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
10126 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Thomas P. Gross, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2316, Silver Spring, 

MD 20993–0002, 301–796–5700, email: 

Thomas.Gross@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s Center for Devices and 

Radiological Health is responsible for 

protecting the public health by assuring 

the safety and effectiveness of medical 

devices. A key part of this mission is to 

monitor medical devices for continued 

safety and effectiveness after they are in 

use and to help the public get the 

accurate, science-based information 

they need to improve their health. 

In September 2012, the FDA 

published a report, ‘‘Strengthening Our 

National System for Medical Device 

Postmarket Surveillance,’’ that proposed 

a strategy for improving the current 

system for monitoring medical device 

safety and effectiveness. In April 2013, 

the FDA issued an update to the 

September 2012 report that incorporated 

public input received and described the 

next steps towards fulfilling the vision 

for building a national postmarket 

surveillance system. These reports can 

be found at FDA’s Web site http://

www.fda.gov/AboutFDA/CentersOffices/

OfficeofMedicalProductsandTobacco/

CDRH/CDRHReports/ucm301912.htm. 

One of these next steps consisted of 

establishing a multistakeholder 

planning board to identify the 

governance structure, practices, 

policies, procedures, methodological 

approaches, and business model(s) 

necessary to facilitate the creation of a 

sustainable, integrated medical device 

postmarket surveillance system that 

leverages and complements existing and 

ongoing efforts. Under a cooperative 

agreement with the FDA, the Engelberg 

Center for Health Care Reform at the 

Brookings Institution convened the 

National Medical Device Postmarket 

Surveillance Planning Board (the 

Planning Board) in 2014. The Planning 

Board membership included 

representatives from a broad array of 

stakeholder groups and areas of 

expertise including patients, provider 

organizations, hospitals, health plans, 

industry, and government agencies, as 

well as methodologists and academic 

researchers. 

The Planning Board was tasked with 

developing a set of long-term principles 

and priorities for a National Postmarket 

Surveillance System. The task included 

identifying potential governance and 

business models that address legal and 

privacy considerations, system 

financing and stability, mechanisms to 

support the appropriate use of data, and 

policies to ensure system transparency. 

The Planning Board was also asked to 

provide recommendations about how to 

leverage the system to meet the needs of 

other medical device stakeholders and 

groups seeking to develop better 

evidence (http://www.brookings.edu/

about/centers/health/call-fornominations and https://dcri.org/

events/past-meetings/MDEpiNetnominations). 

This notice announces the availability 

and Web site location of the Planning 

Board’s report entitled ‘‘Strengthening 

Patient Care: Building an Effective 

National Medical Device Surveillance 

System.’’ FDA invites interested persons 

to submit comments on this report. We 

have established a docket where 

comments may be submitted (see 

ADDRESSES). We believe this docket is 

an important tool for receiving feedback 

on this report from interested parties 

and for sharing this information with 

the public. The report ‘‘Strengthening 

Patient Care: Building an Effective 

National Medical Device Surveillance 

System’’ can be found at FDA’s Web site 

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

CentersOffices/

OfficeofMedicalProductsandTobacco/

CDRH/CDRHReports/ucm301912.htm. 

II. Request for 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 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03886 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–2014–N–2295] 

Request for Information on Specific 

Areas of Public Health Concern 

Related to Racial/Ethnic Demographic 

Subgroups for Additional Research by 

the Office of Minority Health 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

opening a docket to obtain information 

and comments on specific areas of 

public health concern for racial/ethnic 

demographic subgroup populations, 

focusing on certain disease areas where 

significant outcome differences may be 

anticipated. The Agency is seeking 

public input on identifying areas that 

can be addressed through regulatory 

science research. 

DATES: Submit either electronic or 

written comments or information by 

April 27, 2015. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions: Submit 

electronic comments in the following 

way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions: Submit written 

submissions in the following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–2295 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number(s), 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: 

Christine Merenda, Food and Drug 


asabaliauskas on DSK5VPTVN1PROD with NOTICES