[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: 
[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