Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 8327 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the Agency’s Web 

site at http://www.fda.gov/Advisory

Committees/default.htm and scroll 

down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before coming to the meeting. 

Agenda: On February 20, 2015, the 

committee will discuss, make 

recommendations, and vote on 

information regarding the premarket 

approval application (PMA) for the 

Superion InterSpinous Spacer device 

sponsored by Vertiflex Inc. The 

proposed indication for use for the 

Superion InterSpinous Spacer device, as 

stated in the PMA, is as follows: The 

Superion InterSpinous Spacer (the 

Superion ISS) is intended to treat 

skeletally mature patients suffering from 

pain, numbness, and/or cramping in the 

legs (neurogenic intermittent 

claudication) secondary to a diagnosis 

of moderate lumbar spinal stenosis, 

with or without grade 1 

spondylolisthesis, confirmed by x ray, 

magnetic resonance imaging, and/or 

computed tomography evidence of 

thickened ligamentum flavum, 

narrowed lateral recess, and/or central 

canal or foraminal narrowing. The 

Superion ISS is indicated for those 

patients with impaired physical 

function who experience relief in 

flexion from symptoms of leg/buttock/

groin pain, numbness, and/or cramping, 

with or without back pain. The 

Superion ISS may be implanted at one 

or two adjacent lumbar (L) levels in 

patients in whom treatment is indicated 

at no more than two levels, from L1 to 

L5. 

The meeting was originally scheduled 

for December 12, 2014. The meeting 

date is being postponed from December 

12, 2014, until February 20, 2015, due 

to FDA needing additional time to 

review information supplied by 

sponsor. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before February 18, 2015. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before February 

13, 2015. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by February 17, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Anne Marie 

Williams at Annmarie.Williams@

fda.hhs.gov or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

FDA regrets that it was unable to 

publish this notice 15 days prior to the 

February 20, 2015, Orthopaedic and 

Rehabilitation Panel of the Medical 

Devices Advisory Committee meeting. 

Because the Agency believes there is 

some urgency to bring these issues to 

public discussion and qualified 

members of the Orthopaedic and 

Rehabilitation Panel of the Medical 

Devices Advisory Committee were 

available at this time, the Commissioner 

of Food and Drugs concluded that it was 

in the public interest to hold this 

meeting even if there was not sufficient 

time for the customary 15-day public 

notice. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03155 Filed 2–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Food and Drug Administration/Xavier 

University Global Medical Device 

Conference; Public Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

The Food and Drug Administration 

(FDA) Cincinnati District, in 

cosponsorship with Xavier University, 

is announcing a public conference 

entitled ‘‘FDA/Xavier University Global 

Medical Device Conference (MedCon).’’ 

This 3-day public conference includes 

presentations from key FDA officials 

and industry experts with small group 

breakout sessions. The conference is 

intended for companies of all sizes and 

employees at all levels. 

DATES: Dates and Times: The public 

conference will be held on May 6, 2015, 

from 8:30 a.m. to 5 p.m.; May 7, 2015, 

from 8:30 a.m. to 5 p.m.; and May 8, 

2015, from 8:30 a.m. to 12:30 p.m. 

Location: The public conference will 

be held on the campus of Xavier 

University, 3800 Victory Pkwy., 

Cincinnati, OH 45207, 513–745–3016. 

Contact Persons: For information 

regarding this notice: Gina Brackett, 

Food and Drug Administration, 6751 

Steger Dr., Cincinnati, OH 45237, 513– 

679–2700, FAX: 513–679–2771, email: 

gina.brackett@fda.hhs.gov. 

For information regarding the 

conference and registration: Mason 

Rick, Xavier University, 3800 Victory 

Pkwy., Cincinnati, OH 45207–5471, 

513–745–3016, email: 

rickm@xavier.edu, or visit http:// 

www.XavierMedCon.com. 

Registration: There is a conference 

registration fee which covers the cost of 

the presentations, training materials, 

receptions, breakfasts, and lunches for 

the 3 days of the conference. Advanced 

registration begins February 6, 2015. 

Standard registration begins March 6, 

2015. There will be onsite registration. 

The cost of registration is as follows: 


tkelley on DSK3SPTVN1PROD with NOTICES
8328 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 

TABLE 1—REGISTRATION FEES 1

Attendee type Advanced rate 

(2/6/15 to 3/5/15) 

Standard rate 

(after 3/5/15) 

Industry ........................................................................................................................................................ $1,495 $1,695 

Small Business (<100 Employees) ............................................................................................................. 1,000 1,200 

Startup Manufacturer ................................................................................................................................... 250 300 

Academic ..................................................................................................................................................... 250 300 

FDA/Government Employee ........................................................................................................................ Free Free 

1The following forms of payment will be accepted: American Express, Visa, MasterCard, and company checks. 

To register online for the public 

conference, please visit the 

‘‘Registration’’ link on the conference 

Web site at http:// 

www.XavierMedCon.com. FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register. 

To register by mail, please send your 

name, title, firm name, address, 

telephone, email, and payment 

information for the fee to Xavier 

University, Attention: Mason Rick, 3800 

Victory Pkwy., Cincinnati, OH 45207– 

5471. An email will be sent confirming 

your registration. 

Attendees are responsible for their 

own accommodations. The conference 

headquarters hotel is the Downtown 

Hilton Cincinnati Netherland Plaza, 35 

West Fifth St., Cincinnati, OH 45202, 

513–421–9100. Special conference block 

rates are available through April 16, 

2015. To make reservations online, 

please visit the ‘‘Venue/Logistics’’ link 

at http://www.XavierMedCon.com. 

If you need special accommodations 

due to a disability, please contact Mason 

Rick (see Contact Persons) at least 7 

days in advance of the conference. 

SUPPLEMENTARY INFORMATION: The 

public conference helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

conference will provide those engaged 

in FDA-regulated medical devices (for 

humans) with information on the 

following topics: 

• Center Director Corner: Strategic 

Priorities for 2015 and Beyond 

• Office of Compliance Strategic 

Priorities 

• Advancements in Medical Device 

Software Technology 

• Understanding and Preparing for the 

Revision of ISO13485 

• Update from FDA’s Office of 

Combination Products 

• Unique Device Identification— 

Implementation 

• FDA Inspections and Insights 

• Understanding the Current Activities 

of the International Medical Device 

Regulators Forum 

• European Union Medical Device/In 

Vitro Diagnostics Regulation Review 

• Update from the Office of Device 

Evaluation 

• Regulatory Submissions and 

Strategies 

• Complaints, Corrective and 

Preventive Actions, and Recalls 

• Regulatory Challenges in Asia 

• Action Plan Writing 

• Lunch Networking by Topic 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The conference helps to achieve 

objectives set forth in section 406 of the 

Food and Drug Administration 

Modernization Act of 1997 (21 U.S.C. 

393), which includes working closely 

with stakeholders and maximizing the 

availability and clarity of information to 

stakeholders and the public. The 

conference also is consistent with the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (Public Law 104– 

121) by providing outreach activities by 

Government agencies to small 

businesses. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03116 Filed 2–13–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

In Motion: Science Transforming 

Policy in Food, Drug, and Medical 

Device Regulation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

The Food and Drug Administration 

(FDA) Detroit District Office, in 

cosponsorship with the Association of 

Food and Drug Officials (AFDO), is 

announcing a public conference entitled 

‘‘In Motion: Science Transforming 

Policy in Food, Drug, and Medical 

Device Regulation.’’ The conference 

Web site is http://indy.afdo.org/. This 

conference is intended to provide 

information about FDA food, drug, and 

device regulation to the regulated 

industry. 

Date and Time: The public conference 

will be held on June 20 to 24, 2015. 

Times will vary. 

Location: The conference will be held 

at the Sheraton Indianapolis Hotel at 

Keystone Crossing, Indianapolis, 8787 

Keystone Crossing, Indianapolis, IN 

46240, 317–846–2700 or toll-free 888– 

627–7814; www.sheratonindianapolis

keystonecrossing.com. 

Attendees are responsible for their 

own accommodations. To make 

reservations at the Sheraton 

Indianapolis Hotel at the reduced 

conference rate, please call 303–295– 

1234 and mention ‘‘AFDO Conference’’ 

before May 20, 2015. All the hotel 

information needed to call or reserve 

online is available at http:// 

indy.afdo.org/hotel.html. 

AFDO contact information: Randy 

Young, Association of Food and Drug 

Officials, 2550 Kingston Rd., suite 311, 

York, PA 17402, 717–757–2888, FAX: 

717–650–3650, email: ryoung@afdo.org. 

Registration: You are encouraged to 

register by May 20, 2015. The AFDO 

registration fees cover the cost of 

facilities, materials, and breaks. Seats 

are limited; therefore, please submit 

your registration as soon as possible. 

Course space will be filled in order of 

receipt of registration. Those accepted 

into the course will receive 

confirmation. Registration will close 

after the course is filled. Registration at 

the site is not guaranteed but may be 

possible on a space available basis on 

the day of the conference beginning at 

8 a.m. The cost of registration follows: 

Cost of Registration: 

Member—$475.00 

Non-Member—$575.00 

*A $100 late fee will be added if 

payment is postmarked after June 1, 

2015. 

If you need special accommodations 

due to a disability, please contact Randy 

Young (see AFDO contact information) 


tkelley on DSK3SPTVN1PROD with NOTICES