Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals, Inc., 5274 [2018-02345]
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5274
Federal Register / Vol. 83, No. 25 / Tuesday, February 6, 2018 / Notices
United States, or United States
consumers.
In particular, the Commission is
interested in comments that:
(i) Explain how the articles
potentially subject to the requested
remedial orders are used in the United
States;
(ii) Identify any public health, safety,
or welfare concerns in the United States
relating to the requested remedial
orders;
(iii) Identify like or directly
competitive articles that complainant,
its licensees, or third parties make in the
United States which could replace the
subject articles if they were to be
excluded;
(iv) Indicate whether complainant,
complainant’s licensees, and/or third
party suppliers have the capacity to
replace the volume of articles
potentially subject to the requested
exclusion order and/or a cease and
desist order within a commercially
reasonable time; and
(v) Explain how the requested
remedial orders would impact United
States consumers.
Written submissions must be filed no
later than by close of business, eight
calendar days after the date of
publication of this notice in the Federal
Register. There will be further
opportunities for comment on the
public interest after the issuance of any
final initial determination in this
investigation.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
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. 3292) 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.
Issued: February 1, 2018.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2018–02288 Filed 2–5–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Patheon
Pharmaceuticals, Inc.
ACTION:
1 Handbook for Electronic Filing Procedures:
https://www.usitc.gov/documents/handbook_on_
filing_procedures.pdf.
VerDate Sep<11>2014
19:02 Feb 05, 2018
Jkt 244001
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 April 9, 2018.
DATES:
contract personnel will sign appropriate
nondisclosure agreements.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Dated: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–02345 Filed 2–5–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of application.
2 All
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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy 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 11, 2017, Patheon
Pharmaceuticals, Inc., 2110 E Galbraith
Road, Cincinnati, OH 45237 applied for
renewal of their registration as a bulk
manufacturer of the Schedule I control
substance Gamma Hydroxybutyric Acid
(2010) the basic class of controlled
substances.
The Gama Hydroxybutyric Acid will
be produced during the process of
converting gamma-butyrolactone (GBL)
into a new product for development.
The company plans to manufacture the
above listed controlled substance as
Active Pharmaceutical Ingredient (API)
that will be further synthesized into
dosage forms of a new product.
No other activities for this drug code
are authorized for this registration.
ADDRESSES:
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
DATES:
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Page 5274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02345]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Patheon
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
1301.33(a) on or before April 9, 2018.
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 Deputy Assistant Administrator of the DEA Office of Diversion
Control (``Deputy 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 11, 2017, Patheon Pharmaceuticals, Inc., 2110 E Galbraith
Road, Cincinnati, OH 45237 applied for renewal of their registration as
a bulk manufacturer of the Schedule I control substance Gamma
Hydroxybutyric Acid (2010) the basic class of controlled substances.
The Gama Hydroxybutyric Acid will be produced during the process of
converting gamma-butyrolactone (GBL) into a new product for
development. The company plans to manufacture the above listed
controlled substance as Active Pharmaceutical Ingredient (API) that
will be further synthesized into dosage forms of a new product.
No other activities for this drug code are authorized for this
registration.
Dated: January 30, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02345 Filed 2-5-18; 8:45 am]
BILLING CODE 4410-09-P
