Compliance Policy for Required Warning Statements on Small-Packaged Cigars; Guidance for Industry; Availability, 44628-44629 [2017-20426]

Download as PDF 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 date PMA No., Docket No. Applicant Trade name P160003, FDA–2016–M–2652 .......... P150039, FDA–2017–M–1121 .......... P160014, FDA–2017–M–1122 .......... P100044/S023, FDA–2017–M–1228 P140017/S005, FDA–2017–M–1227 Biotronik, Inc .................................... Tryton Medical, Inc .......................... CeloNova BioSciences, Inc ............. Intersect ENT ................................... Medtronic, Inc .................................. 2/14/2017 2/21/2017 2/21/2017 2/23/2017 2/24/2017 P160016, FDA–2017–M–1713 .......... P110033/S020, FDA–2017–M–1714 P160025, FDA–2017–M–1845 .......... P160009, FDA–2017–M–1950 .......... P160024, FDA–2017–M–2594 .......... P160043, FDA–2017–M–2767 .......... P160040, FDA–2017–M–2766 .......... P160046, FDA–2017–M–2768 .......... H150003, FDA–2017–M–3103 .......... P160044, FDA–2017–M–3200 .......... P160041, FDA–2017–M–3430 .......... P140031/S028, FDA–2017–M–3579 P160035, FDA–2017–M–3580 .......... P160047, FDA–2017–M–3778 .......... H160002, FDA–2017–M–3839 .......... P160045, FDA–2017–M–3928 .......... P150046, FDA–2017–M–3982 .......... P150048, FDA–2017–M–3990 .......... Siemens Healthcare Diagnostics, Inc. Allergan ............................................ Biotronik, Inc .................................... iCAD, Inc .......................................... Bard Peripheral Vascular, Inc .......... Medtronic, Inc .................................. Invivoscribe Technologies, Inc ......... Ventana Medical Systems, Inc ........ Wilson-Cook Medical, Inc ................ Abbott Molecular, Inc ....................... Roche Molecular Systems, Inc ........ Edwards Lifesciences LLC .............. Berlin Heart, Inc ............................... AEGEA Medical, Inc ........................ Pulsar Vascular, Inc ......................... Life Technologies Corp .................... SciBase AB ...................................... Edwards Lifesciences, LLC ............. PRO-Kinetic Energy Cobalt Chromium Coronary Stent System ............... TRYTON Side Branch Stent ...................................................................... COBRA PzFTM NanoCoated Coronary Stent System ............................... PROPEL® Contour Sinus Implant .............................................................. MelodyTM Transcatheter Pulmonary Valve, EnsembleTM Transcatheter Valve Delivery System and EnsembleTM II Transcatheter Valve Delivery System. VERSANT® HCV GENOTYPE 2.0 Assay (LiPA) ...................................... 3/17/2017 3/23/2017 3/24/2017 4/24/2017 4/28/2017 4/28/2017 5/1/2017 5/12/2017 5/18/2017 6/1/2017 6/5/2017 6/6/2017 6/14/2017 6/19/2017 6/22/2017 6/28/2017 6/29/2017 P160038, FDA–2017–M–3983 .......... Illumina, Inc ...................................... ´ Juvederm VollureTM XC ............................................................................. Astron Pulsar and Pulsar-18 Stent Systems .............................................. PowerLook® Tomo Detection Software ..................................................... LifeStream Balloon Expandable Vascular Covered Stent ......................... Resolute Onyx Zotarolimus- Eluting Coronary Stent System .................... LeukoStrat® CDx FLT3 Mutation Assay .................................................... VENTANA PD–L1 (SP263) Assay ............................................................. FlourishTM Pediatric Esophageal Atresia Device ....................................... Abbott RealTime CMV ................................................................................ cobas® CMV ............................................................................................... Edwards SAPIEN 3TM Transcatheter Heart Valve and Accessories ......... EXCOR® Pediatric Ventricular Assist Device ............................................ AEGEA Vapor SystemTM ........................................................................... PulseRider® Aneurysm Neck Reconstruction Device (‘‘PulseRider’’) ....... OncomineTM Dx Target Test ...................................................................... Nevisense ................................................................................................... Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. PraxisTM Extended RAS Panel .................................................................. 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. II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. Dated: September 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–20391 Filed 9–22–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–0121] Compliance Policy for Required Warning Statements on SmallPackaged Cigars; Guidance for Industry; Availability AGENCY: Food and Drug Administration, asabaliauskas on DSKBBXCHB2PROD with NOTICES HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Compliance Policy for Required Warning Statements on SmallPackaged Cigars.’’ The guidance is intended to assist any person who manufactures, packages, sells, offers to SUMMARY: VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 The announcement of the guidance is published in the Federal Register on September 25, 2017. DATES: You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 3/14/2017 6/29/2017 • 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 E:\FR\FM\25SEN1.SGM 25SEN1 asabaliauskas on DSKBBXCHB2PROD with NOTICES Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 VerDate Sep<11>2014 19:45 Sep 22, 2017 Jkt 241001 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, AskCTP@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Frm 00075 Fmt 4703 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 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. PO 00000 44629 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration National Advisory Council on Migrant Health Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, notice is hereby given that a National Advisory Council on Migrant Health (NACMH/ Council) meeting has been scheduled. This meeting will be open to the public. The agenda for the NACMH meeting can be obtained by contacting the Designated Federal Officer (DFO) or accessing the Council Web site: https:// bphc.hrsa.gov/qualityimprovement/ strategicpartnerships/nacmh/ index.html. SUMMARY: The meeting will be held on November 7, 2017, 8:30 a.m.to 5:00 p.m. DATES: E:\FR\FM\25SEN1.SGM 25SEN1

Agencies

[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44628-44629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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, AskCTP@fda.hhs.gov.

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

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