Federal Register / Vol. 83, No. 243 / Wednesday, December 19, 2018 / Notices 65169 

Estimated Total Annual Burden 

Hours: 8,003. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW, Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–27398 Filed 12–18–18; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5966] 

Breakthrough Devices Program; 

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 final 

guidance entitled ‘‘Breakthrough 

Devices Program; Guidance for Industry 

and Food and Drug Administration 

Staff.’’ This guidance document 

describes policies that FDA intends to 

use to implement the new Breakthrough 

Devices Program, established by the 21st 

Century Cures Act (Cures Act). The 

Breakthrough Devices Program 

supersedes and combines elements from 

FDA’s Expedited Access Pathway (EAP), 

which was intended to facilitate the 

development and expedite review of 

certain devices that demonstrate the 

potential to address unmet medical 

needs, as well as the Priority Review 

Program, which implemented statutory 

criteria for granting priority review to 

premarket approval applications (PMAs) 

and applied those criteria to other types 

of premarket submissions for medical 

devices. This guidance is intended to 

clarify certain principles and features of 

the new program, the designation 

criteria for Breakthrough Devices, the 

designation request review process, the 

process for withdrawing from the 

program, as well as the recommended 

information device manufacturers 

should provide in their designation 

request for entrance into the program. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 19, 2018. 

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–5966 for ‘‘Breakthrough 

Devices Program; Guidance for Industry 

and Food and Drug Administration 

Staff.’’ Received 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://

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 


amozie on DSK3GDR082PROD with NOTICES1
65170 Federal Register / Vol. 83, No. 243 / Wednesday, December 19, 2018 / Notices 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Breakthrough 

Devices Program; Guidance for Industry 

and Food and Drug Administration 

Staff’’ 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: 

Maureen Dreher, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm.1545, Silver Spring, 

MD 20993–0002, 301–796–2505. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this guidance to 

describe policies that FDA intends to 

use to implement section 515B of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360e–3, as 

created by section 3051 of the Cures Act 

(Pub. L. 114–255) and amended by 

section 901 of the FDA Reauthorization 

Act of 2017 (Pub. L. 115–52) (the 

‘‘Breakthrough Devices Program’’). The 

Breakthrough Devices Program is a 

voluntary program for certain medical 

devices and device-led combination 

products that provide for more effective 

treatment or diagnosis of lifethreatening or irreversibly debilitating 

diseases or conditions. This program is 

intended to help patients have more 

timely access to these medical devices 

by expediting their development, 

assessment, and review, while 

preserving the statutory standards for 

premarket approval, premarket 

notification (510(k)) clearance, and De 

Novo marketing authorization, 

consistent with the Agency’s mission to 

protect and promote public health. 

As part of the Breakthrough Devices 

Program, FDA intends to provide 

interactive and timely communication 

with the sponsor during development 

and throughout the review process for 

devices designated as Breakthrough 

Devices under section 515B(d)(1) of the 

FD&C Act and prioritize the review of 

associated Q-submissions, 

investigational device exemption (IDE) 

applications, PMAs, certain PMA 

supplements, De Novo requests, and/or 

510(k)s. In addition, for Breakthrough 

Devices subject to PMA, FDA may 

consider the amount and nature of data 

that may be collected in the postmarket 

setting, rather than premarket, and the 

extent of uncertainty that may be 

appropriate in the benefit-risk profile at 

the time of approval. Getting the right 

balance between premarket and 

postmarket data collection— 

specifically, where appropriate, a 

greater reliance on postmarket 

collection—can reduce the extent of 

premarket data submission. 

Collectively, these and the other 

principles of the program described in 

this guidance are intended to support a 

least-burdensome approach for 

expediting patient access to 

Breakthrough Devices. 

The Breakthrough Devices Program 

supersedes the EAP, which launched in 

2015. The Breakthrough Devices 

Program contains features of the EAP as 

well as the Innovation Pathway (first 

piloted in 2011; pilot is now 

discontinued), both of which were 

intended to facilitate the development 

and expedite the review of breakthrough 

technologies. 

The Breakthrough Devices Program 

also supersedes the Priority Review 

Program, which implemented statutory 

criteria for granting priority review to 

PMA submissions for medical devices, 

applied those criteria to other types of 

premarket submissions for medical 

devices, and included standard 

procedures to achieve an efficient 

priority review process. 

FDA considered comments received 

on the draft guidance that appeared in 

the Federal Register of October 25, 

2017. FDA revised the guidance as 

appropriate in response to the 

comments. This document supersedes 

the guidance document ‘‘Expedited 

Access for Premarket Approval and De 

Novo Medical Devices Intended for 

Unmet Medical Need for Life 

Threatening or Irreversibly Debilitating 

Diseases or Conditions,’’ issued on April 

13, 2015. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the ‘‘Breakthrough 

Devices Program; Guidance for Industry 

and Food and Drug Administration 

Staff.’’ 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. This 

guidance document is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Breakthrough Devices Program; 

Guidance for Industry and Food and 

Drug Administration Staff’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1833 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information. 

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 the following FDA 

regulations and guidance have been 

approved by OMB as listed in the 

following table: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................ 0910–0120 

814, subparts A through E .......................................................... Premarket approval .................................................................... 0910–0231 

814, subpart H ............................................................................ Humanitarian Device Exemption ............................................... 0910–0332 

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

‘‘De Novo Classification Process (Evaluation of Automatic 

Class III Designation)’’.

De Novo classification process .................................................. 0910–0844 

‘‘Requests for Feedback on Medical Device Submissions: The 

Pre-Submission Program and Meetings with Food and Drug 

Administration Staff’’.

Q-submissions ........................................................................... 0910–0756 


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Federal Register / Vol. 83, No. 243 / Wednesday, December 19, 2018 / Notices 65171 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

Dated: December 14, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27433 Filed 12–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0955–new] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before January 18, 2019. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0955-New-30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: National 

Survey of Health Information Exchange 

Organizations (HIO) 

Abstract: Electronic health 

information exchange (HIE) is one of 

three goals specified by Congress in the 

2009 Health Information Technology for 

Economic and Clinical Health (HITECH) 

Act to ensure that the $30 billion federal 

investment in electronic health records 

(EHRs) results in higher-quality, lowercost care. The ability of providers to 

share data electronically is a core goal 

of HITECH and a central feature of a 

high-performing healthcare delivery 

system. Greater EHR adoption without 

data flowing between systems 

substantially limits quality and 

efficiency gains as well as reduces the 

value of the health IT investment. 

There is growing consensus that 

achieving broad-based HIE is one of the 

most difficult components of HITECH. 

This is because successful HIE at scale 

involves coordination between many 

stakeholders, including but not limited 

to federal and state policymakers, 

healthcare delivery organizations, EHR 

and HIE vendors, and specific 

organizations supporting HIE, such as 

health information organizations (HIOs) 

and health information service 

providers (HISPs). Further, the issues 

requiring coordination are diverse, 

spanning technical standards, consent 

regulations, business models and 

incentives, workflow integration, trust 

and governance, and information 

privacy and security. 

Three HIE issues have proven 

particularly challenging: 

Implementation of and use of standards, 

information blocking, and 

sustainability. The ultimate goal of our 

project is to administer a survey 

instrument to HIOs in order to generate 

the most current national statistics and 

associated actionable insights on 

electronic health information exchange 

to inform policy efforts. 

Need and Proposed Use of the 

Information: Collecting timely, national 

data from HIOs in the three domains of 

standards, information blocking, and 

sustainability is valuable to inform both 

HIE-specific policy efforts as well as 

broader health system reform efforts. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

HIO Survey ...................................................................................................... 200 1 20/60 67 

Total .......................................................................................................... ........................ ........................ ........................ 67 

Terry Clark, 

Assistant Paperwork Reduction Act Reports 

Clearance Officer, Office of the Secretary. 

[FR Doc. 2018–27469 Filed 12–18–18; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–new] 

Agency Information Collection 

Request. 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before January 18, 2019. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 


amozie on DSK3GDR082PROD with NOTICES1