Proposed Data Collection Submitted for Public Comment and Recommendations, 24147-24148 [2019-10837]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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 multidrugresistant 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,
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:10 May 23, 2019
Jkt 247001
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
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
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
24147
Emergency 90-day approval for a New
Information Collection, ‘‘Enhanced
surveillance for cases linked to a
multistate outbreak of multidrugresistant 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 multidrugresistant 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
E:\FR\FM\24MYN1.SGM
24MYN1
24148
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
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
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
General public ...................................
State and Local Health Department
Staff.
Dog Exposure Questionnaire ...........
Dog Exposure Questionnaire ...........
50
50
1
1
15/60
30/60
13
25
Total ...........................................
...........................................................
........................
........................
........................
38
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Solicitation of Nominations for
Appointment to the World Trade
Center Health Program Scientific/
Technical Advisory Committee (STAC)
ACTION:
Notice.
The Centers for Disease
Control and Prevention (CDC) is seeking
nominations for membership on the
WTCHP STAC. The Centers for Disease
Control and Prevention (CDC), in
accordance with provisions of the James
Zadroga 9/11 Health and Compensation
Act of 2010, (42 U.S.C. 300mm–1(a)(2)),
is seeking nominations for membership
on the World Trade Center (WTC)
Health Program STAC. The STAC
consists of 17 members including
experts in fields associated with
occupational medicine, pulmonary
medicine, environmental medicine or
environmental health, industrial
hygiene, epidemiology, toxicology,
mental health, and representatives of
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
Number of
respondents
Type of respondents
VerDate Sep<11>2014
18:10 May 23, 2019
Jkt 247001
WTC responders, as well as
representatives of certified-eligible WTC
survivors. The STAC reviews scientific
and medical evidence and makes
recommendations to the Administrator
of the WTC Health Program on
additional Program eligibility criteria
and additional WTC-related health
conditions, reviews and evaluates
policies and procedures used to
determine whether sufficient evidence
exists to support adding a health
condition to the list of WTC-Related
Health Conditions, makes
recommendations regarding individuals
to conduct independent peer reviews of
the scientific and technical evidence
underlying a final rule adding a
condition to the List of WTC-Related
Health Conditions, and provides
consultation on research regarding
certain health conditions related to the
September 11, 2001 terrorist attacks.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
accomplishing the committee’s
objectives. The Administrator of the
WTC Health Program is seeking
nominations for members fulfilling the
following categories:
• Occupational physician who has
experience treating WTC rescue and
recovery workers;
• Mental health professional;
• Industrial hygienist;
• Representative of WTC responders;
and
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
• Representative of certified-eligible
WTC survivors;
• Physician with expertise in
pulmonary medicine.
Members may be invited to serve for
four-year terms. Selection of members is
based on candidates’ qualifications to
contribute to the accomplishment of
STAC objectives. More information on
the committee is available at https://
www.cdc.gov/wtc/stac.html.
DATES: Nominations for membership on
the STAC must be received no later than
June 28, 2019. Packages received after
this time will not be considered for the
current membership cycle.
ADDRESSES: All nominations should be
mailed to NIOSH Docket 229–H, c/o Mia
Wallace, Committee Management
Specialist, National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
1600 Clifton Rd. NE, MS: E–20, Atlanta,
Georgia 30329, or emailed
(recommended) to nioshdocket@
cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Tania Carreo´n-Valencia, Designated
Federal Officer, WTC Health Program
Associate Director for Science, 1600
Clifton Rd. NE, MS: R–12, Atlanta, GA
30329; telephone (513) 841–4515; email
TCarreonValencia@cdc.gov.
SUPPLEMENTARY INFORMATION: U.S.
Department of Health and Human
Services (HHS) policy stipulates that
committee membership be balanced in
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
