[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Proposed Rules]
[Pages 28783-28784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10689]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1150

[Docket No. FDA-2014-D-0917]


Requirements for the Submission of Data Needed To Calculate User 
Fees for Domestic Manufacturers and Importers of Tobacco Products; 
Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry entitled ``Requirements 
for the Submission of Data Needed to Calculate User Fees for Domestic 
Manufacturers and Importers of Tobacco Products; Small Entity 
Compliance Guide'' for the final user fees rule published July 10, 
2014, and for the new user fees regulation. This revised guidance, a 
small entity compliance guide (SECG), replaces the SECG of the same 
name published on July 16, 2014. The revised SECG is intended to set 
forth in plain language the requirements of the user fee regulations 
and to help small businesses understand and comply with the 
regulations.

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-2014-D-0917 for ``Small Entity Compliance Guide: Requirements for 
the Submission of Data Needed To Calculate User Fees for Domestic 
Manufacturers and Importers of Tobacco Products.'' 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, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 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

[[Page 28784]]

SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a revised guidance for 
industry entitled ``Requirements for the Submission of Data Needed to 
Calculate User Fees for Domestic Manufacturers and Importers of Tobacco 
Products; Small Entity Compliance Guide'' for the final user fee rules 
published July 10, 2014 (79 FR 39302). Also, published elsewhere in 
this edition of the Federal Register, FDA issued a final rule to amend 
21 CFR part 1150 (part 1150) to require domestic manufacturers and 
importers of cigars and pipe tobacco to submit to FDA information 
needed to calculate the amount of user fees assessed under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act). FDA issued this user fee final 
rule together with the final rule, ``Deeming Tobacco Products To Be 
Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the 
Family Smoking Prevention and Tobacco Control Act; Restrictions on the 
Sale and Distribution of Tobacco Products and Required Warning 
Statements for Tobacco Products'' (Deeming rule), which deems all 
products that meet the statutory definition of ``tobacco product,'' 
except accessories of the newly deemed tobacco products, to be subject 
to the FD&C Act. The Deeming rule, among other things, subjects 
domestic manufacturers and importers of cigars and pipe tobacco to the 
FD&C Act's user fee requirements. Consistent with the Deeming rule and 
the requirements of the FD&C Act, this user fee final rule requires the 
submission of the information needed to calculate user fee assessments 
for each manufacturer and importer of cigars and pipe tobacco to FDA. 
In compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Pub. L. 104-121), FDA is making available 
this revised SECG stating in plain language the legal requirements of 
the user fee final regulations set forth in part 1150.

II. Significance of Guidance

    FDA is issuing this revised SECG as a level 2 guidance, consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). 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 unless specific regulatory or statutory requirements are 
cited. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. 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: May 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10689 Filed 5-5-16; 8:45 am]
 BILLING CODE 4164-01-P