Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC, 13136-13137 [2017-04645]

Download as PDF 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 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–04645 Filed 3–8–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Meda Pharmaceuticals, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: asabaliauskas on DSK3SPTVN1PROD with NOTICES Louis J. Milione, Assistant Administrator. [FR Doc. 2017–04648 Filed 3–8–17; 8:45 am] 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 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 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. 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: VerDate Sep<11>2014 17:43 Mar 08, 2017 Jkt 241001 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 December 5, 2016, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523 applied to be registered as an importer of nabilone (7379), a basic class of controlled substance listed in schedule II. The company plans to import the FDA approved drug product in finished dosage form for distribution to its customers. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Foreign Claims Settlement Commission [F.C.S.C. Meeting and Hearing Notice No. 3–17] Sunshine Act Meeting The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows: Thursday, March 23, 2017: 10:00 a.m.—Issuance of Proposed Decisions in claims against Iraq. Status: Open. All meetings are held at the Foreign Claims Settlement Commission, 600 E Street NW., Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Patricia M. Hall, Foreign Claims Settlement Commission, 600 E Street NW., Suite 6002, Washington, DC 20579. Telephone: (202) 616–6975. Brian M. Simkin, Chief Counsel. [FR Doc. 2017–04739 Filed 3–7–17; 11:15 am] BILLING CODE 4410–BA–P DEPARTMENT OF JUSTICE [Docket No. ODAG 170] Notice of Federal Advisory Committee Meeting AGENCY: PO 00000 Department of Justice. Frm 00049 Fmt 4703 Sfmt 4703 13137 Notice of Federal Advisory Committee meeting. Request for public comment. ACTION: The National Commission on Forensic Science will hold meeting thirteen at the time and location listed below. DATES: Public Hearing. The meeting will be held on April 10, 2017 from 9:00 a.m. to 5:00 p.m. and April 11, 2017 from 9:00 a.m. to 4:30 p.m. Written Public Comment. Written public comment regarding National Commission on Forensic Science meeting materials can be submitted through www.regulations.gov starting on March 27, 2017. Any comments should be posted to www.regulations.gov no later than 11:59 p.m. (EST) April 12, 2017. SUMMARY: Office of Justice Programs, 3rd Floor Main Conference Room, 810 7th Street NW., Washington, DC 20531. FOR FURTHER INFORMATION CONTACT: Jonathan McGrath, Ph.D., Senior Policy Analyst at the National Institute of Justice and NCFS Designated Federal Officer, 810 7th Street NW., Washington, DC 20531, by email at Jonathan.McGrath@usdoj.gov or by phone at (202) 514–6277. SUPPLEMENTARY INFORMATION: Agenda: The Commission will receive subcommittee status updates and briefings. A final agenda will be posted to the Commission’s Web site in advance of the meeting. Meeting Accessibility: Pursuant to 41 CFR 102–3.140 through 102–3.165 and the availability of space, the meeting scheduled for April 10, 2017, 9:00 a.m. to 5:00 p.m. and April 11, 2017, 9:00 a.m. to 4:30 p.m. at the Office of Justice Programs is open to the public and webcast. Seating is limited and preregistration is strongly encouraged. Media representatives are also encouraged to register in advance. Written Comments: Pursuant to section 10(a)(3) of the FACA and 41 CFR 102–3.105(j) and 102–3.140, the public or interested organizations may submit written comments to the Commission in response to the stated agenda and meeting material. Meeting material, including work products, will be made available on the Commission’s Web site: http://www.justice.gov/ncfs. Oral Comments: In addition to written statements, members of the public may present oral comments at 4:45 p.m. on April 10, 2017 and at 3:15 p.m. on April 11, 2017. Those individuals interested in making oral comments should indicate their intent through the on-line registration form and time will be allocated on a first-come, first-served ADDRESSES: E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)]
[Notices]
[Pages 13136-13137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04645]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer 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 
1301.33(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 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           Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid........            2010  I
Tetrahydrocannabinols............            7370  I
Codeine-N-oxide..................            9053  I
Dihydromorphine..................            9145  I
Difenoxin........................            9168  I
Morphine-N-oxide.................            9307  I
Normorphine......................            9313  I
Norlevorphanol...................            9634  I
Acetyl Fentanyl (N-(1-                       9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl.................            9822  I
Amphetamine......................            1100  II
Methamphetamine..................            1105  II
Lisdexamfetamine.................            1205  II
Methylphenidate..................            1724  II
Nabilone.........................            7379  II
4-Anilino-N-phenethyl-4-                     8333  II
 piperidine (ANPP).
Codeine..........................            9050  II
Dihydrocodeine...................            9120  II
Oxycodone........................            9143  II
Hydromorphone....................            9150  II
Diphenoxylate....................            9170  II
Ecgonine.........................            9180  II
Hydrocodone......................            9193  II
Levorphanol......................            9220  II
Meperidine.......................            9230  II
Methadone........................            9250  II
Methadone intermediate...........            9254  II
Dextropropoxyphene, bulk (non-               9273  II
 dosage forms).
Morphine.........................            9300  II
Oripavine........................            9330  II
Thebaine.........................            9333  II
Opium tincture...................            9630  II
Opium, powdered..................            9639  II
Oxymorphone......................            9652  II
Noroxymorphone...................            9668  II
Alfentanil.......................            9737  II
Remifentanil.....................            9739  II
Sufentanil.......................            9740  II
Tapentadol.......................            9780  II
Fentanyl.........................            9801  II
------------------------------------------------------------------------


[[Page 13137]]

    The company plans to manufacture bulk active pharmaceutical 
ingredients (APIs) for distribution to its customers.

Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-04645 Filed 3-8-17; 8:45 am]
 BILLING CODE 4410-09-P