44626 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 

Dated: September 19, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20375 Filed 9–22–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2015–M–4474, FDA– 

2016–M–1915, FDA–2016–M–1837, FDA– 

2016–M–1916, FDA–2016–M–1914, FDA– 

2016–M–1917, FDA–2016–M–2182, FDA– 

2016–M–2183, FDA–2016–M–2184, FDA– 

2016–M–2185, FDA–2016–M–2332, FDA– 

2016–M–2334, FDA–2016–M–2333, FDA– 

2016–M–2485, FDA–2016–M–2498, FDA– 

2016–M–2499, FDA–2016–M–2500, FDA– 

2016–M–2649, FDA–2016–M–2650, FDA– 

2016–M–2651, FDA–2016–M–2735, FDA– 

2016–M–2974, FDA–2016–M–2971, FDA– 

2016–M–1972, FDA–2016–M–2973, FDA– 

2016–M–2975, FDA–2016–M–3430, FDA– 

2016–M–3431, FDA–2016–M–3913, FDA– 

2016–M–3653, FDA–2016–M–3914, FDA– 

2016–M–3915, FDA–2016–M–4046, FDA– 

2016–M–4344, FDA–2016–M–4458, FDA– 

2016–M–4459, FDA–2016–M–4483, FDA– 

2016–M–4657, FDA–2016–M–4530, FDA– 

2016–M–4653, FDA–2017–M–0180, FDA– 

2017–M–0181, FDA–2017–M–0229, FDA– 

2017–M–0560, FDA–2017–M–0831, FDA– 

2017–M–0661, FDA–2017–M–0971, FDA– 

2017–M–2652, FDA–2017–M–1121, FDA– 

2017–M–1122, FDA–2017–M–1228, FDA– 

2017–M–1845, FDA–2017–M–1227, FDA– 

2017–M–1713, FDA–2017–M–1714, FDA– 

2017–M–1950, FDA–2017–M–2594, FDA– 

2017–M–2766, FDA–2017–M–2767, FDA– 

2017–M–2768, FDA–2017–M–3103, FDA– 

2017–M–3200, FDA–2017–M–3430, FDA– 

2017–M–3579, FDA–2017–M–3580, FDA– 

2017–M–3778, FDA–2017–M–3839, FDA– 

2017–M–3928, FDA–2017–M–3982, FDA– 

2017–M–3990, and FDA–2017–M–3983] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Dockets Management Staff. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

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 

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 Nos. FDA– 

2015–M–4474, FDA–2016–M–1915, 

FDA–2016–M–1837, FDA–2016–M– 

1916, FDA–2016–M–1914, FDA–2016– 

M–1917, FDA–2016–M–2182, FDA– 

2016–M–2183, FDA–2016–M–2184, 

FDA–2016–M–2185, FDA–2016–M– 

2332, FDA–2016–M–2334, FDA–2016– 

M–2333, FDA–2016–M–2485, FDA– 

2016–M–2498, FDA–2016–M–2499, 

FDA–2016–M–2500, FDA–2016–M– 

2649, FDA–2016–M–2650, FDA–2016– 

M–2651, FDA–2016–M–2735, FDA– 

2016–M–2974, FDA–2016–M–2971, 

FDA–2016–M–1972, FDA–2016–M– 

2973, FDA–2016–M–2975, FDA–2016– 

M–3430, FDA–2016–M–3431, FDA– 

2016–M–3913, FDA–2016–M–3653, 

FDA–2016–M–3914, FDA–2016–M– 

3915, FDA–2016–M–4046, FDA–2016– 

M–4344, FDA–2016–M–4458, FDA– 

2016–M–4459, FDA–2016–M–4483, 

FDA–2016–M–4657, FDA–2016–M– 

4530, FDA–2016–M–4653, FDA–2017– 

M–0180, FDA–2017–M–0181, FDA– 

2017–M–0229, FDA–2017–M–0560, 

FDA–2017–M–0831, FDA–2017–M– 

0661, FDA–2017–M–0971, FDA–2017– 

M–2652, FDA–2017–M–1121, FDA– 

2017–M–1122, FDA–2017–M–1228, 

FDA–2017–M–1845, FDA–2017–M– 

1227, FDA–2017–M–1713, FDA–2017– 

M–1714, FDA–2017–M–1950, FDA– 

2017–M–2594, FDA–2017–M–2766, 

FDA–2017–M–2767, FDA–2017–M– 

2768, FDA–2017–M–3103, FDA–2017– 

M–3200, FDA–2017–M–3430, FDA– 

2017–M–3579, FDA–2017–M–3580, 

FDA–2017–M–3778, FDA–2017–M– 

3839, FDA–2017–M–3928, FDA–2017– 

M–3982, FDA–2017–M–3990, and FDA– 

2017–M–3983 for ‘‘Medical Devices; 

Availability of Safety and Effectiveness 

Summaries for Premarket Approval 

Applications.’’ 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44627 

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. 

FOR FURTHER INFORMATION CONTACT: 

Joshua Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1650, Silver Spring, 

MD 20993–0002, 301–796–6524. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the FD&C 

Act. The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

internet from July 1, 2016, through June 

30, 2017. There were no denial actions 

during this period. The list provides the 

manufacturer’s name, the product’s 

generic name or the trade name, and the 

approval date. 

TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1, 

2016 THROUGH JUNE 30, 2017 

PMA No., Docket No. Applicant Trade name Approval 

date 

P130018, FDA–2015–M–4474 .......... Uromedica, Inc ................................. ProACTTM Adjustable Continence Therapy for Men .................................. 11/24/15 

P140003/S004, FDA–2016–M–1915 Abiomed, Inc .................................... Impella Ventricular Support ........................................................................ 4/7/2016 

P150034, FDA–2016–M–1837 .......... Revision Optics, Inc ......................... Raindrop Near Vision Inlay ........................................................................ 6/29/2016 

P150017, FDA–2016–M–1916 .......... Cartiva, Inc ....................................... Cartiva Synthetic Cartilage Implant ............................................................ 7/1/2016 

P150023, FDA–2016–M–1914 .......... Abbott Vascular ................................ Absorb GT1TM Bioresorbable Vascular Scaffold (BVS) System ............... 7/5/2016 

P100020/S017, FDA–2016–M–1917 Roche Molecular Systems, Inc ........ cobas® HPV Test ....................................................................................... 7/7/2016 

P090029/S003, FDA–2016–M–2182 Medtronic Sofamor Danek USA, Inc Prestige LPTM Cervical Disc ....................................................................... 7/7/2016 

P150038, FDA–2016–M–2183 .......... InSightec, Inc ................................... ExAblate Model 4000 Type 1.0 System (ExAblate Neuro) ........................ 7/11/2016 

P980040/S065, FDA–2016–M–2184 Abbott Medical Optics, Inc ............... TECNIS® Symfony Extended Range of Vision Intraocular Lens ............... 7/15/2016 

P150006, FDA–2016–M–2185 .......... Vasorum, Ltd .................................... Celt ACD Vascular Closure Device ............................................................ 7/20/2016 

P160004, FDA–2016–M–2332 .......... W.L. Gore & Associates, Inc ........... Gore TIGRIS Vascular Stent ...................................................................... 7/27/2016 

P150003/S003, FDA–2016–M–2334 Boston Scientific Corp ..................... SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent 

System (Over-The-Wire & Monorail).

7/29/2016 

P150037, FDA–2016–M–2333 .......... Alcon Laboratories, Inc .................... CyPass® System (Model 241–S) ............................................................... 7/29/2016 

P150001, FDA–2016–M–2500 .......... Medtronic MiniMed ........................... MiniMed 630G System with SmartGuard ................................................... 8/10/2016 

P150036, FDA–2016–M–2485 .......... Edwards Lifesciences, LLC ............. Edwards INTUITY Elite Valve System ....................................................... 8/12/2016 

P130009/S057, FDA–2016–M–2498 Edwards Lifesciences LLC .............. Edwards SAPIEN XT Transcatheter Heart Valve ...................................... 8/18/2016 

P140031/S010, FDA–2016–M–2499 Edwards Lifesciences LLC .............. Edwards SAPIEN 3 Transcatheter Heart Valve ......................................... 8/18/2016 

P020045/S073, 2016–M–2649 .......... Medtronic, Inc .................................. Freezor® Xtra Cardiac Cryoablation Catheter ........................................... 8/31/2016 

P140010/S015, FDA–2016–M–2650 Medtronic Vascular, Inc ................... In PactTM AdmiralTM Paclitaxel-Coated Percutaneous Transluminal 

Angioplasty Balloon Catheter.

9/7/2016 

P160001, FDA–2016–M–2651 .......... Obalon Therapeutics, Inc ................. Obalon Balloon System .............................................................................. 9/8/2016 

P150040, FDA–2016–M–2735 .......... Carl Zeiss Meditec, Inc .................... VisuMax® Femtosecond Laser ................................................................... 9/13/2016 

P000025/S084, FDA–2016–M–2974 MED–EL Corp .................................. MED–EL Cochlear Implant System ............................................................ 9/15/2016 

P150021, FDA–2016–M–2971 .......... Abbott Diabetes Care, Inc ............... Freestyle Libre Pro Flash Glucose Monitoring System ............................. 9/23/2016 

P080020/S020, FDA–2016–M–2975 Seikagaku Corp ............................... Gel-One® .................................................................................................... 9/27/2016 

P160017, FDA–2016–M–1972 .......... Medtronic MiniMed, Inc .................... MiniMed 670G System ............................................................................... 9/28/2016 

P150044, FDA–2016–M–2973 .......... Roche Molecular Systems, Inc ........ cobas® EGFR Mutation Test v2 ................................................................. 9/28/2016 

P150030, FDA–2016–M–3430 .......... Smith & Nephew, Inc ....................... R3TM delta Ceramic Acetabular System .................................................... 10/17/2016 

P160006, FDA–2016–M–3431 .......... Ventana Medical Systems, Inc ........ VENTANA PD–L1 (SP142) Assay ............................................................. 10/18/2016 

P150013/S001, FDA–2016–M–3913 Dako North America, Inc ................. PD–L1 IHC 22C3 pharmDX ....................................................................... 10/24/2016 

P120021, FDA–2016–M–3653 .......... St. Jude Medical, Inc ....................... AmplatzerTM PFO Occluder ....................................................................... 10/28/2016 

P150043, FDA–2016–M–3914 .......... QView Medical, Inc .......................... QVCAD System .......................................................................................... 11/9/2016 

P930016/S045, FDA–2016–M–3915 AMO Manufacturing USA, LLC ........ Star S4 IR Excimer Laser System and iDesign Advanced WaveScan 

Studio.

11/14/2016 

P020050/S023, FDA–2016–M–4046 Alcon Laboratories, Inc .................... WaveLight® EX500 and ALLEGRETTO WAVE® EYE–Q Excimer Laser 

Systems.

11/21/2016 

P140029, FDA–2016–M–4344 .......... Q-Med AB ........................................ Restylane® Refyne and Restylane® Defyne .............................................. 12/9/2016 

P130007/S016, FDA–2016–M–4458 Animas Corporation ......................... OneTouch VibeTM Plus System ................................................................. 12/16/2016 

P160018, FDA–2016–M–4459 .......... Foundation Medicine, Inc ................. FoundationFocusTM CDxBRACA Assay ....................................................... 12/19/2016 

P120005/S041, FDA–2016–M–4483 Dexcom, Inc ..................................... Dexcom G5 Mobile Continuous Glucose Monitoring System .................... 12/20/2016 

P040020/S049, FDA–2016–M–4657 Alcon Laboratories, Inc .................... Acrysof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens .............. 12/22/2016 

P160019, FDA–2016–M–4530 .......... Roche Diagnostics ........................... Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/PreciControl HBsAg 

II.

12/23/2016 

P100022/S020, FDA–2016–M–4653 Cook Medical Inc ............................. Zilver PTX Drug-Eluting Peripheral Stent .................................................. 12/28/2016 

H070005, FDA–2017–M–0180 .......... AGA Medical Corp ........................... AMPLATZERTM Post-Infarct Muscular VSD Occluder ............................... 1/10/2017 

P160031, FDA–2017–M–0181 .......... FUJIFILM Medical Systems U.S.A., 

Inc.

ASPIRE Cristalle Digital Breast Tomosynthesis Option ............................ 1/10/2017 

P160008, FDA–2017–M–0229 .......... HeartSine Technologies LLC ........... HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P Public 

Access Automated External Defibrillators, Accessories and Saver 

EVO® Software Version 1.4.0.

1/12/2017 

P160021, FDA–2017–M–0560 .......... W.L. Gore & Associates, Inc ........... Gore® Viabahn® VBX Balloon Expandable Endoprosthesis ..................... 1/27/2017 

P130024/S009, FDA–2017–M–0831 Lutonix, Inc ....................................... Lutonix® 035 Drug Coated Balloon PTA Catheter ..................................... 2/7/2017 

P140033, FDA–2017–M–0661 .......... St. Jude Medical, Inc ....................... MR Conditional Pacemaker System—Assurity MRITM and Endurity 

MRITM Pacemakers and Tendril MRITM 1200M LPA Lead.

1/31/2017 

P160023, FDA–2017–M–0971 .......... Hologic, Inc ...................................... Aptima® HCV Quant Dx Assay .................................................................. 2/13/2017 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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 

PMA No., Docket No. Applicant Trade name Approval 

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 

Valve Delivery System and EnsembleTM II Transcatheter Valve Delivery System.

2/24/2017 

P160016, FDA–2017–M–1713 .......... Siemens Healthcare Diagnostics, 

Inc.

VERSANT® HCV GENOTYPE 2.0 Assay (LiPA) ...................................... 3/14/2017 

P110033/S020, FDA–2017–M–1714 Allergan ............................................ Juve ́derm 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 

RESILIA Aortic Valve.

6/29/2017 

P160038, FDA–2017–M–3983 .......... Illumina, Inc ...................................... PraxisTM Extended RAS Panel .................................................................. 6/29/2017 

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, 

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 SmallPackaged 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES