82 FR 4892 - Compliance Policy for Required Warning Statements on Small-Packaged Cigars; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 10 (January 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 10 (January 17, 2017)
| Page Range | 4892-4893 | |
| FR Document | 2017-00855 |
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)] [Notices] [Pages 4892-4893] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00855] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-0121] Compliance Policy for Required Warning Statements on Small- Packaged Cigars; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small-Packaged Cigars.'' The draft guidance, when finalized, is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages, in complying with the warning statement requirements in FDA's regulations deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance describes FDA's compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The draft guidance explains that FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 16, 2017. 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-2017-D-0121 for ``Compliance Policy for Required Warning Statements on Small-Packaged Cigars.'' 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 SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Deirdre Jurand, Center for Tobacco [[Page 4893]] Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small- Packaged Cigars.'' On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111- 31) into law. The Tobacco Control Act granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, 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) of the FD&C Act). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to cigars, among other products (81 FR 28974). Among the requirements that now apply to cigars are health warning statements prescribed under section 906(d) of the FD&C Act, which permits restrictions on the sale and distribution of tobacco products that are ``appropriate for the protection of the public health.'' The rule specifies the health warning statements that must be displayed on cigar packaging and where those statements must be placed, among other requirements. The draft guidance discusses FDA's compliance policy for cigars with packaging too small or otherwise unable to accommodate the warning statements and specifications required under the regulation. II. Significance of Draft Guidance FDA is issuing this draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on its compliance policy for cigars in small packaging. 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 draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 1143 have been approved under 0910-0768. 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: January 11, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00855 Filed 1-13-17; 8:45 am] BILLING CODE 4164-01-P
![4892 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices
person and is not binding on FDA or the DATES: Although you can comment on viewable at http://www.regulations.gov
public. You can use an alternative any guidance at any time (see 21 CFR or at the Division of Dockets
approach if it satisfies the requirements 10.115(g)(5)), to ensure that the Agency Management between 9 a.m. and 4 p.m.,
of the applicable statutes and considers your comment on this draft Monday through Friday.
regulations. guidance before it begins work on the • Confidential Submissions—To
II. Electronic Access final version of the guidance, submit submit a comment with confidential
either electronic or written comments information that you do not wish to be
Persons with access to the Internet on the draft guidance by February 16, made publicly available, submit your
may obtain the draft guidance at either 2017. comments only as a written/paper
http://www.fda.gov/Drugs/Guidance submission. You should submit two
ADDRESSES: You may submit comments
ComplianceRegulatoryInformation/ copies total. One copy will include the
Guidances/default.htm or http:// as follows:
information you claim to be confidential
www.regulations.gov. Electronic Submissions with a heading or cover note that states
Dated: January 10, 2017. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Leslie Kux, following way: CONFIDENTIAL INFORMATION.’’ The
Associate Commissioner for Policy. • Federal eRulemaking Portal: http:// Agency will review this copy, including
[FR Doc. 2017–00795 Filed 1–13–17; 8:45 am] www.regulations.gov. Follow the the claimed confidential information, in
BILLING CODE 4164–01–P instructions for submitting comments. its consideration of comments. The
Comments submitted electronically, second copy, which will have the
including attachments, to http:// claimed confidential information
DEPARTMENT OF HEALTH AND www.regulations.gov will be posted to redacted/blacked out, will be available
HUMAN SERVICES the docket unchanged. Because your for public viewing and posted on http://
comment will be made public, you are www.regulations.gov. Submit both
Food and Drug Administration solely responsible for ensuring that your copies to the Division of Dockets
[Docket No. FDA–2017–D–0121] comment does not include any Management. If you do not wish your
confidential information that you or a name and contact information to be
Compliance Policy for Required third party may not wish to be posted, made publicly available, you can
Warning Statements on Small- such as medical information, your or provide this information on the cover
Packaged Cigars; Draft Guidance for anyone else’s Social Security number, or sheet and not in the body of your
Industry; Availability confidential business information, such comments and you must identify this
as a manufacturing process. Please note information as ‘‘confidential.’’ Any
AGENCY: Food and Drug Administration, information marked as ‘‘confidential’’
that if you include your name, contact
HHS. will not be disclosed except in
information, or other information that
ACTION: Notice of availability. identifies you in the body of your accordance with 21 CFR 10.20 and other
SUMMARY: The Food and Drug comments, that information will be applicable disclosure law. For more
Administration (FDA) is announcing the posted on http://www.regulations.gov. information about FDA’s posting of
availability of a draft guidance for • If you want to submit a comment comments to public dockets, see 80 FR
industry entitled ‘‘Compliance Policy with confidential information that you 56469, September 18, 2015, or access
for Required Warning Statements on do not wish to be made available to the the information at: http://www.fda.gov/
Small-Packaged Cigars.’’ The draft public, submit the comment as a regulatoryinformation/dockets/
guidance, when finalized, is intended to written/paper submission and in the default.htm.
assist any person who manufacturers, manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
packages, sells, offers to sell, distributes, Submissions’’ and ‘‘Instructions’’). read background documents or the
or imports cigars in small packages, in electronic and written/paper comments
Written/Paper Submissions
complying with the warning statement received, go to http://
requirements in FDA’s regulations Submit written/paper submissions as www.regulations.gov and insert the
deeming all other products that meet the follows: docket number, found in brackets in the
statutory definition of a tobacco product • Mail/Hand delivery/Courier (for heading of this document, into the
to be subject to Chapter IX of the written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Federal Food, Drug, and Cosmetic Act Dockets Management (HFA–305), Food and/or go to the Division of Dockets
(the FD&C Act). The draft guidance and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
describes FDA’s compliance policy for Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
cigars in packaging that is too small or • For written/paper comments Submit written requests for single
otherwise unable to accommodate a submitted to the Division of Dockets copies of this guidance to the Center for
label with sufficient space to bear the Management, FDA will post your Tobacco Products, Food and Drug
required warning statements. The draft comment, as well as any attachments, Administration, Document Control
guidance explains that FDA does not except for information submitted, Center, Bldg. 71, Rm. G335, 10903 New
intend to take enforcement action with marked and identified, as confidential, Hampshire Ave., Silver Spring, MD
respect to cigars that do not comply if submitted as detailed in 20993–0002. Send one self-addressed
with the size and placement ‘‘instructions.’’ adhesive label to assist that office in
requirements in the regulation when the Instructions: All submissions received processing your request or include a fax
sradovich on DSK3GMQ082PROD with NOTICES
information and specifications required must include the Docket No. FDA– number to which the guidance
under the regulation appear on the 2017–D–0121 for ‘‘Compliance Policy document may be sent. See the
carton or other outer container or for Required Warning Statements on SUPPLEMENTARY INFORMATION section for
wrapper that could accommodate the Small-Packaged Cigars.’’ Received information on electronic access to the
required warning statements, or on a tag comments will be placed in the docket guidance.
otherwise firmly and permanently and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
affixed to the cigar package. ‘‘Confidential Submissions,’’ publicly Deirdre Jurand, Center for Tobacco
VerDate Sep<11>2014 18:21 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/82_FR_4902/page/1.svg)
![Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Notices 4893
Products, Food and Drug III. Paperwork Reduction Act of 1995 considers your comment of this draft
Administration, Document Control This draft guidance also refers to guidance before it begins work on the
Center, Bldg. 71, Rm. G335, 10903 New previously approved collections of final version of the guidance, submit
Hampshire Ave., Silver Spring, MD information found in FDA regulations. either electronic or written comments
20993–0002, 1–877–287–1373, The collections of information in 21 on the draft guidance by February 16,
AskCTP@fda.hhs.gov. CFR part 1143 have been approved 2017.
SUPPLEMENTARY INFORMATION: under 0910–0768. ADDRESSES: You may submit comments
I. Background IV. Electronic Access as follows:
FDA is announcing the availability of Persons with access to the Internet Electronic Submissions
a draft guidance for industry entitled may obtain an electronic version of the Submit electronic comments in the
‘‘Compliance Policy for Required guidance at either http:// following way:
Warning Statements on Small-Packaged www.regulations.gov or http:// • Federal eRulemaking Portal:
Cigars.’’ www.fda.gov/TobaccoProducts/ https://www.regulations.gov. Follow the
On June 22, 2009, the President Labeling/RulesRegulationsGuidance/ instructions for submitting comments.
signed the Family Smoking Prevention default.htm. Comments submitted electronically,
and Tobacco Control Act (Tobacco Dated: January 11, 2017. including attachments, to https://
Control Act) (Pub. L. 111–31) into law. Leslie Kux, www.regulations.gov will be posted to
The Tobacco Control Act granted FDA the docket unchanged. Because your
Associate Commissioner for Policy.
the authority to regulate the comment will be made public, you are
[FR Doc. 2017–00855 Filed 1–13–17; 8:45 am]
manufacture, marketing, and solely responsible for ensuring that your
BILLING CODE 4164–01–P
distribution of cigarettes, cigarette comment does not include any
tobacco, roll-your-own tobacco, and confidential information that you or a
smokeless tobacco products to protect third party may not wish to be posted,
DEPARTMENT OF HEALTH AND
the public health and to reduce tobacco such as medical information, your or
HUMAN SERVICES
use by minors. anyone else’s Social Security number, or
The Tobacco Control Act also gave Food and Drug Administration confidential business information, such
FDA the authority to issue a regulation as a manufacturing process. Please note
deeming all other products that meet the [Docket No. FDA–2017–D–0120] that if you include your name, contact
statutory definition of a tobacco product information, or other information that
Interpretation of and Compliance
to be subject to Chapter IX of the FD&C identifies you in the body of your
Policy for Certain Label Requirement;
Act (section 901(b) of the FD&C Act). On comments, that information will be
Applicability of Certain Federal Food,
May 10, 2016, FDA issued that rule, posted on https://www.regulations.gov.
Drug, and Cosmetic Act Requirements
extending FDA’s tobacco product
to Vape Shops; Draft Guidance for • If you want to submit a comment
authority to cigars, among other with confidential information that you
Industry; Availability
products (81 FR 28974). Among the do not wish to be made available to the
requirements that now apply to cigars AGENCY: Food and Drug Administration, public, submit the comment as a
are health warning statements HHS. written/paper submission and in the
prescribed under section 906(d) of the ACTION: Notice of availability. manner detailed (see ‘‘Written/Paper
FD&C Act, which permits restrictions on Submissions’’ and ‘‘Instructions’’).
the sale and distribution of tobacco SUMMARY: The Food and Drug
products that are ‘‘appropriate for the Administration (FDA or we) is Written/Paper Submissions
protection of the public health.’’ The announcing the availability of a draft Submit written/paper submissions as
rule specifies the health warning guidance for industry entitled follows:
statements that must be displayed on ‘‘Interpretation of and Compliance • Mail/Hand delivery/Courier (for
cigar packaging and where those Policy for Certain Label Requirement; written/paper submissions): Division of
statements must be placed, among other Applicability of Certain Federal Food, Dockets Management (HFA–305), Food
requirements. Drug, and Cosmetic Act Requirements to and Drug Administration, 5630 Fishers
The draft guidance discusses FDA’s Vape Shops.’’ This draft guidance Lane, Rm. 1061, Rockville, MD 20852.
compliance policy for cigars with provides FDA’s interpretation of, and a • For written/paper comments
packaging too small or otherwise unable compliance policy for, the requirement submitted to the Division of Dockets
to accommodate the warning statements that the label of tobacco products Management, FDA will post your
and specifications required under the contain an accurate statement of the comment, as well as any attachments,
regulation. percentage of foreign and domestic except for information submitted,
grown tobacco under the Federal Food, marked and identified, as confidential,
II. Significance of Draft Guidance Drug, and Cosmetic Act (the FD&C Act). if submitted as detailed in
FDA is issuing this draft guidance This draft guidance document is also ‘‘Instructions.’’
consistent with FDA’s good guidance intended to assist retailers who sell Instructions: All submissions received
practices regulation (21 CFR 10.115). newly deemed products by explaining must include the Docket No. FDA–
The draft guidance, when finalized, will whether engaging in certain activities 2017–D–0120 for ‘‘Interpretation of and
represent the current thinking of FDA subjects such establishments to Compliance Policy for Certain Label
sradovich on DSK3GMQ082PROD with NOTICES
on its compliance policy for cigars in additional requirements of the FD&C Requirement; Applicability of Certain
small packaging. It does not establish Act and the limited circumstances Federal Food, Drug, and Cosmetic Act
any rights for any person and is not under which FDA does not intend to Requirements to Vape Shops.’’ Received
binding on FDA or the public. You can enforce compliance. comments will be placed in the docket
use an alternative approach if it satisfies DATES: Although you can comment on and, except for those submitted as
the requirements of the applicable any guidance at any time (see 21 CFR ‘‘Confidential Submissions,’’ publicly
statutes and regulations. 10.115(g)(5)), to ensure that the Agency viewable at https://www.regulations.gov
VerDate Sep<11>2014 18:21 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\17JAN1.SGM 17JAN1](https://thefederalregister.org/doc/82_FR_4902/page/2.svg)
Document Created: 2017-01-14 01:44:59
Document Modified: 2017-01-14 01:44:59
| 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 | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 16, 2017. | |
| Contact | Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, [email protected] | |
| FR Citation | 82 FR 4892 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR