82 FR 32453 - Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 134 (July 14, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 134 (July 14, 2017)
| Page Range | 32453-32457 | |
| FR Document | 2017-14880 |
[Federal Register Volume 82, Number 134 (Friday, July 14, 2017)] [Rules and Regulations] [Pages 32453-32457] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14880] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-460] Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Temporary scheduling order. ----------------------------------------------------------------------- SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryl fentanyl or acryloylfentanyl), and its isomers, esters, ethers, salts and salts of isomers, esters, and ethers, into Schedule I. This action is based on a finding by the Administrator that the placement of acryl fentanyl into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, acryl fentanyl. DATES: This temporary scheduling order is effective July 14, 2017, until July 15, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed. The DEA will publish a document in the Federal Register announcing an extension or permanence. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598- 6812. SUPPLEMENTARY INFORMATION: Legal Authority Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into Schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are [[Page 32454]] initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling \1\ for up to one year. 21 U.S.C. 811(h)(2). --------------------------------------------------------------------------- \1\ Though DEA has used the term ``final order'' with respect to temporary scheduling orders in the past, this document adheres to the statutory language of 21 U.S.C. 811(h), which refers to a ``temporary scheduling order.'' No substantive change is intended. --------------------------------------------------------------------------- Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. Background Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into Schedule I of the CSA.\2\ The Administrator transmitted the notice of intent to place acryl fentanyl into Schedule I on a temporary basis to the Assistant Secretary by letter dated April 17, 2017. The Assistant Secretary responded to this notice by letter dated May 2, 2017, and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for acryl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of acryl fentanyl into Schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). Acryl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for acryl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of acryl fentanyl in Schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to issue a temporary order to schedule acryl fentanyl was published in the Federal Register on June 2, 2017. 82 FR 25564. --------------------------------------------------------------------------- \2\ 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. --------------------------------------------------------------------------- To find that placing a substance temporarily into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3). A substance meeting the statutory requirements for temporary scheduling may only be placed into Schedule I. 21 U.S.C. 811(h)(1). Substances in Schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1). Available data and information for acryl fentanyl, summarized below, indicate that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA's three-factor analysis, and the Assistant Secretary's May 2, 2017, letter, are available in their entirety under the tab ``Supporting Documents'' of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA-2017-0005 (Docket Number DEA-460). Factor 4. History and Current Pattern of Abuse The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. Acryl fentanyl has recently been encountered by law enforcement and public health officials and the adverse health effects and outcomes are demonstrated by fatal overdose cases. The documented negative effects of acryl fentanyl are consistent with those of other opioids. On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on May 5, 2017. STARLiMS registered 36 reports containing acryl fentanyl, from Alabama, Connecticut, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, South Carolina, Tennessee, Texas, and West Virginia. According to STARLiMS, the first laboratory submission of acryl fentanyl occurred in July 2016 in Texas. The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state and local forensic laboratories across the country. NFLIS registered 74 reports containing acryl fentanyl from state or local forensic laboratories in Arkansas, California, Connecticut, Iowa, Kentucky, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin (query date: May 5, 2017).\3\ The first report of acryl fentanyl was reported in Wisconsin in May 2016. The DEA is not aware of any laboratory identifications of acryl fentanyl prior to 2016. --------------------------------------------------------------------------- \3\ Data are still being collected for February 2017-April 2017 due to the normal lag period for labs reporting to NFLIS. --------------------------------------------------------------------------- Evidence suggests that the pattern of abuse of fentanyl analogues, including acryl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of acryl fentanyl have been encountered in powder form, in solution, and packaged similar to that of heroin. Acryl fentanyl has been encountered as a single substance as well as in combination with other substances of abuse, including heroin, fentanyl, 4-fluoroisobutyryl fentanyl, and furanyl fentanyl. Acryl fentanyl has been connected to fatal overdoses, in which insufflation and intravenous routes of administration were documented. Factor 5. Scope, Duration and Significance of Abuse Reports collected by the DEA demonstrate acryl fentanyl is being abused for its opioid properties. This abuse of acryl fentanyl has resulted in morbidity and mortality (see DEA 3-Factor Analysis for full discussion). The DEA has received reports for at least 83 confirmed fatalities associated with acryl fentanyl. Information on these deaths, occurring as early as September 2016, was collected by the DEA from post-mortem toxicology and medical examiner reports. These deaths were reported from, and occurred in, Illinois (27), Maryland (22), New Jersey (1), [[Page 32455]] Ohio (31), and Pennsylvania (2). NFLIS and STARLiMS have a total of 110 drug reports in which acryl fentanyl was identified in drug exhibits submitted to forensic laboratories in 2016 and 2017 from law enforcement encounters in Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, West Virginia, and Wisconsin. It is likely that the prevalence of acryl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate this substance from fentanyl. The population likely to abuse acryl fentanyl overlaps with the population abusing prescription opioid analgesics, heroin, fentanyl, and other fentanyl-related substances. This is evidenced by the routes of drug administration and drug use history documented in acryl fentanyl fatal overdose cases and encounters of the substance by law enforcement officials. Because abusers of acryl fentanyl are likely to obtain this substance through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (i.e., use a drug for the first time) acryl fentanyl abuse are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine, etc.). Factor 6. What, if Any, Risk There Is to the Public Health Acryl fentanyl exhibits pharmacological profiles similar to that of fentanyl and other [micro]-opioid receptor agonists. The toxic effects of acryl fentanyl in humans are demonstrated by overdose fatalities involving this substance. Abusers of acryl fentanyl may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. Based on information reviewed by the DEA, the misuse and abuse of acryl fentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are high. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses. Acryl fentanyl has been associated with numerous fatalities. At least 83 confirmed overdose deaths involving acryl fentanyl abuse have been reported from Illinois, Maryland, New Jersey, Ohio, and Pennsylvania in 2016 and 2017. As the data demonstrates, the potential for fatal and non-fatal overdoses exists for acryl fentanyl; thus, acryl fentanyl poses an imminent hazard to the public safety. Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety In accordance with 21 U.S.C. 811(h)(3), based on the data and information summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of acryl fentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance in treatment in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into Schedule I. Substances in Schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for acryl fentanyl indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated April 17, 2017, notified the Assistant Secretary of the DEA's intention to temporarily place this substance into Schedule I. A notice of intent was subsequently published in the Federal Register on June 2, 2017. 82 FR 25564. Conclusion In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule acryl fentanyl into Schedule I of the CSA, and finds that placement of this synthetic opioid into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety. Because the Administrator hereby finds it necessary to temporarily place this synthetic opioid into Schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling acryl fentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2). The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done ``on the record after opportunity for a hearing'' conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6). Requirements for Handling Upon the effective date of this temporary order, acryl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of Schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, acryl fentanyl must 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, as of July 14, 2017. Any person who currently handles acryl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle acryl fentanyl as of July 14, 2017, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales [[Page 32456]] of Schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after July 14, 2017 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA. 2. Disposal of stocks. Any person who does not desire or is not able to obtain a Schedule I registration to handle acryl fentanyl, must surrender all quantities of currently held acryl fentanyl. 3. Security. Acryl fentanyl is subject to Schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of July 14, 2017. 4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of acryl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from July 14, 2017, to comply with all labeling and packaging requirements. 5. Inventory. Every DEA registrant who possesses any quantity of acryl fentanyl on the effective date of this order must take an inventory of all stocks of this substance on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including acryl fentanyl) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. 6. Records. All DEA registrants must maintain records with respect to acryl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, 1312, 1317, and Sec. 1307.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements. 7. Reports. All DEA registrants who manufacture or distribute acryl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of July 14, 2017. 8. Order Forms. All DEA registrants who distribute acryl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of July 14, 2017. 9. Importation and Exportation. All importation and exportation of acryl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of July 14, 2017. 10. Quota. Only DEA registered manufacturers may manufacture acryl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of July 14, 2017. 11. Liability. Any activity involving acryl fentanyl not authorized by, or in violation of the CSA, occurring as of July 14, 2017, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions. Regulatory Matters Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in Schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1). Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, do not apply to this temporary scheduling action. In the alternative, even assuming that this action might be subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice and comment requirements of 5 U.S.C. 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety. Further, the DEA believes that this temporary scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking. Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the Congressional Review Act, ``any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It is in the public interest to schedule this substance immediately to avoid an imminent hazard to the public safety. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place this substance into Schedule I because it poses an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, [[Page 32457]] Reporting and recordkeeping requirements. For the reasons set out above, the DEA amends 21 CFR part 1308 as follows: PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES 0 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 0 2. Amend Sec. 1308.11 by adding paragraph (h)(17) to read as follows: Sec. 1308.11 Schedule I * * * * * (h) * * * (17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, (9811) its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: acryl fentanyl, acryloylfentanyl)............................ * * * * * Dated: July 10, 2017. Chuck Rosenberg Acting Administrator. [FR Doc. 2017-14880 Filed 7-13-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 134 / Friday, July 14, 2017 / Rules and Regulations 32453
with respect to the United States. This 553(b)(B)). For the same reason, a DEPARTMENT OF JUSTICE
period may be extended for additional delayed effective date is not required
periods of not more than five years if it under 5 U.S.C. 553(d)(3). Drug Enforcement Administration
is determined that the factors which
justified the initial agreement still Regulatory Flexibility Act 21 CFR Part 1308
pertain and no cause for suspension of Because no notice of proposed [Docket No. DEA–460]
the agreement exists. (19 CFR
rulemaking is required, the provisions
12.104g(a)). Schedules of Controlled Substances:
On July 12, 2016, the Department of of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply. Temporary Placement of Acryl
State received a request by the Republic Fentanyl Into Schedule I
of Cyprus to extend the Agreement. The Executive Orders 12866 and 13771
Department of State proposed to extend AGENCY: Drug Enforcement
the import restrictions for an additional Because this rule involves a foreign Administration, Department of Justice.
five years in a notice published in the affairs function of the United States, it ACTION: Temporary scheduling order.
Federal Register (81 FR 52946) on is not subject to either Executive Order
August 10, 2016. On March 22, 2017, 12866 or Executive Order 13771. SUMMARY: The Administrator of the Drug
the Assistant Secretary for Educational Enforcement Administration is issuing
and Cultural Affairs, State Department, Signing Authority this temporary scheduling order to
after consultation with and schedule the synthetic opioid, N-(1-
This regulation is being issued in
recommendations by the Cultural phenethylpiperidin-4-yl)-N-
accordance with 19 CFR 0.1(a)(1). phenylacrylamide (acryl fentanyl or
Property Advisory Committee,
determined that the cultural heritage of List of Subjects in 19 CFR Part 12 acryloylfentanyl), and its isomers,
Cyprus continues to be in jeopardy from esters, ethers, salts and salts of isomers,
pillage of certain archaeological objects Cultural property, Customs duties and esters, and ethers, into Schedule I. This
and certain ethnological materials and inspection, Imports, Prohibited action is based on a finding by the
that the import restrictions should be merchandise. Administrator that the placement of
extended for an additional five-year acryl fentanyl into Schedule I of the
period to July 16, 2022. Diplomatic Amendment to CBP Regulations
Controlled Substances Act is necessary
notes have been exchanged reflecting For the reasons set forth above, part to avoid an imminent hazard to the
the extension of those restrictions for an 12 of title 19 of the Code of Federal public safety. As a result of this order,
additional five-year period. Regulations (19 CFR part 12), is the regulatory controls and
Accordingly, CBP is amending 19 CFR amended as set forth below: administrative, civil, and criminal
12.104g(a) to reflect the extension of the sanctions applicable to Schedule I
import restrictions. PART 12—SPECIAL CLASSES OF controlled substances will be imposed
The Amended Designated List of on persons who handle (manufacture,
MERCHANDISE
archaeological objects and Byzantine distribute, reverse distribute, import,
and post-Byzantine ecclesiastical and export, engage in research, conduct
ritual ethnological materials is set forth ■ 1. The general authority citation for
part 12 and the specific authority instructional activities or chemical
in CBP Dec. 12–13. The herein analysis, or possess), or propose to
mentioned Agreements and the citation for § 12.104g continue to read as
handle, acryl fentanyl.
Designated List and amended follows:
DATES: This temporary scheduling order
Designated Lists may be found at the Authority: 5 U.S.C. 301; 19 U.S.C. 66, is effective July 14, 2017, until July 15,
following Web site address: https:// 1202 (General Note 3(i), Harmonized Tariff 2019, unless it is extended for an
eca.state.gov/cultural-heritage-center/ Schedule of the United States (HTSUS)), additional year or a permanent
cultural-property-protection/bilateral- 1624; scheduling proceeding is completed.
agreements by clicking on ‘‘Cyprus.’’ * * * * * The DEA will publish a document in the
The restrictions on the importation of Sections 12.104 through 12.104i also Federal Register announcing an
these archaeological, and ecclesiastical issued under 19 U.S.C. 2612; extension or permanence.
and ritual ethnological materials from
Cyprus are to continue in effect through * * * * * FOR FURTHER INFORMATION CONTACT:
July 16, 2022. Importation of such Michael J. Lewis, Diversion Control
§ 12.104g [Amended] Division, Drug Enforcement
materials from Cyprus continues to be
restricted through that date unless the ■ 2. In § 12.104g, paragraph (a), the table Administration; Mailing Address: 8701
conditions set forth in 19 U.S.C. 2606 is amended in the entry for ‘‘Cyprus’’ by Morrissette Drive, Springfield, Virginia
and 19 CFR 12.104c are met. adding the words ‘‘extended by CBP 22152; Telephone: (202) 598–6812.
Dec. 17–07’’ after the words ‘‘CBP Dec. SUPPLEMENTARY INFORMATION:
Inapplicability of Notice and Delayed
Effective Date 12–13’’ in the column headed ‘‘Decision Legal Authority
No.’’.
This amendment involves a foreign Section 201 of the Controlled
affairs function of the United States and Kevin K. McAleenan, Substances Act (CSA), 21 U.S.C. 811,
is, therefore, being made without notice Acting Commissioner, U.S. Customs and provides the Attorney General with the
or public procedure under 5 U.S.C. Border Protection. authority to temporarily place a
mstockstill on DSK30JT082PROD with RULES
553(a)(1). In addition, CBP has substance into Schedule I of the CSA for
Approved: July 11, 2017.
determined that such notice or public two years without regard to the
procedure would be impracticable and Timothy E. Skud, requirements of 21 U.S.C. 811(b) if he
contrary to the public interest because Deputy Assistant Secretary of the Treasury. finds that such action is necessary to
the action being taken is essential to [FR Doc. 2017–14822 Filed 7–13–17; 8:45 am] avoid an imminent hazard to the public
avoid interruption of the application of BILLING CODE 9111–14–P safety. 21 U.S.C. 811(h)(1). In addition,
the existing import restrictions (5 U.S.C. if proceedings to control a substance are
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Reporting and recordkeeping PART 1308—SCHEDULES OF ■ 2. Amend § 1308.11 by adding
requirements. CONTROLLED SUBSTANCES paragraph (h)(17) to read as follows:
For the reasons set out above, the DEA ■ 1. The authority citation for part 1308 § 1308.11 Schedule I
amends 21 CFR part 1308 as follows: continues to read as follows: * * * * *
Authority: 21 U.S.C. 811, 812, 871(b), (h) * * *
unless otherwise noted.
(17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its isomers, esters, ethers, salts and salts of isomers, esters and
ethers (Other names: acryl fentanyl, acryloylfentanyl) ................................................................................................................ (9811)
* * * * * those mixtures that do not qualify for phenylacetoacetonitrile (APAAN) was
Dated: July 10, 2017. automatic exemption. added to Table I of the 1988
Chuck Rosenberg DATES: Effective date: August 14, 2017. Convention. This letter was prompted
FOR FURTHER INFORMATION CONTACT: by a March 19, 2014, decision at the
Acting Administrator.
Michael J. Lewis, Diversion Control 57th Session of the United Nations
[FR Doc. 2017–14880 Filed 7–13–17; 8:45 am]
Division, Drug Enforcement Commission on Narcotic Drugs (CND) to
BILLING CODE 4410–09–P add APAAN to Table I. As a Party to the
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 1988 Convention, the United States is
22152; Telephone: (202) 598–6812. obligated, pursuant to article 12, to take
DEPARTMENT OF JUSTICE measures it deems appropriate to
SUPPLEMENTARY INFORMATION:
Drug Enforcement Administration monitor the manufacture and
Legal Authority distribution of APAAN within the
21 CFR Part 1310 The Controlled Substances Act (CSA) United States and to prevent its
gives the Attorney General the authority diversion. Article 12 also obligates the
[Docket No. DEA–379] to specify, by regulation, chemicals as United States to take other specified
RIN 1117–ZA04 list I or list II chemicals. 21 U.S.C. 802 measures related to APAAN, including
(34) and (35). A ‘‘list I chemical’’ is a measures related to its international
Designation of Alpha- chemical that is used in manufacturing trade. By designating APAAN, which is
Phenylacetoacetonitrile (APAAN), a a controlled substance in violation of a primary precursor for the manufacture
Precursor Chemical Used in the Illicit title II of the CSA, and is important to of phenylacetone (also known as
Manufacture of Phenylacetone, the manufacture of the controlled phenyl-2-propanone (P2P) or benzyl
Methamphetamine, and Amphetamine, substance. 21 U.S.C. 802(34). A ‘‘list II methyl ketone), methamphetamine, and
as a List I Chemical chemical’’ is a chemical (other than a amphetamine, as a list I chemical, the
list I chemical) that is used in United States will fulfill its obligations
AGENCY: Drug Enforcement manufacturing a controlled substance in under the 1988 Convention.
Administration, Department of Justice. violation of title II of the CSA. 21 U.S.C.
Designation of APAAN and Its Salts,
ACTION: Final rule. 802(35). The current list of all listed
Optical Isomers, and Salts of Optical
chemicals is published at 21 CFR
SUMMARY: The Drug Enforcement Isomers as a List I Chemical
1310.02. Pursuant to 28 CFR 0.100(b),
Administration (DEA) is finalizing the the Attorney General has delegated his On December 12, 2016, DEA
designation of the chemical alpha- authority to designate list I and list II published a Notice of Proposed
phenylacetoacetonitrile (APAAN) and chemicals to the Administrator of the Rulemaking (NPRM) proposing control
its salts, optical isomers, and salts of Drug Enforcement Administration. of APAAN, due to its use in clandestine
optical isomers, as a list I chemical In addition, the United States is a laboratories to illicitly manufacture the
under the Controlled Substances Act Party to the 1988 United Nations schedule II controlled substances
(CSA). The DEA proposed control of Convention against Illicit Traffic in phenylacetone (also known as phenyl-2-
APAAN, due to its use in clandestine Narcotic Drugs and Psychotropic propanone or P2P), methamphetamine,
laboratories to illicitly manufacture the Substances (1988 Convention). When and amphetamine. 81 FR 89402. In
schedule II controlled substances the United States receives notification response to the NPRM, only one
phenylacetone (also known as phenyl-2- that a chemical has been added to Table comment was received. This comment
propanone or P2P), methamphetamine, I or Table II of the 1988 Convention was supportive of the DEA’s proposed
and amphetamine. This rulemaking pursuant to article 12, the United States control of APAAN. As such, this
finalizes, without change, the control of is required to take measures it deems rulemaking finalizes the control of
APAAN as a list I chemical. appropriate to monitor the manufacture APAAN as a list I chemical.
This action does not establish a and distribution of that chemical within On the effective date of this final rule,
threshold for domestic and international the United States and to prevent its handlers of APAAN shall be subject to
transactions of APAAN. As such, all diversion. In addition, the 1988 the chemical regulatory provisions of
transactions involving APAAN, Convention requires the United States to the CSA, including 21 CFR parts 1309,
regardless of size, shall be regulated. In take other specified measures related to 1310, 1313, and 1316. Since even a
addition, chemical mixtures containing that chemical, including measures small amount of APAAN can make a
mstockstill on DSK30JT082PROD with RULES
APAAN are not exempt from regulatory related to its international trade. significant amount of P2P, this action
requirements at any concentration. does not establish a threshold for
Therefore, all transactions of chemical Background domestic and import transactions of
mixtures containing any quantity of By a letter dated April 9, 2014, the APAAN in accordance with the
APAAN shall be regulated pursuant to Secretary-General of the United Nations provisions of 21 CFR 1310.04(g).
the CSA. However, manufacturers may informed the United States Government Therefore, all APAAN transactions,
submit an application for exemption for that the chemical alpha- regardless of size, will be regulated
VerDate Sep<11>2014 17:00 Jul 13, 2017 Jkt 241001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\14JYR1.SGM 14JYR1](https://thefederalregister.org/doc/82_FR_32587/page/5.svg)
Document Created: 2018-10-24 11:17:07
Document Modified: 2018-10-24 11:17:07
| 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 | Rules and Regulations | |
| Action | Temporary scheduling order. | |
| Dates | This temporary scheduling order is effective July 14, 2017, until July 15, 2019, unless it is extended for an additional year or a permanent scheduling proceeding is completed. The DEA will publish a document in the Federal Register announcing an extension or permanence. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 32453 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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