Importer of Controlled Substances Application: Meridian Medical Technologies, 13135-13136 [2017-04647]

Download as PDF 13135 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 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 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. 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, DATES: 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 November 11, 2016, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Drug code Amphetamine ............................................................................................................................................................. Lisdexamfetamine ...................................................................................................................................................... Methylphenidate ......................................................................................................................................................... Nabilone ..................................................................................................................................................................... Oxycodone ................................................................................................................................................................. Hydromorphone .......................................................................................................................................................... Hydrocodone .............................................................................................................................................................. Morphine .................................................................................................................................................................... Oxymorphone ............................................................................................................................................................. Fentanyl ...................................................................................................................................................................... The company plans to import the listed controlled substances in finished dosage form for clinical trials, research, and analytical purposes. The import of the above listed basic classes of controlled substances will be granted only for analytical testing, research, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–04646 Filed 3–8–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration asabaliauskas on DSK3SPTVN1PROD with NOTICES [Docket No. DEA–392] Importer of Controlled Substances Application: Meridian Medical Technologies 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 1301.34(a) on DATES: VerDate Sep<11>2014 18:42 Mar 08, 2017 Jkt 241001 or before April 10, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 10, 2017. 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 1100 1205 1724 7379 9143 9150 9193 9300 9652 9801 Schedule II II II II II II II II II II 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 29, 2016, Meridian Medical Technologies, 2555 Hermelin Drive, Saint Louis, Missouri 63144 applied to be registered as an importer of morphine (9300), a basic class of controlled substance listed in schedule II. The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards. E:\FR\FM\09MRN1.SGM 09MRN1 13136 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices This is the sole purpose for which the company will be authorized by the DEA to import morphine. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–04647 Filed 3–8–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [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 May 8, 2017. 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 DATES: 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 1301.33(a), this is notice that on November 14, 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 Drug code asabaliauskas on DSK3SPTVN1PROD with NOTICES Gamma Hydroxybutyric Acid ..................................................................................................................................... Tetrahydrocannabinols ............................................................................................................................................... Codeine-N-oxide ........................................................................................................................................................ Dihydromorphine ........................................................................................................................................................ Difenoxin .................................................................................................................................................................... Morphine-N-oxide ....................................................................................................................................................... Normorphine ............................................................................................................................................................... Norlevorphanol ........................................................................................................................................................... Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ......................................................................... Butyryl Fentanyl ......................................................................................................................................................... Amphetamine ............................................................................................................................................................. Methamphetamine ...................................................................................................................................................... Lisdexamfetamine ...................................................................................................................................................... Methylphenidate ......................................................................................................................................................... Nabilone ..................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................... Codeine ...................................................................................................................................................................... Dihydrocodeine .......................................................................................................................................................... Oxycodone ................................................................................................................................................................. Hydromorphone .......................................................................................................................................................... Diphenoxylate ............................................................................................................................................................. Ecgonine .................................................................................................................................................................... Hydrocodone .............................................................................................................................................................. Levorphanol ................................................................................................................................................................ Meperidine .................................................................................................................................................................. Methadone ................................................................................................................................................................. Methadone intermediate ............................................................................................................................................ Dextropropoxyphene, bulk (non-dosage forms) ........................................................................................................ Morphine .................................................................................................................................................................... Oripavine .................................................................................................................................................................... Thebaine .................................................................................................................................................................... Opium tincture ............................................................................................................................................................ Opium, powdered ....................................................................................................................................................... Oxymorphone ............................................................................................................................................................. Noroxymorphone ........................................................................................................................................................ Alfentanil ..................................................................................................................................................................... Remifentanil ............................................................................................................................................................... Sufentanil ................................................................................................................................................................... Tapentadol ................................................................................................................................................................. Fentanyl ...................................................................................................................................................................... VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1 2010 7370 9053 9145 9168 9307 9313 9634 9821 9822 1100 1105 1205 1724 7379 8333 9050 9120 9143 9150 9170 9180 9193 9220 9230 9250 9254 9273 9300 9330 9333 9630 9639 9652 9668 9737 9739 9740 9780 9801 Schedule I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II

Agencies

[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13135-13136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04647]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Meridian Medical 
Technologies

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 10, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before April 10, 2017.

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 29, 2016, Meridian Medical Technologies, 2555 Hermelin Drive, 
Saint Louis, Missouri 63144 applied to be registered as an importer of 
morphine (9300), a basic class of controlled substance listed in 
schedule II.
    The company manufactures a product containing morphine in the 
United States. The company exports this product to customers around the 
world. The company has been asked to ensure that its product, which is 
sold to European customers, meets the standards established by the 
European Pharmacopeia, administered by the Directorate for the Quality 
of Medicines (EDQM). In order to ensure that its product will meet 
European specifications, the company seeks to import morphine supplied 
by EDQM for use as reference standards.

[[Page 13136]]

    This is the sole purpose for which the company will be authorized 
by the DEA to import morphine.

Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-04647 Filed 3-8-17; 8:45 am]
BILLING CODE 4410-09-P