81 FR 15566 - Importer of Controlled Substances Application: Mallinckrodt LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 56 (March 23, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 56 (March 23, 2016)
| Page Range | 15566-15567 | |
| FR Document | 2016-06543 |
[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)] [Notices] [Pages 15566-15567] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06543] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer 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 1301.34(a) on or before April 22, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 22, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug [[Page 15567]] Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). 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 1301.34(a), this is notice that on December 22, 2015, Mallinckrodt LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Phenylacetone (8501)....................... II Coca Leaves (9040)......................... II Opium, raw (9600).......................... II Poppy Straw Concentrate (9670)............. II ------------------------------------------------------------------------ The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical Ingredients for distribution to its customers. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-06543 Filed 3-22-16; 8:45 am] BILLING CODE 4410-09-P
![15566 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices
used in the manufacture of DEA exempt hearing on the application pursuant to authority under the Controlled
products. 21 CFR 1301.43 on or before April 22, Substances Act to the Administrator of
Dated: March 14, 2016. 2016. the Drug Enforcement Administration
Louis J. Milione, ADDRESSES: Written comments should (DEA), 28 CFR 0.100(b). Authority to
Deputy Assistant Administrator. be sent to: Drug Enforcement exercise all necessary functions with
Administration, Attention: DEA Federal respect to the promulgation and
[FR Doc. 2016–06540 Filed 3–22–16; 8:45 am]
Register Representative/ODW, 8701 implementation of 21 CFR part 1301,
BILLING CODE 4410–09–P
Morrissette Drive, Springfield, Virginia incident to the registration of
22152. All request for hearing must be manufacturers, distributors, dispensers,
DEPARTMENT OF JUSTICE sent to: Drug Enforcement importers, and exporters of controlled
Administration, Attn: Administrator, substances (other than final orders in
Drug Enforcement Administration 8701 Morrissette Drive, Springfield, connection with suspension, denial, or
Virginia 22152. All request for hearing revocation of registration) has been
[Docket No. DEA–392] should also be sent to: (1) Drug redelegated to the Deputy Assistant
Enforcement Administration, Attn:
Importer of Controlled Substances Administrator of the DEA Office of
Hearing Clerk/LJ, 8701 Morrissette
Application: R & D Systems, Inc. Diversion Control (‘‘Deputy Assistant
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration, Administrator’’) pursuant to section 7 of
ACTION: Notice of application. 28 CFR part 0, appendix to subpart R.
Attn: DEA Federal Register
DATES: Registered bulk manufacturers of Representative/ODW, 8701 Morrissette In accordance with 21 CFR
the affected basic classes, and Drive, Springfield, Virginia 22152. 1301.34(a), this is notice that on
applicants therefore, may file written Comments and requests for hearing on February 25, 2015, R & D Systems, Inc.,
comments on or objections to the applications to import narcotic raw 614 McKinley Place NE., Minneapolis,
issuance of the proposed registration in material are not appropriate. 72 FR 3417 Minnesota 55413 applied to be
accordance with 21 CFR 1301.34(a) on (January 25, 2007). registered as an importer of the
or before April 22, 2016. Such persons SUPPLEMENTARY INFORMATION: The following basic classes of controlled
may also file a written request for a Attorney General has delegated her substances:
Controlled substance Schedule
Mephedrone (4-Methyl-N-methylcathinone) (1248) .................................................................................................................................... I
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) (7118) .............................................................................................. I
CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) (7297) ................................................................................. I
Marihuana (7360) ........................................................................................................................................................................................ I
Tetrahydrocannabinols (7370) ..................................................................................................................................................................... I
4-Bromo-2,5-dimethoxyamphetamine (7391) .............................................................................................................................................. I
3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................ I
Dimethyltryptamine (7435) .......................................................................................................................................................................... I
Psilocyn (7438) ............................................................................................................................................................................................ I
Amphetamine (1100) ................................................................................................................................................................................... II
Methylphenidate (1724) ............................................................................................................................................................................... II
Pentobarbital (2270) .................................................................................................................................................................................... II
Phencyclidine (7471) ................................................................................................................................................................................... II
Cocaine (9041) ............................................................................................................................................................................................ II
Oxycodone (9143) ....................................................................................................................................................................................... II
Morphine (9300) .......................................................................................................................................................................................... II
Thebaine (9333) .......................................................................................................................................................................................... II
Fentanyl (9801) ........................................................................................................................................................................................... II
The company plans to import the Dated: March 14, 2016. comments on or objections to the
listed controlled substances in dosage Louis J. Milione, issuance of the proposed registration in
form to distribute to researchers. Deputy Assistant Administrator. accordance with 21 CFR 1301.34(a) on
In reference to drug codes 7360 and [FR Doc. 2016–06542 Filed 3–22–16; 8:45 am] or before April 22, 2016. Such persons
7370, the company plans to import a BILLING CODE 4410–09–P may also file a written request for a
synthetic cannabidiol and a synthetic hearing on the application pursuant to
tetrahydrocannabinol. No other activity 21 CFR 1301.43 on or before April 22,
for these drug codes is authorized for DEPARTMENT OF JUSTICE 2016.
this registration. Drug Enforcement Administration ADDRESSES: Written comments should
The import of the above listed basic be sent to: Drug Enforcement
[Docket No. DEA–392] Administration, Attention: DEA Federal
classes of controlled substances would
Register Representative/ODW, 8701
jstallworth on DSK7TPTVN1PROD with NOTICES
be granted only for analytical testing Importer of Controlled Substances
and clinical trials. This authorization Application: Mallinckrodt LLC Morrissette Drive, Springfield, Virginia
does not extend to the import of a 22152. All request for hearing must be
finished Food and Drug Administration ACTION: Notice of application. sent to: Drug Enforcement
approved or non-approved dosage form Administration, Attn: Administrator,
for commercial distribution in the DATES: Registered bulk manufacturers of 8701 Morrissette Drive, Springfield,
United States. the affected basic classes, and Virginia 22152. All request for hearing
applicants therefore, may file written should also be sent to: (1) Drug
VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\23MRN1.SGM 23MRN1](https://thefederalregister.org/doc/81_FR_15622/page/1.svg)
![Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices 15567
Enforcement Administration, Attn: DATES: Registered bulk manufacturers of Dated: March 14, 2016.
Hearing Clerk/LJ, 8701 Morrissette the affected basic classes, and Louis J. Milione,
Drive, Springfield, Virginia 22152; and applicants therefore, may file written Deputy Assistant Administrator.
(2) Drug Enforcement Administration, comments on or objections to the [FR Doc. 2016–06537 Filed 3–22–16; 8:45 am]
Attn: DEA Federal Register issuance of the proposed registration in BILLING CODE 4410–09–P
Representative/ODW, 8701 Morrissette accordance with 21 CFR 1301.33(a) on
Drive, Springfield, Virginia 22152. or before May 23, 2016.
Comments and requests for hearing on DEPARTMENT OF JUSTICE
ADDRESSES: Written comments should
applications to import narcotic raw
be sent to: Drug Enforcement
material are not appropriate. 72 FR 3417 Drug Enforcement Administration
Administration, Attention: DEA Federal
(January 25, 2007).
Register Representative/ODW, 8701 [Docket No. DEA–392]
SUPPLEMENTARY INFORMATION: The Morrissette Drive, Springfield, Virginia
Attorney General has delegated her 22152. Manufacturer of Controlled
authority under the Controlled Substances Registration: Halo
Substances Act to the Administrator of SUPPLEMENTARY INFORMATION: The Pharmaceutical, Inc.
the Drug Enforcement Administration Attorney General has delegated her
(DEA), 28 CFR 0.100(b). Authority to authority under the Controlled ACTION: Notice of registration.
exercise all necessary functions with Substances Act to the Administrator of
SUMMARY: Halo Pharmaceutical, Inc.
respect to the promulgation and the Drug Enforcement Administration
applied to be registered as a
implementation of 21 CFR part 1301, (DEA), 28 CFR 0.100(b). Authority to
manufacturer of certain basic classes of
incident to the registration of exercise all necessary functions with
controlled substances. The Drug
manufacturers, distributors, dispensers, respect to the promulgation and
Enforcement Administration (DEA)
importers, and exporters of controlled implementation of 21 CFR part 1301,
grants Halo Pharmaceutical, Inc.
substances (other than final orders in incident to the registration of
registration as a manufacturer of those
connection with suspension, denial, or manufacturers, distributors, dispensers,
controlled substances.
revocation of registration) has been importers, and exporters of controlled
redelegated to the Deputy Assistant substances (other than final orders in SUPPLEMENTARY INFORMATION: By notice
Administrator of the DEA Office of connection with suspension, denial, or dated October 13, 2015, and published
Diversion Control (‘‘Deputy Assistant revocation of registration) has been in the Federal Register on October 21,
Administrator’’) pursuant to section 7 of redelegated to the Deputy Assistant 2015, 80 FR 63838, Halo
28 CFR part 0, appendix to subpart R. Administrator of the DEA Office of Pharmaceutical, Inc., 30 North Jefferson
In accordance with 21 CFR Diversion Control (‘‘Deputy Assistant Road, Whippany, New Jersey 07981
1301.34(a), this is notice that on Administrator’’) pursuant to section 7 of applied to be registered as a
December 22, 2015, Mallinckrodt LLC, 28 CFR part 0, appendix to subpart R. manufacturer of certain basic classes of
3600 North Second Street, Saint Louis, controlled substances. No comments or
In accordance with 21 CFR objections were submitted for this
Missouri 63147 applied to be registered 1301.33(a), this is notice that on
as an importer of the following basic notice.
November 12, 2015, Siegfried USA, The DEA has considered the factors in
classes of controlled substances: LLC, 33 Industrial Park Road, 21 U.S.C. 823(a) and determined that
Pennsville, New Jersey 08070 applied to the registration of Halo Pharmaceutical,
Controlled substance Schedule be registered as a bulk manufacturer the Inc. to manufacture the basic classes of
Phenylacetone (8501) .................. II following basic classes of controlled controlled substances is consistent with
Coca Leaves (9040) ..................... II substances: the public interest and with United
Opium, raw (9600) ....................... II States obligations under international
Poppy Straw Concentrate (9670) II Controlled substance Schedule
treaties, conventions, or protocols in
Gamma Hydroxybutyric Acid I effect on May 1, 1971. The DEA
The company plans to import the investigated the company’s maintenance
(2010).
listed controlled substances to bulk of effective controls against diversion by
Dihydromorphine (9145) ............... I
manufacture into Active Pharmaceutical Hydromorphinol (9301) ................. I inspecting and testing the company’s
Ingredients for distribution to its Methylphenidate (1724) ................ II physical security systems, verifying the
customers. Amobarbital (2125) ....................... II company’s compliance with state and
Dated: March 14, 2016. Pentobarbital (2270) ..................... II local laws, and reviewing the company’s
Secobarbital (2315) ...................... II
Louis J. Milione,
Codeine (9050) ............................. II
background and history.
Deputy Assistant Administrator. Oxycodone (9143) ........................ II Therefore, pursuant to 21 U.S.C.
[FR Doc. 2016–06543 Filed 3–22–16; 8:45 am] Hydromorphone (9150) ................ II 823(a), and in accordance with 21 CFR
BILLING CODE 4410–09–P Hydrocodone (9193) ..................... II 1301.33, the above-named company is
Methadone (9250) ........................ II granted registration as a bulk
Methadone intermediate (9254) ... II manufacturer of the following basic
DEPARTMENT OF JUSTICE Dextropropoxyphene, bulk (non- II classes of controlled substances:
dosage forms) (9273).
Drug Enforcement Administration Morphine (9300) ........................... II Controlled substance Schedule
jstallworth on DSK7TPTVN1PROD with NOTICES
Oripavine (9330) ........................... II
[Docket No. DEA–392] Thebaine (9333) ........................... II Dihydromorphine (9145) ............... I
Opium tincture (9630) .................. II Hydromorphone (9150) ................ II
Bulk Manufacturer of Controlled Oxymorphone (9652) ................... II
Substances Application: Siegfried The company plans to manufacture
USA, LLC The company plans to manufacture Hydromorphone HCl for sale to other
the listed controlled substances in bulk manufacturers and to manufacture other
ACTION: Notice of application.
for distribution to its customers. controlled substances for distribution to
VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\23MRN1.SGM 23MRN1](https://thefederalregister.org/doc/81_FR_15622/page/2.svg)
Document Created: 2016-03-23 00:03:45
Document Modified: 2016-03-23 00:03:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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 1301.34(a) on or before April 22, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 22, 2016. | |
| FR Citation | 81 FR 15566 |
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