2016-16420. 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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on “Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Hospitals.” This data collection will provide information on the burden and types of healthcare-associated infections, including infections due to antimicrobial-resistant pathogens, and antimicrobial drugs in U.S. short-term acute care hospitals.

DATES:

Written comments must be received on or before September 12, 2016.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2016-0062 by any of the following methods:

• Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.
• Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

Please note: All public comment should be submitted 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 the 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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

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 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 12/31/19 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 respondents other than their time. The total estimated annualized burden for the information collection request is 2,010 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Infection preventionist	Healthcare Facility Assessment (HFA)	300	1	45/60	225
	Patient Information Form (PIF)	300	21	17/60	1785
Total					2010

Jeffrey M. Zirger,

Health Scientist, Acting 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.