Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 7615 

Food and Drug Administration Staff’’ 

are approved under OMB control 

number 0910–0756. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02722 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–M–0867, FDA– 

2014–M–0874, FDA–2014–M–0875, FDA– 

2014–M–1060, FDA–2014–M–1064, FDA– 

2014–M–1113, FDA–2014–M–1114, FDA– 

2014–M–1193, FDA–2014–M–1265, FDA– 

2014–M–1279, and FDA–2014–M–1280] 

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: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 when 

submitting a written request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the summaries of 

safety and effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20993–0002, 301–796–6570. 

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 July 1, 2014, through 

September 30, 2014. 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, 

2014, THROUGH SEPTEMBER 30, 2014 

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

P130021/S002, FDA–2014–M–0867 ..... Medtronic CoreValve LLC .................... Medtronic CoreValveTM System (MCS) June 12, 2014. 

P130009, FDA–2014–M–0874 .............. Edwards Lifesciences, LLC .................. Edwards SAPIEN XTTM Transcatheter 

Heart Valve and Accessories.

June 16, 2014. 

P130029, FDA–2014–M–0875 .............. Bard Peripheral Vascular, Inc ............... Fluency® Plus Endovascular Stent 

Graft.

June 17, 2014. 

P130011, FDA–2014–M–1064 .............. Sorin Group Canada, Inc ...................... Freedom SOLO Stentless Heart Valve 

and SOLO Smart Heart Valve.

June 24, 2014. 

P130030, FDA–2014–M–1060 .............. Boston Scientific Corp .......................... REBELTM Platinum Chromium Coronary Stent System (MonorailTM and 

Over-The-Wire).

June 27, 2014. 

P090029, FDA–2014–M–1113 .............. Medtronic Sofamor Danek USA, Inc .... Prestige® LP Cervical Disc ................... July 24, 2014. 

H130005, FDA–2014–M–1114 .............. MicroVention, Inc .................................. Low-Profile Visualized Intraluminal 

Support Device (LVIS and LVIS Jr.).

July 25, 2014. 

P130017, FDA–2014–M–1193 .............. Exact Sciences, Inc .............................. COLOGUARDTM ................................... August 11, 2014. 

H120003, FDA–2014–M–1265 .............. XVIVO Perfusion, Inc ............................ XVIVO Perfusion System (XPSTM) with 

STEEN SolutionTM Perfusate.

August 12, 2014. 

H130004, FDA–2014–M–1280 .............. Plexision, Inc ......................................... PleximmuneTM ...................................... August 26, 2014. 

P130020, FDA–2014–M–1279 .............. GE Healthcare ...................................... SenoClaire ............................................ August 26, 2014. 


tkelley on DSK3SPTVN1PROD with NOTICES
7616 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http://

www.fda.gov/MedicalDevices/

ProductsandMedicalProcedures/

DeviceApprovalsandClearances/

PMAApprovals/default.htm. 

Dated: February 5, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02783 Filed 2–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0244] 

Patient-Focused Drug Development for 

Functional Gastrointestinal Disorders; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a public meeting and an 

opportunity for public comment on 

Patient-Focused Drug Development for 

functional gastrointestinal (GI) 

disorders, including irritable bowel 

syndrome, gastroparesis, chronic 

persistent symptomatic 

gastroesophageal reflux despite standard 

therapeutic interventions, and chronic 

idiopathic constipation. Patient-Focused 

Drug Development is part of FDA’s 

performance commitments made as part 

of the fifth authorization of the 

Prescription Drug User Fee Act (PDUFA 

V). The public meeting is intended to 

allow FDA to obtain patient 

perspectives on the impact of functional 

GI disorders on daily life and patient 

views on treatment approaches. 

DATES: The public meeting will be held 

on May 11, 2015, from 1 p.m. to 5 p.m. 

Registration to attend the meeting must 

be received by May 1, 2015 (see 

SUPPLEMENTARY INFORMATION for 

instructions). Submit electronic or 

written comments to the public docket 

by July 13, 2015. 

ADDRESSES: The meeting will be held at 

the FDA White Oak Campus, 10903 

New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Participants must enter through 

Building 1 and undergo security 

screening. For more information on 

parking and security procedures, please 

refer to http://www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Submit electronic comments to 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FDA will post the agenda 

approximately 5 days before the meeting 

at http://www.fda.gov/ForIndustry/

UserFees/PrescriptionDrugUserFee/

ucm430885.htm. 

FOR FURTHER INFORMATION CONTACT: 

Pegah Mariani, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1146, 

Silver Spring, MD 20993–0002, 240– 

402–4513, FAX: 301–847–8443, 

Sayyedeh.Mariani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on Patient-Focused Drug 

Development 

FDA has selected functional GI 

disorders as the focus of a public 

meeting under Patient-Focused Drug 

Development, an initiative that involves 

obtaining a better understanding of 

patient perspectives on the severity of a 

disease and the available therapies for 

that condition. Patient-Focused Drug 

Development is being conducted to 

fulfill FDA performance commitments 

that are part of the reauthorization of the 

PDUFA under Title I of the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA) (Pub. L. 112– 

144). The full set of performance 

commitments is available at http://

www.fda.gov/downloads/forindustry/

userfees/prescriptiondruguserfee/

ucm270412.pdf. 

FDA committed to obtain the patient 

perspective on 20 disease areas during 

the course of PDUFA V. For each 

disease area, the Agency will conduct a 

public meeting to discuss the disease 

and its impact on patients’ daily lives, 

the types of treatment benefit that 

matter most to patients, and patients’ 

perspectives on the adequacy of the 

available therapies. These meetings will 

include participation of FDA review 

divisions, the relevant patient 

communities, and other interested 

stakeholders. 

On April 11, 2013, FDA published a 

document in the Federal Register (78 

FR 21613) announcing the disease areas 

for meetings in fiscal years (FYs) 2013– 

2015, the first 3 years of the 5-year 

PDUFA V timeframe. The Agency used 

several criteria outlined in that 

document to develop the list of disease 

areas. FDA obtained public comment on 

the Agency’s proposed criteria and 

potential disease areas through a public 

docket and a public meeting that was 

convened on October 25, 2012. In 

selecting the set of disease areas, FDA 

carefully considered the public 

comments received and the perspectives 

of review divisions at FDA. FDA has 

initiated a second public process for 

determining the disease areas for FY 

2016–2017. More information, including 

the list of disease areas and a general 

schedule of meetings, is posted at http:// 

www.fda.gov/ForIndustry/UserFees/

PrescriptionDrugUserFee/

ucm326192.htm. 

II. Public Meeting Information 

A. Purpose and Scope of the Meeting 

The purpose of this Patient-Focused 

Drug Development meeting is to obtain 

input on the symptoms and other 

impacts of functional GI disorders, such 

as irritable bowel syndrome, 

gastroparesis, chronic persistent 

symptomatic gastroesophageal reflux 

despite standard therapeutic 

interventions, and chronic idiopathic 

constipation, that matter most to 

patients, as well as perspectives on 

current approaches to treating these 

conditions. Functional GI disorders are 

common disorders that are 

characterized by persistent and 

recurring GI symptoms and occur as a 

result of abnormal functioning of the GI 

tract. These disorders are not caused by 

structural abnormalities, thus routine 

medical tests may be normal, and 

diagnosis is based primarily on 

symptoms. Functional GI disorders can 

affect any part of the GI tract, including 

the esophagus, bile duct, and intestines. 

Treatment for functional GI disorders 

focuses on management of different 

symptoms over a period of time. 

Treatments may include dietary 

management as well as over-the-counter 

and prescription medications (e.g., 

antispasmodics, pro-motility agents, 

antidiarrheals, and antidepressants). In 

addition, psychological treatments, such 

as relaxation therapy or cognitive 

behavioral therapy, may help manage 

the symptoms of functional GI 

disorders. 

The questions that will be asked of 

patients and patient stakeholders at the 

meeting are listed in this section, 

organized by topic. For each topic, a 

brief initial patient panel discussion 

will begin the dialogue. This will be 

followed by a facilitated discussion 

inviting comments from other patient 

and patient stakeholder participants. In 


tkelley on DSK3SPTVN1PROD with NOTICES