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