81 FR 45164 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 133 (July 12, 2016)

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.

[Federal Register Volume 81, Number 133 (Tuesday, July 12, 2016)]
[Notices]
[Pages 45164-45166]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16420]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0852; Docket No. CDC-2016-0062]


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 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: 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 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.

[[Page 45165]]

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
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                                                                                                                              Average
                                                                                           Number of        Number of       burden per     Total  burden
              Type of respondents                              Form name                  respondents     responses per    response  (in     (in hrs.)
                                                                                                           respondent          hrs.)
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Infection preventionist.......................  Healthcare Facility Assessment (HFA)..             300                 1           45/60             225
                                                Patient Information Form (PIF)........             300                21           17/60            1785
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    Total.....................................  ......................................  ..............  ................  ..............            2010
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[[Page 45166]]

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.
[FR Doc. 2016-16420 Filed 7-11-16; 8:45 am]
 BILLING CODE 4163-18-P