Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date, 36509-36510 [2021-14678]

Download as PDF 36509 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Rules and Regulations Country Entity License requirement China Academy of Electronics and Information Technology, a.k.a., the following two aliases: —CAEIT; and —CETC CAEIT. 3rd Floor, 9 St. Clare Street, London, United Kingdom. (See alternative address under China.) * * * * * * * * * * * * Supplement No. 6 to Part 744 [Amended] 3. Supplement No. 6 to part 744 is amended under UNITED ARAB 86 FR [INSERT FR PAGE NUMBER, 7/12/21]. * * Kazan Helicopter Plant Repair Service’’ to read as follows: 4. 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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 Food and Drug Administration, Jkt 253001 Final rule; delay of effective 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 13, 2022. DATES: The effective date of the rule amending 21 CFR part 1141 published at 85 FR 15638, March 18, 2020, delayed at 85 FR 32293, May 29, 2020, and 86 FR 3793, January 15, 2021, is further delayed until July 13, 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 SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES 19:45 Jul 09, 2021 * date. BILLING CODE 3510–33–P HHS. * ACTION: [FR Doc. 2021–14656 Filed 7–9–21; 8:45 am] khammond on DSKJM1Z7X2PROD with RULES Case-by-case review for ECCNs 1A004.c, 1A004.d, 1A995, 1A999.a, 1D003, 2A983, 2D983, and 2E983, and for EAR99 items described in the Note to ECCN 1A995; case-by-case review for items necessary to detect, identify and treat infectious disease; and presumption of denial for all other items subject to the EAR. * * EMIRATES by removing the entry for ‘‘TEM International FZC’’. Country VerDate Sep<11>2014 Federal Register citation ■ ■ AGENCY: All items subject to the EAR. (See § 744.11 of the EAR). License review policy PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 * * 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 E:\FR\FM\12JYR1.SGM 12JYR1 36510 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Rules and Regulations khammond on DSKJM1Z7X2PROD with RULES 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 The court ordered that the new effective date of the final rule is July 13, 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 July 13, 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. 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. VerDate Sep<11>2014 16:15 Jul 09, 2021 Jkt 253001 Dated: June 24, 2021. Janet Woodcock, Acting Commissioner of Food and Drugs. Dated: July 06, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2021–14678 Filed 7–9–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF EDUCATION 34 CFR Chapter II [Docket ID ED–2021–OESE–0036] Final Priorities and Requirement— Innovative Approaches to Literacy Office of Elementary and Secondary Education (OESE), Department of Education. ACTION: Final priorities and requirement. AGENCY: The Department of Education (Department) announces four priorities and one requirement under the Innovative Approaches to Literacy (IAL) program, Assistance Listing Number 84.215G. The Department may use one or more of these priorities and requirement for competitions in fiscal year (FY) 2021 and later years. DATES: These priorities are effective August 11, 2021. FOR FURTHER INFORMATION CONTACT: Simon Earle, U.S. Department of Education, 400 Maryland Avenue SW, Room 3E254, Washington, DC 20202– 6450. Telephone: (202) 453–7923. Email: Simon.Earle@ed.gov. If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1–800–877– 8339. SUMMARY: SUPPLEMENTARY INFORMATION: Purpose of Program: The IAL program supports high-quality programs designed to develop and improve literacy skills for children and students from birth through 12th grade in highneed local educational agencies (LEAs) and schools. The Department intends to promote innovative literacy programs that support the development of literacy skills in low-income communities, including programs that: (1) Develop and enhance effective school library programs, which may include providing professional development for school librarians, books, and up-to-date materials to high-need schools; (2) provide early literacy services, including pediatric literacy programs through which, during well-child visits, PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 medical providers trained in researchbased methods of early language and literacy promotion provide developmentally appropriate books and recommendations to parents to encourage them to read aloud to their children starting in infancy; and (3) provide high-quality books on a regular basis to children and adolescents from low-income communities to increase reading motivation, performance, and frequency. Program Authority: 20 U.S.C. 6646. We published a notice of proposed priorities and requirement (NPP) for this program in the Federal Register on April 6, 2021 (86 FR 17757). The priorities included in the NPP were: Proposed Priority 1—Projects, Carried Out in Coordination with School Libraries, for Book Distribution, Childhood Literacy Activities, or Both; Proposed Priority 2—Providing a Learning Environment That Is Racially, Ethnically, Culturally, Disability and Linguistically Responsive and Inclusive, Supportive, and Identity-safe; Proposed Priority 3—Supporting Students in Urban Areas; and Proposed Priority 4— Supporting Students from Low-Income Families. The requirement included in the NPP set forth eligibility criteria. The NPP contained background information and our reasons for proposing the particular priorities and requirement. There are differences between Proposed Priority 2 and Final Priority 2 as discussed in the Analysis of Comments and Changes section elsewhere in this notice. Except for minor editorial and technical revisions, there are no significant changes to Priorities 1, 3, and 4 and the requirement from the NPP. Public Comment: In response to our invitation in the NPP, 28 parties submitted comments, which, in total, addressed all four of the proposed priorities and requirement. Two comments were not relevant to the proposed priorities and are not included in the discussions below. We group major issues according to subject. Generally, we do not address technical and other minor changes, or suggested changes the law does not authorize us to make under the applicable statutory authority. In addition, we do not address the two comments that were not directly related to the NPP. Analysis of Comments and Changes: An analysis of the comments and of any changes in the priorities and requirement since publication of the NPP follows. Comment: One commenter applauded the Department for supporting school library programs during the COVID–19 E:\FR\FM\12JYR1.SGM 12JYR1

Agencies

[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Rules and Regulations]
[Pages 36509-36510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14678]


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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 July 13, 2022.

DATES: The effective date of the rule amending 21 CFR part 1141 
published at 85 FR 15638, March 18, 2020, delayed at 85 FR 32293, May 
29, 2020, and 86 FR 3793, January 15, 2021, is further delayed until 
July 13, 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: 
[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

[[Page 36510]]

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\ The court ordered that the new 
effective date of the final rule is July 13, 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.
---------------------------------------------------------------------------

    \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.
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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 July 13, 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: June 24, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: July 06, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-14678 Filed 7-9-21; 8:45 am]
BILLING CODE 4164-01-P

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