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on NCQA’s evaluation of SNPs using considered in preparing a response from Convention on Narcotic ; MOC scoring guidelines. Based on their the United States to the World Health ; Phenazepam; Etizolam; 1- scores, SNPs receive an approval for a Organization (WHO) regarding the abuse cyclohexyl-4-(1,2-diphenylethyl)- period of 1-, 2-, or 3-years. We are liability and diversion of these drugs. piperazine (MT-45); N-(1- developing an MOC off-cycle revision WHO will use this information to Phenethylpiperidin-4-yl)-N- process so that SNPs can revise the consider whether to recommend that phenylacetamide (Acetylfentanyl); a- MOC to modify its processes and certain international restrictions be Pyrrolidinovalerophenone (a-PVP); 4- strategies for providing care during their placed on these drugs. This notice Fluoroamphetamine (4-FA); para- MOC approval period. We will require requesting comments is required by the Methyl-4-methylaminorex (4,4’-DMAR); that SNPs submit summaries of their Controlled Substances Act (the CSA). para-Methoxymethylamphetamine MOC revisions to CMS for NCQA DATES: Submit either electronic or (PMMA); 2-(ethylamino)-2-(3- evaluation when a SNP makes written comments by October 15, 2015. methoxyphenyl)-cyclohexanone significant changes to its MOC as ( or MXE); Request for ADDRESSES: You may submit comments described in the annual Announcement Comments. Received comments will be as follows: of Medicare Capitation Rates and placed in the docket and, except for Medicare Advantage and Part D Electronic Submissions those submitted as ‘‘Confidential Payment Policies and Final Call letter Submissions,’’ publicly viewable at Submit electronic comments in the for CY 2015 and CY2016. The NCQA http://www.regulations.gov or at the following way: will review the summary of changes to Division of Dockets Management • Federal eRulemaking Portal: http:// verify that the revisions are consistent between 9 a.m. and 4 p.m., Monday www.regulations.gov. Follow the with the acceptable, high quality through Friday. instructions for submitting comments. standards as included in the original • Confidential Submissions—To Comments submitted electronically, approved MOC. The package has been submit a comment with confidential including attachments, to http:// revised subsequent to the publication of information that you do not wish to be www.regulations.gov will be posted to the 60-day Federal Register notice (June made publicly available, submit your the docket unchanged. Because your 17, 2015; 80 FR 34647). Form Number: comments only as a written/paper CMS–10565 (OMB control number comment will be made public, you are submission. You should submit two 0938-New); Frequency: Occasionally; solely responsible for ensuring that your copies total. One copy will include the Affected Public: Private sector (Business comment does not include any information you claim to be confidential or other for-profits and Not-for-profit confidential information that you or a with a heading or cover note that states institutions); Number of Respondents: third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS 313; Total Annual Responses: 421; Total such as medical information, your or CONFIDENTIAL INFORMATION’’. The Annual Hours: 2,400. (For policy anyone else’s Social Security number, or Agency will review this copy, including questions regarding this collection confidential business information, such the claimed confidential information, in contact Susan Radke at 410–786–4450). as a manufacturing process. Please note its consideration of comments. The that if you include your name, contact Dated: September 30, 2015. second copy, which will have the information, or other information that claimed confidential information William N. Parham, III, identifies you in the body of your redacted/blacked out, will be available Director, Paperwork Reduction Staff, Office comments, that information will be for public viewing and posted on http:// of Strategic Operations and Regulatory posted on http://www.regulations.gov. www.regulations.gov. Submit both Affairs. • If you want to submit a comment copies to the Division of Dockets [FR Doc. 2015–25212 Filed 10–2–15; 8:45 am] with confidential information that you Management. If you do not wish your BILLING CODE 4120–01–P do not wish to be made available to the name and contact information to be public, submit the comment as a made publicly available, you can written/paper submission and in the provide this information on the cover DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper HUMAN SERVICES sheet and not in the body of your Submissions’’ and ‘‘Instructions’’). comments and you must identify this Food and Administration Written/Paper Submissions information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ [Docket No. FDA–2015–N–0045] Submit written/paper submissions as will not be disclosed except in follows: accordance with 21 CFR 10.20 and other International Drug Scheduling; • Mail/Hand delivery/Courier (for applicable disclosure law. For more Convention on Psychotropic written/paper submissions): Division of information about FDA’s posting of Substances; Single Convention on Dockets Management (HFA–305), Food comments to public dockets, see 80 FR Narcotic Drugs; Ketamine and Nine and Drug Administration, 5630 Fishers 56469, September 18, 2015, or access Other Substances; Request for Lane, rm. 1061, Rockville, MD 20852. the information at: http://www.fda.gov/ Comments • For written/paper comments regulatoryinformation/dockets/ AGENCY: Food and Drug Administration, submitted to the Division of Dockets default.htm. HHS. Management, FDA will post your Docket: For access to the docket to ACTION: Notice. comment, as well as any attachments, read background documents or the except for information submitted, electronic and written/paper comments SUMMARY: The Food and Drug marked and identified, as confidential, received, go to http:// Administration (FDA) is requesting if submitted as detailed in www.regulations.gov and insert the interested persons to submit comments ‘‘Instructions.’’ docket number, found in brackets in the concerning abuse potential, actual Instructions: All submissions received heading of this document, into the abuse, medical usefulness, trafficking, must include the Docket No. FDA– ‘‘Search’’ box and follow the prompts and impact of scheduling changes on 2015–N–0045 for International Drug and/or go to the Division of Dockets availability for medical use of 10 drug Scheduling; Convention on Management, 5630 Fishers Lane, rm. substances. These comments will be Psychotropic Substances; Single 1061, Rockville, MD 20852.

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FOR FURTHER INFORMATION CONTACT: requires the Secretariat to request relevant Associate Members the assurance of its James R. Hunter, Center for Drug information from Ministers of Health in highest consideration. Evaluation and Research, Controlled Member States to prepare a report for GENEVA, 11 September 2015 Substance Staff, Food and Drug submission to the ECDD. For this purpose, a questionnaire was designed to gather FDA has verified the Web site Administration, 10903 New Hampshire information on the legitimate use, harmful addresses contained in the WHO notice, Ave., Bldg. 51, Rm. 5150, Silver Spring, use, status of national control and potential as of the date this document publishes MD 20993–0002, 301–796–3156, email: impact of international control for each in the Federal Register, but Web sites [email protected]. substance under evaluation. Member States are subject to change over time. SUPPLEMENTARY INFORMATION: are invited to collaborate, as in the past, in this process by providing pertinent III. Substances Under WHO Review I. Background information as requested in the questionnaire and concerning substances under review. Ketamine is classified as a rapid- The United States is a party to the acting general anesthetic agent used for 1971 Convention on Psychotropic It would be appreciated if a person from the Ministry of Health could be designated as short diagnostic and surgical procedures Substances (Psychotropic Convention). the focal point responsible for coordinating that do not require skeletal muscle Article 2 of the Psychotropic and answering the questionnaire. It is relaxation. It is marketed in the United Convention provides that if a party to requested that the focal point’s contact States as an injectable product for the convention or WHO has information details (including email address) be emailed medical and veterinary use. Ketamine is about a substance, which in its opinion to: [email protected]. The designated controlled in Schedule III of the CSA in focal point, and only this person, should may require international control or the United States. It is not controlled change in such control, it shall so notify access and complete the questionnaires via these links: internationally under either the the Secretary-General of the United Psychotropic Convention or the Single Nations (the U.N. Secretary-General) 1. Ketamine INN—https://extranet.who.int/ dataform/961512/lang-en Convention on Narcotic Drugs. The and provide the U.N. Secretary-General 2. Phenazepam—https://extranet.who.int/ WHO Expert Committee on Drug with information in support of its dataform/482684/lang-en Dependence reviewed ketamine at its opinion. 3. Etizolam—https://extranet.who.int/ 34th, 35th, and 36th meetings. On Section 201 of the CSA (21 U.S.C. dataform/278963/lang-en March 13, 2015, the Commission on 811) (Title II of the Comprehensive Drug 4. MT–45—https://extranet.who.int/ Narcotic Drugs decided by consensus to Abuse Prevention and Control Act of dataform/465468/lang-en postpone the consideration of a 1970) provides that when WHO notifies 5. Acetylfentanyl—https://extranet.who.int/ dataform/495475/lang-en proposal concerning the the United States under Article 2 of the recommendation to place ketamine in Psychotropic Convention that it has 6. a-Pyrrolidinovalerophenone (a-PVP)— https://extranet.who.int/dataform/ Schedule IV of the Psychotropic information that may justify adding a 758275/lang-en Convention and to request additional drug or other substances to one of the 7. 4-Fluoroamphetamine (4–FA)—https:// information from the WHO. schedules of the Psychotropic extranet.who.int/dataform/538126/lang- Phenazepam and Etizolam belong to a Convention, transferring a drug or en class of substances known as substance from one schedule to another, 8. para-Methyl-4-methylaminorex (4,4’- benzodiazepines. Benzodiazepines or deleting it from the schedules, the DMAR)—https://extranet.who.int/ dataform/422472/lang-en produce central nervous system Secretary of State must transmit the depression and are commonly used to notice to the Secretary of Health and 9. para-Methoxymethylamphetamine (PMMA)—https://extranet.who.int/ treat insomnia, anxiety, and seizure Human Services (Secretary of HHS). The dataform/665818/lang-en disorders. Phenazepam and Etizolam are Secretary of HHS must then publish the 10. Methoxetamine (MXE)—https:// currently prescribed in some countries, notice in the Federal Register and extranet.who.int/dataform/266376/lang- but neither drug substance is approved provide opportunity for interested en for medical use or controlled in the persons to submit comments that will be Upon accessing the links the focal point United States under the CSA. considered by HHS in its preparation of will be prompted for a token (password) 1-cyclohexyl-4-(1,2-diphenylethyl)- the scientific and medical evaluations of which is the country name in English, non- piperazine (MT–45) is a synthetic the drug or substance. case sensitive and without spaces. For ease of reference a PDF version of the with potent analgesic activity II. WHO Notification questionnaire in English, French and Spanish comparable to despite being The Secretary of HHS received the may be downloaded from the link http:// structurally unrelated to most other following notice from WHO (emphasis www.who.int/medicines/access/controlled- . MT–45 use has been associated substances/ecdd/en/. Further clarification removed): with deaths in the United States and in regarding the questionnaire may be obtained other countries. MT–45 is not currently Ref.: C.L.28.2015 from the Secretariat by emailing: controlled in the United States under The World Health Organization (WHO) [email protected]. the CSA. presents its compliments to Member States Replies to the questionnaire must reach the Secretariat by 15 October 2015 in order to Acetylfentanyl (N-(1- and Associate Members and has the pleasure phenethylpiperidin-4-yl)-N- of informing that the Thirty-sixth Expert facilitate analyses and preparation of the Committee on Drug Dependence (ECDD) will report before the planned meeting. Where phenylacetamide) is a potent opioid meet in Geneva from 16 to 20 November 2015 there is a competent National Authority analgesic in the phenylpiperidine class to review a number of substances with under the International Drug Control of synthetic opioids. With the exception potential for dependence, abuse and harm to Treaties, it is kindly requested that the of its analgesic effects, this fentanyl-like health, and will make recommendations to questionnaire be completed in collaboration substance is similar to other opioid the U.N. Secretary-General, on the need for with such body. analgesics that produce a variety of and level of international control of these The summary information from the pharmacological effects, including questionnaire will be published online as substances. alteration in mood, euphoria, At its 126th session in January 2010, the part of the report on the Web site for the 37th Executive Board approved the publication ECDD linked to the Department of Essential drowsiness, respiratory depression, ‘‘Guidance on the WHO review of Medicines and Health Products (EMP). constriction of pupils (miosis), and psychoactive substances for international The World Health Organization takes this impaired gastrointestinal motility. control’’ (EB126/2010/REC1, Annex 6) which opportunity to renew to Member States and Acetylfentanyl has been associated with

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several confirmed deaths in the United dependence, abuse, and risks to the DEPARTMENT OF HEALTH AND States. On July 17, 2015, Acetylfentanyl public health, thereby recommending HUMAN SERVICES was temporarily placed into Schedule I that Methoxetamine not be placed under of the CSA for 2 years upon finding that international control but be kept under Food and Drug Administration it posed an imminent hazard to the international surveillance. [Docket No. FDA–2012–N–0559] public safety. The Attorney General, though, may extend this temporary IV. Opportunity To Submit Domestic Agency Information Collection scheduling for up to 1 year. Information Activities; Proposed Collection; a-Pyrrolidinovalerophenone (a-PVP Comment Request; Public Health As required by section 201(d)(2)(A) of or alpha-PVP) is a synthetic cathinone Service Guideline on Infectious the CSA (21 U.S.C. 811(d)(2)(A)), FDA, structurally and pharmacologically Disease Issues in Xenotransplantation similar to , 3,4- on behalf of the Department of Health methylenedioxymethamphetamine and Human Services (HHS), invites AGENCY: Food and Drug Administration, (MDMA); cathinone; and other related interested persons to submit comments HHS. substances. Effects reported by abusers regarding the 10 named drugs. Any ACTION: Notice. of synthetic cathinone substances comments received will be considered SUMMARY: The Food and Drug include euphoria; sense of well-being; by HHS when it prepares a scientific Administration (FDA) is announcing an and increased sociability, energy, and medical evaluation of these drugs. opportunity for public comment on the empathy, alertness, and concentration HHS will forward a scientific and and focus. Abusers also report proposed collection of certain medical evaluation of these drugs to information by the Agency. Under the experiencing unwanted effects such as WHO, through the Secretary of State, for tremor, vomiting, agitation, sweating, Paperwork Reduction Act of 1995 (the WHO’s consideration in deciding PRA), Federal Agencies are required to fever, and chest pain. Other adverse or whether to recommend international toxic effects that have been reported publish notice in the Federal Register control/decontrol of any of these drugs. concerning each proposed collection of with the abuse of synthetic cathinones Such control could limit, among other include tachycardia, hypertension, information, including each proposed things, the manufacture and distribution hyperthermia, mydriasis, extension of an existing collection of (import/export) of these drugs and could rhabdomyolysis, hyponatremia, information, and to allow 60 days for seizures, altered mental status (e.g., impose certain recordkeeping public comment in response to this paranoia, hallucinations, or delusions), requirements on them. notice. This notice solicits comments on and even death. On March 7, 2014, Although FDA is, through this notice, the collection of information contained alpha-PVP was temporarily placed into requesting comments from interested in the Public Health Service (PHS) Schedule I of the CSA for 2 years upon persons which will be considered by guideline entitled ‘‘PHS Guideline on finding that it posed an imminent HHS when it prepares an evaluation of Infectious Disease Issues in hazard to the public safety. The these drugs, HHS will not now make Xenotransplantation’’ dated January 19, 2001. Attorney General, though, may extend any recommendations to WHO this temporary scheduling for up to 1 regarding whether any of these drugs DATES: Submit either electronic or year. should be subjected to international written comments on the collection of information by December 4, 2015. 4-Fluoroamphetamine (4–FA) is a controls. Instead, HHS will defer such psychoactive substance of the consideration until WHO has made ADDRESSES: You may submit comments and substituted official recommendations to the as follows: amphetamine chemical classes and produces effects. 4–FA is not Commission on Narcotic Drugs, which Electronic Submissions currently controlled in the United States are expected to be made in early 2016. Submit electronic comments in the under the CSA. Any HHS position regarding following way: Para-Methyl-4-methylaminorex (4,4’- international control of these drugs will • Federal eRulemaking Portal: http:// DMAR) is a derivative of the stimulant be preceded by another Federal Register www.regulations.gov. Follow the drug 4-methylaminorex and has been notice soliciting public comments, as instructions for submitting comments. involved in several deaths in the United required by section 201(d)(2)(B) of the Comments submitted electronically, States. 4,4’-DMAR is not currently CSA. including attachments, to http:// controlled in the United States under www.regulations.gov will be posted to V. Electronic Access the CSA. the docket unchanged. Because your Para-Methoxymethylamphetamine Persons with access to the Internet comment will be made public, you are (PMMA) is a substituted amphetamine may obtain the document at either solely responsible for ensuring that your of the phenethylamine class, as well as http://www.fda.gov/Drugs/Guidance comment does not include any a structural analog of para- ComplianceRegulatoryInformation/ confidential information that you or a methoxyamphetamine (PMA) which third party may not wish to be posted, Guidances/default.htm or http:// produces effects similar but not such as medical information, your or www.regulations.gov. identical to that of MDMA. PMMA is anyone else’s Social Security number, or not currently controlled in the United Dated: September 29, 2015. confidential business information, such States under the CSA. Leslie Kux, as a manufacturing process. Please note 2-(ethylamino)-2-(3-methoxyphenyl)- Associate Commissioner for Policy. that if you include your name, contact cyclohexanone (Methoxetamine or [FR Doc. 2015–25201 Filed 10–2–15; 8:45 am] information, or other information that MXE) is an arylcyclohexamine and is identifies you in the body of your not currently controlled under the CSA BILLING CODE 4164–01–P comments, that information will be in the United States. At its 36th posted on http://www.regulations.gov. meeting, the WHO Expert Committee on • If you want to submit a comment Drug Dependence noted the with confidential information that you insufficiency of data regarding do not wish to be made available to the

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