8326 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices 

clinical investigators, of IRB, and of 

research sponsors. 

Date and Time: The conference will 

be held on March 11 and 12, 

(Wednesday and Thursday) 2015, from 

8:00 a.m. to 5 p.m. 

Location: The conference will be held 

at the Holiday Inn Golden Gateway 

Hotel, 1500 Van Ness Ave., San 

Francisco, CA 91409, 415–441–4000. 

Attendees are responsible for their 

own accommodations. Please mention 

SOCRA to receive the hotel room rate of 

$159.00 plus applicable taxes (available 

until February 13, 2015, or until the 

SOCRA room block is filled). 

Contact Person: Jane Kreis, Food and 

Drug, Administration, 1301 Clay St., 

Suite 1180N, Oakland, CA 94612, 510– 

287–2708, FAX: 510–287–2739 or 

Society of Clinical Research Associates 

(SOCRA), 530 West Butler Ave., Suite 

109, Chalfont, PA 18914. 800–762–7292 

or 215–822–8644, FAX: 215–822–8633, 

email: Office@socra.org Web site: 

www.socra.org. (FDA has verified the 

Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register). 

Registration: The registration fee will 

cover actual expenses including 

refreshments, lunch, materials and 

speaker expenses. Seats are limited; 

please submit your registration as soon 

as possible. Workshop space will be 

filled in order of receipt of registration. 

Those accepted into the workshop will 

receive confirmation. The cost of the 

registration is as follows: SOCRA 

member—$575, SOCRA nonmember 

(includes membership)—$650, Federal 

Government member—$450.00, Federal 

Government nonmember—$525.00, 

FDA Employee—(free) Fee Waived. 

If you need special accommodations 

due to a disability, please contact 

SOCRA (see Contact Person) at least 21 

days in advance. 

Extended periods of question and 

answer and discussion have been 

included in the program schedule. 

SOCRA designates this education 

activity for a maximum of 13.3 

Continuing Education Credits for 

SOCRA continuing education (CE) and 

Nurse continuing nurse education 

(CNE), SOCRA designates this live 

activity for a maximum of 13.3 

American Medical Association 

Physician’s Recognition Award Category 

1 Credit(s)TM. Physicians should claim 

only the credit commensurate with the 

extent of their participation. Continuing 

medical education (CME) for 

Physicians: SOCRA is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide CME for 

physicians. CNE for Nurses: Society of 

Clinical Research Associates is 

accredited as a provider of continuing 

nursing education by the American 

Nurses Credentialing Center’s 

Commission on Accreditation. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, FAX number, and email, 

along with a check or money order 

payable to ‘‘SOCRA’’. Mail to: 

SOCRA(see Contact Person for address). 

To register via the Internet, go to http:// 

www.socra.org/html/ 

FDA_Conference.htm. Payment by 

major credit card is accepted (Visa/ 

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the workshop, 

contact SOCRA (see Contact Person). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related 

informed consent, clinical investigation 

requirements, institutional review board 

inspections, electronic record 

requirements, and investigator initiated 

research Topics for discussion include 

the following: (1) The Role of the FDA 

District Office Relative to the 

Bioresearch Monitoring Program 

(BIMO); (2) Modernizing FDA’s Clinical 

Trials/BIMO Programs; (3) What FDA 

Expects in a Pharmaceutical Clinical 

Trial: (4) Medical Device Aspects of 

Clinical Research; (5) Adverse Event 

Reporting—Science, Regulation, Error 

and Safety; (6) Working with FDA’s 

Center for Biologics Evaluation and 

Research; (7) Ethical Issues in Subject 

Enrollment; (8) Keeping Informed and 

Working Together; (9) FDA Conduct of 

Clinical Investigator Inspections; (10) 

Investigator Initiated Research; (11) 

Meetings with the FDA—Why, When 

and How; (12) Part 11 Compliance— 

Electronic Signatures; (13) IRB 

Regulations and FDA Inspections; (14) 

Informed Consent Regulations; (15) The 

Inspection is Over—What Happens 

Next? Possible FDA Compliance 

Actions; (16) Question and Answer 

Session/Panel Discussion. 

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 workshop helps to achieve 

objectives set forth in section 406 of the 

FDA 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 workshop also is consistent 

with the Small Business Regulatory 

Enforcement Fairness Act of 1996 (Pub. 

L. 104–121), as outreach activities by 

Government Agencies to small 

businesses. 

Dated: February 10, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03118 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] 

Orthopaedic and Rehabilitation Panel 

of the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Orthopaedic and 

Rehabilitation Panel of the Medical 

Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on February 20, 2015, from 8 a.m. 

to 6 p.m. 

Location: Hilton/Washington DC 

North, 620 Perry Pkwy., Gaithersburg, 

MD 20877. The hotel’s telephone 

number is 301–977–8900. Answers to 

commonly asked questions including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

Contact Person: Sara Anderson, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm.1643, 

Silver Spring, MD 20993–0002, 

sara.anderson@fda.hhs.gov, 301–796– 

7047, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). A notice in the Federal Register 

about last minute modifications that 

impact a previously announced 

advisory committee meeting cannot 


tkelley on DSK3SPTVN1PROD with NOTICES
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