83 FR 7123 - Nicotine Steering Committee; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 34 (February 20, 2018)

Page Range		7123-7124
FR Document		2018-03341

The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive suggestions, recommendations, and comments on topics or policy issues for consideration by FDA's Nicotine Steering Committee (NSC). FDA would like to receive feedback from interested parties, including academic institutions, regulated industries, patient representatives, and other interested organizations. These comments will help the Agency identify and address priorities related to the use of therapeutic nicotine for combustible tobacco product cessation.

Federal Register, Volume 83 Issue 34 (Tuesday, February 20, 2018)

[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Proposed Rules]
[Pages 7123-7124]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03341]



[[Page 7123]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2018-N-0128]


Nicotine Steering Committee; Establishment of a Public Docket; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; establishment of a public docket; request for 
comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to receive suggestions, recommendations, 
and comments on topics or policy issues for consideration by FDA's 
Nicotine Steering Committee (NSC). FDA would like to receive feedback 
from interested parties, including academic institutions, regulated 
industries, patient representatives, and other interested 
organizations. These comments will help the Agency identify and address 
priorities related to the use of therapeutic nicotine for combustible 
tobacco product cessation.

DATES: Submit either electronic or written comments by April 16, 2018.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-N-0128 for ``Recommendations and Comments for the Food and 
Drug Administration Nicotine Steering Committee.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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.'' FDA 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1314, Silver 
Spring, MD 20993, 301-796-9203, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The NSC was established in November 2017 to help develop and 
implement nicotine policy and regulation. The primary focus of the NSC 
is on the use of therapeutic nicotine for combustible tobacco product 
cessation. The NSC is comprised of senior leaders from the Center for 
Drug Evaluation and Research, the Center for Tobacco Products, and the 
Office of the Commissioner. The NSC will ensure alignment of FDA's 
Centers and facilitate consensus and development of unified FDA 
positions on cross-cutting issues related to nicotine policy and 
regulation. Additional staff from the Centers and other FDA offices 
provide expertise as needed for specific policy topics under 
consideration. While there are various other mechanisms available to 
raise issues for Agency consideration, by establishing this public 
docket FDA seeks to provide a mechanism for the public to recommend 
specific topics for direct, collective engagement and consideration by 
the NSC. The Agency believes that this process will also further 
enhance transparency in FDA's approach to policy development and 
implementation.

II. Establishment of a Public Docket and Request for Comments

    The docket is being established to solicit suggestions, 
recommendations, and comments relating to the use of therapeutic 
nicotine for combustible tobacco product cessation that may warrant 
consideration by the NSC (see Staff Manual Guide 2010.20, FDA Nicotine 
Steering Committee \1\). Topic suggestion submissions should describe 
the following: (1) The nicotine policy issue recommended for discussion 
(e.g., clarifying previous advice or precedents on a specified 
therapeutic nicotine product policy topic, reconciling seemingly 
differing perspectives within

[[Page 7124]]

FDA or between FDA and regulated industry on a specified therapeutic 
nicotine product policy topic); (2) the rationale for doing so, 
including why direct engagement by the NSC would be appropriate/
helpful; (3) recommendations on how the nicotine policy issue could be 
addressed; and (4) existing policy documents (e.g., final guidance) 
relevant to the nicotine product policy issue. Note that policy issues 
concerning any draft guidance or proposed rule should be submitted to 
the docket for that draft guidance or rulemaking.
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    \1\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM594385.pdf.
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    The Agency will carefully consider all comments submitted. FDA 
generally will not respond directly to the person or organization 
submitting the comment. In general, policy decisions reached by the NSC 
are communicated and implemented in accordance with FDA's good guidance 
practices regulation (21 CFR 10.115) or notice and comment procedures.

    Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03341 Filed 2-16-18; 8:45 am]
BILLING CODE 4164-01-P

7124 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Proposed Rules

FDA or between FDA and regulated comments cannot be edited or removed oxides of nitrogen (NOX) for states with
industry on a specified therapeutic from Regulations.gov. For either manner moderate (or worse) ozone
nicotine product policy topic); (2) the of submission, EPA may publish any nonattainment areas. A major stationary
rationale for doing so, including why comment received to its public docket. source of NOX is defined as stationary
direct engagement by the NSC would be Do not submit electronically any facility or source of air pollutants which
appropriate/helpful; (3) information you consider to be directly emits, or has the potential to
recommendations on how the nicotine confidential business information (CBI) emit 100 tpy or more of NOX. See CAA
policy issue could be addressed; and (4) or other information whose disclosure is section 302(j).
existing policy documents (e.g., final restricted by statute. Multimedia Section 182 of the CAA identifies
guidance) relevant to the nicotine submissions (audio, video, etc.) must be additional plan submissions and
product policy issue. Note that policy accompanied by a written comment. requirements for ozone nonattainment
issues concerning any draft guidance or The written comment is considered the areas. Specifically, section 182(a)(3)(B)
proposed rule should be submitted to official comment and should include of the CAA requires that states develop
the docket for that draft guidance or discussion of all points you wish to and submit rules which establish annual
rulemaking. make. EPA will generally not consider reporting requirements for certain
The Agency will carefully consider all comments or comment contents located stationary sources. Sources that are
comments submitted. FDA generally outside of the primary submission (i.e. within marginal (or worse) ozone
will not respond directly to the person on the web, cloud, or other file sharing nonattainment areas must annually
or organization submitting the system). For additional submission report the actual emissions of NOX and
comment. In general, policy decisions methods, please contact the person VOC to the state. However, states may
reached by the NSC are communicated identified in the FOR FURTHER waive sources that emit under 25 tpy of
and implemented in accordance with INFORMATION CONTACT section. For the NOX and VOC if the state provides an
FDA’s good guidance practices full EPA public comment policy, inventory of emissions from such class
regulation (21 CFR 10.115) or notice and information about CBI or multimedia or category of sources. See CAA section
comment procedures. submissions, and general guidance on 182(a)(3)(B)(ii).
making effective comments, please visit In summary, because Maryland is
Dated: February 13, 2018. located in the OTR, sources that are
Leslie Kux, http://www2.epa.gov/dockets/
commenting-epa-dockets. located in ozone attainment areas and
Associate Commissioner for Policy. emit above 50 tpy of VOC or 100 tpy of
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–03341 Filed 2–16–18; 8:45 am] NOX are considered major sources and
Gavin Huang, (215) 814–2042, or by subject to the requirements of major
BILLING CODE 4164–01–P
email at huang.gavin@epa.gov. stationary sources in moderate (or
SUPPLEMENTARY INFORMATION: worse) nonattainment area, such as an
ENVIRONMENTAL PROTECTION I. Background emissions statement submission as
AGENCY required by CAA section 182(a)(3)(B).
On March 27, 2008, EPA strengthened See CAA sections 182(f) and 184(b)(2).
40 CFR Part 52 the ozone standard from 0.08 to 0.075 Sources that are located in designated
parts per million (ppm). 73 FR 16436. marginal (or worse) nonattainment areas
[EPA–R03–OAR–2017–0637; FRL–9974– On May 21, 2012, EPA designated areas
62—Region 3] must submit an emissions statement as
as nonattainment for the 2008 ozone required by CAA section 182(a)(3)(B).
Approval and Promulgation of Air NAAQS, including the Baltimore and As stated previously, states may waive
Quality Implementation Plans; Washington, DC-MD-VA areas, which sources under that emit 25 tpy of NOX
Maryland; Emissions Statement include the following counties in and 25 tpy of VOC threshold if the state
Requirement for the 2008 Ozone Maryland: Anne Arundel, Baltimore, provides an inventory of emissions from
Standard Baltimore City, Carroll, Harford, such class or category of sources as
Howard, Cecil, Calvert, Charles, required by CAA sections 172 and
AGENCY: Environmental Protection Frederick, Montgomery, and Prince 182.1 See section 182(a)(3)(B)(ii).
Agency (EPA). George’s Counties. See 40 CFR 81.321. On September 25, 2017, the State of
ACTION: Proposed rule. Additionally, Maryland is located in Maryland, through the Maryland
the ozone transport region (OTR) Department of the Environment (MDE),
SUMMARY: The Environmental Protection established by Congress in section 184 submitted a SIP revision to satisfy the
Agency (EPA) is proposing to approve a of the CAA. Pursuant to section emissions statement requirement of
state implementation plan (SIP) revision 184(b)(2), any stationary source that section 182(a)(3)(B) of the CAA for the
submitted by the State of Maryland. emits or has the potential to emit at least 2008 ozone NAAQS.
This revision fulfills Maryland’s 50 tons per year (tpy) of volatile organic
emissions statement requirement for the compounds (VOC) shall be considered a II. Summary of SIP Revision and EPA
2008 ozone national ambient air quality major stationary source and subject to Analysis
standard (NAAQS). This action is being the requirements which would be On October 12, 1994 (59 FR 51517),
taken under the Clean Air Act (CAA). applicable to major stationary sources if EPA approved Maryland’s SIP submittal
DATES: Written comments must be the area were classified as a moderate that satisfies CAA section 182(a)(3)(B).
received on or before March 22, 2018. nonattainment area. See CAA section Maryland’s emissions reporting
sradovich on DSK3GMQ082PROD with PROPOSALS

ADDRESSES: Submit your comments, 184. Thus, states within the OTR are requirements are codified in Maryland
identified by Docket ID No. EPA–R03– subject to plan (or SIP) requirements in regulation COMAR 26.11.01.05–1
OAR–2017–0637 at http:// CAA section 182(b) applicable to
www.regulations.gov, or via email to moderate nonattainment areas. Also, 1 For further information on the emissions

spielberger.susan@epa.gov. For section 182(f)(1) of the CAA requires statement reporting requirements, see ‘‘Guidance on
the Implementation of an Emission Statement
comments submitted at Regulations.gov, that the plan provisions required for Program (July 1992)’’ https://www.epa.gov/sites/
follow the online instructions for major stationary sources of VOC also production/files/2015–09/documents/emission_
submitting comments. Once submitted, apply to major stationary sources of statement_program_zypdf.pdf, pp. 5–9.

VerDate Sep<11>2014 16:10 Feb 16, 2018 Jkt 244001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\20FEP1.SGM 20FEP1

Document Created: 2018-02-17 02:29:27
Document Modified: 2018-02-17 02:29:27

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		Proposed Rules
Action		Notification; establishment of a public docket; request for comments.
Dates		Submit either electronic or written comments by April 16, 2018.
Contact		Allison Hoffman, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1314, Silver Spring, MD 20993, 301-796-9203, [email protected]
FR Citation		83 FR 7123

83 FR 7123 - Nicotine Steering Committee; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 34 (February 20, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration