[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Notices]
[Pages 26688-26690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12372]


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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.

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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: 
[email protected].

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

[[Page 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 Gram-negative 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
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents   responses  per   response  (in     (in hrs)
                                                                     respondent        hrs)
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Healthcare staff..............  Case finding for              25               2           25/50             100
                                 data collection.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             100
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[[Page 26690]]

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