Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Rules and Regulations 37729 

Commerce (Secretary) to designate, 

manage, and protect, as a national 

marine sanctuary, any area of the 

marine environment that is of special 

national significance due to its 

conservation, recreational, ecological, 

historical, scientific, cultural, 

archeological, educational, or esthetic 

qualities (16 U.S.C. 1431 et seq.). NMSA 

provides the legal basis and serves as 

the authority under which NOAA issues 

this action. 

Nicole R. LeBoeuf, 

Assistant Administrator for Ocean Services 

and Coastal Zone Management, National 

Ocean Service. 

[FR Doc. 2022–13570 Filed 6–23–22; 8:45 am] 

BILLING CODE 3510–NK–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1234 

[Docket No. CPSC–2015–0019] 

Safety Standard for Infant Bath Tubs 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Direct final rule. 

SUMMARY: In March 2017, the U.S. 

Consumer Product Safety Commission 

(CPSC) published a consumer product 

safety standard for infant bath tubs 

under section 104 of the Consumer 

Product Safety Improvement Act of 

2008 (CPSIA). The standard 

incorporated by reference the 2017 

ASTM voluntary standard for infant 

bath tubs that was in effect at the time. 

The CPSIA sets forth a process for 

updating mandatory standards for 

durable infant or toddler products that 

are based on a voluntary standard, when 

the voluntary standards organization 

revises the standard. Consistent with the 

CPSIA’s update process, the 

Commission issued a direct final rule in 

October 2018, that revised the 

incorporation by reference for the 

mandatory standard for infant bath tubs 

to reflect ASTM’s revised 2018 

voluntary standard. Also consistent 

with the CPSIA’s update process, this 

direct final rule again updates the 

mandatory standard for infant bath tubs 

to incorporate by reference ASTM’s 

2022 version of the voluntary standard. 

DATES: The rule is effective on 

September 24, 2022, unless CPSC 

receives a significant adverse comment 

by July 25, 2022. If CPSC receives such 

a comment, it will publish a document 

in the Federal Register, withdrawing 

this direct final rule before its effective 

date. The incorporation by reference of 

the publication listed in this rule is 

approved by the Director of the Federal 

Register as of September 24, 2022. 

ADDRESSES: You can submit comments, 

identified by Docket No. CPSC–2015– 

0019, by any of the following methods: 

Electronic Submissions: Submit 

electronic comments to the Federal 

eRulemaking Portal at: https://

www.regulations.gov. Follow the 

instructions for submitting comments. 

CPSC does not accept comments 

submitted by electronic mail (email), 

except as described below. CPSC 

encourages you to submit electronic 

comments by using the Federal 

eRulemaking Portal. 

Mail/Hand Delivery/Courier Written 

Submissions: Submit comments by 

mail/hand delivery/courier to: Division 

of the Secretariat, Consumer Product 

Safety Commission, 4330 East-West 

Highway, Bethesda, MD 20814; 

telephone: (301) 504–7479. If you wish 

to submit confidential business 

information, trade secret information, or 

other sensitive or protected information 

that you do not want to be available to 

the public, you may submit such 

comments by mail, hand delivery, or 

courier, or you may email them to: cpscos@cpsc.gov. 

Instructions: All submissions must 

include the agency name and docket 

number for this direct final rule. CPSC 

may post all comments without change, 

including any personal identifiers, 

contact information, or other personal 

information provided, to: https://

www.regulations.gov. Do not submit 

electronically: confidential business 

information, trade secret information, or 

other sensitive or protected information 

that you do not want to be available to 

the public. If you wish to submit such 

information, please submit it according 

to the instructions for mail/hand 

delivery/courier written submissions. 

Docket: For access to the docket to 

read background documents or 

comments received, go to: https://

www.regulations.gov, and insert the 

docket number, CPSC–2015–0019, into 

the ‘‘Search’’ box, and follow the 

prompts. 

FOR FURTHER INFORMATION CONTACT: 

Salman Sarwar, Compliance Officer, 

U.S. Consumer Product Safety 

Commission, 4330 East-West Highway, 

Bethesda, MD 20814; telephone: (301) 

504–7682; email: ssarwar@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background 

1. Statutory Authority 

Section 104(b)(1) of the CPSIA 

requires the Commission to assess the 

effectiveness of voluntary standards for 

durable infant or toddler products and 

to adopt mandatory standards for these 

products. 15 U.S.C. 2056a(b)(1). A 

mandatory standard must be 

‘‘substantially the same as’’ the 

corresponding voluntary standard, or it 

may be ‘‘more stringent than’’ the 

voluntary standard, if the Commission 

determines that more stringent 

requirements would further reduce the 

risk of injury associated with the 

product. Id. 

Section 104(b)(4)(B) of the CPSIA 

specifies the process for updating the 

Commission’s rules when a voluntary 

standards organization revises a 

standard that the Commission 

previously incorporated by reference 

under section 104(b)(1). First, the 

voluntary standards organization must 

notify the Commission of the revision. 

Once the Commission receives this 

notification, the Commission may reject 

or accept the revised standard. The 

Commission may reject the revised 

standard by notifying the voluntary 

standards organization, within 90 days 

of receiving notice of the revision, that 

it has determined that the revised 

standard does not improve the safety of 

the consumer product and that it is 

retaining the existing standard. If the 

Commission does not take this action to 

reject the revised standard, the revised 

voluntary standard will be considered a 

consumer product safety standard 

issued under section 9 of the Consumer 

Product Safety Act (15 U.S.C. 2058), 

effective 180 days after the Commission 

received notification of the revision or 

on a later date specified by the 

Commission in the Federal Register. 15 

U.S.C. 2056a(b)(4)(B). 

2. Safety Standard for Infant Bath Tubs 

Under section 104(b)(1) of the CPSIA, 

the Commission adopted a mandatory 

rule for infant bath tubs, codified in 16 

CFR part 1234. The rule incorporated by 

reference ASTM F2670–17, Standard 

Consumer Safety Specification for 

Infant Bath Tubs, with no 

modifications. 82 FR 15615 (March 30, 

2017). At the time the Commission 

published the final rule, ASTM F2670– 

17 was the current version of the 

voluntary standard. 

In July 2018, ASTM notified CPSC 

that it had issued a revised standard for 

infant bath tubs, ASTM F2670–18. The 

Commission concluded that the 

revisions improved the safety of infant 

bath tubs. As such, in accordance with 

the procedures set out in section 

104(b)(4)(B) of the CPSIA, the revised 

standard became the new mandatory 

standard for infant bath tubs. The 

Commission published a direct final 


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37730 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Rules and Regulations 

1ASTM also published ASTM F2670–22 in 

March 2022. 

2CPSC staff’s briefing package regarding ASTM 

F2670–22 is available at: https://www.cpsc.gov/s3fspublic/ASTMs-Revised-Safety-Standard-for-InfantBath-Tubs.pdf?VersionId=xRDuGZaaWMa44

CPG5rG2jwa0VdYy5c4M. 

3The Commission voted 3–0–1 to approve this 

notice. Chair Hoehn-Saric, Commissioners Feldman 

and Trumka voted to approve the notice as drafted. 

Commissioner Baiocco did not vote. 

4ASTM convened a task group, ASTM Ad Hoc 

Wording Task Group (Ad Hoc TG), consisting of 

members of the various durable nursery products 

voluntary standards committees, including CPSC 

staff. The purpose of the Ad Hoc TG is to harmonize 

the wording, as well as the warning format, across 

durable infant and toddler product voluntary 

standards. Ad Hoc TG recommendations were 

published as a reference document, titled, ‘‘Ad Hoc 

Wording—May 4, 2016,’’ as part of the F15 

Committee Documents. 

rule to update 16 CFR part 1234, 

incorporating by reference ASTM 

F2670–18, with no modifications. 83 FR 

53371 (Oct. 23, 2018). 

On March 28, 2022, ASTM notified 

CPSC that it has again revised the 

voluntary standard for infant bath tubs, 

by approving ASTM F2670–22 on 

March 1, 2022.1 As discussed in section 

B. Revisions to ASTM F2670, based on 

CPSC staff’s review of ASTM F2670– 

22,2 the Commission will allow the 

revised voluntary standard to become 

the mandatory standard because it 

improves the safety of infant bath tubs.3

Accordingly, by operation of law under 

section 104(b)(4)(B) of the CPSIA, 

ASTM F2670–22 will become the 

mandatory consumer product safety 

standard for infant bath tubs on 

September 24, 2022. 15 U.S.C. 

2056a(b)(4)(B). This direct final rule 

updates 16 CFR part 1234 to incorporate 

by reference the revised voluntary 

standard, ASTM F2670–22. 

B. Revisions to ASTM F2670 

The ASTM standard for infant bath 

tubs includes performance 

requirements, test methods, and 

requirements for warning labels and 

instructional literature, to address 

hazards to children associated with 

infant bath tubs. ASTM F2670–22 

contains substantive revisions as well as 

editorial, non-substantive revisions. 

Revisions to the standard includes 

changes to language in the standard 

describing latching and locking 

mechanisms (i.e., mechanisms that 

prevent the product from folding or 

collapsing in a manner that puts the 

occupant at risk) and new marking, 

labeling, warning, and instructional 

requirements addressing batterypowered infant bath tubs. This section 

describes the changes in ASTM F2670– 

22, as compared to ASTM F2670–18, 

which is the current mandatory 

standard, and includes an assessment of 

those changes. 

1. Substantive Revisions 

a. General Requirements 

The general requirement subsection 

Resistance to Collapse has been 

renamed Latching and Locking 

Mechanism(s). Section 5.4.1 has been 

edited to state that products that fold 

must have a latching and locking 

mechanism(s) or other means to prevent 

the product from folding or collapsing 

in a manner that puts the occupant at 

risk of injury by falling out of the 

product or being subjected to contact or 

pressure by product components. The 

standard states that ‘‘other means’’ can 

include, but are not limited to, designs 

that utilize the occupant, an added 

component, or the water that is placed 

into the product to act in opposition to 

the folding action or collapse of the 

product. Latching and locking 

mechanisms are subject to the same 

general and performance requirements 

as required in 16 CFR part 1234 (some 

non-substantive changes have been 

made to these requirements). 

These changes improve safety, 

because 16 CFR part 1234 currently 

does not explicitly require folding infant 

bath tubs or infant bath tub accessories 

to have latching and locking 

mechanisms or ‘‘other means’’ of 

preventing the product from folding or 

collapsing. 

b. Marking and Labeling 

Revisions to the 2022 standard 

include the addition of specific marking 

requirements for products that are 

battery-operated. Currently, 16 CFR part 

1234 does not contain any marking and 

labeling requirements specifically 

addressing battery-powered infant bath 

tubs. Section 8.4.1 of the 2022 standard 

states that the product’s battery 

compartment, battery compartment 

door/cover, or area immediately 

adjacent to the battery compartment 

must be marked or labeled permanently 

and legibly to show the correct battery 

polarity, size, and voltage. Products 

utilizing one or more non-replaceable 

batteries are exempt from this 

requirement. However, Section 8.4.2 

states that products utilizing one or 

more non-replaceable batteries 

accessible with the use of a coin, 

screwdriver, or other common 

household tool shall be marked or 

labeled permanently and legibly with a 

statement that the batteries are not 

replaceable. If marking or labeling the 

product is not practicable, then this 

statement shall be in the instructions. 

In addition to on-product marking/ 

labeling requirements, ASTM F2670–22 

now includes specific warning 

requirements for battery-powered infant 

bath tubs and infant bath tub accessories 

packaging. Section 8.11 states that 

packages of infant bath tubs and infant 

bath tub accessories that use replaceable 

button or coin cell batteries that are 1.5 

V or greater and that are larger than 15 

mm in diameter but fit within the small 

parts cylinder (see 16 CFR 1501) shall 

include the following warning: 

WARNING 

Contains button or coin cell battery. 

Hazardous if swallowed—see 

instructions. This warning is subject to 

the formatting requirements found in 

section 8.5, which contains no 

substantive changes. 

The changes in this section improve 

safety, as they address battery ingestion 

hazards, which are not currently 

addressed by 16 CFR part 1234. 

c. Instructional Literature 

The requirements for instructional 

literature in ASTM F2670–22 now 

include cautionary and warning 

statements specifically for batteryoperated products, which are not 

addressed in 16 CFR part 1234. Section 

9.4 Cautionary and Warning Statements 

now requires that products that operate 

using replaceable batteries include the 

following: 

CAUTION 

To prevent battery leaks, which can 

burn skin and eyes: 

• Remove batteries when storing 

product for a long time. 

• Dispose of used batteries 

immediately. 

Products that use more than one battery 

in any one circuit must also include the 

following statements under the same 

CAUTION header: 

• Always replace the entire set of 

batteries at one time. 

• Never mix old and new batteries, or 

batteries of different brands or types. 

These changes improve safety, as they 

address burn hazards caused by battery 

leaks, which are not currently addressed 

by 16 CFR part 1234. 

2. Non-Substantive Revisions 

ASTM F2670–22 also includes several 

non-substantive changes, such as 

spacing and formatting. ASTM also 

revised the language in the introduction 

and removed CPSIA from its list of 

referenced documents to bring the 

standard into alignment with current Ad 

Hoc Recommended Language.4 These 

changes to the text and formatting do 

not materially affect the safety of infant 

bath tubs. 


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5 15 U.S.C. 1278a. 

6 15 U.S.C. 2063(a)(5). 

7 15 U.S.C. 2056a(d). 

C. Incorporation by Reference 

Section 1234.2 of the direct final rule 

incorporates by reference ASTM F2670– 

22. The Office of the Federal Register 

(OFR) has regulations regarding 

incorporation by reference. 1 CFR part 

51. Under these regulations, agencies 

must discuss, in the preamble to a final 

rule, ways in which the material the 

agency incorporates by reference is 

reasonably available to interested 

parties, and how interested parties can 

obtain the material. In addition, the 

preamble to the final rule must 

summarize the material. 1 CFR 51.5(b). 

In accordance with the OFR 

regulations, section B. Revisions to 

ASTM F2670 of this preamble 

summarizes the major provisions of 

ASTM F2670–22 that the Commission 

incorporates by reference into 16 CFR 

part 1234. The standard is reasonably 

available to interested parties. Until the 

direct final rule takes effect, a read-only 

copy of ASTM F2670–22 is available for 

viewing, at no cost, on ASTM’s website 

at: https://www.astm.org/CPSC.htm. 

Once the rule takes effect, a read-only 

copy of the standard will be available 

for viewing, at no cost, on the ASTM 

website at: https://www.astm.org/ 

READINGLIBRARY/. Interested parties 

can also schedule an appointment to 

inspect a copy of the standard at CPSC’s 

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. 

Interested parties can purchase a copy 

of ASTM F2670–22 from ASTM 

International, 100 Barr Harbor Drive, 

P.O. Box C700, West Conshohocken, PA 

19428–2959 USA; telephone: (610) 832– 

9585; www.astm.org. 

D. Certification 

Section 14(a) of the Consumer 

Product Safety Act (CPSA; 15 U.S.C. 

2051–2089) requires manufacturers of 

products subject to a consumer product 

safety rule under the CPSA, or to a 

similar rule, ban, standard, or regulation 

under any other act enforced by the 

Commission, to certify that the products 

comply with all applicable CPSC 

requirements. 15 U.S.C. 2063(a). Such 

certification must be based on a test of 

each product, or on a reasonable testing 

program, or for children’s products, on 

tests of a sufficient number of samples 

by a third party conformity assessment 

body accredited by CPSC to test 

according to the applicable 

requirements. As noted, standards 

issued under section 104(b)(1)(B) of the 

CPSIA are ‘‘consumer product safety 

standards.’’ Thus, they are subject to the 

testing and certification requirements of 

section 14 of the CPSA. 

Because infant bath tubs are 

children’s products, a CPSC-accepted 

third party conformity assessment body 

must test samples of the products. 

Products subject to part 1234 also must 

comply with all other applicable CPSC 

requirements, such as the lead content 

requirements in section 101 of the 

CPSIA,5 the tracking label requirements 

in section 14(a)(5) of the CPSA,6 and the 

consumer registration form 

requirements in section 104(d) of the 

CPSIA.7 ASTM F2670–22 makes no 

changes that would impact any of these 

existing requirements. 

E. Notice of Requirements 

In accordance with section 

14(a)(3)(B)(vi) of the CPSA, the 

Commission previously published a 

notice of requirements (NOR) for 

accreditation of third party conformity 

assessment bodies for testing infant bath 

tubs. 82 FR 15615 (March 30, 2017). The 

NOR provided the criteria and process 

for CPSC to accept accreditation of third 

party conformity assessment bodies for 

testing infant bath tubs to 16 CFR part 

1234. The NORs for all mandatory 

standards for durable infant or toddler 

products are listed in the Commission’s 

rule, ‘‘Requirements Pertaining to Third 

Party Conformity Assessment Bodies,’’ 

codified in 16 CFR part 1112. Id. 

ASTM F2670–22 did not change the 

testing requirements, testing equipment, 

or testing protocols for infant bath tubs. 

Accordingly, the revisions do not 

change the way that third party 

conformity assessment bodies test these 

products for compliance with the safety 

standard for infant bath tubs. Testing 

laboratories that have demonstrated 

competence for testing in accordance 

with ASTM F2670–18 therefore are 

competent to test in accordance with the 

revised standard ASTM F2670–22. 

Laboratories will begin testing to the 

new standard when ASTM F2670–22 

goes into effect, and the existing 

accreditations that the Commission has 

accepted for testing to this standard will 

cover testing to the revised standard. 

Therefore, the Commission considers 

the existing CPSC-accepted laboratories 

for testing to ASTM F2670–18 to be 

capable of testing to ASTM F267–22 as 

well. Accordingly, the existing NOR for 

this standard will remain in place, and 

CPSC-accepted third party conformity 

assessment bodies are expected to 

update the scope of the testing 

laboratories’ accreditations to reflect the 

revised standard in the normal course of 

renewing their accreditations. 

F. Direct Final Rule Process 

The Commission is issuing this rule 

as a direct final rule. Although the 

Administrative Procedure Act (APA; 5 

U.S.C. 551–559) generally requires 

agencies to provide notice of a rule and 

an opportunity for interested parties to 

comment on it, section 553 of the APA 

provides an exception when the agency 

‘‘for good cause finds’’ that notice and 

comment are ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ Id. 553(b)(B). The Commission 

concludes that when it updates a 

reference to an ASTM standard that the 

Commission incorporated by reference 

under section 104(b) of the CPSIA, 

notice and comment are not necessary. 

Specifically, under the process set out 

in section 104(b)(4)(B) of the CPSIA, 

when ASTM revises a standard that the 

Commission has previously 

incorporated by reference under section 

104(b)(1)(B) of the CPSIA, that revision 

will become the new CPSC standard, 

unless the Commission determines that 

ASTM’s revision does not improve the 

safety of the product. Thus, unless the 

Commission makes such a 

determination, the ASTM revision 

becomes CPSC’s standard by operation 

of law. The Commission is allowing 

ASTM F2670–22 to become CPSC’s new 

standard because its provisions improve 

product safety. The purpose of this 

direct final rule is to update the Code of 

Federal Regulations (CFR) so that it 

reflects the version of the standard that 

takes effect by statute. This rule updates 

the reference in the CFR, but under the 

terms of the CPSIA, ASTM F2670–22 

takes effect as the new CPSC standard 

for infant bath tubs, even if the 

Commission does not issue this rule. 

Thus, public comments would not alter 

substantive changes to the standard or 

the effect of the revised standard as a 

consumer product safety standard under 

section 104(b) of the CPSIA. Under 

these circumstances, notice and 

comment are unnecessary. 

In Recommendation 95–4, the 

Administrative Conference of the 

United States (ACUS) endorses direct 

final rulemaking as an appropriate 

procedure to expedite rules that are 

noncontroversial and not expected to 

generate significant adverse comments. 

See 60 FR 43108 (Aug. 18, 1995). ACUS 

recommends that agencies use the direct 

final rule process when they act under 

the ‘‘unnecessary’’ prong of the good 

cause exemption in 5 U.S.C. 553(b)(B). 

Consistent with the ACUS 

recommendation, the Commission is 

publishing this rule as a direct final 


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rule, because CPSC does not expect any 

significant adverse comments. 

Unless CPSC receives a significant 

adverse comment within 30 days of this 

notification, the rule will become 

effective on September 24, 2022. In 

accordance with ACUS’s 

recommendation, the Commission 

considers a significant adverse comment 

to be ‘‘one where the commenter 

explains why the rule would be 

inappropriate,’’ including an assertion 

challenging ‘‘the rule’s underlying 

premise or approach,’’ or a claim that 

the rule ‘‘would be ineffective or 

unacceptable without a change.’’ 60 FR 

43108, 43111 (Aug. 18, 1995). As noted, 

this rule merely updates a reference in 

the CFR to reflect a change that occurs 

by statute, and public comments should 

address this specific action. 

If the Commission receives a 

significant adverse comment, the 

Commission will withdraw this direct 

final rule. Depending on the comment 

and other circumstances, the 

Commission may then incorporate the 

adverse comment into a subsequent 

direct final rule or publish a notice of 

proposed rulemaking, providing an 

opportunity for public comment. 

G. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA; 

5 U.S.C. 601–612) generally requires 

agencies to review proposed and final 

rules for their potential economic 

impact on small entities, including 

small businesses, and prepare regulatory 

flexibility analyses. 5 U.S.C. 603, 604. 

The RFA applies to any rule that is 

subject to notice and comment 

procedures under section 553 of the 

APA. Id. As discussed in section F. 

Direct Final Rule Process of this 

preamble, the Commission has 

determined that notice and the 

opportunity to comment are 

unnecessary for this rule. Therefore, the 

RFA does not apply. CPSC also notes 

the limited nature of this document, 

which merely updates the incorporation 

by reference to reflect the mandatory 

CPSC standard that takes effect under 

section 104 of the CPSIA. 

H. Paperwork Reduction Act 

The current mandatory standard for 

infant bath tubs includes requirements 

for marking, labeling, and instructional 

literature that constitute a ‘‘collection of 

information,’’ as defined in the 

Paperwork Reduction Act (PRA; 44 

U.S.C. 3501–3521). While the revised 

mandatory standard adds additional 

marking, labeling, and instructional 

literature language for battery-powered 

infant bath tubs, the new requirements 

would not add to the burden hours 

because the products already require 

marking, labeling, and instructional 

literature. The new requirements merely 

require a small amount of labeling 

language in addition to that already 

required by the standard, for infant bath 

tubs using batteries. Therefore, the new 

requirements are not measurably more 

burdensome than the existing 

requirements. The Commission took the 

steps required by the PRA for 

information collections when it 

promulgated 16 CFR part 1234, and the 

marking, labeling, and instructional 

literature for infant bath tubs are 

currently approved under OMB Control 

Number 3041–0159. Because the 

information collection burden is 

unchanged, the revision does not affect 

the information collection requirements 

or approval related to the standard. 

I. Environmental Considerations 

The Commission’s regulations 

provide a categorical exclusion for the 

Commission’s rules from any 

requirement to prepare an 

environmental assessment or an 

environmental impact statement where 

they ‘‘have little or no potential for 

affecting the human environment.’’ 16 

CFR 1021.5(c)(2). This rule falls within 

the categorical exclusion, so no 

environmental assessment or 

environmental impact statement is 

required. 

J. Preemption 

Section 26(a) of the CPSA provides 

that where a consumer product safety 

standard is in effect and applies to a 

product, no state or political 

subdivision of a state may either 

establish or continue in effect a 

requirement dealing with the same risk 

of injury unless the state requirement is 

identical to the federal standard. 15 

U.S.C. 2075(a). Section 26(c) of the 

CPSA also provides that states or 

political subdivisions of states may 

apply to CPSC for an exemption from 

this preemption under certain 

circumstances. Section 104(b) of the 

CPSIA deems rules issued under that 

provision ‘‘consumer product safety 

standards.’’ Therefore, once a rule 

issued under section 104 of the CPSIA 

takes effect, it will preempt in 

accordance with section 26(a) of the 

CPSA. 

K. Effective Date 

Under the procedure set forth in 

section 104(b)(4)(B) of the CPSIA, when 

a voluntary standards organization 

revises a standard that the Commission 

adopted as a mandatory standard, the 

revision becomes the CPSC standard 

within 180 days of notification to the 

Commission, unless the Commission 

timely notifies the standards 

organization that it has determined that 

the revision does not improve the safety 

of the product, or the Commission sets 

a later date in the Federal Register. 15 

U.S.C. 2056a(b)(4)(B). The Commission 

is taking neither of those actions with 

respect to the standard for infant bath 

tubs. Therefore, ASTM F2670–22 will 

take effect as the new mandatory 

standard for infant bath tubs on 

September 24, 2022, 180 days after 

March 28, 2022, when the Commission 

received notice of the revision. 

L. Congressional Review Act 

The Congressional Review Act (CRA; 

5 U.S.C. 801–808) states that before a 

rule may take effect, the agency issuing 

the rule must submit the rule, and 

certain related information, to each 

House of Congress and the Comptroller 

General. 5 U.S.C. 801(a)(1). The CRA 

submission must indicate whether the 

rule is a ‘‘major rule.’’ The CRA states 

that the Office of Information and 

Regulatory Affairs determines whether a 

rule qualifies as a ‘‘major rule.’’ 

Pursuant to the CRA, this rule does 

not qualify as a ‘‘major rule,’’ as defined 

in 5 U.S.C. 804(2). To comply with the 

CRA, CPSC will submit the required 

information to each House of Congress 

and the Comptroller General. 

List of Subjects in 16 CFR Part 1234 

Consumer protection, Imports, 

Incorporation by reference, Imports, 

Infants and children, Law enforcement, 

Safety, Toys. 

For the reasons discussed in the 

preamble, the Commission amends 16 

CFR chapter II as follows: 

PART 1234—SAFETY STANDARD FOR 

INFANT BATH TUBS 

■ 1. The authority citation for part 1234 

continues to read as follows: 

Authority: The Consumer Product Safety 

Improvement Act of 2008, Pub. L. 110–314, 

104, 122 Stat. 3016 (August 14, 2008); Pub. 

L. 112–28, 125 Stat. 273 (August 12, 2011). 

■ 2. Revise § 1234.2 to read as follows: 

§ 1234.2 Requirements for Infant Bath 

Tubs. 

Each infant bath tub must comply 

with all applicable provisions of ASTM 

F2670–22, Standard Consumer Safety 

Specification for Infant Bath Tubs, 

approved on March 1, 2022. The 

Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. A read-only copy of the 

standard is available for viewing on the 

ASTM website at https://www.astm.org/ 


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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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