Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date, 50854-50855 [2021-19688]

Download as PDF lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Rules and Regulations ... ·''1".1,1,. ,. .''t. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1141 [Docket No. FDA–2019–N–3065] Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date RIN 0910–AI39 !1 Food and Drug Administration, Fmt 4700 11· I'· Sfmt 4700 '1 . E:\FR\FM\13SER1.SGM 13SER1 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 October 11, 2022. DATES: The effective date of the rule amending 21 CFR part 1141 published March 18, 2020, at 85 FR 15638, and delayed at 85 FR 32293, May 29, 2020; 86 FR 3793, January 15, 2021; and 86 FR 36509, July 12, 2021, is further delayed until October 11, 2022. FOR FURTHER INFORMATION CONTACT: Courtney Smith, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, Document Control t-' ·. 1.•1 .. I ••·1.'.1'1 U'."1·.•.1·r·1· ~. ,1. . . . . I li I 1.•.jll • I' Final rule; delay of effective AGENCY: HHS. ACTION: Frm 00018 date. PO 00000 •1 1 •. j I II UH.J ,, 111•1• II , IIIt 1Ullf' •1· I, : 1 1u lfi' 1 uu !I' 'J.' !1.t tl1it ii~t'i ti tttWt NfitltdU'f 1 11 1 41·b.1.li.f1.•.lll'.'.l 1·.l 1.IJ.,J.1. . 1 .f ,,.11\ .frl. i . l f .1dl i}. tll.t:i·.·1·H.·l 1, ••111 -. !1·.lti l!1n11-•.•.•.t i••1ilh1, 11 1 l }• ; . 1f. d Ir ll• } 1f . llrr ff.Ii' l', J1 1 J.11l!•· il JI 1'1'111: I 11i 11·1 Ht 11·.J I 1.111.·. il,U 50854 (2) Long notice. By direction of the Commission. April J. Tabor, Secretary. Jkt 253001 [FR Doc. 2021–19465 Filed 9–10–21; 8:45 am] 16:20 Sep 10, 2021 BILLING CODE 6750–01–C VerDate Sep<11>2014 ER13SE21.004</GPH> 1 1 ,f1'.1 n 1·1.•lt-. 1,. !-if h 1J1f1 1.1..,.h. 11,1·1·l.·1l1.nJ~,i.irh . ,. •-l-1·• ,.Ip, . l•1 l"·l1r•·1p·. . 111:f' ,ai1f 1.·.•1 lI IT l t ,· , . i .. r JlI !J11111 l ·•illI " I rt ·I.'·•1. 11·1' . !I' .. I 1'.1·l.·1·.'·l, I h• J·.lt.tJ· 1.111' . · . . ~ . · ' . 1 . ,1•·1. HJ l••lll +I l-1: · f Ul "·:l• A-t1• 1 IH ..1·11,1 1 l .... 1 : lhf .t1·;.ll·i.·.11,.i11.J.f.rt11.:tl.l t1i.ll.t{1 ~:.•.ft1. If.It l t fl1•lb,••lf:1•ll r1!lh• lP1l1 m,. ,h,1ff •ff. it.t'ifH.1~1."tt.·.111 n.1~.·1.111.t1 rfli r·f 1f ..•i l,11-r•11 !f• i l!tUl •rt·l 'li · 1!1 1 1 1l.rn•. ~ f1'l. itru . ·, 11.' l .lUf W HHttJt. ,..1 •· 11• IPldl"·,l'J.l"·••".1 •r'1'l·i'P1".l l1 1 11i.tnru.· . r Jf lh (-1 f ·111•1· l, 111· I g 1111n11ru • t1f IJ11Jli~t' r. . lt 'I f1 .,,I'' Ulti, 1h -I I' 1U 1•t 11.t.UlJ 11 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 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 The 1 R.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). 2 R.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. 3 R.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. 4 R.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. 5 R.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. 6 R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 (E.D. Tex. August 18, 2021) (order postponing effective date), Doc. No. 92. VerDate Sep<11>2014 16:20 Sep 10, 2021 Jkt 253001 court ordered that the new effective date of the final rule is October 11, 2022. 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 90day postponement of the effective date, until October 11, 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 issuance and implementation of regulations. Dated: September 3, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–19688 Filed 9–10–21; 8:45 am] BILLING CODE 4164–01–P FEDERAL MEDIATION AND CONCILIATION SERVICE 29 CFR Part 1402 RIN 3076–AA16 Notice to Mediation Agency Federal Mediation and Conciliation Service (FMCS). ACTION: Final rule. AGENCY: The Federal Mediation and Conciliation Service (FMCS), issues a final rule amending its existing regulations to modify the submission method of information collection request, Notice to Mediation Agency, (Agency Form F–7) and remove the form titled ‘‘Notice to Mediation Agencies.’’ DATES: This final rule is effective September 13, 2021. ADDRESSES: Please contact the person identified in the FOR FURTHER INFORMATION CONTACT section for additional availability information. FOR FURTHER INFORMATION CONTACT: Arthur Pearlstein, Director, Arbitration, Notice Processing, Shared Neutrals, apearlstein@fmcs.gov, 202–606–8103. SUPPLEMENTARY INFORMATION: SUMMARY: PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 50855 I. Background Parties to private-sector collective bargaining agreements must file certain notices with the Federal Mediation Conciliation Service pursuant to 29 U.S.C. 158(d)(3). This modification changes the submission process of information collection request, Notice to Mediation Agency (Agency Form F–7), from mail-in to electronic submission. This revision is necessary to increase efficiency of FMCS both by allowing FMCS to receive Agency Form F–7’s more quickly, but also to reduce processing time. This will allow the Service to provide its services to the parties more quickly. This modification removes the language which includes the verbiage of the Form–F7, to allow for FMCS to modify the form, if necessary, without necessitating additional rule change. II. Authority for This Rulemaking FMCS’ authority to issue rules is found in 29 U.S.C. 172 of Taft Harley Act of 1947. This regulation is within the scope of that authority. III. Public Comment Period The public comment period on the proposed rule opened on July 22, 2021, the date of its publication in the Federal Register, and closed on August 23, 2021. During this period, FMCS did not receive any comments on our proposed action. List of Subjects in 29 CFR Part 1402 Administrative practice and procedure, Information collection requests, Labor management relations. For the reasons discussed in the preamble, and under the authority 29 U.S.C. 172 of the Taft Hartley Act of 1947, FMCS amends 29 CFR part 1402 as follows: ■ 1. The authority citation for part 1402 continues to read as follows: Authority: Sec. 202, 61 Stat. 153, sec. 3, 80 Stat. 250, sec. 203, 61 Stat. 153; 5 U.S.C. 552, 29 U.S.C. 172, 173. ■ 2. Revise § 1402.1 to read as follows: § 1402.1 Notice of dispute. The notice of dispute filed with the Federal Mediation and Conciliation Service pursuant to the provisions of section 8(d)(3), of the LaborManagement Relations Act, 1947, as amended, shall be submitted electronically via a platform provided by FMCS. If electronic submission creates an undue hardship, the filer may contact the FMCS Notice Processing office to explain the circumstances and receive assistance. The Form F–7, for use by the parties in filing a notice of E:\FR\FM\13SER1.SGM 13SER1

Agencies

[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Rules and Regulations]
[Pages 50854-50855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19688]


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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.

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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 October 11, 2022.

DATES: The effective date of the rule amending 21 CFR part 1141 
published March 18, 2020, at 85 FR 15638, and delayed at 85 FR 32293, 
May 29, 2020; 86 FR 3793, January 15, 2021; and 86 FR 36509, July 12, 
2021, is further delayed until October 11, 2022.

FOR FURTHER INFORMATION CONTACT: Courtney Smith, Office of Regulations, 
Center for Tobacco Products, Food and Drug Administration, Document 
Control

[[Page 50855]]

Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 
20993-0002, 1-877-287-1371, email: [email protected].

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\ The court ordered that the new effective date of 
the final rule is October 11, 2022. 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.
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    \1\ R.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).
    \2\ R.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.
    \3\ R.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.
    \4\ R.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.
    \5\ R.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.
    \6\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex. 
August 18, 2021) (order postponing effective date), Doc. No. 92.
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    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 October 11, 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 issuance and implementation of 
regulations.

    Dated: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19688 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P