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is responsible for oversight and DEPARTMENT OF HEALTH AND such as medical information, your or implementation of the MSP provisions HUMAN SERVICES anyone else’s Social Security number, or as part of its overall authority for the confidential business information, such Medicare program. The CMS Food and Drug Administration as a manufacturing process. Please note accomplishes this through a [Docket No. FDA–2016–N–4619] that if you include your name, contact combination of direct CMS action and information, or other information that work by CMS’ contractors. The CMS International Drug Scheduling; identifies you in the body of your efforts include policy and operational Convention on Psychotropic comments, that information will be guidelines, including regulations (as Substances; Single Convention on posted on https://www.regulations.gov. • If you want to submit a comment necessary), as well as oversight over Narcotic Drugs; World Health with confidential information that you contractor MSP responsibilities. As a Organization; Scheduling Recommendations; 4- do not wish to be made available to the result of litigation in the mid-1990’s, public, submit the comment as a certain GHP insurers were mandated to Methylethcathinone and Nine Other Substances; Request for Comments written/paper submission and in the report coverage information for a manner detailed (see ‘‘Written/Paper number of years. Subsequent to this AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). litigation related mandatory reporting, HHS. Written/Paper Submissions CMS instituted a Voluntary Data ACTION: Notice. Sharing Agreement (VDSA) effort which Submit written/paper submissions as expanded the scope of the GHP SUMMARY: The Food and Drug follows: • participants and added some NGHP Administration (FDA) is providing Mail/Hand delivery/Courier (for participants. This VDSA process interested persons with the opportunity written/paper submissions): Division of complemented the IRS/SSA/CMS Data to submit written comments, and to Dockets Management (HFA–305), Food Match reporting by employers, but request an informal public meeting and Drug Administration, 5630 Fishers concerning recommendations by the Lane, Rm. 1061, Rockville, MD 20852. clearly did not include the universe of • For written/paper comments primary payers and had few NGHP World Health Organization (WHO) to impose international manufacturing and submitted to the Division of Dockets participants. Both GHP and NGHP Management, FDA will post your entities have had and continue to have distributing restrictions, under international treaties, on certain drug comment, as well as any attachments, the responsibility for determining when except for information submitted, they are primary to Medicare and to pay substances. The comments received in response to this notice and/or public marked and identified, as confidential, appropriately, even without the meeting will be considered in preparing if submitted as detailed in mandatory Section 111 process. In order the United States’ position on these ‘‘Instructions.’’ to make this determination, they should proposals for a meeting of the United Instructions: All submissions received already and always be collecting most of Nations Commission on Narcotic Drugs must include the Docket No. FDA– the information CMS will require in (CND) in Vienna, Austria, in March 2016–N–4619 for ‘‘International Drug connection with Section 111 of the 2017. This notice is issued under the Scheduling; Convention on MMSEA. Section 111 establishes Controlled Substances Act (CSA). Psychotropic Substances; Single separate mandatory reporting Convention on Narcotic Drugs; World DATES: Submit either electronic or Health Organization; Scheduling requirements for GHP arrangements as written comments by February 10, 2017. well as for liability insurance (including Recommendations; 4- Submit requests for a public meeting on Methylethcathinone and Nine Other self-insurance), no-fault insurance, and or before January 23, 2017. The short workers’ compensation, these may Substances; Request for Comments.’’ time period for the submission of Received comments will be placed in collectively be referred to as ‘‘Non-GHP comments and requests for a public or NGHP.’’ Form Number: CMS–10265 the docket and, except for those meeting is needed to ensure that HHS submitted as ‘‘Confidential (OMB control number: 0938–1074); may, in a timely fashion, carry out the Submissions,’’ publicly viewable at Frequency: Yearly, Quarterly; Affected required action and be responsive to the https://www.regulations.gov or at the Public: Private Sector (Business or other United Nations. For additional Division of Dockets Management for-profits); Number of Respondents: information, see section IV of this between 9 a.m. and 4 p.m., Monday 19,248; Total Annual Responses: document. through Friday. 5,019,248; Total Annual Hours: 557,826. ADDRESSES: You may submit comments • Confidential Submissions—To (For policy questions regarding this as follows: submit a comment with confidential collection contact John Albert at 410– information that you do not wish to be 786–7457.) Electronic Submissions made publicly available, submit your Dated: January 5, 2017. Submit electronic comments in the comments only as a written/paper William N. Parham, III, following way: submission. You should submit two • Federal eRulemaking Portal: copies total. One copy will include the Director, Paperwork Reduction Staff, Office https://www.regulations.gov. Follow the information you claim to be confidential of Strategic Operations and Regulatory instructions for submitting comments. with a heading or cover note that states Affairs. Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS [FR Doc. 2017–00298 Filed 1–10–17; 8:45 am] including attachments, to https:// CONFIDENTIAL INFORMATION.’’ The BILLING CODE 4120–01–P www.regulations.gov will be posted to Agency will review this copy, including the docket unchanged. Because your the claimed confidential information, in comment will be made public, you are its consideration of comments. The solely responsible for ensuring that your second copy, which will have the comment does not include any claimed confidential information confidential information that you or a redacted/blacked out, will be available third party may not wish to be posted, for public viewing and posted on

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https://www.regulations.gov. Submit discussions and negotiations relating to Secretary of State of the United States of both copies to the Division of Dockets the proposal. America and has the honour to inform the Management. If you do not wish your As detailed in the following Government that the Director-General of the name and contact information to be paragraphs, the Secretary of State has World Health Organization (WHO), pursuant received notification from the Secretary- to article 3, paragraphs 1 and 3 of the Single made publicly available, you can Convention on Narcotic Drugs of 1961 as provide this information on the cover General of the United Nations (the amended by the 1972 Protocol (1961 sheet and not in the body of your Secretary-General) regarding eight Convention) and article 2, paragraphs 1 and comments and you must identify this substances to be considered for control 4 of the Convention on Psychotropic information as ‘‘confidential.’’ Any under the Psychotropic Convention. Substances of 1971 (1971 Convention) information marked as ‘‘confidential’’ This notification reflects the notified the Secretary-General of the will not be disclosed except in recommendation from the 38th WHO following recommendations: accordance with 21 CFR 10.20 and other Expert Committee for Drug Dependence Substances recommended to be placed in Schedule I of the Single Convention on applicable disclosure law. For more (ECDD), which met in November 2016. In the Federal Register of September 19, Narcotic Drugs (1961), as amended by the information about FDA’s posting of 1972 Protocol: 2016 (81 FR 64162), FDA announced the comments to public dockets, see 80 FR —U–4770 56469, September 18, 2015, or access WHO ECDD review and invited interested persons to submit chemical name: 3,4-dichloro-N-(2- the information at: http://www.fda.gov/ dimethylamino-cyclohexyl)-N-methyl- regulatoryinformation/dockets/ information for WHO’s consideration. benzamide default.htm. The full text of the notification from —butyrfentanyl the Secretary-General is provided in chemical name: N-phenyl-N-[1-(2- Docket: For access to the docket to section II of this document. Section read background documents or the phenylethyl)-4-piperidinyl]butanamide 201(d)(2)(B) of the CSA requires the Substances recommended to be placed in electronic and written/paper comments Secretary of HHS, after receiving a received, go to https:// Schedule II of the 1971 Convention: notification proposing scheduling, to —4–MEC (4-methylethcathinone) www.regulations.gov and insert the publish a notice in the Federal Register docket number, found in brackets in the chemical name: 2-(ethylamino)-1-(4- to provide the opportunity for interested methylphenyl)propan-1-one heading of this document, into the persons to submit information and —ethylone ‘‘Search’’ box and follow the prompts comments on the proposed scheduling chemical name: 1-(2H–1,3-benzodioxol-5- and/or go to the Division of Dockets action. yl)-2-(ethylamino)propan-1-one Management, 5630 Fishers Lane, Rm. The United States is also a party to —pentedrone 1061, Rockville, MD 20852. the 1961 Single Convention on Narcotic chemical name: 2-(methylamino)-1- Drugs (1961 Single Convention). The phenylpentan-1-one FOR FURTHER INFORMATION CONTACT: —ethylphenidate James R. Hunter, Center for Drug Secretary of State has received a chemical name: ethyl phenyl(piperidin-2- Evaluation and Research, Controlled notification from the Secretary-General yl)acetate Substance Staff, Food and Drug regarding two substances to be —MPA (methiopropamine) Administration, 10903 New Hampshire considered for control under this chemical name: N-methyl-1-(thiophen-2- Ave., Bldg. 51, Rm. 5150, Silver Spring, convention. The CSA does not require yl)propan-2-amine MD 20993–0002, 301–796–3156, HHS to publish a summary of such —MDMB–CHMICA { [email protected]. information in the Federal Register. chemical name: methyl N- [1- Nevertheless, in an effort to provide (cyclohexylmethyl)-1H-indol-3- SUPPLEMENTARY INFORMATION: } interested and affected persons an yl]carbonyl -3-methyl-L-valinate —5F–APINACA (5F–AKB–48) I. Background opportunity to submit comments chemical name: N-(adamantan-1-yl)-1-(5- regarding the WHO recommendations The United States is a party to the fluoropentyl)-1H-indazole-3- for narcotic drugs, the notification carboxamide 1971 Convention on Psychotropic regarding these substances is also —XLR–11 Substances (Psychotropic Convention). included in this Federal Register notice. chemical name: [1-(5-fluoropentyl)-1H- Section 201(d)(2)(B) of the CSA (21 The comments will be shared with other indol-3-yl](2,2,3,3- U.S.C. 811(d)(2)(B)) provides that when relevant Agencies to assist the Secretary tetramethylcyclopropyl)methanone the United States is notified under of State in formulating the position of In addition, in the letter from the Director- Article 2 of the Psychotropic the United States on the control of these General of the World Health Orgazniation to Convention that the CND proposes to substances. The HHS recommendations the Secretary-General, reference is also made decide whether to add a drug or other are not binding on the representative of to the recommendations by the thirty-eighth substance to one of the schedules of the meeting of the WHO Expert Committee on the United States in discussions and Drug Dependence (ECDD) for carrying out a Psychotropic Convention, transfer a negotiations relating to the proposal drug or substance from one schedule to critical review of one substance at a regarding control of substances under subsequent Expert Committee meeting, as another, or delete it from the schedules, the 1961 Single Convention. well as for one substance to continue to be the Secretary of State must transmit kept under surveillance. Furthermore, the notice of such information to the II. United Nations Notification letter also makes reference to the Secretary of Health and Human Services The formal notification from the recommendation by the Expert Committee (Secretary of HHS). The Secretary of United Nations that identifies the drug with regard to cannabis and its component HHS must then publish a summary of substances and explains the basis for the substances. such information in the Federal recommendations is reproduced as In accordance with the provisions of article Register and provide opportunity for follows (non-relevant text removed): 3, paragraph 2 of the 1961 Convention and interested persons to submit comments. article 2, paragraph 2 of the 1971 Convention, Reference: the Secretary-General hereby transmits the The Secretary of HHS must then NAR/CL.8/2016 notification as annex I to the present note. In evaluate the proposal and furnish a WHO/ECDD38; 1961C–Art.3; 1971C–Art.2 accordance with the provisions of article 3, recommendation to the Secretary of CU 2016/495/DTA/SGB paragraph 2 of the 1961 Convention and State that shall be binding on the The Secretary-General of the United article 2, paragraph 2 of the 1971 Convention, representative of the United States in Nations presents his compliments to the the notification from WHO will be brought to

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the attention of the sixtieth session of the —ethylphenidate conformations each have two enantiomers Commission on Narcotic Drugs (13–17 March chemical name: ethyl phenyl(piperidin-2- [cis: are (1R,2R), and (1S,2S); trans are 2017). yl)acetate (1R,2S) and (1S,2R)]. In connection with the notification, WHO —MPA (methiopropamine) U–47700 was not previously pre-reviewed has also submitted the relevant extract from chemical name: N-methyl-1-(thiophen-2- or critically reviewed by the Committee. A the report of the thirty-eighth meeting of the yl)propan-2-amine direct critical review is proposed based on WHO Expert Committee on Drug Dependence —MDMB–CHMICA information brought to the attention of the which is hereby transmitted as annex II. chemical name: methyl N-{[1- WHO that U–47700 is clandestinely In order to assist the Commission in (cyclohexylmethyl)-1H-indol-3- manufactured, poses risk to public health reaching a decision, it would be appreciated yl]carbonyl}-3-methyl-L-valinate and society, and has no recognized if the Government could communicate any —5F–APINACA (5F–AKB–48) therapeutic use by any Party. economic, social, legal, administrative or chemical name: N-(adamantan-1-yl)-1-(5- U–47700 (3,4-dichloro-N-(2- other factors that it considers relevant to the fluoropentyl)-1H-indazole-3- dimethylamino-cyclohexyl)-N-methyl- possible scheduling of the afore-mentioned carboxamide benzamide) is a compound liable to similar substances that are recommended by WHO to —XLR–11 abuse and with similar ill-effects to be placed under international control under chemical name: [1-(5-fluoropentyl)-1H- controlled opioids such as morphine and the 1961 Convention (namely: U–4770 and indol-3-yl](2,2,3,3- AH–7921 that are included in Schedule I of butyrfentanyl) and the 1971 Convention tetramethylcyclopropyl)methanone. the 1961 Single Convention on Narcotic (namely: 4–MEC, ethylone, pentedrone, In addition, the Expert Committee Drugs. It has no recorded therapeutic use, ethylphenidate, MPA, MDMB–CHMICA, 5F- recommended to carry out a critical review and its use has resulted in fatalities. There is APINACA, and XLR–11). at a subsequent Expert Committee meeting sufficient evidence that it is being or is likely Communications are to be sent at the latest for: to be abused so as to constitute a public by 20 January 2017 to the Executive Director health and social problem warranting the —3–MMC (3-Methylmethcathinone) of the United Nations Office on Drugs and placing of the substance under international chemical name: 2-(methylamino)-1-(3- Crime, c/o Secretary, Commission on control. Thus, because it meets the required methylphenyl)propan-1-one Narcotic Drugs, P.O. Box 500, 1400 Vienna, condition of similarity, it is recommended Austria, fax: +43–1–26060–5885, email: sgb@ It also recommended to continue to keep that U–47700 be placed in Schedule I of the unodc.org. the following substance under surveillance: Single Convention on Narcotic Drugs, 1961, 21 December 2016 —JWH–073 as consistent with Article 3, paragraph 3 (iii) chemical name: (1-butyl-1H-indol-3-yl)(1- His Excellency of that Convention in that the substance is naphthyl)methanone Mr. John Kerry liable to similar abuse and productive of Secretary of State of the United States of The Committee recommended that a similar ill effects as drugs in Schedule I. America specific ECDD meeting dedicated to cannabis Butyrfentanyl and its component substances should be held Annex I Chemically, butyrfentanyl is N-phenyl-N- within the next eighteen months from the [1-(2-phenylethyl)-4-piperidinyl]butanamide. 38th meeting, and will carry out pre-reviews Letter Addressed to the Secretary-General of Butyrfentanyl has not been previously pre- for the following substances: the United Nations From the Director- reviewed or critically reviewed by the General of the World Health Organization —Cannabis plant and cannabis resin; Committee. A direct critical review is ‘‘The Thirty-eighth meeting of the WHO —Extracts and tinctures of cannabis; proposed based on information brought to Expert Committee on Drug Dependence —Delta-9-tetrahydrocannabinol (THC); the attention of the WHO that butyrfentanyl convened from 14 to 18 November 2016, at —Cannabidiol (CBD); is clandestinely manufactured, poses risk to WHO headquarters in Geneva. The objective —Stereoisomers of THC. public health and society, and has no of this meeting was to carry out an in-depth The recommendations and the assessments recognized therapeutic use by any Party. evaluation of psychoactive substances in and findings on which they are based are set Butyrfentanyl (N-phenyl-N-[1-(2- order to determine whether or not WHO out in detail in the Report of the 38th Expert phenylethyl)-4-piperidinyl]butanamide) is a should recommend these substances to be Committee on Drug Dependence, which is compound liable to similar abuse and with placed under international control. the Committee that advises me on these similar ill-effects to controlled opioids such With reference to Article 2, paragraphs 1 issues. An extract of the Committee’s Report as morphine and fentanyl that are included and 4 of the Convention on Psychotropic is attached in Annex 1 to this letter. in Schedule I of the 1961 Single Convention Substances (1971) and Article 3, paragraphs I am very pleased with the ongoing on Narcotic Drugs. It can be converted into 1 and 3 of the Single Convention on Narcotic collaboration among the United Nations fentanyl as well. It has no recorded Drugs (1961), as amended by the 1972 Office on Drugs and Crime (UNODC), therapeutic use and its use has resulted in Protocol, I am pleased to submit International Narcotics Control Board (INCB) fatalities. There is sufficient evidence that it recommendations of the World Health and WHO, in particular, how this is being or is likely to be abused so as to Organization as follows: collaboration has supported the work of the constitute a public health and social problem to be placed in Schedule I of the Single WHO Expert Committee on Drug warranting the placing of the substance Convention on Narcotic Drugs (1961), as Dependence, and more generally, the under international control. Thus, because it amended by the 1972 Protocol: implementation of operational meets either of the required conditions of —U–47700 recommendations from the United Nations similarity or convertibility, it is chemical name: 3,4-dichloro-N-(2- General Assembly Special Session (UNGASS) recommended that butyrfentanyl be placed in dimethylamino-cyclohexyl)-N-methyl- 2016.’’ Schedule I of the Single Convention on benzamide NAR/CL.8/2016 Narcotic Drugs, 1961, as consistent with —butyrfentanyl Article 3, paragraph 3 (iii) of that Convention chemical name: N-phenyl-N-[1-(2- Annex II in that the substance is liable to similar abuse phenylethyl)-4-piperidinyl]butanamide Extract From the Report of the 38th Expert and productive of similar ill effects as drugs to be placed in Schedule II of the Convention Committee on Drug Dependence in Schedule I. on Psychotropic Substances (1971): Substances recommended to be scheduled —4–MEC (4-methylethcathinone) Substances recommended to be scheduled in Schedule II of the Convention on chemical name: 2-(ethylamino)-1-(4- in Schedule I and Schedule IV of the Single Psychotropic Substances (1971): methylphenyl)propan-1-one Convention on Narcotic Drugs (1961), as —ethylone amended by the 1972 Protocol: 4–MEC (4-Methylethcathinone) chemical name: 1-(2H–1,3-benzodioxol-5- U–47700 Chemically, 4-methylethcathinone (4– yl)-2-(ethylamino)propan-1-one Chemically, U–47700 is 3,4-dichloro-N-(2- MEC) is 2-(ethylamino)-1-(4- —pentedrone dimethylamino-cyclohexyl)-N-methyl- methylphenyl)propan-1-one. 4–MEC has a chemical name: 2-(methylamino)-1- benzamide. U47700 has two chiral centres chiral centre giving rise to an enantiomeric phenylpentan-1-one resulting in four isomers; cis and trans pair of (S)-4–MEC and (R)-4–MEC isomers.

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A critical review report on 4–MEC was a chiral centre giving rise to two public health, the Committee recommended discussed in June 2014 at the 36th meeting stereoisomers, (S)- and (R)- pentedrone. that methiopropamine not be placed under of the WHO Expert Committee on Drug Pentedrone has not been previously international control but be kept under Dependence. The Committee recommended reviewed or critically reviewed by the Expert surveillance. Subsequent data collected from that 4–MEC not be placed under Committee on Drug Dependence of the WHO. the literature and from different countries international control at that time due to A direct critical review is proposed based on indicated that this substance may cause insufficiency of data regarding dependence, information brought to WHO’s attention that substantial harm and that it has no medical abuse and risks to public health, but be kept pentedrone is clandestinely manufactured, use warranting an updated critical review. under surveillance. 4–MEC continues to poses serious risk to public health and The Committee considered that the degree appear as a psychostimulant with society, and has no recognized therapeutic of risk to public health and society associated monoamine transporter activity with use by any Party. with the abuse of methiopropamine (N- indications of abuse liability. New data have The Committee considered that the degree methyl-1-(thiophen-2-yl)propan-2-amine) is emerged from in vitro and in vivo studies of risk to public health and society associated substantial. Therapeutic usefulness has not since the 36th ECCD meeting that has with the abuse of pentedrone (2- been recorded. It recognized that it has prompted the current critical review. (methylamino)-1-phenylpentan-1-one) is similar abuse and similar ill-effects as The Committee considered that the degree substantial. Therapeutic usefulness has not substances in Schedule II of the UN 1971 of risk to public health and society associated been recorded. It recognized that it has Convention on Psychotropic Substances. The with the abuse of 4–MEC (2-(ethylamino)-1- similar abuse and similar ill-effects as Committee considered that there is sufficient (4-methylphenyl)propan-1-one) is substances in Schedule II of the UN 1971 evidence that methiopropamine is being or is substantial. Therapeutic usefulness has not Convention on Psychotropic Substances. The likely to be abused so as to constitute a been recorded. It recognized that it has Committee considered that there is sufficient public health and social problem warranting similar abuse and similar ill-effects as evidence that pentedrone is being or is likely the placing of the substance under substances in Schedule II of the UN 1971 to be abused so as to constitute a public international control. As per the Guidance on Convention on Psychotropic Substances. The health and social problem warranting the the WHO review of psychoactive substances Committee considered that there is sufficient placing of the substance under international for international control, higher regard was evidence that 4–MEC is being or is likely to control. As per the Guidance on the WHO accorded to the substantial public health risk be abused so as to constitute a public health review of psychoactive substances for than to the lack of therapeutic usefulness. and social problem warranting the placing of international control, higher regard was The Committee recommended that the substance under international control. As accorded to the substantial public health risk methiopropamine be placed in Schedule II per the Guidance on the WHO review of than to the lack of therapeutic usefulness. under the UN 1971 Convention on psychoactive substances for international The Committee recommended that Psychotropic Substances. control, higher regard was accorded to the pentedrone be placed in Schedule II under MDMB–CHMICA substantial public health risk than to the lack the UN 1971 Convention on Psychotropic of therapeutic usefulness. The Committee Chemically, MDMB–CHMICA is methyl N- Substances. {[1-(cyclohexylmethyl)-1H-indol-3- recommended that 4–MEC be placed in } Schedule II under the UN 1971 Convention Ethylphenidate (EPH) yl]carbonyl -3-methyl-L-valinate. MDMB– on Psychotropic Substances. Chemically, ethylphenidate is ethyl CHMICA has a chiral carbon in the butanoic chain. Therefore, two stereoisomers exist: (S)- Ethylone phenyl(piperidin-2-yl)acetate. Ethylphenidate was not previously pre- MDMB–CHMICA and (R)-MDMB–CHMICA. Chemically, ethylone is 1-(2H-1,3- reviewed or critically reviewed. A direct MDMB–CHMICA has not been previously benzodioxol-5-yl)-2-(ethylamino)propan-1- critical review is proposed based on pre-reviewed or critically reviewed. A direct critical review is proposed based on one. It is a chiral compound with isomers, information brought to the attention of the information brought to the attention of the and its hydrochloride salt can exist in two WHO that ethylphenidate is clandestinely WHO that MDMB–CHMICA is clandestinely conformations (polymorphs) at the C–C bond manufactured, poses serious risk to public linking the side chain to the aromatic ring. manufactured, poses serious risk to public health and society, and has no recognized Ethylone was not previously pre-reviewed health and society, and has no recognized therapeutic use by any Party. or critically reviewed. A direct critical review therapeutic use by any Party. The Committee considered that the degree is proposed based on information brought to The Committee considered that the degree of risk to public health and society associated the attention of the WHO that ethylone is of risk to public health and society associated with the abuse of ethylphenidate (ethyl clandestinely manufactured, poses serious with the abuse of MDMB–CHMICA (methyl phenyl(piperidin-2-yl)acetate) is substantial. risk to public health and society, and has no N-{[1-(cyclohexylmethyl)-1H-indol-3- Therapeutic usefulness has not been recognized therapeutic use by any Party. yl]carbonyl}-3-methyl-L-valinate) is recorded. It recognized that it has similar The Committee considered that the degree substantial. Therapeutic usefulness has not of risk to public health and society associated abuse and similar ill-effects as substances in been recorded. It recognized that it has with the abuse of ethylone (1-(2H-1,3- Schedule II of the UN 1971 Convention on similar abuse and similar ill-effects as benzodioxol-5-yl)-2-(ethylamino)propan-1- Psychotropic Substances. The Committee substances in Schedule II of the UN 1971 one) is substantial. Therapeutic usefulness considered that there is sufficient evidence Convention on Psychotropic Substances. The has not been recorded. It recognized that it that ethylphenidate is being or is likely to be Committee considered that there is sufficient has similar abuse and similar ill-effects as abused so as to constitute a public health and evidence that MDMB–CHMICA is being or is substances in Schedule II of the UN 1971 social problem warranting the placing of the likely to be abused so as to constitute a Convention on Psychotropic Substances. The substance under international control. As per public health and social problem warranting Committee considered that there is sufficient the Guidance on the WHO review of the placing of the substance under evidence that ethylone is being or is likely to psychoactive substances for international international control. As per the Guidance on be abused so as to constitute a public health control, higher regard was accorded to the the WHO review of psychoactive substances and social problem warranting the placing of substantial public health risk than to the lack for international control, higher regard was the substance under international control. As of therapeutic usefulness. The Committee accorded to the substantial public health risk per the Guidance on the WHO review of recommended that ethylphenidate be placed than to the lack of therapeutic usefulness. psychoactive substances for international in Schedule II under the UN 1971 The Committee recommended that MDMB– control, higher regard was accorded to the Convention on Psychotropic Substances. CHMICA be placed in Schedule II under the substantial public health risk than to the lack MPA (Methiopropamine) UN 1971 Convention on Psychotropic of therapeutic usefulness. The Committee Substances. Chemically, methiopropamine is N-methyl- recommended that ethylone be placed in 5F–APINACA (5F–AKB–48) Schedule II under the UN 1971 Convention 1-(thiophen-2-yl)propan-2-amine. It has a on Psychotropic Substances. chiral centre with two enantiomers. Chemically, 5F–APINACA is N- Methiopropamine was previously critically (adamantan-1-yl)-1-(5-fluoropentyl)-1H- Pentedrone (a-Methylaminovalerophenone) reviewed by the Committee at its 36th indazole-3-carboxamide. Chemically, pentedrone is 2- meeting. Owing to the insufficiency of data 5F–APINACA has not been previously pre- (methylamino)-1-phenylpentan-1-one. It has regarding dependence, abuse and risks to reviewed or critically reviewed by the Expert

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Committee on Drug Dependence of the WHO. 3–MMC was not previously pre-reviewed Committee noted that the current Schedule I A direct critical review is proposed based on or critically reviewed. A direct critical review of the 1961 Convention groups together information brought to the attention of the is proposed based on information brought to cannabis and cannabis resin, extracts and WHO that 5F–APINACA is clandestinely the attention of the WHO that 3–MMC is tinctures of cannabis. Cannabis plant and manufactured, poses serious risk to public clandestinely manufactured, poses serious cannabis resin are also in Schedule IV of the health and society, and has no recognized risk to public health and society, and has no 1961 Convention. The Committee further therapeutic use by any Party. recognized therapeutic use by any Party. noted that there are natural and synthetic The Committee considered that the degree The Committee deliberated at length cannabinoids in Schedule I and Schedule II of risk to public health and society associated regarding the information available pertinent of the 1971 Convention. The Committee with the abuse of 5F–APINACA (N- to the degree of risk to public health and recognized: (adamantan-1-yl)-1-(5-fluoropentyl)-1H- society associated with the abuse of 3–MMC —An increase in the use of cannabis and its indazole-3-carboxamide) is substantial. (2-(methylamino)-1-(3-methylphenyl)propan- components for medical purposes; Therapeutic usefulness has not been 1-one). The Committee decided that the —The emergence of new cannabis-related recorded. It recognized that it has similar information as currently provided, and the pharmaceutical preparations for abuse and similar ill-effects as substances in ensuing discussions that had occurred, were therapeutic use; Schedule II of the UN 1971 Convention on inadequate to form a consensus and —Cannabis has never been subject to a Psychotropic Substances. The Committee confident recommendation regarding the formal pre-review or critical review by the considered that there is sufficient evidence scheduling of 3–MMC. As per paragraph 59 ECDD. of the Guidance on the WHO review of that 5F–APINACA is being or is likely to be The Committee requested that the psychoactive substances for international abused so as to constitute a public health and Secretariat prepare relevant documentation control, and as supported by its procedural social problem warranting the placing of the in accordance with the Guidance on the reference to the Thirty-fourth report of the substance under international control. As per WHO review of psychoactive substances for WHO Expert Committee on Drug the Guidance on the WHO review of international control in order to conduct pre- Dependence, ‘‘. . . in cases where additional psychoactive substances for international reviews for the following substances: control, higher regard was accorded to the information concerning the substance under substantial public health risk than to the lack review is required, the Committee may —Cannabis plant and cannabis resin; of therapeutic usefulness. The Committee decide that it will reach a final opinion at a —Extracts and tinctures of cannabis; recommended that 5F–APINACA be placed subsequent meeting.’’ ‘‘. . . then it should —Delta-9-tetrahydrocannabinol (THC); in Schedule II under the UN 1971 request another critical review in order to —Cannabidiol (CBD); Convention on Psychotropic Substances. refer the matter to a subsequent Expert —Stereoisomers of THC. The Committee recommended that these XLR–11 Committee.’’ As directed by these guidelines, the Committee requested that the Secretariat pre-reviews be evaluated at a specific ECDD Chemically, XLR–11 is [1-(5-fluoropentyl)- arrange another critical review of 3–MMC at meeting dedicated to cannabis and its 1H-indol-3-yl](2,2,3,3- a subsequent Expert Committee. component substances to be held within the tetramethylcyclopropyl)methanone. Substance recommended for surveillance: next eighteen months from the 38th meeting. XLR–11 has not been previously pre- JWH–073 The purpose of the pre-review is to reviewed or critically reviewed. A direct determine whether current information critical review is proposed based on Chemically, JWH–073 is (1-butyl-1H-indol- justifies an Expert Committee critical review. information brought to WHO’s attention that 3-yl)(1-naphthyl)methanone. The categories of information for evaluating XLR–11 is clandestinely manufactured, poses During its 36th meeting, the WHO Expert substances in pre-reviews are identical to serious risk to public health and society, and Committee on Drug Dependence discussed those used in critical reviews. The pre-review has no recognized therapeutic use by any the critical review report on JWH–073 and is a preliminary analysis, and findings at this Party. concluded that owing to the current stage should not determine whether the The Committee considered that the degree insufficiency of data regarding dependence, control status of a substance should be of risk to public health and society associated abuse and risks to public health, JWH–073 changed. with the abuse of XLR–11 ([1-(5- should not be placed under international control at that time but be kept under fluoropentyl)-1H-indol-3-yl](2,2,3,3- III. Discussion tetramethylcyclopropyl)methanone) is surveillance. New information on its substantial. Therapeutic usefulness has not pharmacology and abuse potential warranted Although WHO has made specific been recorded. It recognized that it has an update of the critical review report for scheduling recommendations for each of similar abuse and similar ill-effects as discussion at the 38th ECDD. the drug substances, the CND is not substances in Schedule II of the UN 1971 The available pharmacodynamic data obliged to follow the WHO related to JWH–073 (1-butyl-1H-indol-3-yl)(1- Convention on Psychotropic Substances such recommendations. Options available to as JWH–018 and AM–2201. The Committee naphthyl)methanone) demonstrates that this considered that there is sufficient evidence substance has the capacity to produce some the CND for substances considered for that XLR–11 is being or is likely to be abused effects similar to its homologue, JWH–018, control under the Psychotropic so as to constitute a public health and social that is included in Schedule II of the UN Convention include the following: (1) problem warranting the placing of the 1971 Convention on Psychotropic Accept the WHO recommendations; (2) substance under international control. As per Substances. However, the data currently accept the recommendations to control, the Guidance on the WHO review of available does not make it possible to but control the drug substance in a psychoactive substances for international establish a direct link between JWH–073 schedule other than that recommended; control, higher regard was accorded to the abuse and appearance of public health and or (3) reject the recommendations substantial public health risk than to the lack social problems that would be a requirement for placing this substance under international entirely. of therapeutic usefulness. The Committee U–47700 is a synthetic opioid drug recommended that XLR–11 be placed in control. It is therefore recommended not to Schedule II under the UN 1971 Convention place JWH–073 under international control developed in the 1970s. U–47700 is on Psychotropic Substances. but to continue to keep it under surveillance. structurally related to the opioid AH– Substance recommended for critical Update on Cannabis and Cannabis resin: 7921. U–47700 is selective for the m- review: At the 37th ECDD meeting the Committee opioid receptor. U–47700 has never requested that Secretariat begin collecting 3-Methylmethcathinone (3-methyl-N- been studied on humans, but would be data towards a pre-review of cannabis, expected to produce effects similar to methylcathinone; 3–MMC) cannabis resin, extracts and tinctures of Chemically, 3–MMC is 2-(methylamino)-1- cannabis at a future meeting. Consistent with those of other potent opioid agonists, (3-methylphenyl)propan-1-one. 3–MMC this request, two updates on the scientific including strong analgesia, sedation, contains a chiral centre at the C–2 carbon of literature on cannabis were prepared and euphoria, constipation, itching, and the propane sidechain, so two enantiomers subsequently presented to the Expert respiratory depression which could be exist: (R)-3–MMC and (S)-3–MMC. Committee. Following its deliberations the harmful or fatal. Overdoses and

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overdose fatalities have been directly in the Federal Register amending 21 in the United States under the CSA. As attributed to U–47700 misuse. There CFR 1308.11(h) to temporarily place 4– such, additional permanent controls have been reports of U–47700 being MEC and pentedrone into Schedule I of will be necessary to fulfill U.S. encountered in counterfeit pills. On the CSA pursuant to the temporary obligations if MPA is controlled under November 14, 2016, the U.S. Drug scheduling provisions of 21 U.S.C. Schedule II of the 1971 Convention on Enforcement Administration (DEA) 811(h). On March 4, 2016, the Psychotropic Substances. temporarily scheduled U–47700 into temporary Schedule I status of 4–MEC MDMB–CHMICA is an indole-based schedule I pursuant to the temporary and pentedrone was extended for 1 year, synthetic cannabinoid that is a potent scheduling provisions of the Controlled or until permanent scheduling is full agonist at cannabinoid type 1 (CB1) Substances Act. As such, additional completed. Permanent scheduling for 4– receptors and mimics functionally permanent controls will be necessary to MEC and pentedrone was initiated on (biologically) the effects of the fulfill U.S. obligations if U–47700 is March 4, 2016, upon publication of the structurally unrelated delta-9- controlled under Schedule I of the 1961 notice of proposed rulemaking. As such, tetrahydrocannabinol, a Schedule I Single Convention. additional permanent controls will be substance, and the main active Butyrfentanyl (butyrylfentanyl) is a necessary to fulfill U.S. obligations if 4– ingredient of marijuana. Synthetic synthetic opioid and analog of fentanyl. MEC and pentedrone is controlled cannabinoids are marketed under the Fentanyl is controlled in Schedule II of under Schedule II of the 1971 guise of ‘‘herbal incense,’’ and promoted the CSA, and an active ingredient in Convention on Psychotropic by drug traffickers as legal alternatives drug products approved for medical use Substances. to marijuana. MDMB–CHMICA use is and marketed in the United States. In the United States, ethylone has associated with serious adverse events Butyrylfentanyl has a pharmacological been sold as the street drug ‘‘Molly’’ and including death in several European profile similar to that of fentanyl and encountered as a replacement for countries. There are no commercial or other m-opioid receptor agonists. Risks methylone. Ethylone has no known approved medical uses for MDMB– associated with abuse of butyrylfentanyl medical use in the United States. As a CHMICA. MDMB–CHMICA is not include development of substance use positional isomer of the controlled drug controlled under the CSA, but may be disorder, overdose, and death similar to butylone, ethylone is considered a treated as a ‘‘controlled substance that of other m-opioid agonists. The DEA Schedule I controlled substance under analogue’’ under the CSA pursuant to 21 is aware of at least 40 confirmed the CSA. As such, no additional U.S.C. 802(32)(A) and 813, and is a fatalities associated with controls will be necessary to fulfill U.S. controlled substance in the State of butyrylfentanyl. It has no approved obligations if ethylone is controlled Louisiana. As such, additional medical use in the United States. On under Schedule II of the 1971 permanent controls will be necessary to May 12, 2016, butyrylfentanyl was Convention on Psychotropic fulfill U.S. obligations if MDMB– temporarily placed into Schedule I of Substances. CHMICA is controlled under Schedule the CSA for 2 years upon finding that Ethylphenidate is structurally related II of the 1971 Convention on it posed an imminent hazard to the to methylphenidate. Methylphenidate is Psychotropic Substances. public safety. The Attorney General, controlled in Schedule IV of the CSA, 5F–APINACA (5F–AKB48) is a though, may extend this temporary and an active ingredient in drug synthetic cannabinoid belonging to a scheduling for up to 1 year. As such, products approved for medical use and chemical structural class with an additional permanent controls will be marketed in the United States. indazole core. In vitro studies show that necessary to fulfill U.S. obligations if Ethylphenidate is not approved for it binds to the CB1 receptors and butyrylfentanyl is controlled under medical use in the United States. displays agonist properties in functional Schedule I of the 1961 Single Ethylphenidate is structurally related to assays, suggesting that it would share in Convention. methylphenidate are being marketed as vivo effects with delta-9–THC and 4-Methylethcathinone (4–MEC), 3- novel psychoactive substances with various synthetic cannabinoids. There Methylmethcathinone (3-methyl-N- psychoactive effects similar to are no commercial or medical uses for methylcathinone; 3–MMC): 3-methyl- methylphenidate, therefore posing 5F–APINACA. Synthetic cannabinoids methcathinone (3–MMC), pentedrone, similar health risks to the users. are marketed under the guise of ‘‘herbal and ethylone (3,4-methylenedioxy-N- Ethylphenidate is a controlled substance incense,’’ and promoted by drug ethylcathinone; bk-MDEA; MDEC) are in several European countries, and is traffickers as legal alternatives to synthetic cathinones that are not a controlled substance in the United marijuana. SF–APINACA is not a structurally and pharmacologically States under the CSA. As such, controlled substance under the CSA, but similar to amphetamine, 3–4 additional permanent controls will be may be treated as a ‘‘controlled methylenedioxymethamphetamine necessary to fulfill U.S. obligations if substance analogue’’ under the CSA (MDMA), cathinone, and other related ethylphenidate is controlled under pursuant to 21 U.S.C. 802(32)(A) and substances. These substances are central Schedule II of the 1971 Convention on 813. As such, additional permanent nervous system stimulants with Psychotropic Substances. controls will be necessary to fulfill U.S. psychoactive properties similar to Methiopropamine (MPA) is a obligations if SF–APINACA is Schedule I and II amphetamine type structural analogue of the Schedule II controlled under Schedule II of the 1971 substances. Public health risks controlled substance methamphetamine. Convention on Psychotropic associated with the use of synthetic Pharmacologically, it functions as a Substances. cathinones suggest that these substances norepinephrine-dopamine reuptake XLR–11 (5-Fluoro-UR–144, 5F–UR– are associated with cardiac, psychiatric, inhibitor and, secondarily, as a 144) is an indole-based synthetic and neurological symptoms that may serotonin reuptake inhibitor. MPA is a cannabinoid and acts as an agonist at lead to emergency department thiophene based analog of CB1 receptors. Animal studies indicate admissions, violent behaviors causing methamphetamine. It has stimulant that it mimics functionally (biologically) harm to self or others, or death. 4–MEC properties as an inhibitor of dopamine, the effects of the structurally unrelated and pentedrone have no known medical norepinephrine transporters in the delta-9–THC, a Schedule I substance, use in the United States. On March 7, central nervous system. MPA is not and the main active ingredient of 2014, the DEA published a final order approved for medical use or controlled marijuana and numerous other

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Schedule I synthetic cannabinoids. DEPARTMENT OF HEALTH AND • If you want to submit a comment Synthetic cannabinoids are marketed HUMAN SERVICES with confidential information that you under the guise of ‘‘herbal incense,’’ and do not wish to be made available to the promoted by drug traffickers as legal Food and Drug Administration public submit the comment as a written/ paper submission and in the manner alternatives to marijuana. On May 11, [Docket No. FDA–2014–D–1862] 2016, XLR11 was permanently detailed (see ‘‘Written/Paper controlled as a Schedule I substance Recommended Warning for Over-the- Submissions’’ and ‘‘Instructions’’). under the CSA. As such, additional Counter Acetaminophen-Containing Written/Paper Submissions permanent controls will not be Drug Products and Labeling Submit written/paper submissions as necessary to fulfill U.S. obligations if Statements Regarding Serious Skin follows: XLR–11 is controlled under Schedule II Reactions; Guidance for Industry; • Mail/Hand delivery/Courier (for of the 1971 Convention on Psychotropic Availability written/paper submissions): Division of Substances. AGENCY: Food and Drug Administration, Dockets Management (HFA–305), Food FDA, on behalf of the Secretary of HHS. and Drug Administration, 5630 Fishers HHS, invites interested persons to Lane, Rm. 1061, Rockville, MD 20852. ACTION: Notice of availability. • submit comments on the notifications For written/paper comments from the United Nations concerning SUMMARY: The Food and Drug submitted to the Division of Dockets Management, FDA will post your these drug substances. FDA, in Administration (FDA) is announcing the comment, as well as any attachments, cooperation with the National Institute availability of a guidance for industry except for information submitted, on Drug Abuse, will consider the entitled ‘‘Recommended Warning for Over-the-Counter Acetaminophen- marked and identified, as confidential, comments on behalf of HHS in if submitted as detailed in evaluating the WHO scheduling Containing Drug Products and Labeling Statements Regarding Serious Skin ‘‘Instructions.’’ recommendations. Then, under section Instructions: All submissions received Reactions.’’ This guidance is intended to 201(d)(2)(B) of the CSA, HHS will must include the Docket No. FDA– inform manufacturers, members of the recommend to the Secretary of State 2014–D–1862 for ‘‘Recommended what position the United States should medical and scientific community, and Warning for Over-the-Counter take when voting on the other interested persons that at this time Acetaminophen-Containing Drug FDA does not intend to take action recommendations for control of Products and Labeling Statements against the marketing of single- and substances under the Psychotropic Regarding Serious Skin Reactions; combination-ingredient, Guidance for Industry.’’ Received Convention at the CND meeting in acetaminophen-containing, March 2017. comments will be placed in the docket nonprescription (commonly referred to and, except for those submitted as Comments regarding the WHO as over-the-counter (OTC)) drug ‘‘Confidential Submissions,’’ publicly recommendations for control of U– products bearing a warning as described viewable at http://www.regulations.gov 47700 and Butyrylfentanyl under the in the guidance alerting consumers that or at the Division of Dockets 1961 Single Convention will also be the use of acetaminophen may cause Management between 9 a.m. and 4 p.m., forwarded to the relevant Agencies for severe skin reactions. Monday through Friday. consideration in developing the U.S. DATES: Submit either electronic or • Confidential Submissions—To position regarding narcotic substances written comments on Agency guidances submit a comment with confidential at the CND meeting. at any time. information that you do not wish to be made publicly available, submit your IV. Opportunity for Public Meeting ADDRESSES: You may submit comments as follows: comments only as a written/paper submission. You should submit two FDA does not presently plan to hold Electronic Submissions a public meeting. If any person believes copies total. One copy will include the that, in addition to written comments, a Submit electronic comments in the information you claim to be confidential public meeting would contribute to the following way: with a heading or cover note that states • development of the U.S. position on the Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS substances to be considered for control www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The under the Psychotropic Convention, a instructions for submitting comments. Agency will review this copy, including Comments submitted electronically, the claimed confidential information, in request for a public meeting and the including attachments, to http:// its consideration of comments. The reasons for such a request should be www.regulations.gov will be posted to second copy, which will have the FOR sent to James R. Hunter (see the docket unchanged. Because your claimed confidential information FURTHER INFORMATION CONTACT) on or comment will be made public, you are redacted/blacked out, will be available before January 23, 2017. solely responsible for ensuring that your for public viewing and posted on http:// Dated: January 5, 2017. comment does not include any www.regulations.gov. Submit both Leslie Kux, confidential information that you or a copies to the Division of Dockets Associate Commissioner for Policy. third party may not wish to be posted, Management. If you do not wish your such as medical information, your or name and contact information to be [FR Doc. 2017–00373 Filed 1–10–17; 8:45 am] anyone else’s Social Security number, or made publicly available, you can BILLING CODE 4164–01–P confidential business information, such provide this information on the cover as a manufacturing process. Please note sheet and not in the body of your that if you include your name, contact comments and you must identify this information, or other information that information as ‘‘confidential.’’ Any identifies you in the body of your information marked as ‘‘confidential’’ comments, that information will be will not be disclosed except in posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other

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