[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Proposed Rules]
[Pages 14647-14648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05490]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1132

[Docket No. FDA-2016-N-2527]


Tobacco Product Standard for N-Nitrosonornicotine Level in 
Finished Smokeless Tobacco Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the proposed rule that appeared in the 
Federal Register of January 23, 2017. In the proposed rule, FDA 
requested comments on its proposal to establish a limit of N-
nitrosonornicotine (NNN) in finished smokeless tobacco products. The 
Agency is taking this action in response to requests for an extension 
to allow interested persons additional time to submit comments. The 
Agency is also providing notice of a typographical error in a formula 
in the Laboratory Information Bulletin (LIB) titled, ``Determination of 
N-nitrosonornicotine (NNN) in Smokeless Tobacco and Tobacco Filler by 
HPLC-MS/MS'' (LIB No. 4620, January 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'', the 
Agency is also taking this opportunity to provide notice that, as with 
all regulatory actions subject to such memorandum, this proposed rule 
is being reviewed consistent with the memorandum.

DATES: FDA is extending the comment period on the proposed rule 
published January 23, 2017 (82 FR 8004). Submit either electronic or 
written comments by July 10, 2017[. Late, untimely filed comments will 
not be considered. Electronic comments must be submitted on or before 
July 10, 2017. The https://www.regulations.gov electronic filing system 
will accept comments until midnight Eastern Time at the end of [July 
10, 2017. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2527 for ``Tobacco Product Standard for N-nitrosonornicotine 
Level in Finished Smokeless Tobacco Products.'' Received comments, 
those filed in a timely manner (see DATES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management

[[Page 14648]]

between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beth Buckler or Colleen Lee, Office of 
Regulations, Center for Tobacco Products (CTP), Food and Drug 
Administration, Document Control Center, 10903 New Hampshire Ave., 
Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 877-287-1373, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of January 23, 2017, 
FDA published a proposed rule with a 75-day comment period to request 
comments on our proposal to establish a limit for NNN in finished 
smokeless tobacco products. Comments on the proposed rule will inform 
FDA's rulemaking to establish a tobacco product standard for NNN.
    The Agency has received requests for a 75-day extension of the 
comment period for the proposed rule. Each request expressed concern 
that the current 75-day comment period does not allow the public 
sufficient time to develop thoughtful responses to the proposed rule.
    The Agency also has received a request to clarify a formula in the 
Laboratory Information Bulletin (LIB) titled, ``Determination of N-
nitrosonornicotine (NNN) in Smokeless Tobacco and Tobacco Filler by 
HPLC-MS/MS'' (LIB No. 4620, January 2017). Upon further review, FDA has 
determined that the formula for converting NNN on a wet weight basis to 
a dry weight basis contains a typographical error--some of the terms 
and variables in the numerator and denominator were inadvertently 
switched. FDA has revised the LIB to correct this error (LIB No. 4623, 
March 2017, available at https://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM546874.pdf). We note that the typographical error in 
the LIB did not affect our calculations in the preamble of the proposed 
rule or the supporting analyses.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 90 days, until [July 10, 2017. The 90-day 
extension will provide additional time for interested persons to submit 
comments on all aspects of the proposed rule, including whether the 
approach proposed in the rule is appropriate.

    Dated: March 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05490 Filed 3-21-17; 8:45 am]
 BILLING CODE 4164-01-P