Importer of Controlled Substances Application: Mallinckrodt LLC, 23071-23072 [2017-10242]

Download as PDF 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 23072 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices Controlled substance Drug code Phenylacetone ................................................................................................................................................................. Coca Leaves .................................................................................................................................................................... Opium, raw ...................................................................................................................................................................... Poppy Straw Concentrate ............................................................................................................................................... The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical Ingredients for distribution to its customers. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. In reference to drug code 7360 (Marihuana) the company plans to import a synthetic cannabidiol. No other activity for this drug code is authorized for this registration. Dated: May 15, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–10242 Filed 5–18–17; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Dated: May 10, 2017. Andrew G. McCabe, Acting Director. Federal Bureau of Investigation asabaliauskas on DSK3SPTVN1PROD with NOTICES Notice of Charter Reestablishment [FR Doc. 2017–10095 Filed 5–18–17; 8:45 am] In accordance with the provisions of the Federal Advisory Committee Act, Title 5, United States Code, Appendix, and Title 41, Code of Federal Regulations 101–6.1015, with the concurrence of the Attorney General, I have determined that the reestablishment of the Criminal Justice Information Services (CJIS) Advisory Policy Board (APB) is in the public interest. In connection with the performance of duties imposed upon the FBI by law, I hereby give notice of the reestablishment of the APB Charter. The APB provides me with general policy recommendations with respect to the philosophy, concept, and operational principles of the various criminal justice information systems managed by the FBI’s CJIS Division. The APB includes representatives from local and state criminal justice agencies; tribal law enforcement representatives; members of the judicial, prosecutorial, and correctional sectors of the criminal justice community, as well as one individual representing a national security agency; a representative of the National Crime Prevention and Privacy Compact Council; a representative of federal agencies participating in the CJIS Division Systems; and representatives of VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 criminal justice professional associations (i.e., the American Probation and Parole Association; American Society of Crime Laboratory Directors; International Association of Chiefs of Police; National District Attorneys Association; National Sheriffs’ Association; Major Cities Chiefs Association; Major County Sheriffs’ Association; and a representative from a national professional association representing the courts or court administrators nominated by the Conference of Chief Justices). The Attorney General has granted me the authority to appoint all members to the APB. The APB functions solely as an advisory body in compliance with the provisions of the Federal Advisory Committee Act. The Charter has been filed in accordance with the provisions of the Act. BILLING CODE 4410–02–P DEPARTMENT OF JUSTICE [OMB Number 1110–0058] Agency Information Collection Activities; Proposed Collection; Comments Requested National Incident-Based Reporting System (NIBRS) Federal Bureau of Investigation, Department of Justice. ACTION: 30-day notice. AGENCY: Department of Justice (DOJ), Federal Bureau of Investigation, Criminal Justice Information Services Division will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register allowing for a 60-day comment period. DATES: Comments are encouraged and will be accepted for an additional 30 days until June 19, 2017. FOR FURTHER INFORMATION CONTACT: Written comments and/or suggestions SUMMARY: PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 8501 9040 9600 9670 Schedule II II II II regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to Mrs. Amy C. Blasher, Unit Chief, Federal Bureau of Investigation, CJIS Division, Module E–3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306; facsimile (304) 625–3566. Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to OIRA_ submissions@omb.eop.gov. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection: (1) Type of Information Collection: Extension with change, of a currently approved collection. (2) Title of the Form/Collection: National Incident-Based Reporting System. (3) Agency form number, if any, and the applicable component of the Department sponsoring the collection: Agency form number: 1110–0058. Sponsoring component: Department of E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)]
[Notices]
[Pages 23071-23072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10242]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mallinckrodt LLC

ACTION: Notice of application.

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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 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 
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).

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, 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:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Marihuana..........................            7360  I

[[Page 23072]]

 
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. Placement of these drug codes onto the 
company's registration does not translate into automatic approval of 
subsequent permit applications to import controlled substances.
    In reference to drug code 7360 (Marihuana) the company plans to 
import a synthetic cannabidiol. No other activity for this drug code is 
authorized for this registration.

    Dated: May 15, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-10242 Filed 5-18-17; 8:45 am]
BILLING CODE P