[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]
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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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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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.
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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