Emergency Request Memo

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
_______________________________________________________________________________________
Centers for Disease Control
and Prevention (CDC)
Atlanta GA 30341-3724

March 29, 2024
Dominic Mancini
Deputy Director
Office of Information and Regulatory Affairs
Office of Management and Budget
Washington, DC
Subject: Request for Emergency Review and Clearance
Dear Mr. Mancini:
Pursuant to Office of Management and Budget (OMB) procedures established at 5 CFR Part 1320,
Controlling Paperwork Burdens on the Public, I request that the proposed information collection project,
Investigation of Burkholderia multivorans infections in acute care hospital settings following potential
exposure to nonsterile ice and water from ice machines, United States, 2022-2024, hereinafter referred to
as the B. multivorans Ice Machine Multistate Investigation, be processed in accordance with section
1320.13, Emergency Processing.
I have determined that this information must be collected prior to the expiration of time periods
established under Part 1320, and that this information is essential to the continued and uninterrupted
operation of the B. multivorans Ice Machine Multistate Investigation. The B. multivorans Ice Machine
Multistate Investigation is part of the public health response efforts of a federal public health agency, as
specified in the Code of Federal Regulations [45 CFR 46.102(I)(2)], to stop the transmission of a
bacterial pathogen and protect the public from further harm; in order to keep in compliance with the
statute, this information collection request (ICR) needs to go forward as an Emergency to avoid a lapse in
the public health response-related collection activities.
This request includes a new data collection instrument, hereinafter referred as a case report form. Approval
is requested for 180 days from the date of approval.
By way of background, CDC has been assisting state and local jurisdictions investigate clusters of B.
multivorans infections among patients admitted across four hospitals in two non-contiguous states. The
outbreak strain of the bacteria has been identified in environmental samples from ice machines.
Molecular analysis has shown that the bacterial strain identified in ice machines is genetically highly
similar to the patient isolates. Further investigation revealed that the same brand of ice machine and the
same filters, descaling/cleaning, and sanitizing products were used by the four hospitals. Epidemiologic
and laboratory evidence suggest the possibility of contaminated nonsterile ice and water from the same
brand of ice machines as a common source of exposure.
Further investigation is needed to identify the scope of the outbreak and the source of the ice machine
contamination. CDC is issuing a national call for cases requesting that public health authorities report
cases and clusters of B. multivorans. A case report form was developed by CDC to assist jurisdictions in
this effort. Jurisdictions will gather information using this case report form to assist in determining
epidemiologic characteristics and risk factors of patients with B. multivorans as well as potential

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
_______________________________________________________________________________________
Centers for Disease Control
and Prevention (CDC)
Atlanta GA 30341-3724

source(s) of B. multivorans, including ice machines and ice machine-related products (e.g., cleaning
solutions). CDC will use this information to inform additional measures that could stop transmission and
implement mitigation measures to prevent further spread. These public health response activities, which
require the use of a new data collection instrument, are specified in 45 CFR 46.102(I)(2).
CDC cannot reasonably comply with the normal clearance given the fact that this outbreak response
activity is addressing a potential public health emergency, normal clearance processing time will prevent
the rapid response that is warranted during an outbreak investigation. Therefore, the ICR needs to be go
forward as an emergency to prevent a lapse in collection activities.
Please provide an approval/disapproval determination of this request to collect information under an
emergency clearance by close of business 4/05/2024.

Respectfully,

_____________________________________
Daniel B. Jernigan, MD MPH
Director, National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention