Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 6865 

meeting registration is available at: 

http://eclkc.ohs.acf.hhs.gov/hslc/hs/

calendar/tc2016. 

SUPPLEMENTARY INFORMATION: HHS 

announces OHS Tribal Consultations for 

leaders of Tribal Governments operating 

Head Start and Early Head Start 

programs. The agenda for the scheduled 

OHS Tribal Consultations in 

Albuquerque, New Mexico, Arlington, 

Virginia, and Spokane, Washington, will 

be organized around the statutory 

purposes of Head Start Tribal 

Consultations related to meeting the 

needs of American Indian and Alaska 

Native children and families, taking into 

consideration funding allocations, 

distribution formulas, and other issues 

affecting the delivery of Head Start 

services in their geographic locations. In 

addition, OHS will share actions taken 

and in progress to address the issues 

and concerns raised in the 2015 OHS 

Tribal Consultations. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 U.S.C. 

9835, section 640(l)(4)(A)]. Designees 

must have a letter from the Tribal 

Government authorizing them to 

represent the tribe. Tribal Governments 

must submit the designee letter at least 

3 days in advance of the Consultation 

Session to Angie Godfrey at 

Angie.Godfrey@acf.hhs.gov. Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of each Consultation 

Session will be prepared and made 

available within 45 days of the 

Consultation Sessions to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Angie Godfrey at 

Angie.Godfrey@acf.hhs.gov either prior 

to each Consultation Session or within 

30 days after each meeting. OHS will 

summarize oral testimony and 

comments from the Consultation 

Session in each report without 

attribution, along with topics of concern 

and recommendations. 

Dated: February 2, 2016. 

Blanca E. Enriquez, 

Director, Office of Head Start. 

[FR Doc. 2016–02580 Filed 2–8–16; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2015–M–3256, FDA– 

2015–M–3257, FDA–2015–M–3258, FDA– 

2015–M–3376, FDA–2015–M–3377, FDA– 

2015–M–3516, FDA–2015–M–3516, FDA– 

2015–M–3519, FDA–2015–M–3520, FDA– 

2015–M–3521, FDA–2015–M–4013, FDA– 

2015–M–4014, FDA–2015–M–4015, FDA– 

2015–M–4016, FDA–2015–M–4017, FDA– 

2015–M–4018, FDA–2015–M–4069, FDA– 

2015–M–4343, FDA–2015–M–4344, FDA– 

2015–M–4434, FDA–2015–M–4728, FDA– 

2015–M–4947, and FDA–2015–M–4951] 

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 Division of Dockets 

Management. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2015–M–3256, FDA–2015–M–3257, 

FDA–2015–M–3258, FDA–2015–M– 

3376, FDA–2015–M–3377, FDA–2015– 

M–3516, FDA–2015–M–3516, FDA– 

2015–M–3519, FDA–2015–M–3520, 

FDA–2015–M–3521, FDA–2015–M– 

4013, FDA–2015–M–4014, FDA–2015– 

M–4015, FDA–2015–M–4016, FDA– 

2015–M–4017, FDA–2015–M–4018, 

FDA–2015–M–4069, FDA–2015–M– 

4343, FDA–2015–M–4344, FDA–2015– 

M–4434, FDA–2015–M–4728, FDA– 

2015–M–4947, and FDA–2015–M–4951 

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 

http://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION’’. The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

mstockstill on DSK4VPTVN1PROD with NOTICES

6866 Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

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 sections 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 October 1, 2015, through 

December 31, 2015. 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 OCTOBER 1, 

2015, THROUGH DECEMBER 31, 2015 

PMA No., Docket No. Applicant Trade name Approval date 

P150010, FDA–2015–M–3256 ........... Fidia Farmaceutici, S.p.A. ............ HYMOVIS® .............................................................. 8/28/2015 

P100006, FDA–2015–M–3257 ........... Biomimetic Therapeutics, LLC ..... Augment® Bone Graft .............................................. 9/1/2015 

P140005, FDA–2015–M–3258 ........... OrthogenRx, Inc. .......................... GenVisc 850® .......................................................... 9/2/2015 

P140015, FDA–2015–M–3376 ........... Tandem Diabetes Care, Inc. ........ t:slim G4 Insulin Pump With Dexcom G4 Platinum 

CGM.

9/8/2015 

P140016, FDA–2015–M–3377 ........... Cook Medical Inc. ......................... Zenith Alpha Thoracic Endovascular Graft .............. 9/15/2015 

P070015/S128, FDA–2015–M–3516 Abbott Vascular ............................ XIENCE V and XIENCE nano Everolimus Eluting 

Coronary Stent System.

9/23/2015 

P110019/S075, FDA–2015–M–3516 Abbott Vascular ............................ XIENCE PRIME and XIENCE PRIME LL 

Everolimus Eluting Coronary Stent System, 

XIENCE Xpedition, XIENCE Xpedition SV and 

XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine 

Everolimus Eluting Coronary Stent System.

9/23/2015 

P050047/S044, FDA–2015–M–3519 Allergan ........................................ Juve ́derm Ultra XC injectable gel ............................ 9/30/2015 

P120010/S046, FDA–2015–M–4013 Medtronic, Inc. .............................. MiniMed 530G System with Threshold Suspend 

featuring SmartGuardTM technology.

10/2/2015 

P150003, FDA–2015–M–4014 ........... Boston Scientific Corporation ....... SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System.10/2/2015 

P150013, FDA–2015–M–3520 ........... Dako North America, Inc. ............. PD–L1 IHC 22C3 pharmDx ..................................... 10/2/2015 

P100034/S013, FDA–2015–M–4015 Novocure, Ltd. .............................. OptuneTM (Formerly the NovoTTF–100A System) 10/5/2015 

P150025, FDA–2015–M–4016 ........... Dako North America, Inc. ............. PD–L1 IHC 28–8 pharmDx ...................................... 10/9/2015 

P130009/S034, FDA–2015–M–4017 Edwards Lifesciences, LLC .......... Edwards SAPIEN XTTM Transcatheter Heart 

Valve, model 9300TFX, and Accessories.

10/9/2015 

P150014, FDA–2015–M–4069 ........... Roche Molecular Systems, Inc. ... cobas® HBV ............................................................. 10/14/2015 

P150015, FDA–2015–M–4018 ........... Roche Molecular Systems, Inc. ... cobas® HCV ............................................................ 10/14/2015 

P140019, FDA–2015–M–4343 ........... Cerapedics, Inc. ........................... i-FACTORTM Peptide Enhanced Bone Graft ........... 11/3/2015 

P120019/S007, FDA–2015–M–4344 Roche Molecular Systems, Inc. ... cobas® EGFR Mutation Test v2 .............................. 11/13/2015 

P130028, FDA–2015–M–4434 ........... Algostim, LLC ............................... Algovita Spinal Cord Stimulation System ................ 11/20/2015 

P150019, FDA–2015–M–4728 ........... Medtronic MiniMed ....................... Paradigm Real-Time Revel System ........................ 12/7/2015 

P010030/S056, FDA–2015–M–3521 ZOLL Manufacturing Corporation LifeVest Wearable Cardioverter Defibrillator Models 

3000, 3100, and 4000.

12/17/2015 

P140030, FDA–2015–M–4947 ........... Biotronik, Inc. ................................ Astron Peripheral Self-Expanding Nitinol Stent System.12/17/2015 

P980044/S027, FDA–2015–M–4951 Seikagaku Corporation ................. VISCO–3TM .............................................................. 12/21/2015 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http://

www.fda.gov/MedicalDevices/Products

andMedicalProcedures/Device

ApprovalsandClearances/PMA

Approvals/default.htm. 

Dated: February 2, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02522 Filed 2–8–16; 8:45 am] 

BILLING CODE 4164–01–P 

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