Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45853 

pursuant to Executive Order 13708, and 

will expire on September 30, 2017. 

Purpose: The Advisory Board is 

charged with (a) providing advice to the 

Secretary, HHS, on the development of 

guidelines under Executive Order 

13179; (b) providing advice to the 

Secretary, HHS, on the scientific 

validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advise the Secretary on 

whether there is a class of employees at 

any Department of Energy facility who 

were exposed to radiation but for whom 

it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such 

radiation doses may have endangered 

the health of members of this class. SPR 

was established to aid the Advisory 

Board in carrying out its duty to advise 

the Secretary, HHS, on dose 

reconstruction. SPR is responsible for 

overseeing, tracking, and participating 

in the reviews of all procedures used in 

the dose reconstruction process by the 

NIOSH Division of Compensation 

Analysis and Support (DCAS) and its 

dose reconstruction contractor (Oak 

Ridge Associated Universities—ORAU). 

Matters to be Considered: The agenda 

will include discussions on the 

following dose reconstruction 

procedures: DCAS Program Evaluation 

Report 59 (addressing dose 

reconstructions at the Norton Company, 

Worcester MA); DCAS Report 5: 

Alternative Dissolution Models for 

Insoluble Plutonium 238; Outstanding 

Findings of Prior Subcommittee 

Reviews; and DCAS Procedures Not Yet 

Reviewed. Agenda items are subject to 

change as priorities dictate. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–21046 Filed 9–29–17; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5140] 

Display Devices for Diagnostic 

Radiology; Guidance for Industry and 

Food and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the 

guidance entitled ‘‘Display Devices for 

Diagnostic Radiology.’’ This guidance 

document provides recommendations 

for the types of information you should 

provide in your premarket notification 

submission (510(k)) for display devices 

intended for diagnostic radiology with 

the assigned product code PGY. This 

guidance replaces a previously issued 

final guidance entitled ‘‘Display 

Accessories for Full-Field Digital 

Mammography Systems-Premarket 

Notification (510(k)) Submissions’’ 

issued on May 30, 2008. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 2, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–5140 for ‘‘Display Devices for 

Diagnostic Radiology’’ comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https:// 


sradovich on DSK3GMQ082PROD with NOTICES
45854 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for 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 guidance 

document entitled ‘‘Display Devices for 

Diagnostic Radiology’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

Robert Ochs, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4308, Silver Spring, 

MD 20993–0002, 301–796–6661. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance applies to display 

devices intended for diagnostic 

radiology as identified in Section III of 

the guidance and currently classified 

under 21 CFR 892.2050 as class II 

devices according to section 513(a)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(a)(1)) with the assigned product 

code PGY. This guidance is intended to 

assist industry in preparing a 510(k) for 

display devices intended for use in 

diagnostic radiology. This guidance 

provides recommendations for the types 

of information you should provide in 

your 510(k) submission for display 

devices intended for diagnostic 

radiology. This information 

supplements the requirements for a 

510(k) submission found in 21 CFR 807 

Subpart E, as well as recommendations 

provided in other FDA guidance 

documents concerning the specific 

content of a 510(k) submission. 

FDA considered comments on the 

draft guidance that appeared in the 

Federal Register of February 9, 2016 (81 

FR 6869). FDA revised the guidance as 

appropriate in response to the 

comments. 

This guidance applies to workstation 

medical image displays for diagnostic 

radiology. These devices are classified 

as class II devices that are intended to 

be used in controlled viewing 

conditions to display and view digital 

images for primary image interpretation. 

Display devices for diagnostic radiology 

may also be referred to as soft-copy 

displays or medical grade monitors. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the current 

thinking of FDA on Display Devices for 

Diagnostic Radiology. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the 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 https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

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

unable to download an electronic copy 

of ‘‘Display Devices for Diagnostic 

Radiology’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number 1500022 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This 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 (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 801 have 

been approved under OMB control 

number 0910–0485; and the collections 

of information in the guidance entitled 

‘‘Requests for Feedback on Medical 

Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ 

have been approved under OMB control 

number 0910–0756. 

Dated: September 25, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21078 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5372] 

Marketing Clearance of Diagnostic 

Ultrasound Systems and Transducers; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Marketing Clearance 

of Diagnostic Ultrasound Systems and 

Transducers; Draft Guidance for 

Industry and Food and Drug 

Administration Staff.’’ This draft 

guidance provides detailed information 

recommended for manufacturers 

seeking marketing clearance of 

diagnostic ultrasound systems and 

transducers. This draft guidance is not 

final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 2, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 


sradovich on DSK3GMQ082PROD with NOTICES