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regulated drug products on a variety of drug labeling, emerging risk information. No comments were topics related to consumer, patient, or communications, patient labeling, received. healthcare professional perceptions and online sales of medical products, and Annually, we project that 20 studies use of drug products and related consumer and professional education. will be initiated using 160 focus groups materials. These materials may include, In the Federal Register of July 17, with an average of 9 persons per group. but are not limited to direct-to- We assume each focus group will last an 2019 (84 FR 34186), FDA published a consumer prescription drug promotion, average of 1.75 hours. 60-day notice requesting public physician labeling of prescription drugs, We estimate the burden for the guides, over-the-counter comment on the proposed collection of information collection as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response

Focus Group Study ...... 1,440 1 1,440 1.75 2,520 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information Vienna, Austria, in March 2020. This comments, that information will be collection since our last request for notice is issued under the Controlled posted on https://www.regulations.gov. OMB approval, we have made no Substances Act (CSA). • If you want to submit a comment adjustments to our burden estimate. DATES: Submit either electronic or with confidential information that you Dated: December 18, 2019. written comments by January 30, 2020. do not wish to be made available to the Lowell J. Schiller, The short time period for the public, submit the comment as a written/paper submission and in the Principal Associate Commissioner for Policy. submission of comments is needed to ensure that Health and Human Services manner detailed (see ‘‘Written/Paper [FR Doc. 2019–28247 Filed 12–30–19; 8:45 am] (HHS) may, in a timely fashion, carry Submissions’’ and ‘‘Instructions’’). BILLING CODE 4164–01–P out the required action and be Written/Paper Submissions responsive to the United Nations. Submit written/paper submissions as DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments as follows. Please note that late, follows: HUMAN SERVICES • untimely filed comments will not be Mail/Hand Delivery/Courier (for Food and Drug Administration considered. Electronic comments must written/paper submissions): Dockets be submitted on or before January 30, Management Staff (HFA–305), Food and [Docket No. FDA–2019–N–5955] 2020. The https://www.regulations.gov Drug Administration, 5630 Fishers electronic filing system will accept Lane, Rm. 1061, Rockville, MD 20852. International Drug Scheduling; • For written/paper comments Convention on Psychotropic comments until 11:59 p.m. Eastern Time at the end of January 30, 2020. submitted to the Dockets Management Substances; Single Convention on Staff, FDA will post your comment, as Drugs; World Health Comments received by mail/hand delivery/courier (for written/paper well as any attachments, except for Organization; Scheduling information submitted, marked and Recommendations; AB-FUBINACA; 5F- submissions) will be considered timely if they are postmarked or the delivery identified, as confidential, if submitted AMB-PINACA; 5F-MDMB-PICA; 4-F- as detailed in ‘‘Instructions.’’ MDMB-BINACA; 4-CMC; N- service acceptance receipt is on or before that date. Instructions: All submissions received ethylhexedrone; alpha-PHP; DOC; must include the Docket No. FDA-2019- Crotonyl ; Valeryl Fentanyl; Electronic Submissions N-5955 for ‘‘International Drug Flualprazolam and Etizolam; Request Submit electronic comments in the Scheduling; Convention on for Comments following way: Psychotropic Substances; Single AGENCY: Food and Drug Administration, • Federal eRulemaking Portal: Convention on Narcotic Drugs; World HHS. https://www.regulations.gov. Follow the Health Organization; Scheduling ACTION: Notice. instructions for submitting comments. Recommendations; AB-FUBINACA; 5F- Comments submitted electronically, AMB-PINACA; 5F-MDMB-PICA; 4-F- SUMMARY: The Food and Drug including attachments, to https:// MDMB-BINACA; 4-CMC; N- Administration (FDA) is providing www.regulations.gov will be posted to ethylhexedrone; alpha-PHP; DOC; interested persons with the opportunity the docket unchanged. Because your Crotonyl Fentanyl; Valeryl Fentanyl; to submit written comments concerning comment will be made public, you are Flualprazolam and Etizolam; Request recommendations by the World Health solely responsible for ensuring that your for Comments.’’ Received comments, Organization (WHO) to impose comment does not include any those filed in a timely manner (see international manufacturing and confidential information that you or a ADDRESSES), will be placed in the docket distributing restrictions, under third party may not wish to be posted, and, except for those submitted as international treaties, on certain drug such as medical information, your or ‘‘Confidential Submissions,’’ publicly substances. The comments received in anyone else’s Social Security number, or viewable at https://www.regulations.gov response to this notice will be confidential business information, such or at the Dockets Management Staff considered in preparing the United as a manufacturing process. Please note between 9 a.m. and 4 p.m., Monday States’ position on these proposals for a that if you include your name, contact through Friday. meeting of the United Nations information, or other information that • Confidential Submissions—To Commission on Narcotic Drugs (CND) in identifies you in the body of your submit a comment with confidential

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information that you do not wish to be the schedules, the Secretary of State II. United Nations Notification made publicly available, submit your must transmit notice of such The formal notification from the comments only as a written/paper information to the Secretary of Health United Nations that identifies the drug submission. You should submit two and Human Services (Secretary of HHS). substances and explains the basis for the copies total. One copy will include the The Secretary of HHS must then publish scheduling recommendations is information you claim to be confidential a summary of such information in the reproduced as follows (non-relevant text with a heading or cover note that states Federal Register and provide removed): ‘‘THIS DOCUMENT CONTAINS opportunity for interested persons to Reference: NAR/CL.10/2019 CONFIDENTIAL INFORMATION.’’ The submit comments. The Secretary of HHS WHO/ECDD42; 1961C-Art.3, 1971C- Agency will review this copy, including must then evaluate the proposal and Art.2 CU 2019/462/DTA/SGB (A) the claimed confidential information, in furnish a recommendation to the its consideration of comments. The Secretary of State that shall be binding The Secretary-General of the United second copy, which will have the on the representative of the United Nations presents his compliments to the claimed confidential information States in discussions and negotiations Secretary of State of the United States of redacted/blacked out, will be available relating to the proposal. America and has the honour to inform for public viewing and posted on As detailed in the following the Government that in a letter dated 15 https://www.regulations.gov. Submit paragraphs, the Secretary of State has November 2019 the Director-General of both copies to the Dockets Management received notification from the Secretary- the World Health Organization (WHO), Staff. If you do not wish your name and General of the United Nations (the pursuant to article 3, paragraphs 1 and contact information to be made publicly Secretary-General) regarding ten 3 of the Single Convention on Narcotic available, you can provide this substances to be considered for control Drugs of 1961 as amended by the 1972 information on the cover sheet and not under the 1971 Convention. This Protocol (1961 Convention), and article in the body of your comments and you notification reflects the 2, paragraphs 1 and 4 of the Convention must identify this information as recommendation from the 42nd WHO on Psychotropic Substances of 1971 ‘‘confidential.’’ Any information marked Expert Committee for Drug Dependence (1971 Convention), notified the as ‘‘confidential’’ will not be disclosed (ECDD), which met in October 2019. In Secretary-General of the following except in accordance with 21 CFR 10.20 the Federal Register of September 10, recommendations: Substances recommended to be added and other applicable disclosure law. For 2019 (84 FR 47521), FDA announced the to Schedule I of the 1961 Convention: more information about FDA’s posting WHO ECDD review and invited of comments to public dockets, see 80 interested persons to submit Crotonyl fentanyl FR 56469, September 18, 2015, or access information for WHO’s consideration. chemical name: (2E)-N-phenyl-N-[1- the information at: https:// The full text of the notification from (2-phenylethyl)piperidin-4-yl]but-2- www.govinfo.gov/content/pkg/FR-2015- the Secretary-General is provided in enamide Valeryl fentanyl 09-18/pdf/2015-23389.pdf. section II. Section 201(d)(2)(B) of the chemical name: N-phenyl-N-[1-(2- Docket: For access to the docket to CSA requires the Secretary of HHS, after phenylethyl)piperidin-4- read background documents or the receiving a notification proposing yl]pentanamide electronic and written/paper comments scheduling, to publish a notice in the received, go to https:// Federal Register to provide the Substance recommended to be added www.regulations.gov and insert the opportunity for interested persons to to Schedule I of the 1971 Convention: docket number, found in brackets in the submit information and comments on DOC heading of this document, into the the proposed scheduling action. chemical name: 1-(4-chloro-2,5- ‘‘Search’’ box and follow the prompts The United States is also a party to dimethoxyphenyl)propan-2-amine and/or go to the Dockets Management the 1961 Single Convention on Narcotic Substances recommended to be added Staff, 5630 Fishers Lane, Rm. 1061, Drugs (1961 Convention). The Secretary to Schedule II of the 1971 Convention: Rockville, MD 20852. of State has received a notification from AB-FUBINACA FOR FURTHER INFORMATION CONTACT: the Secretary-General regarding two chemical name: N-[1-amino-3-methyl- James R. Hunter, Center for Drug substances to be considered for control 1-oxobutan-2-yl]-1-[(4- Evaluation and Research, Controlled under this convention. The CSA does fluorophenyl)methyl]-1H-indazole- Substance Staff, Food and Drug not require HHS to publish a summary 3-carboxamide Administration, 10903 New Hampshire of such information in the Federal 5F-AMB-PINACA (5F-AMB, 5F-MMB- Ave., Bldg. 51, Rm. 5150, Silver Spring, Register. Nevertheless, to provide PINACA) MD 20993–0002, 301–796–3156, interested and affected persons an chemical name: methyl 2-{[1-(5- [email protected]. opportunity to submit comments fluoropentyl)-1H-indazole-3- SUPPLEMENTARY INFORMATION: regarding the WHO recommendations carbonyl]amino}-3-methylbutanoate for drugs under the 1961 Convention, 5F-MDMB-PICA (5F-MDMB-2201) I. Background the notification regarding these chemical name: methyl 2-{[1-(5- The United States is a party to the substances is also included in this fluoropentyl)-1H-indole-3- 1971 Convention on Psychotropic Federal Register notice. The comments carbonyl]amino}-3,3- Substances (1971 Convention). Section will be shared with other relevant dimethylbutanoate 201(d)(2)(B) of the CSA (21 U.S.C. Agencies to assist the Secretary of State 4F-MDMB-BINACA 811(d)(2)(B)) provides that when the in formulating the position of the chemical name: methyl 2-{[1-(4- United States is notified under Article 2 United States on the control of these fluorobutyl)-1H-indazole-3- of the 1971 Convention that the CND substances. The HHS recommendations carbonyl]amino}-3,3- proposes to decide whether to add a are not binding on the representative of dimethylbutanoate drug or other substance to one of the the United States in discussions and 4-CMC (4-chloromethcathinone; schedules of the 1971 Convention, negotiations relating to the proposal clephedrone) transfer a drug or substance from one regarding control of substances under chemical name: 1-(4-chlorophenyl)-2- schedule to another, or delete it from the 1961 Convention. (methylamino)propan-1-one

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N-Ethylhexedrone Ethylhexedrone, Alpha-PHP, DOC chemical name: 2-(ethylamino)-1- Flualprazolam, Etizolam. chemical name: 1-(4-chloro-2,5- phenylhexan-1-one Communications should be sent to the dimethoxyphenyl)propan-2-amine Alpha-PHP Executive Director of the United Nations To be added to Schedule II of the chemical name: 1-phenyl-2- Office on Drugs and Crime, c/o Convention on Psychotropic Substances (pyrrolidine-1-yl)hexan-1-one Secretary, Commission on Narcotic (1971): Substances recommended to be added Drugs, P.O. Box 500, 1400 Vienna, AB-FUBINACA to Schedule IV of the 1971 Convention: Austria, email: [email protected] (fax: chemical name: N-[1-amino-3-methyl- Flualprazolam +43–1–26060–5885), no later than by 31 1-oxobutan-2-yl]-1-[(4- chemical name: 8-chloro-6-(2- January 2020. fluorophenyl)methyl]-1H-indazole- fluorophenyl)-1-methyl-4H- 2 December 2019 3-carboxamide benzo[f][1,2,4]triazolo[4,3-a][1,4] His Excellency, 5F-AMB-PINACA (5F-AMB, 5F-MMB- diazepine Mr. Rex Tillerson, PINACA) Etizolam Secretary of State of the United States of chemical name: methyl 2-{[1-(5- chemical name: 4-(2-chlorophenyl)-2- America fluoropentyl)-1H-indazole-3- ethyl-9-methyl-6H- } Annex I carbonyl]amino -3-methylbutanoate thieno[3,2f][1,2,4]triazolo[4,3 5F-MDMB-PICA (5F-MDMB-2201) a][1,4]diazepine Letter Addressed to the Secretary- chemical name: methyl 2-{[1-(5- In accordance with the provisions of General of the United Nations From the fluoropentyl)-1H-indole-3- article 3, paragraph 2 of the 1961 Director-General of the World Health carbonyl]amino}-3,3- Convention and article 2, paragraph 2 of Organization dimethylbutanoate the 1971 Convention, the Secretary- ‘‘The Forty-second meeting of the 4-F-MDMB-BINACA General hereby transmits the WHO Expert Committee on Drug chemical name: methyl 2-{[1-(4- notification as annex I to the present Dependence was convened from 21 to fluorobutyl)-1H-indazole-3- note. In connection with the 25 October 2019 at WHO headquarters carbonyl]amino}-3,3- notification, WHO also submitted a in Geneva. The objective of this meeting dimethylbutanoate summary of the rationale of the was to carry out an in-depth evaluation 4-CMC (4-chloromethcathinone; recommendations which is hereby of psychoactive substances in order to clephedrone) transmitted as annex II. For time determine whether WHO should chemical name: 1-(4-chlorophenyl)-2- reasons, this notification and its recommend these substances to be (methylamino)propan-1-one annexes I and II are transmitted in placed under international control or if N-ethylhexedrone English only. The notification and its their level of control should be changed. chemical name: 2-(ethylamino)-1- annexes will be transmitted in French The Forty-second Meeting reviewed phenylhexan-1-one and Spanish as soon as available. thirteen psychoactive substances, five of Alpha-PHP Also in accordance with the same which are synthetic , four chemical name: 1-phenyl-2- provisions, the notification from WHO synthetic stimulants, two fentanyl (pyrrolidine-1-yl)hexan-1-one will be brought to the attention of the analogues, and two benzodiazepines. In To be added to Schedule IV of the 63rd session of the Commission on addition, the Meeting carried out a pre- Convention on Psychotropic Substances Narcotic Drugs (2–6 March 2020) in a review of preparations of (1971): pre-session document that will be made , , Flualprazolam available in the six official languages of , , chemical name: 8-chloro-6-(2- the United Nations on the website of the nicocodine, , fluorophenyl)-1-methyl-4H- 63rd session of the CND: https:// and that are listed in benzo[f][1,2,4]triazolo[4,3- www.unodc.org/unodc/en/ Schedule III of the 1961 Convention on a][1,4]diazepine commissions/CND/session/63_Session_ Narcotic Drugs. Etizolam 2020/session-63-of-the-commission-on- With reference to Article 3, chemical name: 4-(2-chlorophenyl)-2- narcotic-drugs.html. paragraphs 1 and 3 of the Single ethyl-9-methyl-6H- In order to assist the Commission in Convention on Narcotic Drugs (1961), as thieno[3,2f][1,2,4]triazolo [4,3- reaching a decision, it would be amended by the 1972 Protocol, and a][1,4]diazepine appreciated if the Government could Article 2, paragraphs 1 and 4 of the To be kept under surveillance: communicate any comments it Convention on Psychotropic Substances considers relevant to the possible (1971), I am pleased to submit APINACA (AKB-48) scheduling of substances recommended recommendations of the Forty-second chemical name: N-(adamantan-1-yl)- by WHO to be placed under Meeting of ECDD as follows: 1-pentyl-1H-indazole-3- international control under the 1961 To be added to Schedule I of the carboxamide Convention, namely: Crotonyl fentanyl, Single Convention on Narcotic Drugs To proceed to critical review: Valeryl fentanyl, as well as any (1961): —Preparations of acetyldihydrocodeine, economic, social, legal, administrative Crotonyl fentanyl codeine, dihydrocodeine, or other factors that it considers relevant chemical name: (2E)-N-phenyl-N-[1- ethylmorphine, nicocodine, to the possible scheduling of substances (2-phenylethyl)piperidin-4-yl]but-2- nicodicodine, norcodeine and recommended by WHO to be placed enamide pholcodine listed in Schedule III of under international control under the Valeryl fentanyl the 1961 Single Convention on 1971 Convention, namely: DOC, AB- chemical name: N-phenyl-N-[1-(2- Narcotic Drugs FUBINACA, 5F-AMB-PINACA (5F- phenylethyl)piperidin-4- The assessments and findings on AMB, 5F-MMB-PINACA), 5F-MDMB- yl]pentanamide which these recommendations are based PICA (5F-MDMB-2201), 4F-MDMB- To be added to Schedule I of the are set out in detail in the report of the BINACA, 4-CMC (4- Convention on Psychotropic Substances Forty-second Meeting of the WHO chloromethcathinone; clephedrone), N- (1971): Expert Committee on Drug Dependence.

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A summary of the rationale of these phenylethyl)piperidin-4- serious risk to public health, it is recommendations is attached in Annex yl]pentanamide. recommended that it be controlled 1 of this letter. Valeryl fentanyl binds to mu under Schedule I of 1971 Convention on I am very pleased with the ongoing receptors and acts as an opioid agonist. Psychotropic Substances. collaboration between WHO, the United In animal models, valeryl fentanyl Substances recommended to be Nations Office on Drugs and Crime suppresses opioid withdrawal scheduled in Schedule II of the (UNODC) and the International symptoms, produces antinociception Convention on Psychotropic Substances Control Board (INCB) and in and has actions predictive of (1971): particular, how this collaboration has -like subjective effects. The AB-FUBINACA benefited the work of the WHO Expert blocks the The chemical name for AB- Committee on Drug Dependence and effects of valeryl fentanyl. This FUBINACA is N-[1-amino-3-methyl-1- more generally, the implementation of pharmacological profile indicates that oxobutan-2-yl]-1-[(4- the operational recommendations of the valeryl fentanyl is an opioid and fluorophenyl)methyl]-1H-indazole-3- United Nations General Assembly comparative studies suggest that it has carboxamide. Special Session (UNGASS) 2016.’’ a potency less than that of fentanyl. In common with other synthetic Valeryl fentanyl has been detected in Annex II cannabinoids, AB-FUBINACA is a full biological samples from a small number agonist at the CB1 receptor Summary of the Rationale for the of deaths and cases of driving under the that mediates the psychoactive effects of Recommendations of the 42nd Expert influence of drugs. cannabinoids. In animal studies, it Committee on Drug Dependence Valeryl fentanyl has been detected in produced central nervous system seizures from countries across several Substances recommended to be added depression and other typical regions. It has no veterinary or medical to Schedule I of the Single Convention cannabinoid behavioural effects and had use. on Narcotic Drugs (1961), as amended actions predictive of cannabinoid Based on the evidence of its opioid by the 1972 Protocol: subjective effects. mechanism of action and similarity to AB-FUBINACA produces neurological Crotonyl fentanyl drugs such as fentanyl that are signs in animals that are indicative of The chemical name for crotonyl controlled under Schedule I of the toxicity, including seizures, fentanyl is (2E)-N-phenyl-N-[1-(2- Single Convention on Narcotic Drugs, it hyperreflexia and aggression. Based on phenylethyl)piperidin-4-yl]but-2- is recommended that valeryl fentanyl its mechanism of action, it would be enamide. also be controlled under Schedule I of expected to produce a range of adverse Crotonyl fentanyl binds to mu opioid the Single Convention on Narcotic effects in human users that include receptors and acts as an opioid agonist. Drugs (1961). tachycardia, nausea, vomiting, In animal models, crotonyl fentanyl Substance recommended to be added confusion and hallucinations. There are produces antinociception, actions to Schedule I of the Convention on a large number of cases of intoxication predictive of oxycodone-like subjective Psychotropic Substances (1971): resulting from AB-FUBINACA, often in effects and both central nervous system DOC combination with other drugs, and at stimulation and depression. The opioid DOC is also known as 4-chloro-2,5- least one death has been reported that antagonist naltrexone blocks the effects DMA or 2,5-dimethoxy-4- is attributable to the effects of AB- of crotonyl fentanyl. This chloroamphetamine. Its chemical name FUBINACA. pharmacological profile indicates that is 1-(4-chloro-2,5- AB-FUBINACA use has been reported crotonyl fentanyl is an opioid and dimethoxyphenyl)propan-2-amine. in over 30 countries across different comparative studies suggest that it has DOC is an agonist at the serotonergic regions. It has no veterinary or medical a potency intermediate between 5–HT2A receptor, a mechanism it shares use. oxycodone and fentanyl. with such as LSD. Based on its capacity to produce a Consistent with the results from In animal models, DOC has actions state of dependence, its ability to animal studies, the effects of crotonyl predictive of hallucinogenic subjective produce central nervous system fentanyl were reversed by an opioid effects (similar to LSD and DOM) and depression and the evidence that it is antagonist in a clinical admission due to shows evidence of rewarding effects. It abused so as to constitute a public overdose. Due to its opioid mechanism can produce both central nervous health and social problem, it is of action, crotonyl fentanyl has the system stimulation and depression. recommended that AB-FUBINACA be potential to be associated with Based on clinical admissions due to controlled under the 1971 Convention substantial harm. overdose, the adverse effects associated on Psychotropic Substances. As it has Crotonyl fentanyl has been found in with use of DOC include agitation, no medical use and its use constitutes seized material from countries across aggression, hallucinations, tachycardia, a substantial risk to public health, it is several regions. It has no veterinary or hyperthermia and seizures. recommended that it be controlled medical use. DOC has been detected in 40 under Schedule II of 1971 Convention Based on its opioid mechanism of countries. It has no veterinary or on Psychotropic Substances. action and similarity to drugs such as medical use. 5F-AMB-PINACA oxycodone and fentanyl that are Based on its similarity in mechanism 5F-AMB-PINACA is also known as controlled under Schedule I of the of action and effects to currently 5F-AMB and 5F-MMB-PINACA. Its Single Convention on Narcotic Drugs, it scheduled hallucinogens such as LSD chemical name is methyl 2-{[1-(5- is recommended that crotonyl fentanyl and DOM, and the evidence that it is fluoropentyl)-1H-indazole-3- also be controlled under Schedule I of abused so as to constitute a public carbonyl]amino}-3-methylbutanoate. the Single Convention on Narcotic health and social problem, it is In common with other synthetic Drugs (1961). recommended that DOC be controlled cannabinoids, 5F-AMB-PINACA is a full Valeryl fentanyl under the 1971 Convention on agonist at the cannabinoid CB1 receptor The chemical name for valeryl Psychotropic Substances. As it has no that mediates the psychoactive effects of fentanyl is N-phenyl-N-[1-(2- medical use and its use constitutes a cannabinoids. In animal studies it

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produced central nervous system was also detected in biological fluids 4-CMC depression and had actions predictive of from the victims. 4-CMC is also known as 4- cannabinoid-like subjective effects. 5F- 5F-MDMB-PICA has been detected in chloromethcathinone and clephedrone. AMB-PINACA produces impairment of 20 countries. It has no veterinary or Its chemical name is 1-(4-chlorophenyl)- memory and seizures in animals. medical use. 2-(methylamino)propan-1-one. 5F-AMB-PINACA use has been Based on its mechanism of action, 5F- In common with other stimulants associated with a number of cases of MDMB-PICA has the ability to produce used non-medically, 4-CMC increases fatal and non-fatal intoxication often in a state of dependence and central neuronal concentrations of the combination with other drugs. In a case nervous system depression. There is neurotransmitter dopamine. It also has of non-fatal intoxication due to 5F- evidence that it is abused so as to effects on serotonin and, to a lesser AMB-PINACA alone, the effects constitute a public health and social extent, noradrenaline. included cognitive impairment, slowed problem. It is therefore recommended In animal models, 4-CMC has effects movement, slurred speech and poor that 5F-MDMB-PICA be controlled predictive of abuse potential, including coordination. Based on its mechanism under the 1971 Convention on actions predictive of MDMA-like of action, it would also be expected to Psychotropic Substances. As it has no subjective effects and stimulation of produce a range of other effects in medical use and its use constitutes a brain reward centres. It also produces human users that include tachycardia, substantial risk to public health, it is central nervous system stimulation. nausea, vomiting, confusion and recommended that it be controlled Users of the drug report effects similar hallucinations. 5F-AMB-PINACA has under Schedule II of the 1971 to other stimulants, particularly MDMA- Convention on Psychotropic been identified as a causal factor in like effects, including increased energy, Substances. motor vehicle accidents, some of which mood elevation and increased were fatal. 4F-MDMB-BINACA sociability. 5F-AMB-PINACA use has been 4F-MDMB-BINACA is also known as 4-CMC use has been associated with reported in over 30 countries across 4F-MDMB-BUTINACA. Its chemical adverse effects typical of stimulant name is methyl 2-{[1-(4-fluorobutyl)-1H- drugs, including tachycardia, agitation different regions. It has no veterinary or } medical use. indazole-3-carbonyl]amino -3,3- and impaired movement. Based on these dimethylbutanoate. effects and its mechanism of action, Based on its capacity to produce a In common with other synthetic state of dependence, its ability to major risks associated with use of this cannabinoids, 4F-MDMB-BINACA is a drug will include cardiac failure and produce central nervous system full agonist at the CB1 receptor that depression and the evidence that it is psychosis. In association with other mediates the psychoactive effects of drugs, 4-CMC has been involved in abused so as to constitute a public cannabinoids. health and social problem, it is fatalities due to overdose, suicide and Self-reported effects provided by traffic accidents. It has been detected in recommended that 5F-AMB-PINACA be individuals who had used cannabinoid controlled under the 1971 Convention used syringes, indicating the potential products that included 4F-MDMB- for injection related health problems in on Psychotropic Substances. As it has BINACA as the major constituent, no medical use and its use constitutes association with its use. included auditory and visual 4-CMC has been detected in many a substantial risk to public health, it is hallucinations, vomiting, paranoia, countries across different regions. It has recommended that it be controlled euphoria, relaxation, irregular heartbeat, no veterinary or medical use. under Schedule II of the 1971 agitation, confusion, insomnia, and Based on its mechanism of action and Convention on Psychotropic chest pain. These effects are consistent effects, 4-CMC has the ability to produce Substances. with the cannabinoid full agonist a state of dependence and central 5F-MDMB-PICA mechanism of action of 4F-MDMB- nervous system stimulation. There is 5F-MDMB-PICA is also known as 5F- BINACA. Its use has been associated evidence that it is abused so as to MDMB-2201. Its chemical name is with a number of fatal and non-fatal constitute a public health and social intoxications and of cases of driving methyl 2-{[1-(5-fluoropentyl)-1H-indole- problem. It is therefore recommended under the influence of drugs. However, 3-carbonyl]amino}-3,3- that 4-CMC be controlled under the other have been dimethylbutanoate. 1971 Convention on Psychotropic detected in most of these cases. Substances. As it has no medical use In common with other synthetic 4F-MDMB-BINACA has been detected and its use constitutes a substantial risk cannabinoids, 5F-MDMB-PICA is a full in a small number of countries to date, to public health, it is recommended that agonist at the cannabinoid CB1 receptor but its use may be increasing. It has no it be controlled under Schedule II of the that mediates the psychoactive effects of veterinary or medical use. cannabinoids. Based on its mechanism of action, 4F- 1971 Convention on Psychotropic Its use has been associated with a MDMB-BINACA has the ability to Substances. number of fatal and non-fatal produce a state of dependence and N-Ethylhexedrone intoxications that have been central nervous system depression. The chemical name for N- characterised by effects such as There is evidence that it is abused so as ethylhexedrone is 2-(ethylamino)-1- decreased mental status, agitated to constitute a public health and social phenylhexan-1-one. delirium and seizures. While 5F- problem. It is therefore recommended In common with other stimulants MDMB-PICA has been present in that 4F-MDMB-BINACA be controlled used non-medically, N-ethylhexedrone biological samples mostly in under the 1971 Convention on increases neuronal concentrations of the combination with other drugs, in at least Psychotropic Substances. As it has no neurotransmitter dopamine. It also has some of these cases 5F-MDMB-PICA has medical use and its use constitutes a effects on noradrenaline. been assessed as having a high substantial risk to public health, it is In preclinical models, N- contribution to the effects produced. It recommended that it be controlled ethylhexedrone has actions predictive of has been used by victims of three under Schedule II of the 1971 methamphetamine-like subjective apparent mass overdose events, but at Convention on Psychotropic effects and produces central nervous least one other synthetic cannabinoid Substances. system stimulation. Users of the drug

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report effects similar to other to constitute a public health and social as anxiolytic and anticonvulsant stimulants, including increased energy, problem. It is therefore recommended actions. Adverse effects include mood elevation, perceptual changes and that alpha-PHP be controlled under the drowsiness, ataxia, slurred speech, increased sociability. 1971 Convention on Psychotropic cognitive impairment and loss of Information on the adverse effects is Substances. As it has no medical use consciousness. limited, but the effects reported are and its use constitutes a substantial risk Etizolam use has been associated with consistent with the effects of stimulant to public health, it is recommended that a large number of deaths, generally drugs and include tachycardia, tremor, it be controlled under Schedule II of the along with another drug or drugs. seizures and hyperthermia. N- 1971 Convention on Psychotropic Benzodiazepines such as etizolam pose ethylhexedrone has been implicated as Substances. a significant risk when combined with the cause of at least one fatality and of Substances recommended to be as they can potentiate the cases of impaired driving. It has been scheduled in Schedule IV of the respiratory depressant effects of opioids. detected in used syringes, indicating the Convention on Psychotropic Substances Etizolam has been used in a number potential for injection related health (1971): of countries and in some of these problems in association with its use. Flualprazolam countries has been associated with N-ethylhexedrone has been detected The chemical name for flualprazolam reports of fatal and no-fatal intoxication in 30 countries across different regions. is 8-chloro-6-(2-fluorophenyl)-1-methyl- as well as cases of driving under the It has no veterinary or medical use. 4H-benzo[f][1,2,4]triazolo[4,3-a][1,4] influence. It has marketing Based on its mechanism of action and diazepine. authorization for medical use in three effects, N-ethylhexedrone has the ability Flualprazolam is chemically similar countries. to produce a state of dependence and to the benzodiazepines alprazolam and Based on its capacity to produce a central nervous system stimulation. triazolam and in animal models it state of dependence and central nervous There is evidence that it is abused so as produces the typical benzodiazepine system depression similar to other to constitute a public health and social effects of sedation, muscle relaxation controlled benzodiazepines, as well as problem. It is therefore recommended and anticonvulsant actions. Users have evidence that it is abused so as to that N-ethylhexedrone be controlled reported effects such as sedation, constitute a public health and social under the 1971 Convention on disinhibition and memory impairment problem, it is recommended that Psychotropic Substances. As it has no that are common with benzodiazepines etizolam be controlled under Schedule medical use and its use constitutes a and have described it as similar to IV of the 1971 Convention on substantial risk to public health, it is alprazolam and clonazepam. Psychotropic Substances. recommended that it be controlled In toxicology reports, flualprazolam Substance recommended for under Schedule II of the 1971 has been documented as contributing to surveillance: Convention on Psychotropic forensic and clinical events, including APINACA Substances. fatal and non-fatal intoxications and The chemical name for APINACA Alpha-PHP cases of driving under the influence. It (also known as AKB-48) is N- Alpha-PHP is also known as alpha- has no medical use. (adamantan-1-yl)-1-pentyl-1H-indazole- pyrrolidinohexanophenone. Its There is limited information on the 3-carboxamide. It was previously chemical name is 1-phenyl-2- extent of global use of flualprazolam reviewed at the 36th meeting of the (pyrrolidine-1-yl)hexan-1-one. with most reported identifications WHO Expert Committee on Drug In common with other stimulants coming from two countries. There are Dependence in 2014 but was not used non-medically, alpha-PHP numerous reports of its use on internet recommended for control at that time. increases neuronal concentrations of the forums. In common with other synthetic neurotransmitter dopamine. It also has Based on its capacity to produce a cannabinoids, APINACA is an agonist at effects on noradrenaline. state of dependence and central nervous the CB1 receptor that mediates the In animal models, alpha-PHP has system depression similar to the psychoactive effects of cannabinoids. In effects predictive of abuse and controlled benzodiazepine alprazolam, animal studies it produced central dependence potential, including actions which is controlled under Schedule IV nervous system depression and had predictive of methamphetamine-like of the1971 Convention on Psychotropic actions predictive of cannabinoid-like subjective effects and reinforcing Substances, as well as evidence that it subjective effects. properties. It produces central nervous is likely to be abused so as to constitute APINACA produces neurological system stimulation in animals. Users of a public health and social problem, it is signs in animals that include seizures, the drug report effects similar to other recommended that flualprazolam be hyperreflexia and aggression. However, stimulants, including increased energy, controlled under Schedule IV of the there are no studies of the adverse mood elevation, perceptual changes and 1971 Convention on Psychotropic effects of APINACA in human users of appetite suppression. Substances. the drug and no available information The adverse effects of the drug Etizolam regarding fatal or non-fatal include tachycardia, paranoia and The chemical name for etizolam is 4- intoxications. hallucinations. It has been identified as (2-chlorophenyl)-2-ethyl-9-methyl-6H- APINACA use has been reported in a the cause of multiple deaths and clinical thieno[3,2-f][1,2,4]triazolo[4,3- number of countries but its use has been admissions. a][1,4]diazepine. It has been previously declining since 2015 and it is now Alpha-PHP has been detected in over reviewed by the ECDD, most recently at detected very infrequently if at all. 20 countries across different regions. It its 39th meeting in 2017. Owing to the lack of significantly has no veterinary or medical use. Etizolam is an agonist at the more information since the review Based on its mechanism of action and benzodiazepine site on the GABAA conducted by the 36th ECDD in 2014, effects, alpha-PHP has the ability to receptor, inducing central nervous and considering the current produce a state of dependence and system depression. It has typical insufficiency of data regarding central nervous system stimulation. benzodiazepine effects that include dependence, abuse and risks to public There is evidence that it is abused so as sedation and muscle relaxation as well health (including risks to the

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individual), the Committee ethylmorphine, nicocodine, with psychedelic effects. Law recommended that APINACA be kept nicodicodine, norcodeine, and enforcement has encountered DOC in under surveillance. pholcodine when compounded with tablet, capsule, powder, liquid, and Preparations recommended for critical one or more other ingredients and blotter paper forms. Its use has been review: containing not more than 100 associated with at least one death. DOC —Preparations of acetyldihydrocodeine, milligrams of the drug per dosage unit has no currently accepted medical use codeine, dihydrocodeine, and with a concentration of not more in treatment in the United States. DOC ethylmorphine, nicocodine, than 2.5 per cent in undivided is not controlled under the CSA but is nicodicodine, norcodeine and preparations. a Schedule I controlled substance in the state of Florida. As such, additional pholcodine listed in Schedule III of III. Discussion the 1961 Single Convention on permanent controls will be necessary to Narcotic Drugs Although WHO has made specific fulfill United States obligations if DOC scheduling recommendations for each of is controlled under Schedule I of the The Committee considered a pre- the drug substances, the CND is not review of the following preparations 1971 Convention. obliged to follow the WHO AB-FUBINACA (chemical name: N-(1- listed in Schedule III of the 1961 Single recommendations. Options available to amino-3-methyl-1-oxobutan-2-yl)-1-(4- Convention on Narcotic Drugs: the CND for substances considered for fluorobenzyl)-1H-indazole-3- acetyldihydrocodeine, codeine, control under the 1971 Convention carboxamide) is a synthetic cannabinoid dihydrocodeine, ethylmorphine, include the following: (1) Accept the that is a potent full agonist at CB1 nicocodine, nicodicodine, norcodeine WHO recommendations; (2) accept the receptors. This substance functionally and pholcodine, when compounded recommendations to control but control (biologically) mimics the effects of with one or more other ingredients and the drug substance in a schedule other structurally unrelated THC, a Schedule containing not more than 100 than that recommended; or (3) reject the I substance under the CSA, and the milligrams of the drug per dosage unit recommendations entirely. main psychoactive chemical constituent and with a concentration of not more Crotonyl fentanyl (chemical name: N- in . Synthetic cannabinoids than 2.5 per cent in undivided (1-phenethylpiperidin-4-yl)-N- have been marketed under the guise of preparations. phenylbut-2-enamide) and valeryl ‘‘herbal incense,’’ and promoted by drug These preparations have not been fentanyl (chemical name: N-(1- traffickers as legal alternatives to previously reviewed. The ECDD phenethylpiperidin-4-yl)-N- cannabis. AB-FUBINACA use has been Secretariat commissioned a pre-review phenylpentanamide) are synthetic associated with serious adverse events of these preparations, on the basis of opioids that have a pharmacological including death in the United States. concerns regarding abuse and harm of profile similar to other Schedule I and There are no commercial or approved preparations of codeine that were II opioid substances controlled under medical uses for AB-FUBINACA. On conveyed to the Secretariat. As many of the CSA such as cyclopropyl fentanyl, September 6, 2016, AB-FUBINACA was the substances listed in the first entry of fentanyl, and other related mu-opioid permanently placed as a Schedule I Schedule III of the 1961 Single receptor agonist substances. They are controlled substance under the CSA. As Convention are chemically and clandestinely produced and associated such, additional permanent controls pharmacologically similar to codeine, with adverse events typically associated will not be necessary to fulfill United the eight preparations were considered with opioid use such as respiratory States obligations if AB-FUBINACA is together. depression, anxiety, constipation, controlled under Schedule II of the 1971 These preparations have been tiredness, hallucinations, and Convention. marketed and used as antitussive withdrawal. Crotonyl fentanyl and 5F-AMB (5F-AMB-PINACA, 5F-MMB- medicines and for mild to valeryl fentanyl have been encountered PINACA) (chemical name: methyl 2-(1- moderate pain. In many countries these by law enforcement and/or reported in (5-fluoropentyl)-1H-indazole-3- preparations are available without the scientific literature by public health carboxamido)-3-methylbutanoate) is a medical prescription. The active officials as being illicitly distributed and synthetic cannabinoid that is a potent substances in the preparations are abused. Crotonyl fentanyl and valeryl full agonist at CB1 receptors. This opioids and all substances themselves fentanyl have no commercial or substance functionally (biologically) are controlled under Schedule II of the currently accepted medical uses in the mimics the effects of THC, a Schedule 1961 Single Convention on Narcotic United States. On February 1, 2018, I substance under the CSA, and the Drugs. Misuse of and dependence on valeryl fentanyl was temporarily placed main psychoactive chemical constituent preparations of codeine and into Schedule I of the CSA. The in cannabis. Synthetic cannabinoids dihydrocodeine have been well chemical structure of crotonyl fentanyl have been marketed under the guise of described. The pre-review suggested defines it as a fentanyl-related ‘‘herbal incense,’’ and promoted by drug that there may be less evidence substance, as defined in 21 CFR traffickers as legal alternatives to regarding the other preparations. The 1308.11(h)(30); therefore, crotonyl cannabis. The use of synthetic Committee also noted evidence of fentanyl was temporarily controlled as a cannabinoids, including, 5F–AMB has separation of the opioid drug such as Schedule I controlled substance under been associated with nausea and codeine from the other ingredients in the CSA as of February 6, 2018. As such, vomiting, shortness of breath or these preparations by people misusing additional controls will be necessary to depressed breathing, hypertension, these preparations. fulfill United States obligations if tachycardia, chest pain, muscle Based on the evidence available crotonyl fentanyl and valeryl fentanyl twitching, acute renal failure, anxiety, regarding dependence, abuse and risks are placed in Schedules I of the Single agitation, psychosis, suicidal ideation, to public health, the Committee Convention on Narcotic Drugs (1961). and/or cognitive impairment. There are recommended a critical review of the DOC (chemical names: 2,5- no commercial or approved medical following preparations included in Dimethoxy-4-chloroamfetamine; 2,5- uses for 5F–AMB. On April 8, 2019, a Schedule III of the 1961 Convention at dimethoxy-4-chloroamphetamine; 1-(4- Drug Enforcement Administration a future meeting: acetyldihydrocodeine, chloro-2,5-dimethoxyphenyl)propan-2- Notice of Proposed Rulemaking codeine, dihydrocodeine, amine) is a hallucinogenic substance proposed permanently placing 5F–AMB

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into Schedule I of the CSA. As such, 4-CMC (4-chloromethcathinone; on Drug Abuse, will consider the additional permanent controls will not clefedrone, clephedrone) (chemical comments on behalf of HHS in be necessary to fulfill United States name: 1-(4-chlorophenyl)-2- evaluating the WHO scheduling obligations if 5F–AMB is controlled (methylamino)propan-1-one) is a recommendations. Then, under section under Schedule II of the 1971 synthetic cathinone. 4-CMC produces 201(d)(2)(B) of the CSA, HHS will Convention. central nervous system stimulant effects recommend to the Secretary of State 5F-MDMB-PICA (5F-MDMB-2201) and is abused for its psychoactive what position the United States should (chemical name: methyl 2-(1-(5- properties. 4-CMC abuse has been take when voting on the fluoropentyl)-1H-indazole-3- associated with adverse health effects. recommendations for control of carboxamido)-3,3-dimethylbutanoate) is 4-CMC has no currently accepted substances under the 1971 Convention a synthetic cannabinoid that has been medical use in treatment in the United at the CND meeting in March 2020. sold online and used to mimic the States. 4-CMC is not controlled under Comments regarding the WHO biological effects of THC, the main the CSA, but it is considered a Schedule recommendations for control of crotonyl psychoactive chemical constituent in I controlled substance by a number of fentanyl and valeryl fentanyl; under the cannabis. Research and clinical reports states in the United States. As such, 1961 Single Convention will also be have demonstrated that synthetic additional permanent controls will be forwarded to the relevant Agencies for cannabinoids are applied onto plant necessary to fulfill United States consideration in developing the United material so that the material may be obligations if 4-CMC is controlled under States position regarding narcotic smoked as users attempt to obtain a Schedule II of the 1971 Convention. substances at the CND meeting. euphoric and psychoactive ‘‘high.’’ N-Ethylhexedrone (chemical name: 2- Synthetic cannabinoids have been (ethylamino)-1-phenylhexan-1-one; Dated: December 23, 2019. marketed under the guise of ‘‘herbal NEH, hexen, Ethyl-Hex) and alpha-PHP Lowell J. Schiller, incense,’’ and promoted by drug (chemical name: 1-phenyl-2-(pyrrolidin- Principal Associate Commissioner for Policy. traffickers as legal alternatives to 1-yl)hexan-1-one; PV-7, a- [FR Doc. 2019–28269 Filed 12–30–19; 8:45 am] cannabis. 5F-MDMB-PICA has been pyrrolidinohexanophenone) are BILLING CODE 4164–01–P associated with law enforcement synthetic cathinones. N-Ethylhexedrone seizures and overdoses requiring and alpha-PHP produce central nervous emergency medical intervention. On system stimulant effects and are abused DEPARTMENT OF HEALTH AND April 16, 2019, 5F-MDMB-PICA was for their psychoactive properties. N- HUMAN SERVICES temporarily controlled as a Schedule I Ethylhexedrone and alpha-PHP have substance under the CSA. As such, been associated with adverse health Advisory Council on Alzheimer’s additional permanent controls will be effects leading to emergency department Research, Care, and Services; Meeting necessary to fulfill United States admissions, and deaths. N- AGENCY: Assistant Secretary for obligations if 5F-MDMB-PICA is Ethylhexedrone and alpha-PHP have no Planning and Evaluation, HHS. controlled under Schedule II of the 1971 currently accepted medical use in ACTION: Notice of meeting. Convention. treatment in the United States. On July 4F-MDMB-BINACA (4F-ADB) 18, 2019, N-Ethylhexedrone and alpha- SUMMARY: This notice announces the (chemical name: methyl 2-(1-(4- PHP were temporarily controlled as a public meeting of the Advisory Council fluorobutyl)-1H-indazole-3- Schedule I substance under the CSA. As on Alzheimer’s Research, Care, and carboxamido)-3,3-dimethylbutanoate) is such, additional permanent controls Services (Advisory Council). The a synthetic cannabinoid that is a potent will be necessary to fulfill United States Advisory Council provides advice on full agonist at CB1 receptors. This obligations if N-Ethylhexedrone and how to prevent or reduce the burden of substance functionally (biologically) alpha-PHP are controlled under Alzheimer’s disease and related mimics the effects of THC, a Schedule Schedule II of the 1971 Convention. dementias on people with the disease I substance, and the main psychoactive Flualprazolam and etizolam belong to and their caregivers. During the January constituent in cannabis. 4F-MDMB- a class of substances known as 27, 2020 meeting, an invited panel will BINACA has been encountered in benzodiazepines. Benzodiazepines present lessons from epidemiology on numerous synthetic cannabinoid produce central nervous system understanding current rates of products that are smoked for their depression and are commonly used to dementia, future trends, and potential psychoactive effects. Multiple law treat insomnia, anxiety, and seizure preventive strategies. The Advisory enforcement encounters of 4F-MDMB- disorders. Etizolam is currently Council will hear about the Department BINACA have been reported involving prescribed in some countries; however, of Defense’s Peer Reviewed Alzheimer’s overdose deaths, illicit use, and seizures neither drug substance is approved for Research Program as well as an update of drug evidence between December medical use in the United States. on the recommendations from the 2018 and February 2019. There are no Currently, flualprazolam and etizolam Alzheimer’s Disease-Related Dementias commercial or approved medical uses are not controlled under the CSA, but Research Summit. Federal workgroups for 4F-MDMB-BINACA. 4F-MDMB- are controlled in a number of states in will also provide updates on work BINACA is a positional isomer of 5F- the United States. As such, additional completed in the last quarter. AMB (chemical name: methyl 2-(1-(5- permanent controls will be necessary to fluoropentyl)-1H-indazole-3- fulfill United States obligations if DATES: The meeting will be held on carboxamido)-3-methylbutanoate), as flualprazolam and etizolam are January 27, 2020 from 9:30 a.m. to 4:15 defined by 21 CFR 1300.01, and has controlled under Schedule IV of the p.m. EST. been a Schedule I controlled substance 1971 Convention. ADDRESSES: The meeting will be held in under the CSA since April 10, 2017. As FDA, on behalf of the Secretary of Room 800 in the Hubert H. Humphrey such, additional permanent controls HHS, invites interested persons to Building, 200 Independence Avenue will not be necessary to fulfill United submit comments on the notifications SW, Washington, DC 20201. States obligations if 4F-MDMB-BINACA from the United Nations concerning Comments: Time is allocated on the is controlled under Schedule II of the these drug substances. FDA, in agenda to hear public comments. The 1971 Convention. cooperation with the National Institute time for oral comments will be limited

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