89 FR 249 pgs. 106311-106315 - Schedules of Controlled Substances: Extension of Temporary Placement of Seven Specific Fentanyl-Related Substances in Schedule I of the Controlled Substances Act
Type: RULEVolume: 89Number: 249Pages: 106311 - 106315
Pages: 106311, 106312, 106313, 106314, 106315Docket number: [Docket No. DEA-1457]
FR document: [FR Doc. 2024-31130 Filed 12-27-24; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1457]
Schedules of Controlled Substances: Extension of Temporary Placement of Seven Specific Fentanyl-Related Substances in Schedule I of the Controlled Substances Act
AGENCY:
Drug Enforcement Administration, Department of Justice.
ACTION:
Temporary rule; temporary scheduling order; extension.
SUMMARY:
[top] The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of seven specific fentanyl-related substances, as identified in this order, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers. These seven substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. This temporary order was subsequently extended multiple times, most recently on December 29, 2022, through the Consolidated Appropriations Act, 2023, which extended the order until December 31, 2024. This temporary order will extend
DATES:
This temporary scheduling order, which extends schedule I control of seven specific substances covered by an order (83 FR 5188, February 6, 2018), is effective December 31, 2024, and expires on December 31, 2025. If DEA publishes a final rule making this scheduling action permanent, this order will expire on the effective date of that rule, if the effective date is earlier than December 31, 2025.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
In this order, the Drug Enforcement Administration (DEA) extends the temporary scheduling of the following seven controlled substances in schedule I of the Controlled Substances Act (CSA), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:
• para -chlorofentanyl ( N -(4-chlorophenyl)- N -(1-phenethylpiperidin-4-yl)propionamide),
• ortho -chlorofentanyl ( N -(2-chlorophenyl)- N -(1-phenethylpiperidin-4-yl)propionamide),
• meta -fluorofuranyl fentanyl ( N -(3-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)furan-2-carboxamide),
• ortho -methylcyclopropyl fentanyl ( N -(2-methylphenyl)- N -(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide),
• beta -methylacetyl fentanyl ( N -phenyl- N -(1-(2-phenylpropyl)piperidin-4-yl)acetamide),
• tetrahydrothiofuranyl fentanyl ( N -(1-phenethylpiperidin-4-yl)- N -phenyltetrahydrothiophene-2-carboxamide),
• para -fluoro valeryl fentanyl ( N -(4-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)pentanamide).
Background and Legal Authority
On February 6, 2018, pursuant to 21 U.S.C. 811(h)(1), DEA published an order in the Federal Register temporarily placing fentanyl-related substances, as defined in that order, in schedule I of the CSA based upon a finding that these substances pose an imminent hazard to the public safety. 1 As discussed below, the seven substances named in this rule meet the existing definition of fentanyl-related substances as they are not otherwise controlled in any other schedule (i.e., not included under another DEA Controlled Substance Code Number) and are structurally related to fentanyl by one or more of the five modifications listed under the definition. Additionally, as required by 21 U.S.C. 811(h)(2), these specific seven substances have no exemption or approval in effect under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). That temporary order was effective upon the date of publication. Pursuant to 21 U.S.C. 811(h)(2), the temporary control of fentanyl-related substances, a class of substances as defined in the order, as well as the seven specific substances already covered by that order, was set to expire on February 6, 2020. However, on February 6, 2020, as explained in DEA's April 10, 2020 correcting amendment, 2 Congress extended that expiration date until May 6, 2021, by enacting the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act. 3 This temporary order was subsequently extended multiple times, most recently on December 29, 2022, through the Consolidated Appropriations Act, 2023, 4 which extended the order until December 31, 2024. Consequently, the temporary control of these seven substances will remain in effect until December 31, 2024, unless DEA permanently places them in schedule I prior to that date.
Footnotes:
1 ? Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 83 FR 5188 (Feb. 6, 2018).
2 ? Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I; Correction, 85 FR 20155 (Apr. 10, 2020).
3 ?Public Law 116-114, sec. 2, 134 Stat. 103.
4 ?Public Law 117-328, division O, title VI, sec. 601.
As defined in the February 6, 2018 temporary scheduling order, fentanyl-related substances include any substance not otherwise controlled in any schedule ( i.e., not included under any other Administration Controlled Substance Code Number) that is structurally related to fentanyl by one or more of the following modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;
(B) substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
(D) replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or
(E) replacement of the N -propionyl group by another acyl group.
Further, according to the temporary scheduling order, the existence of a substance with any one, or any combination, of the above-mentioned modifications would meet the structural requirements of the definition of fentanyl-related substance. The present seven substances were not otherwise controlled under any schedule at the time of the temporary order and are covered by the order due to having the following modifications:
1. para -chlorofentanyl: substitution on the aniline ring (meets definition for modification D);
2. ortho -chlorofentanyl: substitution on the aniline ring (meets definition for modification D);
3. meta -fluorofuranyl fentanyl: substitution on the aniline ring and replacement of the N- propionyl group with another acyl group (meets definition for modifications D and E);
4. ortho- methylcyclopropyl fentanyl: substitution on the aniline ring and replacement of the N- propionyl group with another acyl group (meets definition for modifications D and E);
5. beta- methylacetyl fentanyl: substitution on the phenethyl group with an alkyl group and replacement of the N- propionyl group with another acyl group (meets definition for modifications B and E);
6. tetrahydrothiofuranyl fentanyl: replacement of the N- propionyl group with another acyl group (meets definition for modification E);
7. para -fluoro valeryl fentanyl: substitution on the aniline ring and replacement of the N- propionyl group with another acyl group (meets definition for modifications D and E).
[top] As noted above, these specific seven substances have no exemption or approval in effect under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355). As explained above, the temporary control of these seven substances will remain in effect until December 31, 2024, unless DEA permanently places them in schedule I prior to that date. However, the CSA also provides that during the pendency of proceedings to permanently schedule a substance under 21 U.S.C. 811(a)(1), such temporary scheduling may be
Footnotes:
5 ?Though DEA has used the term "final order" with respect to temporary scheduling orders in the past, this document adheres to the statutory language of 21 U.S.C. 811(h), which refers to a "temporary scheduling order." No substantive change is intended.
6 ?Because the Secretary of the Department of Health and Human Services has delegated to the Assistant Secretary for Health of the Department of Health and Human Services the authority to make domestic drug scheduling recommendations, for purposes of this temporary order, all subsequent references to "Secretary" have been replaced with "Assistant Secretary."
7 ?21 U.S.C. 811(a).
The Administrator of DEA, on her own motion pursuant to 21 U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to permanently schedule these seven fentanyl-related substances: para -chlorofentanyl, ortho -chlorofentanyl, meta -fluorofuranyl fentanyl, ortho- methylcyclopropyl fentanyl, beta- methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para -fluoro valeryl fentanyl. DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for these substances. On April 3, 2023, DEA submitted a request to HHS to provide DEA with a scientific and medical evaluation of available information and a scheduling recommendation for these seven fentanyl-related substances ( para -chlorofentanyl, ortho -chlorofentanyl, meta -fluorofuranyl fentanyl, ortho- methylcyclopropyl fentanyl, beta- methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para -fluoro valeryl fentanyl) in accordance with 21 U.S.C. 811(b) and (c).
Upon evaluating the scientific and medical evidence, on October 25, 2024, HHS provided DEA with a scientific and medical evaluation and scheduling recommendation to place these seven fentanyl-related substances in schedule I of the CSA.
Upon receipt of the scientific and medical evaluation and scheduling recommendation from HHS, DEA reviewed the documents, and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of these seven fentanyl-related substances in accordance with 21 U.S.C. 811(c). Based on this review, as discussed elsewhere in this issue of the Federal Register , DEA is publishing a notice of proposed rulemaking for the placement of these seven fentanyl-related substances in schedule I of the CSA. If the proposed rule is finalized, DEA will publish a final rule in the Federal Register .
Pursuant to 21 U.S.C. 811(h)(2), the Administrator orders that the temporary scheduling of seven substances, covered by the February 6, 2018 temporary scheduling order, be extended for one year, or until the permanent scheduling proceeding is completed, whichever occurs first. These seven substances are: para -chlorofentanyl, ortho -chlorofentanyl, meta -fluorofuranyl fentanyl, ortho- methylcyclopropyl fentanyl, beta- methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para -fluoro valeryl fentanyl, including their isomers, esters, ethers, salts and salts of isomers, esters, and ethers.
In accordance with this temporary scheduling order, the schedule I requirements for handling para -chlorofentanyl, ortho -chlorofentanyl, meta -fluorofuranyl fentanyl, ortho- methylcyclopropyl fentanyl, beta- methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para -fluoro valeryl fentanyl, including their isomers, esters, ethers, salts and salts of isomers, esters, ethers, will remain in effect for one year, or until the permanent scheduling proceeding is completed, whichever occurs first.
Regulatory Matters
The CSA provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. 8 This provision of the CSA allows the Attorney General, by order, to schedule a substance in schedule I on a temporary basis. 9 It also provides that the temporary scheduling of a substance shall expire at the end of two years from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings to permanently schedule the substance, extend the temporary scheduling for up to one year.
Footnotes:
8 ?21 U.S.C. 811(h).
9 ? Id.
To the extent that 21 U.S.C. 811(h) directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued and extended, the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this extension of the temporary scheduling action. 10 The APA expressly differentiates between orders and rules, as it defines an "order" to mean a "final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making ."? 11 This contrasts with permanent scheduling actions, which are subject to formal rulemaking procedures done "on the record after opportunity for a hearing," and final decisions that conclude the scheduling process and are subject to judicial review. 12 The specific language chosen by Congress indicates an intention for DEA to proceed through the issuance of an order instead of proceeding by rulemaking. Given that Congress specifically requires the Attorney General to follow rulemaking procedures for other kinds of scheduling actions, 13 it is noteworthy that, in subsection 811(h), Congress authorized the issuance of temporary scheduling actions by order rather than by rule.
Footnotes:
10 ?Even if this action were 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 extending the temporary scheduling order would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.
11 ?5 U.S.C. 551(6) (emphasis added).
12 ?21 U.S.C. 811(a) and 877.
13 ? See 21 U.S.C. 811(a).
In the alternative, even if this action were subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice-and-comment requirements and the delayed effective date requirements of such section, as any further delays in the process for extending the temporary scheduling order would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety that these substances would present if scheduling expired, for the reasons expressed in the temporary scheduling order. 14
Footnotes:
14 ? See Schedules of Controlled Substances: Temporary Placement of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene in Schedule I, 87 FR 21556 (Apr. 12, 2022).
[top] Further, DEA believes that this order extending the 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, DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed
Additionally, in accordance with the principles of Executive Orders (E.O.) 12866, 13563, and 14094, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. E.O. 12866, sec. 3(f), as amended by E.O. 14094, sec. 1(b), provides the definition of a "significant regulatory action," requiring review by the Office of Management and Budget. Because this is not a rulemaking action, this is not a significant regulatory action as defined in section 3(f) of E.O. 12866.
This action will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism), it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the CRA, "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."? 15
Footnotes:
15 ?5 U.S.C. 808(2).
It is in the public interest to maintain the temporary placement of these seven substances in schedule I because they pose a public health risk. These substances are: para -chlorofentanyl, ortho -chlorofentanyl, meta -fluorofuranyl fentanyl, ortho- methylcyclopropyl fentanyl, beta- methylacetyl fentanyl, tetrahydrothiofuranyl fentanyl, and para -fluoro valeryl fentanyl. The temporary scheduling action was taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. Under 21 U.S.C. 811(h), temporary scheduling orders are not subject to notice and comment rulemaking procedures. The CSA frames temporary scheduling actions as orders rather than rules to ensure that the process moves swiftly, and this extension of the temporary scheduling order for these seven substances continues to serve that purpose. For the same reasons that underlie 21 U.S.C. 811(h), that is, the need to keep these seven substances in schedule I because they pose an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of this extension of the temporary scheduling order. Therefore, in accordance with section 808(2) of the CRA, this order extending the temporary scheduling order for seven specific substances, currently covered under the definition of fentanyl-related substances in the temporary order, shall take effect immediately upon its publication.
DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808, because, as noted above, this action is an order, not a rule.
Signing Authority
This document of the Drug Enforcement Administration was signed on December 19, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
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, DEA amends 21 CFR part 1308 as follows:
PART 1308-SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR part 1308 continues to read as follows:
Authority:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
2. In §?1308.11, add paragraphs (h)(70) through (76) to read as follows:
§?1308.11 Schedule I.
(h) * * *
| (70) N -phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)acetamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other name: beta -methylacetyl fentanyl | 9868 |
| (71) N -(3-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)furan-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other name: meta -Fluorofuranyl fentanyl) | 9871 |
| (72) N -(2-chlorophenyl)- N -(1-phenethylpiperidin-4-yl)propionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other name: ortho -Chlorofentanyl) | 9828 |
| (73) N -(2-methylphenyl)- N -(1-phenethylpiperidin-4-yl)cyclopropanecarboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other name: ortho -methylcyclopropylfentanyl) | 9849 |
| (74) N -(4-chlorophenyl)- N -(1-phenethylpiperidin-4-yl)propionamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other name: para -Chlorofentanyl) | 9818 |
| (75) N -(4-fluorophenyl)- N -(1-phenethylpiperidin-4-yl)pentanamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other name: para -fluoro valeryl fentanyl | 9870 |
| (76) N -(1-phenethylpiperidin-4-yl)- N -phenyltetrahydrothiophene-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers; other names: tetrahydrothiofuranyl fentanyl; tetrahydrothiophene fentanyl | 9869 |
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[FR Doc. 2024-31130 Filed 12-27-24; 8:45 am]
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