Bulk Manufacturer of Controlled Substances Application: Mallinckrodt, LLC, 13136-13137 [2017-04645]
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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 ......................................................................................................................................................................
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9822
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1205
1724
7379
8333
9050
9120
9143
9150
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9230
9250
9254
9273
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9333
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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:
https://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
