82 FR 44628 - Compliance Policy for Required Warning Statements on Small-Packaged Cigars; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 184 (September 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 184 (September 25, 2017)
| Page Range | 44628-44629 | |
| FR Document | 2017-20426 |
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)] [Notices] [Pages 44628-44629] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20426] ----------------------------------------------------------------------- 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; 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 guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small-Packaged Cigars.'' The guidance is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in FDA's regulations deeming 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 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 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: The announcement of the guidance is published in the Federal Register on September 25, 2017. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time 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 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management [[Page 44629]] Staff, 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 https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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, Silver Spring, MD 20993- 0002, 1-877-287-1373, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Compliance Policy for Required Warning Statements on Small- Packaged Cigars.'' On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) was signed 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 (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 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 28973). 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 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 Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents 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. This guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This 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 https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. Dated: September 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20426 Filed 9-22-17; 8:45 am] BILLING CODE 4164-01-P
![44628 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2016 THROUGH JUNE 30, 2017—Continued
Approval
PMA No., Docket No. Applicant Trade name date
P160003, FDA–2016–M–2652 .......... Biotronik, Inc .................................... PRO-Kinetic Energy Cobalt Chromium Coronary Stent System ............... 2/14/2017
P150039, FDA–2017–M–1121 .......... Tryton Medical, Inc .......................... TRYTON Side Branch Stent ...................................................................... 2/21/2017
P160014, FDA–2017–M–1122 .......... CeloNova BioSciences, Inc ............. COBRA PzFTM NanoCoated Coronary Stent System ............................... 2/21/2017
P100044/S023, FDA–2017–M–1228 Intersect ENT ................................... PROPEL® Contour Sinus Implant .............................................................. 2/23/2017
P140017/S005, FDA–2017–M–1227 Medtronic, Inc .................................. MelodyTM Transcatheter Pulmonary Valve, EnsembleTM Transcatheter 2/24/2017
Valve Delivery System and EnsembleTM II Transcatheter Valve Deliv-
ery System.
P160016, FDA–2017–M–1713 .......... Siemens Healthcare Diagnostics, VERSANT® HCV GENOTYPE 2.0 Assay (LiPA) ...................................... 3/14/2017
Inc.
P110033/S020, FDA–2017–M–1714 Allergan ............................................ Juvéderm VollureTM XC ............................................................................. 3/17/2017
P160025, FDA–2017–M–1845 .......... Biotronik, Inc .................................... Astron Pulsar and Pulsar-18 Stent Systems .............................................. 3/23/2017
P160009, FDA–2017–M–1950 .......... iCAD, Inc .......................................... PowerLook® Tomo Detection Software ..................................................... 3/24/2017
P160024, FDA–2017–M–2594 .......... Bard Peripheral Vascular, Inc .......... LifeStream Balloon Expandable Vascular Covered Stent ......................... 4/24/2017
P160043, FDA–2017–M–2767 .......... Medtronic, Inc .................................. Resolute Onyx Zotarolimus- Eluting Coronary Stent System .................... 4/28/2017
P160040, FDA–2017–M–2766 .......... Invivoscribe Technologies, Inc ......... LeukoStrat® CDx FLT3 Mutation Assay .................................................... 4/28/2017
P160046, FDA–2017–M–2768 .......... Ventana Medical Systems, Inc ........ VENTANA PD–L1 (SP263) Assay ............................................................. 5/1/2017
H150003, FDA–2017–M–3103 .......... Wilson-Cook Medical, Inc ................ FlourishTM Pediatric Esophageal Atresia Device ....................................... 5/12/2017
P160044, FDA–2017–M–3200 .......... Abbott Molecular, Inc ....................... Abbott RealTime CMV ................................................................................ 5/18/2017
P160041, FDA–2017–M–3430 .......... Roche Molecular Systems, Inc ........ cobas® CMV ............................................................................................... 6/1/2017
P140031/S028, FDA–2017–M–3579 Edwards Lifesciences LLC .............. Edwards SAPIEN 3TM Transcatheter Heart Valve and Accessories ......... 6/5/2017
P160035, FDA–2017–M–3580 .......... Berlin Heart, Inc ............................... EXCOR® Pediatric Ventricular Assist Device ............................................ 6/6/2017
P160047, FDA–2017–M–3778 .......... AEGEA Medical, Inc ........................ AEGEA Vapor SystemTM ........................................................................... 6/14/2017
H160002, FDA–2017–M–3839 .......... Pulsar Vascular, Inc ......................... PulseRider® Aneurysm Neck Reconstruction Device (‘‘PulseRider’’) ....... 6/19/2017
P160045, FDA–2017–M–3928 .......... Life Technologies Corp .................... OncomineTM Dx Target Test ...................................................................... 6/22/2017
P150046, FDA–2017–M–3982 .......... SciBase AB ...................................... Nevisense ................................................................................................... 6/28/2017
P150048, FDA–2017–M–3990 .......... Edwards Lifesciences, LLC ............. Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS 6/29/2017
RESILIA Aortic Valve.
P160038, FDA–2017–M–3983 .......... Illumina, Inc ...................................... PraxisTM Extended RAS Panel .................................................................. 6/29/2017
II. Electronic Access sell, distributes, or imports cigars in • Federal eRulemaking Portal:
Persons with access to the Internet small packages with respect to the https://www.regulations.gov. Follow the
may obtain the documents at https:// warning statement requirements in instructions for submitting comments.
www.fda.gov/MedicalDevices/ FDA’s regulations deeming other Comments submitted electronically,
ProductsandMedicalProcedures/ products that meet the statutory including attachments, to https://
DeviceApprovalsandClearances/ definition of a tobacco product to be www.regulations.gov will be posted to
PMAApprovals/default.htm. subject to Chapter IX of the Federal the docket unchanged. Because your
Food, Drug, and Cosmetic Act (the comment will be made public, you are
Dated: September 12, 2017. FD&C Act). The guidance describes solely responsible for ensuring that your
Anna K. Abram, FDA’s compliance policy for cigars in comment does not include any
Deputy Commissioner for Policy, Planning, packaging that is too small or otherwise confidential information that you or a
Legislation, and Analysis. unable to accommodate a label with third party may not wish to be posted,
[FR Doc. 2017–20391 Filed 9–22–17; 8:45 am] sufficient space to bear the required such as medical information, your or
BILLING CODE 4164–01–P warning statements. The guidance anyone else’s Social Security number, or
explains that FDA does not intend to confidential business information, such
take enforcement action with respect to as a manufacturing process. Please note
DEPARTMENT OF HEALTH AND cigars that do not comply with the size that if you include your name, contact
HUMAN SERVICES and placement requirements in the information, or other information that
regulation when the information and identifies you in the body of your
Food and Drug Administration specifications required under the comments, that information will be
[Docket No. FDA–2017–D–0121] regulation appear on the carton or other posted on https://www.regulations.gov.
outer container or wrapper that could • If you want to submit a comment
Compliance Policy for Required accommodate the required warning with confidential information that you
Warning Statements on Small- statements, or on a tag otherwise firmly do not wish to be made available to the
Packaged Cigars; Guidance for and permanently affixed to the cigar public, submit the comment as a
Industry; Availability package. written/paper submission and in the
manner detailed (see ‘‘Written/Paper
AGENCY: Food and Drug Administration, DATES: The announcement of the Submissions’’ and ‘‘Instructions’’).
HHS. guidance is published in the Federal
ACTION: Notice of availability. Written/Paper Submissions
Register on September 25, 2017.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Submit written/paper submissions as
SUMMARY: The Food and Drug ADDRESSES: You may submit either follows:
Administration (FDA) is announcing the electronic or written comments on • Mail/Hand delivery/Courier (for
availability of a guidance for industry Agency guidances at any time as written/paper submissions): Dockets
entitled ‘‘Compliance Policy for follows: Management Staff (HFA–305), Food and
Required Warning Statements on Small- Electronic Submissions Drug Administration, 5630 Fishers
Packaged Cigars.’’ The guidance is Lane, Rm. 1061, Rockville, MD 20852.
intended to assist any person who Submit electronic comments in the • For written/paper comments
manufactures, packages, sells, offers to following way: submitted to the Dockets Management
VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1](https://thefederalregister.org/doc/82_FR_44812/page/1.svg)
![Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44629
Staff, FDA will post your comment, as Tobacco Products, Food and Drug II. Significance of Guidance
well as any attachments, except for Administration, Document Control This guidance is being issued
information submitted, marked and Center, Bldg. 71, Rm. G335, 10903 New consistent with FDA’s good guidance
identified, as confidential, if submitted Hampshire Ave., Silver Spring, MD practices regulation (21 CFR 10.115).
as detailed in ‘‘Instructions.’’ 20993–0002. Send one self-addressed The guidance represents the current
Instructions: All submissions received adhesive label to assist that office in thinking of FDA on its compliance
must include the Docket No. FDA– processing your request or include a Fax policy for cigars in small packaging. It
2017–D–0121 for ‘‘Compliance Policy number to which the guidance
for Required Warning Statements on does not establish any rights for any
document may be sent. See the person and is not binding on FDA or the
Small-Packaged Cigars.’’ Received SUPPLEMENTARY INFORMATION section for
comments will be placed in the docket public. You can use an alternative
information on electronic access to the approach if it satisfies the requirements
and, except for those submitted as guidance.
‘‘Confidential Submissions,’’ publicly of the applicable statutes and
FOR FURTHER INFORMATION CONTACT: regulations. This guidance is not subject
viewable at https://www.regulations.gov
Deirdre Jurand, Center for Tobacco to Executive Order 12866.
or at the Dockets Management Staff
Products, Food and Drug
between 9 a.m. and 4 p.m., Monday III. Paperwork Reduction Act of 1995
Administration, 10903 New Hampshire
through Friday.
• Confidential Submissions—To Ave., Document Control Center, Bldg. This guidance also refers to
submit a comment with confidential 71, Rm. G335, Silver Spring, MD 20993– previously approved collections of
information that you do not wish to be 0002, 1–877–287–1373, AskCTP@ information found in FDA regulations.
made publicly available, submit your fda.hhs.gov. The collections of information in 21
comments only as a written/paper CFR part 1143 have been approved
SUPPLEMENTARY INFORMATION:
submission. You should submit two under 0910–0768.
copies total. One copy will include the I. Background
IV. Electronic Access
information you claim to be confidential FDA is announcing the availability of
with a heading or cover note that states Persons with access to the internet
a guidance for industry entitled may obtain an electronic version of the
‘‘THIS DOCUMENT CONTAINS ‘‘Compliance Policy for Required
CONFIDENTIAL INFORMATION’’. The guidance at either https://
Warning Statements on Small-Packaged www.regulations.gov or https://
Agency will review this copy, including Cigars.’’
the claimed confidential information, in www.fda.gov/TobaccoProducts/
On June 22, 2009, the Family Labeling/RulesRegulationsGuidance/
its consideration of comments. The Smoking Prevention and Tobacco
second copy, which will have the default.htm.
Control Act (Tobacco Control Act) (Pub.
claimed confidential information L. 111–31) was signed into law. The Dated: September 20, 2017.
redacted/blacked out, will be available Tobacco Control Act granted FDA the Anna K. Abram,
for public viewing and posted on Deputy Commissioner for Policy, Planning,
authority to regulate the manufacture,
https://www.regulations.gov. Submit Legislation, and Analysis.
marketing, and distribution of cigarettes,
both copies to the Dockets Management [FR Doc. 2017–20426 Filed 9–22–17; 8:45 am]
cigarette tobacco, roll-your-own tobacco
Staff. If you do not wish your name and
(RYO), and smokeless tobacco products BILLING CODE 4164–01–P
contact information to be made publicly
to protect the public health and to
available, you can provide this
reduce tobacco use by minors.
information on the cover sheet and not DEPARTMENT OF HEALTH AND
in the body of your comments and you The Tobacco Control Act also gave
FDA the authority to issue a regulation HUMAN SERVICES
must identify this information as
‘‘confidential.’’ Any information marked deeming other products that meet the Health Resources and Service
as ‘‘confidential’’ will not be disclosed statutory definition of a tobacco product Administration
except in accordance with 21 CFR 10.20 to be subject to Chapter IX of the FD&C
and other applicable disclosure law. For Act (section 901(b) of the FD&C Act). On National Advisory Council on Migrant
more information about FDA’s posting May 10, 2016, FDA issued that rule, Health
of comments to public dockets, see 80 extending FDA’s tobacco product
authority to cigars, among other AGENCY: Health Resources and Service
FR 56469, September 18, 2015, or access Administration (HRSA), Department of
the information at: https://www.gpo.gov/ products (81 FR 28973). Among the
requirements that now apply to cigars Health and Human Services (HHS).
fdsys/pkg/FR-2015-09-18/pdf/2015-
23389.pdf. are health warning statements ACTION: Notice of meeting.
Docket: For access to the docket to prescribed under section 906(d) of the
FD&C Act, which permits restrictions on SUMMARY: In accordance with the
read background documents or the Federal Advisory Committee Act, notice
electronic and written/paper comments the sale and distribution of tobacco
products that are ‘‘appropriate for the is hereby given that a National Advisory
received, go to https:// Council on Migrant Health (NACMH/
www.regulations.gov and insert the protection of the public health.’’ The
rule specifies the health warning Council) meeting has been scheduled.
docket number, found in brackets in the This meeting will be open to the public.
heading of this document, into the statements that must be displayed on
cigar packaging and where those The agenda for the NACMH meeting can
asabaliauskas on DSKBBXCHB2PROD with NOTICES
‘‘Search’’ box and follow the prompts be obtained by contacting the
and/or go to the Dockets Management statements must be placed, among other
requirements. Designated Federal Officer (DFO) or
Staff, 5630 Fishers Lane, Rm. 1061, accessing the Council Web site: https://
Rockville, MD 20852. The guidance discusses FDA’s
compliance policy for cigars with bphc.hrsa.gov/qualityimprovement/
You may submit comments on any
packaging too small or otherwise unable strategicpartnerships/nacmh/
guidance at any time (see 21 CFR
to accommodate the warning statements index.html.
10.115(g)(5)).
Submit written requests for single and specifications required under the The meeting will be held on
DATES:
copies of this guidance to the Center for regulation. November 7, 2017, 8:30 a.m.to 5:00 p.m.
VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\FR\FM\25SEN1.SGM 25SEN1](https://thefederalregister.org/doc/82_FR_44812/page/2.svg)
Document Created: 2018-10-24 14:42:20
Document Modified: 2018-10-24 14:42:20
| 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 | The announcement of the guidance is published in the Federal Register on September 25, 2017. | |
| Contact | Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993- 0002, 1-877-287-1373, [email protected] | |
| FR Citation | 82 FR 44628 |
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