82 FR 23071 - Importer of Controlled Substances Application: Mallinckrodt LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 96 (May 19, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 96 (May 19, 2017)
| Page Range | 23071-23072 | |
| FR Document | 2017-10242 |
[Federal Register Volume 82, Number 96 (Friday, May 19, 2017)] [Notices] [Pages 23071-23072] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10242] ----------------------------------------------------------------------- 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 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
![Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices 23071
In accordance with 21 CFR Chemicals, Inc., 101 Arc Drive, Saint following basic classes of controlled
1301.33(a), this is notice that on March Louis, Missouri 63146 applied to be substances:
7, 2017, American Radiolabeled registered as a bulk manufacturer of the
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-Thienyl)cyclohexyl]piperidine ............................................................................................................................... 7470 I
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-dosage forms) .............................................................................................................. 9273 II
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 or before June 19, 2017. Such persons SUPPLEMENTARY INFORMATION: The
small quantities of the listed controlled may also file a written request for a Attorney General has delegated his
substances as radiolabeled compounds hearing on the application pursuant to authority under the Controlled
for biochemical research. 21 CFR 1301.43 on or before June 19, Substances Act to the Administrator of
Dated: May 15, 2017. 2017. the Drug Enforcement Administration
Louis J. Milione, ADDRESSES: Written comments should (DEA), 28 CFR 0.100(b). Authority to
be sent to: Drug Enforcement exercise all necessary functions with
Assistant Administrator.
Administration, Attention: DEA Federal respect to the promulgation and
[FR Doc. 2017–10240 Filed 5–18–17; 8:45 am]
Register Representative/DRW, 8701 implementation of 21 CFR part 1301,
BILLING CODE P
Morrissette Drive, Springfield, Virginia incident to the registration of
22152. All requests for hearing must be manufacturers, distributors, dispenses,
sent to: Drug Enforcement importers, and exporters of controlled
DEPARTMENT OF JUSTICE
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] redelegated to the Assistant
should also be sent to: (1) Drug
Enforcement Administration, Attn: Administrator of the DEA Diversion
Importer of Controlled Substances Control Division (‘‘Assistant
Application: Mallinckrodt LLC Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and Administrator’’) pursuant to section 7 of
ACTION: Notice of application. (2) Drug Enforcement Administration, 28 CFR part 0, appendix to subpart R.
Attn: DEA Federal Register In accordance with 21 CFR
DATES: Registered bulk manufacturers of Representative/DRW, 8701 Morrissette 1301.34(a), this is notice that on
the affected basic classes, and Drive, Springfield, Virginia 22152. December 21, 2016, Mallinckrodt LLC,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
applicants therefore, may file written Comments and requests for hearing on 3600 North Second Street, Saint Louis,
comments on or objections to the applications to import narcotic raw Missouri 63147 applied to be registered
issuance of the proposed registration in material are not appropriate. 72 FR 3417 as an importer of the following basic
accordance with 21 CFR 1301.34(a) on (January 25, 2007). classes of controlled substances:
Controlled substance Drug code Schedule
Marihuana ........................................................................................................................................................................ 7360 I
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![23072 Federal Register / Vol. 82, No. 96 / Friday, May 19, 2017 / Notices
Controlled substance Drug code Schedule
Phenylacetone ................................................................................................................................................................. 8501 II
Coca Leaves .................................................................................................................................................................... 9040 II
Opium, raw ...................................................................................................................................................................... 9600 II
Poppy Straw Concentrate ............................................................................................................................................... 9670 II
The company plans to import the criminal justice professional regarding the items contained in this
listed controlled substances to bulk associations (i.e., the American notice, especially the estimated public
manufacture into Active Pharmaceutical Probation and Parole Association; burden and associated response time,
Ingredients for distribution to its American Society of Crime Laboratory should be directed to Mrs. Amy C.
customers. Placement of these drug Directors; International Association of Blasher, Unit Chief, Federal Bureau of
codes onto the company’s registration Chiefs of Police; National District Investigation, CJIS Division, Module
does not translate into automatic Attorneys Association; National E–3, 1000 Custer Hollow Road,
approval of subsequent permit Sheriffs’ Association; Major Cities Clarksburg, West Virginia 26306;
applications to import controlled Chiefs Association; Major County facsimile (304) 625–3566. Written
substances. Sheriffs’ Association; and a comments and/or suggestions can also
In reference to drug code 7360 representative from a national be sent to the Office of Management and
(Marihuana) the company plans to professional association representing Budget, Office of Information and
import a synthetic cannabidiol. No other the courts or court administrators Regulatory Affairs, Attention
activity for this drug code is authorized nominated by the Conference of Chief Department of Justice Desk Officer,
for this registration. Justices). The Attorney General has Washington, DC 20503 or sent to OIRA_
Dated: May 15, 2017. granted me the authority to appoint all submissions@omb.eop.gov.
Louis J. Milione, members to the APB. SUPPLEMENTARY INFORMATION: Written
Assistant Administrator.
The APB functions solely as an comments and suggestions from the
advisory body in compliance with the public and affected agencies concerning
[FR Doc. 2017–10242 Filed 5–18–17; 8:45 am]
provisions of the Federal Advisory the proposed collection of information
BILLING CODE P
Committee Act. The Charter has been are encouraged. Your comments should
filed in accordance with the provisions address one or more of the following
DEPARTMENT OF JUSTICE of the Act. four points:
Dated: May 10, 2017. —Evaluate whether the proposed
Federal Bureau of Investigation Andrew G. McCabe, collection of information is necessary
Acting Director. for the proper performance of the
Notice of Charter Reestablishment
[FR Doc. 2017–10095 Filed 5–18–17; 8:45 am] functions of the agency, including
In accordance with the provisions of BILLING CODE 4410–02–P whether the information will have
the Federal Advisory Committee Act, practical utility;
Title 5, United States Code, Appendix, —Evaluate the accuracy of the agency’s
and Title 41, Code of Federal DEPARTMENT OF JUSTICE estimate of the burden of the
Regulations 101–6.1015, with the proposed collection of information,
[OMB Number 1110–0058]
concurrence of the Attorney General, I including the validity of the
have determined that the Agency Information Collection methodology and assumptions used;
reestablishment of the Criminal Justice Activities; Proposed Collection; —Enhance the quality, utility, and
Information Services (CJIS) Advisory Comments Requested National clarity of the information to be
Policy Board (APB) is in the public Incident-Based Reporting System collected; and
interest. In connection with the (NIBRS) —Minimize the burden of the collection
performance of duties imposed upon the of information on those who are to
FBI by law, I hereby give notice of the AGENCY: Federal Bureau of respond, including through the use of
reestablishment of the APB Charter. Investigation, Department of Justice. appropriate automated, electronic,
The APB provides me with general ACTION: 30-day notice. mechanical, or other technological
policy recommendations with respect to collection techniques or other forms
the philosophy, concept, and SUMMARY: Department of Justice (DOJ), of information technology, e.g.,
operational principles of the various Federal Bureau of Investigation, permitting electronic submission of
criminal justice information systems Criminal Justice Information Services responses.
managed by the FBI’s CJIS Division. Division will be submitting the
The APB includes representatives following information collection request Overview of This Information
from local and state criminal justice to the Office of Management and Budget Collection:
agencies; tribal law enforcement (OMB) for review and approval in (1) Type of Information Collection:
representatives; members of the judicial, accordance with the Paperwork Extension with change, of a currently
prosecutorial, and correctional sectors Reduction Act of 1995. This proposed approved collection.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
of the criminal justice community, as information collection was previously (2) Title of the Form/Collection:
well as one individual representing a published in the Federal Register National Incident-Based Reporting
national security agency; a allowing for a 60-day comment period. System.
representative of the National Crime DATES: Comments are encouraged and (3) Agency form number, if any, and
Prevention and Privacy Compact will be accepted for an additional 30 the applicable component of the
Council; a representative of federal days until June 19, 2017. Department sponsoring the collection:
agencies participating in the CJIS FOR FURTHER INFORMATION CONTACT: Agency form number: 1110–0058.
Division Systems; and representatives of Written comments and/or suggestions Sponsoring component: Department of
VerDate Sep<11>2014 19:15 May 18, 2017 Jkt 241001 PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM 19MYN1](https://thefederalregister.org/doc/82_FR_23167/page/2.svg)
Document Created: 2018-11-08 08:47:32
Document Modified: 2018-11-08 08:47:32
| 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 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. | |
| FR Citation | 82 FR 23071 |
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