32990 Federal Register / Vol. 87, No. 105 / Wednesday, June 1, 2022 / Rules and Regulations 

1R.J. Reynolds Tobacco Co. et al. v. United States 

Food and Drug Administration et al., No. 6:20–cv– 

00176 (E.D. Tex. filed April 3, 2020). 

2R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. May 8, 2020) (order granting joint motion 

and establishing schedule), Doc. No. 33. 

3R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. December 2, 2020) (order granting 

Plaintiffs’ motion and postponing effective date), 

Doc. No. 80. 

4R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. March 2, 2021) (order granting Plaintiffs’ 

motion and postponing effective date), Doc. No. 89. 

5R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. May 21, 2021) (order granting Plaintiffs’ 

motion and postponing effective date), Doc. No. 91. 

6R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. August 18, 2021) (order postponing 

effective date), Doc. No. 92. 

7R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. November 12, 2021) (order postponing 

effective date), Doc. No. 93. 

■ 2. Add § 870.1420 to subpart B to read 

as follows: 

§ 870.1420 Coronary artery disease risk 

indicator using acoustic heart signals. 

(a) Identification. A coronary artery 

disease risk indicator using acoustic 

heart signals is a device that records 

heart sounds including murmurs and 

vibrations to calculate a patient-specific 

risk of presence of coronary artery 

disease, as an aid in cardiac analysis 

and diagnosis. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

fulfill the following: 

(i) Testing must include a discussion 

of the patient population and any 

statistical techniques used for analyzing 

the data; and 

(ii) Testing must be representative of 

the intended use population for the 

device. Any selection criteria or sample 

limitations must be fully described and 

justified. 

(2) Acoustic performance testing must 

evaluate microphone sensitivity, sound 

acquisition bandwidth, and amplitude 

accuracy. The acoustic sensor 

specifications and mechanism used to 

capture heart sounds must be described. 

(3) A scientific justification for the 

validity of the algorithm(s) must be 

provided. This justification must fulfill 

the following: 

(i) All inputs and outputs of the 

algorithm must be fully described; 

(ii) The procedure for segmenting, 

characterizing, and classifying the 

acoustic signal must be fully described; 

and 

(iii) This justification must include 

verification of the algorithm 

calculations and validation using an 

independent data set. 

(4) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(5) Software verification, validation, 

and hazard analysis must be performed. 

(6) Human factors/usability testing 

must demonstrate that the user can 

correctly use the device, including 

device placement, based solely on 

reading the directions for use. 

(7) Performance data must 

demonstrate the electromagnetic 

compatibility and electrical safety of the 

device. 

(8) Labeling must include the 

following: 

(i) A description of what the device 

measures and outputs to the user; 

(ii) Instructions for proper placement 

of the device; 

(iii) Instructions on care and cleaning 

of the device; 

(iv) Warnings identifying sensor 

acquisition factors that may impact 

measurement results and instructions 

for mitigating these factors; and 

(v) The expected performance of the 

device for all intended use populations 

and environments. 

Dated: May 25, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11699 Filed 5–31–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1141 

[Docket No. FDA–2019–N–3065] 

RIN 0910–AI39 

Tobacco Products; Required Warnings 

for Cigarette Packages and 

Advertisements; Delayed Effective 

Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; delay of effective 

date. 

SUMMARY: As required by an order 

issued by the U.S. District Court for the 

Eastern District of Texas, this action 

delays the effective date of the final rule 

(‘‘Tobacco Products; Required Warnings 

for Cigarette Packages and 

Advertisements’’), which published on 

March 18, 2020. The new effective date 

is July 8, 2023. 

DATES: The effective date of the rule 

amending 21 CFR part 1141 published 

at 85 FR 15638, March 18, 2020, and 

delayed at 85 FR 32293, May 29, 2020; 

86 FR 3793, January 15, 2021; 86 FR 

36509, July 12, 2021; 86 FR 50855, 

September 13, 2021; 86 FR 70052, 

December 9, 2021; and 87 FR 11295, 

March 1, 2022, is further delayed until 

July 8, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Courtney Smith, Office of Regulations, 

Center for Tobacco Products, Food and 

Drug Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002, 1–877–287–1371, email: 

CTPRegulations@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 18, 2020, the 

Food and Drug Administration (FDA or 

Agency) issued a final rule establishing 

new cigarette health warnings for 

cigarette packages and advertisements. 

The final rule implements a provision of 

the Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) (Pub. L. 111–31) that requires FDA 

to issue regulations requiring color 

graphics depicting the negative health 

consequences of smoking to accompany 

new textual warning label statements. 

The Tobacco Control Act amends the 

Federal Cigarette Labeling and 

Advertising Act of 1965 (Pub. L. 89–92) 

to require each cigarette package and 

advertisement to bear one of the new 

required warnings. The final rule 

specifies the 11 new textual warning 

label statements and accompanying 

color graphics. Pursuant to section 

201(b) of the Tobacco Control Act, the 

rule was published with an effective 

date of June 18, 2021, 15 months after 

the date of publication of the final rule. 

On April 3, 2020, the final rule was 

challenged in the U.S. District Court for 

the Eastern District of Texas.1 On May 

8, 2020, the court granted a joint motion 

to govern proceedings in that case and 

postpone the effective date of the final 

rule by 120 days.2 On December 2, 2020, 

the court granted a new motion by the 

plaintiffs to postpone the effective date 

of the final rule by an additional 90 

days.3 On March 2, 2021, the court 

granted another motion by the plaintiffs 

to postpone the effective date of the 

final rule by an additional 90 days.4 On 

May 21, 2021, the court granted another 

motion by the plaintiffs to postpone the 

effective date of the final rule by an 

additional 90 days.5 On August 18, 

2021, the court issued an order to 

postpone the effective date of the final 

rule by an additional 90 days.6 On 

November 12, 2021, the court issued 

another order to postpone the effective 

date of the final rule by an additional 90 

days.7 On February 10, 2022, the court 

issued another order to postpone the 

effective date of the final rule by an 


jspears on DSK121TN23PROD with RULES1
Federal Register / Vol. 87, No. 105 / Wednesday, June 1, 2022 / Rules and Regulations 32991 

8R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. February 10, 2022) (order postponing 

effective date), Doc. No. 94. 

9R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. May 10, 2022) (order postponing effective 

date), Doc. No. 96. 

additional 90 days.8 On May 10, 2022, 

the court issued another order to 

postpone the effective date of the final 

rule by an additional 90 days.9 The 

court ordered that the new effective date 

of the final rule is July 8, 2023. Pursuant 

to the court order, any obligation to 

comply with a deadline tied to the 

effective date is similarly postponed, 

and those obligations and deadlines are 

now tied to the postponed effective 

date. 

To the extent that 5 U.S.C. 553 applies 

to this action, the Agency’s 

implementation of this action without 

opportunity for public comment, 

effective immediately upon publication 

today in the Federal Register, is based 

on the good cause exception in 5 U.S.C. 

553(b)(B). Seeking public comment is 

impracticable, unnecessary, and 

contrary to the public interest. The 90- 

day postponement of the effective date, 

until July 8, 2023, is required by court 

order in accordance with the court’s 

authority to postpone a rule’s effective 

date pending judicial review (5 U.S.C. 

705). Seeking prior public comment on 

this postponement would have been 

impracticable, as well as contrary to the 

public interest in the orderly issuance 

and implementation of regulations. 

Dated: May 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11568 Filed 5–31–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–990] 

Schedules of Controlled Substances: 

Placement of Ganaxolone in Schedule 

V 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Interim final rule; request for 

comments. 

SUMMARY: On March 18, 2022, the 

United States Food and Drug 

Administration approved a new drug 

application for ZTALMY, an oral 

suspension of ganaxolone, for the 

treatment of seizures associated with 

cyclin-dependent kinase-like 5 

deficiency disorder in patients two 

years of age and older. The Department 

of Health and Human Services provided 

the Drug Enforcement Administration 

with a scheduling recommendation to 

place ganaxolone and its salts in 

schedule V of the Controlled Substances 

Act. In accordance with the Controlled 

Substances Act, as amended by the 

Improving Regulatory Transparency for 

New Medical Therapies Act, Drug 

Enforcement Administration is hereby 

issuing an interim final rule placing 

ganaxolone, including its salts in 

schedule V of the Controlled Substances 

Act. 

DATES: This rule is effective June 1, 

2022. Comments must be submitted 

electronically or postmarked on or 

before July 1, 2022. Interested persons 

may file written comments on this 

rulemaking in accordance with 21 

U.S.C. 811(j)(3) and 21 CFR 1308.43(g). 

Commenters should be aware that the 

electronic Federal Docket Management 

System will not accept comments after 

11:59 p.m. Eastern Time on the last day 

of the comment period. 

Interested persons may file a request 

for a hearing or waiver of a hearing in 

accordance with 21 U.S.C. 811(j)(3) and 

21 CFR 1308.44. Requests for a hearing 

and waivers of an opportunity for a 

hearing or to participate in a hearing 

must be received on or before July 1, 

2022. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–990’’ on all correspondence, 

including any attachments. 

• Electronic comments: The Drug 

Enforcement Administration (DEA) 

encourages that all comments be 

submitted electronically through the 

Federal eRulemaking Portal, which 

provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to http:// 

www.regulations.gov and follow the 

online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number for your 

comment. Submitted comments are not 

instantaneously available for public 

view on Regulations.gov. If you have 

received a Comment Tracking Number, 

your comment has been successfully 

submitted and there is no need to 

resubmit the same comment. 

• Paper comments: Paper comments 

that duplicate electronic submissions 

are not necessary and are discouraged. 

Should you wish to mail a paper 

comment in lieu of an electronic 

comment, it should be sent via regular 

or express mail to: Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, VA 

22152. 

• Hearing requests: All requests for a 

hearing and waivers of participation, 

together with a written statement of 

position on the matters of fact and law 

asserted in the hearing, must be sent to: 

Drug Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152. All 

requests for hearing and waivers of 

participation should also be sent to: (1) 

Drug Enforcement Administration, Attn: 

Administrator, 8701 Morrissette Drive, 

Springfield, Virginia 22152; and (2) 

Drug Enforcement Administration, Attn: 

DEA Federal Register Representative/ 

DPW, 8701 Morrissette Drive, 

Springfield, Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug & Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: (571) 362– 

3249. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note, all comments received in 

response to this docket are considered 

part of the public record. The Drug 

Enforcement Administration (DEA) will 

make comments available, unless 

reasonable cause is given, for public 

inspection online at http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. The Freedom of 

Information Act applies to all comments 

received. If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want DEA to make 

it publicly available, you must include 

the phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all of the personal identifying 

information you do not want made 

publicly available in the first paragraph 

of your comment and identify what 

information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want DEA to make 

it publicly available, you must include 

the phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. 

DEA will generally make available in 

publicly redacted form comments 


jspears on DSK121TN23PROD with RULES1