10124 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

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 always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

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: The Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee will meet to discuss the 

general topic of how procedural 

sedation for nontherapeutic (research) 

interventions or procedures in the 

pediatric population should be 

considered under the Additional 

Safeguards for Children in Clinical 

Investigations at 21 CFR 50 subpart D. 

A brief summary of the subcommittee’s 

discussion will then be presented to the 

FDA Pediatric Advisory Committee on 

Tuesday, March 24, 2015. 

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 March 9, 2014. Oral 

presentations from the public will be 

scheduled between 11:30 a.m. and 12:30 

p.m. on March 23, 2015. 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 26, 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 

March 2, 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 Walter 

Ellenberg 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/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03900 Filed 2–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0303] 

Robotically-Assisted Surgical Devices: 

Challenges and Opportunities; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing the public 

workshop entitled ‘‘Robotically-Assisted 

Surgical (RAS) Devices: Challenges and 

Opportunities.’’ FDA is holding this 

public workshop to obtain information 

on the current challenges and 

opportunities related to roboticallyassisted surgical medical devices, which 

are classified as Class II medical 

devices. The purpose of this workshop 

is to obtain public feedback on 

scientific, clinical, and regulatory 

considerations associated with RAS 

devices. Comments and suggestions 

generated through this workshop will 

facilitate further development of 

regulatory science for RAS technologies. 

Dates and Times: The public 

workshop will be held on July 27 and 

July 28, 2015, from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

Contact Person: Mark Trumbore, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5402, Silver Spring, MD 20993, 

301–796–5436, Mark.Trumbore@

fda.hhs.gov. 

Registration: Registration is free and 

available on a first-come, first-served 

basis. Persons interested in attending 

this public workshop must register 

online by July 17, 2015, at 4 p.m. Early 

registration is recommended because 

facilities are limited and, therefore, FDA 

may limit the number of participants 

from each organization. If time and 

space permits, onsite registration on the 

day of the meeting/public workshop 

will be provided beginning at 7 a.m. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4321, Silver Spring, 

MD 20993–0002, 301–796–5661, email: 

susan.monahan@fda.hhs.gov no later 

than July 14, 2015. 

To register for the public workshop, 

please visit FDA’s Medical Devices 

News & Events—Workshops & 

Conferences calendar at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this meeting/public 

workshop from the posted events list.) 

Please provide complete contact 

information for each attendee, including 

name, title, affiliation, address, email, 

and telephone number. Those without 

Internet access should contact Mark 

Trumbore to register (see Contact 

Person). Registrants will receive 

confirmation after they have been 

accepted. You will be notified if you are 

on a waiting list. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10125 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be Webcast. Persons interested in 

viewing the Webcast must register 

online by Friday, July 17, 2015. Early 

registration is recommended because 

Webcast connections are limited. 

Organizations are requested to register 

all participants, but to view using one 

connection per location. Webcast 

participants will be sent technical 

system requirements after registration 

and will be sent connection access 

information after July 20, 2015. If you 

have never attended a Connect Pro 

event before, test your connection at 

https://collaboration.fda.gov/common/

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit http://www.adobe.com/

go/connectpro_overview. (FDA has 

verified the Web site addresses in this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) 

Comments: FDA is holding this public 

workshop to obtain information on the 

specific topics outlined in section II. In 

order to permit the widest possible 

opportunity to obtain public comment, 

FDA is soliciting either electronic or 

written comment on all aspects of the 

public workshop topics. The deadline 

for submitting comments related to this 

public workshop is August 26, 2015. 

Regardless of attendance at the public 

workshop, interested persons may 

submit either electronic comments to 

http://www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Please identify comment with the 

docket number found in brackets in the 

heading of this document. In addition, 

when responding to specific topics as 

outlined in section II, please identify the 

topic(s) you are addressing. 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. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see Comments). A transcript will also 

be available in either hardcopy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. A link to the 

transcripts will also be available 

approximately 45 days after the public 

workshop on the Internet at http://

www.fda.gov/MedicalDevices/

NewsEvents/WorkshopsConferences/

default.htm. (Select this public 

workshop from the posted events list). 

SUPPLEMENTARY INFORMATION: 

I. Background 

RAS devices, also known as 

computer-assisted surgical devices, are 

used by trained physicians in an 

operating room environment for 

laparoscopic surgical procedures in 

general surgery, cardiac, colorectal, 

gynecologic, head and neck, thoracic, 

and urologic surgical procedures. These 

medical devices enable the surgeon to 

use computer, software, and robotic 

technologies to control and move 

surgical instruments through the mouth 

or through one or more small incisions 

in the patient’s body for a variety of 

surgical procedures. Some common 

procedures that may involve RAS 

devices include gallbladder, uterus, or 

prostate removal. 

As discussed further in section II, 

there are several clinical and scientific 

challenges associated with regulation of 

RAS devices, such as appropriate 

nonclinical and clinical evaluation of 

RAS devices, use of third-party surgical 

instruments with legally marketed RAS 

devices, and clinical training programs. 

This workshop seeks to involve industry 

and academia in addressing these 

challenges in the development of RAS 

devices to ensure that there is a 

reasonable assurance of safety and 

effectiveness for RAS devices while 

promoting innovation in a rapidlydeveloping field. By bringing together 

relevant stakeholders including 

scientists, patient advocates, clinicians, 

researchers, industry representatives, 

and regulators, we hope to facilitate the 

improvement of this evolving product 

area. 

II. Topics for Discussion at the Public 

Workshop 

Topics to be discussed at the public 

workshop include, but are not limited 

to, the following: 

1. The current landscape of RAS 

devices and the respective Offices, 

Divisions, and Branches within FDA 

involved in the review of pre- and 

postmarket data associated with these 

devices. 

2. Challenges, needs, and benefit/risk 

profiles for indications in various 

surgical areas; e.g. cardio/thoracic, 

gynecological, otolaryngological, 

urological, general. 

3. Unique benefits of RAS devices 

versus traditional surgical procedures. 

4. Scientific and technical 

considerations for third-party 

manufacturers seeking to claim that 

their surgical instruments can be used 

with legally marketed RAS devices. 

5. Design, administration, and 

certification of training programs and 

FDA’s role in this process. 

6. The future landscape of RAS and 

robotic surgery devices. 

7. Considerations regarding 

appropriate selection of preclinical 

(bench and animal) test methods and 

patient-centered outcome metrics in 

clinical use for different stages of device 

development. 

These topics will be presented by 

experts in the associated area, followed 

by more in-depth discussions and Q&A 

from all participants. 

Dated: February 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03769 Filed 2–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0359] 

National Medical Device Postmarket 

Surveillance System Planning Board 

Report; Availability, Web Site Location 

and Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the report and Web site 

location where the Agency has posted 

the report entitled ‘‘Strengthening 

Patient Care: Building an Effective 

National Medical Device Surveillance 

System,’’ developed by the National 

Medical Device Postmarket Surveillance 

System Planning Board. In addition, 

FDA has established a docket where 

stakeholders may provide comments. 

DATES: Submit either electronic or 

written comments by April 27, 2015. 

ADDRESSES: Submit electronic 

comments on this document to http://

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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES