Emergency Request Memo - signed

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

January 18, 2020
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,
“Addition of 2019 – Novel Coronavirus (2019-nCoV) to the National Notifiable Diseases Surveillance
System (0920-0728)” be processed as an Emergency Revision Request 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 CDC’s emergency response to the
outbreak of a novel coronavirus. The outbreak caused by a novel coronavirus has resulted in more than
40 confirmed human infections in China and one exported case in Thailand. Infection is associated with
severe pneumonia, and one patient in China is reported to have died. The outbreak is centered in Wuhan
City, Hubei Province, China. Chinese health authorities report that most patients have reportedly had
exposure to a large seafood and animal market. Much remains unknown about the transmissibility,
severity, and other features associated with 2019-nCoV, and investigations are ongoing. While current
information indicates the risk from 2019-nCoV to the American public is deemed to be low, CDC is
taking proactive preparedness precautions and requires emergency review and clearance to allow for
immediate information collection for patients under investigation and potential cases.
CDC cannot reasonably comply with the normal clearance given the urgent necessity to protect the
American public from potential importation and spread of this novel health threat. Much remains
unknown about the etiology, transmissibility, and characteristics of 2019-nCoV, and as demonstrated by
previous outbreaks of SARS-associated coronavirus and Middle East Respiratory Syndrome (MERS),
novel coronaviruses provide a significant threat of spreading among humans and causing severe illness.
Early detection and intervention remains the best way to control the spread of novel infectious diseases,
and complying with normal clearance timelines for 2019-nCoV would delay effective detection and
control efforts, potentially threatening public health if this novel, poorly understood virus proves to be

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

transmissible among humans.
Therefore, CDC requests a 180-day emergency clearance to launch collection of data for patients under
investigation (PUI) and potential cases for 2019-nCoV under OMB Control Number 0920-0728. Please
provide an approval/disapproval determination of this request to collect information under an emergency
clearance by close of business on January 23, 2020.

Respectfully,

Nancy Messonnier, MD
Director, National Center for Immunization and Respiratory
Disease (NCIRD), Centers for Disease Control and
Prevention (CDC)