82_FR_14701 82 FR 14647 - Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products; Extension of Comment Period

82 FR 14647 - Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 54 (March 22, 2017)

Page Range14647-14648
FR Document2017-05490

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.

Federal Register, Volume 82 Issue 54 (Wednesday, March 22, 2017) 
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Proposed Rules]
[Pages 14647-14648]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05490]


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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.

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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.thefederalregister.org/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

Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Proposed Rules 14647 airworthiness directive (AD) for certain Issued in Burlington, Massachusetts, on mail/hand delivery/courier (for written/ CFE Company (CFE) turbofan engines March 8, 2017. paper submissions) will be considered that published in the Federal Register Carlos A. Pestana, timely if they are postmarked or the on January 5, 2017. The proposed action Acting Assistant Manager, Engine & Propeller delivery service acceptance receipt is on that published in the Federal Register Directorate, Aircraft Certification Service. or before that date. on January 5, 2017 was a duplicate of [FR Doc. 2017–05242 Filed 3–21–17; 8:45 am] ADDRESSES: You may submit comments an NPRM, Directorate Identifier 2016– BILLING CODE 4910–13–P as follows: NE–21–AD, that published in the Electronic Submissions Federal Register on January 3, 2017. Accordingly, we withdraw the proposed DEPARTMENT OF HEALTH AND Submit electronic comments in the rule that published in the Federal HUMAN SERVICES following way: Register on January 5, 2017. • Federal eRulemaking Portal: Food and Drug Administration https://www.regulations.gov. Follow the DATES: As of March 22, 2017, the instructions for submitting comments. proposed rule published January 5, 2017 21 CFR Part 1132 Comments submitted electronically, (82 FR 52) is withdrawn. including attachments, to https:// [Docket No. FDA–2016–N–2527] FOR FURTHER INFORMATION CONTACT: www.regulations.gov will be posted to Martin Adler, Aerospace Engineer, Tobacco Product Standard for N- the docket unchanged. Because your Engine Certification Office, FAA, 1200 Nitrosonornicotine Level in Finished comment will be made public, you are District Avenue, Burlington, MA 01803; Smokeless Tobacco Products; solely responsible for ensuring that your phone: 781–238–7157; fax: 781–238– Extension of Comment Period comment does not include any 7199; email: martin.adler@faa.gov. confidential information that you or a AGENCY: Food and Drug Administration, third party may not wish to be posted, SUPPLEMENTARY INFORMATION: The FAA HHS. such as medical information, your or proposed to amend 14 CFR part 39 with Proposed rule; extension of ACTION: anyone else’s Social Security number, or a proposed AD (82 FR 1258, January 5, comment period. confidential business information, such 2017). Since we published the NPRM, as a manufacturing process. Please note Directorate Identifier 2016–NE–21–AD, SUMMARY: The Food and Drug that if you include your name, contact in the Federal Register on January 5, Administration (FDA or the Agency) is information, or other information that 2017 (82 FR 1258), we discovered that extending the comment period for the identifies you in the body of your it was a duplicate of an NPRM, proposed rule that appeared in the comments, that information will be Directorate Identifier 2016–NE–21–AD, Federal Register of January 23, 2017. In posted on https://www.regulations.gov. that published in the Federal Register the proposed rule, FDA requested • If you want to submit a comment on January 3, 2017 (82 FR 52). This comments on its proposal to establish a with confidential information that you duplication created overlapping limit of N-nitrosonornicotine (NNN) in do not wish to be made available to the finished smokeless tobacco products. public, submit the comment as a comment periods with different The Agency is taking this action in written/paper submission and in the comment period closing dates, which is response to requests for an extension to manner detailed (see ‘‘Written/Paper confusing to commenters. allow interested persons additional time Submissions’’ and ‘‘Instructions’’). Withdrawal of the NPRM (82 FR 1258, to submit comments. The Agency is also January 5, 2017) constitutes only such providing notice of a typographical error Written/Paper Submissions action, and does not preclude the in a formula in the Laboratory Submit written/paper submissions as agency from issuing another notice in Information Bulletin (LIB) titled, follows: the future, nor does it commit the ‘‘Determination of N-nitrosonornicotine • Mail/Hand delivery/Courier (for agency to any course of action in the (NNN) in Smokeless Tobacco and written/paper submissions): Division of future. Tobacco Filler by HPLC–MS/MS’’ (LIB Dockets Management (HFA–305), Food Since this action only withdraws a No. 4620, January 2017). In accordance and Drug Administration, 5630 Fishers notice of proposed rulemaking, it is with the memorandum of January 20, Lane, Rm. 1061, Rockville, MD 20852. neither a proposed nor a final rule. 2017, from the Assistant to the President • For written/paper comments Therefore, Executive Order 12866, the and Chief of Staff, entitled ‘‘Regulatory submitted to the Division of Dockets Regulatory Flexibility Act, or DOT Freeze Pending Review’’, the Agency is Management, FDA will post your Regulatory Policies and Procedures (44 also taking this opportunity to provide comment, as well as any attachments, FR 11034, February 26, 1979) do not notice that, as with all regulatory except for information submitted, actions subject to such memorandum, marked and identified, as confidential, cover this withdrawal. this proposed rule is being reviewed if submitted as detailed in List of Subjects in 14 CFR Part 39 consistent with the memorandum. ‘‘Instructions.’’ DATES: FDA is extending the comment Instructions: All submissions received Air transportation, Aircraft, Aviation period on the proposed rule published must include the Docket No. FDA– safety, Incorporation by reference, January 23, 2017 (82 FR 8004). Submit 2016–N–2527 for ‘‘Tobacco Product Safety. either electronic or written comments Standard for N-nitrosonornicotine Level jstallworth on DSK7TPTVN1PROD with PROPOSALS The Withdrawal by July 10, 2017[. Late, untimely filed in Finished Smokeless Tobacco comments will not be considered. Products.’’ Received comments, those Accordingly, the notice of proposed Electronic comments must be submitted filed in a timely manner (see DATES), rulemaking, Docket No. FAA–2016– on or before July 10, 2017. The https:// will be placed in the docket and, except 9380; Directorate Identifier 2016–NE– www.regulations.gov electronic filing for those submitted as ‘‘Confidential 21–AD, published in the Federal system will accept comments until Submissions,’’ publicly viewable at Register on January 5, 2017 (82 FR midnight Eastern Time at the end of https://www.regulations.gov or at the 1258), is withdrawn. [July 10, 2017. Comments received by Division of Dockets Management VerDate Sep<11>2014 14:55 Mar 21, 2017 Jkt 241001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\22MRP1.SGM 22MRP1

14648 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Proposed Rules between 9 a.m. and 4 p.m., Monday rulemaking to establish a tobacco (SIP) to approve updates to the Energy through Friday. product standard for NNN. Facility Site Evaluation Council • Confidential Submissions—To The Agency has received requests for (EFSEC) air quality regulations. The submit a comment with confidential a 75-day extension of the comment EFSEC regulations primarily adopt by information that you do not wish to be period for the proposed rule. Each reference the Washington Department of made publicly available, submit your request expressed concern that the Ecology (Ecology) general air quality comments only as a written/paper current 75-day comment period does regulations, which the EPA approved in submission. You should submit two not allow the public sufficient time to the fall of 2014 and spring of 2015. copies total. One copy will include the develop thoughtful responses to the Consistent with our approval of the information you claim to be confidential proposed rule. Ecology general air quality regulations, with a heading or cover note that states The Agency also has received a we are also proposing to approve ‘‘THIS DOCUMENT CONTAINS request to clarify a formula in the revisions to implement the CONFIDENTIAL INFORMATION.’’ The Laboratory Information Bulletin (LIB) preconstruction permitting regulations Agency will review this copy, including titled, ‘‘Determination of N- for large industrial (major source) the claimed confidential information, in nitrosonornicotine (NNN) in Smokeless facilities in attainment and its consideration of comments. The Tobacco and Tobacco Filler by HPLC– unclassifiable areas, called the second copy, which will have the MS/MS’’ (LIB No. 4620, January 2017). Prevention of Significant Deterioration claimed confidential information Upon further review, FDA has (PSD) program. The PSD program for redacted/blacked out, will be available determined that the formula for major energy facilities under EFSEC’s for public viewing and posted on converting NNN on a wet weight basis jurisdiction has historically been https://www.regulations.gov. Submit to a dry weight basis contains a operated under a Federal both copies to the Division of Dockets typographical error—some of the terms Implementation Plan (FIP), in Management. If you do not wish your and variables in the numerator and cooperation with the EPA and Ecology. name and contact information to be denominator were inadvertently If finalized, the EPA’s proposed made publicly available, you can switched. FDA has revised the LIB to approval of the EFSEC PSD program provide this information on the cover correct this error (LIB No. 4623, March would narrow the FIP to include only sheet and not in the body of your 2017, available at https://www.fda.gov/ those few potential facilities, emission comments and you must identify this downloads/ScienceResearch/ sources, geographic areas, and permits information as ‘‘confidential.’’ Any FieldScience/UCM546874.pdf). We note for which EFSEC does not have information marked as ‘‘confidential’’ that the typographical error in the LIB jurisdiction or authority. The EPA is will not be disclosed except in did not affect our calculations in the also proposing to approve EFSEC’s accordance with 21 CFR 10.20 and other preamble of the proposed rule or the visibility protection permitting program applicable disclosure law. For more supporting analyses. which overlaps significantly with the information about FDA’s posting of FDA has considered the requests and PSD program in most cases. comments to public dockets, see 80 FR is extending the comment period for the proposed rule for 90 days, until [July 10, DATES: Written comments must be 56469, September 18, 2015, or access 2017. The 90-day extension will provide received on or before April 21, 2017. the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/2015- additional time for interested persons to ADDRESSES: Submit your comments, 23389.pdf. submit comments on all aspects of the identified by Docket ID No. EPA–R10– Docket: For access to the docket to proposed rule, including whether the OAR–2016–0785 at http:// read background documents or the approach proposed in the rule is www.regulations.gov. Follow the online electronic and written/paper comments appropriate. instructions for submitting comments. received, go to https:// Dated: March 15, 2017. Once submitted, comments cannot be www.regulations.gov and insert the Leslie Kux, edited or removed from Regulations.gov. docket number, found in brackets in the Associate Commissioner for Policy. The EPA may publish any comment heading of this document, into the [FR Doc. 2017–05490 Filed 3–21–17; 8:45 am] received to its public docket. Do not ‘‘Search’’ box and follow the prompts submit electronically any information BILLING CODE 4164–01–P and/or go to the Division of Dockets you consider to be Confidential Management, 5630 Fishers Lane, Rm. Business Information (CBI) or other 1061, Rockville, MD 20852. information whose disclosure is ENVIRONMENTAL PROTECTION restricted by statute. Multimedia FOR FURTHER INFORMATION CONTACT: Beth AGENCY submissions (audio, video, etc.) must be Buckler or Colleen Lee, Office of accompanied by a written comment. Regulations, Center for Tobacco 40 CFR Part 52 The written comment is considered the Products (CTP), Food and Drug [EPA–R10–OAR–2016–0785: FRL–9959–02- official comment and should include Administration, Document Control Region 10] discussion of all points you wish to Center, 10903 New Hampshire Ave., make. The EPA will generally not Bldg. 71, Rm. G335, Silver Spring, MD Air Plan Approval; Washington: consider comments or comment 20993–0002, 877–287–1373, General Regulations for Air Pollution contents located outside of the primary CTPRegulations@fda.hhs.gov. Sources, Energy Facility Site submission (i.e. on the web, cloud, or jstallworth on DSK7TPTVN1PROD with PROPOSALS Evaluation Council SUPPLEMENTARY INFORMATION: In the other file sharing system). For Federal Register of January 23, 2017, AGENCY: Environmental Protection additional submission methods, the full FDA published a proposed rule with a Agency (EPA). EPA public comment policy, 75-day comment period to request ACTION: Proposed rule. information about CBI or multimedia comments on our proposal to establish submissions, and general guidance on a limit for NNN in finished smokeless SUMMARY: The Environmental Protection making effective comments, please visit tobacco products. Comments on the Agency (EPA) is proposing to revise the http://www2.epa.gov/dockets/ proposed rule will inform FDA’s Washington State Implementation Plan commenting-epa-dockets. VerDate Sep<11>2014 14:55 Mar 21, 2017 Jkt 241001 PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\22MRP1.SGM 22MRP1


Document Created: 2017-03-22 03:58:10
Document Modified: 2017-03-22 03:58:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule; extension of comment period.
DatesFDA 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.
ContactBeth 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]
FR Citation82 FR 14647 
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