Published 60-Day FRN

Att B - 60 Day FRN.pdf

Prevalence Survey of Healthcare Associated Infections (HAIs) and Antimicrobial Use in U.S. Acute Care Hospitals

Published 60-Day FRN

OMB: 0920-0852

Document [pdf]
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45164

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

the contractor disclosure process and
reduce burden for both contractors and
the Government in the following ways:
1. No more cumbersome Microsoft
Word document that takes more time to
format than to complete;
2. An electronic database would
automatically track all changes made by
contactors, which would make review
easier for both contractors and the
Government;
3. Because this system would include
the contractor’s cognizant contracting
officer(s), it could automatically notify
them of Disclosure Statement revisions;
4. The system could be used for
notifications so that even if Disclosure
Statements have not been updated, the
Government is aware of all new cost
accounting practices;
5. Government auditors could easily
verify the sufficiency of contractors’
annual disclosure of cost accounting
practice changes;
6. On-line tracking of cost accounting
practice changes would improve
visibility into and status of cost impact
proposals and resolutions;
7. Government-wide centralized
access would allow PCOs to verify the
status of Disclosure Statement
submissions and adequacy
determinations.
Response: The Councils appreciate
this analysis and perspective, and will
consult with the CASB on the matter,
which falls outside the scope of the
current information collection. There
are no changes to the burden estimates
based on this comment.

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C. Annual Reporting Burden
Number of Respondents: 903.
Responses per Respondent: 3.
Total Responses: 2709.
Average Burden Hours per Response:
175.
Total Burden Hours: 474,075.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control Number 9000–0129,
Cost Accounting Standards
Administration, in all correspondence.
William Clark,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2016–16382 Filed 7–11–16; 8:45 am]
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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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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.
SUMMARY:

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
ADDRESSES:

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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: omb@cdc.gov.
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.

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 81, No. 133 / Tuesday, July 12, 2016 / Notices
Proposed Project
Prevalence Survey of HealthcareAssociated 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 CDCdefined 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.healthy
people.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.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

Infection preventionist ..

Healthcare Facility Assessment (HFA) .............
Patient Information Form (PIF) .........................

Total ......................

......................................................................

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Number of
responses per
respondent

300
300

1
21

Average
burden per
response
(in hrs.)
45/60
17/60

Total
burden
(in hrs.)
225
1785
2010

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

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

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Agency Forms Undergoing Paperwork
Reduction Act Review
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

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Proposed Project
Performance Monitoring of ‘‘Working
with Publicly Funded Health Centers to
Reduce Teen Pregnancy among Youth
from Vulnerable Populations’’—New—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description

[30Day–16–16MM]

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comments should be received within 30
days of this notice.

In 2014, the US rate of 24.2 births per
1,000 female teens aged 15–19 was the
highest of all Western industrialized
countries. Access to reproductive health
services and the most effective types of
contraception has been shown to reduce
the likelihood that teens become
pregnant. Nevertheless, recent research
and lessons learned through a previous
teen pregnancy prevention project
implemented through CDC in
partnership with the Office of
Adolescent Health (2010–2015; OMB
no. 0920–0952, exp. date 12/31/2015)
demonstrate that many health centers
serving teens do not engage in youthfriendly best practices that may enhance
access to care and to the most effective
types of contraception. Furthermore,
youth at highest risk of experiencing a
teen pregnancy are often not connected
to the reproductive health care that they
need, even when they are part of a
population that is known to be at high
risk for a teen pregnancy. Significant
racial, ethnic and geographic disparities
in teen birth rates persist and continue
to be a focus of public health efforts.
To address these challenges, CDC is
providing funding to three organizations
to strengthen partnerships and
processes that improve reproductive
health services for teens. Mississippi
First, Inc., a non-profit focused on child
well-being and educational
achievement, was funded to work in
Coahoma, Quitman and Tunica counties
in Mississippi. Sexual Health Initiatives
For Teens North Carolina (SHIFT NC),
a non-profit organization focused on the
sexual health of adolescents, was
funded to work in Durham County,
North Carolina. The Georgia Association
for Primary Health Care, Inc, which
represents all of Georgia’s Federally
Qualified Health Centers, was funded to
work in Chatham County, Georgia.
CDC’s awardees will work with
approximately 25 publicly funded
health centers to support
implementation of evidence-based
recommendations for health centers and
providers to improve adolescent access

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to reproductive health services. In
addition, awardees will work with
approximately 35 youth-serving
organizations (YSO) to provide staff
training and develop systematic
approaches to identifying youth who are
at risk for a teen pregnancy and referring
those youth to reproductive health care
services. Finally, awardees will develop
communication campaigns that increase
awareness of the partner health centers’
services for teens. Activities are
expected to result in changes to health
center and YSO partners’ policies, to
staff practices, and to youth health care
seeking and teen pregnancy prevention
behaviors.
The best practices to improve
adolescent access to reproductive health
services included in this program are
supported by evidence in the literature
and recommended by major medical
associations. Each of the components of
the current project has been
implemented as part of past teen
pregnancy prevention efforts. Consistent
with CDC’s mission of using evidence to
improve public health programs,
conducting an evaluation of combined
best practices, in concert with
community-clinical linkage of youth to
services to increase their access to
reproductive health care, can provide
information that will inform future teen
pregnancy prevention efforts. CDC
therefore plans to collect information
needed to assess these efforts.
Information will be collected from the
CDC awardees, the health center and
YSO partner organizations, staff at these
organizations, and the youth served by
the health center partner organizations.
CDC will use the information to
determine the types of training and
technical assistance that are needed, to
monitor whether awardees meet
objectives related to health center and
YSO partners’ policies and staff
practices, to support a data-driven
quality improvement process for
adolescent sexual and reproductive
health care services and referrals, and to
assess whether the project model was
effective in increasing the utilization of
services by youth.
OMB approval is requested for three
years. Participation in the organizational
assessment activities is required for
awardees and partner organizations.
Participation in the Health Center Youth
Survey is voluntary for youth and will
not involve the collection of identifiable
personal information. There are no costs
to respondents other than their time.
The total estimated annualized burden
hours are 1,150.

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