[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Notices]
[Pages 46087-46088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16734]


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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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-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 http://www.regulations.gov or at the Division of Dockets Management 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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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.
    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: Katherine Collins, 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 (GGP) 
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 
requirement that registration and listing submissions be submitted by 
December 31, 2016 (Sec.  10.115(g)(2)). We made this determination 
because the guidance presents a less burdensome policy consistent with 
the public health. Although this guidance document is immediately in 
effect, it remains subject to comment in accordance with FDA''s GGP 
regulation.

[[Page 46088]]

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) added section 905 to the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387e), establishing 
requirements for tobacco product establishment registration and product 
listing.
    FDA revised the registration and listing guidance to include newly 
deemed tobacco products. Cigarettes, cigarette tobacco, roll-your-own 
tobacco, and smokeless tobacco were immediately covered by FDA's 
tobacco product authorities in chapter IX of the FD&C Act, including 
section 905, when the Tobacco Control Act went into effect. As for 
other types of tobacco products, section 901(b) of the FD&C Act (21 
U.S.C. 387a) grants FDA authority to deem those products subject to 
chapter IX of the FD&C Act. Pursuant to that authority, FDA issued a 
proposed rule seeking to deem all other products that meet the 
statutory definition of tobacco product, set forth in section 201(rr) 
of the FD&C Act (21 U.S.C. 321(rr)) (except for accessories of those 
products) (79 FR 23142). After review and consideration of comments on 
the proposed rule, FDA published the final rule on May 10, 2016 (81 FR 
28974) (``the deeming rule'') and it will become effective on August 8, 
2016. As a result, owners and operators of domestic establishments 
engaged in the manufacture, preparation, compounding, or processing of 
tobacco products subject to the deeming rule are now required to comply 
with chapter IX of the FD&C Act, including the establishment 
registration and product listing requirements in section 905.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
current thinking of FDA on registration and product listing for owners 
and operators of domestic tobacco product establishments. 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.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that 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 time 
required to complete this information collection is estimated to 
average 3.75 hours per response, including the time to review 
instructions, search existing data sources, gather the data needed, and 
complete and review the information collection. Send comments regarding 
this burden estimate or suggestions for reducing this burden to: Food 
and Drug Administration, Center for Tobacco Products, Document Control 
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 
20993-0002.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control number for this 
information collection is 0910-0650 (expires June 30, 2019).

IV. Electronic Access

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

    Dated: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16734 Filed 7-14-16; 8:45 am]
 BILLING CODE 4164-01-P