Agency Forms Undergoing Paperwork Reduction Act Review, 12609-12610 [2019-06303]
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12609
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
• Update respondent costs to reflect
current wage data from 2017.
The 12-month approval will allow
CDC to continue to monitor states’
program planning and delivery of public
health activities and the programs’
collaboration with health care systems
for the remainder of the fifth and final
year of cooperative agreement EH14–
1404 (program period: September
2014—August 2019), and the third and
final year of cooperative agreement
EH16–1606 (program period: September
2016—August 2019).
The goal of this data collection is to
provide NCEH with routine information
about the activities and performance of
the state and territorial awardees funded
under the NACP through an annual
reporting system. NACP requires
awardees to report activities related to
partnerships, infrastructure, evaluation
and interventions to monitor the state
programs’ performance in reducing the
burden of asthma. AIRS also includes
two forms to collect aggregate ED and
HD data from awardees.
AIRS was first approved by OMB in
2010 to collect data in a web-based
system to monitor and guide
participating state health departments.
Since implementation in 2010, AIRS
and the technical assistance provided by
CDC staff have provided states with
uniform data reporting methods and
linkages to other states’ asthma program
information and resources. Thus, AIRS
has saved state resources and staff time
when asthma programs embark on
asthma activities similar to those done
elsewhere.
In the past three years, AIRS data
were used to:
• Serve as a resource to NCEH when
addressing congressional, departmental
and institutional inquiries.
• Help the branch align its current
interventions with CDC goals and
allowed the monitoring of progress
toward these goals.
• Allow the NACP and the state
asthma programs to make more
informed decisions about activities to
achieve objectives.
• Facilitate communication about
interventions across states, and enable
inquiries regarding interventions by
populations with a disproportionate
burden, age groups, geographic areas
and other variables of interest.
• Provide feedback to the grantees
about their performance relative to
others through the distribution of two
written reports and several
presentations (webinar and in-person)
summarizing the results.
• Customize and provide technical
assistance and support materials to
address implementation challenges.
There will be no cost to respondents
other than their time to complete the
three AIRS spreadsheets annually. The
estimated annualized burden hours are
89.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Form name
Number of
respondents
State Asthma Program Awardees ..
AIRS Performance Measures Reporting Spreadsheets.
AIRS Emergency Department Visits Reporting Form.
AIRS Hospital Discharge Reporting
Forms.
25 ...................................................
1
150/60
25 ...................................................
1
30/60
25 ...................................................
1
30/60
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–06304 Filed 4–1–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–19LX]
Agency Forms Undergoing Paperwork
Reduction Act Review
amozie on DSK9F9SC42PROD with NOTICES
Number of
responses per
respondent
Type of respondents
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Assessment of
Clinical and Microbiologic Outcomes in
Patients Infected with Shigella with
Decreased Susceptibility to
Ciprofloxacin and Azithromycin
through a Prospective Case-Control
Study in California to the Office of
VerDate Sep<11>2014
18:45 Apr 01, 2019
Jkt 247001
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on May 29,
2018 to obtain comments from the
public and affected agencies. CDC
received one comment 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;
PO 00000
Frm 00035
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Sfmt 4703
(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. 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.
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02APN1
12610
Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / Notices
Proposed Project
Assessment of Clinical and
Microbiologic Outcomes in Patients
Infected with Shigella with Decreased
Susceptibility to Ciprofloxacin and
Azithromycin through a Prospective
Case-Control Study in California—
New—National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
A broad 60-day notice for this project
entitled ‘‘Applied Research to Address
Emerging Public Health priorities’’ was
published on May 29, 2018. This project
is part of a series of CDC research
projects funded under that Broad
Agency Announcement.
Multidrug-resistant Shigella is a
public health problem in the U.S,
including California. Resistance to first
line drugs (azithromycin and
ciprofloxacin) limits treatment options
and may be associated with worse
patient outcomes. In 2017, the Centers
for Disease Control and Prevention
(CDC) reported an increase in Shigella
isolates with ciprofloxacin minimum
inhibitory concentration (MIC)
range=0.12–1.0 mg/mL. In 2018, this was
updated (https://emergency.cdc.gov/
han/han00411.asp) and confirmed a
continued increase in such isolates.
While current Clinical and Laboratory
Standards Institute (CLSI) criteria
categorize Shigella isolates that fall
within this range as susceptible, these
strains often harbor a quinolone
resistance gene, which may be
associated with decreased susceptibility
to ciprofloxacin. Little is known about
the clinical implications of infection
with Shigella with ciprofloxacin MICs
in the range of 0.12–1 mg/mL; including
whether treatment with a
fluoroquinolone is associated with a
worse clinical outcome for the patient,
or will result in prolonged shedding and
further reduction in ciprofloxacin
susceptibility. In addition, CLSI has not
established clinical breakpoints for
azithromycin, making treatment
decisions challenging for clinicians
when managing patients with
multidrug-resistant Shigella infections.
Systematically collected data regarding
the clinical and microbiologic outcomes
of patients infected with Shigella with
ciprofloxacin MIC 0.12–1 mg/mL or that
fall above the epidemiologic cutoffs for
azithromycin (≥16 mg/mL for S. flexneri,
≥32 mg/mL for S. sonnei) are needed to
inform clinical breakpoints.
The primary objectives of the study
are to: (1) Estimate the proportion of
California Shigella isolates with a
ciprofloxacin MIC range of 0.12–1.0 mg/
mL and the proportion of Shigella
isolates that fall above the
epidemiologic cutoffs for azithromycin;
(2) determine whether patients who
were infected with Shigella with a
ciprofloxacin MIC range of 0.12–1.0 mg/
mL and treated with a fluoroquinolone
(and thus have decreased susceptibility
to ciprofloxacin, or DSC Shigella) have
worse clinical and microbiologic
outcomes than patients who were
infected with Shigella with a
ciprofloxacin MIC <0.12 mg/mL and
were also treated with a
fluoroquinolone; (3) systematically
describe the clinical outcomes of
patients infected with Shigella that fall
above the epidemiologic cutoffs for
azithromycin (referred to as decreased
susceptibility to azithromycin, DSA
Shigella); and (4) explore microbiologic
features including antimicrobial
susceptibility testing (AST) patterns and
WGS of Shigella isolates with DSC and
DSA. Results of this investigation will
provide data that may inform CLSI
breakpoints and shape public health
recommendations on management and
prevention of DSC and DSA Shigella
infections.
CDC is seeking one year of OMB
approval. There is no cost to
respondents other than the time to
participate. Total estimated annual
burden is 878 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Shigella cases and controls ...........
Case Interview Form Initial ............
Case Interview Form Second ........
Symptom Log Form .......................
Stool collection and submission initial.
Stool collection and submission
second.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–06303 Filed 4–1–19; 8:45 am]
230
230
230
230
1
1
1
1
45/60
45/60
30/60
90/60
144 .................................................
1
30/60
Centers for Disease Control and
Prevention
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[60 Day–19–19ACB; Docket No. CDC–2019–
0021]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
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Notice with comment period.
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Average
burden per
response
(in hours)
.................................................
.................................................
.................................................
.................................................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Number of
responses per
respondent
Number of
respondents
Type of respondents
Sfmt 4703
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.
This notice invites comment on a
proposed information collection project
titled ‘‘Drug Overdose Surveillance and
Epidemiology (DOSE).’’ This new data
collection effort is an essential
component toward reducing the opioid
crisis, one of HHS Department’s top
priorities. DOSE data is critical to our
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12609-12610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06303]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-19LX]
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 Assessment of Clinical and Microbiologic
Outcomes in Patients Infected with Shigella with Decreased
Susceptibility to Ciprofloxacin and Azithromycin through a Prospective
Case-Control Study in California 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 May 29, 2018 to obtain comments from the public and affected
agencies. CDC received one comment 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
(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 [email protected]. 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.
[[Page 12610]]
Proposed Project
Assessment of Clinical and Microbiologic Outcomes in Patients
Infected with Shigella with Decreased Susceptibility to Ciprofloxacin
and Azithromycin through a Prospective Case-Control Study in
California--New--National Center for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
A broad 60-day notice for this project entitled ``Applied Research
to Address Emerging Public Health priorities'' was published on May 29,
2018. This project is part of a series of CDC research projects funded
under that Broad Agency Announcement.
Multidrug-resistant Shigella is a public health problem in the U.S,
including California. Resistance to first line drugs (azithromycin and
ciprofloxacin) limits treatment options and may be associated with
worse patient outcomes. In 2017, the Centers for Disease Control and
Prevention (CDC) reported an increase in Shigella isolates with
ciprofloxacin minimum inhibitory concentration (MIC) range=0.12-1.0
[mu]g/mL. In 2018, this was updated (https://emergency.cdc.gov/han/han00411.asp) and confirmed a continued increase in such isolates.
While current Clinical and Laboratory Standards Institute (CLSI)
criteria categorize Shigella isolates that fall within this range as
susceptible, these strains often harbor a quinolone resistance gene,
which may be associated with decreased susceptibility to ciprofloxacin.
Little is known about the clinical implications of infection with
Shigella with ciprofloxacin MICs in the range of 0.12-1 [mu]g/mL;
including whether treatment with a fluoroquinolone is associated with a
worse clinical outcome for the patient, or will result in prolonged
shedding and further reduction in ciprofloxacin susceptibility. In
addition, CLSI has not established clinical breakpoints for
azithromycin, making treatment decisions challenging for clinicians
when managing patients with multidrug-resistant Shigella infections.
Systematically collected data regarding the clinical and microbiologic
outcomes of patients infected with Shigella with ciprofloxacin MIC
0.12-1 [mu]g/mL or that fall above the epidemiologic cutoffs for
azithromycin (>=16 [mu]g/mL for S. flexneri, >=32 [mu]g/mL for S.
sonnei) are needed to inform clinical breakpoints.
The primary objectives of the study are to: (1) Estimate the
proportion of California Shigella isolates with a ciprofloxacin MIC
range of 0.12-1.0 [mu]g/mL and the proportion of Shigella isolates that
fall above the epidemiologic cutoffs for azithromycin; (2) determine
whether patients who were infected with Shigella with a ciprofloxacin
MIC range of 0.12-1.0 [mu]g/mL and treated with a fluoroquinolone (and
thus have decreased susceptibility to ciprofloxacin, or DSC Shigella)
have worse clinical and microbiologic outcomes than patients who were
infected with Shigella with a ciprofloxacin MIC <0.12 [mu]g/mL and were
also treated with a fluoroquinolone; (3) systematically describe the
clinical outcomes of patients infected with Shigella that fall above
the epidemiologic cutoffs for azithromycin (referred to as decreased
susceptibility to azithromycin, DSA Shigella); and (4) explore
microbiologic features including antimicrobial susceptibility testing
(AST) patterns and WGS of Shigella isolates with DSC and DSA. Results
of this investigation will provide data that may inform CLSI
breakpoints and shape public health recommendations on management and
prevention of DSC and DSA Shigella infections.
CDC is seeking one year of OMB approval. There is no cost to
respondents other than the time to participate. Total estimated annual
burden is 878 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Shigella cases and controls....... Case Interview Form 230.................. 1 45/60
Initial.
Case Interview Form 230.................. 1 45/60
Second.
Symptom Log Form..... 230.................. 1 30/60
Stool collection and 230.................. 1 90/60
submission initial.
Stool collection and 144.................. 1 30/60
submission second.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-06303 Filed 4-1-19; 8:45 am]
BILLING CODE 4163-18-P
