81 FR 11479 - Schedules of Controlled Substances: Placement of 10 Synthetic Cathinones Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 43 (March 4, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 43 (March 4, 2016)
| Page Range | 11479-11486 | |
| FR Document | 2016-05002 |
[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)] [Proposed Rules] [Pages 11479-11486] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05002] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-436] Schedules of Controlled Substances: Placement of 10 Synthetic Cathinones Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration proposes placing 10 synthetic cathinones: 4-methyl-N-ethylcathinone (4-MEC); 4-methyl- alpha-pyrrolidinopropiophenone (4-MePPP); alpha- pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2- (methylamino)butan-1-one (butylone); 2-(methylamino)-1-phenylpentan-1- one (pentedrone); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone (4-FMC); 3-fluoro-N- methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan- 1-one (naphyrone); alpha-pyrrolidinobutiophenone ([alpha]-PBP) and their optical, positional, and geometric isomers, salts and salts of isomers into schedule I of the Controlled Substances Act. This proposed scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP. DATES: Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Comments must be submitted electronically or postmarked on or before April 4, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those ``adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811),'' may file a request [[Page 11480]] for hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before April 4, 2016. ADDRESSES: To ensure proper handling of comments, please reference ``Docket No. DEA-436'' on all correspondence, including any attachments.Electronic comments: The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments: Paper comments that duplicate the electronic submission are not necessary. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Hearing requests: All requests for hearing and waivers of participation must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing and waivers of participation should also be sent to: Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document and supplemental information to this proposed rule are available at http://www.regulations.gov for easy reference. Request for Hearing or Waiver of Participation in a Hearing Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking ``on the record after opportunity for a hearing.'' Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D. In accordance with 21 CFR 1308.44 (a)-(c), requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing may be submitted only by interested persons, defined as those ``adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).'' 21 CFR 1300.01. Such requests or notices must conform to the requirements of 21 CFR 1308.44 (a) or (b), and 1316.47 or 1316.48, as applicable, and include a statement of interest of the person in the proceeding and the objections or issues, if any, concerning which the person desires to be heard. Any waiver must conform to the requirements of 21 CFR 1308.44(c) and may include a written statement regarding the interested person's position on the matters of fact and law involved in any hearing. Please note that pursuant to 21 U.S.C. 811(a), the purpose and subject matter of a hearing held in relation to this rulemaking are restricted to: ``(A) find[ing] that such drug or other substance has a potential for abuse, and (B) mak[ing] with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed . . .'' All requests for hearing and waivers of participation must be sent to the DEA using the address information provided above. Legal Authority The DEA implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the ``Controlled Substances Act'' and the ``Controlled Substances Import and Export Act,'' respectively, and are collectively referred to as the ``Controlled Substances Act'' or the ``CSA'' for the purposes of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, controlled substances are classified into one of five schedules [[Page 11481]] based upon their potential for abuse, their currently accepted medical use in treatment in the United States, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of scheduled substances is published at 21 CFR part 1308. Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, ``add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by subsection (b) of section 812 of this title for the schedule in which such drug is to be placed . . .'' The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on her own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS); \1\ or (3) on the petition of any interested party. 21 U.S.C. 811(a). This proposed action is supported by a recommendation from the Assistant Secretary of the HHS and an evaluation of all other relevant data by the DEA. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-;FMC, 3-FMC, naphyrone, or [alpha]-PBP. --------------------------------------------------------------------------- \1\ As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993. --------------------------------------------------------------------------- Background On March 7, 2014, the DEA published a final order in the Federal Register amending 21 CFR 1308.11(h) to temporarily place 4-methyl-N- ethylcathinone (4-MEC); 4-methyl-alpha-pyrrolidinopropiophenone (4- MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3- benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone); 2- (methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5- yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2- (pyrrolidin-1-yl)pentan-1-one (naphyrone); and alpha- pyrrolidinobutiophenone ([alpha]-PBP) into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 79 FR 12938. That final order, which became effective on the date of publication, was based on findings by the Deputy Administrator of the DEA that the temporary scheduling of these 10 synthetic cathinones was necessary to avoid an imminent hazard to public safety pursuant to 21 U.S.C. 811(h)(1). At the time the final order took effect, section 201(h)(2) of the CSA (21 U.S.C. 811(h)(2)), required that the temporary scheduling of a substance expire at the end of two years from the date of issuance of the scheduling order, and it provided that, during the pendency of proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, temporary scheduling of that substance could be extended for up to 1 year. Pursuant to 21 U.S.C. 811(h)(2), the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP expires on March 6, 2016, unless extended. An extension of the temporary order is being ordered by the DEA Administrator in a separate action. As described in the final order published on March 7, 2014, 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are structurally and pharmacologically similar to amphetamine, 3,4-methylenedioxymethamphetamine (MDMA), cathinone, and other related substances. While 4-MEC, 4-MePPP, [alpha]- PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP have been used as research chemicals and/or studied due to their misuse and abuse, based on the review of the scientific literature, there are no known currently accepted medical uses for these substances. The Assistant Secretary of Health for the U.S. Department of Health and Human Services (HHS) has advised that there are no exemptions or approvals in effect for 4-MEC, 4-MePPP, [alpha]- PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP under section 505 (21 U.S.C. 355) of the Federal Food, Drug and Cosmetic Act. As stated by the HHS, 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP have no known accepted medical use. They are not the subject of any approved new drug applications (NDAs) or investigational new drug applications (INDs), and are not currently marketed as approved drug products. The HHS recommends that 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP and their salts be placed into schedule I of the Controlled Substances Act (CSA). Proposed Determination To Schedule 4-MEC, 4-MePPP, [alpha]-PVP, Butylone, Pentedrone, Pentylone, 4-FMC, 3-FMC, Naphyrone, and [alpha]- PBP Pursuant to 21 U.S.C. 811(a)(1), proceedings to add a drug or substance to those controlled under the CSA may be initiated by the Attorney General, or her delegate, the DEA Administrator. On December 30, 2014, the DEA requested scientific and medical evaluations and scheduling recommendations from the Assistant Secretary of Health for the HHS for 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP pursuant to 21 U.S.C. 811(b). Upon receipt of the scientific and medical evaluation and scheduling recommendations from the HHS on March 2, 2016, the DEA reviewed the documents and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP pursuant to 21 U.S.C. 811(c). Included below is a brief summary of each of the eight factors as analyzed by the HHS and the DEA, and as considered by the DEA in its proposed scheduling action. Please note that both the DEA 8-Factor and the HHS 8-Factor analyses are available in their entirety under the tab ``Supporting Documents'' of the public docket for this action at http://www.regulations.gov under Docket Number ``DEA-436.'' 1. The Drug's Actual or Relative Potential for Abuse: The term ``abuse'' is not defined in the CSA. However, the legislative history of the CSA suggests that the DEA consider the following criteria when determining whether a particular drug or substance has a potential for abuse: \2\ --------------------------------------------------------------------------- \2\ Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970 U.S.C.C.A.N. 4566, 4603. --------------------------------------------------------------------------- (a) There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or of the community; or [[Page 11482]] (b) There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels; or (c) Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or (d) The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community. As described by the HHS, the abuse potentials of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are associated with their abilities to produce psychoactive effects that are similar to those produced by mephedrone, methylone, MDPV, and other schedule I and II substances such as amphetamine, methamphetamine, cocaine, methcathinone, and MDMA that have a high potential for abuse. The substances 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP have no approved medical uses in the United States and they have been encountered on the illicit market with adverse outcomes on the public health and safety. Because these substances are not approved drug products, a practitioner may not legally prescribe them, and they cannot be dispensed to an individual. Therefore, the use of these substances is without medical advice, leading to the conclusion that the 10 synthetic cathinones are being abused for their psychoactive properties. There are no legitimate drug channels for these synthetic cathinones as marketed drugs but the DEA notes that the 10 synthetic cathinones have use in scientific research. However, despite the limited legitimate use of these substances, reports from public health and law enforcement communicate that these substances are being abused and taken in amounts sufficient to create a hazard to an individual's health. This misuse is evidenced by emergency department admissions and deaths, representing a significant safety issue for those in the community. Papers published in the medical literature (e.g., case reports) related to 4-MEC, 4- MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP describe the effects of these substances to be similar to those of the schedule I cathinone substances MDPV, mephedrone, and methylone and other stimulant and hallucinogenic substances to include methamphetamine, cocaine and MDMA. In particular, the responses in humans to the 10 synthetic cathinones are stimulant- like and include paranoia, agitation, palpitations, tachycardia, hypertension, hyperthermia, and seizures. Data from forensic databases are used as indicators of illicit activity with drugs and abuse \3\ within the United States and include data from the System to Retrieve Information from Drug Evidence (STRIDE),\4\ STARLiMS, and the National Forensic Laboratory Information System (NFLIS).\5\ From January 2010 through December 2015 (query dates: February 10 & 11, 2016), STRIDE, STARLiMS and NFLIS databases registered a total of 20,090 reports pertaining to the 10 synthetic cathinones (4-MEC--2,820 reports; 4- MePPP--438 reports; [alpha]-PVP--13,295 reports; butylone--789 reports; pentedrone--1,645 reports; pentylone--411 reports; FMC--375 reports; naphyrone--84 reports; [alpha]-PBP--233 reports). These drug reports represent all of the 10 synthetic cathinones reported to these databases by participating DEA, State, local, and other forensic laboratories. Consequently, the data indicate that these substances are being abused, and they present safety hazards to the health of individuals who consume them due to their stimulant properties, making them a hazard to the safety of the community. --------------------------------------------------------------------------- \3\ While law enforcement data is not direct evidence of abuse, it can lead to an inference that a drug has been diverted and abused. See 76 FR 77330, 77332, Dec. 12, 2011. \4\ STRIDE was a database that collected analyses of results from drug evidence sent to DEA laboratories. Evidence was submitted by the DEA, other Federal agencies, and select local law enforcement agencies. On October 1, 2014, STARLiMS replaced STRIDE as the DEA system of record for forensic laboratory drug evidence data. \5\ NFLIS is a DEA program and a national forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories in the United States. The NFLIS database also contains Federal data from U.S. Customs and Border Protection (CBP). NFLIS only includes drug chemistry results from completed analyses. --------------------------------------------------------------------------- 2. Scientific Evidence of the Drug's Pharmacological Effects, if Known: Studies show that 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP produce pharmacological effects that are similar to those produced by schedule I and II substances such as methamphetamine, cocaine, MDMA, mephedrone, MDPV, and methylone. Similar to schedule I and II stimulants, the 10 synthetic cathinone substances affect monoamine transmission. The 10 synthetic cathinones, similar to methamphetamine, cocaine, MDMA, mephedrone, MDPV, methylone, and other related schedule I and II substances, bind to transporters for the dopamine, serotonin, and/or norephinephrine neurotransmitters and are uptake inhibitors of these neurotransmitters. Additionally, behavioral studies in animals demonstrate that the 10 synthetic cathinones produce locomotor behavior and discriminative stimulus effects that are similar to those of the schedule I and II substances methamphetamine and cocaine. Furthermore, the 10 synthetic cathinone produce rewarding properties as demonstrated in self-administration and conditioned place preference (CPP) studies. Drugs that have rewarding effects in animals are likely to produce rewarding effects in humans, which is indicative of abuse potential. Overall, these data indicate that the 10 synthetic cathinones produce pharmacological effects and stimulant-like behaviors that are similar to those of the schedule I substances (MDMA, mephedrone, MDPV, methylone), as well as the schedule II stimulants (methamphetamine and cocaine). 3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are synthetic cathinones ([beta]-keto-phenethylamines) of the larger phenethylamine structural class (amphetamines, cathinones, 2C compounds, aminoindanes, etc.). These substances share the core phenethylamine structure with a keto functional group [carbonyl (C=O)] at the [beta]-position and substitutions at the [alpha]-position and on the phenyl ring and nitrogen atom. Available data demonstrate that 4-MEC, 4-MePPP, [alpha]- PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are [beta]-ketophenethylamines (i.e., synthetic cathinones) and are structurally and pharmacologically similar to amphetamine, MDMA, cathinone, mephedrone, methylone, MDPV, and other related substances. Metabolism studies demonstrate that humans metabolize synthetic cathinones to their corresponding amphetamines followed by reduction of the beta-keto group to the corresponding alcohol. According to the HHS, 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, [[Page 11483]] and [alpha]-PBP have no known accepted medical use. They are not the subject of any approved new drug applications (NDAs) or investigational new drug applications (INDs), and are not currently marketed as approved drug products in the U.S or in any other country. The HHS also states that there are no reported clinical trials with the 10 synthetic cathinones. Accordingly, the DEA is not aware of any accepted medical use for 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP in the United States. In addition, although the chemistry of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP is known and has been reproduced, no studies have been undertaken to evaluate the efficacy, toxicology, and safety of these substances in humans. 4. Its History and Current Pattern of Abuse: 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP are synthetic cathinones that emerged on the U.S. illicit drug market around the time of the scheduling of mephedrone, methylone, and MDPV on October 21, 2011. These synthetic cathinone substances, like the schedule I synthetic cathinones (mephedrone, methylone, and MDPV), are promoted as being `legal' alternatives to cocaine, methamphetamine, and MDMA. As reported in the medical literature, synthetic cathinones can induce stimulant effects, especially under high dose conditions, including tachycardia, palpitations, hypertension, tremor, seizures, hallucinations, paranoia, delusions, hyperthermia, sweating, headache, hyponatremia, and rhabdomyolysis. Products that contain 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP are falsely marketed as ``research chemicals,'' ``jewelry cleaner,'' ``stain remover,'' ``plant food or fertilizer,'' ``insect repellants,'' or ``bath salts'' and are sold at smoke shops, head shops, convenience stores, adult book stores, and gas stations. They can also be purchased on the Internet under a variety of product names (e.g., ``White Dove,'' ``Explosion,'' ``Tranquility''). They are commonly encountered in the form of powders, crystals, resins, tablets, and capsules. The packages of these commercial products usually contain the warning ``not for human consumption.'' Information from published scientific studies indicate that the most common routes of administration for synthetic cathinone substances is ingestion by swallowing capsules or tablets, or nasal insufflation by snorting the powder tablets. Evidence from poison centers and published reports suggest that the main users of methylone are young adults. There is evidence that these synthetic cathinone substances are ingested with other substances including other synthetic cathinones, common cutting agents, or other recreational substances. 5. The Scope, Duration, and Significance of Abuse: 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP, like mephedrone, methylone, and MDPV, are popular recreational drugs. Evidence that these synthetic cathinone substances are being abused and trafficked is confirmed by law enforcement encounters of these substances and reports from national databases. Forensic laboratories have analyzed drug exhibits received from state, local, or Federal law enforcement agencies that were found to contain 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, or [alpha]-PBP. NFLIS registered over 17,000 reports from State, local, and other forensic laboratories identifying these substances in drug-related reports for the period from January 2010 to December 2015 from 47 states. STRIDE & STARLiMS registered over 2,000 reports from DEA forensic laboratories from January 2010 to December 2015. Encounters of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP by law enforcement have occurred in several states. Additionally, large seizures of these substances have occurred by the U.S. Customs and Border Protection (CBP). Concerns over the abuse of these synthetic cathinone substances have prompted many States to regulate them. These data demonstrate that 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, and [alpha]-PBP have a scope, duration, and significance of abuse that supports scheduling under the CSA. 6. What, if Any, Risk There is to the Public Health: Available evidence on the overall public health risks associated with the use of synthetic cathinones indicates that 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP can cause acute health problems leading to emergency department (ED) admissions, violent behaviors causing harm to self or others, or death. Law enforcement, forensic laboratories, case reports, and public health officials have reported toxic exposure to some of the 10 synthetic cathinones that demonstrate the public health risks associated with these substances. Serious adverse effects have resulted in documented hospital ED admissions from the ingestion of butylone, 4- FMC, or naphyrone. Individuals under the influence of 4-MEC or [alpha]- PVP have acted violently and unpredictably causing harm, or even death, to themselves or others. Butylone has been directly implicated in two fatalities reported in the medical literature. Other synthetic cathinones, such as [alpha]-PVP, pentedrone, and pentylone, have also been implicated in the deaths of individuals. Acute effects of these substances are those typical of a sympathomimeticagent (e.g., cocaine, methamphetamine, amphetamine) and include among other effects tachycardia, headache, palpitations, agitation, anxiety, mydriasis, tremor, fever or sweating, and hypertension. Other effects, with possible public health risk implications, that have been reported from the use of synthetic cathinone substances include psychological effects such as psychosis, paranoia, hallucinations, and agitation. Finally, the possibility of death for individuals abusing 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP also indicates that these substances pose a serious public health threat. In addition to the recognized harm from ingesting and abusing synthetic cathinones, abusers risk harm when they obtain these drugs through unknown sources. Products containing these synthetic cathinone substances often do not bear labeling information regarding their ingredients and if they do, they may not contain the expected active ingredients or identify the health risks and potential hazards associated with these products. Thus, the limited knowledge about product contents, its purity and lack of information about its effects may pose another level of risk to users. 7. Its Psychic or Physiological Dependence Liability: The DEA is unaware of any clinical studies that have evaluated the dependence potential of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP; however, according to the HHS, synthetic cathinones have rewarding properties in rodents similar to those of schedule II stimulants. Generally, there is a strong correlation between drugs that serve as reinforcers in animals, and drugs associated with problems of addiction, dependence, or abuse by humans. In a self-administration study, [[Page 11484]] [alpha]-PVP and pentedrone were self-administered by rodents. In the intracranial self-stimulation (ICSS) assay, [alpha]-PVP and 4-MEC significantly reduced the ICSS threshold compared to vehicle control. In drug discrimination studies, all 10 synthetic cathinone substances fully generalize to the discriminative stimulus effects produced by the schedule II stimulants--cocaine and methamphetamine. In conditioned place preference (CPP) studies, [alpha]-PBP, [alpha]-PVP, and pentedrone produce CPP in rodents. Thus, these data indicate that 4- MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, and [alpha]-PBP have behavioral and rewarding properties in rodents similar to those of schedule II stimulants and, consequently, psychic dependence on these substances can develop and may contribute to the continued use among individuals who abuse them despite their adverse consequences. 8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled Under the CSA: 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP are not considered immediate precursors of any controlled substance of the CSA. Conclusion: After considering the scientific and medical evaluation conducted by the HHS, the HHS's recommendation, and the DEA's own eight-factor analysis, the DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of 4- MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, and [alpha]-PBP. As such, the DEA hereby proposes to schedule 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP as controlled substances under the CSA. Proposed Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis and recommendation of the Assistant Secretary for the HHS and review of all other available data, the Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that: 1. 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP have a high potential for abuse that is comparable to other schedule I and schedule II substances such as mephedrone, methylone, MDPV, methcathinone, MDMA, amphetamine, methamphetamine, and cocaine; 2. 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP have no currently accepted medical use in treatment in the United States; and 3. There is a lack of accepted safety for use of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP under medical supervision. Based on these findings, the Administrator of the DEA concludes that 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha- pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3- benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N- methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1- (naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone); alpha- pyrrolidinobutiophenone ([alpha]-PBP) and their optical, positional, and geometric isomers, salts and salts of isomers, warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1). Requirements for Handling 4-MEC, 4-MePPP, [alpha]-PVP, Butylone, Pentedrone, Pentylone, 4-FMC, 3-FMC, Naphyrone, and [alpha]-PBP If this rule is finalized as proposed, 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]- PBP would continue \6\ to be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, possession, importing, research, conduct of instructional activities, and exporting of schedule I controlled substances, including the following: --------------------------------------------------------------------------- \6\ 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 79 FR 12938, Mar. 7, 2014. --------------------------------------------------------------------------- 1. Registration. Any person who handles (manufactures, distributes, dispenses, imports, exports, engages in research, conducts instructional activities or chemical analysis with, or possesses) 4- MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, or [alpha]-PBP, or who desires to handle 4-MEC, 4- MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP would be required to be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. 2. Security. 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP would be subject to schedule I security requirements and would need to be handled and stored pursuant to 21 U.S.C. 821 and 823, and in accordance with 21 CFR 1301.71-1301.93. 3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP would need to be in compliance with 21 U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302. 4. Quota. Only registered manufacturers would be permitted to manufacture 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP in accordance with a quota assigned pursuant to 21 U.S.C. 826, and in accordance with 21 CFR part 1303. 5. Inventory. Any person who becomes registered with the DEA on or after the effective date of the final rule must take an initial inventory of all stocks of controlled substances (including 4-MEC, 4- MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP) on hand on the date the registrant first engages in the handling of controlled substances pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including 4-MEC, 4- MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP) on hand every two years pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 6. Records and Reports. Every DEA registrant would be required to maintain records and submit reports with respect to 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and/ or [alpha]-PBP pursuant to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312. 7. Order Forms. Every DEA registrant who distributes 4-MEC, 4- MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP would be required to comply with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305. 8. Importation and Exportation. All importation and exportation of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, [[Page 11485]] naphyrone, or [alpha]-PBP would need to be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312. 9. Liability. Any activity involving 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]- PBP not authorized by, or in violation of, the CSA or its implementing regulations would be unlawful, and could subject the person to administrative, civil, and/ or criminal sanctions. Regulatory Analyses Executive Orders 12866 and 13563 In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures done ``on the record after opportunity for a hearing,'' which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563. Executive Order 12988 This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction. Executive Order 13132 This proposed rulemaking does not have federalism implications warranting the application of Executive Order 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Executive Order 13175 This proposed rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed rule and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. On March 7, 2014, the DEA published a final order to temporarily place 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP into schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The DEA estimates that all entities handling or planning to handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]- PBP are currently registered to handle these substances. There are currently 43 registrations authorized to handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP, as well as a number of registered analytical labs that are authorized to handle schedule I controlled substances generally. These 43 registrations represent 31 entities, of which 11 are small entities. Therefore, the DEA estimates that 11 small entities are affected by this proposed rule. A review of the 43 registrations indicates that all entities that currently handle 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP also handle other schedule I controlled substances, and have established and implemented (or currently maintain) the systems and processes required to handle 4- MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, or [alpha]-PBP. Therefore, the DEA anticipates that this proposed rule will impose minimal or no economic impact on any affected entities; and thus, will not have a significant economic impact on any of the 11 affected small entities. Therefore, the DEA has concluded that this proposed rule will not have a significant effect on the small entities. Unfunded Mandates Reform Act of 1995 In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result ``in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year . . .'' Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995. Paperwork Reduction Act of 1995 This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR part 1308 is proposed to be amended to read as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 0 2. In Sec. 1308.11: 0 a. Add paragraphs (d)(58) through (d)(67); 0 b. Remove paragraphs (h)(11) through (h)(20), 0 c. Redesignate paragraphs (h)(21) through (h)(25) as (h)(11) through (h)(15); The additions to read as follows: Sec. 1308.11 Schedule I. * * * * * (d) * * * (58) 4-methyl-N-ethylcathinone (4MEC).......................... (1249) (59) 4-methyl-alpha-pyrrolidinopropiophenone (4-MePPP)......... (7498) (60) alpha-pyrrolidinopentiophenone ([alpha]-PVP).............. (7545) (61) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (7541) (butylone, bk-MB.............................................. (62) 2-(methylamino)-1-phenylpentan-1-one (pentedrone)......... (1246) (63) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (7542) (pentylone, bk-MBDP).......................................... (64) 4-fluoro-N-methylcathinone (4-FMC; flephedrone)........... (1238) (65) 3-fluoro-N-methylcathinone (3-FMC)........................ (1233) (66) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (1258) (naphyrone)................................................... (67) alpha-pyrrolidinobutiophenone............................. (7546) * * * * * [[Page 11486]] Dated: March 2, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-05002 Filed 3-3-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules 11479
intended use. Servicing cannot change 6. What information do third-party DEPARTMENT OF JUSTICE
the intended use(s) of the device from entities need in order to perform these
its original purpose(s). activities in a way that results in safe Drug Enforcement Administration
3. Repair: Return the device or and effective operation of the medical
component to original specifications device? Please provide specific 21 CFR Part 1308
including replacing non-working examples. [Docket No. DEA–436]
components or parts outside of routine 7. What additional challenges do
or periodic upkeep for the current stakeholders encounter with devices Schedules of Controlled Substances:
owner of the device. that result from these activities? Placement of 10 Synthetic Cathinones
4. Refurbish: Restore device to a Into Schedule I
condition of safety and effectiveness III. Paperwork Reduction Act of 1995
AGENCY: Drug Enforcement
that is comparable to when new. This This document refers to previously Administration, Department of Justice.
includes reconditioning, repair, approved collections of information
installation of certain software/ ACTION: Notice of proposed rulemaking.
found in FDA regulations. These
hardware updates that do not change collections of information are subject to SUMMARY: The Drug Enforcement
the intended use of the original device, review by the Office of Management and Administration proposes placing 10
and replacement of worn parts. Budget (OMB) under the Paperwork synthetic cathinones: 4-methyl-N-
5. Remanufacture: Process, condition, Reduction Act of 1995 (44 U.S.C. 3501– ethylcathinone (4-MEC); 4-methyl-
renovate, repackage, restore, or any 3520). The collections of information in alpha-pyrrolidinopropiophenone (4-
other act done to a finished device that 21 CFR part 820 have been approved MePPP); alpha-
significantly changes the finished under OMB control number 0910–0073; pyrrolidinopentiophenone (a-PVP); 1-
device’s performance, safety the collections of information in 21 CFR (1,3-benzodioxol-5-yl)-2-
specifications, or intended use. parts 1020 and 1040 have been (methylamino)butan-1-one (butylone);
6. Remarket: The act of facilitating the approved under OMB control number 2-(methylamino)-1-phenylpentan-1-one
transfer of a previously owned device 0910–0025. (pentedrone); 1-(1,3-benzodioxol-5-yl)-
from one party to another by sale, 2-(methylamino)pentan-1-one
IV. References
donation, gift, or lease. (pentylone); 4-fluoro-N-
B. Evaluation of Risk Associated With The following references are on methylcathinone (4-FMC); 3-fluoro-N-
These Third-Party and OEM Activities display in the Division of Dockets methylcathinone (3-FMC); 1-
Management (see ADDRESSES) and are (naphthalen-2-yl)-2-(pyrrolidin-1-
In addition to obtaining comments available for viewing by interested yl)pentan-1-one (naphyrone); alpha-
that define the key terms applicable to persons between 9 a.m. and 4 p.m., pyrrolidinobutiophenone (a-PBP) and
this issue, FDA believes that a need Monday through Friday; they are also their optical, positional, and geometric
exists for interested persons to comment available electronically at http:// isomers, salts and salts of isomers into
on the benefits and risks related to the www.regulations.gov. FDA has verified schedule I of the Controlled Substances
previously defined activities. We invite the Web site addresses, as of the date Act. This proposed scheduling action is
interested persons to comment on the this document publishes in the Federal pursuant to the Controlled Substances
following questions: Register, but Web sites are subject to Act which requires that such actions be
1. Who are the different stakeholders change over time. made on the record after opportunity for
involved with the medical device 1. Guidance for Industry and Food and Drug a hearing through formal rulemaking. If
activities listed previously? What are Administration Staff on Assembler’s finalized, this action would impose the
their respective roles? Guide to Diagnostic X-Ray Equipment. regulatory controls and administrative,
2. What evidence exists regarding Available at http://www.fda.gov/ civil, and criminal sanctions applicable
actual problems with the safety and/or downloads/MedicalDevices/.../UCM257 to schedule I controlled substances on
performance of devices that result from 783.pdf. persons who handle (manufacture,
these activities? Specific examples 2. Guidance for Industry and FDA Staff on distribute, import, export, engage in
should be submitted. Information Disclosure by Manufacturers research, conduct instructional
to Assemblers for Diagnostic X-ray
3. What are the potential risks activities or chemical analysis, or
Systems. Available at http://
(patients/users) and failure modes www.fda.gov/downloads/Radiation- possess), or propose to handle 4-MEC, 4-
(devices) introduced as a result of EmittingProducts/ElectronicProduct MePPP, a-PVP, butylone, pentedrone,
performing the previously defined RadiationControlProgram/Industry pentylone, 4-FMC, 3-FMC, naphyrone,
activities on medical devices? Please Guidance/UCM136731.pdf. or a-PBP.
speak to issues common to all devices 3. FDA Executive Summary: Effective DATES: Interested persons may file
as well as specific risks with specific Reprocessing of Endoscopes Used in written comments on this proposal in
devices. Endoscopic Retrograde accordance with 21 CFR 1308.43(g).
4. These activities are performed by Cholangiopancreatography (ERCP)
Procedures, FDA. Available at http://
Comments must be submitted
OEMs and various third-party entities, www.fda.gov/downloads/Advisory electronically or postmarked on or
including hospitals and humanitarian Committees/Committees before April 4, 2016. Commenters
organizations. Are the risks different MeetingMaterials/MedicalDevices/ should be aware that the electronic
depending on who performs the MedicalDevicesAdvisoryCommittee/ Federal Docket Management System
jstallworth on DSK7TPTVN1PROD with PROPOSALS
previously mentioned activities? Gastroenterology-UrologyDevicesPanel/ will not accept comments after 11:59
5. We are interested in knowing if UCM445592.pdf. p.m. Eastern Time on the last day of the
these activities are more difficult or comment period.
riskier to perform on certain devices Dated: February 26, 2016. Interested persons, defined at 21 CFR
versus others. Please cite specific Leslie Kux, 1300.01 as those ‘‘adversely affected or
examples in your response, along with Associate Commissioner for Policy. aggrieved by any rule or proposed rule
an explanation of the source of this [FR Doc. 2016–04700 Filed 3–3–16; 8:45 am] issuable pursuant to section 201 of the
particular complexity. BILLING CODE 4164–01–P Act (21 U.S.C. 811),’’ may file a request
VerDate Sep<11>2014 14:02 Mar 03, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\04MRP1.SGM 04MRP1](https://thefederalregister.org/doc/81_FR_11522/page/1.svg)
![11480 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules
for hearing or waiver of hearing Posting of Public Comments 1308.45; 21 CFR part 1316, subpart D.
pursuant to 21 CFR 1308.44 and in Please note that all comments In accordance with 21 CFR 1308.44 (a)–
accordance with 21 CFR 1316.45 and/or received in response to this docket are (c), requests for hearing, notices of
1316.47, as applicable. Requests for considered part of the public record. appearance, and waivers of an
hearing and waivers of an opportunity They will, unless reasonable cause is opportunity for a hearing or to
for a hearing or to participate in a given, be made available by the Drug participate in a hearing may be
hearing must be received on or before Enforcement Administration (DEA) for submitted only by interested persons,
April 4, 2016. defined as those ‘‘adversely affected or
public inspection online at http://
aggrieved by any rule or proposed rule
ADDRESSES: To ensure proper handling www.regulations.gov. Such information
issuable pursuant to section 201 of the
of comments, please reference ‘‘Docket includes personal identifying
Act (21 U.S.C. 811).’’ 21 CFR 1300.01.
No. DEA–436’’ on all correspondence, information (such as your name,
Such requests or notices must conform
including any attachments. address, etc.) voluntarily submitted by
to the requirements of 21 CFR 1308.44
• Electronic comments: The Drug the commenter. The Freedom of
(a) or (b), and 1316.47 or 1316.48, as
Enforcement Administration encourages Information Act (FOIA) applies to all
applicable, and include a statement of
that all comments be submitted comments received. If you want to
interest of the person in the proceeding
electronically through the Federal submit personal identifying information
and the objections or issues, if any,
eRulemaking Portal which provides the (such as your name, address, etc.) as concerning which the person desires to
ability to type short comments directly part of your comment, but do not want be heard. Any waiver must conform to
into the comment field on the Web page it to be made publicly available, you the requirements of 21 CFR 1308.44(c)
or to attach a file for lengthier must include the phrase ‘‘PERSONAL and may include a written statement
comments. Please go to http:// IDENTIFYING INFORMATION’’ in the regarding the interested person’s
www.regulations.gov and follow the first paragraph of your comment. You position on the matters of fact and law
online instructions at that site for must also place all of the personal involved in any hearing.
submitting comments. Upon completion identifying information you do not want Please note that pursuant to 21 U.S.C.
of your submission you will receive a made publicly available in the first 811(a), the purpose and subject matter
Comment Tracking Number for your paragraph of your comment and identify of a hearing held in relation to this
comment. Please be aware that what information you want redacted. rulemaking are restricted to: ‘‘(A)
submitted comments are not If you want to submit confidential find[ing] that such drug or other
instantaneously available for public business information as part of your substance has a potential for abuse, and
view on Regulations.gov. If you have comment, but do not want it to be made (B) mak[ing] with respect to such drug
received a Comment Tracking Number, publicly available, you must include the or other substance the findings
your comment has been successfully phrase ‘‘CONFIDENTIAL BUSINESS prescribed by subsection (b) of section
submitted and there is no need to INFORMATION’’ in the first paragraph 812 of this title for the schedule in
resubmit the same comment. of your comment. You must also which such drug is to be placed . . .’’
prominently identify confidential All requests for hearing and waivers of
• Paper comments: Paper comments business information to be redacted
that duplicate the electronic submission participation must be sent to the DEA
within the comment. using the address information provided
are not necessary. Should you wish to Comments containing personal above.
mail a paper comment in lieu of an identifying information and confidential
electronic comment, it should be sent business information identified as Legal Authority
via regular or express mail to: Drug directed above will generally be made The DEA implements and enforces
Enforcement Administration, Attn: DEA publicly available in redacted form. If a Titles II and III of the Comprehensive
Federal Register Representative/ODW, comment has so much confidential Drug Abuse Prevention and Control Act
8701 Morrissette Drive, Springfield, business information or personal of 1970, as amended. Titles II and III are
Virginia 22152. identifying information that it cannot be referred to as the ‘‘Controlled
• Hearing requests: All requests for effectively redacted, all or part of that Substances Act’’ and the ‘‘Controlled
hearing and waivers of participation comment may not be made publicly Substances Import and Export Act,’’
must be sent to: Drug Enforcement available. Comments posted to http:// respectively, and are collectively
Administration, Attn: Administrator, www.regulations.gov may include any referred to as the ‘‘Controlled
8701 Morrissette Drive, Springfield, personal identifying information (such Substances Act’’ or the ‘‘CSA’’ for the
Virginia 22152. All requests for hearing as name, address, and phone number) purposes of this action. 21 U.S.C. 801–
and waivers of participation should also included in the text of your electronic 971. The DEA publishes the
be sent to: Drug Enforcement submission that is not identified as implementing regulations for these
Administration, Attn: Hearing Clerk/LJ, directed above as confidential. statutes in title 21 of the Code of Federal
8701 Morrissette Drive, Springfield, An electronic copy of this document Regulations (CFR), chapter II. The CSA
Virginia 22152; and (2) Drug and supplemental information to this and its implementing regulations are
Enforcement Administration, Attn: DEA proposed rule are available at http:// designed to prevent, detect, and
Federal Register Representative/ODW, www.regulations.gov for easy reference. eliminate the diversion of controlled
8701 Morrissette Drive, Springfield, substances and listed chemicals into the
Request for Hearing or Waiver of
Virginia 22152. illicit market while providing for the
jstallworth on DSK7TPTVN1PROD with PROPOSALS
Participation in a Hearing
legitimate medical, scientific, research,
FOR FURTHER INFORMATION CONTACT:
Pursuant to 21 U.S.C. 811(a), this and industrial needs of the United
Barbara J. Boockholdt, Office of
action is a formal rulemaking ‘‘on the States. Controlled substances have the
Diversion Control, Drug Enforcement
record after opportunity for a hearing.’’ potential for abuse and dependence and
Administration; Mailing Address: 8701
Such proceedings are conducted are controlled to protect the public
Morrissette Drive, Springfield, Virginia
pursuant to the provisions of the health and safety.
22152; Telephone: (202) 598–6812.
Administrative Procedure Act (APA), 5 Under the CSA, controlled substances
SUPPLEMENTARY INFORMATION: U.S.C. 551–559. 21 CFR 1308.41– are classified into one of five schedules
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![11482 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules
(b) There is significant diversion of the describe the effects of these substances mephedrone, MDPV, and methylone.
drug or drugs containing such a substance to be similar to those of the schedule I Similar to schedule I and II stimulants,
from legitimate drug channels; or cathinone substances MDPV, the 10 synthetic cathinone substances
(c) Individuals are taking the drug or drugs mephedrone, and methylone and other affect monoamine transmission. The 10
containing such a substance on their own
initiative rather than on the basis of medical
stimulant and hallucinogenic synthetic cathinones, similar to
advice from a practitioner licensed by law to substances to include methamphetamine, cocaine, MDMA,
administer such drugs in the course of his methamphetamine, cocaine and MDMA. mephedrone, MDPV, methylone, and
professional practice; or In particular, the responses in humans other related schedule I and II
(d) The drug or drugs containing such a to the 10 synthetic cathinones are substances, bind to transporters for the
substance are new drugs so related in their stimulant-like and include paranoia, dopamine, serotonin, and/or
action to a drug or drugs already listed as agitation, palpitations, tachycardia, norephinephrine neurotransmitters and
having a potential for abuse to make it likely hypertension, hyperthermia, and are uptake inhibitors of these
that the drug will have the same potentiality seizures. Data from forensic databases neurotransmitters. Additionally,
for abuse as such drugs, thus making it are used as indicators of illicit activity
reasonable to assume that there may be
behavioral studies in animals
significant diversions from legitimate
with drugs and abuse 3 within the demonstrate that the 10 synthetic
channels, significant use contrary to or United States and include data from the cathinones produce locomotor behavior
without medical advice, or that it has a System to Retrieve Information from and discriminative stimulus effects that
substantial capability of creating hazards to Drug Evidence (STRIDE),4 STARLiMS, are similar to those of the schedule I and
the health of the user or to the safety of the and the National Forensic Laboratory II substances methamphetamine and
community. Information System (NFLIS).5 From cocaine. Furthermore, the 10 synthetic
As described by the HHS, the abuse January 2010 through December 2015 cathinone produce rewarding properties
potentials of 4-MEC, 4-MePPP, a-PVP, (query dates: February 10 & 11, 2016), as demonstrated in self-administration
butylone, pentedrone, pentylone, 4- STRIDE, STARLiMS and NFLIS and conditioned place preference (CPP)
FMC, 3-FMC, naphyrone, and a-PBP are databases registered a total of 20,090 studies. Drugs that have rewarding
associated with their abilities to reports pertaining to the 10 synthetic effects in animals are likely to produce
produce psychoactive effects that are cathinones (4–MEC—2,820 reports; 4- rewarding effects in humans, which is
MePPP—438 reports; a-PVP—13,295 indicative of abuse potential. Overall,
similar to those produced by
reports; butylone—789 reports; these data indicate that the 10 synthetic
mephedrone, methylone, MDPV, and
pentedrone—1,645 reports; pentylone— cathinones produce pharmacological
other schedule I and II substances such
411 reports; FMC—375 reports; effects and stimulant-like behaviors that
as amphetamine, methamphetamine,
naphyrone—84 reports; a-PBP—233 are similar to those of the schedule I
cocaine, methcathinone, and MDMA
reports). These drug reports represent substances (MDMA, mephedrone,
that have a high potential for abuse.
all of the 10 synthetic cathinones MDPV, methylone), as well as the
The substances 4–MEC, 4-MePPP, a-
reported to these databases by schedule II stimulants
PVP, butylone, pentedrone, pentylone,
participating DEA, State, local, and (methamphetamine and cocaine).
4-FMC, 3-FMC, naphyrone, and a-PBP
other forensic laboratories.
have no approved medical uses in the 3. The State of Current Scientific
Consequently, the data indicate that
United States and they have been Knowledge Regarding the Drug or Other
these substances are being abused, and
encountered on the illicit market with Substance: 4-MEC, 4-MePPP, a-PVP,
they present safety hazards to the health
adverse outcomes on the public health butylone, pentedrone, pentylone, 4-
of individuals who consume them due
and safety. Because these substances are FMC, 3-FMC, naphyrone, and a-PBP are
to their stimulant properties, making
not approved drug products, a synthetic cathinones (b-keto-
them a hazard to the safety of the
practitioner may not legally prescribe phenethylamines) of the larger
community.
them, and they cannot be dispensed to phenethylamine structural class
2. Scientific Evidence of the Drug’s
an individual. Therefore, the use of (amphetamines, cathinones, 2C
Pharmacological Effects, if Known:
these substances is without medical compounds, aminoindanes, etc.). These
Studies show that 4-MEC, 4-MePPP, a-
advice, leading to the conclusion that substances share the core
PVP, butylone, pentedrone, pentylone,
the 10 synthetic cathinones are being phenethylamine structure with a keto
4-FMC, 3-FMC, naphyrone, and a-PBP
abused for their psychoactive functional group [carbonyl (C=O)] at the
produce pharmacological effects that are
properties. There are no legitimate drug b-position and substitutions at the a-
similar to those produced by schedule I
channels for these synthetic cathinones position and on the phenyl ring and
and II substances such as
as marketed drugs but the DEA notes nitrogen atom. Available data
methamphetamine, cocaine, MDMA,
that the 10 synthetic cathinones have demonstrate that 4-MEC, 4-MePPP, a-
use in scientific research. However, 3 While law enforcement data is not direct PVP, butylone, pentedrone, pentylone,
despite the limited legitimate use of evidence of abuse, it can lead to an inference that 4-FMC, 3-FMC, naphyrone, and a-PBP
these substances, reports from public a drug has been diverted and abused. See 76 FR are b-ketophenethylamines (i.e.,
health and law enforcement 77330, 77332, Dec. 12, 2011. synthetic cathinones) and are
4 STRIDE was a database that collected analyses
communicate that these substances are structurally and pharmacologically
of results from drug evidence sent to DEA
being abused and taken in amounts laboratories. Evidence was submitted by the DEA, similar to amphetamine, MDMA,
sufficient to create a hazard to an other Federal agencies, and select local law cathinone, mephedrone, methylone,
individual’s health. This misuse is enforcement agencies. On October 1, 2014, MDPV, and other related substances.
jstallworth on DSK7TPTVN1PROD with PROPOSALS
evidenced by emergency department STARLiMS replaced STRIDE as the DEA system of Metabolism studies demonstrate that
record for forensic laboratory drug evidence data.
admissions and deaths, representing a 5 NFLIS is a DEA program and a national forensic humans metabolize synthetic
significant safety issue for those in the laboratory reporting system that systematically cathinones to their corresponding
community. Papers published in the collects results from drug chemistry analyses amphetamines followed by reduction of
medical literature (e.g., case reports) conducted by state and local forensic laboratories the beta-keto group to the corresponding
in the United States. The NFLIS database also
related to 4-MEC, 4-MePPP, a-PVP, contains Federal data from U.S. Customs and
alcohol. According to the HHS, 4-MEC,
butylone, pentedrone, pentylone, 4- Border Protection (CBP). NFLIS only includes drug 4-MePPP, a-PVP, butylone, pentedrone,
FMC, 3-FMC, naphyrone, or a-PBP chemistry results from completed analyses. pentylone, 4-FMC, 3-FMC, naphyrone,
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![11486 Federal Register / Vol. 81, No. 43 / Friday, March 4, 2016 / Proposed Rules
Dated: March 2, 2016. Internal Revenue Service, Room 5203, 1(a) and (d) and require executors and
Chuck Rosenberg, P.O. Box 7604, Ben Franklin Station, other persons required to file a return
Acting Administrator. Washington, DC 20044. Submissions under section 6018 to furnish a
[FR Doc. 2016–05002 Filed 3–3–16; 8:45 am] may be hand delivered Monday through statement to the IRS and to each
BILLING CODE 4410–09–P
Friday between the hours of 8 a.m. and beneficiary providing information
4 p.m. to CC:PA:LPD:PR (REG–127923– regarding the value of the property the
15), Courier’s Desk, Internal Revenue beneficiary acquires from the decedent.
Service, 1111 Constitution Avenue NW., The IRS will use this information to
DEPARTMENT OF THE TREASURY
Washington, DC 20224; or sent determine whether the beneficiary (or
Internal Revenue Service electronically via the Federal transferee) reports a basis for that
eRulemaking Portal at http:// property that is consistent with the
26 CFR Parts 1 and 301 www.regulations.gov (IRS–REG– value of that property as finally
127923–15). determined for Federal estate tax
[REG–127923–15] FOR FURTHER INFORMATION CONTACT: purposes when the beneficiary (or
Concerning the proposed regulations, transferee) depreciates the property, or
RIN 1545–BM97
Theresa M. Melchiorre, at (202) 317– sells, exchanges, or otherwise disposes
Consistent Basis Reporting Between 6859; concerning submissions of of some or all of that property in
Estate and Person Acquiring Property comments or, to request a hearing, transactions that result in the
From Decedent Regina Johnson, at (202) 317–6901 (not recognition of gain or loss for Federal
toll-free numbers). income tax purposes.
AGENCY: Internal Revenue Service (IRS), The collection of information may
SUPPLEMENTARY INFORMATION:
Treasury. vary depending on the property
ACTION: Notice of proposed rulemaking, Paperwork Reduction Act includible in the gross estate and the
and notice of proposed rulemaking by The collection of information number of beneficiaries receiving the
cross-reference to temporary contained in this notice of proposed property. The following estimates are
regulations. rulemaking has been submitted to the based on the information that is
Office of Management and Budget for available to the IRS. A respondent may
SUMMARY: This document contains require more or less time, depending on
review in accordance with the
proposed regulations that provide the circumstances.
Paperwork Reduction Act of 1995 (44
guidance regarding the requirement that Estimated total annual reporting
U.S.C. 3507(d). Comments on the
a recipient’s basis in certain property burden. The estimated total annual
collection of information should be sent
acquired from a decedent be consistent reporting burden per respondent is 5.31
to the Office of Management and
with the value of the property as finally hours.
Budget, Attn: Desk Officer for the
determined for Federal estate tax Estimated annual number of
Department of the Treasury, Office of
purposes. In addition, these proposed respondents. The estimated annual
Information and Regulatory Affairs,
regulations provide guidance on the number of respondents is 10,000.
Washington, DC 20503, with copies to
reporting requirements for executors or An agency may not conduct or
the Internal Revenue Service, Attn: IRS
other persons required to file Federal sponsor, and a person is not required to
Reports Clearance Officer,
estate tax returns. Temporary respond to, a collection of information
SE:W:CAR:MP:T:T:SP, Washington, DC
regulations in the Rules and Regulations unless it displays a valid control
20224. Comments on the collection of
section of this issue of the Federal number assigned by the Office of
information should be received by May
Register provide transition relief to Management and Budget.
3, 2016.
executors and other persons required to Books or records relating to a
Comments are specifically requested
file or furnish certain statements. The collection of information must be
concerning:
text of those temporary regulations (TD Whether the proposed collection of retained as long as their contents may
9757) published in the Rules and information is necessary for the proper become material in the administration
Regulations section of this issue of the performance of the functions of the of any internal revenue law. Generally,
Federal Register also serves as the text Internal Revenue Service (IRS), tax returns and tax return information
of the proposed regulations regarding including whether the information will are confidential, as required by 26
the transition relief. These proposed have practical utility; U.S.C. 6103.
regulations as well as TD 9757 The accuracy of the estimated burden Background
published elsewhere in the Rules and associated with the proposed collection
Regulations section of this issue of this of information; 1. Overview
Federal Register affect executors or How the quality, utility, and clarity of On July 31, 2015, the President of the
other persons who file estate tax returns the information to be collected may be United States signed into law H.R. 3236,
after July 31, 2015. The proposed enhanced; the Surface Transportation and
regulations also affect beneficiaries who How the burden of complying with Veterans Health Care Choice
acquire certain property from these the proposed collection of information Improvement Act of 2015, Public Law
estates, and subsequent transferees to may be minimized, including through 114–41, 129 Stat. 443 (Act). Section
whom beneficiaries transfer the the application of automated collection 2004 of the Act enacted sections 1014(f),
jstallworth on DSK7TPTVN1PROD with PROPOSALS
property in transactions that do not techniques or other forms of information 6035, 6662(b)(8), 6662(k), 6724(d)(1)(D),
result in the recognition of gain or loss technology; and and 6724(d)(2)(II) of the Internal
for Federal income tax purposes. Estimates of capital or start-up costs Revenue Code (Code). This document
DATES: Written or electronic comments and costs of operation, maintenance, contains proposed regulations that
and requests for a public hearing must and purchase of service to provide amend 26 CFR parts 1 and 301 under
be received by June 2, 2016. information. those Code provisions to achieve
ADDRESSES: Send submissions to: The reporting requirements in these consistency between a recipient’s basis
CC:PA:LPD:PR (REG–127923–15), proposed regulations are in § 1.6035– in certain property acquired from a
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Document Created: 2018-02-02 15:05:13
Document Modified: 2018-02-02 15:05:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of proposed rulemaking. | |
| Dates | Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Comments must be submitted electronically or postmarked on or before April 4, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. | |
| Contact | Barbara J. Boockholdt, Office of | |
| FR Citation | 81 FR 11479 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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