Agency Forms Undergoing Paperwork Reduction Act Review

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Federal RegisterSep 29, 2016
81 Fed. Reg. 66965 (Sep. 29, 2016)

The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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 submission of responses; and (e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

Proposed Project

Prevalence Survey of Healthcare-Associated Infections (HAIs) and Antimicrobial Use in U.S. Acute Care Hospitals—Revision—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 reducing the emergence and spread of antimicrobial resistance are priorities for the CDC and the U.S. Department of Health and Human Services (DHHS). Improving antimicrobial drug prescribing in the United States is a critical component of strategies to reduce antimicrobial resistance, and is a key component of the President's National Strategy for Combating Antibiotic Resistant Bacteria (CARB), which calls for “inappropriate inpatient antibiotic use for monitored conditions/agents” to be “reduced 20% from 2014 levels” (page 9, https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf ). To achieve these goals and improve patient safety in the United States, it is necessary to know the current burden of infections and antimicrobial drug use in different healthcare settings, including the types of infections and drugs used in short-term acute care hospitals, the pathogens causing infections, and the quality of antimicrobial drug prescribing.

Today more than 5,000 short-term acute care hospitals participate in national HAI surveillance through the CDC's National Healthcare Safety Network (NHSN, OMB Control No. 0920-0666, expiration 12/31/18). These hospitals' surveillance efforts are focused on those HAIs that are required to be reported as part of state legislative mandates or Centers for Medicare & Medicaid Services (CMS) Inpatient Quality Reporting (IQR) Program. Hospitals do not report data on all types of HAIs occurring hospital-wide. Data from a previous prevalence survey showed that approximately 28% of all HAIs are included in the CMS IQR Program. Periodic assessments of the magnitude and types of HAIs occurring in all patient populations in hospitals are needed to inform decisions by local and national policy makers and by hospital infection prevention professionals regarding appropriate targets and strategies for HAI prevention.

The CDC's hospital prevalence survey efforts began in 2008-2009. A pilot survey was conducted over a 1-day period at each of nine acute care hospitals in one U.S. city. This pilot phase was followed in 2010 by a phase 2, limited roll-out HAI and antimicrobial use prevalence survey, conducted in 22 hospitals across 10 Emerging Infections Program sites (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee). A full-scale, phase 3 survey was conducted in 2011, involving 183 hospitals in the 10 Emerging Infections Program (EIP) sites. Data from this survey conducted in 2011 showed that there were an estimated 722,000 HAIs in U.S acute care hospitals in 2011, and about half of the 11,282 patients included in the survey in 2011 were receiving antimicrobial drugs. The survey was repeated in 2015-2016 to update the national HAI and antimicrobial drug use burden; data from this survey will also provide baseline information on the quality of antimicrobial drug prescribing for selected, common clinical conditions in hospitals. Data collection is ongoing at this time.

A revision of the prevalence survey's existing OMB approval is sought to reduce the data collection burden and to extend the approval to allow another short-term acute care hospital survey to be conducted in 2019. Data from the 2019 survey will be used to evaluate progress in eliminating HAIs and improving antimicrobial drug use.

The 2019 survey will be performed in a sample of up to 300 acute care hospitals, drawn from the acute care hospital populations in each of the 10 EIP sites (and including participation from many hospitals that participated in prior phases of the survey). Infection prevention personnel in participating hospitals and EIP site personnel will collect demographic and clinical data from the medical records of a sample of eligible patients in their hospitals on a single day in 2019, to identify CDC-defined HAIs and collect information on antimicrobial drug use. The survey data will be used to estimate the prevalence of HAIs and antimicrobial drug use and describe the distribution of infection types and pathogens. The data will also be used to determine the quality of antimicrobial drug prescribing. These data will inform strategies to reduce and eliminate healthcare-associated infections—a DHHS Healthy People 2020 objective ( http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=17 ). This survey project also supports the CDC Winnable Battle goal of improving national surveillance for healthcare-associated infections ( http://www.cdc.gov/ winnablebattles/Goals.html ) and the CARB National Strategy ( https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf ) and Action Plan ( https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf ).

There are no costs to the respondents other than their time. The total estimated annual burden hours is 1,860. This represents a reduction in the total estimated annual burden hours from the previous approval due to a reduction in the number of respondents.

Estimated Annualized Burden Hours

Type of respondents Form name Number of respondents Number of responses per respondent Average burden per response (in hrs.)
Infection preventionist Healthcare Facility Assessment (HFA) 100 1 45/60
Infection preventionist Patient Information Form (PIF) 100 63 17/60

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.

[FR Doc. 2016-23506 Filed 9-28-16; 8:45 am]

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