80 FR 42381 - Schedules of Controlled Substances: Temporary Placement of Acetyl Fentanyl Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 137 (July 17, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 137 (July 17, 2015)
| Page Range | 42381-42385 | |
| FR Document | 2015-17563 |
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)] [Rules and Regulations] [Pages 42381-42385] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17563] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-413F] Schedules of Controlled Substances: Temporary Placement of Acetyl Fentanyl Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl), and its optical, positional, and geometric isomers, salts and salts of isomers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this opioid substance 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, import, export, engage in research, or possess), or propose to handle, acetyl fentanyl. DATES: This final order is effective on July 17, 2015. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812. SUPPLEMENTARY INFORMATION: Legal Authority The Drug Enforcement Administration (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 purpose 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 ensuring an adequate supply is available 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, every controlled substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other 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 all scheduled substances is published at 21 CFR part 1308. Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a [[Page 42382]] substance into schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she 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 initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2). 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 her 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 the Administrator's intention to temporarily place a substance into schedule I of the CSA.\1\ The Administrator transmitted the notice of intent to place acetyl fentanyl into schedule I on a temporary basis to the Assistant Secretary by letter dated April 7, 2015. The Assistant Secretary responded to this notice by letter dated April 29, 2015 (received by the DEA on May 05, 2015), and advised that based on review by the FDA, there are currently no investigational new drug applications or approved new drug applications for acetyl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of acetyl 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). Acetyl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for acetyl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the scheduling of acetyl fentanyl in schedule I on a temporary basis is necessary to avoid an imminent hazard to public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule acetyl fentanyl was published in the Federal Register on May 21, 2015. 80 FR 29227. --------------------------------------------------------------------------- \1\ Because the Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations, for purposes of this final order, all subsequent references to ``Secretary'' have been replaced with ``Assistant Secretary.'' As set forth in a memorandum of understanding entered into by HHS, 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 Assistant Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. --------------------------------------------------------------------------- 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 acetyl 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 analysis is available in its entirety under the tab ``Supporting and Related Material'' of the public docket of this action at www.regulations.gov under Docket Number DEA-413F. Factor 4. History and Current Pattern of Abuse Clandestinely produced substances structurally related to the schedule II opioid analgesic fentanyl were trafficked and abused on the West Coast in the late 1970s and 1980s. These clandestinely produced fentanyl-like substances were commonly known as designer drugs, and recently, there has been a reemergence in the trafficking and abuse of designer drug substances, including fentanyl-like substances. Alpha- methylfentanyl, the first fentanyl analogue identified in California, was placed into schedule I of the CSA in September 1981. Following the control of alpha-methylfentanyl, the DEA identified several other fentanyl analogues (3-methylthiofentanyl, acetyl-alpha-methylfentanyl, beta-hydroxy-3-methylfentanyl, alpha-methylthiofentanyl, thiofentanyl, beta-hydroxyfentanyl, para-fluorofentanyl and 3-methylfentanyl) in submissions to forensic laboratories. These substances were temporarily controlled under schedule I of the CSA after finding that they posed an imminent hazard to public safety and were subsequently permanently placed into schedule I of the CSA. 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 State and local forensic laboratories across the country. The first laboratory submission of acetyl fentanyl was recorded in Maine in April 2013 according to NFLIS. NFLIS registered eight reports containing acetyl fentanyl in 2013 in Louisiana, Maine, and North Dakota; and 30 reports in 2014 in Florida, Illinois, Louisiana, Maine, New Jersey, Ohio, Oregon, Pennsylvania, and Virginia. The System to Retrieve Information from Drug Evidence (STRIDE) is a database of drug exhibits sent to DEA laboratories for analysis. Exhibits from this database are from the DEA, other Federal agencies, and some local law enforcement agencies. Acetyl fentanyl was first reported to STRIDE in September 2013 from exhibits obtained through a controlled purchase in Louisiana. In October 2013, an exhibit collected from a controlled purchase of suspected oxycodone tablets in Rhode Island contained acetyl fentanyl as the primary substance. In 2014, STARLiMS (a Web-based, commercial laboratory information management system that is in transition to replace STRIDE) and STRIDE reported eight additional seizures in Colorado, Florida, Georgia, and Washington. In August 2013, the Centers for Disease Control and Prevention published an article in its Morbidity and Mortality Weekly Report documenting a series of 14 fatalities related to acetyl fentanyl that occurred between March and May 2013. In December 2013, another fatality associated with acetyl fentanyl was reported in Rhode Island for a total of 15 fatalities. In February 2014, the North Carolina Department of Health and Human Services issued a health advisory related to acetyl fentanyl following at least three deaths related to this synthetic drug. Toxicologists at the North Carolina Office of the Chief Medical Examiner detected acetyl fentanyl in specimens associated with deaths that occurred in January 2014 in Sampson, Person, and [[Page 42383]] Transylvania counties. In July and August 2014, four additional fatalities involving acetyl fentanyl were reported for a total of seven fatalities in North Carolina. Deaths involving acetyl fentanyl have also been reported in California (1), Louisiana (14), Oregon (1) and Pennsylvania (1). A significant seizure of acetyl fentanyl occurred in April 2013 during a law enforcement investigation in Montreal, Canada. Approximately three kilograms of acetyl fentanyl in powder form and approximately 11,000 tablets containing acetyl fentanyl were seized. Given that a typical dose of acetyl fentanyl is in the microgram range, a three kilogram quantity could potentially produce millions of dosage units. In the United States, tablets that mimic pharmaceutical opioid products have been reported in multiple states, including Colorado, Florida, Georgia, Rhode Island, and Washington. Recent reports indicate that acetyl fentanyl in powder form is available over the Internet and has been imported to addresses within the United States. Evidence also suggests that the pattern of abuse of fentanyl analogues, including acetyl fentanyl, parallels that of heroin and prescription opioid analgesics. For example, seizures of acetyl fentanyl have been encountered both in powder and in tablet form. It is also known to have caused many fatal overdoses, in which intravenous routes of administration and histories of drug abuse are documented. Factor 5. Scope, Duration and Significance of Abuse The DEA is currently aware of at least 39 fatalities associated with acetyl fentanyl. These deaths occurred in 2013 and 2014 from six states including California, Louisiana, North Carolina, Oregon, Pennsylvania, and Rhode Island. STARLiMS and STRIDE, databases capturing drug evidence information from DEA forensic laboratories, have a total of 10 drug reports in which acetyl fentanyl was identified in six cases for analyzed drugs submitted from January 2010--December 2014 from Colorado, Florida, Georgia, Louisiana, Rhode Island, and Washington. It is likely that the prevalence of acetyl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported since standard immunoassays cannot differentiate acetyl fentanyl from fentanyl. The population likely to abuse acetyl fentanyl overlaps with the populations abusing prescription opioid analgesics and heroin. This is evidenced by the routes of administration and drug use history documented in acetyl fentanyl fatal overdose cases. Because abusers of acetyl fentanyl are likely to obtain the drug through illicit sources, the identity, purity, and quantity is uncertain and inconsistent, thus posing significant adverse health risks to its abusers. This risk is particularly heightened by the fact that acetyl fentanyl is a highly potent opioid (15.7 fold more potent than that of morphine as tested in mice using an acetic acid writhing method). Thus small changes in the amount and purity of the substance could potentially lead to overdose and death. Factor 6. What, if Any, Risk There Is to the Public Health Acetyl fentanyl exhibits a pharmacological profile similar to that of fentanyl and other opioid analgesic compounds, and it is a potent opioid analgesic reported to be 1/3 as potent as fentanyl and 15.7 times as potent as morphine in mice tested in an acetic acid writhing method. In addition, studies also showed that the range between the effective dose (ED50) and the lethal dose (LD50) of acetyl fentanyl is narrower than that of morphine and fentanyl, increasing the risk of fatal overdose. Thus, its abuse is likely to pose quantitatively greater risks to the public health and safety than abuse of traditional opioid analgesics such as morphine. Based on the above pharmacological data, the abuse of acetyl fentanyl at least leads to the same qualitative public health risks as heroin, fentanyl, and other opioid analgesic compounds. The public health risks attendant to the abuse of heroin and opioid analgesics are well established. The abuse of opioid analgesics has resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses. Acetyl fentanyl has been associated with numerous fatalities. At least 39 overdose deaths due to acetyl fentanyl abuse have been reported in six states in 2013 and 2014, California, Louisiana, North Carolina, Oregon, Pennsylvania, and Rhode Island. This indicates that acetyl fentanyl poses an imminent hazard to public safety. Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard to Public Safety Based on the data and information summarized above, the continued uncontrolled manufacture, distribution, importation, exportation, and abuse of acetyl fentanyl poses an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance 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 acetyl 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 7, 2015, notified the Assistant Secretary of the DEA's intention to temporarily place this substance into schedule I. 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 N-(1-phenethylpiperidin-4-yl)- N-phenylacetamide (acetyl 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 final order temporarily scheduling acetyl 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. Regular 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 regular 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 regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary [[Page 42384]] scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6). Requirements for Handling Upon the effective date of this final order, acetyl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, research, conduct of instructional activities, and possession of schedule I controlled substances including the following: 1. Registration. Any person who handles (manufactures, distributes, imports, exports, engages in research, conducts instructional activities with, or possesses), or who desires to handle, acetyl 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 17, 2015. Any person who currently handles acetyl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle acetyl fentanyl as of July 17, 2015, 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 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 17, 2015 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA. 2. Security. Acetyl 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 17, 2015. 3. Labeling and packaging. All labels, labeling, and packaging for commercial containers of acetyl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302 as of July 17, 2015. Current DEA registrants shall have 30 calendar days from July 17, 2015, to comply with all labeling and packaging requirements. 4. Inventory. Every DEA registrant who possesses any quantity of acetyl fentanyl on the effective date of this order must take an inventory of all stocks of this substance on hand as of July 17, 2015, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11(a) and (d). 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 acetyl 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. 5. Records. All DEA registrants must maintain records with respect to acetyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. Current DEA registrants authorized to handle acetyl fentanyl shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements. 6. Reports. All DEA registrants who manufacture or distribute acetyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, 1307, and 1312 as of July 17, 2015. 7. Order Forms. All DEA registrants who distribute acetyl 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 17, 2015. 8. Importation and Exportation. All importation and exportation of acetyl 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 17, 2015. 9. Quota. Only DEA registered manufacturers may manufacture acetyl 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 17, 2015. 10. Liability. Any activity involving acetyl fentanyl not authorized by, or in violation of the CSA, occurring as of July 17, 2015, 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 an expedited 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 final order 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. 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 these substances immediately because they pose a public health risk. 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 [[Page 42385]] 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 public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, in accordance with 5 U.S.C. 808(2), this order shall take effect immediately upon its publication. 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, 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)(24) to read as follows: Sec. 1308.11 Schedule I. * * * * * (h) * * * (24) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its (9821). optical, positional, and geometric isomers, salts and salts of isomers (Other names: acetyl fentanyl)........... * * * * * Dated: July 13, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015-17563 Filed 7-16-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations 42381
untreated wood components. Therefore ingested, must comply with solubility Substances Act. This action is based on
this rule would be expected to impact limits that the toy standard establishes a finding by the Administrator that the
only a small number of manufacturers for eight heavy elements. Materials used placement of this opioid substance into
and importers or at most, a small in toys subject to section 4.3.5 of the toy schedule I of the Controlled Substances
portion of the toys in the market. standard must comply with the third Act is necessary to avoid an imminent
Second, manufacturers of toys party testing requirements of section hazard to the public safety. As a result
containing unfinished and untreated 14(a)(2) of the Consumer Product Safety of this order, the regulatory controls and
wood components still would be Act (‘‘CPSA’’), unless listed in § 1251.2. administrative, civil, and criminal
required to test to other aspects of the sanctions applicable to schedule I
ASTM toy standard, so the impact of § 1251.2 Wood. controlled substances will be imposed
this rule relative to production costs for (a) Unfinished and untreated wood on persons who handle (manufacture,
most firms should be small. Due to the does not exceed the limits for the heavy distribute, import, export, engage in
small number of entities affected and elements established in section 4.3.5 of research, or possess), or propose to
the limited scope of the impact, the the toy standard with a high degree of handle, acetyl fentanyl.
Commission certifies that this rule will assurance as that term is defined in 16 DATES: This final order is effective on
not have a significant impact on a CFR part 1107, provided that the July 17, 2015.
substantial number of small entities material has been neither treated nor
FOR FURTHER INFORMATION CONTACT: John
pursuant to section 605(b) of the RFA, adulterated with materials that could
5 U.S.C. 605(b). R. Scherbenske, Office of Diversion
result in the addition of any of the
Control, Drug Enforcement
G. Environmental Considerations heavy elements listed in the toy
Administration; Mailing Address: 8701
standard at levels above their respective
The Commission’s regulations Morrissette Drive, Springfield, Virginia
solubility limits.
provide a categorical exclusion for 22152, Telephone: (202) 598–6812.
(b) For purposes of this section,
Commission rules from any requirement unfinished and untreated wood means SUPPLEMENTARY INFORMATION:
to prepare an environmental assessment wood harvested from the trunks of trees Legal Authority
or an environmental impact statement with no added surface coatings (such as,
because they ‘‘have little or no potential The Drug Enforcement
varnish, paint, shellac, or polyurethane)
for affecting the human environment.’’ Administration (DEA) implements and
and no materials added to the wood
16 CFR 1021.5(c)(2). This rule falls enforces titles II and III of the
substrate (such as, stains, dyes,
within the categorical exclusion, so no Comprehensive Drug Abuse Prevention
preservatives, antifungals, or
environmental assessment or and Control Act of 1970, as amended.
insecticides). Unfinished and untreated
environmental impact statement is Titles II and III are referred to as the
wood does not include manufactured or
required. The Commission’s regulations ‘‘Controlled Substances Act’’ and the
engineered woods (such as pressed
state that safety standards for products ‘‘Controlled Substances Import and
wood, plywood, particle board, or
normally have little or no potential for Export Act,’’ respectively, and are
fiberboard).
affecting the human environment. 16 collectively referred to as the
Dated: July 13, 2015. ‘‘Controlled Substances Act’’ or the
CFR 1021.5(c)(1). Nothing in this rule
alters that expectation. Todd A. Stevenson, ‘‘CSA’’ for the purpose of this action. 21
Secretary, Consumer Product Safety U.S.C. 801–971. The DEA publishes the
List of Subjects Commission. implementing regulations for these
Business and industry, Infants and [FR Doc. 2015–17413 Filed 7–16–15; 8:45 am] statutes in title 21 of the Code of Federal
children, Consumer protection, Imports, BILLING CODE 6355–01–P Regulations (CFR), chapter II. The CSA
Product testing and certification, Toys. and its implementing regulations are
Accordingly, 16 CFR part 1251 is designed to prevent, detect, and
added to read as follows: DEPARTMENT OF JUSTICE eliminate the diversion of controlled
substances and listed chemicals into the
PART 1251—TOYS: DETERMINATIONS Drug Enforcement Administration illicit market while ensuring an
REGARDING HEAVY ELEMENTS adequate supply is available for the
LIMITS FOR CERTAIN MATERIALS 21 CFR Part 1308 legitimate medical, scientific, research,
and industrial needs of the United
Sec. [Docket No. DEA–413F]
1251.1 The toy standard and testing States. Controlled substances have the
requirements. Schedules of Controlled Substances: potential for abuse and dependence and
1251.2 Wood. Temporary Placement of Acetyl are controlled to protect the public
Authority: Sec. 3, Pub. L. 110–314, 122 Fentanyl Into Schedule I health and safety.
Stat. 3016; 15 U.S.C. 2063(d)(3)(B). Under the CSA, every controlled
AGENCY: Drug Enforcement substance is classified into one of five
§ 1251.1 The toy standard and testing Administration, Department of Justice. schedules based upon its potential for
requirements. ACTION: Final order. abuse, its currently accepted medical
The Consumer Product Safety use in treatment in the United States,
Improvement Act of 2008 (‘‘CPSIA’’) SUMMARY: The Administrator of the Drug and the degree of dependence the drug
made provisions of ASTM F963, Enforcement Administration is issuing or other substance may cause. 21 U.S.C.
asabaliauskas on DSK5VPTVN1PROD with RULES
Consumer Product Safety Specifications this final order to temporarily schedule 812. The initial schedules of controlled
for Toy Safety (‘‘toy standard’’), a the synthetic opioid, N-(1- substances established by Congress are
mandatory consumer product safety phenethylpiperidin-4-yl)-N- found at 21 U.S.C. 812(c), and the
standard. Among the mandated phenylacetamide (acetyl fentanyl), and current list of all scheduled substances
provisions is section 4.3.5 of ASTM its optical, positional, and geometric is published at 21 CFR part 1308.
F963 which requires that surface coating isomers, salts and salts of isomers, into Section 201 of the CSA, 21 U.S.C. 811,
materials and accessible substrates of schedule I pursuant to the temporary provides the Attorney General with the
toys that can be sucked, mouthed, or scheduling provisions of the Controlled authority to temporarily place a
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![Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations 42385
from standard notice and comment Big Foot Tension Leg Platform email Mr. Rusty Wright, U.S. Coast
rulemaking procedures to ensure that construction site, located in Walker Guard, District Eight Waterways
the process moves swiftly. For the same Ridge Block 29 on the Outer Continental Management Branch; telephone 504–
reasons that underlie 21 U.S.C. 811(h), Shelf (OCS) in the Gulf of Mexico. The 671–2138, rusty.h.wright@uscg.mil. If
that is, the DEA’s need to move quickly purpose of this interim rule is to include you have questions on viewing or
to place this substance into schedule I the construction area and protect the submitting material to the docket, call
because it poses an imminent hazard to facility and all operations during the Cheryl Collins, Program Manager,
public safety, it would be contrary to the construction phase from all vessels Docket Operations, telephone (202)
public interest to delay implementation operating outside the normal shipping 366–9826.
of the temporary scheduling order. channels and fairways that are not SUPPLEMENTARY INFORMATION:
Therefore, in accordance with 5 U.S.C. providing services to or working with
808(2), this order shall take effect the facility. Placing a safety zone around Table of Acronyms
immediately upon its publication. the facility while under construction DHS Department of Homeland Security
that includes the construction site will NPRM Notice of Proposed Rulemaking
List of Subjects in 21 CFR Part 1308 OCS Outer Continental Shelf
significantly reduce the threat of
Administrative practice and allisions, collisions, security breaches, A. Public Participation and Request for
procedure, Drug traffic control, oil spills, releases of natural gas, and Comments
Reporting and recordkeeping thereby protect the safety of life,
requirements. property, and the environment. We encourage you to participate in
For the reasons set out above, the DEA DATES: This rule is effective without this rulemaking by submitting
amends 21 CFR part 1308 as follows: comments and related materials. All
actual notice July 17, 2015. For the comments received will be posted
purposes of enforcement, actual notice without change to http://
PART 1308—SCHEDULES OF
will be used from June 3, 2015 until July www.regulations.gov and will include
CONTROLLED SUBSTANCES
17, 2015. Comments and related any personal information you have
■ 1. The authority citation for part 1308 material must be received by the Coast provided.
continues to read as follows: Guard on or before August 3, 2015.
ADDRESSES: Documents mentioned in 1. Submitting Comments
Authority: 21 U.S.C. 811, 812, 871(b),
unless otherwise noted. this preamble are part of Docket Number If you submit a comment, please
USCG–2014–0863. To view documents include the docket number for this
■ 2. Amend § 1308.11 by adding mentioned in this preamble as being rulemaking, indicate the specific section
paragraph (h)(24) to read as follows: available in the docket, go to http:// of this document to which each
§ 1308.11 Schedule I. www.regulations.gov, type the docket comment applies, and provide a reason
number in the ‘‘SEARCH’’ box and click for each suggestion or recommendation.
* * * * * ‘‘SEARCH.’’ Click on ‘‘Open Docket
(h) * * * You may submit your comments and
Folder’’ on the line associated with this material online at http://
(24) N-(1-phenethylpiperidin- rulemaking. You may also visit the
4-yl)-N-phenylacetamide, its
www.regulations.gov, or by fax, mail, or
optical, positional, and geo-
Docket Management Facility in Room hand delivery, but please use only one
metric isomers, salts and W12–140 on the ground floor of the of these means. If you submit a
salts of isomers (Other Department of Transportation West comment online, it will be considered
names: acetyl fentanyl) ........ (9821). Building, 1200 New Jersey Avenue SE., received by the Coast Guard when you
Washington, DC 20590, between 9 a.m. successfully transmit the comment. If
* * * * *
and 5 p.m., Monday through Friday, you fax, hand deliver, or mail your
Dated: July 13, 2015. except Federal holidays. comment, it will be considered as
Chuck Rosenberg, You may submit comments, identified having been received by the Coast
Acting Administrator. by docket number, using any one of the Guard when it is received at the Docket
[FR Doc. 2015–17563 Filed 7–16–15; 8:45 am] following methods: Management Facility. We recommend
BILLING CODE 4410–09–P (1) Federal eRulemaking Portal: that you include your name and a
http://www.regulations.gov. mailing address, an email address, or a
(2) Fax: (202) 493–2251. telephone number in the body of your
DEPARTMENT OF HOMELAND (3) Mail or Delivery: Docket document so that we can contact you if
SECURITY Management Facility (M–30), U.S. we have questions regarding your
Department of Transportation, West submission.
Coast Guard Building Ground Floor, Room W12–140, To submit your comment online, go to
1200 New Jersey Avenue SE., http://www.regulations.gov, type the
33 CFR Part 147 Washington, DC 20590–0001. Deliveries docket number in the ‘‘SEARCH’’ box
accepted between 9 a.m. and 5 p.m., and click ‘‘SEARCH.’’ Click on ‘‘Submit
[Docket Number USCG–2014–0863]
Monday through Friday, except federal a Comment’’ on the line associated with
RIN 1625–AA00 holidays. The telephone number is 202– this rulemaking.
366–9329. If you submit your comments by mail
Safety Zone; Big Foot TLP, Walker See the ‘‘Public Participation and or hand delivery, submit them in an
asabaliauskas on DSK5VPTVN1PROD with RULES
Ridge 29, Outer Continental Shelf on Request for Comments’’ portion of the unbound format, no larger than 81⁄2 by
the Gulf of Mexico SUPPLEMENTARY INFORMATION section 11 inches, suitable for copying and
AGENCY: Coast Guard, DHS.
below for further instructions on electronic filing. If you submit
submitting comments. To avoid comments by mail and would like to
ACTION: Interim rule and request for
duplication, please use only one of know that they reached the Facility,
comments.
these three methods. please enclose a stamped, self-addressed
SUMMARY: The Coast Guard is FOR FURTHER INFORMATION CONTACT: If postcard or envelope. We will consider
establishing a safety zone around the you have questions on this rule, call or all comments and material received
VerDate Sep<11>2014 17:58 Jul 16, 2015 Jkt 235001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\17JYR1.SGM 17JYR1](https://thefederalregister.org/doc/80_FR_42518/page/5.svg)
Document Created: 2018-02-23 09:21:31
Document Modified: 2018-02-23 09:21:31
| 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 | Final order. | |
| Dates | This final order is effective on July 17, 2015. | |
| Contact | John R. Scherbenske, Office of | |
| FR Citation | 80 FR 42381 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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