Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10123 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Technical 

Performance Assessment of Digital 

Pathology Whole Slide Imaging 

Devices’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

Submit electronic comments on the 

draft guidance to http://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. 

FOR FURTHER INFORMATION CONTACT: 

Nicholas Anderson, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5570, Silver Spring, 

MD 20993–0002, 301–796–4310; or 

Aldo Badano, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 3116, Silver Spring, 

MD 20993–0002, 301–796–2534. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Recent technological advances in 

digital microscopy, in particular the 

development of whole slide scanning 

systems, have accelerated the adoption 

of digital imaging in pathology, similar 

to the digital transformation that 

radiology departments have experienced 

over the last decade. FDA regulates WSI 

systems manufacturers to ensure that 

the images produced for clinical 

intended uses are safe and effective for 

such purposes. Essential to the 

regulation of these systems is the 

understanding of the technical 

performance of the components in the 

imaging chain, from image acquisition 

to image display and their effect on 

pathologist’s diagnostic performance 

and workflow. 

This draft guidance provides industry 

and Agency staff with recommendations 

regarding the technical performance 

assessment data that should be included 

for regulatory evaluation of a WSI. This 

document does not cover the clinical 

submission data that may be necessary 

to support approval or clearance. The 

guidance provides our suggestions on 

how to best characterize the technical 

aspects that are relevant to WSI 

performance for their intended use and 

determine any possible limitations that 

might affect their safety and 

effectiveness. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on technical performance assessment of 

digital pathology WSI devices. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Technical Performance Assessment 

of Digital Pathology Whole Slide 

Imaging Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1400053 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120, 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231, and 

the collections of information in 21 CFR 

part 801 and 21 CFR 809.10 have been 

approved under OMB control number 

0910–0485. 

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 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03843 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–0001] 

Pediatric Ethics Subcommittee of the 

Pediatric 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: Pediatric Ethics 

Subcommittee of the Pediatric Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency 

regarding ethical protections for 

children in FDA-regulated clinical 

trials. 

Date and Time: The meeting will be 

held on Monday, March 23, 2015 from 

8:30 a.m. to 4:30 p.m. 

Location: Doubletree by Hilton Hotel, 

8727 Colesville Rd., Silver Spring, MD 

20910. 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/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Walter Ellenberg, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5154, 

Silver Spring, MD 20993, 301–796– 

0885, email walter.ellenberg@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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