Emergency Request Memo

D EPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

_______________________________________________________________________________________

Centers for Disease Control

and Prevention (CDC)

Atlanta GA 30341-3724

March 20, 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, “Investigation of a cluster of extensively drug resistant shigellosis associated with a cruise ship” be processed in accordance with section 1320.13, Emergency Processing.

I have determined that the information must be collected prior to the expiration of time period established under Part 1320, and that this information is essential to CDC’s ability, as well as that of state and local health departments, to effectively address the national public health crisis caused by the Novel Coronavirus (COVID-19). As rates of infection and resulting deaths continue to rise across the nation, healthcare facilities and public health departments are facing significant strain on patient care and infection prevention efforts. NHSN plans to introduce a new surveillance module that will enable hospitals to report daily COVID-19 patient counts to NHSN, and NHSN in turn will enable state and local health departments to gain immediate access to the COVID-19 data for hospitals in their jurisdiction. COVID-19 data submitted to NHSN also will be used immediately by CDC’s emergency COVID-19 response. NHSN’s role as a shared platform for healthcare-associated infection surveillance provides a valuable foundation for COVID-19 surveillance. The COVID-19 modules can additionally be adapted for future outbreaks of COVID or other infectious diseases. A large majority of the nation’s hospitals already participate in NHSN, and infection preventionists (IPs) in those hospitals use NHSN for surveillance and reporting of healthcare-associated infection and antimicrobial resistance.

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 information collection instruments in the existing NHSN web-based application for 180 days to enable immediate CDC and public health departments with immediate access to COVID-19 patient impact data. The data collection instrument consists of the COVID-19 Patient Impact Form, which will be used by hospital IPs to report daily counts of patients hospitalized in an NHSN inpatient care location who have suspected or confirmed COVID-19 and patients with suspected or confirmed COVID-19 who died in the hospital, ED or any overflow location.

The information solicited from hospitals for COVID-19 surveillance will consist of fewer than 10 elements and will involve no patient-level data collection. Data requested by the aforementioned form can be entered in NHSN manually or via a comma-separated values (CSV) file. Once the data are submitted in NHSN, CDC will have immediate access to this information. Additionally, health departments will have immediate access to the COVID-19 data submitted by healthcare facilities in their jurisdictions. The impact data will then be used to monitor medical capacity and respond to the pandemic at local, state, and national levels. NHSN is optimally positioned to begin receiving such data in as short a time periodas possible, leveraging an existing platform that allows healthcare facilities to share data directly with public health partners. Absent this emergency approval, CDC will not be able to implement COVID-19 healthcare surveillance 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 March 23, 2020.

Respectfully,

Rima Khabbaz, MD

Director, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC