[Federal Register Volume 82, Number 180 (Tuesday, September 19, 2017)]
[Notices]
[Pages 43768-43770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]


Registration and Product Listing for Owners and Operators of 
Domestic Tobacco Product Establishments; 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 revised guidance for industry entitled ``Registration 
and Product Listing for Owners and Operators of Domestic Tobacco 
Product Establishments.'' This guidance is intended to assist persons 
making tobacco product establishment registration and product listing 
submissions to FDA.

DATES: The announcement of the guidance is published in the Federal 
Register on September 19, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time 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:

[[Page 43769]]

     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-2009-D-0508 for ``Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments.'' 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.'' 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.
    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.
    Submit written requests for single copies of this 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 guidance document may be sent. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a revised guidance for 
industry entitled ``Registration and Product Listing for Owners and 
Operators of Domestic Tobacco Product Establishments.'' This guidance 
is intended to assist persons making tobacco product establishment 
registration and product listing submissions to FDA. We are issuing 
this guidance consistent with our good guidance practices regulation 
(Sec.  10.115 (21 CFR 10.115)). We are implementing this guidance 
without prior public comment because we have determined that prior 
public participation is not feasible or appropriate given the upcoming 
compliance deadline for registration and listing for certain owners and 
operators of tobacco product manufacturing establishments. In addition, 
the compliance policy for certain product listing labeling submissions 
set forth in this revised guidance presents a less burdensome policy 
consistent with the public health (Sec.  10.115(g)(2)). Although this 
guidance document is immediately in effect, it remains subject to 
comment in accordance with FDA's GGP regulation.
    This revised guidance communicates a compliance policy for certain 
product listing labeling submissions. Specifically, FDA does not, at 
this time, intend to enforce the requirement that owners and operators 
of tobacco product establishments submit the labeling for each 
individually listed tobacco product if the registrant submits 
information that represents the labeling for a selected line of 
products. In deciding whether a registrant's submitted information 
falls within this compliance policy, FDA may consider whether the 
tobacco products' labeling is essentially identical (e.g., the same 
formatting, fonts, colors, background text, and images) and whether the 
variations are limited to package size, nicotine strength, propylene 
glycol/vegetable glycerin ratio, and flavor. Under this compliance 
policy, a registrant could submit information that represents the 
labeling for a selected line of products, and FDA would not intend to 
enforce the requirements in subsections 905(i)(1)(A) and (B) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
387e(1)(A) and (B)) with regard to labeling submissions.
    This revised guidance also updates the compliance date for 
registration and listing for persons who owned or operated domestic 
manufacturing establishments engaged in the manufacture of newly deemed 
products prior to August 8, 2016, and continued to own or operate such 
establishment(s) on or after August 8, 2016. Such persons are required 
to register and submit product listing information under section 905 of 
the FD&C Act by December 31, 2016. However, in a guidance issued in May 
2017, FDA announced that it does not intend to enforce these 
requirements with respect to newly deemed products provided the 
registration and product listing submissions are received by FDA on or 
before September 30, 2017.
    The guidance represents the current thinking of FDA on this topic. 
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.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in section 905 of the FD&C Act have been 
approved under OMB control number 0910-0650.

III. Electronic Access

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


[[Page 43770]]


    Dated: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19928 Filed 9-18-17; 8:45 am]
 BILLING CODE 4164-01-P