81 FR 28780 - The Food and Drug Administration Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 90 (May 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 90 (May 10, 2016)
| Page Range | 28780-28781 | |
| FR Document | 2016-10684 |
[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)] [Proposed Rules] [Pages 28780-28781] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10684] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1100, 1140, and 1143 [Docket No. FDA-2014-N-0189] The Food and Drug Administration Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide.'' This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the deeming regulation and to help small businesses understand and comply with the regulation. 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-N-0189 for ``FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements; Small Entity Compliance Guide.'' 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 [[Page 28781]] 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 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, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 1-877-287-1373, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements, Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with FDA's implementation of the final rule entitled ``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 is published elsewhere in this edition of the Federal Register. Specifically, this guidance is intended to help small businesses understand how to comply with FDA's final rule deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (``FD&C Act''), as amended by the Family Smoking Prevention and Tobacco Control Act (``Tobacco Control Act''). The Deeming rule extends FDA's authority in Chapter IX of the FD&C Act to include all tobacco products, except accessories of newly deemed tobacco products. The Deeming rule also prohibits the sale of covered tobacco products to individuals under the age of 18, prohibits vending machine sales unless sold in adult-only facilities, and requires the display of health warning statements on cigarette tobacco, roll-your-own tobacco, and covered tobacco product packages and in advertisements. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121), FDA is making available this SECG stating in plain language the legal requirements of the Deeming final rule, set forth in 21 CFR parts 1100, 1140, and 1143. II. Significance of Guidance FDA is issuing this 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. 2016-10684 Filed 5-5-16; 8:45 am] BILLING CODE 4164-01-P
![28780 Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Proposed Rules
rule on Deeming Tobacco Products To DEPARTMENT OF HEALTH AND public, submit the comment as a
Be Subject to the Federal Food, Drug, HUMAN SERVICES written/paper submission and in the
and Cosmetic Act, as Amended by the manner detailed (see ‘‘Written/Paper
Family Smoking Prevention and Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
Tobacco Control Act; Restrictions on the Written/Paper Submissions
Sale and Distribution of Tobacco 21 CFR Parts 1100, 1140, and 1143
Submit written/paper submissions as
Products and Required Warning [Docket No. FDA–2014–N–0189] follows:
Statements for Tobacco Products. The • Mail/Hand delivery/Courier (for
collections of information in the final The Food and Drug Administration
written/paper submissions): Division of
rule are subject to review by the Office Deems Certain Tobacco Products
Dockets Management (HFA–305), Food
of Management and Budget (OMB) Subject to FDA Authority, Sales and
and Drug Administration, 5630 Fishers
under the Paperwork Reduction Act of Distribution Restrictions, and Health
Lane, Rm. 1061, Rockville, MD 20852.
1995 (PRA) (44 U.S.C. 3501–3520). As Warning Requirements for Packages • For written/paper comments
required by the PRA, FDA has and Advertisements; Small Entity submitted to the Division of Dockets
published an analysis of the information Compliance Guide; Availability Management, FDA will post your
collection provisions elsewhere in this AGENCY: Food and Drug Administration, comment, as well as any attachments,
issue of the Federal Register and has HHS. except for information submitted,
submitted them for OMB approval. marked and identified, as confidential,
ACTION: Notification of availability.
if submitted as detailed in
This guidance also refers to
SUMMARY: The Food and Drug ‘‘Instructions.’’
previously approved collections of Instructions: All submissions received
information. These collections of Administration (FDA) is announcing the
availability of a guidance for industry must include the Docket No. FDA–
information are subject to review by the 2014–N–0189 for ‘‘FDA Deems Certain
entitled ‘‘FDA Deems Certain Tobacco
Office of Management and Budget Tobacco Products Subject to FDA
Products Subject to FDA Authority,
(OMB) under the PRA (44 U.S.C. 3501– Authority, Sales and Distribution
Sales and Distribution Restrictions, and
3520). The collections of information in Health Warning Requirements for Restrictions, and Health Warning
section 905(j) of the Federal Food, Drug, Packages and Advertisements; Small Requirements for Packages and
and Cosmetic Act (FD&C Act) have been Entity Compliance Guide.’’ This small Advertisements; Small Entity
approved under OMB control number entity compliance guide (SECG) is Compliance Guide.’’ Received
0910–0673; the collections of intended to set forth in plain language comments will be placed in the docket
information in sections 904(a)(1), (c) the requirements of the deeming and, except for those submitted as
and 905(b), (c), (d), (h), (i) of the FD&C regulation and to help small businesses ‘‘Confidential Submissions,’’ publicly
Act have been approved under OMB understand and comply with the viewable at http://www.regulations.gov
control number 0910–0650; the regulation. or at the Division of Dockets
collections of information in section Management between 9 a.m. and 4 p.m.,
DATES: Submit either electronic or Monday through Friday.
904(a)(4) of the FD&C Act have been written comments on Agency guidances • Confidential Submissions—To
approved under OMB control number at any time. submit a comment with confidential
0910–0654; the collections of
ADDRESSES: You may submit comments information that you do not wish to be
information in 21 CFR 1107.1(b) and (c), made publicly available, submit your
as follows:
21 CFR 25.40, and section comments only as a written/paper
905(j)(1)(A)(ii) of the FD&C Act have Electronic Submissions submission. You should submit two
been approved under OMB control Submit electronic comments in the copies total. One copy will include the
number 0910–0684; the collections of following way: information you claim to be confidential
information in sections 904(a)(3) and • Federal eRulemaking Portal: http:// with a heading or cover note that states
904(c)(1) of the FD&C Act have been www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
approved under OMB control number instructions for submitting comments. CONFIDENTIAL INFORMATION’’. The
0910–0732; and the collections of Comments submitted electronically, Agency will review this copy, including
information in section 910 have been including attachments, to http:// the claimed confidential information, in
approved under OMB control number www.regulations.gov will be posted to its consideration of comments. The
0910–0775. the docket unchanged. Because your second copy, which will have the
comment will be made public, you are claimed confidential information
III. Electronic Access solely responsible for ensuring that your redacted/blacked out, will be available
Persons with access to the Internet comment does not include any for public viewing and posted on http://
may obtain an electronic version of the confidential information that you or a www.regulations.gov. Submit both
guidance at either http:// third party may not wish to be posted, copies to the Division of Dockets
www.regulations.gov or http:// such as medical information, your or Management. If you do not wish your
anyone else’s Social Security number, or name and contact information to be
www.fda.gov/TobaccoProducts/
confidential business information, such made publicly available, you can
Labeling/RulesRegulationsGuidance/
as a manufacturing process. Please note provide this information on the cover
default.htm. that if you include your name, contact sheet and not in the body of your
ehiers on DSK5VPTVN1PROD with PROPOSALS
Dated: May 3, 2016. information, or other information that comments and you must identify this
Leslie Kux, identifies you in the body of your information as ‘‘confidential.’’ Any
Associate Commissioner for Policy. comments, that information will be information marked as ‘‘confidential’’
[FR Doc. 2016–10690 Filed 5–5–16; 8:45 am]
posted on http://www.regulations.gov. will not be disclosed except in
• If you want to submit a comment accordance with 21 CFR 10.20 and other
BILLING CODE 4164–01–P
with confidential information that you applicable disclosure law. For more
do not wish to be made available to the information about FDA’s posting of
VerDate Sep<11>2014 15:20 May 09, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4702 Sfmt 4702 E:\FR\FM\10MYP1.SGM 10MYP1](https://thefederalregister.org/doc/81_FR_28870/page/1.svg)
![Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Proposed Rules 28781
comments to public dockets, see 80 FR amended by the Family Smoking DEPARTMENT OF HEALTH AND
56469, September 18, 2015, or access Prevention and Tobacco Control Act HUMAN SERVICES
the information at: http://www.fda.gov/ (‘‘Tobacco Control Act’’). The Deeming
regulatoryinformation/dockets/ rule extends FDA’s authority in Chapter Food and Drug Administration
default.htm. IX of the FD&C Act to include all
Docket: For access to the docket to tobacco products, except accessories of 21 CFR Parts 1100, 1140, and 1143
read background documents or the newly deemed tobacco products. The [Docket No. FDA–2015–D–2496]
electronic and written/paper comments Deeming rule also prohibits the sale of
received, go to http:// covered tobacco products to individuals Premarket Tobacco Product
www.regulations.gov and insert the under the age of 18, prohibits vending Applications for Electronic Nicotine
docket number, found in brackets in the machine sales unless sold in adult-only Delivery Systems; Draft Guidance for
heading of this document, into the Industry; Availability; Agency
facilities, and requires the display of
‘‘Search’’ box and follow the prompts Information Collection Activities;
health warning statements on cigarette
and/or go to the Division of Dockets Proposed Collection; Comment
tobacco, roll-your-own tobacco, and
Management, 5630 Fishers Lane, Rm. Request
1061, Rockville, MD 20852. covered tobacco product packages and
Submit written requests for single in advertisements. AGENCY: Food and Drug Administration,
copies of this guidance to the Center for In compliance with section 212 of the HHS.
Tobacco Products, Food and Drug Small Business Regulatory Enforcement ACTION: Notification of availability.
Administration, Document Control Fairness Act (Pub. L. 104–121), FDA is SUMMARY: The Food and Drug
Center, Bldg. 71, Rm. G335, 10903 New making available this SECG stating in Administration (FDA) is announcing the
Hampshire Ave., Silver Spring, MD plain language the legal requirements of availability of a draft guidance for
20993–0002. Send one self-addressed the Deeming final rule, set forth in 21 industry entitled ‘‘Premarket Tobacco
adhesive label to assist that office in CFR parts 1100, 1140, and 1143. Product Applications for Electronic
processing your request or include a fax Nicotine Delivery Systems.’’ Given the
number to which the guidance II. Significance of Guidance
relatively new presence of electronic
document may be sent. See the nicotine delivery systems (ENDS) on the
FDA is issuing this SECG as a level 2
SUPPLEMENTARY INFORMATION section for U.S. market and FDA’s final rule
guidance, consistent with FDA’s good
information on electronic access to the deeming these products to be subject to
guidance. guidance practices regulation (21 CFR
10.115). The guidance represents the the tobacco product authorities in the
FOR FURTHER INFORMATION CONTACT: Federal Food, Drug, and Cosmetic Act
current thinking of FDA on this topic.
Katherine Collins, Center for Tobacco (FD&C Act), FDA expects to receive
It does not establish any rights for any
Products, Food and Drug premarket tobacco product application
Administration, Document Control person and is not binding on FDA or the
(PMTA) submissions from
Center, Bldg. 71, Rm. G335, 10903 New public unless specific regulatory or
manufacturers of ENDS. This draft
Hampshire Ave., Silver Spring, MD statutory requirements are cited. You guidance is intended to assist persons
20993–2000, 1–877–287–1373, email: can use an alternative approach if it with their PMTA submissions for ENDS
AskCTP@fda.hhs.gov. satisfies the requirements of the products.
SUPPLEMENTARY INFORMATION:
applicable statutes and regulations. DATES: Although you can comment on
III. Electronic Access any guidance at any time (see 21 CFR
I. Background
10.115(g)(5)), to ensure that the Agency
FDA is announcing the availability of Persons with access to the Internet considers your comment on this draft
a guidance for industry entitled ‘‘FDA may obtain an electronic version of the guidance before it begins work on the
Deems Certain Tobacco Products guidance at either http:// final version of the guidance, submit
Subject to FDA Authority, Sales and www.regulations.gov or http://www.fda. either electronic or written comments
Distribution Restrictions, and Health gov/TobaccoProducts/Labeling/Rules on the draft guidance by July 11, 2016.
Warning Requirements for Packages and RegulationsGuidance/default.htm. ADDRESSES: You may submit comments
Advertisements, Small Entity as follows:
Dated: May 3, 2016.
Compliance Guide.’’ This guidance is
intended to help small businesses Leslie Kux, Electronic Submissions
understand and comply with FDA’s Associate Commissioner for Policy. Submit electronic comments in the
implementation of the final rule entitled [FR Doc. 2016–10684 Filed 5–5–16; 8:45 am] following way:
‘‘Deeming Tobacco Products To Be BILLING CODE 4164–01–P • Federal eRulemaking Portal: http://
Subject to the Federal Food, Drug, and www.regulations.gov. Follow the
Cosmetic Act, as Amended by the instructions for submitting comments.
Family Smoking Prevention and Comments submitted electronically,
Tobacco Control Act; Restrictions on the including attachments, to http://
Sale and Distribution of Tobacco www.regulations.gov will be posted to
Products and Required Warning the docket unchanged. Because your
Statements for Tobacco Products’’ comment will be made public, you are
(Deeming rule), which is published solely responsible for ensuring that your
ehiers on DSK5VPTVN1PROD with PROPOSALS
elsewhere in this edition of the Federal comment does not include any
Register. Specifically, this guidance is confidential information that you or a
intended to help small businesses third party may not wish to be posted,
understand how to comply with FDA’s such as medical information, your or
final rule deeming tobacco products to anyone else’s Social Security number, or
be subject to the Federal Food, Drug, confidential business information, such
and Cosmetic Act (‘‘FD&C Act’’), as as a manufacturing process. Please note
VerDate Sep<11>2014 15:20 May 09, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4702 Sfmt 4702 E:\FR\FM\10MYP1.SGM 10MYP1](https://thefederalregister.org/doc/81_FR_28870/page/2.svg)
Document Created: 2016-05-10 05:18:48
Document Modified: 2016-05-10 05:18:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Katherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000, 1-877-287-1373, email: [email protected] | |
| FR Citation | 81 FR 28780 | |
| CFR Citation | 21
CFR
1100 21 CFR 1140 21 CFR 1143 |
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