80_FR_78899 80 FR 78657 - Schedules of Controlled Substances: Placement of Eluxadoline Into Schedule IV; Correction

80 FR 78657 - Schedules of Controlled Substances: Placement of Eluxadoline Into Schedule IV; Correction

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 242 (December 17, 2015)

Page Range78657-78657
FR Document2015-31843

The Drug Enforcement Administration (DEA) is correcting a final rule that appeared in the Federal Register of November 12, 2015 (80 FR 69861). The document issued an action placing the substance 5- [[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1- oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2- methoxybenzoic acid (eluxadoline), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act. This document inadvertently included a paragraph in the regulatory text that was not intended for publication, and was unable to be removed before being placed on public inspection. This document corrects the final rule by removing this paragraph.

Federal Register, Volume 80 Issue 242 (Thursday, December 17, 2015)
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Rules and Regulations]
[Page 78657]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31843]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-419F]


Schedules of Controlled Substances: Placement of Eluxadoline Into 
Schedule IV; Correction

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule; correction.

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SUMMARY: The Drug Enforcement Administration (DEA) is correcting a 
final rule that appeared in the Federal Register of November 12, 2015 
(80 FR 69861). The document issued an action placing the substance 5-
[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-
oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-
methoxybenzoic acid (eluxadoline), including its salts, isomers, and 
salts of isomers, into schedule IV of the Controlled Substances Act. 
This document inadvertently included a paragraph in the regulatory text 
that was not intended for publication, and was unable to be removed 
before being placed on public inspection. This document corrects the 
final rule by removing this paragraph.

DATES: Effective December 17, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 
598-6812.

SUPPLEMENTARY INFORMATION: In FR Doc. 2015-28718 appearing on page 
69864 in the Federal Register of Thursday, November 12, 2015, the 
following correction is made:

Administrative Procedure Act [Corrected]

    1. On page 69864, in the preamble, at the bottom of the first and 
top of the second columns, the section titled Administrative Procedure 
Act is removed entirely.

    Dated: December 11, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-31843 Filed 12-16-15; 8:45 am]
BILLING CODE 4410-09-P



                                                            Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Rules and Regulations                                      78657

                                           § 1251.2   Wood.                                         document corrects the final rule by                   Office of Surface Mining Reclamation
                                              (a) Unfinished and untreated wood                     removing this paragraph.                              and Enforcement, 501 Belle Street, Suite
                                           does not exceed the limits for the heavy                 DATES: Effective December 17, 2015.                   216, Alton, IL 62002, Telephone: (618)
                                           elements established in the toy standard                 FOR FURTHER INFORMATION CONTACT: John                 463–6460, Email: lmeier@osmre.gov.
                                           with a high degree of assurance as that                  R. Scherbenske, Office of Diversion                   SUPPLEMENTARY INFORMATION:
                                           term is defined in 16 CFR part 1107,                     Control, Drug Enforcement                             I. Background on the Missouri Program
                                           provided that the material has been                      Administration; Mailing Address: 8701                 II. Submission of the Amendment
                                           neither treated nor adulterated with                     Morrissette Drive, Springfield, Virginia              III. OSMRE’s Findings
                                           materials that could result in the                       22152, Telephone: (202) 598–6812.                     IV. Summary and Disposition of Comments
                                           addition of any of the heavy elements                                                                          V. OSMRE’s Decision
                                                                                                    SUPPLEMENTARY INFORMATION: In FR Doc.
                                           listed in the toy standard at levels above                                                                     VI. Procedural Determinations
                                                                                                    2015–28718 appearing on page 69864 in
                                           their respective solubility limits.                      the Federal Register of Thursday,                     I. Background on the Missouri Program
                                              (b) For purposes of this section,                     November 12, 2015, the following                         Section 503(a) of the Act permits a
                                           unfinished and untreated wood means                      correction is made:                                   State to assume primacy for the
                                           wood harvested from the trunks of trees
                                                                                                    Administrative Procedure Act                          regulation of surface coal mining and
                                           with no added surface coatings (such as,                                                                       reclamation operations on non-Federal
                                           varnish, paint, shellac, or polyurethane)                [Corrected]
                                                                                                                                                          and non-Indian lands within its borders
                                           and no materials added to the wood                         1. On page 69864, in the preamble, at               by demonstrating that its State program
                                           substrate (such as, stains, dyes,                        the bottom of the first and top of the                includes, among other things, ‘‘a State
                                           preservatives, antifungals, or                           second columns, the section titled                    law which provides for the regulation of
                                           insecticides). Unfinished and untreated                  Administrative Procedure Act is                       surface coal mining and reclamation
                                           wood does not include manufactured or                    removed entirely.                                     operations in accordance with the
                                           engineered woods (such as pressed                          Dated: December 11, 2015.                           requirements of this Act . . .; and rules
                                           wood, plywood, particle board, or                        Chuck Rosenberg,                                      and regulations consistent with
                                           fiberboard).                                                                                                   regulations issued by the Secretary
                                                                                                    Acting Administrator.
                                             Dated: December 9, 2015.                               [FR Doc. 2015–31843 Filed 12–16–15; 8:45 am]          pursuant to this Act.’’ See 30 U.S.C.
                                           Todd A. Stevenson,                                       BILLING CODE 4410–09–P
                                                                                                                                                          1253(a)(1) and (7). On the basis of these
                                           Secretary, Consumer Product Safety                                                                             criteria, the Secretary of the Interior
                                           Commission.                                                                                                    conditionally approved the Missouri
                                           [FR Doc. 2015–31723 Filed 12–16–15; 8:45 am]             DEPARTMENT OF THE INTERIOR                            program on November 21, 1980. You
                                           BILLING CODE 6355–01–P                                                                                         can find background information on the
                                                                                                    Office of Surface Mining Reclamation                  Missouri program, including the
                                                                                                    and Enforcement                                       Secretary’s findings, the disposition of
                                                                                                                                                          comments, and conditions of approval,
                                           DEPARTMENT OF JUSTICE                                    30 CFR Part 925                                       in the November 21, 1980, Federal
                                                                                                                                                          Register (45 FR 77017). You can find
                                           Drug Enforcement Administration                          [SATS No. MO–041–FOR; Docket ID: OSM–                 later actions concerning the Missouri
                                                                                                    2013–0008; S1D1S SS08011000 SX064A000
                                                                                                    167S180110; S2D2S SS08011000
                                                                                                                                                          program and program amendments at 30
                                           21 CFR Part 1308                                                                                               CFR 925.10, 925.12, 925.15, and 925.16.
                                                                                                    SX064A000 16XS501520]
                                           [Docket No. DEA–419F]                                                                                          II. Submission of the Amendment
                                                                                                    Missouri Regulatory Program
                                                                                                                                                             By letter dated August 12, 2013
                                           Schedules of Controlled Substances:                      AGENCY:  Office of Surface Mining                     (Administrative Record No. MO–678),
                                           Placement of Eluxadoline Into                            Reclamation and Enforcement, Interior.                Missouri sent us an amendment to its
                                           Schedule IV; Correction
                                                                                                    ACTION: Final rule; approval of                       Program under SMCRA (30 U.S.C. 1201
                                           AGENCY:  Drug Enforcement                                amendment.                                            et seq.). Missouri sent the amendment in
                                           Administration, Department of Justice.                                                                         response to a January 31, 2008, letter
                                                                                                    SUMMARY:    We, the Office of Surface                 (Administrative Record No. MO–669)
                                           ACTION: Final rule; correction.                          Mining Reclamation and Enforcement                    we sent to Missouri in accordance with
                                           SUMMARY:    The Drug Enforcement                         (OSMRE), are approving an amendment                   30 CFR 732.17(c) concerning changes to
                                           Administration (DEA) is correcting a                     to the Missouri regulatory program                    valid existing rights requirements.
                                           final rule that appeared in the Federal                  (Missouri program) under the Surface                  Missouri also made changes to eliminate
                                           Register of November 12, 2015 (80 FR                     Mining Control and Reclamation Act of                 required program amendments recorded
                                           69861). The document issued an action                    1977 (SMCRA or the Act). Missouri                     at 30 CFR 925.16(p)(4), (p)(20) and (v);
                                           placing the substance 5-[[[(2S)-2-amino-                 proposed revisions to its regulations                 and program disapprovals at 30 CFR
                                           3-[4-aminocarbonyl)-2,6-                                 concerning several topics regarding:                  925.12(d). Missouri revised other
                                           dimethylphenyl]-1-oxopropyl][(1S)-1-(4-                  Valid Existing Rights; Protection of                  sections of its regulations at its own
                                           phenyl-1H-imidazol-2-                                    Hydrologic Balance; Post-mining Land                  initiative. Missouri proposed revisions
                                           yl)ethyl]amino]methyl]-2-                                Use; Permit Applications; and Air                     to title 10 of its Code of State
                                           methoxybenzoic acid (eluxadoline),                       Resource Protection. Missouri intends to              Regulations (CSR) under Division 40
                                           including its salts, isomers, and salts of               revise its program to be no less effective            Land Reclamation Commission. The
                                           isomers, into schedule IV of the                         than the Federal regulations, to clarify              specific sections of 10 CSR 40 in
Lhorne on DSK5TPTVN1PROD with RULES




                                           Controlled Substances Act. This                          ambiguities, and to improve operational               Missouri’s amendment are discussed in
                                           document inadvertently included a                        efficiency.                                           Part III OSMRE’s Findings. Missouri
                                           paragraph in the regulatory text that was                DATES: Effective Date: December 17,                   intends to revise its program to be no
                                           not intended for publication, and was                    2015.                                                 less effective than the Federal
                                           unable to be removed before being                        FOR FURTHER INFORMATION CONTACT: Len                  regulations, to clarify ambiguities, and
                                           placed on public inspection. This                        Meier, Director Alton Field Division,                 improve operational efficiency.


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Document Created: 2018-03-02 09:18:57
Document Modified: 2018-03-02 09:18:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; correction.
DatesEffective December 17, 2015.
ContactJohn R. Scherbenske, Office of
FR Citation80 FR 78657 

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