2020-08170. 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.

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 National Healthcare Safety Network (NHSN) Patient Module for Coronavirus (COVID-19) Surveillance in Healthcare Facilities. Two modules will be added within NHSN to capture the daily, aggregate impact of COVID-19 on healthcare facilities and monitor medical capacity to respond at local, state, and national levels.

DATES:

CDC must receive written comments on or before June 16, 2020.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2020-0038 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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

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 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

National Healthcare Safety Network (NHSN) Patient Impact Module for Coronavirus (COVID-19) Surveillance in Healthcare Facilities—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) collects data from healthcare facilities in the National Healthcare Safety Network (NHSN) under OMB Control Number 0920-0666. NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship.

On March 11, 2020, the World Health Organization declared COVID-19 a pandemic, and the President of the United States (U.S.) proclaimed the outbreak a national emergency on March 13, 2020. As rates of infection continue to rise across the U.S., healthcare facilities and public health departments are facing significant strain on patient care and infection prevention efforts. NHSN plans to introduce a new COVID-19 module in the Patient Safety Component 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.

NHSN's role as a shared platform for HAI surveillance provides a valuable foundation for COVID-19 surveillance. A very large number of the nation's hospitals participate in NHSN, and infection preventionists (IPs) in those hospitals already use NHSN for surveillance and reporting. Hospitals' IPs will voluntarily report COVID-19 patient surveillance data to NHSN by manual entry or by uploading a comma separated values (CSV) file. State and local health departments will be able to gain immediate access to this data reported by facilities in their jurisdictions via existing NHSN groups.

This information will be used to inform the overall real-time COVID-19 response efforts and possible resource allocation, including an understanding of cases that are community-acquired versus healthcare-associated. CDC and health departments alike will use this surveillance data to prioritize the allocation of resources and response efforts. Metrics collected in NHSN will include:

• Number of and proportion of hospitalized patients with suspected or confirmed COVID-19
• Number of and proportion of hospitalized patients with suspected or confirmed COVID-19 that are on mechanical ventilators
• Number of patients with suspected or confirmed COVID-19 who are in the emergency department (ED) or any overflow locations awaiting an inpatient bed
• Number of and proportion of inpatient COVID-19 patients with suspected or confirmed COVID-19 with onset 14 or more days after hospitalization (most likely healthcare-associated)
• Proportion of inpatient beds occupied by those who are suspected or confirmed with COVID-19 (or proportion of inpatients who are suspected or confirmed with COVID-19)

There will be no cost to respondents other than their time to complete the COVID-19 Patient Impact Module Form on a daily basis, for 180 days. The estimated annualized time burden is 292,500 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Microbiologist	COVID-19 Patient Impact Module Form	3,900	180	25/60	292,500
Total					292,500

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.