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37866 Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Notices

the Commonwealth of Northern Mariana Islands.

ANNUAL BURDEN ESTIMATES

Number of Average Instrument Number of responses per burden hours Total burden respondents respondent per response hours

Post-Expenditure Reporting Form ...... 56 1 110 6,160 Use of Post-Expenditure Reporting Form as Part of the Intended Use Plan 56 1 2 112

Estimated Total Annual Burden concerning abuse potential, actual comments, that information will be Hours: 6,272. abuse, medical usefulness, trafficking, posted on https://www.regulations.gov. Additional Information: Copies of the and impact of scheduling changes on • If you want to submit a comment proposed collection may be obtained by availability for medical use of 17 with confidential information that you writing to the Administration for substances. These comments will be do not wish to be made available to the Children and Families, Office of considered in preparing a response from public, submit the comment as a Planning, Research and Evaluation, 330 the United States to the World Health written/paper submission and in the C Street SW., Washington, DC 20201. Organization (WHO) regarding the abuse manner detailed (see ‘‘Written/Paper Attention Reports Officer. All liability and diversion of these . Submissions’’ and ‘‘Instructions’’). requests should be identified by the title WHO will use this information to Written/Paper Submissions of the information collection. Email consider whether to recommend that address: [email protected]. certain international restrictions be Submit written/paper submissions as follows: OMB Comment: OMB is required to placed on these drugs. This notice • make a decision concerning the requesting comments is required by the Mail/Hand Delivery/Courier (for collection of information between 30 Controlled Substances Act (the CSA). Written/Paper Submissions): Dockets Management Staff (HFA–305), Food and and 60 days after publication of this DATES: Submit either electronic or document in the Federal Register. written comments by September 13, Drug Administration, 5630 Fishers Therefore, a comment is best assured of 2017. Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments having its full effect if OMB receives it ADDRESSES: You may submit comments submitted to the Dockets Management within 30 days of publication. Written as follows. Please note that late, Staff, FDA will post your comment, as comments and recommendations for the untimely filed comments will not be well as any attachments, except for proposed information collection should considered. Electronic comments must information submitted, marked and be sent directly to the following: Office be submitted on or before September 13, identified, as confidential, if submitted of Management and Budget, Paperwork _ 2017. The https://www.regulations.gov as detailed in ‘‘Instructions.’’ Reduction Project, Email: OIRA electronic filing system will accept Instructions: All submissions received [email protected], Attn: comments until midnight Eastern Time must include the Docket No. FDA– Desk Officer for the Administration for at the end of September 13, 2017. 2017–N–4515 for ‘‘International Drug Children and Families. Comments received by mail/hand Scheduling; Convention on Robert Sargis, delivery/courier (for written/paper Psychotropic Substances; Single Reports Clearance Officer. submissions) will be considered timely Convention on Drugs; [FR Doc. 2017–17098 Filed 8–11–17; 8:45 am] if they are postmarked or the delivery ; Furanyl (Fu-F); service acceptance receipt is on or Acryloylfentanyl (); BILLING CODE 4184–24–P before that date. ; 4-fluoroisobutyrfentanyl (4– FIBF); Tetrahydrofuranylfentanyl (THF– Electronic Submissions DEPARTMENT OF HEALTH AND F); 4-fluoroamphetamine (4–FA); AB– HUMAN SERVICES Submit electronic comments in the PINACA; AB–CHMINACA; 5F–PB–22; following way: UR–144; 5F–ADB; ; ; • Food and Drug Administration Federal eRulemaking Portal: ; ; ; https://www.regulations.gov. Follow the Request for Comments.’’ Received [Docket No. FDA–2017–N–4515] instructions for submitting comments. comments, those filed in a timely Comments submitted electronically, International Drug Scheduling; manner (see ADDRESSES), will be placed including attachments, to https:// in the docket and, except for those Convention on Psychotropic www.regulations.gov will be posted to Substances; Single Convention on submitted as ‘‘Confidential the docket unchanged. Because your Submissions,’’ publicly viewable at Narcotic Drugs; Ocfentanil, comment will be made public, you are Carfentanil, Pregabalin, Tramadol, https://www.regulations.gov or at the solely responsible for ensuring that your Dockets Management Staff between Cannabidiol, Ketamine, and Eleven comment does not include any Other Substances; Request for 9 a.m. and 4 p.m., Monday through confidential information that you or a Friday. Comments third party may not wish to be posted, • Confidential Submissions—To AGENCY: Food and Drug Administration, such as medical information, your or submit a comment with confidential HHS. anyone else’s Social Security number, or information that you do not wish to be ACTION: Notice. confidential business information, such made publicly available, submit your as a manufacturing process. Please note comments only as a written/paper SUMMARY: The Food and Drug that if you include your name, contact submission. You should submit two Administration (FDA) is requesting information, or other information that copies total. One copy will include the interested persons to submit comments identifies you in the body of your information you claim to be confidential

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with a heading or cover note that states the United States under Article 2 of the 11. UR–144 ‘‘THIS DOCUMENT CONTAINS Psychotropic Convention that it has 12. 5F–ADB CONFIDENTIAL INFORMATION.’’ The information that may justify adding a 13. Etizolam Agency will review this copy, including drug or other substances to one of the 14. Pregabalin 15. Tramadol the claimed confidential information, in schedules of the Psychotropic 16. Cannabidiol its consideration of comments. The Convention, transferring a drug or 17. Ketamine second copy, which will have the substance from one schedule to another, PDF versions of the questionnaire in claimed confidential information or deleting it from the schedules, the English, French and Spanish may be redacted/blacked out, will be available Secretary of State must transmit the downloaded from the link http:// for public viewing and posted on notice to the Secretary of Health and www.who.int//access/controlled- https://www.regulations.gov. Submit Human Services (Secretary of HHS). The substances/ecdd/en/. Please note that these both copies to the Dockets Management Secretary of HHS must then publish the versions are for reference only and all Staff. If you do not wish your name and notice in the Federal Register and questionnaires must be answered through the contact information to be made publicly provide opportunity for interested online system. Further clarification regarding the questionnaire may be obtained from the available, you can provide this persons to submit comments that will be Secretariat by emailing: ecddsecretariat@ information on the cover sheet and not considered by HHS in its preparation of who.int. in the body of your comments and you the scientific and medical evaluations of Replies to the questionnaire must the must identify this information as the drug or substance. Secretariat by 30 September 2017 in order to ‘‘confidential.’’ Any information marked facilitate analyses and preparation of the II. WHO Notification as ‘‘confidential’’ will not be disclosed report before the planned meeting. Where except in accordance with 21 CFR 10.20 The Secretary of HHS received the there is a competent National Authority and other applicable disclosure law. For following notice from WHO (non- under the International Drug Control relevant text removed): Treaties, it is kindly requested that the more information about FDA’s posting questionnaire be completed in collaboration of comments to public dockets, see 80 Ref.: C.L.xx.2017 with such body. FR 56469, September 18, 2015, or access The World Health Organization (WHO) The summary information from the the information at: https://www.gpo.gov/ presents its compliments to Member States questionnaire will be published online as fdsys/pkg/FR-2015-09-18/pdf/2015- and Associate Members and has the pleasure part of the report on the Web site for the 23389.pdf. of informing that the Thirty-ninth Expert Thirty-ninth ECDD linked to the Department Docket: For access to the docket to Committee on Drug Dependence (ECDD) will of Essential Medicines and Health Products read background documents or the meet in Geneva from 6 to 10 November 2017 (EMP). The provisional agenda of the Thirty- electronic and written/paper comments to review a number of substances with ninth ECDD and the list of psychoactive potential for dependence, abuse and harm to substances under review are also published received, go to https:// health, and will make recommendations to on Thirty-ninth ECDD Web page: http:// www.regulations.gov and insert the the U.N. Secretary-General, on the need for www.who.int/medicines/access/controlled- docket number, found in brackets in the and level of international control of these substances/ecdd/en/. heading of this document, into the substances. Member States are also encouraged to ‘‘Search’’ box and follow the prompts At its 126th session in January 2010, the provide any additional relevant information and/or go to the Dockets Management Executive Board approved the publication (unpublished or published) that is available Staff, 5630 Fishers Lane, Rm. 1061, ‘‘Guidance on the WHO review of on these substances to: ecddsecretariat@ Rockville, MD 20852. psychoactive substances for international who.int. This information will be an control’’ (EB126/2010/REC1, Annex 6) which invaluable contribution to the ECDD and all FOR FURTHER INFORMATION CONTACT: requires the Secretariat to request relevant submissions will be treated as confidential. James R. Hunter, Center for Drug information from Ministers of Health in The World Health Organization takes this Evaluation and Research, Controlled Member States to prepare a report for opportunity to renew to Member States and Substance Staff, Food and Drug submission to the ECDD. For this purpose, a Associate Members the assurance of its Administration, 10903 New Hampshire questionnaire was designed to gather highest consideration. Ave., Bldg. 51, Rm. 5150, Silver Spring, information on the legitimate use, harmful GENEVA, 7 July 2017 use, status of national control and potential MD 20993–0002, 301–796–3156, email: impact of international control for each FDA has verified the Web site [email protected]. substance under evaluation. Member States addresses contained in the WHO notice, SUPPLEMENTARY INFORMATION: are invited to collaborate, as in the past, in as of the date this document publishes this process by providing pertinent I. Background in the Federal Register, but Web sites information as requested in the questionnaire are subject to change over time. The United States is a party to the and concerning substances under review. 1971 Convention on Psychotropic It would be appreciated if a person from III. Substances Under WHO Review Substances (Psychotropic Convention). the Ministry of Health could be designated as the focal point responsible for coordinating Ocfentanil is a synthetically produced Article 2 of the Psychotropic and answering the questionnaire. (non that is structurally related to Convention provides that if a party to relevant information from letter not shown, fentanyl and approximately equipotent the convention or WHO has information see letter for text not shown here) The in effect. Reported risks associated with about a substance, which in its opinion designated focal point, and only this person, use of ocfentanil include development may require international control or should access and complete the of , overdose, and change in such control, it shall so notify questionnaires: fatal overdose. It has no approved the Secretary-General of the United 1. Ocfentanil medical use in the United States and is Nations (the U.N. Secretary-General) 2. Furanyl fentanyl (Fu-F) not a controlled substance in the United and provide the U.N. Secretary-General 3. Acryloylfentanyl (Acrylfentanyl) States under the CSA. with information in support of its 4. Carfentanil Furanyl fentanyl (Fu-F) is a potent 5. 4-fluoroisobutyrfentanyl (4–FIBF) opinion. 6. Tetrahydrofuranylfentanyl (THF–F) clandestinely produced synthetic opioid Section 201 of the CSA (21 U.S.C. 7. 4-fluoroamphetamine (4–FA) that is an analog of fentanyl. Evidence 811) (Title II of the Comprehensive Drug 8. AB–PINACA suggests that the pattern of abuse of Abuse Prevention and Control Act of 9. AB–CHMINACA fentanyl analogues, including furanyl 1970) provides that when WHO notifies 10. 5F–PB–22 fentanyl, parallels that of and

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prescription opioid . Fu-F 4-fluoroisobutyrfentanyl is a AB–CHMINACA is a clandestinely produces the typical opioid effects that clandestinely produced synthetic opioid produced synthetic include respiratory depression and loss that is an analog of fentanyl. It has m- that is approximately 16 times more of consciousness. of Fu-F have agonist activity similar to that potent than delta-9- been encountered in powder form. Fu- of fentanyl. This would result in effects . Adverse effects F has been connected to fatal overdoses, associated with opioid such as produced by cannabinoid agonists in which intravenous routes of analgesia, respiratory depression, include tachycardia, agitation, administration are documented. It has , , tiredness, hallucination, chest , , no approved medical use in the United hallucinations, withdrawal, the anxiety, acute , and death. States. On November 29, 2016, the Drug development of opioid use disorder, AB–CHMINACA has been detected in Enforcement Administration (DEA) overdose, and fatal overdose. The use of illicit synthetic cannabinoid substances issued a final order to temporarily 4-fluoroisobutyrfentanyl has been and found in cases of overdose and schedule Fu-F and its isomers, esters, implicated in several cases of overdose hospitalizations. AB–CHMINACA has ethers, salts and salts of isomers, esters and fatal overdoses. 4- not been pre-reviewed or critically and ethers, into Schedule I pursuant to fluoroisobutyrfentanyl has not been reviewed by the WHO. On January 27, the temporary scheduling provisions of approved for medical use in the U.S. On 2017, the DEA published a Notice of the CSA. May 3, 2017, the DEA issued a Proposed Rulemaking to permanently Acryloylfentanyl (Acrylfentanyl) temporary order to temporarily schedule control AB–CHMINACA as a Schedule belongs to the 4-anilidopiperidine class 4-fluoroisobutyrfentanyl, its isomers, I substance under the CSA. of synthetic and is similar in esters, ethers, salts and salts of isomers, 5F–PB–22 is a synthetic cannabinoid structure to fentanyl. Acryloylfentanyl esters and ethers, into Schedule I agonist with similar effects to delta-9- is a clandestinely produced analog of pursuant to the temporary scheduling tetrahydrocannabinol, one of the main fentanyl and sold illegally as a research provisions of the CSA. psychoactive components of . chemical on several Web sites. Tetrahydrofuranylfentanyl (THF–F) is Adverse effects produced by Acryloylfentanyl has also been a synthetic opioid that is an analog of cannabinoid agonists include associated with adverse events typically fentanyl. It has m-receptor agonist tachycardia, agitation, hallucination, associated with opioid use such as activity similar to that of fentanyl, chest pain, seizure, anxiety, acute respiratory depression, anxiety, resulting in effects associated with psychosis, and death. 5F–PB–22 is constipation, tiredness, hallucinations, opioid agonists such as analgesia, clandestinely produced. It has been and withdrawal. The use of respiratory depression, anxiety, found laced on plant material and acryloylfentanyl has also been linked to constipation, tiredness, hallucinations, marketed as herbal products, and is the development of opioid use disorder, withdrawal, the development of opioid smoked for its psychoactive effects. overdose, and fatal overdose. use disorder, overdose, and fatal According to the WHO, 5F–PB–22 has Acryloylfentanyl has no commercial or overdose. THF–F is not approved for been associated with fatal intoxications. medical uses. On July 14, 2017, the DEA medical use or controlled in the United On September 6, 2016, the DEA issued issued a temporary order to temporarily States under the CSA. a final rule to permanently place 5F– schedule acryloylfentanyl, its isomers, 4-Fluoroamphetamine (4–FA) is a PB–22 into Schedule I of the CSA. esters, ethers, salts and salts of isomers, psychoactive substance of the UR–144 is a clandestinely produced esters, and ethers, into Schedule I phenethylamine and substituted synthetic cannabinoid agonist. In pursuant to the temporary scheduling chemical classes and general, adverse effects produced by provisions of the CSA. produces effects. WHO cannabinoid agonists include Carfentanil, also known as 4- reports that 4–FA is clandestinely tachycardia, agitation, hallucination, carbomethoxyfentanyl, is an extremely produced, and its use is associated with chest pain, seizure, anxiety, and acute potent synthetic opioid that is similar in fatal and non-fatal intoxications. 4–FA psychosis. UR–144 has been detected in structure to and approximately 100 was reviewed at the 37th ECDD (2015) herbal blends that are sold as times more potent than fentanyl as an and, while not placed under herbal . In June 2014, the 36th . At one time legitimately international control due to insufficient (2014) ECDD reviewed UR–144 and produced, carfentanil is no longer data, was kept under surveillance. 4–FA recommended that it be placed under manufactured, marketed, or used in the is not approved for medical use in the surveillance. On May 11, 2016, the DEA United States; it is approved by FDA for United States and it is not controlled issued a final rule to permanently use under restricted conditions by under the CSA. schedule UR–144 into Schedule I of the veterinarians as a immobilizing agent AB–PINACA is a clandestinely CSA. for certain large animals. Illicitly produced synthetic cannabinoid agonist 5F–ADB is a clandestinely produced produced carfentanil is a particularly approximately 1.5 times as potent as synthetic cannabinoid agonist. In harmful fentanyl analogue that is also delta-9-tetrahydrocannabinol. Adverse general, adverse effects produced by being laced into heroin or sold by itself effects produced by cannabinoid cannabinoid agonists include and trafficked in the United States. It is agonists include tachycardia, agitation, tachycardia, agitation, hallucination, not approved for human use. Drug hallucination, chest pain, seizure, chest pain, seizure, anxiety, and acute seizure data indicate that carfentanil is anxiety, acute psychosis, and death. psychosis. 5F–ADB has been identified typically used in small doses to cut AB–PINACA has been detected in illicit in overdose and/or cases involving heroin and other illicitly abused drugs. synthetic cannabinoid substances, and death attributed to their abuse. Adverse The significant risk to public health reported in cases of overdose and health effects reported from incidents associated with carfentanil use stems hospitalizations. It has not been involving 5F–ADB and other synthetic from its respiratory depressive effects approved for medical use in the United have included: , with very small amounts. Several States. On January 27, 2017, the DEA persistent , agitation, altered fatalities have been reported as the published a Notice of Proposed mental status, seizures, convulsions, result of carfentanil overdoses. On Rulemaking to permanently control AB– loss of consciousness, and/or cardio October 28, 1988, the DEA placed PINACA as a Schedule I substance toxicity. On April 10, 2017, the DEA carfentanil in Schedule II of the CSA. under the CSA. issued a temporary scheduling order to

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temporarily schedule 5F–ADB, its treatment of moderate to moderately IV. Opportunity To Submit Domestic isomers, esters, ethers, salts and salts of severe pain. On July 2, 2014, the DEA Information isomers, esters, and ethers into published a final rule in the Federal As required by section 201(d)(2)(A) of Schedule I pursuant to the temporary Register controlling tramadol as a the CSA, FDA, on behalf of HHS, invites scheduling provisions of the CSA. Schedule IV substance of the CSA interested persons to submit comments Etizolam belongs to a class of effective from August 18, 2014. regarding the 17 named drug substances known as . Tramadol was pre-reviewed by the substances. Any comments received Benzodiazepines produce central ECDD at its 28th (1992) and 32nd (2000) will be considered by HHS when it nervous system depression and are meetings, and critically reviewed at the prepares a scientific and medical commonly used to treat , 33rd (2002) meeting and not evaluation of these drug substances. anxiety, and seizure disorders. Etizolam recommended for international control HHS will forward a scientific and is currently prescribed in some but placed on surveillance. Tramadol medical evaluation of these drug countries to treat generalized anxiety was pre-reviewed again by the ECDD at substances to WHO, through the disorder with depressive symptoms, but its 34th (2006) meeting; however, the Secretary of State, for WHO’s is not approved for medical use or ECDD concluded that there was not consideration in deciding whether to controlled in the United States under sufficient evidence to justify a critical recommend international control/ the CSA. WHO reported that non-fatal review. At the 36th (2014) meeting, the decontrol of any of these drug intoxications that include cases of ECDD considered updated information substances. Such control could limit, driving under the influence of drugs on tramadol, but again concluded that among other things, the manufacture have been linked to etizolam. The ECDD there was insufficient evidence to and distribution (import/export) of these at its 37th (2015 meeting reviewed warrant a critical review. drug substances and could impose etizolam and recommended that a Cannabidiol (CBD) is one of the active certain recordkeeping requirements on critical review of etizolam is warranted. cannabinoids identified in cannabis. them. Pregabalin is an -type CBD has been shown to be beneficial in Although FDA is, through this notice, drug used to treat pain generated from experimental models of several requesting comments from interested the nervous system. It is available as an neurological disorders, including those persons, which will be considered by oral and oral and of seizure and . In the United HHS when it prepares an evaluation of approved for medical use in the United States, CBD-containing products are in these drug substances, HHS will not States for the management of human clinical testing in three now make any recommendations to associated with therapeutic areas, but no such products WHO regarding whether any of these diabetic , post- are approved by FDA for marketing for drugs should be subjected to herpetic neuralgia, and adjunctive medical purposes in the United States. international controls. Instead, HHS will therapy for partial onset seizures, defer such consideration until WHO has , and neuropathic pain CBD is a Schedule I controlled made official recommendations to the associated with spinal cord injury. substance under the CSA. At the 37th Commission on Narcotic Drugs, which Although the of (2015) meeting of the ECDD, the are expected to be made in early 2018. pregabalin is unknown, studies in committee requested that the Secretariat Any HHS position regarding animals suggest that binding to the prepare relevant documentation to international control of these drug nervous system tissues may be involved conduct pre-reviews for several substances will be preceded by another in its pain-relieving and anti-seizure substances, including CBD. Federal Register notice soliciting public effects. Pregabalin binds with high Ketamine is classified as a rapid- comments, as required by section affinity to the alpha 2-delta receptor site acting general anesthetic agent used for 201(d)(2)(B) of the CSA. (a subunit of voltage-gated short diagnostic and surgical procedures channels) in the central nervous system. that do not require skeletal muscle V. Electronic Access The binding of pregabalin at this site is relaxation. It is marketed in the United States as a solution for injection. Persons with access to the Internet thought to be responsible for its may obtain the document at either therapeutic effect on neuropathic pain. Ketamine is controlled in Schedule III of the CSA in the United States. It is not https://www.fda.gov/Drugs/Guidance Reports indicate that patients are self- ComplianceRegulatoryInformation/ administering higher than controlled internationally under the Convention on Psychotropic Substances Guidances/default.htm or https://www. recommended doses to achieve regulations.gov. , especially patients who have or the Single Convention on Narcotic a history of , Drugs. The ECDD reviewed ketamine at Dated: August 9, 2017. particularly opioids, and psychiatric its 34th (2006), 35th (2012), and 36th Anna K. Abram, illness. While effects of excessively high (2014) meetings. On March 13, 2015, the Deputy Commissioner for Policy, Planning, doses are generally non-lethal, Commission on Narcotic Drugs (CND) Legislation, and Analysis. such as pregabalin are decided by consensus to postpone the [FR Doc. 2017–17119 Filed 8–11–17; 8:45 am] increasingly being identified in post- consideration of a proposal concerning BILLING CODE 4164–01–P mortem toxicology analyses. Pregabalin the recommendation to place ketamine is a Schedule V controlled substance in in Schedule IV of the Psychotropic the United States under the CSA. Convention. The CND requested DEPARTMENT OF HEALTH AND Tramadol is an opioid analgesic that additional information from the WHO. HUMAN SERVICES produces its primary opioid-like action The ECDD reviewed updated through an referred to information at its 37th (2015) meeting Indian Health Service as the M1 metabolite (O- and found no reason to recommend a Division of Behavioral Health; Office of desmethyltramadol). Tramadol was first new pre-review or critical review of Clinical and Preventive Services; approved for marketing in the United ketamine that could potentially change Behavioral Health Integration Initiative States in 1995 and is available as its standing 2014 recommendation that (BH2I) immediate-release, extended-release, ketamine should not be placed under and combination products for the international control. Announcement Type: New.

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