[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Proposed Rules]
[Pages 7123-7124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03341]



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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.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 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

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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


