[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