Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Rules and Regulations 37733 

READINGLIBRARY/. You may obtain a 

copy from ASTM International, 100 Barr 

Harbor Drive, P.O. Box C700, West 

Conshohocken, PA 19428–2959; 

telephone (610) 832–9585; 

www.astm.org. You may inspect a copy 

at the Division of the Secretariat, U.S. 

Consumer Product Safety Commission, 

Room 820, 4330 East-West Highway, 

Bethesda, MD 20814, telephone (301) 

504–7479, email cpsc-os@cpsc.gov, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, email fr.inspection@

nara.gov, or go to: www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

Alberta E. Mills, 

Secretary Consumer Product Safety 

Commission. 

[FR Doc. 2022–13255 Filed 6–23–22; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–808] 

Schedules of Controlled Substances: 

Placement of Serdexmethylphenidate 

in Schedule IV 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: This final rule adopts, 

without change, an interim final rule 

with request for comments published in 

the Federal Register on May 7, 2021, 

placing serdexmethylphenidate, 

including its salts, isomers, and salts of 

isomers, in schedule IV of the 

Controlled Substances Act. 

DATES: Effective July 25, 2022. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: This final 

rule refers to the single entity, 

serdexmethylphenidate. The chloride 

salt of serdexmethylphenidate is 

chemically known as 3-[[[(1S)-1- 

carboxy-2-hydroxyethyl]- 

amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2- 

methoxy-2-oxo-1-phenylethyl]-1- 

piperidinyl]carbonyl

]oxy]methyl]pyridinium chloride. This 

rule maintains the placement of 

serdexmethylphenidate, including its 

salts, isomers, and salts of isomers, in 

schedule IV of the Controlled 

Substances Act (CSA), thereby 

facilitating the commercial distribution 

of AZSTARYS as a controlled 

substance. 

Background and Legal Authority 

Under the CSA, as amended in 2015 

by the Improving Regulatory 

Transparency for New Medical 

Therapies Act (section 2(b) of Pub. L. 

114–89), when the Drug Enforcement 

Administration (DEA) receives 

notification from the Department of 

Health and Human Services (HHS) that 

the Secretary has approved a certain 

new drug and HHS recommends control 

in the CSA schedule II–V, DEA is 

required to issue an interim final rule 

(IFR), with opportunity for public 

comment and to request a hearing, 

controlling the drug within a specified 

90-day timeframe and to subsequently 

issue a final rule. 21 U.S.C. 811(j). When 

controlling a drug pursuant to 

subsection (j), DEA must apply the 

scheduling criteria of 21 U.S.C. 811(b) 

through (d) and 812(b). 21 U.S.C. 

811(j)(3). 

On March 2, 2021, DEA received 

notification that the United States Food 

and Drug Administration approved, on 

that same date, a new drug application 

for AZSTARYS capsules for oral use, a 

combination drug product containing 

serdexmethylphenidate chloride (3- 

[[[(1S)-1-carboxy-2-hydroxyethyl]- 

amino]carbonyl]-1-[[[[(2R)-2-[(1R)-2- 

methoxy-2-oxo-1-phenylethyl]-1- 

piperidinyl]

carbonyl]oxy]methyl]pyridinium 

chloride) and dexmethylphenidate 

hydrochloride, for the treatment of 

Attention Deficit Hyperactivity Disorder 

in patients six years of age or older. In 

addition, on that same date, HHS 

recommended that DEA place 

serdexmethylphenidate in schedule IV 

of the CSA. On May 7, 2021, DEA, 

pursuant to 21 U.S.C. 811(j), published 

an IFR to place serdexmethylphenidate 

(including its salts, isomers, and salts of 

isomers) in schedule IV. 86 FR 24487. 

The IFR provided an opportunity for 

interested persons to submit comments, 

as well as file a request for hearing or 

waiver of hearing, on or before June 7, 

2021. DEA did not receive any requests 

for hearing or waiver of hearing. 

Comments Received 

In response to the IFR, DEA received 

seven comments. The submissions were 

from individuals or anonymous 

commenters. Four of the seven 

commenters were in support of the IFR 

to place serdexmethylphenidate in 

schedule IV of the CSA and one 

commenter was opposed to the 

placement of serdexmethylphenidate in 

schedule IV of the CSA. Of the two 

remaining comments, one had no 

relevant content and the other was 

against the scheduling of drugs in 

general and did not specifically 

comment on serdexmethylphenidate. 

This latter commenter associated the 

scheduling of substances with the ‘‘war 

on drugs,’’ which according to the 

commenter ‘‘has failed.’’ No response is 

necessary for the former comment and 

the latter comment is outside the scope 

of this current scheduling action and, 

therefore, these comments will not be 

addressed. 

Support of the Interim Final Rule 

Four commenters supported 

controlling serdexmethylphenidate as a 

schedule IV controlled substance. These 

commenters indicated support for 

scheduling serdexmethylphenidate 

under the CSA due to its similarity to 

phentermine, a schedule IV substance. 

Three of the commenters also 

recommended monitoring 

serdexmethylphenidate for increased 

public health risk or undertaking more 

clinical research to determine its longterm effects, but did not specify who 

should perform this monitoring or 

research. One of these commenters 

expressed concern about the misuse, 

including overprescribing, and abuse of 

stimulant medications in general, and 

believes that additional prevention 

measures are needed besides just 

placing the drug in schedule IV. 

DEA Response. DEA appreciates the 

support for this rulemaking. The 

requests for additional research or 

prevention measures suggested by the 

commenters are outside of DEA’s 

purview. Therefore, DEA has no 

response to these requests. 

Opposition to the Interim Final Rule 

One commenter opposed the IFR to 

control serdexmethylphenidate as a 

schedule IV drug. The commenter’s 

primary issue with the scheduling of 

serdexmethylphenidate was that, as a 

new drug, there was no documented 

evidence of abuse potential. While the 

commenter did not completely disagree 

with the placement of 

serdexmethylphenidate in schedule IV, 

the commenter suggested that DEA 

should ‘‘let scientists experiment with it 

first to determine if it has any beneficial 

use’’ or if serdexmethylphenidate is 

more effective for controlling Attention 

Deficit Hyperactivity Disorder compared 

to current drug treatments. Thus, the 

commenter thought DEA should only 

schedule serdexmethylphenidate if 

problems occur. The commenter also 

referred to ongoing clinical studies for 


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37734 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Rules and Regulations 

use of this substance in the treatment of 

Stimulant Use Disorder and the 

potential for future expansion of its use. 

DEA Response: Scheduling a drug 

does not preclude its use as a 

therapeutic medication. Substances are 

scheduled to protect the public health 

and safety. In addition, substances that 

are scheduled are subject to regulatory 

controls and administrative, civil, and 

criminal sanctions of the schedule that 

it is placed to allow an adequate supply 

of controlled substances while 

preventing those substances from being 

diverted for illicit purposes. Thus, 

pursuant to 21 U.S.C. 811(a), the CSA 

authorizes the Administrator of DEA, 

under authority delegated by the 

Attorney General, to control any drug or 

other substance if it is found that the 

drug or other substance has a potential 

for abuse, and makes with respect to 

such drug or other substance the 

findings prescribed by 21 U.S.C. 812(b). 

As discussed in the IFR, after 

considering the eight factors in 21 

U.S.C. 811(c), including consideration 

of the substance’s abuse potential based 

upon the available information and all 

relevant data, DEA concluded that 

serdexmethylphenidate warranted 

control in schedule IV of the CSA. 

The commenter’s reference to ongoing 

clinical studies investigating the 

usefulness of serdexmethylphenidate in 

stimulant use disorder and its future 

therapeutic potential is not relevant. 

DEA continues to support through this 

final rule its scheduling determination, 

and adopts the IFR, without change. 

Requirements for Handling 

Serdexmethylphenidate 

As indicated above, 

serdexmethylphenidate has been a 

schedule IV controlled substance by 

virtue of an IFR issued by DEA in May 

2021. Thus, this final rule does not alter 

the regulatory requirements applicable 

to handlers of serdexmethylphenidate 

that have been in place since that time. 

Nonetheless, for informational 

purposes, we restate here those 

requirements. Serdexmethylphenidate is 

subject to the CSA’s schedule IV 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, reverse 

distribution, dispensing, importing, 

exporting, research, and conduct of 

instructional activities and chemical 

analysis with, and possession involving 

schedule IV substances, including the 

following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, dispenses, imports, 

exports, engages in research, or 

conducts instructional activities or 

chemical analysis with, or possesses), or 

who desires to handle, 

serdexmethylphenidate, must be 

registered with DEA to conduct such 

activities pursuant to 21 U.S.C. 822, 

823, 957, and 958 and in accordance 

with 21 CFR parts 1301 and 1312. Any 

person who intends to handle 

serdexmethylphenidate, and is not 

registered with DEA, must submit an 

application for registration and may not 

handle serdexmethylphenidate unless 

DEA approves that application for 

registration, pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. These 

registration requirements, however, are 

not applicable to patients (end users) 

who possess serdexmethylphenidate 

pursuant to a lawful prescription. 

2. Disposal of stocks. Any person who 

obtains a schedule IV registration to 

handle serdexmethylphenidate but who 

subsequently does not desire or is not 

able to maintain such registration must 

surrender all quantities of 

serdexmethylphenidate or may transfer 

all quantities of serdexmethylphenidate 

to a person registered with DEA in 

accordance with 21 CFR part 1317, in 

additional to all other applicable 

Federal, State, local, and tribal laws. 

3. Security. Serdexmethylphenidate is 

subject to schedule III–V security 

requirements for DEA registrants and it 

must be handled and stored in 

accordance with 21 CFR 1301.71– 

1301.77. Non-practitioners handling 

serdexmethylphenidate must also 

comply with the employee screening 

requirements of 21 CFR 1301.90– 

1301.93. These requirements, however, 

are not applicable to patients (end users) 

who possess serdexmethylphenidate 

pursuant to a lawful prescription. 

4. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of serdexmethylphenidate 

must comply with 21 U.S.C. 825, and be 

in accordance with 21 CFR part 1302. 

5. Inventory. Every DEA registrant 

who possesses any quantity of 

serdexmethylphenidate was required to 

keep an inventory of 

serdexmethylphenidate on hand, as of 

May 7, 2021, pursuant to 21 U.S.C. 827 

and 958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11. These 

requirements, however, are not 

applicable to patients (end users) who 

possess serdexmethylphenidate 

pursuant to a lawful prescription. 

6. Records and Reports. DEA 

registrants must maintain records and 

submit reports for 

serdexmethylphenidate, pursuant to 21 

U.S.C. 827 and 832(a), and in 

accordance with 21 CFR 1301.74(b) and 

(c) and parts 1304, 1312, and 1317. 

7. Prescriptions. All prescriptions for 

serdexmethylphenidate, or products 

containing serdexmethylphenidate, 

must comply with 21 U.S.C. 829, and be 

issued in accordance with 21 CFR parts 

1306 and 1311, subpart C. 

8. Manufacturing and Distributing. In 

addition to the general requirements of 

the CSA and DEA regulations that are 

applicable to manufacturers and 

distributors of schedule IV controlled 

substances, such registrants should be 

advised that (consistent with the 

foregoing considerations) any 

manufacturing or distribution of 

serdexmethylphenidate may only be for 

the legitimate purposes consistent with 

the drug’s labeling, or for research 

activities authorized by the Federal 

Food and Drug Cosmetic Act and the 

CSA. 

9. Importation and Exportation. All 

importation and exportation of 

serdexmethylphenidate must be in 

compliance with 21 U.S.C. 952, 953, 

957, and 958, and in accordance with 21 

CFR part 1312. 

10. Liability. Any activity involving 

serdexmethylphenidate not authorized 

by, or in violation of, the CSA or its 

implementing regulations, is unlawful, 

and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Administrative Procedure Act 

This final rule, without change, 

affirms the amendment made by the IFR 

that is already in effect. Section 553 of 

the Administrative Procedure Act (APA) 

(5 U.S.C. 553) generally requires notice 

and comment for rulemakings. 

However, 21 U.S.C. 811(j) provides that 

in cases where a certain new drug is: (1) 

Approved by HHS) and (2) HHS 

recommends control in CSA schedule 

II–V, DEA shall issue an IFR scheduling 

the drug within 90 days. Additionally, 

subsection (j) specifies that the 

rulemaking shall become immediately 

effective as an IFR without requiring 

DEA to demonstrate good cause. DEA 

issued an IFR on May 7, 2021, and 

solicited public comments on that rule. 

Subsection (j) further states that after 

giving interested persons the 

opportunity to comment and to request 

a hearing, the Attorney General, as 

delegated to the Administrator of DEA, 

shall issue a final rule in accordance 

with the scheduling criteria of 21 U.S.C. 

811(b) through (d) and 812(b). DEA is 

now responding to the comments 

submitted by the public and issuing the 

final rule, in accordance with 21 U.S.C. 

811(j). 


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Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Rules and Regulations 37735 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

In accordance with 21 U.S.C. 811(a) 

and (j), this scheduling action is subject 

to formal rulemaking procedures 

performed ‘‘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 procedures and 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. 

Executive Order 12988, Civil Justice 

Reform 

This 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 rulemaking does not have 

federalism implications warranting the 

application of E.O. 13132. The final rule 

does not have substantial direct effects 

on the states, on the relationship 

between the national government and 

the states, or on the distribution of 

power and responsibilities among the 

various levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This final 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 Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) applies to rules that 

are subject to notice and comment 

under section 553(b) of the APA. As 

noted in the above discussion regarding 

the applicability of the APA, DEA was 

not required to publish a general notice 

of proposed rulemaking. Consequently, 

the RFA does not apply. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined 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 action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995. 44 U.S.C. 3501–3521. This action 

would not impose recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. 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. 

Congressional Review Act 

This final rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. However, 

pursuant to the CRA, DEA is submitting 

a copy of this final rule to both Houses 

of Congress and to the Comptroller 

General. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on June 21, 2022, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

■ Accordingly, the interim final rule 

amending 21 CFR part 1308, which 

published on May 7, 2021 (86 FR 

24487), is adopted as a final rule 

without change. 

Scott Brinks, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2022–13538 Filed 6–23–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2022–0475] 

RIN 1625–AA08 

Special Local Regulation; Marine 

Events; Annual Bayview Mackinac 

Race, Lake Huron, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the special local regulations found in 33 

CFR 100.902 for the annual Bayview 

Yacht Club Port Huron to Mackinac 

Race. These special local regulations are 

necessary to safely control vessel 

movements in the vicinity of the race 

and provide for the safety of the general 

boating public and commercial 

shipping. During this enforcement 

period, no person or vessel may enter 

the regulated area without the 

permission of the Coast Guard Patrol 

Commander (PATCOM). 

DATES: The regulation in 33 CFR 

100.902 will be enforced from 10 a.m. 

through 3 p.m. on July 16, 2022. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this notice of 

enforcement, call or email Tracy Girard, 

Waterway Management Division, U.S. 

Coast Guard Sector Detroit, 110 Mt. 

Elliott Street, Detroit, MI at (313) 568– 

9564 or tracy.m.girard@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the special local 

regulation in 33 CFR 100.902 for the 

Annual Bayview Mackinac Race from 10 

a.m. through 3 p.m. on July 16, 2022. 

This notice of enforcement is necessary 

to safely control vessel movements in 

the vicinity of the race and provide for 

the safety of the general boating public 

and commercial shipping. This notice of 

enforcement applies to all U.S. 

navigable waters of the Black River, St. 

Clair River, and lower Lake Huron, 

bound by a line starting at latitude 

042°58′47′′ N, longitude 082°26′0′′ W; 

then easterly to latitude 042°58′24′′ N, 

longitude 082°24′47′′ W; then northward 

along the International Boundary to 

latitude 043°02′48′′ N, longitude 

082°23′47′′ W; then westerly to the 

shoreline at approximate location 

latitude 043°02′48′′ N, longitude 

082°26′48′′ W; then southward along the 

U.S. shoreline to latitude 042°58′54′′ N, 

longitude 082°26′01′′ W; then back to 

the beginning [DATUM: NAD 83]. 


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