26688 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 

including awareness and use of the US 

MEC, US SPR and QFP; (2) describing 

current attitudes and practices among 

family planning providers and clinics 

related to recommendations included in 

the US MEC, US SPR, and QFP and 

assessing changes from previous data 

collections; and (3) identifying training 

needs in use of guidance and family 

planning service delivery (e.g., provider 

tools, continuing education modules). 

As in previous phases of data 

collection, CDC plans to administer 

surveys to private and public sector 

family planning providers and clinic 

administrators in the United States. The 

design, methodology, and analytic 

approach that CDC plans to implement 

are based on methods previously 

approved for the 2013–2014 survey, 

with different instruments being 

administered to providers and clinic 

administrators. Minor changes to survey 

content will be made to eliminate 

unnecessary questions, add new 

questions of interest, and improve 

formatting, usability, and data quality. 

OMB approval is requested for one year. 

The estimated burden per response for 

providers is 15 minutes and has not 

changed since the previous OMB 

approval. The estimated burden per 

response for administrators will be 

reduced from 40 minutes to 35 minutes. 

The total burden for participants is 

estimated at 1,916 hours. Participation 

is voluntary and there are no costs to 

respondents other than their time. 

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) 

Office-based physicians (private sector).2018–2019 Survey of Health Care 

Providers about Family Planning 

Attitudes and Practices.

1,000 1 15/60 250 

Title X clinic providers (public sector) 2018–2019 Survey of Health Care 

Providers about Family Planning 

Attitudes and Practices.

1,000 1 15/60 250 

Non-Title X publicly funded clinic 

providers (public sector).

2018–2019 Survey of Health Care 

Providers about Family Planning 

Attitudes and Practices.

1,000 1 15/60 250 

Title X clinic administrators (public 

sector).

2018–2019 Survey of Administrators 

of Health Centers that Provide 

Family Planning.

1,000 1 35/60 583 

Non-Title X publicly funded clinic administrators (public sector).2018–2019 Survey of Administrators 

of Health Centers that Provide 

Family Planning.

1,000 1 35/60 583 

Total ........................................... ........................................................... ........................ ........................ ........................ 1,916 

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. 2018–12373 Filed 6–7–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–18–18ACN; Docket No. CDC–2018– 

0042] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled Undetermined cause of Serratia 

marcescens infections—Multiple States, 

2018. The goal of this investigation is to 

identify potential risk factors leading to 

an outbreak of Serratia marcescens 

infections among U.S. healthcare 

patients. Data will be used to identify a 

cause of the infections and prevent 

additional events from occurring. 

DATES: CDC must receive written 

comments on or before August 7, 2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2018– 

0042 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Leroy A. 

Richardson, Information Collection 

Review Office, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE, MS–D74, Atlanta, Georgia 

30329; phone: 404–639–7570; Email: 

omb@cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26689 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. 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; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. 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 submissions 

of responses. 

5. Assess information collection costs. 

Proposed Project 

Undetermined cause of Serratia 

marcescens infections—Multiple States, 

2018—New—National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

Serratia marcescens is a Gramnegative bacillus that can be found in 

the environment and thrives in moist 

environments. In healthcare settings, it 

can be found on the hands of healthcare 

workers and as a contaminant of 

medical products and devices, 

particularly aqueous products. It is a 

known cause of healthcare-associated 

infections, particularly urinary tract 

infection, wound infections, and 

bloodstream infections, and it is an 

important opportunistic pathogen in 

neonatal and pediatric intensive care 

units. Serratia marcescens has been 

implicated previously in multistate 

outbreaks of bloodstream infections 

caused by intrinsic contamination of 

prefilled syringes of heparin and 

isotonic sodium chloride solution. 

On March 27, 2018, the Colorado 

Department of Public Health and 

Environment (CDPHE) notified CDC of 4 

cases of Serratia marcescens bacteremia 

among pediatric patients with central 

lines in an acute care hospital between 

January 20 and March 23, 2018. This 

cluster of cases was above the normal 

baseline of 1–3 cases per year at that 

facility. The facility examined 

exposures including common staff and 

medications and identified 

commonalities related to the 

maintenance and care of central lines as 

well as several medical products 

including prefilled normal saline 

syringes and prefilled heparin flushes. 

On March 28, CDPHE issued a call for 

cases to other state and local health 

departments through the Epidemic 

Information Exchange (Epi-X) system. 

On March 29, the Tennessee 

Department of Health (TDH) notified 

CDC of 3 cases of Serratia marcescens 

bacteremia in pediatric patients with 

central lines in a pediatric hospital 

between March 6 and March 21, 2018; 

initial examination of medications and 

common products identified central 

venous catheter line products as a 

possible source of infections, including 

prefilled heparin and normal saline 

syringes. 

CDC is currently conducting a 

multistate investigation to support state 

health departments. Currently, eight 

state health departments have reported 

a total of 26 cases to CDC. However, 

since more than nine states are 

ultimately expected to participate, CDC 

is pursuing emergency OMB clearance 

to collect patient-level information from 

ten or more state/local health 

departments. 

Most identified patient infections are 

bloodstream infections, but other body 

sites (e.g., respiratory) have also been 

described. Because these events could 

be linked to a healthcare product (e.g., 

medical device or pharmaceutical 

product) with widespread distribution, 

broad case-finding efforts are needed. 

Early investigations identified prefilled 

normal saline syringes and prefilled 

heparin flushes as common exposures, 

however healthcare facility records 

often provide an inadequate basis for 

identifying the specific product or lot 

number that was administered to a 

particular patient, and only facility-level 

information is available. The products 

identified in common at this stage of the 

investigation are widespread in 

healthcare facilities across the United 

States and incorrect identification as the 

source of infections could reasonably be 

anticipated to create panic in regards to 

use of these products and limitations in 

the safe care delivered to thousands of 

patients. 

Communications with the Food and 

Drug Administration (FDA) and product 

manufacturers indicate a nation-wide 

shortage of saline following disruption 

of manufacturing in Puerto Rico during 

Hurricane Maria in September 2017. 

FDA has stated that saline shortages in 

the U.S. mean that alternatives to 

prefilled saline are limited. In addition, 

the products are manufactured and 

subject to Current Good Manufacturing 

Practice regulations including terminal 

sterilization of many products using 

steam sterilization, which reduce 

opportunities for contamination. 

This information is essential to the 

CDC’s ability to identify a cause of these 

events and prevent additional events 

from occurring. 

Nationwide case-finding has been 

implemented through the Epi-X system. 

The target audience of the case finding 

will include, but not be limited to, state 

and local health departments. They will 

be asked to report any potential cases to 

CDC. Information on each case will be 

collected using a data collection form 

that can be completed online or filled 

out and returned to CDC. Depending on 

the nature of each case, CDC may reach 

out to relevant healthcare facilities or 

healthcare staff for additional 

information and recommendation of any 

prevention measures. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hrs) 

Total burden 

(in hrs) 

Healthcare staff ................................. Case finding for data collection ....... 25 2 25/50 100 

Total ........................................... ........................................................... ........................ ........................ ........................ 100 


amozie on DSK3GDR082PROD with NOTICES1
26690 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 

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. 2018–12372 Filed 6–7–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–18LQ] 

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 Assessment of 

Occupational Injury among Fire Fighters 

Using a Follow-back Survey 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 February 13, 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 

Assessment of Occupational Injury 

among Fire Fighters Using a Followback Survey—New—National Institute 

for Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Studies have reported that fire fighters 

have high rates of non-fatal injuries and 

illnesses as compared to the general 

worker population. As fire fighters 

undertake many critical public safety 

activities and are tasked with protecting 

the safety and health of the public, it 

follows that understanding and 

preventing injuries and exposures 

among fire fighters will have a benefit 

reaching beyond the workers to the 

general public. 

As mandated in the Occupational 

Safety and Health Act of 1970 (Pub. L. 

91–596), the mission of NIOSH is to 

conduct research and investigations on 

occupational safety and health. Related 

to this mission, the purpose of this 

project is to conduct research that will 

provide a detailed description of nonfatal occupational injuries and 

exposures incurred by fire fighters. This 

information will offer detailed insight 

into events that lead to the largest 

number of nonfatal injuries and 

exposures among fire fighters. The 

project will use two related data 

sources. The first source is data 

abstracted from medical records of fire 

fighters treated in a nationally stratified 

sample of emergency departments. 

These data are routinely collected 

through the occupational supplement to 

the National Electronic Injury 

Surveillance System (NEISS-Work). The 

second data source, for which NIOSH is 

seeking OMB approval for three years, is 

responses to telephone interview 

surveys of the injured and exposed fire 

fighters identified within NEISS-Work. 

The proposed telephone interview 

surveys will supplement NEISS-Work 

data with an extensive description of 

fire fighter injuries and exposures, 

including worker characteristics, injury 

types, injury circumstances, injury 

outcomes, and use of personal 

protective equipment. Previous reports 

describing occupational injuries and 

exposures to fire fighters provide 

limited details on specific regions or 

sub-segments of the population. As 

compared to these earlier studies, the 

scope of the telephone interview data 

will be broader as it includes sampled 

cases nationwide and has no limitations 

in regards to type of employment (i.e., 

volunteer versus career). Results from 

the telephone interviews will be 

weighted and reported as national 

estimates. 

The sample size for the telephone 

interview survey is estimated to be 

approximately 240 fire fighters annually 

for the proposed three year duration of 

the study. This is based on the number 

of fire fighters identified in previous 

years of NEISS-Work data and a 30 to 

40% response rate that is comparable to 

the rate of previously conducted 

National Electronic Injury Surveillance 

System telephone interview studies. 

Each telephone interview will take 

approximately 30 minutes to complete, 

resulting in an annualized burden 

estimate of 120 hours. Using the routine 

NEISS-Work data, an analysis of all 

identified EMS workers will be 

performed to determine if there are 

differences between the telephone 

interview responder and non-responder 

groups. 

The Division of Safety Research (DSR) 

within NIOSH is conducting this 

project. DSR has a strong interest in 

improving surveillance of fire fighter 

injuries and exposures to provide the 

information necessary for effectively 

targeting and implementing prevention 

efforts and, consequently, reducing 

occupational injuries and exposures to 

fire fighters. The Consumer Product 

Safety Commission (CPSC) will also 

contribute to this project, as they are 

responsible for coordinating the 

collection of all NEISS-Work data and 

for overseeing the collection of all 

telephone interview data. The estimated 

annual Burden Hours are 120. There is 

no cost to respondents other than their 

time. 


amozie on DSK3GDR082PROD with NOTICES1