82 FR 58575 - Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 238 (December 13, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 238 (December 13, 2017)
| Page Range | 58575-58578 | |
| FR Document | 2017-26854 |
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)] [Proposed Rules] [Pages 58575-58578] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26854] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-475] Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Proposed amendment; notification of intent. ----------------------------------------------------------------------- SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule seven fentanyl-related substances in schedule I. These seven substances are: N-(1-phenethylpiperidin-4-yl)- N-phenylpentanamide (valeryl fentanyl), N-(4-fluorophenyl)- N-(1-phenethylpiperidin- 4-yl)butyramide (para-fluorobutyryl fentanyl), N-(4-methoxyphenyl)- N-(1- phenethylpiperidin-4-yl)butyramide (para-methoxybutyryl fentanyl), N- (4-chlorophenyl)- N-(1-phenethylpiperidin-4-yl)isobutyramide (para- chloroisobutyryl fentanyl), N-(1-phenethylpiperidin- 4-yl)-N- phenylisobutyramide (isobutyryl fentanyl), N-(1-phenethylpiperidin-4- yl)- N-phenylcyclopentane carboxamide (cyclopentyl fentanyl), and N-(2- fluorophenyl)- 2-methoxy-N-(1-phenethylpiperidin- 4-yl)acetamide (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids in schedule I of the Controlled Substances Act (CSA) is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids. DATES: December 13, 2017. ADDRESSES: The DEA's three-factor analysis is available in its entirety under ``Supporting and Related Material'' of the public docket for this action at www.regulations.gov under Docket Number DEA-475. 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: This notice of intent contained in this document is issued pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to issue a temporary scheduling order (in the form of a temporary amendment) to add valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil to schedule I of the Controlled Substances Act.\1\ The temporary scheduling order will be published in the Federal Register, but will not be issued before January 12, 2018. --------------------------------------------------------------------------- \1\ Though DEA has used the term ``final order'' with respect to temporary scheduling orders in the past, this notice of intent adheres to the statutory language of 21 U.S.C. 811(h), which refers to a ``temporary scheduling order.'' No substantive change is intended. --------------------------------------------------------------------------- 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 in 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 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); 21 CFR part 1308. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100. [[Page 58576]] 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 in schedule I of the CSA.\2\ The Administrator transmitted notice of his intent to place valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I on a temporary basis to the Assistant Secretary for Health of HHS by letter dated October 20, 2017. The Assistant Secretary responded to this notice of intent by letter dated November 8, 2017 and advised that based on a review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of these seven substances in schedule I of the CSA. Valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil are not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for these seven substances under section 505 of the FDCA, 21 U.S.C. 355. --------------------------------------------------------------------------- \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 in 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 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). The recent identification of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in forensic evidence indicates that these substances are being misused and abused. No approved medical use has been identified for these seven substances, nor have they been approved by the FDA for human consumption. Available data and information for valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil, summarized below, 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. The DEA's three-factor analysis is available in its entirety under ``Supporting and Related Material'' of the public docket for this action at www.regulations.gov under Docket Number DEA- 475. Factor 4. History and Current Pattern of Abuse The recreational abuse of fentanyl-related substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. Evidence suggests that the pattern of abuse of these fentanyl-related substances parallels that of heroin and prescription opioid analgesics. Valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil are fentanyl-related substances that have been encountered by law enforcement and/or reported in the scientific literature by public health officials. Adverse health effects and outcomes related to the abuse of fentanyl-related substances have been documented in previous temporary scheduling actions (see DEA 3-Factor Analysis). 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 November 2, 2017. STARLiMS registered the following reports: Valeryl fentanyl (15), para- fluorobutyryl fentanyl (5), isobutyryl fentanyl (116), and cyclopentyl fentanyl (1). These identifications were made beginning in 2015. 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 was queried on November 3, 2017 \3\ and the following substances (number of drug reports) were identified from state and local forensic laboratories since 2015: Valeryl fentanyl (69), para-fluorobutyryl fentanyl (220), para-methoxybutyryl fentanyl (1), and isobutyryl fentanyl (4). The identification in other countries of para- fluorobutyryl fentanyl (Poland and Sweden), para-methoxybutyryl fentanyl (Sweden), ocfentanil (Belgium and Switzerland), cylcopentyl fentanyl (Sweden), and para-chloroisobutyryl fentanyl (Sweden) in toxicological samples associated with fatal and non-fatal overdoses was reported in the scientific literature. --------------------------------------------------------------------------- \3\ Data are still being collected for July 2017-October 2017 due to the normal lag period for labs reporting to NFLIS. --------------------------------------------------------------------------- Factor 5. Scope, Duration and Significance of Abuse Fentanyl-related substances have recently re-emerged on the illicit market (see DEA 3-Factor Analysis for full discussion). Valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil have been identified in evidence submitted to law enforcement and/or reported in the scientific literature by public health forensic laboratories. The identification of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in forensic evidence indicates that these substances are intended to be replacements for controlled synthetic opioids, heroin, and/or prescription opioids. Because abusers of these [[Page 58577]] fentanyl-related substances obtain these substances 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) abuse of these substances 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). Factor 6. What, if Any, Risk There Is to the Public Health With no legitimate medical use, valeryl fentanyl, para- fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para- chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil have emerged on the illicit drug market. Substances within this chemical structural class have demonstrated pharmacological profiles similar to that of fentanyl and other [mu]-opioid receptor agonists (see DEA 3-Factor Analysis). The abuse of these fentanyl- related substances poses significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. The toxic effects of substances within this structural class in humans are demonstrated by overdose fatalities described in previous scheduling actions. Based on information received by the DEA, the misuse and abuse of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil lead to, at least, 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. Finding of Necessity of Schedule I Placement To Avoid an Imminent Hazard to the Public Safety In accordance with 21 U.S.C. 811(h)(3), based on the available data and information, summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil, resulting from the lack of control of these substances, pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these seven fentanyl-related 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para- methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil 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 October 20, 2017, notified the Assistant Secretary of the DEA's intention to temporarily place these substances in schedule I. Conclusion This notice of intent provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h), of DEA's intent to issue a temporary scheduling order. 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 valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I of the CSA, and finds that placement of these seven fentanyl-related substances into schedule I of the CSA is necessary in order to avoid an imminent hazard to the public safety. The temporary placement of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I of the CSA will take effect pursuant to a temporary scheduling order, which will not be issued before January 12, 2018. Because the Administrator hereby finds that it is necessary to temporarily place valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I to avoid an imminent hazard to the public safety, the temporary order scheduling these substances will be effective on the date that order is published 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 a temporary scheduling order as soon as possible after the expiration of 30 days from the date of publication of this notice. Upon publication of the temporary order, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil will 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 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 [[Page 58578]] 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 took into consideration comments submitted by the Assistant Secretary in response to notice that DEA transmitted to the Assistant Secretary pursuant to section 811(h)(4). 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. 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)(23) through (29) to read as follows: Sec. 1308.11 Schedule I. * * * * * (h) * * * (23) N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: valeryl fentanyl) . . . (9804) (24) N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-fluorobutyryl fentanyl) . . . (9823) (25) N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-methoxybutyryl fentanyl) . . . (9837) (26) N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: para-chloroisobutyryl fentanyl) . . . (9826) (27) N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: isobutyryl fentanyl) . . . (9827) (28) N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: cyclopentyl fentanyl) . . . (9847) (29) N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4- yl)acetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: ocfentanil) . . . (9832) Dated: December 5, 2017. Robert W. Patterson, Acting Administrator. [FR Doc. 2017-26854 Filed 12-12-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Proposed Rules 58575
If you need special accommodations Dated: December 4, 2017. DATES: December 13, 2017.
due to a disability, please contact Leslie Kux, ADDRESSES: The DEA’s three-factor
Kathleen Davies at least 7 days before Associate Commissioner for Policy. analysis is available in its entirety under
the hearing. [FR Doc. 2017–26785 Filed 12–11–17; 8:45 am] ‘‘Supporting and Related Material’’ of
Streaming Webcast of the Public BILLING CODE 4164–01–P the public docket for this action at
Hearing: This public hearing will also www.regulations.gov under Docket
be webcast for those unable to attend in Number DEA–475.
person. To join the hearing via the DEPARTMENT OF JUSTICE FOR FURTHER INFORMATION CONTACT:
webcast, please go to https:// Michael J. Lewis, Diversion Control
collaboration.fda.gov/opsc. Drug Enforcement Administration Division, Drug Enforcement
Administration; Mailing Address: 8701
If you have never attended a Connect
21 CFR Part 1308 Morrissette Drive, Springfield, Virginia
Pro event before, test your connection at
22152; Telephone: (202) 598–6812.
https://collaboration.fda.gov/common/ [Docket No. DEA–475]
SUPPLEMENTARY INFORMATION: This
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro Schedules of Controlled Substances: notice of intent contained in this
program, visit https://www.adobe.com/ Temporary Placement of Seven document is issued pursuant to the
Fentanyl-Related Substances in temporary scheduling provisions of 21
go/connectpro_overview. FDA has
Schedule I U.S.C. 811(h). The Drug Enforcement
verified the website addresses in this
Administration (DEA) intends to issue a
document, as of the date this document AGENCY: Drug Enforcement temporary scheduling order (in the form
publishes in the Federal Register, but Administration, Department of Justice. of a temporary amendment) to add
websites are subject to change over time.
ACTION: Proposed amendment; valeryl fentanyl, para-fluorobutyryl
Transcripts: Please be advised that as notification of intent. fentanyl, para-methoxybutyryl fentanyl,
soon as a transcript of the public para-chloroisobutyryl fentanyl,
hearing is available, it will be accessible SUMMARY: The Administrator of the Drug isobutyryl fentanyl, cyclopentyl
at https://www.regulations.gov. It may Enforcement Administration is issuing fentanyl, and ocfentanil to schedule I of
be viewed at the Dockets Management this notice of intent to publish a the Controlled Substances Act.1 The
Staff (HFA–305), Food and Drug temporary order to schedule seven temporary scheduling order will be
Administration, 5630 Fishers Lane, Rm. fentanyl-related substances in schedule published in the Federal Register, but
1061, Rockville, MD 20852. I. These seven substances are: N-(1- will not be issued before January 12,
phenethylpiperidin-4-yl)- 2018.
IV. Notice of Public Hearing Under 21 N-phenylpentanamide (valeryl
CFR Part 15 fentanyl), N-(4-fluorophenyl)- Legal Authority
N-(1-phenethylpiperidin- Section 201 of the Controlled
The Commissioner of Food and Drugs 4-yl)butyramide (para-fluorobutyryl Substances Act (CSA), 21 U.S.C. 811,
is announcing that the public hearing fentanyl), N-(4-methoxyphenyl)- provides the Attorney General with the
will be held in accordance with part 15 N-(1-phenethylpiperidin-4- authority to temporarily place a
(21 CFR part 15). The hearing will be yl)butyramide (para-methoxybutyryl substance in schedule I of the CSA for
conducted by a presiding officer, fentanyl), N-(4-chlorophenyl)- two years without regard to the
accompanied by FDA senior N-(1-phenethylpiperidin-4- requirements of 21 U.S.C. 811(b) if he
management from the Office of the yl)isobutyramide (para-chloroisobutyryl finds that such action is necessary to
Commissioner and the relevant centers/ fentanyl), N-(1-phenethylpiperidin- avoid an imminent hazard to the public
offices. Under § 15.30(f) (21 CFR 4-yl)-N- safety. 21 U.S.C. 811(h)(1). In addition,
15.30(f)), the hearing is informal and the phenylisobutyramide (isobutyryl if proceedings to control a substance are
rules of evidence do not apply. Only the fentanyl), N-(1-phenethylpiperidin-4- initiated under 21 U.S.C. 811(a)(1), the
presiding officer and panel members yl)- Attorney General may extend the
may question any person during or at N-phenylcyclopentane temporary scheduling for up to one
the conclusion of each presentation carboxamide (cyclopentyl fentanyl), and year. 21 U.S.C. 811(h)(2).
(§ 15.30(e)). Public hearings under part N-(2-fluorophenyl)- Where the necessary findings are
15 are subject to FDA’s policy and 2-methoxy-N-(1-phenethylpiperidin- made, a substance may be temporarily
procedures for electronic media 4-yl)acetamide (ocfentanil). This action scheduled if it is not listed in any other
coverage of FDA’s public administrative is based on a finding by the schedule under section 202 of the CSA,
proceedings (21 CFR part 10, subpart C) Administrator that the placement of 21 U.S.C. 812, or if there is no
(§ 10.203(a)). Under § 10.205, these seven synthetic opioids in exemption or approval in effect for the
representatives of the electronic media schedule I of the Controlled Substances substance under section 505 of the
may be permitted, subject to certain Act (CSA) is necessary to avoid an Federal Food, Drug, and Cosmetic Act
limitations, to videotape, film, or imminent hazard to the public safety. (FDCA), 21 U.S.C. 355. 21 U.S.C.
otherwise record FDA’s public When it is issued, the temporary 811(h)(1); 21 CFR part 1308. The
administrative proceedings, including scheduling order will impose the Attorney General has delegated
presentations by participants. The administrative, civil, and criminal scheduling authority under 21 U.S.C.
sradovich on DSK3GMQ082PROD with PROPOSALS
hearing will be transcribed as stipulated sanctions and regulatory controls 811 to the Administrator of the DEA. 28
in § 15.30(b) (see section V). To the applicable to schedule I controlled CFR 0.100.
extent that the conditions for the substances under the CSA on the
hearing as described in this document manufacture, distribution, reverse 1 Though DEA has used the term ‘‘final order’’
conflict with any provisions set out in distribution, possession, importation, with respect to temporary scheduling orders in the
past, this notice of intent adheres to the statutory
part 15, this notice acts as a waiver of exportation, research, and conduct of language of 21 U.S.C. 811(h), which refers to a
those provisions as specified in instructional activities, and chemical ‘‘temporary scheduling order.’’ No substantive
§ 15.30(h). analysis of these synthetic opioids. change is intended.
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order is to be issued, and (2) the date federalism implications to warrant the DEPARTMENT OF HOMELAND
that notice of the proposed temporary preparation of a Federalism Assessment. SECURITY
scheduling order is transmitted to the
List of Subjects in 21 CFR Part 1308 Coast Guard
Assistant Secretary of HHS. 21 U.S.C.
811(h)(1). Administrative practice and
Inasmuch as section 201(h) of the procedure, Drug traffic control, 33 CFR Part 100
CSA directs that temporary scheduling Reporting and recordkeeping [Docket Number USCG–2017–0332]
actions be issued by order and sets forth requirements.
the procedures by which such orders are RIN 1625–AA08
For the reasons set out above, the DEA
to be issued, the DEA believes that the proposes to amend 21 CFR part 1308 as Special Local Regulation; Gasparilla
notice and comment requirements of follows: Marine Parade; Hillsborough Bay;
section 553 of the Administrative
Tampa, FL
Procedure Act (APA), 5 U.S.C. 553, do PART 1308—SCHEDULES OF
not apply to this notice of intent. In the CONTROLLED SUBSTANCES AGENCY: Coast Guard, DHS.
alternative, even assuming that this ACTION: Notice of proposed rulemaking.
notice of intent might be subject to ■ 1. The authority citation for part 1308
section 553 of the APA, the continues to read as follows: SUMMARY: The Coast Guard is
Administrator finds that there is good Authority: 21 U.S.C. 811, 812, 871(b), establishing a special local regulation
cause to forgo the notice and comment unless otherwise noted. for the annual Gasparilla Marine Parade
requirements of section 553, as any ■ 2. In § 1308.11, add paragraphs (h)(23) on the waters of Hillsborough Bay in the
further delays in the process for through (29) to read as follows: vicinity of Tampa, Florida. This event is
issuance of temporary scheduling orders expected to attract over 600 spectator
would be impracticable and contrary to § 1308.11 Schedule I. craft along the parade route, with
the public interest in view of the * * * * * approximately 18 vessels participating
manifest urgency to avoid an imminent (h) * * * in the official flotilla. The parade is
hazard to the public safety. (23) N-(1-phenethylpiperidin-4-yl)-N- scheduled to take place annually on the
Although the DEA believes this notice phenylpentanamide, its isomers, esters, last Saturday in January. This regulation
of intent to issue a temporary ethers, salts and salts of isomers, esters is necessary to ensure the safety of
scheduling order is not subject to the and ethers (Other name: valeryl public, the official flotilla, and spectator
notice and comment requirements of fentanyl) . . . (9804) vessels before, during, and after the
section 553 of the APA, the DEA notes (24) N-(4-fluorophenyl)-N-(1- conclusion of the parade.
that in accordance with 21 U.S.C. phenethylpiperidin-4-yl)butyramide, its DATES: Comments and related material
811(h)(4), the Administrator took into isomers, esters, ethers, salts and salts of must be received by the Coast Guard on
consideration comments submitted by isomers, esters and ethers (Other name: or before January 12, 2018.
the Assistant Secretary in response to para-fluorobutyryl fentanyl) . . . (9823) ADDRESSES: You may submit comments
notice that DEA transmitted to the (25) N-(4-methoxyphenyl)-N-(1- identified by docket number USCG–
Assistant Secretary pursuant to section phenethylpiperidin-4-yl)butyramide, its 2017–0332 using the Federal
811(h)(4). isomers, esters, ethers, salts and salts of eRulemaking Portal at http://
Further, the DEA believes that this isomers, esters and ethers (Other name: www.regulations.gov. See the ‘‘Public
temporary scheduling action is not a para-methoxybutyryl fentanyl) . . . Participation and Request for
‘‘rule’’ as defined by 5 U.S.C. 601(2), (9837) Comments’’ portion of the
and, accordingly, is not subject to the (26) N-(4-chlorophenyl)-N-(1- SUPPLEMENTARY INFORMATION section for
requirements of the Regulatory phenethylpiperidin-4-yl)isobutyramide, further instructions on submitting
Flexibility Act (RFA). The requirements its isomers, esters, ethers, salts and salts comments.
for the preparation of an initial of isomers, esters and ethers (Other
regulatory flexibility analysis in 5 U.S.C. FOR FURTHER INFORMATION CONTACT: If
name: para-chloroisobutyryl fentanyl)
603(a) are not applicable where, as here, you have questions about this proposed
. . . (9826)
the DEA is not required by section 553 rulemaking, call or email Marine
(27) N-(1-phenethylpiperidin-4-yl)-N- Science Technician First Class Michael
of the APA or any other law to publish phenylisobutyramide, its isomers,
a general notice of proposed D. Shackleford, Sector St. Petersburg
esters, ethers, salts and salts of isomers, Prevention Department, Coast Guard;
rulemaking. esters and ethers (Other name:
Additionally, this action is not a telephone (813)228–2191, email
isobutyryl fentanyl) . . . (9827) Michael.D.Shackleford@uscg.mil.
significant regulatory action as defined (28) N-(1-phenethylpiperidin-4-yl)-N-
by Executive Order 12866 (Regulatory SUPPLEMENTARY INFORMATION:
phenylcyclopentanecarboxamide, its
Planning and Review), section 3(f), and, isomers, esters, ethers, salts and salts of I. Table of Abbreviations
accordingly, this action has not been isomers, esters and ethers (Other name:
reviewed by the Office of Management CFR Code of Federal Regulations
cyclopentyl fentanyl) . . . (9847) DHS Department of Homeland Security
and Budget. (29) N-(2-fluorophenyl)-2-methoxy-N- FR Federal Register
This action will not have substantial (1-phenethylpiperidin-4-yl)acetamide, NPRM Notice of proposed rulemaking
direct effects on the States, on the
sradovich on DSK3GMQ082PROD with PROPOSALS
its isomers, esters, ethers, salts and salts Pub. L. Public Law
relationship between the national of isomers, esters and ethers (Other § Section
government and the States, or on the name: ocfentanil) . . . (9832) U.S.C. United States Code
distribution of power and
responsibilities among the various Dated: December 5, 2017. II. Background, Purpose, and Legal
levels of government. Therefore, in Robert W. Patterson, Basis
accordance with Executive Order 13132 Acting Administrator. The Coast Guard proposes to establish
(Federalism) it is determined that this [FR Doc. 2017–26854 Filed 12–12–17; 8:45 am] a special local regulation on the waters
action does not have sufficient BILLING CODE 4410–09–P of the Hillsborough Bay, Tampa, Florida
VerDate Sep<11>2014 16:09 Dec 12, 2017 Jkt 244001 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 E:\FR\FM\13DEP1.SGM 13DEP1](https://thefederalregister.org/doc/82_FR_58813/page/4.svg)
Document Created: 2017-12-13 01:24:05
Document Modified: 2017-12-13 01:24:05
| 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 | Proposed amendment; notification of intent. | |
| Dates | December 13, 2017. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 58575 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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