Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Rules and Regulations 3793 

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. et al., 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. et al., No. 6:20–cv– 

00176 (E.D. Tex. May 8, 2020) (order granting 

Plaintiffs’ motion and postponing effective date), 

Doc. No. 80. 

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 January 14, 2022. 

DATES: The effective date of the rule 

amending 21 CFR part 1141 published 

at 85 FR 15638, March 18, 2020, is 

delayed until January 14, 2022. 

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: 

AskCTPRegulations@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 same Court granted a new motion by 

Plaintiffs in the same case to postpone 

the effective date of the final rule by an 

additional 90 days.3 The new effective 

date of the final rule is January 14, 2022. 

Pursuant to the court order, any 

obligation to comply with a deadline 

tied to the effective date of the final rule 

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 January 14, 2022, 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 issue and implementation of 

regulations. 

Dated: January 6, 2021. 

Stephen M. Hahn, 

Commissioner of Food and Drugs. 

Dated: January 8, 2021. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–00703 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 585 

Hong Kong-Related Sanctions 

Regulations 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Final rule. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is adding regulations to 

implement a July 14, 2020, Hong Kongrelated Executive order. OFAC intends 

to supplement these regulations with a 

more comprehensive set of regulations, 

which may include additional 

interpretive and definitional guidance, 

general licenses, and statements of 

licensing policy. 

DATES: This rule is effective January 15, 

2021. 

FOR FURTHER INFORMATION CONTACT: 

OFAC: Assistant Director for Licensing, 

202–622–2480; Assistant Director for 

Regulatory Affairs, 202–622–4855; or 

Assistant Director for Sanctions 

Compliance & Evaluation, 202–622– 

2490. 

SUPPLEMENTARY INFORMATION: 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website 

(www.treasury.gov/ofac). 

Background 

On July 14, 2020, the President, 

invoking the authority of, inter alia, the 

International Emergency Economic 

Powers Act (50 U.S.C. 1701–1706) 

(IEEPA), issued Executive Order (E.O.) 

13936 of July 14, 2020, ‘‘The President’s 

Executive Order on Hong Kong 

Normalization’’ (85 FR 43413, July 17, 

2020). 

In E.O. 13936, the President 

determined that, pursuant to section 202 

of the United States-Hong Kong Policy 

Act of 1992, the Special Administrative 

Region of Hong Kong (Hong Kong) is no 

longer sufficiently autonomous to justify 

differential treatment in relation to the 

People’s Republic of China (PRC or 

China) under the particular United 

States laws and provisions thereof set 

out in E.O. 13936. The President stated 

that in late May 2020, the National 

People’s Congress of China announced 

its intention to unilaterally and 

arbitrarily impose national security 

legislation on Hong Kong. He indicated 

that this announcement was China’s 

latest in a series of actions that have