60 day FRN

Attachment_B_60-Day_0920-0852 Published Federal Register.pdf

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

60 day FRN

OMB: 0920-0852

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44723

Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Notices
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. 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 submissions
of responses; and
5. Assess information collection costs.
Proposed Project
One Health SARS–CoV–2 Animal
Testing Form—New—National Center
for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).

authorities. Additional information on
the overall number of animals tested for
SARS–CoV–2 will allow us to refine our
understanding of the clinical course and
presentation in animals, gain a sense of
the burden that SARS–COV–2 testing
places on health officials, and develop
an estimate of national prevalence of
SARS–CoV–2. In turn, these data can
help inform guidance and
recommendations, as well as
surveillance directives for future
emerging infectious diseases.
The need for these data has been
discussed with federal, state, tribal,
local, and territorial partners and the
questionnaire was developed in
consultation with these stakeholders.
CDC requests approval for an estimated
8,000 annual burden hours. There is no
cost to respondents other than their
time.

Background and Brief Description
The goal of this project is to collect
information from state, tribal, local, and
territorial partners on the scope and
context of SARS–CoV–2 testing in
animals in order to understand and
monitor testing burden and prevalence
of the virus among animal populations.
Currently, most animal samples that test
positive for SARS–CoV–2 are confirmed
by the United States Department of
Agriculture (USDA) National Veterinary
Services Lab (NVSL), and are reported
to the World Organization for Animal
Health (OIE). However, no reporting
requirements or mechanisms are in
place to determine the number of
negative results, total number of
samples tested, and samples for which
testing was not approved by state,
territorial, local, or tribal health

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

State public health veterinarians, State animal health officials, and wildlife veterinarians.

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–17348 Filed 8–12–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–0852; Docket No. CDC–2021–
0082]

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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.

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SUMMARY:

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Number of
respondents

Form name

Jkt 253001

State Level Veterinary Authority Surveillance Questionnaire.

80

This notice invites comment on a
proposed information collection project
titled Prevalence Survey of HealthcareAssociated Infections and Antimicrobial
Use in U.S. Acute Care Hospitals. This
project examines the numbers and types
of Healthcare-Associated Infections and
causative pathogens, types of
antimicrobial drugs (such as antibiotics)
used, and the quality of antimicrobial
prescribing in U.S. acute care hospitals.
DATES: CDC must receive written
comments on or before October 12,
2021.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2021–
0082 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

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Number of
responses per
respondent
400

Average
burden per
response
(in hours)

Total burden
(in hours)

15/60

8,000

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
FOR FURTHER INFORMATION CONTACT:

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44724

Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Notices

for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. 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 submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Prevalence Survey of HealthcareAssociated Infections and Antimicrobial
Use in U.S. Acute Care Hospitals (OMB
Control No. 0920–0852,
Exp. 10/31/2022)—Extension—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 improving
antimicrobial use (AU) are both CDC
and national priorities. An essential step
in reducing the occurrence of HAIs is to
accurately estimate the burden of these
infections in U.S. acute care hospitals
and to describe the types of HAIs and
causative pathogens. Periodic
assessments of the magnitude and types
of HAIs and AU occurring in all patient
populations within acute care hospitals
are needed to inform decisions by
policy makers and hospital infection

medical records of a sample of
randomly selected patients on a single
day in 2023. Patients will not be
interviewed, and no direct interaction
with patients will occur. Hospital and
patient-level data will be collected using
unique identification codes. EIP site
personnel will submit hospital and
patient-level data to CDC using a secure
data management system.
Based on experiences from previous
surveys, the time required to complete
the Healthcare Facility Assessment
Form (HFA) and Patient Information
Form (PIF) is estimated to be 45 and 17
minutes, respectively. To conduct the
full-scale survey in a three-year
approval period, 100 hospital
respondents will complete both the
HFA (1x) and the PIF (on average 63x)
per year.
To assess changes in HAIs and AU
over time, EIP sites will seek
participation from the same hospitals
that participated in prior surveys. These
hospitals were originally selected for
participation using a stratified random
sampling scheme based on the number
of staffed acute care beds (i.e., small:
<150 staffed beds; medium: 151–399
staffed beds; large: >400 staffed beds).
Each site will also have the option to
recruit additional hospitals for a total of
up to 30 in each site. As in previous
surveys, hospital participation will
remain voluntary. Within each
participating hospital, EIP site
personnel will establish patient sample
size targets based on the number of
staffed acute care beds (e.g., up to 75
patients in small hospitals, 75 patients
in medium hospitals, and 100 patients
in large hospitals).
The total estimated annualized public
burden is 1,860 hours, which represents
no change from the 2019 OMB approval.
There is no cost to respondents other
than their time.

control personnel (ICP) regarding
appropriate targets and strategies for
HAI prevention and antimicrobial
stewardship.
Since 2009, CDC has conducted four
prevalence surveys (i.e., pilot survey in
2009, limited-scale survey in 2010, and
two full-scale surveys in 2011 and 2015)
in partnership with the CDC’s Emerging
Infections Program (EIP) sites. Findings
from the most recent survey showed a
reduction in the percentage of patients
with healthcare-associated infections
compared with 2011. CDC was granted
approval from OMB to conduct a fifth
survey in 2020, but due to the COVID–
19 pandemic the survey was postponed
to 2023.
Minor adjustments to data collection
instruments since the previous 2019
OMB approval have been made. These
adjustments were made to enhance
future analyses and utility of the survey
data. These changes are non-substantive
and are not expected to increase the
public reporting burden. An extension
of the prevalence survey’s existing OMB
approval is sought to allow a repeat HAI
and AU Prevalence Survey to be
performed in 2023. A repeat survey will
allow assessment of changes in HAI and
AU prevalence, pathogen distribution,
and quality of antimicrobial prescribing.
These data will also allow CDC and its
partners to continue to monitor HAI and
AU trends, to measure progress in
meeting national targets, and to further
refine prevention strategies. In the 2023
survey, data collection will occur within
acute care general hospitals of varying
size in each of the 10 EIP sites (i.e., CA,
CO, CT, GA, MD, MN, NM, NY, OR, &
TN).
Infection Control Personnel (ICP) in
participating hospitals may assist EIP
site personnel in collecting
demographic and limited clinical data
from the electronic or paper-based

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Hospital
Staff
Preventionist).

(i.e.,

Infection

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

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Number of
respondents

Form name

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
(in hours)

Healthcare Facility Assessment .......

100

1

45/60

75

Patient Information Form .................

100

63

17/60

1,785

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

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

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

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

1,860

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Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–17353 Filed 8–12–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–0792]

jbell on DSKJLSW7X2PROD with NOTICES

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Environmental
Health Specialists Network (EHS-Net)
Program’’ to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on April 5,
2021 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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

VerDate Sep<11>2014

17:06 Aug 12, 2021

Jkt 253001

(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.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
Environmental Health Specialists
Network (EHS-Net) Program (OMB
Control No. 0920–0792, Exp. 8/31/
2021)—Revision—National Center for
Environmental Health (NCEH), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The CDC is requesting a three-year
Paperwork Reduction Act (PRA)
clearance for this generic clearance.
This Revision information collection
request (ICR) will allow the
Environmental Health Specialists
Network (EHS-Net) to collect research
data focused on identifying and
addressing the environmental causes of
foodborne illness.
An estimated 47.8 million foodborne
illnesses occur annually in the United
States, resulting in 127,839
hospitalizations, and 3,037 deaths
annually. These figures indicate that
foodborne illness is a significant
problem in the U.S. Reducing foodborne
illness requires identification and
understanding of the environmental
factors that cause these illnesses, and it
needs to be understood how and why
food becomes contaminated with
foodborne illness pathogens. This
information can then be used to
determine effective food safety
prevention methods, increase regulatory
program effectiveness, and decrease
foodborne illness. The purpose of this
food safety research program is to
identify and understand environmental
factors associated with foodborne illness

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and outbreaks. This program is
conducted by the EHS-Net, a
collaborative project of CDC, FDA,
USDA, and local and state sites.
Environmental factors associated with
foodborne illness include both food
safety practices (e.g., inadequate
cleaning practices) and the factors in the
environment associated with those
practices (e.g., worker and retail food
establishment characteristics). To
understand these factors, we need to
collect data from those who prepare
food (i.e., food workers) and on the
environments in which the food is
prepared (i.e., retail food establishment
kitchens). Thus, data collection methods
for this generic package include: (1)
Manager and worker interviews/
information collection instruments, and
(2) observation of kitchen environments.
Both methods allow data collection on
food safety practices and environmental
factors associated with those practices.
To date, EHS-Net has conducted five
studies under this generic clearance.
The data from these studies have been
disseminated to environmental public
health/food safety regulatory programs
and the food industry in the form of
presentations at conferences and
meetings, scientific journal
publications, and website postings.
The current package differs from the
previous package in three primary ways,
described below.
• The sites in which data will be
collected differ. CDC funded a renewal
of the EHS-Net cooperative agreement in
2020; as a result, one site was dropped
from the agreement (California), and one
was added (Franklin County, Ohio). The
other sites remained the same. These
are: Harris County, Texas; Minnesota;
New York; New York City, New York;
Rhode Island; Southern Nevada Health
District, Nevada; and Tennessee.
• Since the previous PRA clearance,
the National Center for Environmental
Health (NCEH) Human Subjects
Coordinator has determined that EHSNet information collections are not
human subjects research, and thus, do
not require IRB review or approval.
• The annual burden estimate has
been revised downward by 933 hours
from 1,777 hours in 2018 to 844 hours
in 2021. We estimated interviewing 10
workers per restaurant in the last cycle;
we have revised this down to five
workers per restaurant.
There is no cost to the respondents
other than their time. The total annual
time burden requested is 844 hours.

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