Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc., 15565-15566 [2016-06540]

Download as PDF Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices concentrate (9670), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance to bulk manufacture into other controlled substances for sale to its customers. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Pharmacore ACTION: Notice of application. Registered bulk manufacturers of the affected basic class, 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 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, dispenser, 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 January 26, 2016, Pharmacore, 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265 applied to be registered as an importer of poppy straw jstallworth on DSK7TPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. 15565 The company plans to manufacture the listed controlled substance as an intermediate in the manufacture of an active pharmaceutical ingredient to sell to its customers. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–06534 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2016–06541 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc. Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc. ACTION: Notice of registration. PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 Notice of application. Registered bulk manufacturers of the affected basic class, 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 23, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: Cody Laboratories, Inc. applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63835, Cody Laboratories, Inc., Steven Hartman—Vice President of Compliance, 601 Yellowstone Avenue, Cody, Wyoming 82414 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 Cody Laboratories, 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 methadone intermediate (9254), a basic class of controlled substance listed in schedule II. SUMMARY: ACTION: 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 December 14, 2015, Siemens Healthcare Diagnostics, Inc., 100 GBC Drive, Mailstop 514, Newark, Delaware 19702 applied to be registered as a bulk manufacturer of ecgonine (9180) a basic class of controlled substance listed in schedule II. The company plans to produce the listed controlled substance in bulk to be SUPPLEMENTARY INFORMATION: E:\FR\FM\23MRN1.SGM 23MRN1 15566 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices used in the manufacture of DEA exempt products. Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–06540 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: R & D Systems, 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 in accordance with 21 CFR 1301.34(a) on or before April 22, 2016. Such persons may also file a written request for a DATES: 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 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 February 25, 2015, R & D Systems, Inc., 614 McKinley Place NE., Minneapolis, Minnesota 55413 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Schedule jstallworth on DSK7TPTVN1PROD with NOTICES Mephedrone (4-Methyl-N-methylcathinone) (1248) .................................................................................................................................... JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) (7118) .............................................................................................. CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) (7297) ................................................................................. Marihuana (7360) ........................................................................................................................................................................................ Tetrahydrocannabinols (7370) ..................................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (7391) .............................................................................................................................................. 3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................ Dimethyltryptamine (7435) .......................................................................................................................................................................... Psilocyn (7438) ............................................................................................................................................................................................ Amphetamine (1100) ................................................................................................................................................................................... Methylphenidate (1724) ............................................................................................................................................................................... Pentobarbital (2270) .................................................................................................................................................................................... Phencyclidine (7471) ................................................................................................................................................................................... Cocaine (9041) ............................................................................................................................................................................................ Oxycodone (9143) ....................................................................................................................................................................................... Morphine (9300) .......................................................................................................................................................................................... Thebaine (9333) .......................................................................................................................................................................................... Fentanyl (9801) ........................................................................................................................................................................................... The company plans to import the listed controlled substances in dosage form to distribute to researchers. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. The import of the above listed basic classes of controlled substances would be granted only for analytical testing and clinical trials. This authorization does not extend to the import of a finished Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States. VerDate Sep<11>2014 15:26 Mar 22, 2016 Jkt 238001 Dated: March 14, 2016. Louis J. Milione, Deputy Assistant Administrator. I I I I I I I I I II II II II II II II II II DEPARTMENT OF JUSTICE 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. Drug Enforcement Administration ADDRESSES: [FR Doc. 2016–06542 Filed 3–22–16; 8:45 am] BILLING CODE 4410–09–P [Docket No. DEA–392] Importer of Controlled Substances Application: Mallinckrodt LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written DATES: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 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 E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Pages 15565-15566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06540]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Siemens 
Healthcare Diagnostics, Inc.

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic class, 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 23, 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 
December 14, 2015, Siemens Healthcare Diagnostics, Inc., 100 GBC Drive, 
Mailstop 514, Newark, Delaware 19702 applied to be registered as a bulk 
manufacturer of ecgonine (9180) a basic class of controlled substance 
listed in schedule II.
    The company plans to produce the listed controlled substance in 
bulk to be

[[Page 15566]]

used in the manufacture of DEA exempt products.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06540 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P