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Therefore, under authority delegated SUPPLEMENTARY INFORMATION: FDA is of Food and Drugs, 21 CFR part 876 is to the Commissioner of Food and Drugs amending § 876.4730 (21 CFR 876.4730, amended as follows: and redelegated to the Center for Manual gastroenterology-urology Veterinary Medicine, and in accordance surgical instrument and accessories), by PART 876—GASTROENTEROLOGY- with § 514.116 Notice of withdrawal of adding language to the identification of UROLOGY DEVICES the device to reflect that specialized approval of application (21 CFR ■ 514.116), notice is given that approval surgical instrumentation for use with 1. The authority citation for part 876 of NADA 135–773 and ANADA 200– urogynecologic surgical mesh is no continues to read as follows: 421, and all supplements and longer regulated under § 876.4730. Authority: 21 U.S.C. 351, 360, 360c, 360e, amendments thereto, is hereby In the Federal Register of November 360j, 360l, 371. withdrawn, effective March 13, 2017. 23, 1983 (48 FR 53012), FDA issued a ■ 2. Amend § 876.4730 by revising Elsewhere in this issue of the Federal final rule classifying manual paragraph (a) to read as follows: Register, FDA is amending the animal gastroenterology-urology surgical drug regulations to reflect the voluntary instrument and accessories into class I § 876.4730 Manual gastroenterology- withdrawal of approval of these under § 876.4730 (48 FR 53012 at urology surgical instrument and applications. 53025). Certain specialized surgical accessories. instrumentation for use with (a) Identification. A manual Dated: February 23, 2017. urogynecologic surgical mesh was gastroenterology-urology surgical Leslie Kux, regulated as class I devices under that instrument and accessories is a device Associate Commissioner for Policy. regulation. In the Federal Register of designed to be used for [FR Doc. 2017–03931 Filed 2–28–17; 8:45 am] January 6, 2017 (82 FR 1598), FDA gastroenterological and urological BILLING CODE 4164–01–P issued a final order reclassifying surgical procedures. The device may be specialized surgical instrumentation for nonpowered, hand-held, or hand- use with urogynecologic surgical mesh manipulated. Manual gastroenterology- DEPARTMENT OF HEALTH AND from class I (general controls) exempt urology surgical instruments include the HUMAN SERVICES from premarket notification to class II biopsy forceps cover, biopsy tray (special controls) and subject to without biopsy instruments, line clamp, Food and Drug Administration premarket notification. As a result of nonpowered rectal probe, nonelectrical that final reclassification order, FDA is clamp, colostomy spur-crushers, locking 21 CFR Part 876 amending the identification at device for intestinal clamp, needle [Docket No. FDA–2016–N–4661] § 876.4730(a) to reflect that specialized holder, gastro-urology hook, gastro- surgical instrumentation for use with urology probe and director, nonself- Gastroenterology-Urology Devices; urogynecologic surgical mesh is now retaining retractor, laparotomy rings, Manual Gastroenterology-Urology regulated under 21 CFR 884.4910. nonelectrical snare, rectal specula, Surgical Instruments and Accessories FDA finds good cause for issuing this bladder neck spreader, self-retaining amendment as a final rule without AGENCY: Food and Drug Administration, retractor, and scoop. A manual surgical notice and comment because this rule HHS. instrument that is intended specifically only updates the identification of the for use as an aid in the insertion, ACTION: Final rule; technical device under § 876.4730 to reflect amendment. placement, fixation, or anchoring of changes made in the recently issued surgical mesh during urogynecologic SUMMARY: The Food and Drug final reclassification order for procedures are classified under Administration (FDA) is amending the specialized surgical instrumentation for § 884.4910 of this chapter. use with urogynecologic surgical mesh identification of manual * * * * * gastroenterology-urology surgical (5 U.S.C. 553(b)(B)). In addition, FDA Dated: February 23, 2017. instruments and accessories to reflect finds good cause for this amendment to that the device does not include become effective on the date of Leslie Kux, specialized surgical instrumentation for publication of this action. The Associate Commissioner for Policy. use with urogyencologic surgical mesh Administrative Procedure Act allows an [FR Doc. 2017–03997 Filed 2–28–17; 8:45 am] specifically intended for use as an aid effective date less than 30 days after BILLING CODE 4164–01–P in the insertion, placement, fixation, or publication as ‘‘provided by the agency anchoring of surgical mesh during for good cause found and published urogynecologic procedures with the rule’’ (5 U.S.C. 553(d)(3)). A DEPARTMENT OF JUSTICE (‘‘specialized surgical instrumentation delayed effective date is unnecessary in for use with urogynecologic surgical this case because the amendment to Drug Enforcement Administration mesh’’). These amendments are being § 876.4730 does not impose any new made to reflect changes made in the regulatory requirements on affected 21 CFR Part 1308 parties. As a result, affected parties do recently issued final reclassification not need time to prepare before the rule [Docket No. DEA–436] order for specialized surgical takes effect. Therefore, FDA finds good instrumentation for use with Schedules of Controlled Substances: cause for this amendment to become urogynecologic surgical mesh. Placement of 10 Synthetic effective on the date of publication of Into Schedule I DATES: This rule is effective March 1, this action. 2017. AGENCY: List of Subjects in 21 CFR Part 876 Drug Enforcement FOR FURTHER INFORMATION CONTACT: Administration, Department of Justice. Gastroenterology-urology devices, Sharon Andrews, Center for Devices and ACTION: Final rule. Radiological Health, 10903 New Medical devices. Hampshire Ave., Bldg. 66, Rm. G110, Therefore, under the Federal Food, SUMMARY: With the issuance of this final Silver Spring, MD 20993, 301–796– Drug, and Cosmetic Act and under rule, the Drug Enforcement 6529, [email protected]. authority delegated to the Commissioner Administration places 10 synthetic

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cathinones: 4-methyl-N-ethylcathinone controlled substances and listed a-PVP, , pentedrone, (4-MEC); 4-methyl-alpha- chemicals into the illicit market while , 4-FMC, 3-FMC, , pyrrolidinopropiophenone (4-MePPP); ensuring an adequate supply is available or a-PBP. alpha-pyrrolidinopentiophenone (a- for the legitimate medical, scientific, Background PVP); 1-(1,3-benzodioxol-5-yl)-2- research, and industrial needs of the (methylamino)butan-1-one (butylone, United States. Controlled substances On January 28, 2014, the DEA bk-MBDB e); 2-(methylamino)-1- have the potential for abuse and published a notice of intent to phenylpentan-1-one (pentedrone); 1- dependence and are controlled to temporarily place 4-methyl-N- (1,3-benzodioxol-5-yl)-2- protect the public health and safety. ethylcathinone (4-MEC); 4-methyl- (methylamino)pentan-1-one (pentylone, Under the CSA, each controlled alpha-pyrrolidinopropiophenone (4- bk-MBDP); 4-fluoro-N-methylcathinone substance is classified into one of five MePPP); alpha- (4-FMC, ); 3-fluoro-N- schedules based upon its potential for pyrrolidinopentiophenone (a-PVP); 1- methylcathinone (3-FMC); 1- abuse, its currently accepted medical (1,3-benzodioxol-5-yl)-2- (naphthalen-2-yl)-2-(pyrrolidin-1- use in treatment in the United States, (methylamino)butan-1-one (butylone); yl)pentan-1-one (naphyrone); alpha- and the degree of dependence the 2-(methylamino)-1-phenylpentan-1-one pyrrolidinobutiophenone (a-PBP) and substance may cause. 21 U.S.C. 812. The (pentedrone); 1-(1,3-benzodioxol-5-yl)- their optical, positional, and geometric initial schedules of controlled 2-(methylamino)pentan-1-one isomers, salts and salts of isomers, substances established by Congress are (pentylone); 4-fluoro-N- whenever the existence of such salts, found at 21 U.S.C. 812(c), and the methylcathinone (4-FMC); 3-fluoro-N- isomers, and salts of isomers is possible, current list of scheduled substances is methylcathinone (3-FMC); 1- into schedule I of the Controlled published at 21 CFR part 1308. (naphthalen-2-yl)-2-(pyrrolidin-1- Substances Act. This scheduling action Pursuant to 21 U.S.C. 811(a)(1), the yl)pentan-1-one (naphyrone); and alpha- is pursuant to the Controlled Substances Attorney General may, by rule, ‘‘add to pyrrolidinobutiophenone (a-PBP) into Act which requires that such actions be such a schedule or transfer between schedule I pursuant to the temporary made on the record after opportunity for such schedules any drug or other scheduling provisions of the CSA. 79 FR a hearing through formal rulemaking. substance if he * * * finds that such 4429. On March 7, 2014, the DEA This rule continues the imposition of drug or other substance has a potential published a final order amending 21 the regulatory controls and for abuse, and * * * makes with respect CFR 1308.11(h) to temporarily place administrative, civil, and criminal to such drug or other substance the these 10 synthetic cathinones into schedule I of the CSA. 79 FR 12938. sanctions applicable to schedule I findings prescribed by subsection (b) of That final order, effective on the date of controlled substances on persons who section 812 of this title for the schedule publication, was based on findings by handle (manufacture, distribute, reverse in which such drug is to be placed * * *.’’ The Attorney General has the DEA that the temporary scheduling distribute, import, export, engage in delegated scheduling authority under 21 of these 10 synthetic cathinones was research, conduct instructional U.S.C. 811 to the Administrator of the necessary to avoid an imminent hazard activities or chemical analysis, or DEA. 28 CFR 0.100. to the public safety pursuant to 21 possess), or propose to handle 4-MEC, 4- The CSA provides that proceedings U.S.C. 811(h)(1). Section 201(h)(2) of the MePPP, a-PVP, butylone, pentedrone, for the issuance, amendment, or repeal CSA requires that the temporary control pentylone, 4-FMC, 3-FMC, naphyrone, of the scheduling of any drug or other of these substances expires two years or a-PBP. substance may be initiated by the from the issuance date of the scheduling DATES: Effective date: March 1, 2017. Attorney General (1) on his own motion; order, or on or before March 6, 2016. 21 FOR FURTHER INFORMATION CONTACT: (2) at the request of the Secretary of the U.S.C. 811(h)(2). However, the CSA also Michael J. Lewis, Diversion Control Department of Health and Human provides that the temporary scheduling Division, Drug Enforcement Services (HHS); 1 or (3) on the petition may be extended for up to one year Administration; Mailing Address: 8701 of any interested party. 21 U.S.C. 811(a). during the pendency of proceedings Morrissette Drive, Springfield, Virginia This action was initiated on the under 21 U.S.C. 811(a)(1). Id. 22152; Telephone: (202) 598–6812. Attorney General’s own motion, as Accordingly, on March 4, 2016, the DEA SUPPLEMENTARY INFORMATION: delegated to the Administrator of the extended the temporary scheduling of 4- DEA, and is supported by, inter alia, a MEC, 4-MePPP, a-PVP, butylone, Legal Authority recommendation from the Assistant pentedrone, pentylone, 4-FMC, 3-FMC, The Drug Enforcement Secretary for Health of the HHS and an naphyrone, and a-PBP by one year, until Administration (DEA) implements and evaluation of all relevant data by the March 3, 2017. 81 FR 11429. Also, on enforces titles II and III of the DEA. This action continues the March 4, 2016, the DEA published a Comprehensive Drug Abuse Prevention imposition of the regulatory controls notice of proposed rulemaking (NPRM) and Control Act of 1970, as amended. 21 and administrative, civil, and criminal to permanently control 4-MEC, 4- U.S.C. 801–971. Titles II and III are sanctions of schedule I controlled MePPP, a-PVP, butylone, pentedrone, referred to as the ‘‘Controlled substances on any person who handles pentylone, 4-FMC, 3-FMC, naphyrone, Substances Act’’ and the ‘‘Controlled or proposes to handle 4-MEC, 4-MePPP, and a-PBP in schedule I of the CSA. 81 Substances Import and Export Act,’’ FR 11479. Specifically, the DEA respectively, and are collectively 1 As set forth in a memorandum of understanding proposed to add these 10 synthetic referred to as the ‘‘Controlled entered into by the Food and Drug Administration cathinones to 21 CFR 1308.11(d), Substances Act’’ or the ‘‘CSA’’ for the (FDA) and the National Institute on Drug Abuse hallucinogenic substances. purposes of this action. The DEA (NIDA), the FDA acts as the lead agency within the Department of Health and Human Services (HHS) DEA and HHS Eight Factor Analyses publishes the implementing regulations in carrying out the Secretary’s scheduling for these statutes in title 21 of the Code responsibilities under the CSA, with the By letter dated March 2, 2016, the of Federal Regulations (CFR), chapter II. concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. HHS provided the DEA with a scientific The Secretary of the HHS has delegated to the The CSA and its implementing Assistant Secretary for Health of the HHS the and medical evaluation document regulations are designed to prevent, authority to make domestic drug scheduling prepared by the FDA entitled ‘‘Basis for detect, and eliminate the diversion of recommendations. 58 FR 35460, July 1, 1993. the Recommendation to Control 4-

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methyl-N-ethylcathinone (4-MEC), 4- regulations on or before April 4, 2016. legitimate medical use, safety and methyl-pyrrolidinopropiophenone (4- No requests for such a hearing were dependence liability, the Assistant MePPP), alpha- received by the DEA. The NPRM also Secretary of the HHS recommended that pyrrolidinopentiophenone (a-PVP), 1- provided an opportunity for interested 4-MEC, 4-MePPP, a-PVP, butylone, (1,3-benzodioxol-5-yl)-2- persons to submit written comments on pentedrone, pentylone, 4-FMC, 3-FMC, (methylamino)butan-1-one (butylone), the proposal on or before April 4, 2016. naphyrone, a-PBP and their salts be controlled in schedule I of the CSA. The 2-(methylamino)-1-phenylpentan-1-one Comments Received (pentedrone), 1-(1,3-benzodioxol-5-yl)- recommendations of the HHS to the 2-(methylamino)pentan-1-one The DEA received two comments on DEA are binding on the DEA as to the (pentylone), 4-fluoro-N- the proposed rule to control 4-MEC, 4- scientific and medical matters. The DEA methylcathinone (4-FMC), 3-fluoro-N- MePPP, a-PVP, butylone, pentedrone, reviewed HHS’s scientific and medical methylcathinone (3-FMC), 1- pentylone, 4-FMC, 3-FMC, naphyrone, evaluations and all other relevant data (naphthalen-2-yl)-2-(pyrrolidin-1- and a-PBP in schedule I of the CSA. on these substances and concurs with yl)pentan-1-one (naphyrone), alpha- Both commenters were in opposition to the HHS evaluations and findings. The pyrrolidinobutiophenone (a-PBP) and the proposed scheduling of 4-MEC, 4- current scientific, medical and other their Salts in Schedule I of the MePPP, a-PVP, butylone, pentedrone, evidence on 4-MEC, 4-MePPP, a-PVP, Controlled Substances Act (CSA).’’ After pentylone, 4-FMC, 3-FMC, naphyrone, butylone, pentedrone, pentylone, 4- considering the eight factors in 21 and a-PBP in schedule I of the CSA, but FMC, 3-FMC, naphyrone, and a-PBP U.S.C. 811(c), including consideration the reasons for the opposition were warrant control of these substances and of each substance’s abuse potential, different. The first commenter their optical, positional, and geometric legitimate medical use, and dependence associated the scheduling of these isomers, salts and salts of isomers in liability, the Assistant Secretary of the substances with the ‘‘War on Drugs,’’ schedule I of the CSA. HHS recommended that 4-MEC, 4- which according to the commenter ‘‘has While the DEA appreciates the MePPP, a-PVP, butylone, pentedrone, proven to be ineffective in past years in commenter’s suggestions regarding the pentylone, 4-FMC, 3-FMC, naphyrone, reducing the number of drug abuse problems related to drug abuse, some of a-PBP, and their salts be controlled in victims in the United States.’’ The the suggested alternative solutions are schedule I of the CSA. In response, the second commenter questioned the outside the scope of the current DEA conducted its own eightfactor findings considered by the DEA to scheduling action which pursuant to 21 a analysis of 4-MEC, 4-MePPP, a-PVP, control 4-MEC, 4-MePPP, -PVP, U.S.C. 811 and 812 is to add drugs into butylone, pentedrone, pentylone, 4- butylone, pentedrone, pentylone, 4- one of the five schedules, remove drugs FMC, 3-FMC, naphyrone, and a-PBP. FMC, 3-FMC, naphyrone, and a-PBP. from the schedules, or transfer drugs Both commenters offered alternative Both the DEA and HHS analyses are within the schedules based on the methods to address problems related to available in their entirety, under the tab drug’s potential for abuse, medicinal drug abuse instead of scheduling the 10 ‘‘Supporting Documents’’ of the public value, harmfulness, and psychological synthetic cathinones in schedule I of the docket of this action at http:// or physical dependence. However, CSA. www.regulations.gov, under FDMS please note that in addition to law Opposition from First Commenter. enforcement operations to reduce the Docket ID: DEA–2016–0004 (Docket No. The first commenter stated that he DEA–436).2 supply of illicit controlled drugs, the understood the DEA’s reasons for DEA also recommends and supports Determination To Schedule 4-MEC, 4- proposing to schedule 4-MEC, 4-MePPP, non-enforcement programs such as the MePPP, a-PVP, Butylone, Pentedrone, a-PVP, butylone, pentedrone, DEA 360 and the DEA Demand Pentylone, 4-FMC, 3-FMC, Naphyrone, pentylone, 4-FMC, 3-FMC, naphyrone, Reduction Section programs. The DEA and a-PBP and a-PBP in schedule I of the CSA, but 360 strategy involves community still opposed the control of these After a review of the available data, outreach activities such as the substances because, according to the dissemination of drug information to including the scientific and medical commenter, it would neither reduce the evaluations and the scheduling increase the public’s awareness about number of drug users nor stop the the dangers associated with drug use. recommendations from the HHS, the production of illegal drugs. The DEA published an NPRM entitled The DEA’s Community Outreach and commenter suggested that the DEA Prevention Support Section supports ‘‘Schedules of Controlled Substances: consider harm reduction solutions such initiatives to reduce the demand for Placement of 10 Synthetic Cathinones as establishing drug clinics, finding jobs drugs and gives assistance to into Schedule I,’’ proposing to control 4- for prior offenders, and offering community coalitions and drug MEC, 4-MePPP, a-PVP, butylone, treatment and health care for drug users prevention initiatives. pentedrone, pentylone, 4-FMC, 3-FMC, to address problems related to drug Some of the alternative methods naphyrone, a-PBP, and their optical, abuse. suggested by the commenter to address positional and geometric isomers, salts DEA Response: Substances are the problems related to drug abuse that and salts of isomers in schedule I of the controlled to protect the public health are outside of the scope of the DEA are, CSA. 81 FR 11479, Mar. 4, 2016. The and safety. Pursuant to 21 U.S.C. 811(a), in fact, part of the initiatives of other proposed rule provided an opportunity the CSA authorizes the DEA, under federal institutions. For example, the for interested persons to file a request authority delegated by the Attorney Office of National Drug Control Policy for hearing in accordance with the DEA General, to control any drug or other (ONDCP), a component of the Executive substance if it is found that the drug or Office of the President of the United 2 Although the published notice of proposed rulemaking stated that the DEA 8-factor analysis other substance has a potential for States that coordinates drug-control had been placed into the docket on http:// abuse, and makes with respect to such activities and related funding across the www.regulations.gov, DEA discovered in preparing drug or other substance the findings Federal government including the DEA, this final rule that it had in fact not been posted. prescribed by 21 U.S.C. 812(b). After incorporates community-based However, this document was available for review at the DEA. The DEA posted the cited analysis to considering the eight factors in 21 prevention programs, policies and http://www.regulations.gov upon discovery of the U.S.C. 811(c), including consideration systems to divert non-violent drug omission. of each substance’s abuse potential, offenders into treatment instead of jail,

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outreach programs as well as other drug to controlling these 10 synthetic studies indicate that the abuse potential control policies in its long term plans to cathinones, this commenter suggested and pharmacological effects of the 10 reduce drug use and its consequences. ‘‘placing restrictions on who can sell synthetic cathinones are similar to those Opposition from Second Commenter. products with these compounds in of certain schedule I and II substances. The second commenter also opposed them, and a restriction of the quantity Preclinical studies indicated that the 10 the control of 4-MEC, 4-MePPP, a-PVP, that can be sold to any individual,’’ and synthetic cathinones, like butylone, pentedrone, pentylone, 4- allowing States to regulate these (schedule II), FMC, 3-FMC, naphyrone, and a-PBP in substances. (schedule II), (schedule schedule I of the CSA, but for different DEA Response: Pursuant to 21 U.S.C. I), and MDMA (schedule I) have reasons than the first commenter. The 811, the DEA considered the eight pharmacological effects at monoamine second commenter maintained that the factors enumerated in 21 U.S.C. 811(c), transporters. Furthermore, behavioral three arguments the DEA relied on in its the scientific and medical evaluations effects of the 10 synthetic cathinones in proposed rule for the scheduling of the and scheduling recommendations from animals were found to be similar to 10 synthetic cathinones: (1) ‘‘no medical the HHS, and all other available data those of schedule I and II substances or scientific use for these drugs;’’ (2) before making the required findings which have a high potential for abuse. ‘‘there is a distinct public safety concern under 21 U.S.C. 812 to place these drugs In humans, the 10 synthetic cathinones allowing these drugs to be sold;’’ and (3) into schedule I of the CSA. The DEA are expected to produce subjective ‘‘the use of this drug poses health does not consider these finding to be responses similar to methamphetamine concerns to those who use it,’’ were illogical and based on faulty premises or and cocaine based on drug illogical and based on faulty premises or speculative data. The summary of each discrimination studies in rodents. speculative data. The commenter also factor as analyzed by the HHS and the Accordingly, published case reports stated that the number of reported cases DEA, and as considered by the DEA in demonstrate that some of the 10 (or law enforcement drug reports) this scheduling action, was provided in synthetic cathinones produce involving these substances, especially if the proposed rule. The information in pharmacological effects including considered over the defined five year these factors is from legitimate sources adverse effects that are characteristic of period (i.e., January 2010 through such as peer reviewed publications, substances like MDMA, methamphetamine, and cocaine that December 2015), along with the national statistics (e.g., seizure numbers, have a effect. However, there population of the United States, is surveys), law enforcement is no currently accepted medical use in ‘‘miniscule’’ which indicates that these communications, medical examiner treatment in the United States for any of substances do not pose a large public reports, etc. the 10 synthetic cathinones. There are safety concern. For example, the As of March 7, 2014, the date the final reports of emergency room admissions commenter provided information that order to temporarily place the 10 and deaths associated with the abuse of estimated the U.S. population for 2015 synthetic cathinones into schedule I of synthetic cathinones in general. to be 320 million, and considered this the CSA was published and became Regarding the 10 synthetic cathinones, with the 20,090 total reported cases for effective, all persons handling the 10 synthetic cathinones were subject to the butylone, a-PVP, pentedrone, and all ten substances, as well as the 84 pentylone have been implicated in the reported cases for naphyrone alone, over regulatory controls and administrative, civil, and criminal sanctions applicable deaths of individuals. Consequently, the the defined five year period. abuse of the 10 synthetic cathinones Extrapolating this data further, the to schedule I controlled substances. Based on a review of the DEA’s records, presents the possibility of death and commenter estimated 4,018 reported potential safety hazards to the health of cases annually for all ten substances each of the 43 registrations that have been identified to handle any of the 10 individuals. (i.e., 20,090 divided by 5 = 4,018), Law enforcement data indicate that potentially impacting 0.000013 percent synthetic cathinones also handle other schedule I controlled substances. They the 10 synthetic cathinones are being of the U.S. population (4,018 divided by abused. Since 2010, law enforcement 320 million = 0.000013 percent), and 17 have already established and implemented the systems and processes encounters of the 10 synthetic reported cases annually for naphyrone cathinones have increased and have alone (84 divided by 5 = 17). required to handle any of the 10 synthetic cathinones. Any additional been encountered in nearly every State Furthermore, the commenter stated that (47 States as of December 2015). there is no toxicology, efficacy, or safety cost to handle the one or more of the 10 synthetic cathinones is estimated to be Regardless of the number of encounters data on these 10 synthetic cathinones in of these 10 synthetic cathinones, minimal. Both the DEA and the HHS human beings indicating that these evidence indicates that the abuse of the analyses have been made available in substances actually cause harm. The 10 synthetic cathinones is widespread. their entirety under ‘‘Supporting commenter also expressed concern that Thus, taking into consideration the Documents’’ section of the public the proposed scheduling of the 10 harm that these substances can cause as docket for this rule at http:// synthetic cathinones would prohibit or demonstrated in case reports and other www.regulations.gov, under FDMS significantly restrict the use of these related information, the DEA believes Docket ID: DEA–2016–0004 (Docket No. substances in scientific and medical that there is potential for widespread DEA–436).3 research, and that schedule I placement harm to the public health. would put barriers in place for As detailed in the HHS and DEA The DEA also considered all other clinicians or researchers who might be analyses and the HHS recommendation, relevant data including public interested in investigating the potential comments regarding the proposed 3 Although the published notice of proposed benefits of these substances in patients. rulemaking stated that the DEA 8-factor analysis scheduling before controlling these In addition, this commenter believed had been placed into the docket on http:// drugs. After careful consideration of that the proposed rule was unduly www.regulations.gov, DEA discovered in preparing preclinical studies, case reports, law burdensome, leading to increased this final rule that it had in fact not been posted. enforcement data and all other relevant However, this document was available for review at regulation and costs with ‘‘little, if no the DEA. The DEA posted the cited analysis to data and in accordance with 21 U.S.C. impact’’ on deterring abuse of these 10 http://www.regulations.gov upon discovery of the 811(a) and (b) and considering the synthetic cathinones. As an alternative omission. factors enumerated in 21 U.S.C. 811(c),

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the DEA finds that the 10 synthetic also outlines the findings required to research, conducting instructional cathinones have a high potential for place a drug or other substance in any activities or chemical analysis, or abuse, have no currently accepted particular schedule. 21 U.S.C. 812(b). possession of schedule I controlled medical use in treatment in the United After consideration of the analysis and substances, including those listed States, and lack accepted safety for use recommendation of the Assistant below. These controls will continue on under medical supervision, thus Secretary for the HHS and review of all a permanent basis: supporting their placement in schedule other available data, the Administrator 1. Registration. Any person who handles I of the CSA. of the DEA, pursuant to 21 U.S.C. 811(a) (manufactures, distributes, reverse The DEA does not agree that and 21 U.S.C. 812(b)(1), finds that: distributes, imports, exports, engages in placement of these substances in (1) 4-MEC, 4-MePPP, a-PVP, butylone, research, conducts instructional activities or schedule I of the CSA precludes pentedrone, pentylone, 4-FMC, 3-FMC, chemical analysis with, or possesses) 4-MEC, scientific research from being conducted naphyrone, and a-PBP each have a high 4-MePPP, a-PVP, butylone, pentedrone, using these substances. Persons potential for abuse that is comparable to pentylone, 4-FMC, 3-FMC, naphyrone, or a- interested in using any of the 10 other schedule I and schedule II substances PBP, or who desires to handle 4-MEC, 4- synthetic cathinones for research such as , , MDPV, MePPP, a-PVP, butylone, pentedrone, methcathinone, MDMA, methamphetamine, pentylone, 4-FMC, 3-FMC, naphyrone, or a- purposes can do so provided that they PBP must be registered with the DEA to have a DEA schedule I researcher and cocaine; (2) 4-MEC, 4-MePPP, a-PVP, butylone, conduct such activities pursuant to 21 U.S.C. registration and meet all other statutory pentedrone, pentylone, 4-FMC, 3-FMC, 822, 823, 957, and 958, and in accordance and regulatory criteria. This registration naphyrone, and a-PBP have no currently with 21 CFR parts 1301 and 1312. can be obtained by submitting an accepted medical use in treatment in the 2. Security. 4-MEC, 4-MePPP, a-PVP, application for schedule I registration in United States; and butylone, pentedrone, pentylone, 4-FMC, 3- accordance with 21 CFR 1301.11, (3) There is a lack of accepted safety for use FMC, naphyrone, and a-PBP are subject to 1301.13, 1301.18 and 1301.32. of 4-MEC, 4-MePPP, a-PVP, butylone, schedule I security requirements and must be As for the commenter’s suggestion to pentedrone, pentylone, 4-FMC, 3-FMC, handled and stored pursuant to 21 U.S.C. 821 allow States to regulate these naphyrone, and a-PBP under medical and 823, and in accordance with 21 CFR supervision. 1301.71–1301.93. substances, the DEA has no statutory 3. Labeling and Packaging. All labels, authority under the CSA to require Based on these findings, the labeling, and packaging for commercial states to regulate these substances. With Administrator of the DEA concludes containers of 4-MEC, 4-MePPP, a-PVP, regard to the suggestion by the that 4-methyl-N-ethylcathinone (4- butylone, pentedrone, pentylone, 4-FMC, 3- commenter to place ‘‘restrictions on MEC); 4-methyl-alpha- FMC, naphyrone, or a-PBP must be in who can sell products with these pyrrolidinopropiophenone (4-MePPP); compliance with 21 U.S.C. 825 and 958(e), compounds in them, and a restriction alpha-pyrrolidinopentiophenone (a- and be in accordance with 21 CFR part 1302. on the quantity that can be sold to any PVP); 1-(1,3-benzodioxol-5-yl)-2- 4. Quota. Only registered manufacturers are permitted to manufacture 4-MEC, 4- individual,’’ the CSA and its (methylamino)butan-1-one (butylone); 2-(methylamino)-1-phenylpentan-1-one MePPP, a-PVP, butylone, pentedrone, implementing regulations do provide pentylone, 4-FMC, 3-FMC, naphyrone, or a- regulatory controls and administrative (pentedrone); 1-(1,3-benzodioxol-5-yl)- PBP in accordance with a quota assigned sanctions applicable to schedule I 2-(methylamino)pentan-1-one pursuant to 21 U.S.C. 826, and in accordance substances such as controls on persons (pentylone); 4-fluoro-N- with 21 CFR part 1303. who handle (manufacture, distribute, methylcathinone (4-FMC); 3-fluoro-N- 5. Inventory. Every DEA registrant required reverse distribute, import, export, methylcathinone (3-FMC); 1- to keep records and who possesses any engage in research, conduct (naphthalen-2-yl)-2-(pyrrolidin-1- quantity of 4-MEC, 4-MePPP, a-PVP, instructional activities or chemical yl)pentan-1-one (naphyrone); alpha- butylone, pentedrone, pentylone, 4-FMC, 3- pyrrolidinobutiophenone (a-PBP) and FMC, naphyrone, and/or a-PBP is required to analysis, or possess) schedule I maintain inventory of all stocks of 4-MEC, 4- substances. their optical, positional, and geometric isomers, salts and salts of isomers, MePPP, a-PVP, butylone, pentedrone, Scheduling Conclusion pentylone, 4-FMC, 3-FMC, naphyrone, and a- whenever the existence of salts, isomers, PBP on hand, pursuant to 21 U.S.C. 827 and After consideration of the relevant and salts of isomers is possible, warrant 958, and in accordance with 21 CFR 1304.03, matter presented as a result of public control in schedule I of the CSA. 21 1304.04, and 1304.11. comment, the scientific and medical U.S.C. 812(b)(1). 6. Records and Reports. Every DEA evaluations and accompanying Requirements for Handling 4-MEC, 4- registrant must maintain records and submit recommendations of the HHS, and the reports pursuant to 21 U.S.C. 827 and 958, MePPP, a-PVP, butylone, pentedrone, and in accordance with 21 CFR parts 1304 DEA’s consideration of its own eight- pentylone, 4-FMC, 3-FMC, naphyrone, factor analysis, the DEA finds that these and 1317. Manufacturers and distributors and a-PBP must submit reports regarding 4-MEC, 4- facts and all other relevant data MePPP, a-PVP, butylone, pentedrone, constitute substantial evidence of 4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, pentylone, 4-FMC, 3-FMC, naphyrone, and/ potential for abuse of 4-MEC, 4-MePPP, a naphyrone, and a-PBP are currently or -PBP to the Automation of Reports and a-PVP, butylone, pentedrone, Consolidated Orders System (ARCOS) pentylone, 4-FMC, 3-FMC, naphyrone, scheduled on a temporary basis in pursuant to 21 U.S.C. 827 and in accordance 4 and a-PBP. As such, the DEA is schedule I and are therefore currently with 21 CFR 1304.33. permanently scheduling 4-MEC, 4- subject to the regulatory controls and 8. Order Forms. Every DEA registrant who MePPP, a-PVP, butylone, pentedrone, administrative, civil, and criminal distributes 4-MEC, 4-MePPP, a-PVP, pentylone, 4-FMC, 3-FMC, naphyrone, sanctions applicable to the manufacture, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, or a-PBP must continue to and a-PBP as controlled substances distribution, reverse distribution, importation, exportation, engaging in comply with the order form requirements, under the CSA. pursuant to 21 U.S.C. 828, and 21 CFR part 1305. Determination of Appropriate Schedule 4 4-MEC, 4-MePPP, a-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and a-PBP 9. Importation and Exportation. All The CSA establishes five schedules of are currently subject to schedule I controls on a importation and exportation of 4-MEC, 4- controlled substances known as temporary basis, pursuant to 21 U.S.C. 811(h). 79 MePPP, a-PVP, butylone, pentedrone, schedules I, II, III, IV, and V. The CSA FR 12938, Mar. 7, 2014. pentylone, 4-FMC, 3-FMC, naphyrone, and a-

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PBP must continue to be in compliance with Regulatory Flexibility Act butylone, pentedrone, pentylone, 4- 21 U.S.C. 952, 953, 957, and 958, and in The Administrator, in accordance FMC, 3-FMC, naphyrone, or a-PBP. accordance with 21 CFR part 1312. with the Regulatory Flexibility Act Therefore, the DEA anticipates that this 10. Liability. Any activity involving 4-MEC, (RFA), 5 U.S.C. 601–602, has reviewed rule will impose minimal or no 4-MePPP, a-PVP, butylone, pentedrone, this final rule and by approving it, economic impact on any affected pentylone, 4-FMC, 3-FMC, naphyrone, or a- entities; and thus, will not have a PBP not authorized by, or in violation of, the certifies that it will not have a significant economic impact on a significant economic impact on any of CSA or its implementing regulations is the 11 affected small entities. unlawful, and may subject the person to substantial number of small entities. On March 7, 2014, the DEA published a Accordingly, the DEA has concluded administrative, civil, and/or criminal that this rule will not have a significant sanctions. final order amending 21 CFR 1308.11(h) to temporarily place these ten synthetic economic impact on a substantial Regulatory Analyses cathinones into schedule I of the CSA number of small entities. Executive Orders 12866 and 13563, pursuant to the temporary scheduling Unfunded Mandates Reform Act of 1995 Regulatory Planning and Review, and provisions of 21 U.S.C. 811(h). 79 FR 12938. On March 4, 2016, the DEA In accordance with the Unfunded Improving Regulation and Regulatory Mandates Reform Act (UMRA) of 1995, Review published a final order extending the temporary placement of these 2 U.S.C. 1501 et seq., the DEA has In accordance with 21 U.S.C. 811(a), substances in schedule I of the CSA for determined and certifies that this action this final scheduling action is subject to up to one year pursuant to 21 U.S.C. would not result in any Federal formal rulemaking procedures done ‘‘on 811(h)(2). 81 FR 11429. The DEA mandate that may result ‘‘in the the record after opportunity for a estimates that all entities handling or expenditure by State, local, and tribal hearing,’’ which are conducted pursuant planning to handle 4-MEC, 4-MePPP, a- governments, in the aggregate, or by the to the provisions of 5 U.S.C. 556 and PVP, butylone, pentedrone, pentylone, private sector, of $100,000,000 or more 557. The CSA sets forth the criteria for 4-FMC, 3-FMC, naphyrone, or a-PBP are (adjusted for inflation) in any one year scheduling a drug or other substance. currently registered to handle these * * *.’’ Therefore, neither a Small Such actions are exempt from review by substances. There are currently 43 Government Agency Plan nor any other the Office of Management and Budget registrants authorized to handle 4-MEC, action is required under UMRA of 1995. (OMB) pursuant to section 3(d)(1) of 4-MePPP, a-PVP, butylone, pentedrone, Paperwork Reduction Act of 1995 Executive Order 12866 and the pentylone, 4-FMC, 3-FMC, naphyrone, principles reaffirmed in Executive Order or a-PBP, as well as a number of This action does not impose a new 13563. registered analytical labs that are collection of information under the authorized to handle schedule I Paperwork Reduction Act of 1995. 44 Executive Order 12988, Civil Justice controlled substances generally.5 These U.S.C. 3501–3521. This action would Reform 43 registrants represent 31 entities, of not impose recordkeeping or reporting requirements on State or local This regulation meets the applicable which 11 are small entities based on governments, individuals, businesses, or standards set forth in sections 3(a) and RFA definition of ‘‘small entity’’ and organizations. An agency may not 3(b)(2) of Executive Order 12988 to Small Business Administration size conduct or sponsor, and a person is not eliminate drafting errors and ambiguity, standards. Therefore, the DEA estimates required to respond to, a collection of minimize litigation, provide a clear legal that 11 small entities are affected by this information unless it displays a standard for affected conduct, and rule. currently valid OMB control number. promote simplification and burden A review of the 43 registrants reduction. indicates that all entities that currently Congressional Review Act handle 4-MEC, 4-MePPP, a-PVP, Executive Order 13132, Federalism butylone, pentedrone, pentylone, 4- This rule is not a major rule as FMC, 3-FMC, naphyrone, or a-PBP also defined by section 804 of the Small This rulemaking does not have handle other schedule I controlled Business Regulatory Enforcement federalism implications warranting the substances, and have established and Fairness Act of 1996 (Congressional application of Executive Order 13132. implemented (or currently maintain) the Review Act (CRA)). This rule will not The rule does not have substantial systems and processes required to result in: ‘‘an annual effect on the direct effects on the States, on the handle 4-MEC, 4-MePPP, a-PVP, economy of $100,000,000 or more; a relationship between the national major increase in costs or prices for government and the States, or the 5 While analytical labs are required to obtain a consumers, individual industries, distribution of power and registration for schedule I controlled substances, in Federal, State, or local government responsibilities among the various order to handle any of the 10 synthetic cathinones, agencies, or geographic regions; or levels of government. analytical labs are not required to identify the substances on their registration. Therefore, while significant adverse effects on Executive Order 13175, Consultation every analytical lab that is authorized to handle competition, employment, investment, and Coordination With Indian Tribal schedule I controlled substances may handle any of productivity, innovation, or on the the 10 synthetic cathinones, the DEA does not have ability of U.S.-based companies to Governments a basis by which to estimate the number of analytical labs that actually handle the 10 synthetic compete with foreign based companies This rule does not have tribal cathinones. Since an analytical lab registered to in domestic and export markets.’’ implications warranting the application handle schedule I controlled substances may However, pursuant to the CRA, the DEA manufacture or obtain any of the 10 synthetic has submitted a copy of this final rule of Executive Order 13175. It does not cathinones without any modification to the have substantial direct effects on one or analytical lab’s registration, the DEA believes to both Houses of Congress and to the more Indian tribes, on the relationship analytical labs’ inventories of these substances are Comptroller General. between the Federal Government and not significant and will have minimal impact on existing schedule I controlled substance storage List of Subjects in 21 CFR Part 1308 Indian tribes, or on the distribution of space. Therefore, for the purposes of this analysis, power and responsibilities between the the DEA assumes that no analytical lab is affected Administrative practice and Federal Government and Indian tribes. by this rule. procedure, Drug traffic control,

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Reporting and recordkeeping Authority: 21 U.S.C. 811, 812, 871(b), ■ d. Remove reserved paragraphs (h)(20) requirements. unless otherwise noted. through (22). For the reasons set out above, 21 CFR ■ 2. In § 1308.11: The additions read as follows: part 1308 is amended as follows: ■ a. Add paragraphs (d)(59) through § 1308.11 Schedule I. PART 1308—SCHEDULES OF (68); ■ * * * * * CONTROLLED SUBSTANCES b. Remove paragraphs (h)(1) through (10); (d) * * * ■ 1. The authority citation for 21 CFR ■ c. Redesignate paragraphs (h)(11) part 1308 continues to read as follows: through (19) as (h)(1) through (9); and

(59) 4-methyl-N-ethylcathinone (4-MEC) ...... (1249) (60) 4-methyl-alpha-pyrrolidinopropiophenone (4-MePPP) ...... (7498) (61) alpha-pyrrolidinopentiophenone (a-PVP) ...... (7545) (62) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone, bk-MBDB) ...... (7541) (63) 2-(methylamino)-1-phenylpentan-1-one (pentedrone) ...... (1246) (64) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone, bk-MBDP) ...... (7542) (65) 4-fluoro-N-methylcathinone (4-FMC; flephedrone) ...... (1238) (66) 3-fluoro-N-methylcathinone (3-FMC) ...... (1233) (67) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone) ...... (1258) (68) alpha-pyrrolidinobutiophenone (a-PBP) ...... (7546)

* * * * * deviation, call or email Mr. Mickey through the bridge in the closed Dated: February 22, 2017. Sanders, Bridge Administration Branch position. The Coast Guard will also Chuck Rosenberg, Fifth District, Coast Guard; telephone inform the users of the waterways (757) 398–6587, email through our Local and Broadcast Notice Acting Administrator. [email protected]. to Mariners of the change in operating [FR Doc. 2017–03974 Filed 2–28–17; 8:45 am] SUPPLEMENTARY INFORMATION: The North schedule for the bridge so that vessel BILLING CODE 4410–09–P Carolina Department of Transportation, operators can arrange their transits to owner and operator of the Cape Fear minimize any impact caused by this Memorial Bridge that carries US 17 temporary deviation. DEPARTMENT OF HOMELAND across the Cape Fear River, mile 26.8, at In accordance with 33 CFR 117.35(e), SECURITY Wilmington, NC, has requested a the drawbridge must return to its regular temporary deviation from the current operating schedule immediately at the Coast Guard operating schedule to accommodate a end of this effective period of this routine biennial maintenance and temporary deviation. This deviation 33 CFR Part 117 inspection of the vertical lift span for from the operating regulations is [Docket No. USCG–2017–0055] the drawbridge. The bridge has a authorized under 33 CFR 117.35. vertical clearance of 65 feet above mean Dated: February 23, 2017. Drawbridge Operation Regulation; high water (MHW) in the closed Hal R. Pitts, Cape Fear River, Wilmington, NC position and 135 feet above MHW in the open position. Bridge Program Manager, Fifth Coast Guard AGENCY: Coast Guard, DHS. The current operating schedule is set District. ACTION: Notice of deviation from out in 33 CFR 117.822. Under this [FR Doc. 2017–03987 Filed 2–28–17; 8:45 am] drawbridge regulation. temporary deviation, the bridge will be BILLING CODE 9110–04–P SUMMARY: The Coast Guard has issued a maintained in the closed-to-navigation temporary deviation from the operating position for two separate four (4) day periods from 9 a.m. until 4 p.m. from DEPARTMENT OF HOMELAND schedule that governs the Cape Fear SECURITY Memorial Bridge which carries US 17 March 7, 2017, through March 10, 2017, across the Cape Fear River, mile 26.8, at and from 9 a.m. until 4 p.m. from March Coast Guard Wilmington, NC. The deviation is 14, 2017, through March 17, 2017. necessary to facilitate routine biennial During the closure periods, the bridge 33 CFR Part 165 maintenance and inspection of the lift will open on signal if at least 3 hours span for the bridge. This deviation notice is given. The bridge will open on [USCG–2014–1037] allows the bridge to remain in the signal at all other times. The Cape Fear River is used by a RIN 1625–AA00 closed-to-navigation position. variety of vessels including small DATES: This deviation is effective from Safety Zone: Eastport Breakwater commercial vessels, recreational vessels Terminal, Eastport, Maine 9 a.m. on March 7, 2017, through 4 p.m. and tug and barge traffic. The Coast on March 17, 2017. Guard has carefully considered the AGENCY: Coast Guard, DHS. ADDRESSES: The docket for this nature and volume of vessel traffic on ACTION: Temporary final rule; change in deviation, [USCG–2017–0055] is the waterway in publishing this effective period. available at http://www.regulations.gov. temporary deviation. Type the docket number in the Vessels able to pass through the SUMMARY: The Coast Guard is extending ‘‘SEARCH’’ box and click ‘‘SEARCH’’. bridge in the closed position may do so the effective period of a safety zone in Click on Open Docket Folder on the line if at least 15 minutes notice is given. the vicinity of the Eastport Breakwater associated with this deviation. The bridge will not be able to open for Terminal, Eastport, Maine. This safety FOR FURTHER INFORMATION CONTACT: If emergencies and there is no immediate zone was established on January 9, 2015 you have questions on this temporary alternate route for vessels unable to pass (80 FR 1344). This rule will extend the

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