Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Revised Effective Date, 8894 [2017-02174]

Download as PDF 8894 Federal Register / Vol. 82, No. 20 / Wednesday, February 1, 2017 / Rules and Regulations effective date for this action to give DOC officials the opportunity to further review and consider the revision, consistent with the Memorandum. The rule published November 25 containing the revision was exempt from notice and comment because it involved a military and foreign affairs function of the United States (See 5 U.S.C. 553(a)(1)). Given the imminence of the new effective date, seeking prior public comment on this temporary delay would be impractical, unnecessary, and also contrary to the public interest in the orderly promulgation and implementation of regulations. Dated: January 27, 2017. Matthew S. Borman, Deputy Assistant Secretary for Export Administration. [FR Doc. 2017–02164 Filed 1–31–17; 8:45 am] BILLING CODE 3510–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1105 [Docket No. FDA–2016–N–1555] Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Revised Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; delay of effective date. In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘‘Regulatory Freeze Pending Review,’’ this action revises the effective date of the final rule (‘‘Refuse to Accept Procedures for Premarket Tobacco Product Submissions’’) published December 29, 2016, from January 30, 2017, until March 21, 2017. DATES: The effective date of the rule that published on December 29, 2016, at 81 FR 95863, is delayed until March 21, 2017. SUMMARY: pmangrum on DSK3GDR082PROD with RULES FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993–0002, email: AskCTP@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On December 29, 2016, the Food and Drug Administration (FDA or Agency) issued a final rule describing when FDA will refuse to accept a tobacco product VerDate Sep<11>2014 15:00 Jan 31, 2017 Jkt 241001 submission (or application) because the application has not met a minimum threshold for acceptability for FDA review (81 FR 95863). Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. The rule was published with an effective date of January 30, 2017. FDA bases this action on the memorandum of January 20, 2017 (82 FR 8346), from the Assistant to the President and Chief of Staff, entitled ‘‘Regulatory Freeze Pending Review.’’ That memorandum directed the heads of Executive Departments and Agencies to temporarily postpone for 60 days from the date of the memorandum the effective dates of all regulations that had been published in the Federal Register but had not yet taken effect, for the purpose of ‘‘reviewing questions of fact, law, and policy they raise.’’ FDA, therefore, is revising the effective date of the rule that published on December 29, 2016 (81 FR 95863), to March 21, 2017. To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, 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 exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Seeking public comment is impracticable, unnecessary, and contrary to the public interest. The temporary delay in the effective date until March 21, 2017, is necessary to give Agency officials the opportunity for further review and consideration of the new regulation, consistent with the memorandum described previously. Given the imminence of the effective date and the brief length of the extension of the effective date, seeking prior public comment on this temporary delay would have been impracticable, as well as contrary to the public interest in the orderly promulgation and implementation of regulations.1 FDA also believes that affected entities need to be informed as soon as possible of the extension and its length in order to plan and adjust their implementation process accordingly. 1 In the event that this rule does not publish on or before January 30, 2017, good cause similarly exists to stay the effectiveness of the rule published December 29, 2016, and revise its effective date until March 21, 2017. PO 00000 Frm 00002 Fmt 4700 Sfmt 4700 Dated: January 27, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–02174 Filed 1–30–17; 11:15 am] BILLING CODE 4164–01–P DEPARTMENT OF JUSTICE 28 CFR Part 31 [Docket No.: OJP (OJJDP) 1719E] RIN 1121–AA83 Juvenile Justice and Delinquency Prevention Act Formula Grant Program Office of Justice Programs, Department of Justice. ACTION: Final rule; delay of effective date. AGENCY: On January 17, 2017, the Office of Juvenile Justice and Delinquency Prevention (‘‘OJJDP’’) of the U.S. Department of Justice’s Office of Justice Programs (‘‘OJP’’), published a partial final rule to amend portions of the formula grant program (‘‘Formula Grant Program’’) regulation to reflect changes in OJJDP policy. That rule is scheduled to become effective February 16, 2017. In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘‘Regulatory Freeze Pending Review,’’ this action hereby temporarily delays the effective date of the final rule entitled ‘‘Juvenile Justice and Delinquency Prevention Act Formula Grant Program’’ until March 21, 2017 (which is 60 days from January 20, 2017). This temporary delay will allow Department of Justice officials an opportunity to review any potential questions of fact, law and policy raised by this regulation, consistent with the Chief of Staff’s memorandum of January 20, 2017. DATES: This rule is effective February 1, 2017. The effective date of the final rule amending 28 CFR part 31 published in the Federal Register on January 17, 2017, at 82 FR 4783, is delayed to March 21, 2017. FOR FURTHER INFORMATION CONTACT: Mr. Gregory Thompson, Senior Advisor, Office of Juvenile Justice and Delinquency Prevention, at 202–307– 5911. SUMMARY: The OJJDP Formula Grant Program is authorized by the Juvenile Justice and Delinquency Prevention Act (‘‘JJDPA’’). The JJDPA authorizes OJJDP to provide an annual grant to each State to improve its juvenile justice system and to support SUPPLEMENTARY INFORMATION: E:\FR\FM\01FER1.SGM 01FER1

Agencies

[Federal Register Volume 82, Number 20 (Wednesday, February 1, 2017)]
[Rules and Regulations]
[Page 8894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]


Refuse To Accept Procedures for Premarket Tobacco Product 
Submissions; Revised Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of effective date.

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SUMMARY: In accordance with the memorandum of January 20, 2017, from 
the Assistant to the President and Chief of Staff, entitled 
``Regulatory Freeze Pending Review,'' this action revises the effective 
date of the final rule (``Refuse to Accept Procedures for Premarket 
Tobacco Product Submissions'') published December 29, 2016, from 
January 30, 2017, until March 21, 2017.

DATES: The effective date of the rule that published on December 29, 
2016, at 81 FR 95863, is delayed until March 21, 2017.

FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and 
Drug Administration, 10903 New Hampshire Ave., Document Control Center, 
Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, email: 
AskCTP@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On December 29, 2016, the Food and Drug 
Administration (FDA or Agency) issued a final rule describing when FDA 
will refuse to accept a tobacco product submission (or application) 
because the application has not met a minimum threshold for 
acceptability for FDA review (81 FR 95863). Under the rule, FDA will 
refuse to accept a tobacco product submission, for example, that is not 
in English, does not pertain to a tobacco product, or does not identify 
the type of submission. The rule was published with an effective date 
of January 30, 2017.
    FDA bases this action on the memorandum of January 20, 2017 (82 FR 
8346), from the Assistant to the President and Chief of Staff, entitled 
``Regulatory Freeze Pending Review.'' That memorandum directed the 
heads of Executive Departments and Agencies to temporarily postpone for 
60 days from the date of the memorandum the effective dates of all 
regulations that had been published in the Federal Register but had not 
yet taken effect, for the purpose of ``reviewing questions of fact, 
law, and policy they raise.'' FDA, therefore, is revising the effective 
date of the rule that published on December 29, 2016 (81 FR 95863), to 
March 21, 2017.
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of 
procedure under 5 U.S.C. 553(b)(A). Alternatively, 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 exceptions in 5 U.S.C. 553(b)(B) and (d)(3). 
Seeking public comment is impracticable, unnecessary, and contrary to 
the public interest. The temporary delay in the effective date until 
March 21, 2017, is necessary to give Agency officials the opportunity 
for further review and consideration of the new regulation, consistent 
with the memorandum described previously. Given the imminence of the 
effective date and the brief length of the extension of the effective 
date, seeking prior public comment on this temporary delay would have 
been impracticable, as well as contrary to the public interest in the 
orderly promulgation and implementation of regulations.\1\ FDA also 
believes that affected entities need to be informed as soon as possible 
of the extension and its length in order to plan and adjust their 
implementation process accordingly.
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    \1\ In the event that this rule does not publish on or before 
January 30, 2017, good cause similarly exists to stay the 
effectiveness of the rule published December 29, 2016, and revise 
its effective date until March 21, 2017.

    Dated: January 27, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02174 Filed 1-30-17; 11:15 am]
 BILLING CODE 4164-01-P
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