Schedules of Controlled Substances: Placement of UR-144, XLR11, and AKB48 Into Schedule I; Correction, 15188-15190 [2016-06474]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 15188 Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules Latex Medical Gloves (Surgeons’ and Examination) Powdered Latex Medical Gloves (Surgeons’ and Examination),’’ 1998, MDA: London. 66. Latza, U., F. Haamann, and X. Baur, ‘‘Effectiveness of a Nationwide Interdisciplinary Preventive Programme for Latex Allergy,’’ International Archives of Occupational and Environmental Health, 78(5):394–402, 2005, available at: http:// link.springer.com/article/ 10.1007%2Fs00420-004-0594-2. 67. U.S. Department of Labor, OSHA, Potential for Sensitization and Possible Allergic Reaction To Natural Rubber Latex Gloves and Other Natural Rubber Products, 2008. Available at: https:// www.osha.gov/dts/shib/ shib012808.html. 68. Bolyard, E.A., O.C. Tablan, W.W. Williams, et al., ‘‘Guideline for Infection Control in Healthcare Personnel, 1998. Hospital Infection Control Practices Advisory Committee,’’ Infection Control and Hospital Epidemiology, 19(6):407– 463, 1998. 69. Blumenstock, J.S., E. Bresnitz, and K. O’Leary, Guidelines Management of Natural Rubber Latex Allergy; Selecting the Right Glove for the Right Task in Healthcare Facilities, New Jersey Department of Health and Senior Services, ed. B. Gerwel, 2000. 70. United Kingdom National Health Service, N.P., Royal College of Physicians, Faculty of Occupational Medicine, ‘‘Latex Allergy: Occupational Aspects of Management. A National Guideline,’’ 2008, London: RCP. 71. Olmsted, R., ‘‘APIC response to FDA Docket # FDA–2011–N–0027,’’ available at www.regulations.gov, 2011. 72. ‘‘Finding of No Significant Impact (FONSI) and Environmental Analysis for Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove.’’ 73. Korniewicz, D.M., N. Chookaew, M. ElMasri, et al., ‘‘Conversion to LowProtein, Powder-Free Surgical Gloves: Is It Worth the Cost?’’ American Association of Occupational Health Nurses Journal, 53(9):388–393, 2005. 74. Ranta, P.M. and D.R. Ownby, ‘‘A Review of Natural-Rubber Latex Allergy in Health Care Workers,’’ Clinical Infectious Diseases, 38(2):252–256, 2004. 75. ‘‘Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Banned Devices; Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove,’’ available at http:// www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ EconomicAnalyses/default.htm. List of Subjects 21 CFR Parts 878 and 880 Medical devices. VerDate Sep<11>2014 17:38 Mar 21, 2016 Jkt 238001 21 CFR Part 895 PART 895—BANNED DEVICES Administrative practice and procedure, Labeling, Medical devices. ■ Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 878, 880, and 895 be amended as follows: Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371. PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for 21 CFR part 878 continues to read as follows: ■ Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Amend § 878.4460 by revising the heading and paragraph (a) to read as follows: ■ § 878.4460 glove. Non-powdered surgeon’s (a) Identification. A non-powdered surgeon’s glove is a device made of natural rubber latex or synthetic latex, intended to be worn by operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon’s glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. * * * * * § 878.4480 [Removed] 6. The authority citation for 21 CFR part 895 continues to read as follows: 7. Add § 895.102 to subpart B to read as follows: ■ § 895.102 Powdered surgeon’s glove. A powdered surgeon’s glove is a device made of natural rubber latex or synthetic latex, intended to be worn by operating room personnel to protect a surgical wound from contamination. A powdered surgeon’s glove incorporates powder for purposes other than manufacturing. ■ 8. Add § 895.103 to subpart B to read as follows: § 895.103 glove. Powdered patient examination A powdered patient examination glove is a disposable device made of natural rubber latex or synthetic latex, intended for medical purposes, that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. A powdered patient examination glove incorporates powder for purposes other than manufacturing. ■ 9. Add § 895.104 to subpart B to read as follows: § 895.104 Absorbable powder for lubricating a surgeon’s glove. Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. Absorbable powder for lubricating a surgeon’s glove is a powder made from cornstarch that meets the specifications for absorbable powder in the United States Pharmacopeia (U.S.P.) and that is intended to be used to lubricate the surgeon’s hand before putting on a surgeon’s glove. The device is absorbable through biological degradation. 5. Amend § 880.6250 by revising the heading and paragraph (a) to read as follows: Dated: March 16, 2016. Leslie Kux, Associate Commissioner for Policy. ■ 3. Remove § 878.4480. PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES 4. The authority citation for 21 CFR part 880 continues to read as follows: ■ ■ § 880.6250 Non-powdered patient examination glove. (a) Identification. A non-powdered patient examination glove is a disposable device made of either natural rubber latex or synthetic latex, intended for medical purposes, that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. * * * * * PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 [FR Doc. 2016–06360 Filed 3–21–16; 8:45 am] BILLING CODE 4164–01–P 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 Drug Enforcement Administration, Department of Justice. AGENCY: E:\FR\FM\22MRP1.SGM 22MRP1 Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules Notice of proposed rulemaking; correction. ACTION: The Drug Enforcement Administration published a document in the Federal Register of May 14, 2015, concerning the proposal to place (1pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3yl](2,2,3,3tetramethylcyclopropyl)methanone (5fluoro-UR-144, XLR11), and N-(1adamantyl)-1-pentyl-1H-indazole-3carboxamide (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 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 17:36 Mar 21, 2016 Jkt 238001 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) PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 15189 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 E:\FR\FM\22MRP1.SGM 22MRP1 15190 Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules 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. 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-1Hindol-3-yl)(2,2,3,3tetramethylcyclopropyl)methanone (UR144), [1-(5-fluoro-pentyl)-1H-indol-3yl](2,2,3,3tetramethylcyclopropyl)methanone (5fluoro-UR-144, XLR11), and N-(1- adamantyl)-1-pentyl-1H-indazole-3carboxamide (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. ■ 1. On page 27616 in the 3rd column, correct amendatory instruction 2.a. to read as follows: ‘‘Adding paragraphs (d)(65) through (67); and’’. ■ 2. On page 27616 in the 3rd column, correct § 1308.11 Schedule I regulatory text to read as follows: § 1308.11 * Schedule I. * * (d) * * * * * (65) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144) ...................................................................... (66) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl) methanone (5-fluoro-UR-144, XLR11) ........................ (67) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) .......................................................................... restoration, or coastal wetlands restoration projects by Federal, State, or local government agencies, or use in construction projects authorized by or funded in whole or in part by the [FR Doc. 2016–06474 Filed 3–21–16; 8:45 am] Federal Government. The proposed rule BILLING CODE 4410–09–P describes the negotiated noncompetitive agreement process for qualifying projects and codifies new and existing DEPARTMENT OF THE INTERIOR procedures. DATES: Submit comments by May 23, Bureau of Ocean Energy Management 2016. The Bureau of Ocean Energy Management (BOEM) may not fully 30 CFR Part 583 consider comments received after this RIN 1010–AD90 date. Submit comments to the Office of Management and Budget (OMB) on the [Docket ID: BOEM–2010–0041] information collection (IC) burden in Negotiated Noncompetitive Leasing for this proposed rule by April 21, 2016. the Use of Sand, Gravel, and Shell This does not affect the deadline for the Resources on the Outer Continental public to comment to BOEM on the Shelf proposed regulation. ADDRESSES: You may submit comments AGENCY: Bureau of Ocean Energy on the rulemaking by any of the Management, Interior. following methods. Please use the ACTION: Proposed rule. Regulation Identifier Number (RIN) SUMMARY: This rule proposes regulations 1010–AD90 as an identifier in your comment. Please reference ‘‘Outer to address the use of Outer Continental Continental Shelf Marine Sand, Gravel Shelf (OCS) sand, gravel and shell and Shell Resources, 1010–AD90’’ in resources for shore protection, beach your comments and include your name and return address. • Federal eRulemaking Portal: http:// www.regulations.gov. Under the tab ‘‘More Search Options,’’ click ‘‘Advanced Docket Search,’’ then select ‘‘Bureau of Ocean Energy Management’’ from the agency drop-down menu, then click the submit button. In the Docket ID column, select BOEM–2010–0041 to submit public comments and to view supporting and related materials available for this rulemaking. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site’s ‘‘User Tips’’ link. BOEM will post comments on www.regulations.gov. • Mail or hand-carry comments to the U.S. Department of the Interior; Bureau of Ocean Energy Management; Attn: Office of Policy, Regulation and Analysis, 45600 Woodland Road, VAM– BOEM DIR, Sterling, Virginia 20166. • Send comments on the IC in this proposed rule to: Interior Desk Officer 1010–AD90, Office of Management and Budget; 202–395–5806 (fax); email: 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 Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. * * * * * Dated: March 16, 2016. Chuck Rosenberg, Acting Administrator. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS (7144) (7011) (7048) VerDate Sep<11>2014 17:36 Mar 21, 2016 Jkt 238001 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 PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 E:\FR\FM\22MRP1.SGM 22MRP1

Agencies

[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Pages 15188-15190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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