82 FR 8894 - Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Revised Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 20 (February 1, 2017)

Page Range		8894-8894
FR Document		2017-02174

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.

Federal Register, Volume 82 Issue 20 (Wednesday, February 1, 2017)

[Federal Register Volume 82, Number 20 (Wednesday, February 1, 2017)]
[Rules and Regulations]
[Page 8894]
From the Federal Register Online  [www.thefederalregister.org]
[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: 
[email protected].

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

8894 Federal Register / Vol. 82, No. 20 / Wednesday, February 1, 2017 / Rules and Regulations

effective date for this action to give DOC submission (or application) because the Dated: January 27, 2017.
officials the opportunity to further application has not met a minimum Leslie Kux,
review and consider the revision, threshold for acceptability for FDA Associate Commissioner for Policy.
consistent with the Memorandum. The review (81 FR 95863). Under the rule, [FR Doc. 2017–02174 Filed 1–30–17; 11:15 am]
rule published November 25 containing FDA will refuse to accept a tobacco BILLING CODE 4164–01–P
the revision was exempt from notice product submission, for example, that is
and comment because it involved a not in English, does not pertain to a
military and foreign affairs function of tobacco product, or does not identify the DEPARTMENT OF JUSTICE
the United States (See 5 U.S.C. type of submission. The rule was
553(a)(1)). Given the imminence of the published with an effective date of 28 CFR Part 31
new effective date, seeking prior public January 30, 2017.
comment on this temporary delay [Docket No.: OJP (OJJDP) 1719E]
would be impractical, unnecessary, and FDA bases this action on the RIN 1121–AA83
also contrary to the public interest in memorandum of January 20, 2017 (82
the orderly promulgation and FR 8346), from the Assistant to the Juvenile Justice and Delinquency
implementation of regulations. President and Chief of Staff, entitled Prevention Act Formula Grant Program
Dated: January 27, 2017.
‘‘Regulatory Freeze Pending Review.’’
AGENCY: Office of Justice Programs,
That memorandum directed the heads
Matthew S. Borman, Department of Justice.
of Executive Departments and Agencies
Deputy Assistant Secretary for Export ACTION: Final rule; delay of effective
Administration. to temporarily postpone for 60 days
from the date of the memorandum the date.
[FR Doc. 2017–02164 Filed 1–31–17; 8:45 am]
effective dates of all regulations that had SUMMARY: On January 17, 2017, the
BILLING CODE 3510–33–P
been published in the Federal Register Office of Juvenile Justice and
but had not yet taken effect, for the Delinquency Prevention (‘‘OJJDP’’) of
purpose of ‘‘reviewing questions of fact, the U.S. Department of Justice’s Office
DEPARTMENT OF HEALTH AND
law, and policy they raise.’’ FDA, of Justice Programs (‘‘OJP’’), published a
HUMAN SERVICES
therefore, is revising the effective date of partial final rule to amend portions of
Food and Drug Administration the rule that published on December 29, the formula grant program (‘‘Formula
2016 (81 FR 95863), to March 21, 2017. Grant Program’’) regulation to reflect
21 CFR Part 1105 To the extent that 5 U.S.C. 553 applies changes in OJJDP policy. That rule is
to this action, it is exempt from notice scheduled to become effective February
[Docket No. FDA–2016–N–1555] 16, 2017.
and comment because it constitutes a
rule of procedure under 5 U.S.C. In accordance with the memorandum
Refuse To Accept Procedures for
553(b)(A). Alternatively, the Agency’s of January 20, 2017, from the Assistant
Premarket Tobacco Product
to the President and Chief of Staff,
Submissions; Revised Effective Date implementation of this action without
entitled ‘‘Regulatory Freeze Pending
opportunity for public comment,
AGENCY: Food and Drug Administration, Review,’’ this action hereby temporarily
effective immediately upon publication delays the effective date of the final rule
HHS.
today in the Federal Register, is based entitled ‘‘Juvenile Justice and
ACTION: Final rule; delay of effective on the good cause exceptions in 5 U.S.C.
date. Delinquency Prevention Act Formula
553(b)(B) and (d)(3). Seeking public Grant Program’’ until March 21, 2017
SUMMARY: In accordance with the comment is impracticable, unnecessary, (which is 60 days from January 20,
memorandum of January 20, 2017, from and contrary to the public interest. The 2017). This temporary delay will allow
the Assistant to the President and Chief temporary delay in the effective date Department of Justice officials an
of Staff, entitled ‘‘Regulatory Freeze until March 21, 2017, is necessary to opportunity to review any potential
Pending Review,’’ this action revises the give Agency officials the opportunity for questions of fact, law and policy raised
effective date of the final rule (‘‘Refuse further review and consideration of the by this regulation, consistent with the
to Accept Procedures for Premarket new regulation, consistent with the Chief of Staff’s memorandum of January
Tobacco Product Submissions’’) memorandum described previously. 20, 2017.
published December 29, 2016, from Given the imminence of the effective DATES: This rule is effective February 1,
January 30, 2017, until March 21, 2017. date and the brief length of the 2017. The effective date of the final rule
DATES: The effective date of the rule that extension of the effective date, seeking amending 28 CFR part 31 published in
published on December 29, 2016, at 81 prior public comment on this temporary the Federal Register on January 17,
FR 95863, is delayed until March 21, delay would have been impracticable, as 2017, at 82 FR 4783, is delayed to March
2017. well as contrary to the public interest in 21, 2017.
FOR FURTHER INFORMATION CONTACT: the orderly promulgation and FOR FURTHER INFORMATION CONTACT: Mr.
Center for Tobacco Products, Food and implementation of regulations.1 FDA Gregory Thompson, Senior Advisor,
Drug Administration, 10903 New also believes that affected entities need Office of Juvenile Justice and
Hampshire Ave., Document Control to be informed as soon as possible of the Delinquency Prevention, at 202–307–
Center, Bldg. 71, Rm. G335, Silver extension and its length in order to plan 5911.
pmangrum on DSK3GDR082PROD with RULES

Spring, MD 20993–0002, email: and adjust their implementation process SUPPLEMENTARY INFORMATION: The OJJDP
AskCTP@fda.hhs.gov. accordingly. Formula Grant Program is authorized by
SUPPLEMENTARY INFORMATION: On the Juvenile Justice and Delinquency
1 In the event that this rule does not publish on
December 29, 2016, the Food and Drug Prevention Act (‘‘JJDPA’’). The JJDPA
or before January 30, 2017, good cause similarly
Administration (FDA or Agency) issued exists to stay the effectiveness of the rule published
authorizes OJJDP to provide an annual
a final rule describing when FDA will December 29, 2016, and revise its effective date grant to each State to improve its
refuse to accept a tobacco product until March 21, 2017. juvenile justice system and to support

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Document Created: 2017-02-01 00:05:55
Document Modified: 2017-02-01 00:05:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; delay of effective date.
Dates		The effective date of the rule that published on December 29, 2016, at 81 FR 95863, is delayed until March 21, 2017.
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: [email protected]
FR Citation		82 FR 8894

82 FR 8894 - Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Revised Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 20 (February 1, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration