# 90 FR 57534: Schedules of Controlled Substances: Placement of CUMYL-PEGACLONE in Schedule I

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2025-22495

## Section

- **Citation:** 90 FR 57534
- **Heading:** Schedules of Controlled Substances: Placement of CUMYL-PEGACLONE in Schedule I
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 90 / 90 FR 57534

## Text

16.49, as applicable. Requests for a hearing and waivers of an opportunity for a hearing or to participate in a hearing, together with a written statement of position on the matters of fact and law asserted in the hearing, must be received or postmarked on or before January 12, 2026.

ADDRESSES:
Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). To ensure proper handling of comments, please reference “Docket No. DEA1356” on all electronic and written correspondence, including any attachments.
• Electronic comments: The Drug Enforcement Administration (DEA) encourages commenters to submit comments electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
• Paper comments: Paper comments that duplicate the electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152
t day of the comment period.
• Paper comments: Paper comments that duplicate the electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
• Hearing requests: All requests for a hearing and waivers of participation, together with a written statement of position on the matters of fact and law asserted in the hearing, must be filed with the DEA Administrator, who will make the determination of whether a hearing will be needed to address such matters of fact and law in the rulemaking. Such requests must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. For informational purposes, a courtesy copy of requests for hearing and waivers of participation should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule may be found in the docket for this rulemaking at www.regulations.gov
ter Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Dr. Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule may be found in the docket for this rulemaking at www.regulations.gov.

SUPPLEMENTARY INFORMATION:
The Drug Enforcement Administration (DEA) proposes to permanently schedule CUMYL-PEGACLONE (SGT-151; 5-pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one) in schedule I of the Controlled Substances Act (CSA), including its salts, isomers (including optical, positional, and geometric isomers), and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.
Posting of Public Comments
All comments received in response to this docket are considered part of the public record. DEA will make comments available for public inspection online at http://www.regulations.gov, unless reasonable cause is given. Such information includes personal or business identifiers (such as name, address, state of federal identifiers, etc.) voluntarily submitted by the commenter.
Commenters submitting comments which include personal identifying information (PII), confidential, or proprietary business information that the commenter does not want to be made publicly available should submit two copies of the comment. One copy must be marked “CONTAINS CONFIDENTIAL INFORMATION” and should clearly identify all PII or business information the commenter does not want to be made publicly available, including any supplemental materials. DEA will review this copy, including the claimed PII and confidential business information, in its consideration of comments. The second copy should be marked “TO BE PUBLICLY POSTED” and must have all claimed confidential PII and business information already redacted
00.01(b), may file requests for a hearing in conformity with the requirements of 21 CFR 1308.44(a) and 1316.47(a), and such requests must:
1 5 U.S.C. 551-559; 21 CFR 1308.41-1308.45; 21 CFR part 1316, subpart D.
(1) state with particularity the interest of the person in the proceeding;
(2) state with particularity the objections or issues concerning which the person desires to be heard; and
(3) state briefly the position of the person regarding the objections or issues.
Any interested person may file a waiver of an opportunity for a hearing or to participate in a hearing in conformity with the requirements of 21 CFR 1308.44(c), together with a written statement of position on the matters of fact and law involved in any hearing. 2
2 21 CFR 1316.49.
All requests for a hearing and waivers of participation, together with a written statement of position on the matters of fact and law involved in such hearing, must be sent to DEA using the address information provided above. The decision whether a hearing will be needed to address such matters of fact and law in the rulemaking will be made by the Administrator. If a hearing is needed, DEA will publish a notice of hearing on the proposed rulemaking in the Federal Register . 3 Further, once the Administrator determines a hearing is needed to address such matters of fact and law in rulemaking, he will then designate an Administrative Law Judge (ALJ) to preside over the hearing. The ALJ's functions shall commence upon designation, as provided in 21 CFR 1316.52.
3 21 CFR 1308.44(b), 1316.53.
In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing would be to determine whether CUMYL-PEGACLONE meets the statutory criteria for placement in schedule I, as proposed in this rulemaking
ll then designate an Administrative Law Judge (ALJ) to preside over the hearing. The ALJ's functions shall commence upon designation, as provided in 21 CFR 1316.52.
3 21 CFR 1308.44(b), 1316.53.
In accordance with 21 U.S.C. 811 and 812, the purpose of a hearing would be to determine whether CUMYL-PEGACLONE meets the statutory criteria for placement in schedule I, as proposed in this rulemaking.
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (delegated to the Administrator of DEA pursuant to 28 CFR 0.100) on her own motion, at the request of the Secretary of Health and Human Services (HHS), or on the petition of an interested party. 4 This proposed action is initiated on the Administrator's own motion and supported by, inter alia, a recommendation from the then-Assistant Secretary for Health of the HHS (Assistant Secretary) and an evaluation of all other relevant data by DEA. If finalized, this action would make permanent the existing temporary regulatory controls and administrative, civil, and criminal sanctions of schedule I controlled substances on any person who handles or proposes to handle CUMYL-PEGACLONE.
4 21 U.S.C. 811(a).
In addition, the United States is a party to the 1971 United Nations Convention on Psychotropic Substances (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are set forth in 21 U.S.C. 811(d)(2)-(4)
ances on any person who handles or proposes to handle CUMYL-PEGACLONE.
4 21 U.S.C. 811(a).
In addition, the United States is a party to the 1971 United Nations Convention on Psychotropic Substances (1971 Convention), February 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are set forth in 21 U.S.C. 811(d)(2)-(4). When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971 Convention indicating that a drug or other substance has been added to a schedule specified in the notification, the Secretary of HHS (Secretary), 5 after consultation with the Attorney General, shall first determine whether existing legal controls under subchapter I of the CSA and the Federal Food, Drug, and Cosmetic Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. 6 In the event that the Secretary did not consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control.
5 As discussed in a memorandum of understanding entered into by the FDA and the National Institute on Drug Abuse (NIDA), FDA acts as the lead agency within 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 has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460 (July 1, 1993).
6 21 U.S.C. 811(d)(3).
Pursuant to 21 U.S.C
bstance has been added to Schedule II of the 1971 Convention. Pursuant to the 1971 Convention, the United States must require licenses for the manufacture, export and import, and distribution of CUMYL-PEGACLONE. The CSA's registration requirement as set forth in 21 U.S.C. 822, 823, 957, and 958, as well as implementing regulations in 21 CFR parts 1301 and 1312, set forth this licensing requirement.
In addition, the United States must adhere to specific export and import provisions set forth in the 1971 Convention. The CSA's export and import provisions established in 21 U.S.C. 952, 953, 957, and 958, and implemented in 21 CFR part 1312, execute these requirements.
Likewise, under Article 13, paragraphs 1 and 2 of the 1971 Convention, a party to the 1971 Convention may notify through the U.N. Secretary-General that it prohibits the importation of a substance in Schedule II, III, or IV of the 1971 Convention. If such notice is presented to the United States, the United States shall take measures to ensure that the named substance is not exported to the notifying country. The CSA's above-mentioned export provisions set forth these procedures.
Further, under Article 16, paragraph 4, of the 1971 Convention, the United States is required to provide annual statistical reports to the International Narcotics Control Board (INCB). Using INCB Form P, the United States shall provide the following information: (1) In regard to each substance in Schedule I and II of the 1971 Convention, quantities manufactured, exported to, and imported from each country or region as well as stocks held by manufacturers; (2) in regard to each substance in Schedule III and IV of the 1971 Convention, quantities manufactured, as well as quantities exported and imported; (3) in regard to each substance in Schedule II and III of the 1971 Convention, quantities used in
Lastly, under Article 2 of the 1971 Convention, the United States must adopt measures in accordance with Article 22 to address violations of any statutes or regulations that a
bstance in Schedule III and IV of the 1971 Convention, quantities manufactured, as well as quantities exported and imported; (3) in regard to each substance in Schedule II and III of the 1971 Convention, quantities used in
Lastly, under Article 2 of the 1971 Convention, the United States must adopt measures in accordance with Article 22 to address violations of any statutes or regulations that are adopted pursuant to its obligations under the 1971 Convention. Persons acting outside the legal framework established by the CSA are subject to administrative, civil, and/or criminal action.
DEA notes that there are differences between the schedules of substances in the 1971 Convention and the CSA. The CSA has five schedules (schedules I-V) with specific criteria set forth for each schedule. Schedule I is the only possible schedule in which a drug or other substance may be placed if it has high potential for abuse and no currently accepted medical use in treatment in the United States. 7 In contrast, the 1971 Convention has four schedules (Schedules I-IV) but does not have specific criteria for each schedule. The 1971 Convention simply defines its four schedules, in Article 1, to mean the correspondingly numbered lists of psychotropic substances annexed to the Convention and altered in accordance with Article 2.
7 See 21 U.S.C. 812(b).
Proposed Determination To Schedule CUMYL-PEGACLONE
Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on CUMYL-PEGACLONE and, on June 12, 2023, submitted it to the then-Assistant Secretary for Health of HHS with a request for a scientific and medical evaluation of available information and a scheduling recommendation for CUMYL-PEGACLONE.
On December 12, 2023, the previous Administrator published a temporary scheduling order in the Federal Register temporarily placing six synthetic cannabinoids (SCs) in schedule I of the CSA based on the finding that these substances pose an imminent threat to public safety
In addition, there is no evidence by qualified experts that CUMYL-PEGACLONE is accepted as having therapeutic uses. In the HHS report, the Food and Drug Administration (FDA) concluded that CUMYL-PEGACLONE has no currently accepted medical use in the United States. Similarly, DEA concludes CUMYL-PEGACLONE has no currently accepted medical use according to established DEA procedure and case law.
4. History and Current Pattern of Abuse
In their review, HHS described how the history and current pattern of abuse of CUMYL-PEGACLONE was evidenced by law enforcement data from DEA regarding drug seizures and poison control center reports, indicating the substance is used for abuse purposes. HHS noted that while law enforcement data is not direct evidence of abuse, it can be inferred that CUMYL-PEGACLONE has been consumed for its psychoactive and intoxicating effects as with other SCs. CUMYL-PEGACLONE was described in a patent from 2014. In addition, CUMYL-PEGACLONE was first reported as an adulterated plant material in Germany in December 2016 and appeared in the United States in September 2018.
5. Scope, Duration and Significance of Abuse
Evidence shows that CUMYL-PEGACLONE is a recreational drug of abuse. HHS noted in their recommendation that SCs continue to be encountered on the illicit market despite scheduling actions that attempt to safeguard the public from the adverse effects and safety issues associated with these substances. Novel substances continue to be encountered that differ only by small chemical structural modifications intended to avoid prosecution, while maintaining the pharmacological effects. Law enforcement and health care professionals continue to report the abuse of these substances and their associated products. These encounters of CUMYL-PEGACLONE by law enforcement indicate that this substance is being trafficked and abused in the United States. Furthermore, evidence also indicates that CUMYL-PEGACLONE is abused internationally.
6
that CUMYL-PEGACLONE would retain a physiological and psychological dependence liability that is similar to that of other schedule I SCs such as JWH-018 and AM2201. Thus, it is reasonable to conclude that the cannabinoid-like properties of CUMYL-PEGACLONE may produce a psychic and/or physiological dependence liability that is similar to other SCs already controlled in schedule I under the CSA.
8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled Under the CSA
CUMYL-PEGACLONE is not an immediate precursor of any substance controlled under the CSA, as defined in 21 U.S.C. 802(23).
Conclusion
After considering the scientific and medical evaluation conducted and accompanying recommendation of HHS, and DEA's own eight-factor analysis, DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of CUMYL-PEGACLONE. As such, DEA hereby proposes to permanently schedule CUMYL-PEGACLONE as a schedule I controlled substance under the CSA. This action would also enable the United States to meet its obligations under the 1971 Convention.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 11 After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all other available data, the Administrator of DEA, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:
11 21 U.S.C. 812(b).
1. CUMYL-PEGACLONE Has a High Potential for Abuse
CUMYL-PEGACLONE has a high potential for abuse, evidenced in part by data from in vitro binding affinity and functional activity studies, as well as by data from in vivo drug discrimination tests in animals
here is no evidence that CUMYL-PEGACLONE has a currently accepted medical use in treatment in the United States. 12
12 Pursuant to 21 U.S.C. 812(b)(1)(B), when placing a drug or other substance in schedule I of the CSA, DEA must consider whether the substance has a currently accepted medical use in treatment in the United States. First, DEA looks to whether the drug or substance has FDA approval. When no FDA approval exists, DEA has traditionally applied a five-part test to determine whether a drug or substances has a currently accepted medical use: (1) the drug's chemistry must be known and reproducible; (2) there must be adequate safety studies; (3) there must be adequate and well-controlled studies proving efficacy; (4) the drug must be accepted by qualified experts; and (5) the scientific evidence must be widely available. Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR 10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir. 1994). DEA and HHS applied the traditional five-part test for currently accepted medical use in this matter. In a recent published letter in a different context, HHS applied an additional two-part test to determine currently accepted medical use for substances that do not satisfy the five-part test: (1) whether there exists widespread, current experience with medical use of the substance by licensed health care practitioners operating in accordance with implemented jurisdiction-authorized programs, where medical use is recognized by entities that regulate the practice of medicine, and, if so, (2) whether there exists some credible scientific support for at least one of the medical conditions for which the part 1 is satisfied. On April 11, 2024, the Department of Justice's Office of Legal Counsel (OLC) issued an opinion, which, among other things, concluded that HHS's two-part test would be sufficient to establish that a drug has a currently accepted medical use
of medicine, and, if so, (2) whether there exists some credible scientific support for at least one of the medical conditions for which the part 1 is satisfied. On April 11, 2024, the Department of Justice's Office of Legal Counsel (OLC) issued an opinion, which, among other things, concluded that HHS's two-part test would be sufficient to establish that a drug has a currently accepted medical use. Office of Legal Counsel, Memorandum for Merrick B. Garland Attorney General Re: Questions Related to the Potential Rescheduling of Marijuana at 3 (Apr. 11, 2024). In its eight-factor assessment, HHS determined that CUMYL-PEGACLONE does not satisfy this two-part test. Therefore, since both DEA and HHS have determined that this substance does not satisfy the five-part test, and HHS has determined that this substance does not satisfy the additional two-part test, DEA concludes that CUMYL-PEGACLONE does not have a currently accepted medical use.
3. There is a Lack of Accepted Safety for Use of CUMYL-PEGACLONE Under Medical Supervision
Because CUMYL-PEGACLONE has no approved medical use and has not been thoroughly investigated as new drugs, its safety for use under medical supervision is not determined. Thus, there is a lack of accepted safety for use of these substances under medical supervision.
Based on these findings, the Administrator concludes that CUMYL-PEGACLONE (SGT-151; 5-pentyl-2-(2-phenylpropan-2-yl)pyrido[4,3-b]indol-1-one), including its salts, isomers (including optical, positional, and geometric isomers), and salts of isomers, warrants control in schedule I of the CSA. More precisely, because of its hallucinogenic-like effects, DEA is proposing to place CUMYL-PEGACLONE in 21 CFR 1308.11(d) (the hallucinogens category of schedule I)
f Reports and Consolidated Order System pursuant 21 U.S.C. 827, and in accordance with 21 CFR parts 1304 and 1312.
7. Order Forms. Every DEA registrant who distributes CUMYL-PEGACLONE must comply with the order form requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of CUMYL-PEGACLONE must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312.
9. Liability. Any activity involving CUMYL-PEGACLONE not authorized by, or in violation of, the CSA or its implementing regulations would be unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866, 13563, 14192, and 14294
In accordance with 21 U.S.C. 811(a), this proposed scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563. DEA scheduling actions are not subject to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal Regulations.
Executive Order 12988, Civil Justice Reform
This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132
ulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal Governments
This proposed rule does not have Tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-602, has reviewed this proposed rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.
On December 12, 2023, DEA published an order to temporarily place CUMYL-PEGACLONE, including its salts, isomers (including optical, positional, and geometric isomers), and salts of isomers, in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates that all entities handling or planning to handle CUMYL-PEGACLONE have already established and implemented systems and processes required to handle these substances. This action was taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances
in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). DEA estimates that all entities handling or planning to handle CUMYL-PEGACLONE have already established and implemented systems and processes required to handle these substances. This action was taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, dispense, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle CUMYL-PEGACLONE.
According to HHS, CUMYL-PEGACLONE has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks accepted safety for use under medical supervision. There appear to be no legitimate sources for CUMYL-PEGACLONE as a marketed drug in the United States, but DEA notes that this substance is available for purchase from legitimate suppliers for scientific research. There is no evidence of significant diversion of CUMYL-PEGACLONE from legitimate suppliers. Therefore, DEA has concluded that this proposed rule, if finalized, will not have a significant economic impact on a substantial number of small entities.
14 Executive Office of the President Office of Management and Budget, North American Industry Classification System, United States, 2022, https://www.census.gov/naics/reference_files_tools/2022_NAICS_Manual.pdf .
The entities affected by this proposed rule include the manufacturers, distributors, importers, exporters, and researchers of CUMYL-PEGACLONE. DEA determines the North American Industry Classification System (NAICS) industries that best represent these business activities. Table 1 lists the business activities and corresponding NAICS industries
ers 7,012 250 employees 6,760 96.4 424690—Other Chemical and Allied Products Merchant Wholesalers 5,487 175 employees 5,197 94.7 541715—Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) 10,042 1,000 employees 9,599 95.6 611310—Colleges, Universities and Professional Schools 2,494 $34.5 million 1,515 60.8 Based on the American Chemical Society's SciFinder database, 18 DEA identified three entities supplying CUMYL-PEGACLONE across the industries 325412, 424210, and 424690. However, one entity has already registered with DEA to handle controlled substances. Hence, DEA expects only two of the entities in the 325412, 424210, and 424690 industries will be affected by this rule. Assuming that all affected suppliers were small entities and concentrated in the smallest NAICS industry, 325412—Pharmaceutical Preparation Manufacturing, they would account for insubstantial number of small entities in that industry, 0.18 percent. 19
15 Statistics of U.S. Businesses, 2022 SUSB Annual Data Tables by Establishment Industry, https://www.census.gov/data/tables/2021/econ/susb/2021-susb-annual.html (Accessed 6/24/2025).
16 U.S. Small Business Administration, Table of size standards, Version March 2023, Effective: March 17, 2023, https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023%20%282%29.pdf (Accessed 6/24/2025).
17 Based on the estimated number of firms below the SBA size standard for each industry.
18 SciFinder; Chemical Abstracts Service: Columbus, OH; CAS 2504100-70-1; https://scifinder.cas.org (accessed May 14, 2024).
19 2/1,099 = 0.18%.
Additionally, DEA expects that the number of researchers working with CUMYL-PEGACLONE is small, because CUMYL-PEGACLONE is not approved for medical use and has a substantial capability to be a hazard to the health of the user and to the safety of the community
der; Chemical Abstracts Service: Columbus, OH; CAS 2504100-70-1; https://scifinder.cas.org (accessed May 14, 2024).
19 2/1,099 = 0.18%.
Additionally, DEA expects that the number of researchers working with CUMYL-PEGACLONE is small, because CUMYL-PEGACLONE is not approved for medical use and has a substantial capability to be a hazard to the health of the user and to the safety of the community. Also, DEA believes that the researchers working with CUMYL-PEGACLONE may also work with other controlled substances; hence, these researchers are likely already registered with DEA and are qualified to handle controlled substances. For these reasons, DEA believes the number of affected researchers that are small entities is not a substantial number of small entities in 541715 and 611310 industries.
In summary, the small entities affected by this proposed rule are those in 325412—Pharmaceutical Preparation Manufacturing, 424210—Drugs and Druggists' Sundries Merchant Wholesalers, and 424690—Other Chemical and Allied Products Merchant Wholesalers. The affected small entities account for less than 0.18 percent of the small businesses and are not likely to manufacture or carry inventory of CUMYL-PEGACLONE. As such, the proposed rule, if finalized, is not expected to result in a significant economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1532, DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year . . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995
1532, DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year . . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This proposed rule would not impose a new collection or modify an existing collection of information under the Paperwork Reduction Act of 1995. 20 Also, this propsed rule would not impose new or modify existing recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. However, this proposed rule would require compliance with the following existing OMB collections: 1117-0003, 1117-0004, 1117-0006, 1117-0008, 1117-0009, 1117-00010, 1117-00012, 1117-00014, 1117-00021, 1117-00023, 1117-00029, 1117-00056. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
20 44 U.S.C. 3501-3521.
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 proposes to amend 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES

1. The authority citation for 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:
a. Add a new paragraph (d)(107) to read as follows:
§ 1308.11 Schedule I.

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- [90 FR 578 Airworthiness Directives; Bombardier, Inc., Airplanes](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-31624.md)
- [90 FR 581 Section 30C Alternative Fuel Vehicle Refueling Property Credit; Hearing](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-31233.md)
- [90 FR 1050 Modification of Class E Airspace; Battle Mountain Airport, Battle Mountain, NV](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-31694.md)
- [90 FR 1054 Endangered and Threatened Wildlife and Plants; Removal of Ute Ladies'-Tresses From the List of Endangered and Threatened Plants](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-30380.md)
- [90 FR 1419 Endangered and Threatened Wildlife and Plants; 90-Day Finding on Two Petitions for Gray Wolf](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-31754.md)
- [90 FR 1421 Endangered and Threatened Wildlife and Plants; Endangered Species Status for the Bleached Sandhill Skipper](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-31761.md)
- [90 FR 1909 Federal Baseline Water Quality Standards for Indian Reservations; Withdrawal of Proposed Rule](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-31219.md)
- [90 FR 2550 Amendments to Definitions and Related Provisions Under the Randolph-Sheppard Vending Facility Program](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2025-00124.md)
- [90 FR 3046 Airworthiness Directives; Siam Hiller Holdings, Inc, Helicopters](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2025-00588.md)
- [90 FR 3107 C.I. Pigment Violet 29 (PV29); Regulation Under the Toxic Substances Control Act (TSCA)](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2024-30931.md)
- [90 FR 3720 Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Increased Assessment Rate](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2025-00193.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2025-22495. Check the current official text before relying on it. Not legal advice.