81 FR 15485 - Schedules of Controlled Substances: Temporary Placement of Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 56 (March 23, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 56 (March 23, 2016)
| Page Range | 15485-15489 | |
| FR Document | 2016-06468 |
[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)] [Proposed Rules] [Pages 15485-15489] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-06468] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-434] Schedules of Controlled Substances: Temporary Placement of Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of intent. ----------------------------------------------------------------------- SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the synthetic opioids, N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide (butyryl fentanyl) and N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N- phenylpropionamide (beta-hydroxythiofentanyl), 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 these synthetic opioids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, possession, [[Page 15486]] importation, and exportation of, and research and conduct with, instructional activities of these synthetic opioids. DATES: March 23, 2016. 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: Any final order will be published in the Federal Register and may not be effective prior to April 22, 2016. 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. 21 U.S.C. 801-971. 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. 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, each 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 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 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 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.\1\ The Administrator transmitted notice of his intent to place butyryl fentanyl and beta-hydroxythiofentanyl in schedule I on a temporary basis to the Assistant Secretary by letter dated December 21, 2015 (received by the HHS on December 23, 2015). The Assistant Secretary responded to this notice by letter dated January 13, 2016, 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 butryl fentanyl or beta-hydroxythiofentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of butryl fentanyl or beta-hydroxythiofentanyl into schedule I of the CSA. Neither butryl fentanyl nor beta-hydroxythiofentanyl are currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for butryl fentanyl or beta-hydroxythiofentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of butryl fentanyl and beta-hydroxythiofentanyl in schedule I on a temporary basis are necessary to avoid an imminent hazard to public safety. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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 in 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). Butyryl Fentanyl and Beta-Hydroxythiofentanyl Available data and information for butyryl fentanyl and beta- hydroxythiofentanyl, summarized below, indicate that these synthetic opioid substances 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. The DEA's three- factor analysis is available in its entirety under of the public docket of this action as a supporting document at www.regulations.gov under Docket Number DEA-434. 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. 46 FR 46799. 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 [[Page 15487]] schedule I of the CSA after finding that they posed an imminent hazard to public safety and were subsequently permanently placed in schedule I of the CSA. On July 17, 2015, acetyl fentanyl was temporarily controlled under schedule I of the CSA after a finding by the Administrator that it posed an imminent hazard to public safety. 80 FR 42381. Prior to October 1, 2014, the System to Retrieve Information from Drug Evidence (STRIDE) collected the results of drug evidence analyzed at DEA laboratories and reflected evidence submitted by the DEA, other federal law enforcement agencies, and some local law enforcement agencies. STRIDE data were queried through September 30, 2014, by date submitted to federal forensic laboratories. Since October 1, 2014, STARLiMS (a web-based, commercial laboratory information management system) has replaced STRIDE as the DEA 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 December 21, 2015. The National Forensic Laboratory Information System (NFLIS) is a program of the DEA that collects drug identification results from drug cases analyzed by other federal, state, and local forensic laboratories. NFLIS reports from other federal, state, and local forensic laboratories were queried on December 22, 2015.\2\ --------------------------------------------------------------------------- \2\ Data are still being reported for September-November 2015, due to normal lag time for laboratories to report to NFLIS. --------------------------------------------------------------------------- The first laboratory submission of butyryl fentanyl was recorded in Kansas in March 2014 according to NFLIS. STRIDE, STARLiMS and NFLIS registered seven reports containing butyryl fentanyl in 2014 in Illinois, Kansas, Minnesota, and Pennsylvania; 81 reports of butyryl fentanyl were recorded in 2015 in California, Connecticut, Florida, Indiana, North Dakota, New York, Ohio, Oregon, Tennessee, Virginia, and Wisconsin. A total of three reports of beta-hydroxythiofentanyl were recorded by STARLiMS, all of which were reported in 2015 from Florida. To date, beta-hydroxythiofentanyl has not been reported in NFLIS; however, this substance was identified in June 2015 by a forensic laboratory in Oregon. Evidence also suggests that the pattern of abuse of fentanyl analogues, including butyryl fentanyl and beta-hydroxythiofentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of butyryl fentanyl have been encountered in tablet and powder form. Butyryl fentanyl was identified on bottle caps and spoons and residue was detected within glassine bags, on digital scales, and on sifters which demonstrates the abuse of this substance as a replacement for heroin or other opioids, either knowingly or unknowingly. Butyryl fentanyl has been encountered as a single substance as well as in combination with other illicit substances, such as acetyl fentanyl, heroin, cocaine, or methamphetamine. Like butyryl fentanyl, beta- hydroxythiofentanyl has been encountered in both tablet and powder form. Both butyryl fentanyl and beta-hydroxythiofentanyl have caused fatal overdoses, in which intravenous routes of administration are documented. Factor 5. Scope, Duration and Significance of Abuse The DEA is currently aware of at least 40 confirmed fatalities associated with butyryl fentanyl and 7 confirmed fatalities associated with beta-hydroxythiofentanyl. The information on these deaths occurring in 2015 was collected from toxicology and medical examiner reports and was reported from four states--Florida (7, beta- hydroxythiofentanyl), Maryland (1, butyryl fentanyl), New York (38, butyryl fentanyl), and Oregon (1, butyryl fentanyl). STRIDE, STARLiMS, and NFLIS have a total of 88 drug reports in which butyryl fentanyl was identified in drug exhibits submitted in 2014 and 2015 from California, Connecticut, Florida, Illinois, Indiana, Kansas, Minnesota, North Dakota, New York, Ohio, Oregon, Pennsylvania, Tennessee, Virginia, and Wisconsin. STARLiMS has a total of three drug reports in which beta- hydroxythiofentanyl was identified in drug exhibits submitted in 2015 from Florida. It is likely that the prevalence of butyryl fentanyl and beta-hydroxythiofentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays cannot differentiate these substances from fentanyl. The population likely to abuse butyryl fentanyl and beta- hydroxythiofentanyl overlaps with the populations abusing prescription opioid analgesics and heroin. This is evidenced by the routes of administration and drug use history documented in butyryl fentanyl and beta-hydroxythiofentanyl fatal overdose cases. Because abusers of these fentanyl analogues are likely to obtain these substances through illicit sources, the identity, purity, and quantity is uncertain and inconsistent, thus posing significant adverse health risks to abusers of butyryl fentanyl and beta-hydroxythiofentanyl. Individuals who initiate (i.e. use an illicit drug for the first time) butyryl fentanyl or beta-hydroxythiofentanyl 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 Butyryl fentanyl and beta-hydroxythiofentanyl exhibit pharmacological profiles similar to that of fentanyl and other mu- opioid receptor agonists. Due to limited scientific data, their potency and toxicity are not known; however, the toxic effects of both butyryl fentanyl and beta-hydroxythiofentanyl in humans are demonstrated by overdose fatalities involving these substances. Abusers of these fentanyl analogues may not know the origin, identity, or purity of these substances, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. Based on the documented case reports of overdose fatalities, the abuse of butyryl fentanyl and beta-hydroxythiofentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. 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. Butyryl fentanyl and beta-hydroxythiofentanyl have been associated with numerous fatalities. At least 40 confirmed overdose deaths involving butyryl fentanyl abuse have been reported in Maryland (1), New York (38), and Oregon (1) in 2015. At least seven confirmed overdose fatalities involving beta-hydroxythiofentanyl have been reported in Florida in 2015. This indicates that both butyryl fentanyl and beta-hydroxythiofentanyl pose 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 available data and information, summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of butyryl fentanyl and beta-hydroxythiofentanyl pose an imminent hazard to the public [[Page 15488]] safety. The DEA is not aware of any currently accepted medical uses for these substances in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in 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 butyryl fentanyl and beta-hydroxythiofentanyl indicate that these substances 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. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated December 21, 2015, notified the Assistant Secretary of the DEA's intention to temporarily place this substance in schedule I. Conclusion This notice of intent initiates an expedited temporary scheduling action and provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h). 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 set forth the grounds for his determination that it is necessary to temporarily schedule butyryl fentanyl and beta-hydroxythiofentanyl in schedule I of the CSA, and finds that placement of these opioid substances into schedule I of the CSA is necessary in order to avoid an imminent hazard to the public safety. Because the Administrator hereby finds that it is necessary to temporarily place these synthetic opioids into schedule I to avoid an imminent hazard to the public safety, any subsequent final order temporarily scheduling these substances 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). It is the intention of the Administrator to issue such a final order as soon as possible after the expiration of 30 days from the date of publication of this notice. Butyryl fentanyl and beta-hydroxythiofentanyl will then be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, research, conduct of instructional activities and chemical analysis, and possession of a schedule I controlled substance. 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 scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6). 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 of HHS. 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 section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent. In the alternative, even assuming that this notice of intent might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 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. Although the DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice and comment requirements of section 553 of the APA, the DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator will take into consideration any comments submitted by the Assistant Secretary with regard to the proposed temporary scheduling order. 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 (RFA). 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 section 553 of 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. 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 proposes to amend 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. In Sec. 1308.11, add paragraphs (h)(26) and (27) to read as follows: Sec. 1308.11 Schedule I * * * * * (h) * * * (26) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: butyryl fentanyl)--(9822) (27) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N- phenylpropionamide, its isomers, esters, [[Page 15489]] ethers, salts and salts of isomers, esters and ethers (Other names: beta-hydroxythiofentanyl)--(9836) Dated: March 16, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-06468 Filed 3-22-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Proposed Rules 15485
this NOPR under section 380.4(a)(15) of and the impact the regulation has on 34. From the Commission’s Home
the Commission’s regulations, which larger competitors.’’ 36 The Commission Page on the Internet, this information is
provides a categorical exemption for does not consider the estimated burden available on eLibrary. The full text of
approval of actions under sections 205 to be a significant economic impact. As this document is available on eLibrary
and 206 of the FPA relating to the filing a result, the Commission certifies that in PDF and Microsoft Word format for
of schedules containing all rates and the reforms proposed in this NOPR viewing, printing, and/or downloading.
charges for the transmission or sale of would not have a significant economic To access this document in eLibrary,
electric energy subject to the impact on a substantial number of small type the docket number excluding the
Commission’s jurisdiction, plus the entities. last three digits of this document in the
classification, practices, contracts and docket number field.
VI. Comment Procedures 35. User assistance is available for
regulations that affect rates, charges,
classifications, and services.33 The 29. The Commission invites interested eLibrary and the Commission’s Web site
revisions proposed in this NOPR would persons to submit comments on the during normal business hours from the
update and clarify the application of the matters and issues proposed in this Commission’s Online Support at (202)
Commission’s standard interconnection notice to be adopted, including any 502–6652 (toll free at 1–866–208–3676)
requirements to small generating related matters or alternative proposals or email at ferconlinesupport@ferc.gov,
facilities. Therefore, this NOPR falls that commenters may wish to discuss. or the Public Reference Room at (202)
within the categorical exemptions Comments are due May 23, 2016. 502–8371, TTY (202) 502–8659. Email
provided in the Commission’s Comments must refer to Docket No. the Public Reference Room at
regulations, and as a result neither an RM16–8–000, and must include the public.referenceroom@ferc.gov.
environmental impact statement nor an commenter’s name, the organization By direction of the Commission.
environmental assessment is required. they represent, if applicable, and their Issued: March 17, 2016.
address in their comments.
V. Regulatory Flexibility Act 30. The Commission encourages
Nathaniel J. Davis, Sr.,
26. The Regulatory Flexibility Act of Deputy Secretary.
comments to be filed electronically via
1980 (RFA) 34 generally requires a the eFiling link on the Commission’s [FR Doc. 2016–06509 Filed 3–22–16; 8:45 am]
description and analysis of proposed Web site at http://www.ferc.gov. The BILLING CODE 6717–01–P
rules that will have significant Commission accepts most standard
economic impact on a substantial word processing formats. Documents
number of small entities. The RFA does created electronically using word DEPARTMENT OF JUSTICE
not mandate any particular outcome in processing software should be filed in
a rulemaking. It only requires native applications or print-to-PDF Drug Enforcement Administration
consideration of alternatives that are format and not in a scanned format.
less burdensome to small entities and an Commenters filing electronically do not 21 CFR Part 1308
agency explanation of why alternatives need to make a paper filing. [Docket No. DEA–434]
were rejected. 31. Commenters that are not able to
27. The Small Business file comments electronically must send Schedules of Controlled Substances:
Administration (SBA) revised its size an original of their comments to: Temporary Placement of Butyryl
standards (effective January 22, 2014) Federal Energy Regulatory Commission, Fentanyl and Beta-Hydroxythiofentanyl
for electric utilities from a standard Secretary of the Commission, 888 First Into Schedule I
based on megawatt hours to a standard Street NE., Washington, DC 20426. AGENCY: Drug Enforcement
based on the number of employees, 32. All comments will be placed in Administration, Department of Justice.
including affiliates. Under SBA’s the Commission’s public files and may
standards, some transmission owners ACTION: Notice of intent.
be viewed, printed, or downloaded
will fall under the following category remotely as described in the Document SUMMARY: The Administrator of the Drug
and associated size threshold: Electric Availability section below. Commenters Enforcement Administration is issuing
bulk power transmission and control, at on this proposal are not required to this notice of intent to temporarily
500 employees.35 serve copies of their comments on other schedule the synthetic opioids, N-(1-
28. The Commission estimates that commenters. phenethylpiperidin-4-yl)-N-
the total number of public utility phenylbutyramide (butyryl fentanyl)
transmission providers that would have VII. Document Availability
and N-[1-[2-hydroxy-2-(thiophen-2-
to modify the SGIAs within their 33. In addition to publishing the full yl)ethyl]piperidin-4-yl]-N-
currently effective OATTs is 118. Of text of this document in the Federal phenylpropionamide (beta-
these, the Commission estimates that Register, the Commission provides all hydroxythiofentanyl), into schedule I
approximately 43 percent are small interested persons an opportunity to pursuant to the temporary scheduling
entities. The Commission estimates the view and/or print the contents of this provisions of the Controlled Substances
average total cost to each of these document via the Internet through the Act. This action is based on a finding by
entities will be minimal, requiring on Commission’s Home Page (http:// the Administrator that the placement of
average 7.5 hours or $540. According to www.ferc.gov) and in the Commission’s these synthetic opioids into schedule I
SBA guidance, the determination of Public Reference Room during normal of the Controlled Substances Act is
mstockstill on DSK4VPTVN1PROD with PROPOSALS
significance of impact ‘‘should be seen business hours (8:30 a.m. to 5:00 p.m. necessary to avoid an imminent hazard
as relative to the size of the business, Eastern time) at 888 First Street NE., to the public safety. Any final order will
the size of the competitor’s business, Room 2A, Washington, DC 20426. impose the administrative, civil, and
33 18
criminal sanctions and regulatory
CFR 380.4(a)(15). 36 U.S. Small Business Administration, A Guide
34 5
controls applicable to schedule I
U.S.C. 601–612. for Government Agencies How to Comply with the
35 13 CFR 121.201, Sector 22 (Utilities), NAICS Regulatory Flexibility Act, at 18 (May 2012), https://
controlled substances under the
code 221121 (Electric Bulk Power Transmission and www.sba.gov/sites/default/files/advocacy/rfaguide_ Controlled Substances Act on the
Control). 0512_0.pdf. manufacture, distribution, possession,
VerDate Sep<11>2014 16:29 Mar 22, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 E:\FR\FM\23MRP1.SGM 23MRP1](https://thefederalregister.org/doc/81_FR_15541/page/1.svg)
![15488 Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Proposed Rules
safety. The DEA is not aware of any conduct of instructional activities and that in accordance with 21 U.S.C.
currently accepted medical uses for chemical analysis, and possession of a 811(h)(4), the Administrator will take
these substances in the United States. A schedule I controlled substance. into consideration any comments
substance meeting the statutory The CSA sets forth specific criteria for submitted by the Assistant Secretary
requirements for temporary scheduling, scheduling a drug or other substance. with regard to the proposed temporary
21 U.S.C. 811(h)(1), may only be placed Regular scheduling actions in scheduling order.
in schedule I. Substances in schedule I accordance with 21 U.S.C. 811(a) are Further, the DEA believes that this
are those that have a high potential for subject to formal rulemaking procedures temporary scheduling action is not a
abuse, no currently accepted medical done ‘‘on the record after opportunity ‘‘rule’’ as defined by 5 U.S.C. 601(2),
use in treatment in the United States, for a hearing’’ conducted pursuant to and, accordingly, is not subject to the
and a lack of accepted safety for use the provisions of 5 U.S.C. 556 and 557. requirements of the Regulatory
under medical supervision. Available 21 U.S.C. 811. The regular scheduling Flexibility Act (RFA). The requirements
data and information for butyryl process of formal rulemaking affords for the preparation of an initial
fentanyl and beta-hydroxythiofentanyl interested parties with appropriate regulatory flexibility analysis in 5 U.S.C.
indicate that these substances have a process and the government with any 603(a) are not applicable where, as here,
high potential for abuse, no currently additional relevant information needed the DEA is not required by section 553
accepted medical use in treatment in the to make a determination. Final of the APA or any other law to publish
United States, and a lack of accepted decisions that conclude the regular a general notice of proposed
safety for use under medical scheduling process of formal rulemaking.
supervision. As required by section rulemaking are subject to judicial Additionally, this action is not a
201(h)(4) of the CSA, 21 U.S.C. review. 21 U.S.C. 877. Temporary significant regulatory action as defined
811(h)(4), the Administrator, through a scheduling orders are not subject to by Executive Order 12866 (Regulatory
letter dated December 21, 2015, notified judicial review. 21 U.S.C. 811(h)(6). Planning and Review), section 3(f), and,
the Assistant Secretary of the DEA’s Regulatory Matters accordingly, this action has not been
intention to temporarily place this reviewed by the Office of Management
substance in schedule I. Section 201(h) of the CSA, 21 U.S.C. and Budget (OMB).
811(h), provides for an expedited This action will not have substantial
Conclusion temporary scheduling action where direct effects on the States, on the
This notice of intent initiates an such action is necessary to avoid an relationship between the national
expedited temporary scheduling action imminent hazard to the public safety. government and the States, or on the
and provides the 30-day notice pursuant As provided in this subsection, the distribution of power and
to section 201(h) of the CSA, 21 U.S.C. Attorney General may, by order, responsibilities among the various
811(h). In accordance with the schedule a substance in schedule I on a levels of government. Therefore, in
provisions of section 201(h) of the CSA, temporary basis. Such an order may not accordance with Executive Order 13132
21 U.S.C. 811(h), the Administrator be issued before the expiration of 30 (Federalism) it is determined that this
considered available data and days from (1) the publication of a notice action does not have sufficient
information, herein set forth the in the Federal Register of the intention federalism implications to warrant the
grounds for his determination that it is to issue such order and the grounds preparation of a Federalism Assessment.
necessary to temporarily schedule upon which such order is to be issued,
butyryl fentanyl and beta- and (2) the date that notice of the List of Subjects in 21 CFR Part 1308
hydroxythiofentanyl in schedule I of the proposed temporary scheduling order is Administrative practice and
CSA, and finds that placement of these transmitted to the Assistant Secretary of procedure, Drug traffic control,
opioid substances into schedule I of the HHS. 21 U.S.C. 811(h)(1). Reporting and recordkeeping
CSA is necessary in order to avoid an Inasmuch as section 201(h) of the requirements.
imminent hazard to the public safety. CSA directs that temporary scheduling
For the reasons set out above, the DEA
Because the Administrator hereby actions be issued by order and sets forth
proposes to amend 21 CFR part 1308 as
finds that it is necessary to temporarily the procedures by which such orders are
follows:
place these synthetic opioids into to be issued, the DEA believes that the
schedule I to avoid an imminent hazard notice and comment requirements of PART 1308—SCHEDULES OF
to the public safety, any subsequent section 553 of the Administrative CONTROLLED SUBSTANCES
final order temporarily scheduling these Procedure Act (APA), 5 U.S.C. 553, do
substances will be effective on the date not apply to this notice of intent. In the ■ 1. The authority citation for part 1308
of publication in the Federal Register, alternative, even assuming that this continues to read as follows:
and will be in effect for a period of two notice of intent might be subject to Authority: 21 U.S.C. 811, 812, 871(b),
years, with a possible extension of one section 553 of the APA, the unless otherwise noted.
additional year, pending completion of Administrator finds that there is good ■ 2. In § 1308.11, add paragraphs (h)(26)
the regular (permanent) scheduling cause to forgo the notice and comment and (27) to read as follows:
process. 21 U.S.C. 811(h)(1) and (2). It requirements of section 553, as any
is the intention of the Administrator to further delays in the process for § 1308.11 Schedule I
issue such a final order as soon as issuance of temporary scheduling orders * * * * *
possible after the expiration of 30 days would be impracticable and contrary to
mstockstill on DSK4VPTVN1PROD with PROPOSALS
(h) * * *
from the date of publication of this the public interest in view of the (26) N-(1-phenethylpiperidin-4-yl)-N-
notice. Butyryl fentanyl and beta- manifest urgency to avoid an imminent phenylbutyramide, its isomers, esters,
hydroxythiofentanyl will then be hazard to the public safety. ethers, salts and salts of isomers, esters
subject to the regulatory controls and Although the DEA believes this notice and ethers (Other names: butyryl
administrative, civil, and criminal of intent to issue a temporary fentanyl)—(9822)
sanctions applicable to the manufacture, scheduling order is not subject to the (27) N-[1-[2-hydroxy-2-(thiophen-2-
distribution, reverse distribution, notice and comment requirements of yl)ethyl]piperidin-4-yl]-N-
importation, exportation, research, section 553 of the APA, the DEA notes phenylpropionamide, its isomers, esters,
VerDate Sep<11>2014 16:29 Mar 22, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 E:\FR\FM\23MRP1.SGM 23MRP1](https://thefederalregister.org/doc/81_FR_15541/page/4.svg)
![Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Proposed Rules 15489
ethers, salts and salts of isomers, esters I. Table of Abbreviations Executive Order 13563 emphasizes the
and ethers (Other names: beta- CFR Code of Federal Regulations
importance of quantifying both costs
hydroxythiofentanyl)—(9836) DHS Department of Homeland Security and benefits, of reducing costs, of
Dated: March 16, 2016. FR Federal Register harmonizing rules, and of promoting
Chuck Rosenberg, NPRM Notice of proposed rulemaking flexibility. This NPRM has not been
§ Section designated a ‘‘significant regulatory
Acting Administrator.
U.S.C. United States Code action,’’ under Executive Order 12866.
[FR Doc. 2016–06468 Filed 3–22–16; 8:45 am] Accordingly, the NPRM has not been
II. Background, Purpose, and Legal
BILLING CODE 4410–09–P reviewed by the Office of Management
Basis
and Budget.
On January 30, 2016, Super Boat The Coast Guard has determined that
International Productions, Inc. notified this NPRM is not a significant regulatory
DEPARTMENT OF HOMELAND
the Coast Guard that it will be action for the following reasons: (1) The
SECURITY
conducting a series of high speed boat special local regulation would be
Coast Guard races in the Atlantic Ocean, offshore enforced for a total of only seven hours;
from Cocoa Beach, FL on May 15, 2016 (2) although persons and vessels would
33 CFR Part 100 from 10 a.m. to 5 p.m. The COTP not be able to enter, transit through,
Jacksonville has determined that the anchor in, or remain within the
[Docket Number USCG–2016–0141] potential hazards associated with high regulated area without authorization
speed boat races necessitate the from the COTP Jacksonville or a
RIN 1625–AA08 establishment of a special local designated representative, they would
regulation. be able to operate in the surrounding
Special Local Regulation; Space Coast The purpose of this rulemaking is to area during the enforcement period; (3)
Super Boat Grand Prix; Atlantic Ocean, ensure the safety of life on the navigable persons and vessels would still be able
Cocoa Beach, FL waters of the United States by to enter, transit through, anchor in, or
prohibiting all vessels and persons not remain within the regulated area if
AGENCY: Coast Guard, DHS. participating in the event from entering authorized by the COTP Jacksonville or
ACTION: Notice of proposed rulemaking. the regulated area. The Coast Guard a designated representative; and (4) the
proposes this rulemaking under Coast Guard would provide advance
SUMMARY: The Coast Guard proposes to notification of the special local
authority in 33 U.S.C. 1233.
establish a special local regulation on regulation to the local maritime
the waters of the Atlantic Ocean III. Discussion of Proposed Rule
community via Broadcast Notice to
offshore from Cocoa Beach, FL during The COTP proposes to establish a Mariners or by on-scene designated
the Space Coast Super Boat Grand Prix, special local regulation for the Space representative.
a series of high-speed boat races. This Coast Super Boat Grand Prix, a series of
action is necessary to provide for the high-speed boat races. The regulated B. Impact on Small Entities
safety of life on the navigable waters area includes the waters of the Atlantic The Regulatory Flexibility Act of
surrounding the event. This special Ocean offshore from Cocoa Beach, 1980, 5 U.S.C. 601–612, as amended,
local regulation will be enforced from Florida and will be enforced daily from requires Federal agencies to consider
10 a.m. to 5 p.m. on May 15, 2016. This 10 a.m. to 5 p.m., on May 15, 2016. the potential impact of regulations on
proposed rulemaking would prohibit Approximately 30 high-speed boats are small entities during rulemaking. The
persons and vessels from being in the anticipated to participate in the races. term ‘‘small entities’’ comprises small
regulated area unless authorized by the The regulated area would encompass an businesses, not-for-profit organizations
Captain of the Port (COTP) Jacksonville offshore area that is approximately two that are independently owned and
or a designated representative. We and a half nautical miles long by a half operated and are not dominant in their
invite your comments on this proposed nautical mile wide. No vessel or person fields, and governmental jurisdictions
rulemaking. would be permitted to enter the with populations of less than 50,000.
DATES: Comments and related material regulated area without obtaining The Coast Guard certifies under 5 U.S.C.
must be received by the Coast Guard on permission from the COTP or a 605(b) that this proposed rule would not
or before April 22, 2016. designated representative. The have a significant economic impact on
ADDRESSES: You may submit comments regulatory text we are proposing appears a substantial number of small entities.
identified by docket number USCG– at the end of this document. While some owners or operators of
2016–0141 using the Federal vessels intending to transit through the
IV. Regulatory Analyses regulated area may be small entities, for
eRulemaking Portal at http://
www.regulations.gov. See the ‘‘Public We developed this proposed rule after the reasons stated in section IV.A above,
Participation and Request for considering numerous statutes and this proposed rule would not have a
Comments’’ portion of the Executive orders related to rulemaking. significant economic impact on any
SUPPLEMENTARY INFORMATION section for Below we summarize our analyses vessel owner or operator.
further instructions on submitting based on a number of these statutes and If you think that your business,
comments. Executive orders and we discuss First organization, or governmental
jurisdiction qualifies as a small entity
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Amendment rights of protestors.
FOR FURTHER INFORMATION CONTACT: If and that this rule would have a
you have questions about this proposed A. Regulatory Planning and Review significant economic impact on it,
rulemaking, call or email Lieutenant Executive Orders 12866 and 13563 please submit a comment (see
Allan Storm, Sector Jacksonville, direct agencies to assess the costs and ADDRESSES) explaining why you think it
Waterways Management Division, U.S. benefits of available regulatory qualifies and how and to what degree
Coast Guard; telephone (904) 714–7616, alternatives and, if regulation is this rule would economically affect it.
email Allan.H.Storm@uscg.mil. necessary, to select regulatory Under section 213(a) of the Small
SUPPLEMENTARY INFORMATION: approaches that maximize net benefits. Business Regulatory Enforcement
VerDate Sep<11>2014 16:29 Mar 22, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4702 Sfmt 4702 E:\FR\FM\23MRP1.SGM 23MRP1](https://thefederalregister.org/doc/81_FR_15541/page/5.svg)
Document Created: 2016-03-23 00:03:42
Document Modified: 2016-03-23 00:03:42
| 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 intent. | |
| Dates | March 23, 2016. | |
| Contact | Barbara J. Boockholdt, Office of | |
| FR Citation | 81 FR 15485 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR