Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products; Extension of Comment Period, 14647-14648 [2017-05490]

Download as PDF Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Proposed Rules airworthiness directive (AD) for certain CFE Company (CFE) turbofan engines that published in the Federal Register on January 5, 2017. The proposed action that published in the Federal Register on January 5, 2017 was a duplicate of an NPRM, Directorate Identifier 2016– NE–21–AD, that published in the Federal Register on January 3, 2017. Accordingly, we withdraw the proposed rule that published in the Federal Register on January 5, 2017. As of March 22, 2017, the proposed rule published January 5, 2017 (82 FR 52) is withdrawn. DATES: FOR FURTHER INFORMATION CONTACT: Issued in Burlington, Massachusetts, on March 8, 2017. Carlos A. Pestana, Acting Assistant Manager, Engine & Propeller Directorate, Aircraft Certification Service. [FR Doc. 2017–05242 Filed 3–21–17; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1132 [Docket No. FDA–2016–N–2527] Tobacco Product Standard for NNitrosonornicotine Level in Finished Smokeless Tobacco Products; Extension of Comment Period The FAA proposed to amend 14 CFR part 39 with a proposed AD (82 FR 1258, January 5, 2017). Since we published the NPRM, Directorate Identifier 2016–NE–21–AD, in the Federal Register on January 5, 2017 (82 FR 1258), we discovered that it was a duplicate of an NPRM, Directorate Identifier 2016–NE–21–AD, that published in the Federal Register on January 3, 2017 (82 FR 52). This duplication created overlapping comment periods with different comment period closing dates, which is confusing to commenters. Withdrawal of the NPRM (82 FR 1258, January 5, 2017) constitutes only such action, and does not preclude the agency from issuing another notice in the future, nor does it commit the agency to any course of action in the future. Since this action only withdraws a notice of proposed rulemaking, it is neither a proposed nor a final rule. Therefore, Executive Order 12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979) do not cover this withdrawal. HHS. jstallworth on DSK7TPTVN1PROD with PROPOSALS List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Withdrawal Accordingly, the notice of proposed rulemaking, Docket No. FAA–2016– 9380; Directorate Identifier 2016–NE– 21–AD, published in the Federal Register on January 5, 2017 (82 FR 1258), is withdrawn. VerDate Sep<11>2014 14:55 Mar 21, 2017 Jkt 241001 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 Martin Adler, Aerospace Engineer, Engine Certification Office, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781–238–7157; fax: 781–238– 7199; email: martin.adler@faa.gov. SUPPLEMENTARY INFORMATION: 14647 AGENCY: Food and Drug Administration, Proposed rule; extension of comment period. ACTION: 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 SUMMARY: PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 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 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 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/201523389.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. jstallworth on DSK7TPTVN1PROD with PROPOSALS 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, CTPRegulations@fda.hhs.gov. 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 SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 14:55 Mar 21, 2017 Jkt 241001 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 Nnitrosonornicotine (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 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R10–OAR–2016–0785: FRL–9959–02Region 10] Air Plan Approval; Washington: General Regulations for Air Pollution Sources, Energy Facility Site Evaluation Council Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to revise the Washington State Implementation Plan SUMMARY: PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 (SIP) to approve updates to the Energy Facility Site Evaluation Council (EFSEC) air quality regulations. The EFSEC regulations primarily adopt by reference the Washington Department of Ecology (Ecology) general air quality regulations, which the EPA approved in the fall of 2014 and spring of 2015. Consistent with our approval of the Ecology general air quality regulations, we are also proposing to approve revisions to implement the preconstruction permitting regulations for large industrial (major source) facilities in attainment and unclassifiable areas, called the Prevention of Significant Deterioration (PSD) program. The PSD program for major energy facilities under EFSEC’s jurisdiction has historically been operated under a Federal Implementation Plan (FIP), in cooperation with the EPA and Ecology. If finalized, the EPA’s proposed approval of the EFSEC PSD program would narrow the FIP to include only those few potential facilities, emission sources, geographic areas, and permits for which EFSEC does not have jurisdiction or authority. The EPA is also proposing to approve EFSEC’s visibility protection permitting program which overlaps significantly with the PSD program in most cases. Written comments must be received on or before April 21, 2017. DATES: Submit your comments, identified by Docket ID No. EPA–R10– OAR–2016–0785 at https:// www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/ commenting-epa-dockets. ADDRESSES: E:\FR\FM\22MRP1.SGM 22MRP1

Agencies

[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]


=======================================================================
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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.

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

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, 
CTPRegulations@fda.hhs.gov.

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
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