Emergency Review Request Memo

Emergency Review Request Memo - EIP Tracking of SARS-CoV-2 Infections among HCP_signed.pdf

Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel

Emergency Review Request Memo

OMB: 0920-1296

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

April 9, 2020
Dominic Mancini
Acting 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 the Office of Management and Budget (OMB) procedures established at 4 CFR 1320,
Controlling Paperwork Burdens on the Public, I am writing to request that the following collection of
information, Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare
Personnel, be processed in accordance with section 1320.13 Emergency Processing.
I have determined that the information must be collected as soon as possible and that this information is
essential to CDC’s and state and local health departments’ ability, as well as that of healthcare facilities,
to effectively address the national public health crisis caused by the novel coronavirus SARS-CoV-2
(COVID-19). As rates of infection and resulting hospitalizations continue to rise across the nation,
healthcare personnel (HCP) are facing significant risk of contracting SARS-CoV-2 during their
interactions with patients with suspected or confirmed COVID-19 or patients with unrecognized infection.
Understanding the factors that place HCP at greater risk for infection as well as factors that may reduce
risk is critical to the nation’s effective pandemic response. The U.S. healthcare workforce is among our
most vital assets, and protecting our workforce also protects patients.
The CDC, in collaboration with Emerging Infections Program (EIP) sites, plans to implement a system to
track and assess risk factors for SARS-CoV-2 infections among HCP. The objectives are to: 1)
determine the extent of COVID-19 among HCP working in U.S. healthcare facilities; 2) describe
characteristics of HCP exposed to or infected with SARS-CoV-2, including clinical activities and personal
protective equipment use; and 3) compare exposures and other characteristics of HCP cases and
exposed HCP that do not become cases to identify risk factors or protective factors for COVID-19.
Through this system, EIP site staff will identify a convenience sample of healthcare facilities within the
EIP catchment areas. Hospitals and nursing homes are prioritized for inclusion, but other types of
facilities may participate. Each EIP site will seek to identify three or more facilities to participate and will
regularly obtain lists of HCP cases and contact information from state or local health departments or
from healthcare facilities’ occupational health departments or infection control programs. In some sites
and facilities, EIP staff will also work with occupational health departments or infection control programs
to obtain lists of HCP who are exposed to COVID-19 patient but did not become cases themselves. EIP
staff will collect data from HCP via telephone interviews or a self-administered electronic case report
form, including demographic information and information on underlying conditions, healthcare role, work
locations, clinical activities, use of personal protective equipment, and exposures in community and
healthcare settings. Data reported to EIP sites by HCP will be entered into a secure, CDC-developed
database, such as a REDCap database. CDC staff will have immediate access to data submitted from
all EIP sites; each EIP site will maintain access to its own data. Direct HCP identifiers such as name,
email address or telephone number will not be shared with CDC.

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

CDC cannot reasonably comply with the normal clearance procedures due to the public harm that could
escalate if routine processing of this request is required. CDC requests authorization to use a previously
OMB-approved form (OMB Control No. 0920-1011, expiration date 04/23/2020) with minor modifications
for 180 days to enable CDC and EIP sites to proceed immediately with tracking and interviewing of HCP
infected with or exposed to SARS-CoV-2. Absent this emergency approval, CDC will not be able to
implement Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare
Personnel with the urgency that is required.
Please provide an approval/ disapproval determination of this request to collect information under an
emergency clearance by close of business April 10, 2020.

Respectfully,
Digitally signed by

Rima F.
Rima F. Khabbaz -S
2020.04.09
Khabbaz -S Date:
11:13:08 -04'00'
Rima Khabbaz, MD
Director, National Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers for Disease Control
and Prevention (CDC)


File Typeapplication/pdf
AuthorSamuel, Lee (CDC/OID/NCEZID)
File Modified2020-04-09
File Created2020-04-09

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