Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC, 31959-31960 [2016-11940]
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31959
Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
representative consumer organizations
have the right to appear as parties in
Commission antidumping and
countervailing duty investigations. The
Secretary will prepare a public service
list containing the names and addresses
of all persons, or their representatives,
who are parties to the investigations.
Background
On March 31, 2016, Compass
Chemical International LLC, Smyrna,
Georgia, filed a petition with the
Commission and Commerce, alleging
that an industry in the United States is
materially injured or threatened with
material injury by reason of LTFV and
subsidized imports of 1hydroxyethylidene-1, 1-diphosphonic
acid from China. Accordingly, effective
March 31, 2016, the Commission,
pursuant to sections 703(a) and 733(a) of
the Tariff Act of 1930 (19 U.S.C.
1671b(a) and 1673b(a)), instituted
countervailing duty investigation No.
701–TA–558 and antidumping duty
investigation No. 731–TA–1316
(Preliminary).
Notice of the institution of the
Commission’s investigations and of a
public conference to be held in
connection therewith was given by
posting copies of the notice in the Office
of the Secretary, U.S. International
Trade Commission, Washington, DC,
and by publishing the notice in the
Federal Register of April 7, 2016 (81 FR
20416). The conference was held in
Washington, DC, on April 21, 2016, and
all persons who requested the
opportunity were permitted to appear in
person or by counsel.
The Commission made these
determinations pursuant to sections
703(a) and 733(a) of the Tariff Act of
1930 (19 U.S.C. 1671b(a) and 1673b(a)).
It completed and filed its
determinations in these investigations
on May 16, 2016. The views of the
Commission are contained in USITC
Publication 4612 (May 2016), entitled 1Hydroxyethylidene-1, 1-Diphosphonic
Acid from China: Investigation Nos.
701–TA–558 and 731–TA–1316
(Preliminary).
By order of the Commission.
Issued: May 16, 2016.
Lisa R. Barton,
Secretary to the Commission.
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–11891 Filed 5–19–16; 8:45 am]
BILLING CODE 7020–02–P
Drug Enforcement Administration
Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[Docket No. DEA–392]
[FR Doc. 2016–11939 Filed 5–19–16; 8:45 am]
DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances Registration: Pharmacore,
Inc.
ACTION:
Drug Enforcement Administration
Notice of registration.
Pharmacore, Inc. applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants
Pharmacore, Inc. registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated January 27, 2016, and published
in the Federal Register on February 4,
2016, 81 FR 6044, Pharmacore, Inc.,
4180 Mendenhall Oaks Parkway, High
Point, North Carolina 27265 applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. No comments or objections
were submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Pharmacore, Inc. to
manufacture the basic classes of
controlled substances is consistent with
the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Oxymorphone (9652) ....................
Noroxymorphone (9668) ...............
DEPARTMENT OF JUSTICE
Schedule
II
II
The company plans to manufacture
the listed controlled substances as
active pharmaceutical ingredients (APIs)
for clinical trials.
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Mallinckrodt,
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 19, 2016.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
The
Attorney General has delegated her
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
February 19, 2016, Mallinckrodt, LLC,
3600 North Second Street, Saint Louis,
Missouri 63147 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
Codeine-N-oxide (9053) ..............................................................................................................................................................................
Dihydromorphine (9145) ..............................................................................................................................................................................
Difenoxin (9168) ..........................................................................................................................................................................................
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Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
Controlled substance
Schedule
Morphine-N-oxide (9307) .............................................................................................................................................................................
Normorphine (9313) ....................................................................................................................................................................................
Norlevorphanol (9634) .................................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) (9821) ...............................................................................................
Amphetamine (1100) ...................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
Lisdexamfetamine (1205) ............................................................................................................................................................................
Methylphenidate (1724) ...............................................................................................................................................................................
Nabilone (7379) ...........................................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) .....................................................................................................................................
Codeine (9050) ............................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Oxycodone (9143) .......................................................................................................................................................................................
Hydromorphone (9150) ...............................................................................................................................................................................
Diphenoxylate (9170) ..................................................................................................................................................................................
Ecgonine (9180) ..........................................................................................................................................................................................
Hydrocodone (9193) ....................................................................................................................................................................................
Levorphanol (9220) .....................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Methadone (9250) .......................................................................................................................................................................................
Methadone intermediate (9254) ..................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Morphine (9300) ..........................................................................................................................................................................................
Oripavine (9330) ..........................................................................................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
Opium tincture (9630) ..................................................................................................................................................................................
Opium, powdered (9639) .............................................................................................................................................................................
Oxymorphone (9652) ...................................................................................................................................................................................
Noroxymorphone (9668) ..............................................................................................................................................................................
Alfentanil (9737) ..........................................................................................................................................................................................
Remifentanil (9739) .....................................................................................................................................................................................
Sufentanil (9740) .........................................................................................................................................................................................
Tapentadol (9780) .......................................................................................................................................................................................
Fentanyl (9801) ...........................................................................................................................................................................................
The company plans to manufacturer
bulk active pharmaceutical ingredients
(APIs) for distribution to its customers.
Drug Enforcement Administration
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 19, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–11940 Filed 5–19–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: American
Radiolabeled Chemicals
ACTION:
Notice of application.
DATES:
The
Attorney General has delegated her
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 March
3, 2016, American Radiolabeled
Chemicals, 101 Arc Drive, Saint Louis,
Missouri 63146 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
mstockstill on DSK3G9T082PROD with NOTICES
Controlled substance
Schedule
Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................
Ibogaine (7260) ...........................................................................................................................................................................................
Lysergic Acid Diethylamide (7315) ..............................................................................................................................................................
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
Dimethyltryptamine (7435) ..........................................................................................................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ...............................................................................................................................................
Dihydromorphine (9145) ..............................................................................................................................................................................
Heroin (9200) ...............................................................................................................................................................................................
Normorphine (9313) ....................................................................................................................................................................................
Amphetamine (1100) ...................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
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]]>Agencies
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31959-31960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11940]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application:
Mallinckrodt, 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 19, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
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
February 19, 2016, Mallinckrodt, LLC, 3600 North Second Street, Saint
Louis, Missouri 63147 applied to be registered as a bulk manufacturer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)............ I
Tetrahydrocannabinols (7370)................ I
Codeine-N-oxide (9053)...................... I
Dihydromorphine (9145)...................... I
Difenoxin (9168)............................ I
[[Page 31960]]
Morphine-N-oxide (9307)..................... I
Normorphine (9313).......................... I
Norlevorphanol (9634)....................... I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4- I
yl)-N-phenylacetamide) (9821).
Amphetamine (1100).......................... II
Methamphetamine (1105)...................... II
Lisdexamfetamine (1205)..................... II
Methylphenidate (1724)...................... II
Nabilone (7379)............................. II
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Codeine (9050).............................. II
Dihydrocodeine (9120)....................... II
Oxycodone (9143)............................ II
Hydromorphone (9150)........................ II
Diphenoxylate (9170)........................ II
Ecgonine (9180)............................. II
Hydrocodone (9193).......................... II
Levorphanol (9220).......................... II
Meperidine (9230)........................... II
Methadone (9250)............................ II
Methadone intermediate (9254)............... II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Morphine (9300)............................. II
Oripavine (9330)............................ II
Thebaine (9333)............................. II
Opium tincture (9630)....................... II
Opium, powdered (9639)...................... II
Oxymorphone (9652).......................... II
Noroxymorphone (9668)....................... II
Alfentanil (9737)........................... II
Remifentanil (9739)......................... II
Sufentanil (9740)........................... II
Tapentadol (9780)........................... II
Fentanyl (9801)............................. II
------------------------------------------------------------------------
The company plans to manufacturer bulk active pharmaceutical
ingredients (APIs) for distribution to its customers.
Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-11940 Filed 5-19-16; 8:45 am]
BILLING CODE 4410-09-P
