–19, the Office of the Secretary is
not able to serve parties that have not
retained counsel or otherwise provided
a point of contact for electronic service.
Accordingly, pursuant to Commission
Rules 201.16(a) and 210.7(a)(1) (19 CFR
201.16(a), 210.7(a)(1)), the Commission
orders that the Complainants complete
service for any party/parties without a
method of electronic service noted on
the attached Certificate of Service and
shall file proof of service on the
Electronic Document Information
System (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
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67567
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: October 20, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–23548 Filed 10–22–20; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–731]
Importer of Controlled Substances
Application: Mylan Technologies Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Mylan Technologies Inc. has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before November 23, 2020. Such
persons may also file a written request
for a hearing on the application on or
before November 23, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on October 6, 2020, Mylan
Technologies Inc., 110 Lake Street, Saint
Albans, Vermont 05478–2266, applied
to be registered as an importer of the
following basic class(es) of controlled
substance(s):
SUMMARY:
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Federal Register / Vol. 85, No. 206 / Friday, October 23, 2020 / Notices
Controlled substance
Drug code
Methylphenidate ..............................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
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 finished dosage form to
foreign markets. 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–23511 Filed 10–22–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Office of the Attorney General
Designation of Criminal Division as
‘‘Designated Authority’’ Under an
Agreement With the United Kingdom;
AG Order No. 4876–2020
Department of Justice.
Notice of Attorney General
designation.
AGENCY:
Designation of the Criminal Division as
the Designated Authority
ACTION:
The Agreement between the
Government of the United States of
America and the Government of the
United Kingdom of Great Britain and
Northern Ireland on Access to
Electronic Data for the Purpose of
Countering Serious Crime (the ‘‘U.S.U.K. CLOUD Agreement’’ or
‘‘Agreement’’) defines ‘‘Designated
Authority’’ for the United States as the
government entity designated by the
Attorney General and assigns certain
responsibilities to the Designated
Authority. This notice designates the
Criminal Division as the Designated
Authority for purposes of the
Agreement.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
The designation made by this
notice is effective October 23, 2020.
FOR FURTHER INFORMATION CONTACT:
Vaughn Ary, Director, Office of
DATES:
VerDate Sep<11>2014
18:09 Oct 22, 2020
Jkt 253001
International Affairs, Criminal Division,
U.S. Department of Justice, Washington,
DC 20005; Telephone (202) 514–0000.
SUPPLEMENTARY INFORMATION: On
October 3, 2019, the Home Secretary of
the United Kingdom and the Attorney
General of the United States signed the
U.S.-U.K. CLOUD Agreement. A copy of
the U.S.-U.K. CLOUD Agreement is
available at: https://www.justice.gov/
dag/cloudact. In accordance with the
Clarifying Lawful Overseas Use of Data
Act, Public Law 115–141, Div. V,
Section 105(a) (March 23, 2018), 18
U.S.C. 2523 (‘‘CLOUD Act’’), the
Agreement will enter into force on the
date of the later note completing an
exchange of diplomatic notes between
the parties indicating that each has
taken the steps necessary to bring the
Agreement into force. See 85 FR 12578
(Mar. 3, 2020) (providing notice that the
Attorney General notified Congress that
he had certified the U.S.-U.K. CLOUD
Agreement, in accordance with the
terms of the CLOUD Act, on January 10,
2020, allowing it to become operative
not earlier than 180 days later) and
Article 16 of the U.S.-U.K. CLOUD
Agreement (addressing entry in force).
The Agreement assigns certain
responsibilities to the ‘‘Designated
Authority’’ for each country. Article 1.8
defines ‘‘Designated Authority,’’ for the
United States, as ‘‘the governmental
entity designated . . . by the Attorney
General.’’
In accordance with Article 1.8 of the
U.S.-U.K. CLOUD Agreement, the
Attorney General hereby designates the
Criminal Division of the Department of
Justice as the Designated Authority for
the United States under the Agreement.
Dated: October 19, 2020.
William P. Barr,
Attorney General.
[FR Doc. 2020–23556 Filed 10–20–20; 4:15 pm]
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On October 19, 2020, the Department
of Justice lodged a proposed Consent
Decree with the Court for the Western
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II
II
District of Texas, San Antonio Division
in the lawsuit entitled United States of
America v. Valero Energy Corporation,
et al., Civil Action No. Case 5:20–cv–
01237.
In its Complaint, the United States
alleges Valero violated Section 211 of
the Clean Air Act (‘‘CAA’’) and its
implementing regulations at 40 CFR part
80, arising from the production and
importation of gasoline and diesel fuel
that did not meet certain fuel standards
or programmatic requirements. The
violations occurred at 11 refineries
located in Louisiana, Texas, Tennessee,
New Jersey, Arkansas, and Indiana and
one import facility located in New York.
The proposed Consent Decree, which
resolves all violations alleged in the
Complaint, recovers a civil penalty of
$2,850,000. Injunctive relief secured by
the proposed Consent Decree requires
development and implementation of a
company-wide Fuels Management
System to facilitate Valero’s production
of gasoline and diesel fuel in accordance
with the CAA and the Fuels
Regulations. The proposed Consent
Decree also includes mitigation projects
estimated to reduce volatile organic
compound emissions from certain
Valero facilities by 22.72 tons per year.
The publication of this notice opens
a period for public comment on the
Consent Decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States of America v. Valero
Energy Corporation, et al., D.J. Ref. No.
90–5–2–1–111769. All comments must
be submitted no later than thirty (30)
days after the publication date of this
notice. Comments may be submitted
either by email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington, DC
20044–7611.
By mail .........
BILLING CODE 4410–14–P
DEPARTMENT OF JUSTICE
1724
9801
Schedule
During the public comment period,
the Consent Decree may be examined
and downloaded at this Justice
Department website: https://
www.justice.gov/enrd/consent-decrees.
We will provide a paper copy of the
Consent Decree upon written request
and payment of reproduction costs.
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]]>Agencies
[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Notices]
[Pages 67567-67568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23511]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-731]
Importer of Controlled Substances Application: Mylan Technologies
Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Mylan Technologies Inc. has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplemental Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before November 23,
2020. Such persons may also file a written request for a hearing on the
application on or before November 23, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on October 6, 2020, Mylan Technologies Inc., 110 Lake
Street, Saint Albans, Vermont 05478-2266, applied to be registered as
an importer of the following basic class(es) of controlled
substance(s):
[[Page 67568]]
------------------------------------------------------------------------
Controlled substance Drug 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 finished
dosage form to foreign markets. 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-23511 Filed 10-22-20; 8:45 am]
BILLING CODE 4410-09-P
