82 FR 13136 - Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 45 (March 9, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 45 (March 9, 2017)
| Page Range | 13136-13137 | |
| FR Document | 2017-04645 |
[Federal Register Volume 82, Number 45 (Thursday, March 9, 2017)] [Notices] [Pages 13136-13137] From the Federal Register Online [www.thefederalregister.org] [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
![13136 Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices
This is the sole purpose for which the DATES: Registered bulk manufacturers of respect to the promulgation and
company will be authorized by the DEA the affected basic classes, and implementation of 21 CFR part 1301,
to import morphine. applicants therefore, may file written incident to the registration of
comments on or objections to the manufacturers, distributors, dispensers,
Louis J. Milione,
issuance of the proposed registration in importers, and exporters of controlled
Assistant Administrator. accordance with 21 CFR 1301.33(a) on substances (other than final orders in
[FR Doc. 2017–04647 Filed 3–8–17; 8:45 am] or before May 8, 2017. connection with suspension, denial, or
BILLING CODE 4410–09–P revocation of registration) has been
ADDRESSES: Written comments should
be sent to: Drug Enforcement redelegated to the Assistant
Administration, Attention: DEA Federal Administrator of the DEA Diversion
DEPARTMENT OF JUSTICE
Register Representative/DRW, 8701 Control Division (‘‘Assistant
Drug Enforcement Administration Morrissette Drive, Springfield, Virginia Administrator’’) pursuant to section 7 of
22152. 28 CFR part 0, appendix to subpart R.
[Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The In accordance with 21 CFR
Attorney General has delegated his 1301.33(a), this is notice that on
Bulk Manufacturer of Controlled authority under the Controlled November 14, 2016, Mallinckrodt, LLC,
Substances Application: Mallinckrodt, Substances Act to the Administrator of 3600 North Second Street, Saint Louis,
LLC the Drug Enforcement Administration Missouri 63147 applied to be registered
(DEA), 28 CFR 0.100(b). Authority to as a bulk manufacturer of the following
ACTION: Notice of application.
exercise all necessary functions with 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-phenethylpiperidin-4-yl)-N-phenylacetamide) ......................................................................... 9821 I
Butyryl Fentanyl ......................................................................................................................................................... 9822 I
Amphetamine ............................................................................................................................................................. 1100 II
Methamphetamine ...................................................................................................................................................... 1105 II
Lisdexamfetamine ...................................................................................................................................................... 1205 II
Methylphenidate ......................................................................................................................................................... 1724 II
Nabilone ..................................................................................................................................................................... 7379 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................... 8333 II
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-dosage forms) ........................................................................................................ 9273 II
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
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![Federal Register / Vol. 82, No. 45 / Thursday, March 9, 2017 / Notices 13137
The company plans to manufacture Administrator’’) pursuant to section 7 of Notice of Federal Advisory
ACTION:
bulk active pharmaceutical ingredients 28 CFR part 0, appendix of subpart R. Committee meeting. Request for public
(APIs) for distribution to its customers. In accordance with 21 CFR comment.
1301.34(a), this is notice that on
Louis J. Milione, SUMMARY: The National Commission on
December 5, 2016, Meda
Assistant Administrator. Forensic Science will hold meeting
Pharmaceuticals, Inc., 705 Eldorado
[FR Doc. 2017–04645 Filed 3–8–17; 8:45 am]
Street, Decatur, Illinois 62523 applied to thirteen at the time and location listed
BILLING CODE 4410–09–P be registered as an importer of nabilone below.
(7379), a basic class of controlled DATES: Public Hearing. The meeting will
substance listed in schedule II. be held on April 10, 2017 from 9:00 a.m.
DEPARTMENT OF JUSTICE to 5:00 p.m. and April 11, 2017 from
The company plans to import the
FDA approved drug product in finished 9:00 a.m. to 4:30 p.m.
Drug Enforcement Administration Written Public Comment. Written
dosage form for distribution to its
[Docket No. DEA–392] customers. Approval of permit public comment regarding National
applications will occur only when the Commission on Forensic Science
Importer of Controlled Substances meeting materials can be submitted
registrant’s business activity is
Application: Meda Pharmaceuticals, through www.regulations.gov starting on
consistent with what is authorized
Inc. March 27, 2017. Any comments should
under 21 U.S.C. 952(a)(2).
AGENCY: Drug Enforcement be posted to www.regulations.gov no
Louis J. Milione, later than 11:59 p.m. (EST) April 12,
Administration, Justice.
Assistant Administrator. 2017.
ACTION: Notice of application.
[FR Doc. 2017–04648 Filed 3–8–17; 8:45 am]
ADDRESSES: Office of Justice Programs,
DATES: Registered bulk manufacturers of BILLING CODE 4410–09–P 3rd Floor Main Conference Room, 810
the affected basic class, and applicants 7th Street NW., Washington, DC 20531.
therefore, may file written comments on FOR FURTHER INFORMATION CONTACT:
or objections to the issuance of the DEPARTMENT OF JUSTICE
Jonathan McGrath, Ph.D., Senior Policy
proposed registration in accordance Analyst at the National Institute of
Foreign Claims Settlement
with 21 CFR 1301.34(a) on or before Justice and NCFS Designated Federal
Commission
April 10, 2017. Such persons may also Officer, 810 7th Street NW.,
file a written request for a hearing on Washington, DC 20531, by email at
the application pursuant to 21 CFR [F.C.S.C. Meeting and Hearing Notice No.
3–17] Jonathan.McGrath@usdoj.gov or by
1301.43 on or before April 10, 2017. phone at (202) 514–6277.
ADDRESSES: Written comments should Sunshine Act Meeting SUPPLEMENTARY INFORMATION:
be sent to: Drug Enforcement Agenda: The Commission will receive
Administration, Attention: DEA Federal The Foreign Claims Settlement subcommittee status updates and
Register Representative/DRW, 8701 Commission, pursuant to its regulations briefings. A final agenda will be posted
Morrissette Drive, Springfield, Virginia (45 CFR 503.25) and the Government in to the Commission’s Web site in
22152. All requests for hearing must be the Sunshine Act (5 U.S.C. 552b), advance of the meeting.
sent to: Drug Enforcement hereby gives notice in regard to the Meeting Accessibility: Pursuant to 41
Administration, Attn: Administrator, scheduling of open meetings as follows: CFR 102–3.140 through 102–3.165 and
8701 Morrissette Drive, Springfield, Thursday, March 23, 2017: 10:00 the availability of space, the meeting
Virginia 22152. All request for hearing a.m.—Issuance of Proposed Decisions in scheduled for April 10, 2017, 9:00 a.m.
should also be sent to: (1) Drug claims against Iraq. to 5:00 p.m. and April 11, 2017, 9:00
Enforcement Administration, Attn: Status: Open. a.m. to 4:30 p.m. at the Office of Justice
Hearing Clerk/LJ, 8701 Morrissette All meetings are held at the Foreign Programs is open to the public and
Drive, Springfield, Virginia 22152; and Claims Settlement Commission, 600 E webcast. Seating is limited and pre-
(2) Drug Enforcement Administration, Street NW., Washington, DC. Requests registration is strongly encouraged.
Attn: DEA Federal Register for information, or advance notices of Media representatives are also
Representative/DRW, 8701 Morrissette intention to observe an open meeting, encouraged to register in advance.
Drive, Springfield, Virginia 22152. may be directed to: Patricia M. Hall, Written Comments: Pursuant to
SUPPLEMENTARY INFORMATION: The Foreign Claims Settlement Commission, section 10(a)(3) of the FACA and 41 CFR
Attorney General has delegated his 600 E Street NW., Suite 6002, 102–3.105(j) and 102–3.140, the public
authority under the Controlled Washington, DC 20579. Telephone: or interested organizations may submit
Substances Act to the Administrator of (202) 616–6975. written comments to the Commission in
the Drug Enforcement Administration Brian M. Simkin, response to the stated agenda and
(DEA), 28 CFR 0.100(b). Authority to Chief Counsel. meeting material. Meeting material,
exercise all necessary functions with including work products, will be made
[FR Doc. 2017–04739 Filed 3–7–17; 11:15 am]
respect to the promulgation and available on the Commission’s Web site:
BILLING CODE 4410–BA–P
implementation of 21 CFR part 1301, http://www.justice.gov/ncfs.
incident to the registration of Oral Comments: In addition to written
asabaliauskas on DSK3SPTVN1PROD with NOTICES
manufacturers, distributors, dispensers, DEPARTMENT OF JUSTICE statements, members of the public may
importers, and exporters of controlled present oral comments at 4:45 p.m. on
substances (other than final orders in April 10, 2017 and at 3:15 p.m. on April
connection with suspension, denial, or [Docket No. ODAG 170] 11, 2017. Those individuals interested
revocation of registration) has been Notice of Federal Advisory Committee in making oral comments should
redelegated to the Assistant Meeting indicate their intent through the on-line
Administrator of the DEA Diversion registration form and time will be
Control Division (‘‘Assistant AGENCY: Department of Justice. allocated on a first-come, first-served
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Document Created: 2017-03-09 04:58:35
Document Modified: 2017-03-09 04:58:35
| 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 1301.33(a) on or before May 8, 2017. | |
| FR Citation | 82 FR 13136 |
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