81_FR_15243 81 FR 15188 - Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 Into Schedule I; Correction

81 FR 15188 - Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 Into Schedule I; Correction

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 55 (March 22, 2016)

Page Range15188-15190
FR Document2016-06474

The Drug Enforcement Administration published a document in the Federal Register of May 14, 2015, concerning the proposal to place (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR- 144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3- tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1- adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act (CSA), specifically under cannabimimetic agents. This corrected notice of proposed rulemaking proposes to place such substances into schedule I of the CSA under hallucinogenic substances.

Federal Register, Volume 81 Issue 55 (Tuesday, March 22, 2016)
[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Pages 15188-15190]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06474]


=======================================================================
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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-417C]


Schedules of Controlled Substances: Placement of UR-144, XLR11, 
and AKB48 Into Schedule I; Correction

AGENCY: Drug Enforcement Administration, Department of Justice.

[[Page 15189]]


ACTION: Notice of proposed rulemaking; correction.

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

SUMMARY: The Drug Enforcement Administration published a document in 
the Federal Register of May 14, 2015, concerning the proposal to place 
(1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-
144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1-
adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) 
including their salts, isomers, and salts of isomers whenever the 
existence of such salts, isomers, and salts of isomers is possible, 
into schedule I of the Controlled Substances Act (CSA), specifically 
under cannabimimetic agents. This corrected notice of proposed 
rulemaking proposes to place such substances into schedule I of the CSA 
under hallucinogenic substances.

DATES: Interested persons may file written comments on this correction 
to the initial proposal in accordance with 21 CFR 1308.43(g). The DEA 
is requesting comments on this change only and is not soliciting 
comments on other aspects of the May 14, 2015, notice of proposed 
rulemaking published at 80 FR 27611. Electronic comments must be 
submitted, and written comments must be postmarked, on or before April 
21, 2016. Commenters should be aware that the electronic Federal Docket 
Management System will not accept comments after 11:59 p.m. Eastern 
Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-417C'' on all correspondence, including any 
attachments. The Drug Enforcement Administration encourages that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the Web page or to attach a file for lengthier 
comments. Please go to http://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment. Paper comments that duplicate the electronic submission are 
not necessary and are discouraged. Should you wish to mail a paper 
comment in lieu of an electronic comment, it should be sent via regular 
or express mail to: Drug Enforcement Administration, Attn: DEA Federal 
Register Representative/ODW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

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

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement Administration (DEA) for public 
inspection online at http://www.regulations.gov. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter. The Freedom of 
Information Act (FOIA) applies to all comments received. If you want to 
submit personal identifying information (such as your name, address, 
etc.) as part of your comment, but do not want it to be made publicly 
available, you must include the phrase ``PERSONAL IDENTIFYING 
INFORMATION'' in the first paragraph of your comment. You must also 
place all of the personal identifying information you do not want made 
publicly available in the first paragraph of your comment and identify 
what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

    The DEA implements and enforces Titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. 21 U.S.C. 801-971. Titles II and III are referred to as the 
``Controlled Substances Act'' and the ``Controlled Substances Import 
and Export Act,'' respectively, and are collectively referred to as the 
``Controlled Substances Act'' or the ``CSA'' for the purposes of this 
action. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), chapter II. The CSA and its implementing regulations 
are designed to prevent, detect, and eliminate the diversion of 
controlled substances and listed chemicals into the illicit market 
while providing for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Under the CSA, each controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the substance may cause. 21 U.S.C. 812. The initial 
schedules of controlled substances established by Congress are found at 
21 U.S.C. 812(c) and the current list of scheduled substances is 
published at 21 CFR part 1308. 21 U.S.C. 812(a).
    Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, 
``add to such a schedule or transfer between such schedules any drug or 
other substance if he * * * finds that such drug or other substance has 
a potential for abuse, and * * * makes with respect to such drug or 
other substance the findings prescribed by subsection (b) of section 
812 of this title for the schedule in which such drug is to be placed * 
* *.'' The Attorney General has delegated scheduling authority under 21 
U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
    The CSA provides that proceedings for the issuance, amendment, or 
repeal of the scheduling of any drug or other substance may be 
initiated by the Attorney General (1) on her own motion; (2) at the 
request of the Secretary of the Department of Health

[[Page 15190]]

and Human Services (HHS),\1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This proposed action (80 FR 27611, May 14, 
2015) is supported by a recommendation from the Assistant Secretary of 
the HHS and an evaluation of all other relevant data by the DEA. If 
finalized, this action would impose the regulatory controls and 
administrative, civil, and criminal sanctions of schedule I controlled 
substances on any person who handles, or proposes to handle, UR-144, 
XLR11, or AKB48.
---------------------------------------------------------------------------

    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
---------------------------------------------------------------------------

Background

    UR-144, XLR11, and AKB48 are currently subject to schedule I 
controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 80 FR 
27854, May 15, 2015. On May 14, 2015, the Administrator of the DEA 
published a notice of proposed rulemaking (NPRM) to permanently 
schedule (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, 
XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide 
(APINACA, AKB48) into schedule I pursuant to the CSA. 80 FR 27611.
    In the NPRM, the DEA inadvertently proposed the addition of these 
substances in schedule I under 21 CFR 1308.11(g), cannabimimetic 
agents, by adding paragraphs (g)(16) through (18). These substances 
should have been proposed to be added in schedule I under 21 CFR 
1308.11(d), hallucinogenic substances. This rulemaking therefore 
corrects the NPRM by proposing the placement of these substances in 21 
CFR 1308.11(d) by adding paragraphs (d)(48) through (50). Because the 
DEA is proposing to classify these substances as schedule I 
hallucinogenic substances, then by operation of 21 U.S.C. 802(14), this 
classification will include any optical, positional, or geometric 
isomers. Interested persons may file written comments on this change in 
accordance with 21 CFR 1308.43(g). The DEA is requesting comments on 
this change only and is not soliciting comments on other aspects of the 
May 14, 2015, NPRM. The DEA previously had provided an opportunity for 
comments on other aspects of the NPRM on May 14, 2015, through June 15, 
2015.

Regulatory Analyses

    This correction has no effect on the regulatory analyses statements 
that were published with the notice of proposed rulemaking published in 
the Federal Register on May 14, 2015, at 80 FR 27611.

Correction

    In proposed rule FR Doc. 2015-11762, beginning on page 27611 in the 
issue of May 14, 2015, make the following corrections.

0
1. On page 27616 in the 3rd column, correct amendatory instruction 2.a. 
to read as follows: ``Adding paragraphs (d)(65) through (67); and''.
0
2. On page 27616 in the 3rd column, correct Sec.  1308.11 Schedule I 
regulatory text to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

(65) (1-pentyl-1H-indol-3-yl)(2,2,3,3-                            (7144)
 tetramethylcyclopropyl)methanone (UR-144)..............
(66) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                 (7011)
 tetramethylcyclopropyl) methanone (5-fluoro-UR-144,
 XLR11).................................................
(67) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide           (7048)
 (APINACA, AKB48).......................................
 

* * * * *

    Dated: March 16, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-06474 Filed 3-21-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                      15188                   Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules

                                                           Latex Medical Gloves (Surgeons’ and                21 CFR Part 895                                       PART 895—BANNED DEVICES
                                                           Examination) Powdered Latex Medical
                                                           Gloves (Surgeons’ and Examination),’’                Administrative practice and                         ■ 6. The authority citation for 21 CFR
                                                           1998, MDA: London.                                 procedure, Labeling, Medical devices.                 part 895 continues to read as follows:
                                                      66. Latza, U., F. Haamann, and X. Baur,
                                                           ‘‘Effectiveness of a Nationwide                      Therefore, under the Federal Food,                    Authority: 21 U.S.C. 352, 360f, 360h, 360i,
                                                           Interdisciplinary Preventive Programme             Drug, and Cosmetic Act and under                      371.
                                                           for Latex Allergy,’’ International                 authority delegated to the Commissioner               ■ 7. Add § 895.102 to subpart B to read
                                                           Archives of Occupational and                       of Food and Drugs, it is proposed that                as follows:
                                                           Environmental Health, 78(5):394–402,               21 CFR parts 878, 880, and 895 be
                                                           2005, available at: http://                        amended as follows:                                   § 895.102   Powdered surgeon’s glove.
                                                           link.springer.com/article/                                                                                 A powdered surgeon’s glove is a
                                                           10.1007%2Fs00420-004-0594-2.                       PART 878—GENERAL AND PLASTIC                          device made of natural rubber latex or
                                                      67. U.S. Department of Labor, OSHA,                     SURGERY DEVICES
                                                           Potential for Sensitization and Possible                                                                 synthetic latex, intended to be worn by
                                                           Allergic Reaction To Natural Rubber                                                                      operating room personnel to protect a
                                                                                                              ■ 1. The authority citation for 21 CFR                surgical wound from contamination. A
                                                           Latex Gloves and Other Natural Rubber
                                                           Products, 2008. Available at: https://             part 878 continues to read as follows:                powdered surgeon’s glove incorporates
                                                           www.osha.gov/dts/shib/                               Authority: 21 U.S.C. 351, 360, 360c, 360e,          powder for purposes other than
                                                           shib012808.html.                                   360j, 360l, 371.                                      manufacturing.
                                                      68. Bolyard, E.A., O.C. Tablan, W.W.                                                                          ■ 8. Add § 895.103 to subpart B to read
                                                           Williams, et al., ‘‘Guideline for Infection        ■ 2. Amend § 878.4460 by revising the
                                                                                                                                                                    as follows:
                                                           Control in Healthcare Personnel, 1998.             heading and paragraph (a) to read as
                                                           Hospital Infection Control Practices               follows:                                              § 895.103   Powdered patient examination
                                                           Advisory Committee,’’ Infection Control                                                                  glove.
                                                           and Hospital Epidemiology, 19(6):407–              § 878.4460    Non-powdered surgeon’s
                                                                                                              glove.                                                  A powdered patient examination
                                                           463, 1998.
                                                      69. Blumenstock, J.S., E. Bresnitz, and K.                                                                    glove is a disposable device made of
                                                                                                                (a) Identification. A non-powdered                  natural rubber latex or synthetic latex,
                                                           O’Leary, Guidelines Management of
                                                                                                              surgeon’s glove is a device made of                   intended for medical purposes, that is
                                                           Natural Rubber Latex Allergy; Selecting
                                                           the Right Glove for the Right Task in              natural rubber latex or synthetic latex,              worn on the examiner’s hand or finger
                                                           Healthcare Facilities, New Jersey                  intended to be worn by operating room                 to prevent contamination between
                                                           Department of Health and Senior                    personnel to protect a surgical wound                 patient and examiner. A powdered
                                                           Services, ed. B. Gerwel, 2000.                     from contamination. A non-powdered                    patient examination glove incorporates
                                                      70. United Kingdom National Health Service,             surgeon’s glove does not incorporate                  powder for purposes other than
                                                           N.P., Royal College of Physicians,                 powder for purposes other than                        manufacturing.
                                                           Faculty of Occupational Medicine,                  manufacturing. The final finished glove               ■ 9. Add § 895.104 to subpart B to read
                                                           ‘‘Latex Allergy: Occupational Aspects of           includes only residual powder from
                                                           Management. A National Guideline,’’                                                                      as follows:
                                                                                                              manufacturing.
                                                           2008, London: RCP.
                                                                                                              *     *     *     *     *                             § 895.104 Absorbable powder for
                                                      71. Olmsted, R., ‘‘APIC response to FDA
                                                                                                                                                                    lubricating a surgeon’s glove.
                                                           Docket # FDA–2011–N–0027,’’ available
                                                           at www.regulations.gov, 2011.                      § 878.4480    [Removed]                                 Absorbable powder for lubricating a
                                                      72. ‘‘Finding of No Significant Impact                  ■   3. Remove § 878.4480.                             surgeon’s glove is a powder made from
                                                           (FONSI) and Environmental Analysis for                                                                   cornstarch that meets the specifications
                                                           Banned Devices; Proposal to Ban                    PART 880—GENERAL HOSPITAL AND                         for absorbable powder in the United
                                                           Powdered Surgeon’s Gloves, Powdered                PERSONAL USE DEVICES                                  States Pharmacopeia (U.S.P.) and that is
                                                           Patient Examination Gloves, and                                                                          intended to be used to lubricate the
                                                           Absorbable Powder for Lubricating a                ■ 4. The authority citation for 21 CFR                surgeon’s hand before putting on a
                                                           Surgeon’s Glove.’’                                 part 880 continues to read as follows:
                                                      73. Korniewicz, D.M., N. Chookaew, M. El-                                                                     surgeon’s glove. The device is
                                                           Masri, et al., ‘‘Conversion to Low-                  Authority: 21 U.S.C. 351, 360, 360c, 360e,          absorbable through biological
                                                           Protein, Powder-Free Surgical Gloves: Is           360j, 371.                                            degradation.
                                                           It Worth the Cost?’’ American                                                                              Dated: March 16, 2016.
                                                           Association of Occupational Health                 ■ 5. Amend § 880.6250 by revising the
                                                                                                              heading and paragraph (a) to read as                  Leslie Kux,
                                                           Nurses Journal, 53(9):388–393, 2005.
                                                      74. Ranta, P.M. and D.R. Ownby, ‘‘A Review              follows:                                              Associate Commissioner for Policy.
                                                           of Natural-Rubber Latex Allergy in                                                                       [FR Doc. 2016–06360 Filed 3–21–16; 8:45 am]
                                                           Health Care Workers,’’ Clinical                    § 880.6250 Non-powdered patient
                                                                                                                                                                    BILLING CODE 4164–01–P
                                                           Infectious Diseases, 38(2):252–256, 2004.          examination glove.
                                                      75. ‘‘Preliminary Regulatory Impact Analysis,             (a) Identification. A non-powdered
                                                           Initial Regulatory Flexibility Analysis,           patient examination glove is a
                                                           and Unfunded Mandates Reform Act                                                                         DEPARTMENT OF JUSTICE
                                                                                                              disposable device made of either natural
                                                           Analysis for Banned Devices; Proposal to
                                                                                                              rubber latex or synthetic latex, intended             Drug Enforcement Administration
                                                           Ban Powdered Surgeon’s Gloves,
                                                                                                              for medical purposes, that is worn on
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                           Powdered Patient Examination Gloves,
                                                           and Absorbable Powder for Lubricating a            the examiner’s hand or finger to prevent              21 CFR Part 1308
                                                           Surgeon’s Glove,’’ available at http://            contamination between patient and
                                                           www.fda.gov/AboutFDA/                              examiner. A non-powdered patient                      [Docket No. DEA–417C]
                                                           ReportsManualsForms/Reports/                       examination glove does not incorporate
                                                           EconomicAnalyses/default.htm.                      powder for purposes other than                        Schedules of Controlled Substances:
                                                                                                              manufacturing. The final finished glove               Placement of UR–144, XLR11, and
                                                      List of Subjects                                                                                              AKB48 Into Schedule I; Correction
                                                                                                              includes only residual powder from
                                                      21 CFR Parts 878 and 880                                manufacturing.                                        AGENCY:Drug Enforcement
                                                        Medical devices.                                      *     *     *     *     *                             Administration, Department of Justice.


                                                 VerDate Sep<11>2014   17:38 Mar 21, 2016   Jkt 238001   PO 00000   Frm 00018   Fmt 4702   Sfmt 4702   E:\FR\FM\22MRP1.SGM   22MRP1


                                                                              Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules                                            15189

                                                      ACTION: Notice of proposed rulemaking;                  submission are not necessary and are                  included in the text of your electronic
                                                      correction.                                             discouraged. Should you wish to mail a                submission that is not identified as
                                                                                                              paper comment in lieu of an electronic                directed above as confidential.
                                                      SUMMARY:    The Drug Enforcement                        comment, it should be sent via regular                   An electronic copy of this document
                                                      Administration published a document                     or express mail to: Drug Enforcement                  is available at http://
                                                      in the Federal Register of May 14, 2015,                Administration, Attn: DEA Federal                     www.regulations.gov for easy reference.
                                                      concerning the proposal to place (1-                    Register Representative/ODW, 8701
                                                      pentyl-1H-indol-3-yl)(2,2,3,3-                                                                                Legal Authority
                                                                                                              Morrissette Drive, Springfield, Virginia
                                                      tetramethylcyclopropyl)methanone (UR-                   22152.                                                   The DEA implements and enforces
                                                      144), [1-(5-fluoro-pentyl)-1H-indol-3-                                                                        Titles II and III of the Comprehensive
                                                                                                              FOR FURTHER INFORMATION CONTACT:                      Drug Abuse Prevention and Control Act
                                                      yl](2,2,3,3-
                                                      tetramethylcyclopropyl)methanone (5-                    Barbara J. Boockholdt, Office of                      of 1970, as amended. 21 U.S.C. 801–971.
                                                      fluoro-UR-144, XLR11), and N-(1-                        Diversion Control, Drug Enforcement                   Titles II and III are referred to as the
                                                      adamantyl)-1-pentyl-1H-indazole-3-                      Administration; Mailing Address: 8701                 ‘‘Controlled Substances Act’’ and the
                                                      carboxamide (APINACA, AKB48)                            Morrissette Drive, Springfield, Virginia              ‘‘Controlled Substances Import and
                                                      including their salts, isomers, and salts               22152; Telephone: (202) 598–6812.                     Export Act,’’ respectively, and are
                                                      of isomers whenever the existence of                    SUPPLEMENTARY INFORMATION:                            collectively referred to as the
                                                      such salts, isomers, and salts of isomers               Posting of Public Comments                            ‘‘Controlled Substances Act’’ or the
                                                      is possible, into schedule I of the                                                                           ‘‘CSA’’ for the purposes of this action.
                                                      Controlled Substances Act (CSA),                           Please note that all comments                      21 U.S.C. 801–971. The DEA publishes
                                                      specifically under cannabimimetic                       received are considered part of the                   the implementing regulations for these
                                                      agents. This corrected notice of                        public record. They will, unless                      statutes in title 21 of the Code of Federal
                                                      proposed rulemaking proposes to place                   reasonable cause is given, be made                    Regulations (CFR), chapter II. The CSA
                                                      such substances into schedule I of the                  available by the Drug Enforcement                     and its implementing regulations are
                                                      CSA under hallucinogenic substances.                    Administration (DEA) for public                       designed to prevent, detect, and
                                                                                                              inspection online at http://                          eliminate the diversion of controlled
                                                      DATES: Interested persons may file                      www.regulations.gov. Such information                 substances and listed chemicals into the
                                                      written comments on this correction to                  includes personal identifying                         illicit market while providing for the
                                                      the initial proposal in accordance with                 information (such as your name,                       legitimate medical, scientific, research,
                                                      21 CFR 1308.43(g). The DEA is                           address, etc.) voluntarily submitted by               and industrial needs of the United
                                                      requesting comments on this change                      the commenter. The Freedom of                         States. Controlled substances have the
                                                      only and is not soliciting comments on                  Information Act (FOIA) applies to all                 potential for abuse and dependence and
                                                      other aspects of the May 14, 2015,                      comments received. If you want to                     are controlled to protect the public
                                                      notice of proposed rulemaking                           submit personal identifying information               health and safety.
                                                      published at 80 FR 27611. Electronic                    (such as your name, address, etc.) as                    Under the CSA, each controlled
                                                      comments must be submitted, and                         part of your comment, but do not want                 substance is classified into one of five
                                                      written comments must be postmarked,                    it to be made publicly available, you                 schedules based upon its potential for
                                                      on or before April 21, 2016.                            must include the phrase ‘‘PERSONAL                    abuse, its currently accepted medical
                                                      Commenters should be aware that the                     IDENTIFYING INFORMATION’’ in the                      use in treatment in the United States,
                                                      electronic Federal Docket Management                    first paragraph of your comment. You                  and the degree of dependence the
                                                      System will not accept comments after                   must also place all of the personal                   substance may cause. 21 U.S.C. 812. The
                                                      11:59 p.m. Eastern Time on the last day                 identifying information you do not want               initial schedules of controlled
                                                      of the comment period.                                  made publicly available in the first                  substances established by Congress are
                                                      ADDRESSES: To ensure proper handling                    paragraph of your comment and identify                found at 21 U.S.C. 812(c) and the
                                                      of comments, please reference ‘‘Docket                  what information you want redacted.                   current list of scheduled substances is
                                                      No. DEA–417C’’ on all correspondence,                      If you want to submit confidential                 published at 21 CFR part 1308. 21
                                                      including any attachments. The Drug                     business information as part of your                  U.S.C. 812(a).
                                                      Enforcement Administration encourages                   comment, but do not want it to be made                   Pursuant to 21 U.S.C. 811(a)(1), the
                                                      that all comments be submitted                          publicly available, you must include the              Attorney General may, by rule, ‘‘add to
                                                      electronically through the Federal                      phrase ‘‘CONFIDENTIAL BUSINESS                        such a schedule or transfer between
                                                      eRulemaking Portal, which provides the                  INFORMATION’’ in the first paragraph                  such schedules any drug or other
                                                      ability to type short comments directly                 of your comment. You must also                        substance if he * * * finds that such
                                                      into the comment field on the Web page                  prominently identify confidential                     drug or other substance has a potential
                                                      or to attach a file for lengthier                       business information to be redacted                   for abuse, and * * * makes with respect
                                                      comments. Please go to http://                          within the comment.                                   to such drug or other substance the
                                                      www.regulations.gov and follow the                         Comments containing personal                       findings prescribed by subsection (b) of
                                                      online instructions at that site for                    identifying information and confidential              section 812 of this title for the schedule
                                                      submitting comments. Upon completion                    business information identified as                    in which such drug is to be placed
                                                      of your submission you will receive a                   directed above will generally be made                 * * *.’’ The Attorney General has
                                                      Comment Tracking Number for your                        publicly available in redacted form. If a             delegated scheduling authority under 21
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                      comment. Please be aware that                           comment has so much confidential                      U.S.C. 811 to the Administrator of the
                                                      submitted comments are not                              business information or personal                      DEA. 28 CFR 0.100.
                                                      instantaneously available for public                    identifying information that it cannot be                The CSA provides that proceedings
                                                      view on Regulations.gov. If you have                    effectively redacted, all or part of that             for the issuance, amendment, or repeal
                                                      received a Comment Tracking Number,                     comment may not be made publicly                      of the scheduling of any drug or other
                                                      your comment has been successfully                      available. Comments posted to http://                 substance may be initiated by the
                                                      submitted and there is no need to                       www.regulations.gov may include any                   Attorney General (1) on her own
                                                      resubmit the same comment. Paper                        personal identifying information (such                motion; (2) at the request of the
                                                      comments that duplicate the electronic                  as name, address, and phone number)                   Secretary of the Department of Health


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                                                      15190                     Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules

                                                      and Human Services (HHS),1 or (3) on                     adamantyl)-1-pentyl-1H-indazole-3-                        NPRM. The DEA previously had
                                                      the petition of any interested party. 21                 carboxamide (APINACA, AKB48) into                         provided an opportunity for comments
                                                      U.S.C. 811(a). This proposed action (80                  schedule I pursuant to the CSA. 80 FR                     on other aspects of the NPRM on May
                                                      FR 27611, May 14, 2015) is supported                     27611.                                                    14, 2015, through June 15, 2015.
                                                      by a recommendation from the Assistant                     In the NPRM, the DEA inadvertently
                                                                                                               proposed the addition of these                            Regulatory Analyses
                                                      Secretary of the HHS and an evaluation
                                                      of all other relevant data by the DEA. If                substances in schedule I under 21 CFR                       This correction has no effect on the
                                                      finalized, this action would impose the                  1308.11(g), cannabimimetic agents, by                     regulatory analyses statements that were
                                                      regulatory controls and administrative,                  adding paragraphs (g)(16) through (18).                   published with the notice of proposed
                                                      civil, and criminal sanctions of schedule                These substances should have been                         rulemaking published in the Federal
                                                      I controlled substances on any person                    proposed to be added in schedule I                        Register on May 14, 2015, at 80 FR
                                                      who handles, or proposes to handle,                      under 21 CFR 1308.11(d),                                  27611.
                                                      UR-144, XLR11, or AKB48.                                 hallucinogenic substances. This
                                                                                                               rulemaking therefore corrects the NPRM                    Correction
                                                      Background                                               by proposing the placement of these                         In proposed rule FR Doc. 2015–11762,
                                                         UR-144, XLR11, and AKB48 are                          substances in 21 CFR 1308.11(d) by                        beginning on page 27611 in the issue of
                                                      currently subject to schedule I controls                 adding paragraphs (d)(48) through (50).                   May 14, 2015, make the following
                                                      on a temporary basis, pursuant to 21                     Because the DEA is proposing to classify                  corrections.
                                                      U.S.C. 811(h). 80 FR 27854, May 15,                      these substances as schedule I                            ■ 1. On page 27616 in the 3rd column,
                                                      2015. On May 14, 2015, the                               hallucinogenic substances, then by                        correct amendatory instruction 2.a. to
                                                      Administrator of the DEA published a                     operation of 21 U.S.C. 802(14), this                      read as follows: ‘‘Adding paragraphs
                                                      notice of proposed rulemaking (NPRM)                     classification will include any optical,                  (d)(65) through (67); and’’.
                                                      to permanently schedule (1-pentyl-1H-                    positional, or geometric isomers.                         ■ 2. On page 27616 in the 3rd column,
                                                      indol-3-yl)(2,2,3,3-                                     Interested persons may file written                       correct § 1308.11 Schedule I regulatory
                                                      tetramethylcyclopropyl)methanone (UR-                    comments on this change in accordance                     text to read as follows:
                                                      144), [1-(5-fluoro-pentyl)-1H-indol-3-                   with 21 CFR 1308.43(g). The DEA is
                                                      yl](2,2,3,3-                                             requesting comments on this change                        § 1308.11     Schedule I.
                                                      tetramethylcyclopropyl)methanone (5-                     only and is not soliciting comments on                    *       *    *        *       *
                                                      fluoro-UR-144, XLR11), and N-(1-                         other aspects of the May 14, 2015,                            (d) * * *

                                                      (65) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144) ......................................................................         (7144)
                                                      (66) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl) methanone (5-fluoro-UR-144, XLR11) ........................                           (7011)
                                                      (67) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) ..........................................................................            (7048)


                                                      *      *      *       *      *              restoration, or coastal wetlands                                       your comments and include your name
                                                        Dated: March 16, 2016.                    restoration projects by Federal, State, or                             and return address.
                                                                                                  local government agencies, or use in                                      • Federal eRulemaking Portal: http://
                                                      Chuck Rosenberg,
                                                                                                  construction projects authorized by or                                 www.regulations.gov. Under the tab
                                                      Acting Administrator.                                                                                              ‘‘More Search Options,’’ click
                                                                                                  funded in whole or in part by the
                                                      [FR Doc. 2016–06474 Filed 3–21–16; 8:45 am]                                                                        ‘‘Advanced Docket Search,’’ then select
                                                                                                  Federal Government. The proposed rule
                                                      BILLING CODE 4410–09–P                      describes the negotiated noncompetitive                                ‘‘Bureau of Ocean Energy Management’’
                                                                                                  agreement process for qualifying                                       from the agency drop-down menu, then
                                                                                                  projects and codifies new and existing                                 click the submit button. In the Docket ID
                                                      DEPARTMENT OF THE INTERIOR                  procedures.                                                            column, select BOEM–2010–0041 to
                                                                                                                                                                         submit public comments and to view
                                                      Bureau of Ocean Energy Management           DATES: Submit comments by May 23,
                                                                                                                                                                         supporting and related materials
                                                                                                  2016. The Bureau of Ocean Energy
                                                                                                                                                                         available for this rulemaking.
                                                      30 CFR Part 583                             Management (BOEM) may not fully
                                                                                                                                                                         Information on using Regulations.gov,
                                                                                                  consider comments received after this
                                                      RIN 1010–AD90                                                                                                      including instructions for accessing
                                                                                                  date. Submit comments to the Office of
                                                                                                                                                                         documents, submitting comments, and
                                                      [Docket ID: BOEM–2010–0041]                 Management and Budget (OMB) on the
                                                                                                                                                                         viewing the docket after the close of the
                                                                                                  information collection (IC) burden in
                                                                                                                                                                         comment period, is available through
                                                      Negotiated Noncompetitive Leasing for this proposed rule by April 21, 2016.
                                                                                                                                                                         the site’s ‘‘User Tips’’ link. BOEM will
                                                      the Use of Sand, Gravel, and Shell          This does not affect the deadline for the
                                                                                                                                                                         post comments on www.regulations.gov.
                                                      Resources on the Outer Continental          public to comment to BOEM on the                                          • Mail or hand-carry comments to the
                                                      Shelf                                       proposed regulation.                                                   U.S. Department of the Interior; Bureau
                                                      AGENCY: Bureau of Ocean Energy              ADDRESSES  : You may submit comments                                   of Ocean Energy Management; Attn:
                                                      Management, Interior.                       on the rulemaking by any of the                                        Office of Policy, Regulation and
                                                      ACTION: Proposed rule.                      following methods. Please use the                                      Analysis, 45600 Woodland Road, VAM–
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS




                                                                                                  Regulation Identifier Number (RIN)                                     BOEM DIR, Sterling, Virginia 20166.
                                                      SUMMARY: This rule proposes regulations 1010–AD90 as an identifier in your                                            • Send comments on the IC in this
                                                      to address the use of Outer Continental     comment. Please reference ‘‘Outer                                      proposed rule to: Interior Desk Officer
                                                      Shelf (OCS) sand, gravel and shell          Continental Shelf Marine Sand, Gravel                                  1010–AD90, Office of Management and
                                                      resources for shore protection, beach       and Shell Resources, 1010–AD90’’ in                                    Budget; 202–395–5806 (fax); email:
                                                        1 As discussed in a memorandum of                      within the HHS in carrying out the Secretary’s            Assistant Secretary for Health of the HHS the
                                                      understanding entered into by the Food and Drug          scheduling responsibilities under the CSA, with the       authority to make domestic drug scheduling
                                                      Administration (FDA) and the National Institute on       concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.            recommendations. 58 FR 35460, July 1, 1993.
                                                      Drug Abuse (NIDA), the FDA acts as the lead agency       The Secretary of the HHS has delegated to the



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Document Created: 2018-02-02 15:15:50
Document Modified: 2018-02-02 15:15:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking; correction.
DatesInterested persons may file written comments on this correction to the initial proposal in accordance with 21 CFR 1308.43(g). The DEA is requesting comments on this change only and is not soliciting comments on other aspects of the May 14, 2015, notice of proposed rulemaking published at 80 FR 27611. Electronic comments must be submitted, and written comments must be postmarked, on or before April 21, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
ContactBarbara J. Boockholdt, Office of
FR Citation81 FR 15188 

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