Importer of Controlled Substances Application: Mylan Pharmaceuticals Inc., 8107 [2018-03723]
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Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
stated above and submit 8 true paper
copies to the Office of the Secretary by
noon the next day pursuant to § 210.4(f)
of the Commission’s Rules of Practice
and Procedure (19 CFR 210.4(f)).
Submissions should refer to the docket
number (‘‘Docket No. 3297) in a
prominent place on the cover page and/
or the first page. (See Handbook for
Electonic Filing Procedures, Electronic
Filing Procedures.1) 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 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,2 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.3
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of §§ 201.10 and 210.8(c) of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
1 Handbook for Electronic Filing Procedures:
https://www.usitc.gov/documents/handbook_on_
filing_procedures.pdf.
2 All contract personnel will sign appropriate
nondisclosure agreements.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
VerDate Sep<11>2014
18:52 Feb 22, 2018
Jkt 244001
Issued: February 20, 2018.
Katherine M. Hiner,
Supervisory Attorney.
[FR Doc. 2018–03774 Filed 2–22–18; 8:45 am]
BILLING CODE 7020–02–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 on
or before March 26, 2018. Such persons
may also file a written request for a
hearing on the application March 26,
2018.
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
December 7, 2017, Mylan
DATES:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
8107
Pharmaceuticals Inc., 2898
Manufacturers Road, Greensboro, NC
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
listed controlled substance in finished
dosage form for commercial distribution
purposes only. No other activity for this
drug code 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 non-approved finished
dosage forms for commercial sale.
Dated: February 14, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–03723 Filed 2–22–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1105—New]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; New
Civil Division, Department of
Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice,
Civil Division, is 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: The Department of Justice
encourages public comment and will
accept input until April 24, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have additional 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
Talitha Guinn-Shaver, 950 Pennsylvania
Ave. NW, Washington, DC 20005, Attn:
Civil Communications Office (Attn:
Elder Justice Initiative) (Phone: 202–
598–0292).
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:
SUMMARY:
E:\FR\FM\23FEN1.SGM
23FEN1
Agencies
[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Page 8107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03723]
=======================================================================
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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 on or before March 26, 2018. Such
persons may also file a written request for a hearing on the
application March 26, 2018.
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
December 7, 2017, Mylan Pharmaceuticals Inc., 2898 Manufacturers Road,
Greensboro, NC 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 listed controlled substance in
finished dosage form for commercial distribution purposes only. No
other activity for this drug code 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 non-approved finished dosage forms for commercial sale.
Dated: February 14, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-03723 Filed 2-22-18; 8:45 am]
BILLING CODE 4410-09-P