[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24147-24148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10837]



[[Page 24147]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-19APK; Docket No. CDC-2019-0038]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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.

DATES: CDC must receive written comments on or before July 23, 2019.

ADDRESSES: 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.

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: 
[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 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.

Proposed Project

    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

[[Page 24148]]

acid, 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
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
General public................  Dog Exposure                  50               1           15/60              13
                                 Questionnaire.
State and Local Health          Dog Exposure                  50               1           30/60              25
 Department Staff.               Questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              38
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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