[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Notices]
[Pages 44723-44725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0852; Docket No. CDC-2021-0082]


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.

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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: 404-639-7570; Email: 
[email protected].

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

[[Page 44724]]

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
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                                                                                      Average
                                                     Number of       Number of      burden per     Total  burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Hospital Staff (i.e.,           Healthcare                   100               1           45/60              75
 Infection Preventionist).       Facility
                                 Assessment.
                                Patient                      100              63           17/60           1,785
                                 Information
                                 Form.
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    Total.....................  ................  ..............  ..............  ..............           1,860
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[[Page 44725]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-17353 Filed 8-12-21; 8:45 am]
BILLING CODE 4163-18-P