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 


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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Service 

Administration 

National Advisory Council on Migrant 

Health 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: 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. 

DATES: The meeting will be held on 

November 7, 2017, 8:30 a.m.to 5:00 p.m. 


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