46490 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

research activities in the health field. 

Historically, data have been used 

extensively in the development and 

monitoring of goals for the Year 2000, 

2010, and 2020 Healthy People 

Objectives. 

There is no cost to respondents other 

than their time to participate. The total 

annualized burden is 7,080 hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Hospital Director of Health Information Management (DHIM) or Director of Health Information Technology (DHIT).Initial Hospital Intake Questionnaire 150 1 1 150 

Hospital Chief Executive Officer 

(CEO)/Chief Financial Officer 

(CFO).

Recruitment Survey Presentation .... 150 1 1 150 

Hospital DHIM or DHIT ..................... Prepare and transmit UB–04 or 

State File for Inpatient and Ambulatory.

399 12 1 4,788 

Hospital DHIM or DHIT ..................... Prepare and transmit EHR for Inpatient and Ambulatory.199 4 1 796 

Hospital CEO/CFO ............................ Annual Hospital Interview ................ 598 1 2 1,196 

Total ........................................... ........................................................... ........................ ........................ ........................ 7,080 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–19901 Filed 9–12–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–0666] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled National 

Healthcare Safety Network to the Office 

of Management and Budget (OMB) for 

review and approval. CDC previously 

published a ‘‘Proposed Data Collection 

Submitted for Public Comment and 

Recommendations’’ notice on May 11, 

2018 to obtain comments from the 

public and affected agencies. CDC 

received one comment related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Direct 

written comments and/or suggestions 

regarding the items contained in this 

notice to the Attention: CDC Desk 

Officer, Office of Management and 

Budget, 725 17th Street, NW, 

Washington, DC 20503 or by fax to (202) 

395–5806. Provide written comments 

within 30 days of notice publication. 

Proposed Project 

National Healthcare Safety Network 

(0920–0666, Expiration Date 1/31/ 

2021)—Revision—National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

NHSN is a public health surveillance 

system that collects, analyzes, reports, 

and makes available data for 

monitoring, measuring, and responding 

to healthcare associated infections 

(HAIs), antimicrobial use and resistance, 

blood transfusion safety events, and the 

extent to which healthcare facilities 

adhere to infection prevention practices 

and antimicrobial stewardship. 

Specifically, resulting data estimates the 

magnitude of Healthcare Associated 

Infections (HAI), monitor HAI trends, 

and facilitate inter-facility and intrafacility comparisons with risk-adjusted 

data used for local quality improvement 

activities. The data will be used to 

detect changes in the epidemiology of 

adverse events resulting from new and 

current medical therapies and changing 

risks. The NHSN currently consists of 

six components: Patient Safety, 

Healthcare Personnel Safety, 

Biovigilance, Long-Term Care Facility 

(LTCF), Outpatient Procedure 

Component, and Dialysis. 

Changes were made to 34 data 

collection facility surveys with this 

revision ICR. CDC revised three annual 

facility surveys for the Patient Safety 

component for Hospitals, Long-Term 

Acute Care Facilities, and Inpatient 

Rehabilitation Facilities. CDC’s 

revisions clarify the reporting 

requirements for the data collected on 

fungal testing, facility locations, and 

laboratory testing locations. 

Additionally, corresponding response 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46491 

options for these questions have been 

revised to include updated testing 

methods used by facilities to capture 

current HAI specific data specification 

requirements for NHSN. New required 

questions have been added to all Patient 

Safety component surveys. The new 

questions are designed to provide data 

on surveillance processes, policies, and 

standards that are used by reporting 

facilities to ensure that when an event 

is detected, the facility has the 

appropriate mechanism to conduct 

complete reporting. The Hospital 

Annual Survey added new required 

questions to provide data about neonatal 

antimicrobial stewardship practices 

because the focus of stewardship efforts 

in neonatology differ from the focus in 

adult and pediatric practice. Questions 

were removed and replaced on all three 

Patient Safety surveys to align better 

with the Core Elements of Hospital 

Antibiotic Stewardship Programs 

specified by CDC. The Core Elements 

defined by CDC are part of broad-based 

efforts by CDC and its healthcare and 

public health partners to combat the 

threat of antibiotic-resistant bacteria. 

The new Antibiotic Stewardship 

Program questions will provide 

additional data about operational 

features of the programs that hospitals 

have implemented, which in turn will 

enable CDC and its healthcare and 

public health partners to target their 

efforts to help invigorate and extend 

antibiotic stewardship. 

CDC is introducing a new optional 

survey form that is designed to be 

completed by state and local health 

departments that participate in HAI 

surveillance and prevention activities. 

This new form will provide data on 

legal and regulatory requirements that 

are pertinent to HAI reporting. CDC 

plans to include data the health 

department survey in its annual 

National and State HealthcareAssociated Infection Progress Report. 

The report helps identify the progress in 

HAI surveillance and prevention at the 

state and national levels. Data about the 

extent to which state health 

departments have validated HAI data 

that healthcare facilities in their 

jurisdiction report to NHSN and the 

extent of state and local health 

department HAI reporting requirements 

are important data for users of CDC’s 

HAI Progress Report to consider when 

they are reviewing and interpreting data 

in the report. 

NHSN now includes a ventilatorassociated event available for NICU 

locations, which requires additional 

denominator reporting, in which CDC 

has provided an option to accommodate 

facilities that are reporting requested 

data by updating the corresponding 

surveys. The Pediatric VentilatorAssociated Event (PedVAE) was 

removed from the survey because a 

single algorithm is used to detect 

PedVAE events. 

NHSN has made updates to the 

Antimicrobial Use and Resistance 

(AUR) data collection tools for the 

purposes of monitoring additional 

microorganisms and their antimicrobial 

susceptibility profiles. Use of these 

updates in AUR surveillance will 

provide important additional data for 

clinical and public health responses to 

mounting antibiotic resistance 

problems. 

The Long-term Care Facility 

Component (LTCF) will be updating 

three forms, two of which will include 

an update for facilities to document the 

‘‘CDI treatment start’’ variable. Early CDI 

reporting data from nursing homes has 

shown exceptionally low event rates for 

many reporting facilities (e.g., zero 

events for six or more months). Since 

current CDI event detection is based on 

presence of a positive laboratory 

specimen, variability in the use of 

diagnostic testing as part of CDI 

management will have direct impact on 

the estimate of CDI burden in a facility 

(e.g., empiric treatment for CDI without 

confirmatory testing may result in the 

appearance of low disease burden). In 

order to determine whether low CDI 

event rates might be due to empiric CDI 

treatment practices, a new process 

measure will be incorporated into the 

monthly summary data on CDI for 

LTCFs. This measure, called ‘‘CDI 

treatment starts,’’ will allow providers 

to capture the number of residents 

started on antibiotic treatment for CDI 

that month based on clinical decisions 

(i.e., even those without a positive CDI 

test). This process measure should 

provide data on clinically-treated CDI in 

order to inform our understanding of 

CDI management practices and serve as 

a proxy for CDI burden in nursing 

homes. 

Overall, minor revisions have been 

made to a total of 34 forms within the 

package to clarify and/or update 

surveillance definitions, increase or 

decrease the number of reporting 

facilities, and add new forms. 

Finally, NHSN has achieved 

significant burden reduction with this 

ICR due to a decrease in the number of 

respondents for the Specialty Care Area 

(SCA) and Oncology (ONC) facilities 

reporting to NHSN. NHSN re-evaluated 

these reporting facilities and determined 

that approximately 2,000 SCA and ONC 

facilities are reporting to NHSN 

compared to the estimated 6,000 that 

was estimated last year. Additionally, 

NHSN streamlined many response 

options, which also attributed to a 

reduction in the overall burden. 

The previously approved NHSN 

package included 72 individual 

collection forms; the current revision 

request includes a total of 73 forms. The 

reporting burden will decrease by 

109,745 hours, for a total of 5,393,725 

hours. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Healthcare facility ................... 57.100 NHSN Registration Form ........................................... 2,000 1 5/60 

57.101 Facility Contact Information ....................................... 2,000 1 10/60 

57.103 Patient Safety Component—Annual Hospital Survey 6,000 1 75/60 

57.105 Group Contact Information ......................................... 1,000 1 5/60 

57.106 Patient Safety Monthly Reporting Plan ...................... 6,000 12 15/60 

57.108 Primary Bloodstream Infection (BSI) ......................... 6,000 44 33/60 

57.111 Pneumonia (PNEU) .................................................... 1,800 72 30/60 

57.112 Ventilator-Associated Event ....................................... 6,000 144 28/60 

57.113 Pediatric Ventilator-Associated Event (PedVAE) ....... 100 120 30/60 

57.114 Urinary Tract Infection (UTI) ...................................... 6,000 40 20/60 

57.115 Custom Event ............................................................. 600 91 35/60 

57.116 Denominators for Neonatal Intensive Care Unit 

(NICU).

6,000 12 4 


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46492 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC).2,000 9 302/60 

57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA).6,000 60 302/60 

57.120 Surgical Site Infection (SSI) ....................................... 6,000 36 35/60 

57.121 Denominator for Procedure ........................................ 6,000 540 10/60 

57.122 HAI Progress Report State Health Department Survey.55 1 45/60 

57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables.1,000 12 5/60 

57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy 

Data Electronic Upload Specification Tables.

2,000 12 5/60 

57.125 Central Line Insertion Practices Adherence Monitoring.100 100 25/60 

57.126 MDRO or CDI Infection Form .................................... 6,000 72 30/60 

57.127 MDRO and CDI Prevention Process and Outcome 

Measures Monthly Monitoring.

6,000 24 15/60 

57.128 Laboratory-identified MDRO or CDI Event ................ 6,000 240 20/60 

57.129 Adult Sepsis ............................................................... 50 250 25/60 

57.137 Long-Term Care Facility Component—Annual Facility Survey.2,600 1 2 

57.138 Laboratory-identified MDRO or CDI Event for LTCF 2,600 12 20/60 

57.139 MDRO and CDI Prevention Process Measures 

Monthly Monitoring for LTCF.

2,600 12 20/60 

57.140 Urinary Tract Infection (UTI) for LTCF ....................... 2,600 14 35/60 

57.141 Monthly Reporting Plan for LTCF .............................. 2,600 12 5/60 

57.142 Denominators for LTCF Locations ............................. 2,600 12 250/60 

57.143 Prevention Process Measures Monthly Monitoring 

for LTCF.

2,600 12 5/60 

57.150 LTAC Annual Survey ................................................. 400 1 70/60 

57.151 Rehab Annual Survey ................................................ 1,000 1 70/60 

57.200 Healthcare Personnel Safety Component Annual Facility Survey.50 1 8 

57.203 Healthcare Personnel Safety Monthly Reporting Plan 19,500 1 5/60 

57.204 Healthcare Worker Demographic Data ...................... 50 200 20/60 

57.205 Exposure to Blood/Body Fluids .................................. 50 50 1 

57.206 Healthcare Worker Prophylaxis/Treatment ................ 50 30 15/60 

57.207 Follow-Up Laboratory Testing .................................... 50 50 15/60 

57.210 Healthcare Worker Prophylaxis/Treatment-Influenza 50 50 10/60 

57.300 Hemovigilance Module Annual Survey ...................... 500 1 85/60 

57.301 Hemovigilance Module Monthly Reporting Plan ........ 500 12 1/60 

57.303 Hemovigilance Module Monthly Reporting Denominators.500 12 70/60 

57.305 Hemovigilance Incident .............................................. 500 10 10/60 

57.306 Hemovigilance Module Annual Survey—Non-acute 

care facility.

200 1 35/60 

57.307 Hemovigilance Adverse Reaction—Acute Hemolytic 

Transfusion Reaction.

500 4 20/60 

57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction.500 4 20/60 

57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction.500 1 20/60 

57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction.500 2 20/60 

57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction.500 4 20/60 

57.312 Hemovigilance Adverse Reaction—Hypotensive 

Transfusion Reaction.

500 1 20/60 

57.313 Hemovigilance Adverse Reaction—Infection ............. 500 1 20/60 

57.314 Hemovigilance Adverse Reaction—Post Transfusion 

Purpura.

500 1 20/60 

57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea.500 1 20/60 

57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease.500 1 20/60 

57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury.500 1 20/60 

57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload.500 2 20/60 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46493 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction.500 1 20/60 

57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction.500 1 20/60 

57.400 Outpatient Procedure Component—Annual Facility 

Survey.

5,000 1 10/60 

57.401 Outpatient Procedure Component—Monthly Reporting Plan.5,000 12 20/60 

57.402 Outpatient Procedure Component Same Day Outcome Measures.1,200 25 40/60 

57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures.1,200 12 40/60 

57.404 Outpatient Procedure Component—SSI Denominator.5,000 540 10/60 

57.405 Outpatient Procedure Component—Surgical Site 

(SSI) Event.

5,000 36 35/60 

57.500 Outpatient Dialysis Center Practices Survey ............. 7,000 1 127/60 

57.501 Dialysis Monthly Reporting Plan ................................ 7,000 12 5/60 

57.502 Dialysis Event ............................................................. 7,000 60 25/60 

57.503 Denominator for Outpatient Dialysis .......................... 7,000 12 10/60 

57.504 Prevention Process Measures Monthly Monitoring 

for Dialysis.

2,000 12 85/60 

57.505 Dialysis Patient Influenza Vaccination ....................... 325 75 10/60 

57.506 Dialysis Patient Influenza Vaccination Denominator 325 5 10/60 

57.507 Home Dialysis Center Practices Survey .................... 350 1 30/60 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–19902 Filed 9–12–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0294] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Contact 

Substance Notification Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection associated with the Food 

Contact Substance Notification Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 13, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 13, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 13, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

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– 

2012–N–0294 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 


daltland on DSKBBV9HB2PROD with NOTICES