[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)
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General public................ Dog Exposure 50 1 15/60 13
Questionnaire.
State and Local Health Dog Exposure 50 1 30/60 25
Department Staff. Questionnaire.
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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]
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