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)

Page Range		45164-45166
FR Document		2016-16420

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 Issue 133 (Tuesday, July 12, 2016)

[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.

-----------------------------------------------------------------------

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

Federal Register / Vol. 81, No. 133 / Tuesday, July 12, 2016 / Notices 45165

Proposed Project Hospitals do not report data on all types allow another short-term acute care
Prevalence Survey of Healthcare- of HAIs occurring hospital-wide. Data hospital survey to be conducted in 2019.
Associated Infections (HAIs) and from a previous prevalence survey Data from the 2019 survey will be used
Antimicrobial Use in U.S. Acute Care showed that approximately 28% of all to evaluate progress in eliminating HAIs
Hospitals—Revision—National Center HAIs are included in the CMS IQR and improving antimicrobial drug use.
for Emerging and Zoonotic Infectious Program. Periodic assessments of the The 2019 survey will be performed in
Diseases (NCEZID), Centers for Disease magnitude and types of HAIs occurring a sample of up to 300 acute care
Control and Prevention (CDC). in all patient populations in hospitals hospitals, drawn from the acute care
are needed to inform decisions by local hospital populations in each of the 10
Background and Brief Description and national policy makers and by EIP sites (and including participation
Preventing healthcare-associated hospital infection prevention from many hospitals that participated in
infections (HAIs) and reducing the professionals regarding appropriate prior phases of the survey). Infection
emergence and spread of antimicrobial targets and strategies for HAI prevention personnel in participating
resistance are priorities for the CDC and prevention. hospitals and EIP site personnel will
the U.S. Department of Health and The CDC’s hospital prevalence survey collect demographic and clinical data
Human Services (DHHS). Improving efforts began in 2008–2009. A pilot from the medical records of a sample of
antimicrobial drug prescribing in the survey was conducted over a 1-day eligible patients in their hospitals on a
United States is a critical component of period at each of nine acute care single day in 2019, to identify CDC-
strategies to reduce antimicrobial hospitals in one U.S. city. This pilot defined HAIs and collect information on
resistance, and is a key component of phase was followed in 2010 by a phase antimicrobial drug use. The survey data
the President’s National Strategy for 2, limited roll-out HAI and will be used to estimate the prevalence
Combating Antibiotic Resistant Bacteria antimicrobial use prevalence survey, of HAIs and antimicrobial drug use and
(CARB), which calls for ‘‘inappropriate conducted in 22 hospitals across 10 describe the distribution of infection
inpatient antibiotic use for monitored Emerging Infections Program sites types and pathogens. The data will also
conditions/agents’’ to be ‘‘reduced 20% (California, Colorado, Connecticut, be used to determine the quality of
from 2014 levels’’ (page 9, https:// Georgia, Maryland, Minnesota, New antimicrobial drug prescribing. These
www.whitehouse.gov/sites/default/files/ Mexico, New York, Oregon, and data will inform strategies to reduce and
docs/carb_national_strategy.pdf). To Tennessee). A full-scale, phase 3 survey eliminate healthcare-associated
achieve these goals and improve patient was conducted in 2011, involving 183 infections—a DHHS Healthy People
safety in the United States, it is hospitals in the 10 EIP sites. Data from 2020 objective (http://www.healthy
necessary to know the current burden of this survey conducted in 2011 showed people.gov/2020/topicsobjectives2020/
infections and antimicrobial drug use in that there were an estimated 722,000 overview.aspx?topicid=17). This survey
different healthcare settings, including HAIs in U.S acute care hospitals in project also supports the CDC Winnable
the types of infections and drugs used 2011, and about half of the 11,282 Battle goal of improving national
in short-term acute care hospitals, the patients included in the survey in 2011 surveillance for healthcare-associated
pathogens causing infections, and the were receiving antimicrobial drugs. The infections (http://www.cdc.gov/
quality of antimicrobial drug survey was repeated in 2015–2016 to winnablebattles/Goals.html) and the
prescribing. Today more than 5,000 update the national HAI and CARB National Strategy (https://www.
short-term acute care hospitals antimicrobial drug use burden; data whitehouse.gov/sites/default/files/docs/
participate in national HAI surveillance from this survey will also provide carb_national_strategy.pdf) and Action
through the CDC’s National Healthcare baseline information on the quality of Plan (https://www.whitehouse.gov/sites/
Safety Network (NHSN, OMB Control antimicrobial drug prescribing for default/files/docs/national_action_
No. 0920–0666, expiration 12/31/18). selected, common clinical conditions in plan_for_combating_antibotic-resistant_
These hospitals’ surveillance efforts are hospitals. Data collection is ongoing at bacteria.pdf).
focused on those HAIs that are required this time. There are no costs to respondents
to be reported as part of state legislative A revision of the prevalence survey’s other than their time. The total
mandates or Centers for Medicare & existing OMB approval is sought to estimated annualized burden for the
Medicaid Services (CMS) Inpatient reduce the data collection burden and to information collection request is 2,010
Quality Reporting (IQR) Program. extend the approval to 12/31/19 to hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden per
Type of respondents Form name responses per burden
respondents response
respondent (in hrs.)
(in hrs.)

Infection preventionist .. Healthcare Facility Assessment (HFA) ............. 300 1 45/60 225
Patient Information Form (PIF) ......................... 300 21 17/60 1785
Total ...................... ...................................................................... 2010
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45166 Federal Register / Vol. 81, No. 133 / Tuesday, July 12, 2016 / Notices

Jeffrey M. Zirger, comments should be received within 30 to reproductive health services. In
Health Scientist, Acting Chief, Information days of this notice. addition, awardees will work with
Collection Review Office, Office of Scientific approximately 35 youth-serving
Integrity, Office of the Associate Director for Proposed Project
organizations (YSO) to provide staff
Science, Office of the Director, Centers for Performance Monitoring of ‘‘Working training and develop systematic
Disease Control and Prevention. with Publicly Funded Health Centers to approaches to identifying youth who are
[FR Doc. 2016–16420 Filed 7–11–16; 8:45 am] Reduce Teen Pregnancy among Youth at risk for a teen pregnancy and referring
BILLING CODE 4163–18–P from Vulnerable Populations’’—New— those youth to reproductive health care
National Center for Chronic Disease services. Finally, awardees will develop
Prevention and Health Promotion communication campaigns that increase
DEPARTMENT OF HEALTH AND (NCCDPHP), Centers for Disease Control
HUMAN SERVICES awareness of the partner health centers’
and Prevention (CDC). services for teens. Activities are
Centers for Disease Control and Background and Brief Description expected to result in changes to health
Prevention center and YSO partners’ policies, to
In 2014, the US rate of 24.2 births per staff practices, and to youth health care
[30Day–16–16MM] 1,000 female teens aged 15–19 was the seeking and teen pregnancy prevention
highest of all Western industrialized behaviors.
Agency Forms Undergoing Paperwork countries. Access to reproductive health
Reduction Act Review services and the most effective types of The best practices to improve
contraception has been shown to reduce adolescent access to reproductive health
The Centers for Disease Control and services included in this program are
Prevention (CDC) has submitted the the likelihood that teens become
pregnant. Nevertheless, recent research supported by evidence in the literature
following information collection request and recommended by major medical
to the Office of Management and Budget and lessons learned through a previous
teen pregnancy prevention project associations. Each of the components of
(OMB) for review and approval in the current project has been
accordance with the Paperwork implemented through CDC in
partnership with the Office of implemented as part of past teen
Reduction Act of 1995. The notice for pregnancy prevention efforts. Consistent
the proposed information collection is Adolescent Health (2010–2015; OMB
no. 0920–0952, exp. date 12/31/2015) with CDC’s mission of using evidence to
published to obtain comments from the
demonstrate that many health centers improve public health programs,
public and affected agencies.
Written comments and suggestions serving teens do not engage in youth- conducting an evaluation of combined
from the public and affected agencies friendly best practices that may enhance best practices, in concert with
concerning the proposed collection of access to care and to the most effective community-clinical linkage of youth to
information are encouraged. Your types of contraception. Furthermore, services to increase their access to
comments should address any of the youth at highest risk of experiencing a reproductive health care, can provide
following: (a) Evaluate whether the teen pregnancy are often not connected information that will inform future teen
proposed collection of information is to the reproductive health care that they pregnancy prevention efforts. CDC
necessary for the proper performance of need, even when they are part of a therefore plans to collect information
the functions of the agency, including population that is known to be at high needed to assess these efforts.
whether the information will have risk for a teen pregnancy. Significant Information will be collected from the
practical utility; (b) Evaluate the racial, ethnic and geographic disparities CDC awardees, the health center and
accuracy of the agencies estimate of the in teen birth rates persist and continue YSO partner organizations, staff at these
burden of the proposed collection of to be a focus of public health efforts. organizations, and the youth served by
information, including the validity of To address these challenges, CDC is the health center partner organizations.
the methodology and assumptions used; providing funding to three organizations CDC will use the information to
(c) Enhance the quality, utility, and to strengthen partnerships and determine the types of training and
clarity of the information to be processes that improve reproductive technical assistance that are needed, to
collected; (d) Minimize the burden of health services for teens. Mississippi monitor whether awardees meet
the collection of information on those First, Inc., a non-profit focused on child objectives related to health center and
who are to respond, including through well-being and educational YSO partners’ policies and staff
the use of appropriate automated, achievement, was funded to work in practices, to support a data-driven
electronic, mechanical, or other Coahoma, Quitman and Tunica counties quality improvement process for
technological collection techniques or in Mississippi. Sexual Health Initiatives adolescent sexual and reproductive
other forms of information technology, For Teens North Carolina (SHIFT NC), health care services and referrals, and to
e.g., permitting electronic submission of a non-profit organization focused on the assess whether the project model was
responses; and (e) Assess information sexual health of adolescents, was effective in increasing the utilization of
collection costs. funded to work in Durham County, services by youth.
To request additional information on North Carolina. The Georgia Association OMB approval is requested for three
the proposed project or to obtain a copy for Primary Health Care, Inc, which years. Participation in the organizational
of the information collection plan and represents all of Georgia’s Federally assessment activities is required for
instruments, call (404) 639–7570 or Qualified Health Centers, was funded to awardees and partner organizations.
send an email to omb@cdc.gov. Written work in Chatham County, Georgia. Participation in the Health Center Youth
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comments and/or suggestions regarding CDC’s awardees will work with Survey is voluntary for youth and will
the items contained in this notice approximately 25 publicly funded not involve the collection of identifiable
should be directed to the Attention: health centers to support personal information. There are no costs
CDC Desk Officer, Office of Management implementation of evidence-based to respondents other than their time.
and Budget, Washington, DC 20503 or recommendations for health centers and The total estimated annualized burden
by fax to (202) 395–5806. Written providers to improve adolescent access hours are 1,150.

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Document Created: 2016-07-12 01:59:14
Document Modified: 2016-07-12 01:59:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before September 12, 2016.
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]
FR Citation		81 FR 45164

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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