[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7084-7085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3244]


Enforcement Policy for Certain Marketed Tobacco Products; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Enforcement 
Policy for Certain Marketed Tobacco Products.'' FDA is issuing this 
draft guidance to provide information regarding FDA's enforcement 
policy for certain marketed tobacco products that become the subject of 
a not substantially equivalent (NSE) order. This policy primarily 
involves ``provisional'' tobacco products that become subject to NSE 
orders issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(provisional tobacco products are tobacco products that were first 
introduced or delivered for introduction into interstate commerce for 
commercial distribution after February 15, 2007, and prior to March 22, 
2011, and for which a substantial equivalence report (SE Report) was 
submitted no later than March 22, 2011). The draft guidance also 
provides information on FDA's enforcement policy when an applicant 
files a request for supervisory review of an NSE order.

DATES: Submit either electronic or written comments on the draft 
guidance by April 30, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-D-3244 for ``Enforcement Policy for Certain Marketed Tobacco 
Products.'' 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

[[Page 7085]]

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 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this draft guidance to 
the Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a fax number to which 
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
1-877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Enforcement Policy for Certain Marketed Tobacco Products.'' 
FDA is issuing this draft guidance to provide information regarding 
FDA's enforcement policy for certain marketed tobacco products that 
become the subject of an NSE order. This policy primarily involves 
provisional tobacco products that become subject to NSE orders issued 
under section 910(a)(2)(B) of the FD&C Act (21 U.S.C. 387j(a)(2)(B)). 
This policy extends to new tobacco products created by modifying the 
quantity of a provisional tobacco product in a pending SE Report that 
become subject to NSE orders. The draft guidance also provides 
information on FDA's enforcement policy for when FDA receives from an 
applicant a request for supervisory review under 21 CFR 10.75 within 30 
calendar days of the issue date of the NSE order. The draft guidance 
provides that for these new tobacco products, FDA intends to offer 
copies of those final scientific reviews that supported the basis of 
the Agency's decision to the applicant concurrent with the NSE order 
for provisional tobacco products.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Enforcement 
Policy for Certain Marketed Tobacco Products,'' and will supersede 
``Enforcement Policy for Certain (Provisional) Tobacco Products That 
the Food and Drug Administration Finds Not Substantially Equivalent; 
Guidance for Industry and Tobacco Retailers'' (the availability of 
which was announced in the Federal Register (80 FR 55124, September 14, 
2015)). It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations. 
This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the draft guidance at either https://www.regulations.gov or 
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: February 25, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03657 Filed 2-28-19; 8:45 am]
 BILLING CODE 4164-01-P