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Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
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 “Enhanced Surveillance for Cases Linked to a Multistate Outbreak of Multidrug-resistant Campylobacter Infections Linked to Contact with Pet Store Puppies.” This investigation will determine the scope of multidrug-resistant infections caused by contact with pet store dogs during a 2016-2018 outbreak to inform infection prevention recommendations and interventions.
CDC must receive written comments on or before July 23, 2019.
You may submit comments, identified by Docket No. CDC-2019-0038 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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FOR FURTHER INFORMATION CONTACT:
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: firstname.lastname@example.org.
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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 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; and
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.
5. Assess information collection costs.
Enhanced surveillance for cases linked to a multistate outbreak of multidrug-resistant Campylobacter infections linked to contact with pet store puppies—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) requested an Emergency 90-day approval for a New Information Collection, “Enhanced surveillance for cases linked to a multistate outbreak of multidrug-resistant Campylobacter infections linked to contact with pet store puppies,” and was approved in April 2019. This standard OMB Clearance is being requested so that information collection that may proceed beyond the Emergency Clearance approval period will come under OMB approval.
During 2016-2018 CDC, several states, and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service investigated a multistate outbreak of multidrug-resistant Campylobacter infections. Epidemic and laboratory evidence indicated that contact with puppies sold through Petland stores was the major source of this outbreak. A total of 113 people with laboratory-confirmed infections or symptoms consistent with Campylobacter infection were linked to this outbreak. Illnesses were reported from 17 states. Illnesses started on dates ranging from January 12, 2016 to January 7, 2018. Ill people ranged in age from less than one year to 86, with a median age of 27. Sixty-three percent of ill people were female. Of 103 people with available information, 23 (22%) were hospitalized. No deaths were reported. Whole genome sequencing (WGS) showed that isolates from people infected with Campylobacter were closely related genetically. The outbreak investigation was closed on January 30, 2018.
Campylobacter jejuni isolated from clinical samples from people sickened in this outbreak were resistant to commonly recommended, first-line antibiotics. Antibiotic resistance may be associated with increased risk of hospitalization, development of a bloodstream infection, or treatment failure in patients. Using WGS, we identified multiple antimicrobial resistance genes and mutations in most isolates from 38 ill people and 10 puppies in this outbreak. This finding matched results from standard antibiotic susceptibility testing methods used by CDC's National Antimicrobial Resistance Monitoring System laboratory on isolates from five ill people and seven puppies in this outbreak. The 12 isolates tested by standard methods were resistant to azithromycin, ciprofloxacin, clindamycin, erythromycin, nalidixic Start Printed Page 24148acid, telithromycin, and tetracycline. In addition, 10 were resistant to gentamicin, and two were resistant to florfenicol. This resistance pattern is very rare, only being documented in 0.3 percent of surveillance isolates. NARMS has been conducting surveillance for antimicrobial resistance in Campylobacter isolates since 1997.
Unlike for most multistate foodborne disease outbreaks, the outbreak vehicle could not be removed from commerce. Therefore, it is likely that cases of human illness have continued. Current Campylobacter surveillance will likely not detect ongoing cases associated with the outbreak. Therefore we propose an enhanced surveillance project screening DNA sequences of Campylobacter isolates for the unique multidrug resistance pattern using predictive resistance software. Epidemiologic information regarding contact with puppies or dogs to determine ongoing transmission would then be collected from the newly identified cases to determine if they can be linked to the outbreak. We are concerned about continued human illnesses and the potential for ongoing transmission of the multidrug-resistant outbreak strain. Without actions and interventions put in place to address the use of antimicrobials, the outbreak will likely continue.
Therefore we propose an enhanced surveillance project screening available Campylobacter isolates for the unique multidrug resistance pattern using predictive resistance software. Epidemiologic information would then be collected from newly identified cases to determine if cases were associated with the outbreak. There is no cost to respondents other than the time to participate. Total estimated burden is 38 hours. Authorizing legislation comes from Section 301 of the Public Health Service Act (42 U.S.C. 241).
Estimated Annualized Burden Hours
|Type of respondents||Form name||Number of respondents||Number of responses
respondent||Average burden per
(in hours)||Total burden (in hours)|
|General public||Dog Exposure Questionnaire||50||1||15/60||13|
|State and Local Health Department Staff||Dog Exposure Questionnaire||50||1||30/60||25|
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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. 2019-10837 Filed 5-23-19; 8:45 am]
BILLING CODE 4163-18-P