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contains a stage 7 port, P/N 2614M30P01, (k) Material Incorporated by Reference Administration makes a correction to with a port casting serial number (S/N) listed (1) The Director of the Federal Register the above mentioned chemical name of in Table 1 in Planning Information, approved the incorporation by reference oliceridine by removing the word Paragraph 3.A., of CFM Service Bulletin (SB) (IBR) of the service information listed in this ‘‘fumarate’’ to read as N-[(3- LEAP–1A–72–00–0421–01A–930A–D, Issue paragraph under 5 U.S.C. 552(a) and 1 CFR { 001, dated October 22, 2020. methoxythiophen-2-yl)methyl]( 2-[(9R)- part 51. 9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9- (d) Subject (2) You must use this service information yl]ethyl}amine. This change clarifies the Joint Aircraft System Component (JASC) as applicable to do the actions required by control of oliceridine free base and its Code 7250, Turbine Section. this AD, unless the AD specifies otherwise. (i) CFM Service Bulletin LEAP–1A–72–00– salts, to include the fumarate salt, by (e) Unsafe Condition 0421–01A–930A–D, Issue 001, dated October definition. This AD was prompted by a report of a 22, 2020. DATES: Effective July 12, 2021. manufacturing quality escape found during (ii) [Reserved] FOR FURTHER INFORMATION CONTACT: Dr. inspection of an HPT case. The FAA is (3) For CFM service information identified Terrence L. Boos, Drug and Chemical in this AD, contact CFM International, S.A., issuing this AD to prevent failure of the HPT Evaluation Section, Diversion Control case. The unsafe condition, if not addressed, Aviation Operations Center, 1 Neumann could result in failure of the HPT case, Way, M/D Room 285, Cincinnati, OH 45125; Division, Drug Enforcement uncontained rotor release, damage to the phone: (877) 432–3272; email: Administration; Telephone: (571) 362– engine, and damage to the airplane. [email protected]. 3249. (4) You may view this service information SUPPLEMENTARY INFORMATION: (f) Compliance at FAA, Airworthiness Products Section, Comply with this AD within the Operational Safety Branch, 1200 District Background and Legal Authority compliance times specified, unless already Avenue, Burlington, MA 01803. For done. information on the availability of this On October 30, 2020, the Drug Enforcement Administration (DEA), (g) Required Actions material at the FAA, call (781) 238–7759. (5) You may view this service information pursuant to 21 U.S.C. 811(j), published Before the HPT case exceeds the cycles that is incorporated by reference at the an interim final rule (IFR) to place since new limit in Table 1, Planning National Archives and Records oliceridine (including its isomers, Information, Paragraph 3.A., of CFM SB Administration (NARA). For information on esters, ethers, salts and salts of isomers, LEAP–1A–72–00–0421–01A–930A–D, Issue the availability of this material at NARA, esters and ethers whenever the 001, dated October 22, 2020, or during the email: [email protected], or go to: next piece part exposure, whichever occurs existence of such isomers, esters, ethers https://www.archives.gov/federal-register/cfr/ and salts is possible), a medication first after the effective date of this AD, ibr-locations.html. remove the affected HPT case from service approved recently by the Food and Drug and replace with a part eligible for Issued on May 21, 2021. Administration (FDA) for medical use as installation. Lance T. Gant, an intravenous drug for the management (h) Definitions Director, Compliance & Airworthiness of acute pain severe enough to require Division, Aircraft Certification Service. For the purpose of this AD: an intravenous opioid analgesic and for (1) A part eligible for installation is an HPT [FR Doc. 2021–12137 Filed 6–9–21; 8:45 am] patients for whom alternative treatments case, P/N 2668M94G01, that contains a stage BILLING CODE 4910–13–P are inadequate, in schedule II of the 7 port, P/N 2614M30P01, with an S/N that Controlled Substances Act (CSA). 85 FR is not listed in Table 1 in Planning 68749. The IFR provided an opportunity Information, Paragraph 3.A., of CFM SB DEPARTMENT OF JUSTICE for interested persons to submit LEAP–1A–72–00–0421–01A–930A–D, Issue comments, as well as file a request for 001, dated October 22, 2020. (2) Piece-part exposure is when the HPT Drug Enforcement Administration hearing or waiver of hearing, on or case is removed from the engine and fully 21 CFR Part 1308 before November 30, 2020. DEA disassembled. [Docket No. DEA–715] received three comments and did not receive any requests for hearing or (i) Alternative Methods of Compliance (AMOCs) Schedules of Controlled Substances: waiver of hearing. Placement of Oliceridine in Schedule II (1) The Manager, ECO Branch, FAA, has Comments Received the authority to approve AMOCs for this AD, AGENCY: Drug Enforcement In response to the IFR, DEA received if requested using the procedures found in 14 Administration, Department of Justice. three comments. The submissions were CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector ACTION: Final rule. from individuals or anonymous or local Flight Standards District Office, as commenters. One commenter suggested appropriate. If sending information directly SUMMARY: This final rule adopts, with a that oliceridine be placed in schedule III to the manager of the certification office, change as mentioned below, an interim rather than schedule II, one commenter send it to the attention of the person final rule with request for comments had a statement on the controlled name, identified in Related Information. You may published in the Federal Register on and the third commenter discussed email your request to: ANE-AD-AMOC@ October 30, 2020, placing oliceridine, N- another substance entirely that was faa.gov. [(3-methoxythiophen-2-yl)methyl]({2- (2) Before using any approved AMOC, unrelated to oliceridine. As such, the [(9R)-9-(pyridin-2-yl)-6- third comment was outside the scope of notify your appropriate principal inspector, } or lacking a principal inspector, the manager oxaspiro[4.5]decan-9-yl]ethyl )amine this current scheduling action. of the local flight standards district office/ fumarate, including its isomers, esters, Comment: One commenter suggested certificate holding district office. ethers, salts and salts of isomers, esters that oliceridine be placed in schedule III (j) Related Information and ethers whenever the existence of of the CSA, rather than schedule II. The such isomers, esters, ethers and salts is commenter mentioned that placement of For more information about this AD, possible, in schedule II of the Controlled oliceridine in schedule II will limit its contact Christopher McGuire, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Substances Act. In response to an error medical applications and limit access to Avenue, Burlington, MA 01803; phone: (781) in the chemical name of oliceridine as the drug due to schedule II 238–7120; fax: (781) 238–7199; email: noted by one of the commenters to the manufacturing quotas. The commenter [email protected]. interim final rule, the Drug Enforcement stated that oliceridine has the potential

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to revolutionize gastrointestinal listing minus the salt designation to a person registered with DEA in endoscopy because it does not cause (‘‘fumarate’’) is readily understood by accordance with 21 CFR part 1317, in respiratory depression. Lastly, the those registered to handle the substance addition to all other applicable Federal, commenter stated that since oliceridine and would not be misunderstood by the State, local, and tribal laws. is not indicated for home-use, abuse of public. For this reason, DEA believes 4. Security. Oliceridine is subject to the medication by drug users would be the change will not have an impact. schedule II security requirements and difficult. Based on the rationale set forth in the must be handled and stored pursuant to DEA Response: DEA notes that FDA interim final rule, DEA adopts the IFR, 21 U.S.C. 821 and 823 and in approved a New Drug Application with the above mentioned correction to accordance with 21 CFR 1301.71– (NDA) for oliceridine and provided DEA the chemical name of oliceridine. 1301.93. Non-practitioners handling with a scheduling recommendation for oliceridine must also comply with the Requirements for Handling Oliceridine oliceridine. The scheduling employee screening requirements of 21 recommendation by Health and Human As indicated above, oliceridine has CFR 1301.90–1301.93. Services (HHS) and their notification to been a schedule II controlled substance 5. Labeling and Packaging. All labels, DEA regarding the FDA approval of the by virtue of an IFR issued by DEA in labeling, and packaging for commercial NDA initiated the DEA review and October 2020. Thus, this final rule does containers of oliceridine must comply scheduling action. As stated in the IFR, not alter the regulatory requirements with 21 U.S.C. 825 and 958(e) and be in after careful consideration of data from applicable to handlers of oliceridine accordance with 21 CFR part 1302. preclinical and clinical studies, DEA that have been in place since that time. 6. Inventory. Every DEA registrant concurred with the HHS Nonetheless, for informational who possesses any quantity of recommendation that oliceridine has purposes, we restate here those oliceridine must take an inventory of abuse potential comparable to other requirements. Oliceridine is subject to oliceridine on hand, pursuant to 21 schedule II opioids and therefore the CSA’s schedule II regulatory U.S.C. 827 and 958(e), and in supported—and continues to support controls and administrative, civil, and accordance with 21 CFR 1304.03, through this final rule—placement of criminal sanctions applicable to the 1304.04, and 1304.11. oliceridine in schedule II under the manufacture, distribution, reverse Any person who becomes registered CSA. Contrary to the commenter’s distribution, dispensing, importing, with DEA to handle oliceridine must opinion about schedule II controls on a exporting, research, and conduct of take an initial inventory of all stocks of drug limiting its medical applications instructional activities and chemical controlled substances containing and access due to manufacturing quota analysis with, and possession involving oliceridine on hand on the date the requirements, DEA notes that currently schedule II substances, including the registrant first engages in the handling several schedule II drugs (oxycodone, following: of controlled substances, pursuant to 21 hydrocodone etc.) are extensively 1. Registration. Any person who U.S.C. 827 and 958(e), and in prescribed and used in medical practice. handles (manufactures, distributes, accordance with 21 CFR 1304.03, Comment: One commenter stated that reverse distributes, dispenses, imports, 1304.04, and 1304.11. the chemical name provided in the exports, engages in research, or After the initial inventory, every DEA interim final rule indicates oliceridine is conducts instructional activities or registrant must take a new inventory of ‘‘N-[(3-methoxythiophen-2- chemical analysis with, or possesses) all stocks of controlled substances yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6- oliceridine, or who desires to handle (including oliceridine) on hand every oxaspiro[4.5]decan-9-yl]ethyl})amine oliceridine, must be registered with two years, pursuant to 21 U.S.C. 827 fumarate’’, though this is the name of DEA to conduct such activities pursuant and 958(e), and in accordance with 21 the fumarate salt of oliceridine. The to 21 U.S.C. 822, 823, 957, and 958 and CFR 1304.03, 1304.04, and 1304.11. commenter noted that the other in accordance with 21 CFR parts 1301 7. Records and Reports. DEA substances listed in 21 CFR 1308.12, and 1312. Any person who currently registrants must maintain records and and in most other sections of the CSA handles or intends to handle submit reports for oliceridine, pursuant list only the base form of the drug, and oliceridine, and is not registered with to 21 U.S.C. 827 and 958(e), and in control salts by definition. The DEA, must submit an application for accordance with 21 CFR parts 1304, commenter suggested to provide the registration and may not continue to 1312, and 1317. chemical name for oliceridine base, and handle oliceridine, unless DEA has 8. Orders for oliceridine. Every DEA the fumarate salt would be controlled approved the application for registrant who distributes oliceridine is under the preamble in 12 CFR 1308.12. registration, pursuant to 21 U.S.C. 822, required to comply with order form DEA Response: DEA agrees with 823, 957, and 958, and in accordance requirements, pursuant to 21 U.S.C. 828, commenter regarding the error in the with 21 CFR parts 1301 and 1312. These and in accordance with 21 CFR part chemical name of oliceridine and registration requirements, however, are 1305. corrects appropriately by removing the not applicable to patients (end users) 9. Prescriptions. All prescriptions for word ‘‘fumarate’’ to read oliceridine as, who possess oliceridine pursuant to a oliceridine or products containing N-[(3-methoxythiophen-2-yl)methyl]({2- lawful prescription. oliceridine must comply with 21 U.S.C. [(9R)-9-(pyridin-2-yl)-6- 2. Quota. Only registered 829, and be issued in accordance with oxaspiro[4.5]decan-9-yl]ethyl})amine. manufacturers are permitted to 21 CFR parts 1306 and 1311, subpart C. The correction will make clear precisely manufacture oliceridine in accordance 10. Manufacturing and Distributing. which substance is being controlled with a quota assigned pursuant to 21 In addition to the general requirements because the fumarate salt was not the U.S.C. 826 and in accordance with 21 of the CSA and DEA regulations that are accurate designation for the controlled CFR part 1303. applicable to manufacturers and substance. The listing of the base form 3. Disposal of stocks. Any person who distributors of schedule II controlled and removal of the salt designation is does not desire or is not able to substances, such registrants should be consistent with other controlled maintain a schedule II registration must advised that (consistent with the substance listings under the CFR and surrender all quantities of currently foregoing considerations) any the substance designated for control held oliceridine, or may transfer all manufacturing or distribution of remains unchanged. The base form quantities of currently held oliceridine oliceridine may only be for the

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legitimate purposes consistent with the to formal rulemaking procedures 2 U.S.C. 1501 et seq., DEA has drug’s labeling, or for research activities performed ‘‘on the record after determined that this action would not authorized by the Federal Food, Drug, opportunity for a hearing,’’ which are result in any Federal mandate that may and Cosmetic Act, as applicable, and the conducted pursuant to the provisions of result ‘‘in the expenditure by State, CSA. 5 U.S.C. 556 and 557. The CSA sets local, and tribal governments, in the 11. Importation and Exportation. All forth the procedures and criteria for aggregate, or by the private sector, of importation and exportation of scheduling a drug or other substance. $100 million or more (adjusted for oliceridine must be in compliance with Such actions are exempt from review by inflation) in any one year.’’ Therefore, 21 U.S.C. 952, 953, 957, and 958, and the Office of Management and Budget neither a Small Government Agency in accordance with 21 CFR part 1312. (OMB) pursuant to section 3(d)(1) of Plan nor any other action is required 12. Liability. Any activity involving Executive Order (E.O.)12866 and the under UMRA of 1995. oliceridine not authorized by, or in principles reaffirmed in E.O. 13563. violation of, the CSA or its Paperwork Reduction Act of 1995 Executive Order 12988, Civil Justice implementing regulations, is unlawful, This action does not impose a new Reform and may subject the person to collection of information requirement administrative, civil, and/or criminal This regulation meets the applicable under the Paperwork Reduction Act of sanctions. standards set forth in sections 3(a) and 1995. 44 U.S.C. 3501–3521. This action Regulatory Analyses 3(b)(2) of E.O. 12988 to eliminate does not impose recordkeeping or drafting errors and ambiguity, minimize reporting requirements on State or local Administrative Procedure Act litigation, provide a clear legal standard governments, individuals, businesses, or This final rule, with a correction in for affected conduct, and promote organizations. An agency may not the chemical name of oliceridine as simplification and burden reduction. conduct or sponsor, and a person is not discussed above, affirms the amendment Executive Order 13132, Federalism required to respond to, a collection of made by the IFR that is already in effect. information unless it displays a Section 553 of the Administrative This rulemaking does not have currently valid OMB control number. federalism implications warranting the Procedure Act (APA) (5 U.S.C. 553) Congressional Review Act generally requires notice and comment application of E.O. 13132. The rule does for rulemaking. However, 21 U.S.C. not have substantial direct effects on the This rule is not a major rule as 811(j) provides that in cases where a States, on the relationship between the defined by the Congressional Review certain new drug is: (1) Approved by national government and the States, or Act (CRA), 5 U.S.C. 804. However, HHS and (2) HHS recommends control on the distribution of power and pursuant to the CRA, DEA is submitting in CSA schedule II–V, DEA shall issue responsibilities among the various a copy of this final rule to both Houses an IFR scheduling the drug within 90 levels of government. of Congress and to the Comptroller days. Additionally, subsection (j) Executive Order 13175, Consultation General. specifies that the rulemaking shall and Coordination With Indian Tribal List of Subjects in 21 CFR Part 1308 become immediately effective as an Governments interim final rule without requiring DEA Administrative practice and to demonstrate good cause. DEA issued This rule does not have tribal procedure, Drug traffic control, an IFR on October 30, 2020, and implications warranting the application Reporting and recordkeeping solicited public comments on that rule. of E.O. 13175. It does not have requirements. Subsection (j) further provides that after substantial direct effects on one or more Accordingly, the interim final rule giving interested persons the Indian tribes, on the relationship amending 21 CFR part 1308, which opportunity to comment and to request between the Federal government and published on October 30, 2020 (85 FR a hearing, the Attorney General, as Indian tribes, or on the distribution of 68749), is adopted as a final rule with delegated to the Administrator of DEA, power and responsibilities between the the following amendment: shall issue a final rule in accordance Federal government and Indian tribes. with the scheduling criteria of 21 U.S.C. Regulatory Flexibility Act PART 1308—SCHEDULES OF 811(b) through (d) and 812(b). DEA is CONTROLLED SUBSTANCES now responding to the comments The Regulatory Flexibility Act (RFA) submitted by the public and issuing the (5 U.S.C. 601–612) applies to rules that ■ 1. The authority citation for part 1308 final rule, in conformity with the APA are subject to notice and comment continues to read as follows: and the procedure required by 21 U.S.C. under section 553(b) of the APA. Under 811. 21 U.S.C. 811(j), DEA is not required to Authority: 21 U.S.C. 811, 812, 871(b), publish a general notice of proposed 956(b), unless otherwise noted. Executive Orders 12866 (Regulatory rulemaking. Consequently, the RFA ■ 2. Amend § 1308.12 by revising Planning and Review) and 13563 does not apply. paragraph (c)(18) to read as follows: (Improving Regulation and Regulatory Review) Unfunded Mandates Reform Act of 1995 § 1308.12 Schedule II. In accordance with 21 U.S.C. 811(a) In accordance with the Unfunded * * * * * and (j), this scheduling action is subject Mandates Reform Act (UMRA) of 1995, (c) * * *

(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine) ...... 9245

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* * * * * • 1-(4-cyanobutyl)-N-(2- CUMYL-BUTINACA, 4-cyano-CUMYL- phenylpropan-2-yl)-1H-indazole-3- BUTINACA, 4-CN-CUMYL BINACA, D. Christopher Evans, carboxamide (other names: 4-CN- CUMYL-4CN-BINACA or SGT-78); Acting Administrator. CUMYL-BUTINACA, 4-cyano-CUMYL- methyl 2-(1-(cyclohexylmethyl)-1H- [FR Doc. 2021–11981 Filed 6–9–21; 8:45 am] BUTINACA; 4-CN-CUMYL BINACA, indole-3-carboxamido)-3- BILLING CODE 4410–09–P CUMYL-4CN-BINACA, or SGT-78), methylbutanoate (other names: MMB- • methyl 2-(1-(cyclohexylmethyl)-1H- CHMICA or AMB-CHMICA) and 1-(5- indole-3-carboxamido)-3- fluoropentyl)-N-(2-phenylpropan-2-yl)- DEPARTMENT OF JUSTICE methylbutanoate (other names: MMB- 1H-pyrrolo[2,3-b]pyridine-3- CHMICA or AMB-CHMICA), and carboxamide (other name: 5F-CUMYL- Drug Enforcement Administration • 1-(5-fluoropentyl)-N-(2- P7AICA) in schedule I of the CSA phenylpropan-2-yl)-1H-pyrrolo[2,3- pursuant to the temporary scheduling 21 CFR Part 1308 b]pyridine-3-carboxamide (other name: provisions of 21 U.S.C. 811(h). 83 FR [Docket No. DEA–479] 5F-CUMYL-P7AICA). 31877. That temporary scheduling order Legal Authority took effect on the date of publication, Schedules of Controlled Substances: and was based on findings by the former Placement of NM2201, 5F-AB-PINACA, The CSA provides that issuing, Acting Administrator of DEA that the 4-CN-CUMYL-BUTINACA, MMB- amending, or repealing of the temporary scheduling of these five CHMICA, and 5F-CUMYL-P7AICA in scheduling of any drug or other synthetic cannabinoids (SCs) was Schedule I substance may be initiated by the necessary to avoid an imminent hazard Attorney General (1) on his own motion; to the public safety pursuant to 21 AGENCY: Drug Enforcement (2) at the request of the Secretary of the U.S.C. 811(h)(1). Administration, Department of Justice. Department of Health and Human On July 13, 2020, DEA published an ACTION: Final rule. Services (HHS); 1 or (3) on the petition order to extend the temporary of any interested party. 21 U.S.C. 811(a). scheduling of the five SCs by one year, SUMMARY: By this rule, the Drug The Attorney General initiated this until July 10, 2021. 85 FR 42296. Also, Enforcement Administration action on his own motion, as delegated on that same date and in the same issue permanently places five synthetic to the Administrator of DEA, and is of the Federal Register, DEA published cannabinoids, as identified in this final supported by, inter alia, a a notice of proposed rulemaking rule, in schedule I of the Controlled recommendation from the Assistant (NPRM) to permanently control the five Substances Act. These five substances Secretary for Health of HHS (Assistant SCs in schedule I of the CSA. 85 FR are currently listed in Schedule I Secretary) and an evaluation of all 42290. Specifically, DEA proposed to pursuant to a temporary scheduling relevant data by DEA. The regulatory add these five SCs to the hallucinogenic order. As a result of this rule, the controls and administrative, civil, and substances list under 21 CFR regulatory controls and administrative, criminal sanctions of schedule I 1308.11(d). civil, and criminal sanctions applicable controlled substances on any person to schedule I controlled substances on who handles (manufactures, distributes, DEA and HHS Eight Factor Analyses persons who handle (manufacture, imports, exports, engages in research, or On May 29, 2020, HHS provided DEA distribute, import, export, engage in conducts instructional activities or with a scientific and medical evaluation research, conduct instructional chemical analysis with, or possesses) or and scheduling recommendation, activities or chemical analysis, or proposes to handle NM2201, 5F-AB- prepared by the Food and Drug possess), or propose to handle these five PINACA, 4-CN-CUMYL-BUTINACA, Administration (FDA), entitled ‘‘Basis specified controlled substances will MMB-CHMICA, and 5F-CUMYL- for the Recommendation to Place continue to apply. P7AICA will continue to apply as a Naphthalen-1-yl 1-(5-fluoropentyl)-lH- DATES: Effective June 10, 2021. result of this action. indole-3-carboxylate [NM2201; CBL2201], N-(1-amino-3-methyl-1- FOR FURTHER INFORMATION CONTACT: Background oxobutan-2-yl)-1-(5-fluoropentyl)-lH- Terrence L. Boos, Drug & Chemical On July 10, 2018, DEA published an indazole-3-carboxamide [5F-AB- Evaluation Section, Diversion Control order in the Federal Register amending PINACA], 1-(4-cyanobutyl)-N-(2- Division, Drug Enforcement 21 CFR 1308.11(h) to temporarily place phenylpropan-2-yl)lH-indazole-3- Administration; Telephone: (571) 362– naphthalen-1-yl 1-(5-fluoropentyl)-1H- carboxamide (4-CN-CUMYL- 3249. indole-3-carboxylate (other names: BUTINACA; 4-cyano-CUMYL- SUPPLEMENTARY INFORMATION: In this NM2201 or CBL2201); N-(1-amino-3- BUTINACA; 4-CN-CUMYL BINACA; final rule, the Drug Enforcement methyl-1-oxobutan-2-yl)-1-(5- CUMYL-4CN-BINACA; SGT-78], methyl Administration (DEA) is permanently fluoropentyl)-1H-indazole-3- 2-(1-(cyclohexylmethyl)-lH-indole-3- scheduling the following five controlled carboxamide (other name: 5F-AB- carboxamido)-3-methylbutanoate substances in schedule I of the PINACA); 1-(4-cyanobutyl)-N-(2- [MMB-CHMICA; AMB-CHMICA], and 1- Controlled Substances Act (CSA), phenylpropan-2-yl)-1H-indazole-3- (5-fluoropentyl)-N-(2-phenylpropan-2- including their salts, isomers, and salts carboxamide (other names: 4-CN- yl)-1H-pyrrolo[2,3-b]pyridine-3- of isomers whenever the existence of carboxamide [5F-CUMYL-P7AICA; such salts, isomers, and salts of isomers 1 As set forth in a memorandum of understanding CUMYL-5F-P7AICA; SGT-263] and is possible: entered into by the Food and Drug Administration Their Salts in Schedule I of the • (FDA) and the National Institute on Drug Abuse naphthalen-1-yl 1-(5-fluoropentyl)- (NIDA), FDA acts as the lead agency within HHS Controlled Substances Act.’’ 1H-indole-3-carboxylate (other names: in carrying out the Secretary’s scheduling After considering the eight factors in NM2201 or CBL2201), responsibilities under the CSA, with the 21 U.S.C. 811(c), each substance’s abuse • N-(1-amino-3-methyl-1-oxobutan-2- concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. potential, lack of legitimate medical use The Secretary of HHS has delegated to the Assistant yl)-1-(5-fluoropentyl)-1H-indazole-3- Secretary for Health of HHS the authority to make in the United States, and lack of carboxamide (other name: 5F–AB- domestic drug scheduling recommendations. 58 FR accepted safety for use under medical PINACA), 35460, July 1, 1993. supervision pursuant to 21 U.S.C.

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