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that authority because it addresses an (1) With a switch unit serial number (S/N) Branch, send it to the attention of the person unsafe condition that is likely to exist or 1413, 1414, 1415, 1424, 1428, 1430, 1432, or identified in paragraph (i)(1) of this AD. develop on helicopters identified in this 1433 installed, or Information may be emailed to: 9-AVS-AIR- rulemaking action. (2) With a missing or illegible switch unit [email protected]. S/N or if the S/N cannot be determined, (2) Before using any approved AMOC, Regulatory Findings installed. notify your appropriate principal inspector, Note 1 to paragraph (c): Helicopters with or lacking a principal inspector, the manager This AD will not have federalism a 206L–1+ designation are Model 206L–1 of the local flight standards district office/ implications under Executive Order helicopters. Helicopters with a 206L–3+ certificate holding district office. 13132. This AD will not have a designation are Model 206L–3 helicopters. (i) Related Information substantial direct effect on the States, on Note 2 to paragraph (c): The switch unit the relationship between the national is located on the aft fuel boost pump (1) For more information about this AD, government and the States, or on the assembly. The P/N and S/N for the switch contact Hal Jensen, Aerospace Engineer, unit could be on the outside face of the Operational Safety Branch, FAA, 950 distribution of power and L’Enfant Plaza N SW, Washington, DC 20024; responsibilities among the various attachment flange, in the cross hatched area of the switch unit. telephone (202) 267–9167; email hal.jensen@ levels of government. faa.gov. For the reasons discussed above, I (d) Subject (2) Bell Helicopter Textron Alert Service certify that this AD: Joint Aircraft Service Component (JASC) Bulletin No. 206L–04–132, Revision A, dated (1) Is not a ‘‘significant regulatory Code: 2842, Fuel Quantity Sensor. October 4, 2004, which is not incorporated action’’ under Executive Order 12866, by reference, contains additional information (e) Unsafe Condition (2) Will not affect intrastate aviation about the subject of this AD. For service in Alaska, and This AD was prompted by a manufacturing information identified in this AD, contact (3) Will not have a significant flaw that could cause a switch unit to hang Bell Textron Canada Limited, 12,800 Rue de in the high position and fail to indicate a low l’Avenir, Mirabel, Quebec J7J1R4; telephone economic impact, positive or negative, fuel condition. The FAA is issuing this AD (450) 437–2862 or (800) 363–8023; fax (450) on a substantial number of small entities to prevent failure of the switch unit to 433–0272; or at https:// under the criteria of the Regulatory indicate a low fuel condition that could lead www.bellcustomer.com. You may view this Flexibility Act. to fuel exhaustion and which if not referenced service information at the FAA, addressed, could result in a subsequent Office of the Regional Counsel, Southwest List of Subjects in 14 CFR Part 39 forced landing. Region, 10101 Hillwood Pkwy., Room 6N– 321, Fort Worth, TX 76177. For information Air transportation, Aircraft, Aviation (f) Compliance safety, Incorporation by reference, on the availability of this material at the Comply with this AD within the Safety. FAA, call (817) 222–5110. compliance times specified, unless already (3) The subject of this AD is addressed in The Amendment done. Transport Canada AD CF–2004–24, dated November 24, 2004. You may view the (g) Required Actions Accordingly, under the authority Transport Canada AD on the internet at delegated to me by the Administrator, (1) For a switch unit identified in https://www.regulations.gov in Docket No. the FAA amends 14 CFR part 39 as paragraph (c)(1) of this AD, on or before the FAA–2006–25084. follows: next 100-hour time-in-service inspection after the effective date of this AD, remove the (j) Material Incorporated by Reference PART 39—AIRWORTHINESS switch unit from service. None. DIRECTIVES (2) For a switch unit identified in paragraph (c)(2) of this AD, on or before the Issued on April 28, 2021. Lance T. Gant, ■ 1. The authority citation for part 39 next 100-hour time-in-service inspection continues to read as follows: after the effective date of this AD: Director, Compliance & Airworthiness (i) Determine the color of the switch unit Division, Aircraft Certification Service. Authority: 49 U.S.C. 106(g), 40113, 44701. mounting flange. If the mounting flange color [FR Doc. 2021–09278 Filed 5–6–21; 8:45 am] is any color other than red, determine the § 39.13 [Amended] purchase date. If the purchase date of the BILLING CODE 4910–13–P ■ 2. The FAA amends § 39.13 by adding switch unit is between April 19 and July 26, the following new airworthiness 2004, or cannot be determined, do an operational test. DEPARTMENT OF JUSTICE directive: (ii) If the switch unit fails the operational 2021–10–08 Bell Textron Canada Limited test, before further flight, remove the switch Drug Enforcement Administration (Type Certificate Previously Held by Bell unit from service. Helicopter Textron Canada Limited): (3) As of the effective date of this AD, do 21 CFR Part 1308 Amendment 39–21541 Docket No. FAA– not install a switch unit identified in 2006–25084; Project Identifier 2005– paragraph (c)(1) of this AD on any helicopter. [Docket No. DEA–808] SW–38–AD. (4) As of the effective date of this AD, do not install a switch unit identified in Schedules of Controlled Substances: (a) Effective Date paragraph (c)(2) of this AD on any helicopter Placement of Serdexmethylphenidate This airworthiness directive (AD) is unless the actions in paragraphs (g)(2)(i) and in Schedule IV effective June 11, 2021. (ii) of this AD have been accomplished. AGENCY: Drug Enforcement (b) Affected ADs (h) Alternative Methods of Compliance Administration, Department of Justice. (AMOCs) None. ACTION: Interim final rule with request (1) The Manager, International Validation (c) Applicability Branch, FAA, has the authority to approve for comments. This AD applies to Bell Textron Canada AMOCs for this AD, if requested using the SUMMARY: On March 2, 2021, the United Limited (type certificate previously held by procedures found in 14 CFR 39.19. In Bell Helicopter Textron Canada Limited) accordance with 14 CFR 39.19, send your States Food and Drug Administration Model 206L, 206L–1, 206L–3, and 206L–4 request to your principal inspector or local approved a new drug application for helicopters, certificated in any category, with Flight Standards District Office, as AZSTARYS capsules for oral use, a a low fuel level detector switch unit (switch appropriate. If sending information directly combination drug product containing unit) part number (P/N) 206–063–613–003: to the manager of the International Validation serdexmethylphenidate chloride and

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hydrochloride, for your comment has been successfully received. If you want to submit personal the treatment of Attention Deficit submitted and there is no need to identifying information (such as your Hyperactivity Disorder in patients six resubmit the same comment. name, address, etc.) as part of your years of age or older. The Department of • Paper comments: Paper comments comment, but do not want it to be made Health and Human Services provided that duplicate the electronic submission publicly available, you must include the the Drug Enforcement Administration are not necessary and are discouraged. phrase ‘‘PERSONAL IDENTIFYING with a scheduling recommendation to Should you wish to mail a paper INFORMATION’’ in the first paragraph place serdexmethylphenidate and its comment in lieu of an electronic of your comment. You must also place salts in schedule IV of the Controlled comment, it should be sent via regular all of the personal identifying Substances Act. In accordance with the or express mail to: Drug Enforcement information you do not want made Controlled Substances Act, as amended Administration, Attn: DEA Federal publicly available in the first paragraph by the Improving Regulatory Register Representative/DPW, 8701 of your comment and identify what Transparency for New Medical Morrissette Drive, Springfield, VA information you want redacted. If you Therapies Act, Drug Enforcement 22152. want to submit confidential business Administration is hereby issuing an • Hearing requests: All requests for information as part of your comment, interim final rule placing hearing and waivers of participation but do not want it to be made publicly serdexmethylphenidate, including its must be sent to: Drug Enforcement available, you must include the phrase salts, isomers, and salts of isomers, in Administration, Attn: Administrator, ‘‘CONFIDENTIAL BUSINESS schedule IV of the Controlled 8701 Morrissette Drive, Springfield, INFORMATION’’ in the first paragraph Substances Act, thereby facilitating the Virginia 22152. All requests for hearing of your comment. You must also commercial distribution of AZSTARYS and waivers of participation should also prominently identify the confidential as a lawful controlled substance. be sent to: (1) Drug Enforcement business information to be redacted DATES: The effective date of this Administration, Attn: Hearing Clerk/ within the comment. Comments containing personal rulemaking is May 7, 2021. Interested OALJ, 8701 Morrissette Drive, identifying information and confidential persons may file written comments on Springfield, Virginia 22152; and (2) business information identified as this rulemaking in accordance with 21 Drug Enforcement Administration, Attn: directed above will generally be made U.S.C. 811(j)(3) and 21 CFR 1308.43(g). DEA Federal Register Representative/ publicly available in redacted form. If a Electronic comments must be DPW, 8701 Morrissette Drive, comment has so much confidential submitted, and written comments must Springfield, Virginia 22152. business information or personal be postmarked, on or before June 7, FOR FURTHER INFORMATION CONTACT: identifying information that it cannot be 2021. Commenters should be aware that Terrence L. Boos, Drug & Chemical effectively redacted, all or part of that the electronic Federal Docket Evaluation Section, Diversion Control Division, Drug Enforcement comment may not be made publicly Management System will not accept available. Comments posted to http:// comments after 11:59 p.m. Eastern Time Administration; Telephone: (571) 362– 3249. www.regulations.gov may include any on the last day of the comment period. personal identifying information (such Interested persons may file a request SUPPLEMENTARY INFORMATION: This as name, address, and phone number) for hearing or waiver of hearing in interim final rule refers to the single included in the text of your electronic accordance with 21 U.S.C. 811(j)(3) and entity, serdexmethylphenidate. The submission that is not identified as 21 CFR 1308.44. Requests for hearing chloride salt of serdexmethylphenidate directed above as confidential. and waivers of an opportunity for a is chemically known as 3-[[[(1S)-1- An electronic copy of this document hearing or to participate in a hearing, carboxy-2-hydroxyethyl]- and supplemental information, together with a written statement of amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2- including the complete Department of position on the matters of fact and law methoxy-2-oxo-1-phenylethyl]-1- Health and Human Services (HHS) and asserted in the hearing, must be piperidinyl] DEA eight-factor analyses, to this received on or before June 7, 2021. carbonyl]oxy]methyl]pyridinium interim final rule are available at http:// ADDRESSES: To ensure proper handling chloride. This rule places www.regulations.gov for easy reference. of comments, please reference ‘‘Docket serdexmethylphenidate, including its Request for Hearing or Waiver of No. DEA–808’’ on all correspondence, salts, isomers, and salts of isomers, in Participation in a Hearing including any attachments. schedule IV of the Controlled • Electronic comments: The Drug Substances Act (CSA), thereby Pursuant to 21 U.S.C. 811(a), this Enforcement Administration (DEA) facilitating the commercial distribution action is a formal rulemaking ‘‘on the encourages that all comments be of AZSTARYS as a controlled record after opportunity for a hearing.’’ submitted electronically through the substance. Such proceedings are conducted Federal eRulemaking Portal, which pursuant to the provisions of the provides the ability to type short Posting of Public Comments Administrative Procedure Act (APA), 5 comments directly into the comment Please note that all comments U.S.C. 551–559. 21 CFR 1308.41– field on the web page or attach a file for received are considered part of the 1308.45; 21 CFR part 1316, subpart D. lengthier comments. Please go to http:// public record. They will, unless Such requests or notices must conform www.regulations.gov and follow the reasonable cause is given, be made to the requirements of 21 CFR online instructions at that site for available by the Drug Enforcement 1308.44(a) or (b), and 1316.47 or submitting comments. Upon completion Administration (DEA) for public 1316.48, as applicable, and include a of your submission, you will receive a inspection online at http:// statement of the person’s interests in the Comment Tracking Number for your www.regulations.gov. Such information proceeding and the objections or issues, comment. Please be aware that includes personal identifying if any, concerning which the person submitted comments are not information (such as your name, desires to be heard. Any waiver must instantaneously available for public address, etc.) voluntarily submitted by conform to the requirements of 21 CFR view on Regulations.gov. If you have the commenter. The Freedom of 1308.44(c) and may include a written received a Comment Tracking Number, Information Act applies to all comments statement regarding the interested

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person’s position on the matters of fact methoxy-2-oxo-1-phenylethyl]-1- review pursuant to 21 U.S.C. 811(c). and law involved in any hearing. piperidinyl]carbonyl]oxy]methyl] DEA concluded that SDX meets the 21 All requests for a hearing and waivers pyridinium chloride) is a new molecular U.S.C. 812(b)(4) criteria for placement in of participation must be sent to DEA entity (NME) without CNS activity. schedule IV of the CSA. using the address information provided However, according to HHS, because Pursuant to subsection 811(j), and above. serdexmethylphenidate chloride (SDX) based on HHS’ scheduling Background and Legal Authority is metabolized in the large intestine to recommendation, the approval of the dexmethylphenidate (d-MPH), a NDA by HHS/FDA, and DEA’s Under the CSA, as amended in 2015 schedule II drug and a CNS , determination, DEA is issuing this by the Improving Regulatory SDX is a prodrug of d-MPH. interim final rule to schedule SDX as a Transparency for New Medical On March 2, 2020, Commave schedule IV controlled substance under Therapies Act (section 2(b) of Pub. L. Therapeutics S.A. submitted an NDA to the CSA. 114–89), DEA is required to commence FDA, in partnership with KemPharm, Included below is a brief summary of an expedited scheduling action with Inc., for a combination drug product each factor as analyzed by HHS and respect to certain new drugs approved containing SDX and d-MPH, both as DEA, and as considered by DEA in its by the Food and Drug Administration chloride salts. On March 2, 2021, DEA scheduling action. Please note that both (FDA). As provided in 21 U.S.C. 811(j), received notification that FDA, on the DEA and HHS analyses are available in this expedited scheduling is required same date, approved this NDA for their entirety under ‘‘Supporting where both of the following conditions AZSTARYS capsules for oral use, a Documents’’ in the public docket for apply: (1) The Secretary of HHS has combination drug product containing this interim final rule at http:// advised DEA that a New Drug dexmethylphenidate hydrochloride and www.regulations.gov, under Docket Application (NDA) has been submitted serdexmethylphenidate chloride, under Number ‘‘DEA–808.’’ Full analysis of, for a drug that has a stimulant, section 505(c) of the Federal Food, Drug, and citations to, the information depressant, or hallucinogenic effect on and Cosmetic Act (FDCA), for the referenced in the summary may also be the central nervous system (CNS), and treatment of Attention Deficit found in the supporting and related that it appears that such drug has an Hyperactivity Disorder (ADHD) in material. abuse potential; and (2) the Secretary of patients six years of age or older. HHS recommends that DEA control the According to the FDA-approved product 1. Its Actual or Relative Potential for drug in schedule II, III, IV, or V label, AZSTARYS contains 28 mg/6 mg, Abuse pursuant to 21 U.S.C. 811(a) and (b). In 42 mg/9 mg, or 56 mg/12 mg of SDX is an NME that has not been these circumstances, DEA is required to serdexmethylphenidate chloride/ marketed in the United States or any issue an interim final rule controlling dexmethylphenidate hydrochloride country. Thus, evidence regarding its the drug within 90 days. (equivalent to 26.1 mg/5.2 mg, 39.2 mg/ diversion and actual abuse is lacking. Subsection (j)(2) states that the 90-day 7.8 mg, and 52.3 mg/10.4 mg of SDX only recently became available for timeframe starts the later of (1) the date serdexmethylphenidate/ DEA receives HHS’ scientific and medical treatment, has not been dexmethylphenidate, respectively).2 medical evaluation/scheduling diverted from legitimate sources, and The 90-day time frame, as stipulated individuals have not taken this recommendation, or (2) the date DEA to in subsection 811(j)(2) and discussed receives notice of the NDA approval by substance in amounts sufficient to above, was triggered on March 2, 2021. create a hazard to public health and HHS. Subsection (j)(3) specifies that the Therefore, DEA must issue an interim rulemaking shall become immediately safety. DEA notes that there are no final rule controlling reports for SDX in the National Forensic effective as an interim final rule without serdexmethylphenidate on or before requiring DEA to demonstrate good Laboratory Information System May 31, 2021. 3 cause therefore. Thus, the purpose of (NFLIS), which collects drug cases subsection (j) is to speed the process by Determination To Schedule submitted to and analyzed by state and which DEA schedules newly approved Serdexmethylphenidate local forensic laboratories. As stated by HHS, clinical studies drugs that are currently either in On March 2, 2021, DEA received from schedule I or not controlled (but which show that SDX, when taken by the oral HHS a scientific and medical evaluation route, produces effects that are similar have sufficient abuse potential to entitled ‘‘Basis for the Recommendation warrant control) so that such drugs may to other stimulant drugs in schedule IV, to Control Serdexmethylphenidate and such as phentermine. The be marketed without undue delay its Salts in schedule IV of the Controlled following FDA approval.1 pharmacological mechanism of action of Substances Act’’ and a scheduling SDX is based on its prodrug Subsection (j)(3) further provides that recommendation. Pursuant to 21 U.S.C. the interim final rule shall give characteristics, as it must be 811(b) and (c), this document contained metabolized to d-MPH to exert its interested persons the opportunity to an eight-factor analysis of the abuse comment and to request a hearing. After effects. In clinical studies, SDX potential, legitimate medical use, and demonstrated a lower potential for the conclusion of such proceedings, dependence liability of DEA must issue a final rule in serdexmethylphenidate, along with 3 accordance with the scheduling criteria NFLIS represents an important resource in HHS’s recommendation to control monitoring illicit drug trafficking, including the of 21 U.S.C. 811(b) through (d) and serdexmethylphenidate and its salts diversion of legally manufactured pharmaceuticals 812(b). under schedule IV of the CSA. into illegal markets. NFLIS is a comprehensive Serdexmethylphenidate chloride (3- In response, DEA reviewed the information system that includes data from forensic [[[(1S)-1-carboxy-2-hydroxyethyl]- laboratories that handle more than 96% of an scientific and medical evaluation and estimated 1.0 million distinct annual State and amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2- scheduling recommendation provided local drug analysis cases. NFLIS includes drug by HHS, along with all other relevant chemistry results from completed analyses only. 1 Given the parameters of subsection (j), in DEA’s While NFLIS data is not direct evidence of abuse, view, it would not apply to a reformulation of a data, and completed its own eight-factor it can lead to an inference that a drug has been drug containing a substance currently in schedules diverted and abused. See 76 FR 77330, 77332, Dec. II through V for which an NDA has recently been 2 https://www.accessdata.fda.gov/drugsatfda_ 12, 2011. NFLIS data were queried on March 4, approved. docs/label/2021/212994s000lbl.pdf. 2021.

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abuse when compared to d-MPH and or illegally, in the United States. HHS analysis, DEA has determined that these similar potential for abuse when notes that SDX produces abuse-related facts and all relevant data constitute compared to phentermine. This signals, such as euphoric mood and substantial evidence of potential for evidence demonstrates that SDX is hypervigilance, and abuse potential abuse of SDX. As such, DEA hereby related in action and effect to the similar to that of schedule IV controlled schedules SDX as a controlled substance schedule IV substance phentermine, and substance phentermine. In March 2021, under the CSA. can therefore be expected to have a DEA searched the NFLIS database for Determination of Appropriate Schedule similar potential for abuse. SDX encounters. Consistent with the fact that SDX is an NME, this database The CSA lists the findings required to 2. Scientific Evidence of Its place a drug or other substance in any Pharmacological Effects, if Known had no records of encounters of SDX by law enforcement. particular schedule (I, II, III, IV, or V). SDX itself has no CNS activity and 21 U.S.C. 812(b). After consideration of must be metabolized to d-MPH to exert 5. The Scope, Duration, and the analysis and recommendation of the its effect. As HHS notes, in vitro binding Significance of Abuse Assistant Secretary for Health of HHS studies demonstrated that SDX does not SDX is not marketed in the United and review of all available data, the interact with and States, legally or illegally. Thus, Acting Administrator of DEA, pursuant transporters, which are information on the scope, duration, and to 21 U.S.C. 812(b)(4), finds that: the sites of action for d-MPH, a schedule significance of abuse for SDX is lacking. 1. Serdexmethylphenidate has a low II drug. Moreover, SDX does not bind to However, as stated by HHS, data from potential for abuse relative to the drugs any other receptor systems that are animal and human studies indicate that or other substances in schedule III. associated with drugs of abuse. SDX has abuse potential similar to Receptor binding studies demonstrate In a human abuse potential (HAP) phentermine. Therefore, upon that SDX does not bind to dopamine study, therapeutic and supratherapeutic marketing, SDX scope of abuse is and norepinephrine transporters and doses of SDX administered orally expected to be similar to phentermine. other receptors typically associated with produced positive subjective responses abuse potential. Upon oral such as Drug Liking and Drug High 6. What, if Any, Risk There Is to the administration, SDX is metabolized to similar to those of phentermine and Public Health d-MPH, a schedule II drug, in the large higher than placebo. In addition, abuse- The extent of abuse potential of a drug intestine and showed an abuse potential related adverse events such as euphoric is an indication of its public health risk. lower than that of d-MPH, but similar to mood and hypervigilance occurred less Data from preclinical and clinical that of phentermine, a schedule IV drug. frequently in SDX-treated subjects than studies showed that SDX has abuse Results from an observational animal in those treated with d-MPH. However, potential similar to that of the schedule behavioral study demonstrate that lower SDX-treated subjects reported more IV stimulant phentermine. Therefore, doses of SDX (12 and 25 mg/kg) did not abuse-related adverse events than those upon availability for marketing, SDX is produce any CNS effects and only the treated with placebo. As concluded by likely to pose a public health risk to a highest dose of SDX (50 mg/kg) HHS, results from preclinical and degree similar to schedule IV increased CNS activity. In a HAP study, clinical studies indicate that SDX has , such as phentermine. SDX at the therapeutic and supra- abuse potential similar to phentermine, therapeutic doses produced positive a schedule IV substance. 7. Its Psychic or Physiological subjective responses such as Drug Dependence Liability Liking and Drug High similar to those of 3. The State of Current Scientific As HHS notes, no animal studies were phentermine (schedule IV) and Knowledge Regarding the Drug or Other done to test physical dependence significantly higher than placebo. Substance liability of SDX. A hallmark of physical Furthermore, data from other clinical SDX is an NME. It is chemically dependence are withdrawal symptoms studies show that SDX produced abuse- known as 3-[[[(1S)-1-carboxy-2- resulting from drug discontinuation. In related adverse events, namely euphoric hydroxyethyl]-amino]carbonyl]-1- clinical studies, there was no adverse mood and hypervigilance. Because SDX [[[[(2R)-2-[(1R)-2-methoxy-2-oxo-1- events indicative of withdrawal from is similar to phentermine (schedule IV) phenylethyl]-1-piperidinyl] discontinuation of the SDX/d-MPH in its abuse potential, SDX has a lower carbonyl]oxy]methyl]pyridinium combination treatment. potential for abuse relative to the drugs chloride. It is a white to off-white SDX produced positive subjective or other substances in schedule III. crystalline solid that is freely soluble in responses to ratings of Drug Liking and 2. Serdexmethylphenidate has a water at pH that was tested up to 6.8. Drug High in a HAP study. The currently accepted medical use in the On March 2, 2021, FDA approved the responses were significantly higher than United States. NDA for AZSTARYS, a combination the placebo and similar to phentermine, On March 2, 2021, FDA approved the drug product containing d-MPH and a schedule IV stimulant. HHS NDA for AZSTARYS capsules, a SDX for the treatment of ADHD in concluded that SDX can produce combination drug product containing d- patients six years of age or older. Thus, psychic dependence to a similar extent MPH and SDX for the treatment of SDX has an accepted medical use in the as phentermine. ADHD in patients six years of age or United States. SDX will be marketed in older. Thus, SDX has a currently 8. Whether the Substance Is an combination with d-MPH (SDX/d-MPH) accepted medical use for treatment in Immediate Precursor of a Substance as immediate-release capsules in three the United States. Already Controlled Under the CSA strengths of 28 mg/6 mg, 42 mg/9 mg, 3. Serdexmethylphenidate may lead and 56 mg/12 mg. SDX is not an immediate precursor of to limited physical dependence or any controlled substance, as defined by psychological dependence relative to 4. Its History and Current Pattern of 21 U.S.C. 802(23). the drugs or other substances in Abuse Conclusion: After considering the schedule III. There is no information on the history scientific and medical evaluation and There were no animal studies and current pattern of abuse for SDX, scheduling recommendation provided performed to evaluate physical since it has not been marketed, legally by HHS, and its own eight-factor dependence of SDX. In clinical studies,

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SDX demonstrated no indication of additional to all other applicable substances, such registrants should be physical dependence after abrupt Federal, state, local, and tribal laws. advised that (consistent with the discontinuation of the drug. In a HAP 3. Security. Serdexmethylphenidate is foregoing considerations) any study, SDX increased drug-liking scores subject to schedule III–V security manufacturing or distribution of that were significantly greater than that requirements for DEA registrants and it serdexmethylphenidate may only be for of placebo and were similar to that of must be handled and stored in the legitimate purposes consistent with phentermine. In addition, SDX accordance with 21 CFR 1301.71– the drug’s labeling, or for research produced euphoria-related adverse 1301.77. Non-practitioners handling activities authorized by the FDCA and events in a HAP study. These data serdexmethylphenidate must also CSA. collectively suggest that SDX abuse may comply with the employee screening lead to limited psychological requirements of 21 CFR 1301.90– 9. Importation and Exportation. All dependence relative to drugs in 1301.93. These requirements, however, importation and exportation of schedule III and largely similar to that are not applicable to patients (end users) serdexmethylphenidate must be in of schedule IV stimulants. who possess serdexmethylphenidate compliance with 21 U.S.C. 952, 953, Based on these findings, the Acting pursuant to a lawful prescription. 957, and 958, and in accordance with 21 Administrator of DEA concludes that 4. Labeling and Packaging. All labels, CFR part 1312. SDX warrants control in schedule IV of labeling, and packaging for commercial 10. Liability. Any activity involving the CSA. 21 U.S.C. 812(b)(4). containers of serdexmethylphenidate serdexmethylphenidate not authorized must comply with 21 U.S.C. 825 and Requirements for Handling by, or in violation of, the CSA or its 958(e), and be in accordance with 21 implementing regulations, is unlawful, Serdexmethylphenidate CFR part 1302. and may subject the person to Serdexmethylphenidate is subject to 5. Inventory. Every DEA registrant the CSA’s schedule IV regulatory who possesses any quantity of administrative, civil, and/or criminal controls and administrative, civil, and serdexmethylphenidate must take an sanctions. criminal sanctions applicable to the inventory of serdexmethylphenidate on Regulatory Analyses manufacture, distribution, reverse hand, pursuant to 21 U.S.C. 827 and distribution, dispensing, importing, 958, and in accordance with 21 CFR Administrative Procedure Act exporting, research, and conduct of 1304.03, 1304.04, and 1304.11. instructional activities and chemical Any person who becomes registered Section 553 of the APA (5 U.S.C. 553) analysis with, and possession involving with DEA to handle generally requires notice and comment schedule IV substances, including the serdexmethylphenidate must take an for rulemakings. However, 21 U.S.C. following: initial inventory of all stocks of 811(j) provides that in cases where a 1. Registration. Any person who controlled substances (including certain new drug is (1) approved by handles (manufactures, distributes, serdexmethylphenidate) on hand on the HHS, under section 505(c) of the FDCA reverse distributes, dispenses, imports, date the registrant first engages in the and (2) HHS recommends control in exports, engages in research, or handling of controlled substances, CSA schedule II–V, DEA shall issue an conducts instructional activities or pursuant to 21 U.S.C. 827 and 958(e), interim final rule scheduling the drug chemical analysis with, or possesses), or and in accordance with 21 CFR 1304.03, within 90 days. As stated in the legal who desires to handle, 1304.04, and 1304.11. authority section, the 90-day time frame serdexmethylphenidate, must be After the initial inventory, every DEA is the later of: (1) The date DEA receives registered with DEA to conduct such registrant must take a new inventory of HHS’s scientific and medical activities pursuant to 21 U.S.C. 822, all stocks of controlled substances evaluation/scheduling recommendation, 823, 957, and 958 and in accordance (including serdexmethylphenidate) on or (2) the date DEA receives notice of with 21 CFR parts 1301 and 1312. Any hand every two years, pursuant to 21 the NDA approval by HHS. person who currently handles or U.S.C. 827 and 958(e), and in Additionally, subsection (j) specifies intends to handle accordance with 21 CFR 1304.03, that the rulemaking shall become serdexmethylphenidate and is not 1304.04, and 1304.11. These immediately effective as an interim final registered with DEA must submit an requirements, however, are not rule without requiring DEA to application for registration and may not applicable to patients (end users) who demonstrate good cause. continue to handle possess serdexmethylphenidate serdexmethylphenidate unless DEA has pursuant to a lawful prescription. Executive Orders 12866 (Regulatory approved that application for 6. Records and Reports. DEA Planning and Review) and 13563 registration, pursuant to 21 U.S.C. 822, registrants must maintain records and (Improving Regulation and Regulatory 823, 957, and 958, and in accordance submit reports for Review) with 21 CFR parts 1301 and 1312. These serdexmethylphenidate, pursuant to 21 registration requirements, however, are U.S.C. 827, 832(a), and 958(e), and in In accordance with 21 U.S.C. 811(a) not applicable to patients (end users) accordance with 21 CFR 1301.74(b) and and (j), this scheduling action is subject who possess serdexmethylphenidate (c) and parts 1304, 1312, and 1317. to formal rulemaking procedures pursuant to a lawful prescription. 7. Prescriptions. All prescriptions for performed ‘‘on the record after 2. Disposal of stocks. Any person who serdexmethylphenidate, or products opportunity for a hearing,’’ which are obtains a schedule IV registration to containing serdexmethylphenidate, conducted pursuant to the provisions of handle serdexmethylphenidate but who must comply with 21 U.S.C. 829, and be 5 U.S.C. 556 and 557. The CSA sets subsequently does not desire or is not issued in accordance with 21 CFR parts forth the procedures and criteria for able to maintain such registration must 1306 and 1311, subpart C. scheduling a drug or other substance. surrender all quantities of 8. Manufacturing and Distributing. In Such actions are exempt from review by serdexmethylphenidate or may transfer addition to the general requirements of the Office of Management and Budget all quantities of serdexmethylphenidate the CSA and DEA regulations that are (OMB) pursuant to section 3(d)(1) of to a person registered with DEA in applicable to manufacturers and Executive Order (E.O.) 12866 and the accordance with 21 CFR part 1317, in distributors of schedule IV controlled principles reaffirmed in E.O. 13563.

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Executive Order 12988, Civil Justice organizations. An agency may not Championship. This special local Reform conduct or sponsor, and a person is not regulation prohibits non-participant This regulation meets the applicable required to respond to, a collection of persons and vessels from entering, standards set forth in sections 3(a) and information unless it displays a transiting through, anchoring in, or 3(b)(2) of E.O. 12988 to eliminate currently valid OMB control number. remaining within the race area and prohibits vessels from transiting at drafting errors and ambiguity, minimize Congressional Review Act litigation, provide a clear legal standard speeds that cause wake within the for affected conduct, and promote This rule is not a major rule as spectator area unless authorized by simplification and burden reduction. defined by the Congressional Review Captain of the Port Sector Ohio Valley Act (CRA), 5 U.S.C. 804. However, or a designated representative. Executive Order 13132, Federalism pursuant to the CRA, DEA is submitting DATES: This rule is effective from 6 a.m. This rulemaking does not have a copy of this interim final rule to both until 6 p.m. from May 8, 2021, to May federalism implications warranting the Houses of Congress and to the 9, 2021. Comptroller General. application of E.O. 13132. The rule does ADDRESSES: To view documents not have substantial direct effects on the List of Subjects in 21 CFR Part 1308 mentioned in this preamble as being States, on the relationship between the available in the docket, go to https:// national government and the States, or Administrative practice and procedure, Drug traffic control, www.regulations.gov, type USCG–2021– on the distribution of power and 0215 in the ‘‘SEARCH’’ box and click responsibilities among the various Reporting and recordkeeping requirements. ‘‘SEARCH.’’ Click on Open Docket levels of government. Folder on the line associated with this For the reasons set out above, DEA Executive Order 13175, Consultation rule. amends 21 CFR part 1308 as follows: and Coordination With Indian Tribal FOR FURTHER INFORMATION CONTACT: If Governments PART 1308—SCHEDULES OF you have questions on this rule, call or This rule does not have tribal CONTROLLED SUBSTANCES email Petty Officer First Class Nicholas implications warranting the application Jones, Marine Safety Detachment of E.O. 13175. It does not have ■ 1. The authority citation for part 1308 Nashville, U.S. Coast Guard; telephone substantial direct effects on one or more continues to read as follows: 615–736–5421, email Nicholas.J.Jones@ Indian tribes, on the relationship Authority: 21 U.S.C. 811, 812, 871(b), uscg.mil. between the Federal government and 956(b) unless otherwise noted. SUPPLEMENTARY INFORMATION: Indian tribes, or on the distribution of ■ 2. In § 1308.14: I. Table of Abbreviations power and responsibilities between the ■ a. Redesignate paragraphs (f)(11) Federal government and Indian tribes. through (13) as (f)(12) through (14); and CFR Code of Federal Regulations DHS Department of Homeland Security Regulatory Flexibility Act ■ b. Add new paragraph (f)(11). The addition reads as follows: FR Federal Register The Regulatory Flexibility Act (RFA) NPRM Notice of proposed rulemaking (5 U.S.C. 601–612) applies to rules that § 1308.14 Schedule IV. § Section U.S.C. United States Code are subject to notice and comment * * * * * under section 553(b) of the APA. As (f) * * * II. Background Information and noted in the above discussion regarding (11) Serdexmethylphenidate ...... 1729 Regulatory History the applicability of the APA, DEA is not required to publish a general notice of * * * * * The Coast Guard is issuing this proposed rulemaking. Consequently, the temporary rule without prior notice and D. Christopher Evans, opportunity to comment pursuant to RFA does not apply to this interim final Acting Administrator. rule. authority under section 4(a) of the [FR Doc. 2021–09738 Filed 5–6–21; 8:45 am] Administrative Procedure Act (APA) (5 Unfunded Mandates Reform Act of 1995 BILLING CODE 4410–09–P U.S.C. 553(b)). This provision In accordance with the Unfunded authorizes an agency to issue a rule Mandates Reform Act (UMRA) of 1995, without prior notice and opportunity to 2 U.S.C. 1501 et seq., DEA has DEPARTMENT OF HOMELAND comment when the agency for good determined that this action would not SECURITY cause finds that those procedures are result in any Federal mandate that may ‘‘impracticable, unnecessary, or contrary result ‘‘in the expenditure by State, Coast Guard to the public interest.’’ Under 5 U.S.C. local, and tribal governments, in the 553(b)(B), the Coast Guard finds that aggregate, or by the private sector, of 33 CFR Part 100 good cause exists for not publishing a $100,000,000 or more (adjusted [Docket Number USCG–2021–0215] notice of proposed rulemaking (NPRM) annually for inflation) in any 1 year.’’ with respect to this rule because it is RIN 1625–AA08 Therefore, neither a Small Government impracticable. We must establish this temporary safety zone by May 8, 2021 Agency Plan nor any other action is Special Local Regulation; Clinch River, and lack sufficient time to provide a required under UMRA of 1995. Oak Ridge, TN reasonable comment period and then Paperwork Reduction Act of 1995 AGENCY: Coast Guard, DHS. consider those comments before issuing This action does not impose a new ACTION: Temporary final rule. the rule. collection of information requirement Under 5 U.S.C. 553(d)(3), the Coast under the Paperwork Reduction Act of SUMMARY: The Coast Guard establishes a Guard finds that good cause exists for 1995. 44 U.S.C. 3501–3521. This action temporary special local regulation for all making this rule effective less than 30 would not impose recordkeeping or navigable waters on the Clinch River days after publication in the Federal reporting requirements on State or local from mile marker (MM) 48.5 to MM 52.0 Register. Delaying the effective date of governments, individuals, businesses, or during the U.S. Rowing Southeast Youth this rule would be contrary to the public

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