Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date, 70052-70053 [2021-26643]
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Rules and Regulations
■ 12. In § 356.12, revise paragraph (a)(5)
to read as follows:
§ 356.12 Sanctions for violation of a
protective order or disclosure undertaking.
(a) * * *
(5) Required to destroy and certify to
the Department the destruction of all
material previously provided by the
investigating authority, and all other
materials containing the proprietary
information, such as briefs, notes, or
charts based on any such information
received under a protective order or a
disclosure undertaking.
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■ 13. In § 356.14, revise paragraphs
(d)(2) and (4) to read as follows:
§ 356.14 Report of violation and
investigation.
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(d) * * *
(2) Failure to follow the detailed
procedures outlined in the protective
order for safeguarding proprietary
information, including requiring all
employees who obtain access to
proprietary information (under the
terms of a protective order granted their
employer) to sign and date a copy of
that protective order.
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(4) Failure to destroy and certify to
the Department the destruction of all
copies of the original documents and all
notes, memoranda, and submissions
containing proprietary information at
the close of the proceeding for which
the data were obtained by burning or
shredding of the documents or by
erasing electronic memory, computer
disk, or tape memory, as set forth in the
protective order.
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■ 14. In § 356.18, revise paragraph (c)(4)
to read as follows:
§ 356.18
Interim sanctions.
khammond on DSKJM1Z7X2PROD with RULES
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(c) * * *
(4) Requiring the person to destroy
and certify to the Department the
destruction of all material previously
provided by the Department or the
investigating authority of the involved
FTA country, and all other materials
containing the proprietary information,
such as briefs, notes, or charts based on
any such information received under a
protective order or disclosure
undertaking.
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■ 15. In § 356.27, revise the paragraph
(d) subject heading to read as follows:
§ 356.27
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Final decision.
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VerDate Sep<11>2014
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16:33 Dec 08, 2021
Jkt 256001
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(d) Contents of final decision. * * *
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[FR Doc. 2021–26551 Filed 12–8–21; 8:45 am]
BILLING CODE 3510–DS–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.
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 9, 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; and 86 FR 50854,
September 13, 2021, is further delayed
until January 9, 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)
SUMMARY:
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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 The court ordered that the new
effective date of the final rule is January
9, 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.
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.
7 R.J. Reynolds Tobacco Co., No. 6:20–cv–00176
(E.D. Tex. November 12, 2021) (order postponing
effective date), Doc. No. 93.
E:\FR\FM\09DER1.SGM
09DER1
Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Rules and Regulations
553(b)(B). Seeking public comment is
impracticable, unnecessary, and
contrary to the public interest. The 90day postponement of the effective date,
until January 9, 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: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26643 Filed 12–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
22 CFR Part 126
[Public Notice: 11601]
RIN 1400–AF47
International Traffic in Arms
Regulations: Addition of Cambodia to
List of Proscribed Countries
Department of State.
ACTION: Final rule.
AGENCY:
khammond on DSKJM1Z7X2PROD with RULES
VerDate Sep<11>2014
16:33 Dec 08, 2021
Jkt 256001
Regulatory Analysis and Notices
Administrative Procedure Act
The Department of State is
amending the International Traffic in
Arms Regulations (ITAR) to add
Cambodia in the list of countries for
which it is the policy of the United
States to deny licenses and other
approvals for exports and imports of
defense articles and defense services.
This change reflects that it is the policy
of the United States to deny all licenses
and other approvals to export and
import defense articles and defense
services destined for or originating in
Cambodia, except as otherwise provided
herein.
DATES: The rule is effective on
December 9, 2021.
FOR FURTHER INFORMATION CONTACT: Ms.
Engda Wubneh, Foreign Affairs Officer,
Office of Defense Trade Controls Policy,
U.S. Department of State, telephone
(202) 663–1809, or email
DDTCCustomerService@state.gov.
ATTN: Regulatory Change, ITAR
Section 126.1 Cambodia.
SUPPLEMENTARY INFORMATION: On June 1,
2021, the Department expressed serious
concerns about the People’s Republic of
China’s (PRC’s) military presence and
other activities in Cambodia and
emphasized that a PRC military base in
Cambodia would undermine Cambodian
sovereignty, threaten regional security,
SUMMARY:
and negatively impact U.S.-Cambodia
relations. Senior officials at the
Departments of State and Defense
continue to voice these concerns but
Cambodia continues to allow the PRC to
expand its military presence and
construct exclusive-use facilities on the
Gulf of Thailand.
In response to significant credible
evidence of corruption, human rights
abuses, and an exclusive agreement
with the People’s Republic of China
(PRC) on military expansion in
Cambodia by the Cambodian
government, effective immediately, the
Department is amending ITAR § 126.1
by adding Cambodia in paragraph (o)
and revising the country policy chart in
paragraph (d)(2). The policy of denial
applies to licenses or other approvals for
exports and imports of defense articles
and defense services destined for or
originating in Cambodia, with
exceptions related to conventional
weapons destruction and humanitarian
demining activities. This action also
precludes the use of exemptions from
licensing or other approval
requirements as described in that
section.
The Department of State is of the
opinion that controlling the import and
export of defense articles and services is
a military or foreign affairs function of
the United States Government and that
rules implementing this function are
exempt from sections 553 (rulemaking)
and 554 (adjudications) of the
Administrative Procedure Act (APA),
pursuant to 5 U.S.C. 553(a)(1). Since
this rule is exempt from 5 U.S.C 553, the
provisions of section 553(d) do not
apply to this rulemaking. Therefore, this
rule is effective upon publication.
Regulatory Flexibility Act
Since this rule is exempt from the
notice-and-comment provisions of 5
U.S.C. 553(b), there is no requirement
for an analysis under the Regulatory
Flexibility Act.
Unfunded Mandates Reform Act of 1995
This rulemaking does not involve a
mandate that will result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
in any year and it will not significantly
or uniquely affect small governments.
Therefore, no actions are deemed
necessary under the provisions of the
Unfunded Mandates Reform Act of
1995.
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70053
Congressional Review Act
This amendment has been found not
to be a major rule within the meaning
of the Small Business Regulatory
Enforcement Fairness Act of 1996.
Executive Orders 12372 and 13132
This rulemaking will not have
substantial direct effects on the States,
on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with Executive Order 13132,
the Department has determined that this
rulemaking does not have sufficient
federalism implications to require
consultations or warrant the preparation
of a federalism summary impact
statement. The regulations
implementing Executive Order 12372
regarding intergovernmental
consultation on Federal programs and
activities do not apply to this
rulemaking.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributed impacts, and equity).
Because the scope of this rule does not
impose additional regulatory
requirements or obligations, the
Department believes costs associated
with this rule will be minimal. This rule
has not been designated a ‘‘significant
regulatory action’’ by the Office and
Information and Regulatory Affairs
under Executive Order 12866.
Executive Order 12988
The Department of State has reviewed
this rulemaking in light of Executive
Order 12988 to eliminate ambiguity,
minimize litigation, establish clear legal
standards, and reduce burden.
Executive Order 13175
The Department of State has
determined that this rulemaking will
not have tribal implications, will not
impose substantial direct compliance
costs on Indian tribal governments, and
will not preempt tribal law.
Accordingly, Executive Order 13175
does not apply to this rulemaking.
Paperwork Reduction Act
This rulemaking does not impose or
revise any information collections
subject to 44 U.S.C. Chapter 35.
E:\FR\FM\09DER1.SGM
09DER1
]]>Agencies
[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Rules and Regulations]
[Pages 70052-70053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26643]
=======================================================================
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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.
-----------------------------------------------------------------------
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 9, 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;
and 86 FR 50854, September 13, 2021, is further delayed until January
9, 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:
[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\ On November 12, 2021, the court issued another
order to postpone the effective date of the final rule by an additional
90 days.\7\ The court ordered that the new effective date of the final
rule is January 9, 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.
---------------------------------------------------------------------------
\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.
\7\ R.J. Reynolds Tobacco Co., No. 6:20-cv-00176 (E.D. Tex.
November 12, 2021) (order postponing effective date), Doc. No. 93.
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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.
[[Page 70053]]
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 9, 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: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26643 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P
