[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26876-26877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-19-0852; Docket No. CDC-2019-0026]


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 August 9, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0026 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 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

    Prevalence Survey of Healthcare-Associated Infections and 
Antimicrobial Use in U.S. Acute Care Hospitals (OMB Control No. 0920-
0852, Exp. 12/31/2019)--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 CDC and national priorities. An essential 
step in reducing the occurrence of HAIs is to estimate accurately 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.
    Minor adjustments to data collection instruments since the previous 
2016 OMB approval have been made. These

[[Page 26877]]

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 2020. 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 2020 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).
    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 2020. 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 the HFA one time and the 
PIF on average 63 times per year. The total estimated annualized public 
burden is 1,860 hours, which represents no change from the 2016 OMB 
approval.
    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).

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in 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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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-12137 Filed 6-7-19; 8:45 am]
BILLING CODE 4163-18-P