2021-17353. 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 Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Acute Care Hospitals. This project examines the numbers and types of Healthcare-Associated Infections and causative pathogens, types of antimicrobial drugs (such as antibiotics) used, and the quality of antimicrobial prescribing in U.S. acute care hospitals.

DATES:

CDC must receive written comments on or before October 12, 2021.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2021-0082 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;

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; and

5. Assess information collection costs.

Proposed Project

Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Acute Care Hospitals (OMB Control No. 0920-0852, Exp. 10/31/2022)—Extension—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Preventing healthcare-associated infections (HAIs) and improving antimicrobial use (AU) are both CDC and national priorities. An essential step in reducing the occurrence of HAIs is to accurately estimate the burden of these infections in U.S. acute care hospitals and to describe the types of HAIs and causative pathogens. Periodic assessments of the magnitude and types of HAIs and AU occurring in all patient populations within acute care hospitals are needed to inform decisions by policy makers and hospital infection control personnel (ICP) regarding appropriate targets and strategies for HAI prevention and antimicrobial stewardship.

Since 2009, CDC has conducted four prevalence surveys (i.e., pilot survey in 2009, limited-scale survey in 2010, and two full-scale surveys in 2011 and 2015) in partnership with the CDC's Emerging Infections Program (EIP) sites. Findings from the most recent survey showed a reduction in the percentage of patients with healthcare-associated infections compared with 2011. CDC was granted approval from OMB to conduct a fifth survey in 2020, but due to the COVID-19 pandemic the survey was postponed to 2023.

Minor adjustments to data collection instruments since the previous 2019 OMB approval have been made. These adjustments were made to enhance future analyses and utility of the survey data. These changes are non-substantive and are not expected to increase the public reporting burden. An extension of the prevalence survey's existing OMB approval is sought to allow a repeat HAI and AU Prevalence Survey to be performed in 2023. A repeat survey will allow assessment of changes in HAI and AU prevalence, pathogen distribution, and quality of antimicrobial prescribing. These data will also allow CDC and its partners to continue to monitor HAI and AU trends, to measure progress in meeting national targets, and to further refine prevention strategies. In the 2023 survey, data collection will occur within acute care general hospitals of varying size in each of the 10 EIP sites (i.e., CA, CO, CT, GA, MD, MN, NM, NY, OR, & TN).

Infection Control Personnel (ICP) in participating hospitals may assist EIP site personnel in collecting demographic and limited clinical data from the electronic or paper-based medical records of a sample of randomly selected patients on a single day in 2023. Patients will not be interviewed, and no direct interaction with patients will occur. Hospital and patient-level data will be collected using unique identification codes. EIP site personnel will submit hospital and patient-level data to CDC using a secure data management system.

Based on experiences from previous surveys, the time required to complete the Healthcare Facility Assessment Form (HFA) and Patient Information Form (PIF) is estimated to be 45 and 17 minutes, respectively. To conduct the full-scale survey in a three-year approval period, 100 hospital respondents will complete both the HFA (1x) and the PIF (on average 63x) per year.

To assess changes in HAIs and AU over time, EIP sites will seek participation from the same hospitals that participated in prior surveys. These hospitals were originally selected for participation using a stratified random sampling scheme based on the number of staffed acute care beds (i.e., small: <150 staffed beds; medium: 151-399 staffed beds; large: >400 staffed beds). Each site will also have the option to recruit additional hospitals for a total of up to 30 in each site. As in previous surveys, hospital participation will remain voluntary. Within each participating hospital, EIP site personnel will establish patient sample size targets based on the number of staffed acute care beds (e.g., up to 75 patients in small hospitals, 75 patients in medium hospitals, and 100 patients in large hospitals).

The total estimated annualized public burden is 1,860 hours, which represents no change from the 2019 OMB approval. There is no cost to respondents other than their time.

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)
Hospital Staff (i.e., Infection Preventionist)	Healthcare Facility Assessment	100	1	45/60	75
	Patient Information Form	100	63	17/60	1,785
Total					1,860

Jeffrey M. Zirger,

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