82 FR 22338 - Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 92 (May 15, 2017)

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule.'' This guidance is intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations.

[Federal Register Volume 82, Number 92 (Monday, May 15, 2017)]
[Notices]
[Pages 22338-22340]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09754]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2834]


Three-Month Extension of Certain Tobacco Product Compliance 
Deadlines Related to the Final Deeming Rule; 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 guidance for industry entitled ``Three-Month 
Extension of Certain Tobacco Product Compliance Deadlines Related to 
the Final Deeming Rule.'' This guidance is intended to assist persons 
who manufacture, package, sell, offer to sell, distribute, or import 
for sale and distribution within the United States newly regulated 
tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in 
complying with the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 
as amended by the Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act), and FDA 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: 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

[[Page 22339]]

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): 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-2017-D-2834 for ``Three-Month Extension of Certain Tobacco Product 
Compliance Deadlines Announced in the Final Deeming Rule.'' 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 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 https://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: https://www.thefederalregister.org/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 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 SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Three-Month Extension of Certain Tobacco Product Compliance 
Deadlines Related to the Final Deeming Rule.'' This guidance is 
intended to assist persons who manufacture, package, sell, offer to 
sell, distribute, or import for sale and distribution within the United 
States newly regulated tobacco products, RYO tobacco, and cigarette 
tobacco in complying with the FD&C Act, as amended by the Tobacco 
Control Act, and FDA regulations. 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 that the 3-month 
extension applies to provisions with imminent compliance deadlines 
(Sec.  10.115(g)(2)). We made this determination because FDA needs to 
communicate in a timely manner that the guidance provides a 3-month 
extension to the compliance deadlines for certain provisions under the 
final deeming rule that are set for as early as May 2017. Although this 
guidance document is immediately effective, it remains subject to 
comment in accordance with FDA's GGP regulation.
    The Tobacco Control Act (Pub. L. 111-31) granted FDA the authority 
to immediately regulate the manufacture, marketing, and distribution of 
cigarettes, cigarette tobacco, RYO, and smokeless tobacco products to 
protect the public health and to reduce tobacco use by minors.
    The Tobacco Control Act also gave FDA the authority to issue a 
regulation deeming all other products that meet the statutory 
definition of a tobacco product to be subject to Chapter IX of the FD&C 
Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 
2016, FDA issued that rule, extending FDA's tobacco product authority 
to all products that meet the definition of tobacco product in the law 
(except for accessories of newly regulated tobacco products), including 
electronic nicotine delivery systems, cigars, hookah, pipe tobacco, 
nicotine gels, dissolvables that were not already subject to the FD&C 
Act, and other tobacco products that may be developed in the future (81 
FR 28974 at 28976) (``the final deeming rule'')).\1\ Chapter IX of the 
FD&C Act now applies to newly regulated tobacco products, including 
sections 904(a)(1) and (4) (21 U.S.C.387d(a)(1) and (4)) (ingredient 
listing, health document submissions), 903(a)(4) and (a)(8) (21 U.S.C. 
387c(a)(4) and (a)(8)) (labeling requirements), 904(c)(1), 905(b), (c), 
(d), (h) (registration), (21 U.S.C. 387e(b), (c), (d), (h)) 905(i)(1) 
(product listing), 907(a)(1)(B) (21 U.S.C. 387g(a)(1)(B)) (additional 
special rule), 911 (21 U.S.C. 387k) (modified risk claims), 904(a)(3) 
and 915 (21 U.S.C. 387o) (harmful and potentially harmful constituent 
reporting), and 920 (21 U.S.C. 387t) (labeling, recordkeeping, records 
inspection). The final rule also included several requirements that 
apply to a

[[Page 22340]]

subgroup of products referred to as ``covered tobacco products.''
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    \1\ ``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,'' 81 FR28974 (May 10, 2016).
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    FDA is providing a 3-month extension that applies to effective 
dates and compliance deadlines for requirements under the final rule 
set for May 10, 2017, or later and to all categories of the newly 
regulated products, as well as the addictiveness warning requirement 
for RYO and cigarette tobacco.
    The guidance represents the current thinking of the 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. 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 910(c)(1)(A)(i) of the FD&C Act and 21 CFR part 1143 have been 
approved under OMB control number 0910-0768; the collections of 
information in section 905(j) of the FD&C Act have been approved under 
OMB control number 0910-0673; the collections of information in section 
904(a)(4) of the FD&C Act have been approved under OMB control number 
0910-0654; the collections of information in 21 CFR part 1107 have been 
approved under OMB control number 0910-0684; the collections of 
information in section 904(c)(1), 905(b),(c),(d), (h),and 905(i)(1) 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.

    Dated: May 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09754 Filed 5-12-17; 8:45 am]
 BILLING CODE 4164-01-P