Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, 23070-23071 [2017-10240]

Download as PDF 23070 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 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 June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 2017. 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 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/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 of subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on November 10, 2016, Galephar Pharmaceutical Research, Inc., #100 Carr 198, Industrial Park, Juncos, Puerto Rico 00777–3873 applied to be registered as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in finished dosage form for clinical trials, research and analytical purposes. The import of this class of controlled substance 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. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10234 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Whatever LLC 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 June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 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. 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 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 DATES: PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 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 October 16, 2015, Whatever LLC, 4370 N. Randall Street, Flagstaff, Arizona 86004 applied to be registered as an importer of opium poppy (9650), a basic class of controlled substance listed in schedule II. The company plans to import opium poppy (9650), for dried floral decorative arrangements. Approval of permit application will occur only when the registrant’s business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10243 Filed 5–18–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals 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 18, 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 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. DATES: E:\FR\FM\19MYN1.SGM 19MYN1 23071 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices In accordance with 21 CFR 1301.33(a), this is notice that on March 7, 2017, American Radiolabeled Chemicals, Inc., 101 Arc Drive, Saint Louis, Missouri 63146 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Ibogaine ........................................................................................................................................................................... Lysergic acid diethylamide .............................................................................................................................................. Tetrahydrocannabinols .................................................................................................................................................... Dimethyltryptamine .......................................................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]piperidine ............................................................................................................................... Dihydromorphine ............................................................................................................................................................. Heroin .............................................................................................................................................................................. Normorphine .................................................................................................................................................................... Amphetamine ................................................................................................................................................................... Methamphetamine ........................................................................................................................................................... Amobarbital ...................................................................................................................................................................... Phencyclidine ................................................................................................................................................................... Phenylacetone ................................................................................................................................................................. Cocaine ............................................................................................................................................................................ Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Metazocine ...................................................................................................................................................................... Methadone ....................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. Morphine .......................................................................................................................................................................... Oripavine ......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Oxymorphone .................................................................................................................................................................. Phenazocine .................................................................................................................................................................... Carfentanil ....................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mallinckrodt LLC 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: asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 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/DRW, 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). ADDRESSES: [FR Doc. 2017–10240 Filed 5–18–17; 8:45 am] ACTION: or before June 19, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before June 19, 2017. 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, dispenses, 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 21, 2016, 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: Drug code Marihuana ........................................................................................................................................................................ 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 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 SUPPLEMENTARY INFORMATION: Controlled substance VerDate Sep<11>2014 2010 7260 7315 7370 7435 7470 9145 9200 9313 1100 1105 2125 7471 8501 9041 9050 9120 9143 9150 9180 9193 9230 9240 9250 9273 9300 9330 9333 9652 9715 9743 9801 Schedule E:\FR\FM\19MYN1.SGM 19MYN1 7360 Schedule I

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23070-23071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10240]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: American 
Radiolabeled Chemicals

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 18, 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 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.

[[Page 23071]]

    In accordance with 21 CFR 1301.33(a), this is notice that on March 
7, 2017, American Radiolabeled Chemicals, Inc., 101 Arc Drive, Saint 
Louis, Missouri 63146 applied to be registered as a bulk manufacturer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..........            2010  I
Ibogaine...........................            7260  I
Lysergic acid diethylamide.........            7315  I
Tetrahydrocannabinols..............            7370  I
Dimethyltryptamine.................            7435  I
1-[1-(2-                                       7470  I
 Thienyl)cyclohexyl]piperidine.
Dihydromorphine....................            9145  I
Heroin.............................            9200  I
Normorphine........................            9313  I
Amphetamine........................            1100  II
Methamphetamine....................            1105  II
Amobarbital........................            2125  II
Phencyclidine......................            7471  II
Phenylacetone......................            8501  II
Cocaine............................            9041  II
Codeine............................            9050  II
Dihydrocodeine.....................            9120  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Ecgonine...........................            9180  II
Hydrocodone........................            9193  II
Meperidine.........................            9230  II
Metazocine.........................            9240  II
Methadone..........................            9250  II
Dextropropoxyphene, bulk (non-                 9273  II
 dosage forms).
Morphine...........................            9300  II
Oripavine..........................            9330  II
Thebaine...........................            9333  II
Oxymorphone........................            9652  II
Phenazocine........................            9715  II
Carfentanil........................            9743  II
Fentanyl...........................            9801  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances as radiolabeled compounds for biochemical 
research.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10240 Filed 5-18-17; 8:45 am]
 BILLING CODE P