Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 6869 

1https://www.gpo.gov/fdsys/pkg/PLAW112publ144/pdf/PLAW-112publ144.pdf. 

2www.fda.gov/downloads/MedicalDevices/News

Events/WorkshopsConferences/UCM295454.pdf. 3www.fda.gov/downloads/MedicalDevices/Device

RegulationandGuidance/Overview/MDUFAIII/

UCM378202.pdf. 

4http://www.fda.gov/downloads/ForIndustry/

UserFees/MedicalDeviceUserFee/UCM484146.pdf. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1504] 

Independent Assessment of the 

Process for the Review of Device 

Submissions; Implementation 

Evaluation Report 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing Booz Allen Hamilton’s final 

evaluation report submitted as part of 

their independent assessment of the 

process for the review of medical device 

submissions. The evaluation is part of 

the FDA performance commitments 

relating to the Medical Device User Fee 

Amendments of 2012 (MDUFA III), 

which reauthorized device user fees for 

fiscal years 2013 through 2017. The 

assessment is described in section V, 

Independent Assessment of Review 

Process Management, of the 

commitment letter entitled ‘‘MDUFA 

Performance Goals and Procedures’’ 

(MDUFA III Commitment Letter). The 

evaluation has been conducted as the 

second phase (Phase 2) and is the last 

of a series of deliverables, as outlined in 

the contract statement of work. 

FOR FURTHER INFORMATION CONTACT: 

Raphaela Simon, Office of Planning, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

3379, Silver Spring, MD 20993–0002, 

301–796–9169, Raphaela.Simon@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, President Obama 

signed into law the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144) (FDASIA).1 Title 

II of FDASIA is the Medical Device User 

Fee Amendments of 2012 (MDUFA III), 

which gives FDA the authority to collect 

device user fees from industry for fiscal 

years 2013 through 2017. MDUFA III 

took effect on October 1, 2012, and will 

continue through September 30, 2017. 

Device user fees were first established 

by Congress in 2002. Medical device 

companies pay fees to FDA when they 

register their establishment and list their 

devices with the Agency, whenever they 

submit an application or a notification 

to market a new medical device in the 

United States, and for certain other 

types of submissions. Under MDUFA III, 

FDA is authorized to collect user fees 

that will total approximately $595 

million (plus adjustments for inflation) 

over 5 years. With this additional 

funding, FDA will be able to hire more 

than 200 full-time-equivalent workers 

over the course of MDUFA III. In 

exchange, FDA has committed to meet 

certain performance goals outlined in 

the MDUFA III Commitment Letter.2

II. Assessment of FDA’s Process for the 

Review of Device Submissions 

Section V of the MDUFA III 

Commitment Letter states that FDA and 

the device industry will participate in a 

comprehensive assessment of the 

process for the review of device 

applications. The assessment will 

include consultation with both FDA and 

industry. The assessment will be 

conducted in two phases by a private, 

independent consulting firm, under 

contract with FDA, that is capable of 

performing the technical analysis, 

management assessment, and program 

evaluation tasks required to address the 

assessment as described in the MDUFA 

III Commitment Letter. 

FDA awarded the contract in June 

2013 to the consulting firm Booz Allen 

Hamilton. Findings on high-priority 

recommendations (i.e., those likely to 

have a significant impact on review 

times) were published in December 

2013.3 Final comprehensive findings 

and recommendations were scheduled 

to be published within 1 year of the 

contract award and are included in the 

report available at www.fda.gov/

downloads/ForIndustry/UserFees/

MedicalDeviceUserFee/UCM426392.pdf. 

FDA agreed to publish an 

implementation plan within 1 year of 

the final findings and recommendations. 

The final implementation plan, ‘‘Plan of 

Action,’’ was published December 2014 

and is available at www.fda.gov/

downloads/ForIndustry/UserFees/

MedicalDeviceUserFee/UCM426392.pdf. 

Examination of the final comprehensive 

findings and recommendations report 

led FDA to conclude that the 

recommendations could be expanded to 

further enhance the efficiency of 

premarket reviews. Those actions were 

also outlined in the Plan of Action. To 

distinguish actions in direct response to 

the recommendations from additional 

actions to further improve the premarket 

review process, FDA used a ‘‘Stage’’ 

approach. In the Plan of Action ‘‘Stage 

1’’ actions directly addressed the 

recommendations in the independent 

assessment and ‘‘Stage 2’’ actions 

outlined additional long-term actions 

the Agency intended to implement to 

further enhance the premarket review 

process. In addition, FDA has publicly 

stated in the ‘‘Plan of Action’’ that the 

Agency intended to complete all Stage 

1 actions by December 31, 2015. 

For Phase 2 of the independent 

assessment, the contractor evaluated the 

implementation of recommendations, 

described under Stage 1 in the ‘‘Plan of 

Action,’’ and is publishing its written 

assessment 4 no later than February 1, 

2016. 

FDA has implemented all Stage 1 

actions outlined in the Plan of Action, 

and incorporated the resulting 

enhancements into the management of 

the premarket review program. 

Resources permitting, the Center for 

Devices and Radiological Health will 

continue to implement Stage 2 actions. 

FDA will monitor implemented 

improvements for accomplishment of 

intended results and the process for the 

review of device submissions for 

additional improvement opportunities. 

Dated: February 4, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02545 Filed 2–8–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–0270] 

Display Devices for Diagnostic 

Radiology; Draft Guidance for Industry 

and Food and Drug Administration 

Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Display Devices for 

Diagnostic Radiology’’. This draft 

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, when 

finalized, will replace a previously 

issued final guidance entitled ‘‘Display 

Accessories for Full-Field Digital 

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6870 Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 

Mammography Systems-Premarket 

Notification (510(k)) Submissions,’’ 

issued on May 30, 2008. This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 9, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

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 http://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): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, 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– 

2016–D–0270 for ‘‘Display Devices for 

Diagnostic Radiology; Draft Guidance 

for Industry and Food and Drug 

Administration Staff; Availability’’. 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Division of Dockets Management 

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 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. 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: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

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 Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

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 draft 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: 

Mary Pastel, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4312, Silver Spring, 

MD 20993–0002, 301–796–6887. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance, when finalized, will 

apply to display devices intended for 

diagnostic radiology as identified in 

section III ‘‘Scope’’ 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 (21 U.S.C 

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

code PGY. This draft guidance is 

intended to assist industry in preparing 

a 510(k) for display devices intended for 

use in diagnostic radiology. This draft 

guidance provides recommendations for 

the types of information to provide in 

510(k) submissions for display devices 

intended for diagnostic radiology. This 

information supplements the 

requirements for a 510(k) submission 

found in 21 CFR part 807, subpart E, as 

well as recommendations provided in 

other FDA guidance documents 

concerning the specific content of a 

510(k) submission. 

This guidance, when finalized, will 

apply 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 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 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. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 6871 

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 ‘‘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 

The 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 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 807 have 

been approved under OMB control 

number 0910–0120 and the collections 

of information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485. 

Dated: February 2, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02521 Filed 2–8–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: HHS–OS–4040–New– 

30D] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, has submitted an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB) for 

review and approval. The ICR is for a 

new collection. Comments submitted 

during the first public review of this ICR 

will be provided to OMB. OMB will 

accept further comments from the 

public on this ICR during the review 

and approval period. 

DATES: Comments on the ICR must be 

received on or before March 10, 2016. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.Collection

Clearance@hhs.gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

Information Collection Request Title 

and document identifier HHS–OS– 

4040–New–30D for reference. 

Information Collection Request Title: 

DATA Act Sec. 5. ‘‘Simplifying Federal 

Award Reporting’’ Grants Pilot 

Abstract: Public Law 113–101, The 

Digital Accountability and 

Transparency Act of 2014 (DATA Act) 

expands the Federal Funding 

Accountability and Transparency Act of 

2006 by increasing accountability and 

transparency in Federal spending. 

Section 5 of the DATA Act (‘‘Sec. 5. 

Simplifying Federal Award Reporting’’) 

tasks the Director of the Office of 

Management and Budget (OMB) to 

establish a pilot program (Sec. 5 (b)). 

OMB has designated the Department 

of Health and Human Services (HHS) as 

the executing agent of the pilot program. 

Within HHS, the DATA Act Program 

Management Office (PMO) (DAP) has 

been established under the Office of the 

Assistant Secretary for Financial 

Resources (ASFR) in order to implement 

this pilot program. ASFR/DAP, in 

coordination with Grants.gov, is 

requesting a generic clearance for the 

purpose of conducting tests under the 

pilot program to obtain qualitative and 

quantitative data and gain an 

understanding of the burden imposed 

on Federal recipients. 

The DAP has designed several test 

models to evaluate recipient burden and 

assess quality of data. The goal of these 

test models is to determine whether new 

technology, data standards, processes, 

and forms aid in reducing recipient 

burden and increase the accuracy and 

quality of the data submitted. Under this 

clearance, a variety of methods (surveys, 

focus groups, etc.) could be used to 

collect data, with the exact nature of the 

questions currently undetermined. DAP 

expects these questions to include, but 

not be limited to, topics pertaining to 

the Standard Form (SF) 424, the 

Consolidated Federal Financial Reports, 

and the expanded Single Audit form 

(SF–SAC). If this data is not collected, 

the requirements of the DATA Act 

Section 5 pilot will not be met. The 

types of collections that this generic 

clearance covers include, but are not 

limited to: 

• Surveys, 

• Focus Groups, 

• Other qualitative methods such as 

interviews, small discussion groups, 

and case studies. 

Likely Respondents: Recipients of 

Federal contracts, grants, and subawards. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Estimated annual reporting burden 

Type of collection Number of 

respondents 

Annual 

frequency per 

response 

Hours per 

response Total hours 

Surveys, Focus Groups, and other qualitative methods ................................. 300 1 56.25 16,875 

Total .......................................................................................................... 300 ........................ ........................ 16,875 

Darius Taylor, 

Information Collection Clearance Officer. 

[FR Doc. 2016–02472 Filed 2–8–16; 8:45 am] 

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