74832 Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / 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. November 7, 2022) (order postponing 

effective date), Doc. No. 104. See also ‘‘Tobacco 

Products; Required Warnings for Cigarette Packages 

and Advertisements; Delayed Effective Date,’’ 87 FR 

72384 (November 25, 2022). 

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

(E.D. Tex. December 7, 2022) (opinion and order; 

final judgment), Docs. No. 106; 107. 

4R.J. Reynolds Tobacco Co. et al., v. United States 

Food and Drug Administration et al., No. 23–40076 

(5th Cir. March 21, 2024) (panel opinion), Doc. No. 

140–1. 

5R.J. Reynolds Tobacco Co. et al., No. 23–40076 

(5th Cir. May 21, 2024) (order denying petition for 

rehearing), Doc. No. 162–2. 

6R.J. Reynolds Tobacco Co. et al., No. 23–40076 

(5th Cir. May 29, 2024) (mandate), Doc. No. 163– 

2. 

Warnings for Cigarette Packages and 

Advertisements.’’ This guidance 

describes FDA’s enforcement policy for 

the final rule, ‘‘Tobacco Products; 

Required Warnings for Cigarette 

Packages and Advertisements’’ (85 FR 

15638, March 18, 2020; codified at 21 

CFR part 1141), which established new 

required cigarette health warnings for 

cigarette packages and advertisements. 

The guidance is intended to assist 

entities required to comply with the 

rule. We are issuing this guidance 

consistent with our good guidance 

practices (GGP) regulation (21 CFR 

10.115). We are implementing this 

guidance without prior public comment 

because we have determined that prior 

public participation is not feasible or 

appropriate (§ 10.115(g)(2)). We made 

this determination because FDA needs 

to communicate its enforcement policy 

in a timely manner given that the rule 

is now in effect due to developments in 

litigation, as explained below. Although 

this guidance document is being 

implemented immediately, it remains 

subject to comment in accordance with 

FDA’s GGP regulation. 

In the Federal Register of March 18, 

2020, FDA 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 statements. The 

Tobacco Control Act amends the 

Federal Cigarette Labeling and 

Advertising Act (15 U.S.C. 1333) 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. Additionally, the final 

rule requires the random and equal 

display and distribution of the required 

warnings for cigarette packages and 

quarterly rotation of the required 

warnings for cigarette advertisements in 

accordance with an FDA-approved plan 

(referred to as cigarette plans), 

consistent with the Tobacco Control 

Act. 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 The 

District Court issued multiple orders 

postponing the effective date of the rule, 

the most recent of which postponed the 

effective date to November 6, 2023.2 On 

December 7, 2022, the District Court 

issued an order vacating the rule.3 On 

March 21, 2024, the U.S. Court of 

Appeals for the Fifth Circuit issued an 

opinion reversing the District Court and 

concluding that FDA’s rule is consistent 

with the First Amendment.4 The 

opinion remanded the case to the 

District Court for consideration of 

plaintiffs’ remaining claims. A petition 

for rehearing en banc was denied on 

May 21, 2024,5 and the court’s mandate 

issued on May 29, 2024.6 Accordingly, 

the rule is no longer vacated. Because 

the November 6, 2023, date in the 

District Court’s most recent order 

postponing the rule’s effective date has 

passed, the rule is now in effect. 

FDA recognizes that some 

manufacturers, distributors, and 

retailers already may have begun to 

prepare to implement the rule’s 

requirements. For instance, some 

manufacturers, distributors, and 

retailers already have submitted and 

obtained approval of cigarette plans. 

Even so, FDA recognizes that entities 

may need time to implement the rule’s 

requirements. In the guidance, FDA sets 

out its enforcement policy for the final 

rule. As discussed in the guidance, FDA 

intends to exercise enforcement 

discretion and generally not enforce 

requirements of the final rule for 15 

months after the issuance of this 

guidance, until December 12, 2025. FDA 

also intends to exercise enforcement 

discretion and generally not enforce 

requirements of the final rule for an 

additional 30 days, until January 12, 

2026, with respect to products 

manufactured before December 12, 

2025. These time periods are consistent 

with section 201(b) of the Tobacco 

Control Act and the effective date of the 

final rule upon its publication. As FDA 

recommended at the time of publication 

of the final rule, FDA recommends that 

entities that do not already have 

approved cigarette plans submit such 

plans as soon as possible, but in any 

event, within 5 months, by February 10, 

2025. 

The guidance represents the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR 1141.10 have been approved 

under OMB control number 0910–0877. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

guidance at https://

www.regulations.gov, https://

www.fda.gov/tobacco-products/rulesregulations-and-guidance/guidance, or 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20850 Filed 9–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 501 

Reporting, Procedures and Penalties 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Interim final rule; request for 

comments. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is issuing this interim 

final rule to amend the Reporting, 

Procedures and Penalties Regulations 

(the ‘‘Regulations’’), extending 

recordkeeping requirements for certain 

transactions from five to 10 years, 

consistent with the statute of limitations 


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Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Rules and Regulations 74833 

for violations of certain sanctions 

administered by the Office of Foreign 

Assets Control (OFAC). 

DATES: 

Effective date: This interim final rule 

is effective March 12, 2025. 

Comments due date: Written 

comments may be submitted on or 

before October 15, 2024. 

ADDRESSES: You may submit comments 

via the following methods, electronic is 

preferred: 

Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions on the website for 

submitting comments. Refer to Docket 

Number OFAC–2024–0004. 

Mail: Office of Foreign Assets Control, 

U.S. Department of the Treasury, 

Treasury Annex/Freedman’s Bank 

Building, 1500 Pennsylvania Avenue 

NW, Washington, DC 20220. Refer to 

Docket Number OFAC–2024–0004. 

Instructions: All submissions received 

must include the agency name and the 

Federal Register Doc. number that 

appears at the end of this document. All 

comments, including attachments and 

other supporting materials, will become 

part of the public record and subject to 

public disclosure. Sensitive personal 

information, such as account numbers 

or Social Security numbers, should not 

be included. Comments generally will 

not be edited to remove any identifying 

or contact information. 

FOR FURTHER INFORMATION CONTACT: 

Assistant Director for Licensing, 202– 

622–2480; Assistant Director for 

Regulatory Affairs, 202–622–4855; 

Assistant Director for Compliance, 202– 

622–2490 or https://ofac.treasury.gov/ 

contact-ofac. 

SUPPLEMENTARY INFORMATION: 

Background 

On April 24, 2024, the President 

signed into law the 21st Century Peace 

through Strength Act, Public Law 118– 

50, div. D (the ‘‘Act’’). Section 3111 of 

the Act extended from five years to 10 

years the statute of limitations for civil 

and criminal violations of the 

International Emergency Economic 

Powers Act, 50 U.S.C. 1701 et seq. 

(IEEPA), and the Trading with the 

Enemy Act, 50 U.S.C. 4301 et seq. 

(TWEA). Prior to the Act’s enactment, 

civil enforcement actions brought by 

OFAC under IEEPA or TWEA were 

subject to the five-year statute of 

limitations set forth in 28 U.S.C. 2462. 

The new 10-year statute of limitations— 

codified at 50 U.S.C. 1705(d) and 

4315(d)—became effective upon the 

President’s signature of the Act on April 

24, 2024. This new 10-year statute of 

limitations applies to any violation that 

was not time-barred at the time of its 

enactment. Consequently, OFAC may 

now commence an enforcement action 

for civil violations of IEEPA- or TWEAbased sanctions prohibitions within 10 

years of the latest date of the violation 

if such date was after April 24, 2019. As 

set forth in the Act, the commencement 

of a civil enforcement action includes 

the issuance of a pre-penalty notice or 

a finding of violation. 

To match the new statute of 

limitations period, OFAC is publishing 

this interim final rule extending from 

five years to 10 years the recordkeeping 

requirements codified at 31 CFR 

501.601, paragraph IV.B of appendix A 

to part 501, and 515.572. OFAC is 

soliciting public comments for 30 days 

on this interim final rule. 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website: https://

ofac.treasury.gov. 

Public Participation 

Because the amendment of the 

Regulations is a rule of agency 

procedure and involves a foreign affairs 

function, the provisions of Executive 

Order 12866 of September 30, 1993, 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993), as 

amended, and the Administrative 

Procedure Act (5 U.S.C. 553) requiring 

notice of proposed rulemaking, 

opportunity for public participation, 

and delay in effective date are 

inapplicable. Because no notice of 

proposed rulemaking is required for this 

rule, the Regulatory Flexibility Act (5 

U.S.C. 601–612) does not apply. 

Paperwork Reduction Act 

Pursuant to the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3507), the 

collections of information related to 31 

CFR 501.601, paragraph IV.B of 

appendix A to part 501, and 515.572 

have been previously approved by the 

Office of Management and Budget 

(OMB) under control number 1505– 

0164. This final rule modifies the 

requirements for recordkeeping under 

these sections by increasing the period 

for recordkeeping to 10 years from five 

years to align with a statutory 

amendment. This modification to this 

collection of information, as well as an 

unrelated consolidation of certain OFAC 

information collections, will be 

submitted to OMB for review under 

control number 1505–0164. Written 

comments and recommendations for the 

modified collection can be submitted by 

visiting https://www.reginfo.gov/public/ 

do/PRAMain. Find this document by 

selecting ‘‘Currently Under Review— 

Open for Public Comments’’ or by using 

the search function. Comments are 

welcome and must be received by 

November 13, 2024. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless the collection of information 

displays a valid control number. The 

likely filers and record-keepers affected 

by these collections of information 

contained in 31 CFR part 501 are 

financial institutions, business 

organizations, nonprofit organizations, 

individuals, households, nongovernmental organizations, and legal 

representatives. 

The burden of the recordkeeping 

requirement imposed by this rule is 

minimal because the records required to 

be maintained are likely maintained 

under standard business practice. The 

recent increase in the recordkeeping 

period to 10 years from five years could 

impose a temporary incremental burden 

on recordkeepers while they update 

their recordkeeping practices and adjust 

storage requirements to maintain 

records for a longer period of time. 

Accordingly, the total burden for this 

collection is estimated to be: 

Estimated Number of Respondents: 

2,505,086. 

Frequency of Response: When 

requested by OFAC. 

Estimated Total Number of Annual 

Responses: 2,505,086. 

Estimated Time per Response: No 

additional time to retain records for 

additional time. 

Comments are invited on: (a) Whether 

the collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information has practical 

utility; (b) the accuracy of the agency’s 

estimate of the burden of the collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

required to provide information. 

List of Subjects in 31 CFR Part 501 

Administrative practice and 

procedure, Banks, Banking, Exports, 

Foreign trade, Licensing and 

registration, Penalties, Reporting and 

recordkeeping requirements. 

For the reasons set forth in the 

preamble, OFAC amends 31 CFR parts 

501 and 515 as follows: 


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74834 Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Rules and Regulations 

PART 501—REPORTING, 

PROCEDURES AND PENALTIES 

REGULATIONS 

■ 1. The authority citation for part 501 

continues to read as follows: 

Authority: 8 U.S.C. 1189; 18 U.S.C. 2332d, 

2339B; 19 U.S.C. 3901–3913; 21 U.S.C. 1901– 

1908; 22 U.S.C. 287c, 2370(a), 6009, 6032, 

7205, 8501–8551; 31 U.S.C. 321(b); 50 U.S.C. 

1701 et seq., 4301–4341; Pub. L. 101–410, 

104 Stat. 890, as amended (28 U.S.C. 2461 

note). 

Subpart C—Reports 

■ 2. Revise and republish § 501.601 to 

read as follows: 

§ 501.601 Records and recordkeeping 

requirements. 

Except as otherwise provided, every 

person engaging in any transaction 

subject to the provisions of this chapter 

shall keep a full and accurate record of 

each such transaction engaged in, 

regardless of whether such transaction 

is effected pursuant to license or 

otherwise, and such record shall be 

available for examination for at least 10 

years after the date of such transaction. 

Except as otherwise provided, every 

person holding property blocked 

pursuant to the provisions of this 

chapter or funds transfers retained 

pursuant to § 596.504(b) of this chapter 

shall keep a full and accurate record of 

such property, and such record shall be 

available for examination for the period 

of time that such property is blocked 

and for at least 10 years after the date 

such property is unblocked. 

■ 3. Revise paragraph IV.B of appendix 

A to part 501 to read as follows: 

Appendix A to Part 501—Economic 

Sanctions Enforcement Guidelines 

* * * * * 

IV. * * * 

B. The late filing of a required report, 

whether set forth in regulations or in a 

specific license, may result in a civil 

monetary penalty in an amount up to $3,550, 

if filed within the first 30 days after the 

report is due, and a penalty in an amount up 

to $7,104 if filed more than 30 days after the 

report is due. If the report relates to blocked 

assets, the penalty may include an additional 

$1,422 for every 30 days that the report is 

overdue, up to 10 years. 

* * * * * 

PART 515—CUBAN ASSETS 

CONTROL REGULATIONS 

■ 4. The authority citation for part 515 

continues to read as follows: 

Authority: 22 U.S.C. 2370(a), 6001–6010, 

7201–7211; 31 U.S.C. 321(b); 50 U.S.C. 4301 

et seq.; Pub. L. 101–410, 104 Stat. 890 (28 

U.S.C. 2461 note); 22 U.S.C. 6021–6091; Pub. 

L. 105–277, 112 Stat. 2681; Pub. L. 111–8, 

123 Stat. 524; Pub. L. 111–117, 123 Stat. 

3034; E.O. 9989, 13 FR 4891, 3 CFR, 1943– 

1948 Comp., p. 748; Proc. 3447, 27 FR 1085, 

3 CFR, 1959–1963 Comp., p. 157; E.O. 12854, 

58 FR 36587, 3 CFR, 1993 Comp., p. 614. 

■ 5. Revise and republish paragraph 

(b)(1) of § 515.572 as follows: 

§ 515.572 Provision of travel, carrier, other 

transportation-related, and remittance 

forwarding services. 

* * * * * 

(b) * * * 

(1) Persons subject to U.S. jurisdiction 

providing services authorized pursuant 

to paragraphs (a)(1) through (4) of this 

section must retain for at least 10 years 

from the date of the transaction a 

certification from each customer 

indicating the section of this part that 

authorizes the person to travel or send 

remittances to Cuba. In the case of a 

customer traveling under a specific 

license, the specific license number or 

a copy of the license must be 

maintained on file with the person 

subject to U.S. jurisdiction providing 

services authorized pursuant to this 

section. 

* * * * * 

Lisa M. Palluconi, 

Acting Director, Office of Foreign Assets 

Control. 

[FR Doc. 2024–20674 Filed 9–11–24; 8:45 am] 

BILLING CODE 4810–AL–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2024–0255; FRL–12071– 

02–R1] 

Air Plan Approval; New Hampshire; 

Ambient Air Quality Standards 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving most of a 

State Implementation Plan (SIP) 

revision submitted by the State of New 

Hampshire. This revision updates the 

State regulation containing ambient air 

quality standards. EPA is approving all 

the State’s updated standards, except 

the primary annual fine particle (PM2.5) 

standard, which we are conditionally 

approving because it does not match 

EPA’s current National Ambient Air 

Quality Standard for PM2.5. This action 

is being taken in accordance with the 

Clean Air Act. 

DATES: This rule is effective on October 

15, 2024. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R01–OAR– 

2024–0255. All documents in the docket 

are listed on the https://

www.regulations.gov website. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available at https://

www.regulations.gov or at the U.S. 

Environmental Protection Agency, EPA 

Region 1 Regional Office, Air and 

Radiation Division, 5 Post Office 

Square—Suite 100, Boston, MA. EPA 

requests that if at all possible, you 

contact the contact listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 a.m. to 

4:30 p.m., excluding legal holidays and 

facility closures due to COVID–19. 

FOR FURTHER INFORMATION CONTACT: 

Alison C. Simcox, Air Quality Branch, 

Air and Radiation Division (Mail Code 

5–MD), U.S. Environmental Protection 

Agency, Region 1, 5 Post Office Square, 

Suite 100, Boston, Massachusetts, 

02109–3912, (617) 918–1684; 

simcox.alison@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. 

Table of Contents 

I. Background and Purpose 

II. Final Action 

III. Incorporation by Reference 

IV. Statutory and Executive Order Reviews 

I. Background and Purpose 

On July 11, 2024 (89 FR 56825), EPA 

published a Notice of Proposed 

Rulemaking (NPRM) for the State of 

New Hampshire. 

The NPRM proposed approval of New 

Hampshire’s update to its Env-A 300, 

‘‘Ambient Air Quality Standards’’ 

(AAQS). The formal SIP revision was 

submitted by the state on December 22, 

2022. 

EPA determined that the state’s 

updated AAQS are consistent with the 

National Ambient Air Quality Standards 

(NAAQS) in 40 CFR part 50 for all 

standards except the PM2.5 primary 

annual standard, which EPA 

strengthened subsequent to New 

Hampshire’s SIP submittal (89 FR 

16202). 


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