App 1_Burden Memos

Appendix 1. Burden Memos.pdf

Emergency Epidemic Investigation Data Collections - Expedited Reviews (Y3Q4)

App 1_Burden Memos

OMB: 0920-1011

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2016017-XXX
2016-033
New York City Department of Health

Undetermined risk factors for Exophiala dermatitidis among oncology patients — New
York City, 2016
Purpose of Investigation: (Use The purpose of the investigation was to 1) conduct case-finding; 2) characterize
as much space as necessary) epidemiological and clinical aspects of case-patients, including exposures of interest; 3)
conduct an epidemiological study to evaluate potential association between exposures
and cases; 4) conduct an assessment of the infection control practices at oncology clinic;
5) perform environmental sampling as indicated by findings of the epidemiologic study;
and 6) provide recommendations for preventative measures and remediation.
Duration of Data Collection: 2 weeks
Date Began:
June 1, 2016
Date Ended:
June 15, 2016
Lead Investigator
Name:
Amber Vasquez
CIO/Division/Branch:
NCEZID/DHQP
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Medical Chart Abstraction Form
Type of Respondent
General public
Other (describe):

Healthcare staff
Federal employees

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Data on exposure to medications was collected from medical
charts of all 38 patients who received IV medications at
Oncology Clinic A
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
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Other (describe):
Medical Record Abstraction (describe): Data on exposure to medications was collected from medical charts of
all 38 patients who received IV medications at Oncology Clinic A
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
NA
Total No. Sampled/Eligible to Respond (B): NA
Response Rate (A/B):
NA

Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)
Medical Chart Abstraction
Federal Staff 2
19
Form

Burden per
Response in
Minutes (C)
0

Total Burden
in Hours
(A x B x C)/60*
0

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

Page 2 of 2

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2016018-XXX
2016-036
Mississippi State Department of Health (MSDH)

Undetermined source and risk factors for botulism among prisoners at a correctional
facility — Mississippi, 2016
Purpose of Investigation: (Use On June 9, 2016, the MSDH notified the CDC botulism consultation service regarding a
as much space as necessary) suspected outbreak of botulism at a single federal correctional institution. Preliminary
information suggests that the affected inmates consumed homemade intoxicant, also
known as hooch or pruno.

Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

The MSDH requested assistance with investigating the scope and identifying the source of
the outbreak, determining risk factors for illness, and developing public health
recommendations to prevent future outbreaks.
90 days
6/13/2016
9/11/2016
Kevin Chatham-Stephens
CDC/NCEZID/EDEB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Interview questionnaire
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Inmates from the affected correctional facility who reported exposure to homemade intoxicant

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Case patients and inmates at risk for infection interviewed

to identify exposures, risk factors for illness, and relevant
symptoms.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
The questionnaire was administered via face-to-face interview
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
33
Total No. Sampled/Eligible to Respond (B): 34
Response Rate (A/B):
97.1%
Data Collection Instrument 2
Name of Data Collection Instrument: Medical chart abstraction tool
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Medical charts abstracted by CDC and MSDH staff based on healthcare staff records

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Abstracted medical charts from the prison health services unit
and hospitals for exposed inmates that reported signs and

symptoms consistent with botulism during the interview.
Abstracted data to identify exposures, describe signs and
symptoms consistent with botulism, and assess risk factors
for severe illness.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): Copies of medical charts were reviewed using chart abstraction tool.
Since patients were often transferred (up to four times) there were
multiple charts to abstract for many of the patients.
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
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Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
28
Total No. Sampled/Eligible to Respond (B): 33
Response Rate (A/B):
84% (note: only partial chart abstraction was possible for a some
patients)
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Laboratory test results

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
CDC routinely performed botulism testing on serum and stool for
suspected cases of botulism in many states, including Mississippi and
Oklahoma. As part of this investigation, CDC performed testing for
the suspected cases in both states when requested by local health
authorities.
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Page 3 of 4

28
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Total No. Sampled/Eligible to Respond (B): 33
Response Rate (A/B):
84%

(Additional Data Collection Instrument sections may be added if necessary.)

Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)
Interview Questionnaire
Inmates
33
1
Medical Chart Abstraction
Federal staff 0
0
Medical Chart Abstraction
State staff
4
5

Burden per
Response in
Minutes (C)
30
0
30

Total Burden
in Hours
(A x B x C)/60*
17
0
10

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

Page 4 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2016019-XXX
2016-038
Wisconsin Division of Public Health

Undetermined source of Elizabethkingia anophelis infections among Wisconsin residents
— Wisconsin, 2016
Purpose of Investigation: (Use Elizabethkingia anophelis is a rare, gram-negative bacillus identified in 2011 that is
as much space as necessary) intrinsically multidrug-resistant, resulting in high mortality rates ranging from 23 to 52%.
Although most E. anophelis infections have occurred in healthcare settings, communityacquired infections have also been reported.
On January 5, 2016, the Centers for Disease Control and Prevention (CDC) was notified
by the Wisconsin Division of Public Health (WDPH) of an outbreak of E. anophelis
infections. A joint CDC-WDPH investigation identified 66 cases of primarily
community-associated infections, all occurring in southeastern Wisconsin, northeastern
Illinois, and western Michigan. Specimen collection dates ranged from November 23,
2015 to May 30, 2016 and the epidemiologic curve seemed to indicate a point source for
the infection. Patients have a variety of healthcare-associated and community-associated
exposures, as well as co-morbidities. Hypothesis-generating interviews, structured
interviews, and environmental sampling did not demonstrate a clear food or water source,
personal care product, healthcare product, or healthcare setting as a point source.
Although the number of reported cases is decreasing, the number of reported persons
with infection in the last quarter was 9 and still well above the baseline of 3-5 reported
per year . Identifying a potential point source of infections is critical to prevention of new
infections and may inform future community-associated E. anophelis outbreaks. Group
ethnographic interviews with small subclusters of patients may identify a common,
shared exposure missed by traditional outbreak investigation approaches.

Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

WDPH requested CDC assistance with: 1) identification of potential exposures though
group ethnographic interviews and 2) application of findings from activity 1 to identify
prevention and control measures.
10 days
7/18/2016
7/27/2016
Sharoda Dasgupta
NCHHSTP/DHAP/HICSB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Ethnographic interview guide
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Open-ended, hypothesis-generating ethnographic interviews
conducted both in group (in-person) and individual settings (by phone)
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Group ethnographic in-person interviews
Telephone Interview (describe):
In-depth individual phone interviews with eligible persons who
could not meet for a group ethnographic in-person interview
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
9
Total No. Sampled/Eligible to Respond (B): 22
Response Rate (A/B):
9/22 = 41%
Data Collection Instrument 2
Name of Data Collection Instrument: Detailed enterics questionnaire
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Structured phone interviews to evaluate exposure to special order
fruits or nuts from delivery trucks or local fundraisers
Data Collection Mode (check all that apply)
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Telephone interviews conducted with a convenience sample of
patients to evaluate exposure to special order fruits or nuts from
delivery trucks or local fundraisers
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
7
Total No. Sampled/Eligible to Respond (B): 22
Response Rate (A/B):
7/22 = 32%
Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)
Ethnographic interview
Patient
9
1
guide
Detailed enterics
Patient
7
1
questionnaire

Burden per
Response in
Minutes (C)
120

Total Burden
in Hours
(A x B x C)/60*
18

60

7

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

Page 3 of 3

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:
Purpose of Investigation: (Use
as much space as necessary)

2016020

Utah Department of Public Health
Undetermined Mode of Transmission Zika Virus among Utah Community Members, 2016
On July 1st, an adult male family contact reported developing a subjective fever and then
progressed to develop a rash and conjunctivitis. The family contact had no history of
travel or sexual contact with someone who traveled, but had been in contact with the
index patient during his period of viremia. Testing of urine obtained 7 days after illness
onset for the family contact was positive for Zika viral RNA at the Utah State Public
Health Laboratory. Because the family contact did not report travel to a Zika-affected area
or sexual contact with anyone who had recently traveled to a Zika-affected area, there is
concern about local transmission through a potentially unidentified mode of transmission
or by local mosquito-borne transmission.
The team performed enhanced surveillance of community members residing within 200
meter radius of the properties of interest for evidence of recent Zika virus
infection/disease. Community members were surveyed about potential exposures and
asked to provide a blood sample for Zika testing.

Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

Erin Staples
CDC/ DVBD/ADB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument:
Undetermined Mode of Transmission: Zika Virus among Utah Community
Members, 2016
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Community Based serosurvey
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
For those who provide blood sample
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Households within the 200 meter radius were visited by
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
investigation teams consisting of an interviewer, a phlebotomist, and
a person familiar with the location, either an employee of the local
health department or other government employee.
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond (B):
Response Rate (A/B):

Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)

Community Investigation
Questionnaire

General
public

209

1

Burden per
Response in
Minutes (C)

10

Total Burden
in Hours
(A x B x C)/60*

35

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

Page 2 of 2

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2016021

Healthcare Personnel Risk Assessment Questionnaire and Serosurvey for Zika Virus
Exposure—Utah, 2016
Purpose of Investigation: (Use On July 1st, an adult male family contact reported developing a subjective fever and then
as much space as necessary) progressed to develop a rash and conjunctivitis. The family contact had no history of
travel or sexual contact with someone who traveled, but had been in contact with the
index patient during his period of viremia. Testing of urine obtained 7 days after illness
onset for the family contact was positive for Zika viral RNA at the Utah State Public
Health Laboratory. Because the family contact did not report travel to a Zika-affected area
or sexual contact with anyone who had recently traveled to a Zika-affected area, there is
concern about local transmission through a potentially unidentified mode of transmission
or by local mosquito-borne transmission.
The team performed enhanced surveillance of the Health care providers (HCP) involved
in the care of the deceased patient. This surveillance included a detailed risk assessment
questionnaire and, for those determined to have had significant direct contact with the
patient, blood draws to test for the presence of Zika IgM antibody.
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

Bryan Christensen
CDC/ DHQP/OD

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument:
Healthcare Personnel Risk Assessment Questionnaire and Serosurvey for Zika
Virus Exposure—Utah, 2016
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
seroprevalence survey with matched cohort
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Face-to-face Interview (describe):

Investigators administered a detailed questionnaire to determine the
level of contact each identified healthcare worker had with the
deceased patient. Information collected included type of contact,
type of care provided, exposure to blood or body fluids, and use of
PPE during care. We also collected relevant information on the
employee's history, including recent travel, vaccinations, and
pregnancy status.

Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond (B):
Response Rate (A/B):

Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)

Health Care Worker
Assessment-Cases
Health Care Worker
Assessment-Controls

Healthcare
Worker
Healthcare
Worker

Burden per
Response in
Minutes (C)

Total Burden
in Hours
(A x B x C)/60*

96

1

10

32

113

1

3

6

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

Page 2 of 2

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2016022-XXX
2016-046
Hawaii State Department of Health
Undetermined source and risk factors for Hepatitis A virus (HAV) outbreak —
Hawaii, 2016.

Purpose of Investigation: (Use The objectives of the investigation included: providing epidemiologic support to better
as much space as necessary) elucidate the possible implication of restaurants involved in HAV transmission during
the current outbreak, assistance in a case re-analysis to obtain more definitive
epidemiologic evidence for suspect food items, facilitate product traceback through data
collection and analysis, facilitate clinical review of case data to better understand the
potential health impacts suffered by infected persons.
Duration of Data Collection: 5 days
Date Began:
August 22, 2016
Date Ended:
August 26, 2016
Lead Investigator
Name:
Monique Foster, MD, MPH
CIO/Division/Branch:
NCHHSTP/Division of Viral Hepatitis/Epidemiology and Surveillance Branch
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Hepatitis A: Supplemental Case Questionnaire
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cases who did not initially report exposure to the implicated
restaurant or food item were re-contacted to better elucidate their
true exposures to a source of the outbreak.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Cases who did not initially report exposure to the implicated
restaurant or food item were contacted via telephone and then the
accompanying questionnaire was completed by trained
interviewers.
Self-administered Paper-and-Pencil
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
47
Total No. Sampled/Eligible to Respond (B): 103
Response Rate (A/B):
46%

Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)
Hepatitis A: Supplemental
General
47
1
Case Questionnaire
Public

Burden per
Response in
Minutes (C)
5

Total Burden
in Hours
(A x B x C)/60*
4

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

Page 2 of 2

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
EPI AID No. (if applicable):
Requesting entity (e.g.,
jurisdiction):
Title of Investigation:

2016023-XXX

2016-049
South Carolina Department of Health and Environmental Control

Undetermined source for Salmonella Infantis infections among detention center inmates
— South Carolina, 2016
Purpose of Investigation: (Use On July 27, 2016, the South Carolina Department of Health and Environmental Control
as much space as necessary) notified CDC of a cluster of illnesses with isolates matching a rare, emerging strain of
Salmonella Infantis, defined by the PFGE pattern JFXX01.0787. Salmonella Infantis is
known to cause long-term, asymptomatic infections. It also causes more severe infections
than other common Salmonella serotypes.
The South Carolina cluster includes four isolates that matched a multistate outbreak
strain that CDC is currently investigating. The four isolates were from inmates in a
county detention center that reported 131 cases of gastrointestinal illness. Illness onset
began on July 12, with the majority of cases reported within 24 hours. The source of the
infection among this cluster is currently unknown.
This Salmonella Infantis strain is of particular public health interest because previous
isolates matching this PFGE pattern have been found to contain a large, mobile plasmid
containing a CTX-M-65 type extended-spectrum beta-lactamase, as well as resistance to
9-10 other drugs. Together, this strain has been resistant to ampicillin, ceftriaxone,
chloramphenicol, sulfisoxazole, tetracycline, nalidixic acid, and
trimethoprim/sulfamethoxazole and had intermediate susceptibility to ciprofloxacin and
gentamicin and is associated with more severe illness.
Phylogenetic analysis revealed that clinical isolates from this cluster group closely with
the previous isolates characterized, as well as a CTX-M-65-positive isolate from retail
chicken. This evidence indicate that infections may be associated with consumption of
chicken meat. Due to frequent association of this strain with a clinically important
multidrug resistance, the epidemic potential of the MDR plasmid, and the potential
association with chicken, an urgent public health response is warranted.
The purpose of the investigation was to
1)
Describe the extent of the cluster of gastroenteritis among detention center
inmates.
2)
Assess exposures and risk factors for acquisition of Salmonella Infantis
infection.
3)
Describe the clinical course of illness of affected patients including severity of
infection, treatment and outcomes.
4)
Determine if persons previously reporting illness are currently shedding
Salmonella Infantis PFGE pattern, JFXX01.0787.
5)
Based on findings of the investigation, recommend measures to reduce inmate
risk and for ongoing surveillance.
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

8/16/16
8/26/16
Sarah Luna
NCEZID/DFWED/EDEB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Name of Data Collection Instrument:
Type of Respondent

Case Interview Form

General public
Healthcare staff
X Other (describe): Detention center detainees

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
X Cohort Study (describe):
Demographic and clinical characteristics, food exposures,
medication exposures and medical history of inmates at the
detention center during the outbreak was collected
X Case-Control Study (describe):
Food exposures associated with illness was collected
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
X Face-to-face Interview (describe): Individual interviews with persons who reported illness during the
outbreak.
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
66
Total No. Sampled/Eligible to Respond (B): 81
Response Rate (A/B):
0.81
Data Collection Instrument 2
Name of Data Collection Instrument: Control Screening and Interview Form
Type of Respondent
General public
Healthcare staff
X Other (describe): Detention center detainees

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Descriptive Study (describe):
Cross-sectional Study (describe):
X Cohort Study (describe):

X

Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):

Demographic and clinical characteristics, food exposures,
medication exposures and medical history of inmates at the
detention center during the outbreak was collected
Food exposures associated with illness was collected

Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
X Face-to-face Interview (describe): Individual interviews with persons who did not report illness during
the cluster.
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
159
Total No. Sampled/Eligible to Respond (B): 267
Response Rate (A/B):
0.60
(Additional Data Collection Instrument sections may be added if necessary.)
Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Data Collection Instrument
Type of
Respondents
per Respondent
Name
Respondent
(A)
(B)
Case Interview Form
Person
66
1
Control Screening and
Person
159
1
Interview Form

Burden per
Response in
Minutes (C)
45
30

Total Burden
in Hours
(A x B x C)/60*
50
80

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).

Page 3 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
EEI Information Collection Request Liaison:
Danice Eaton, PhD, MPH
EIS Program Staff Epidemiologist
Epidemiology Workforce Branch
Division of Scientific Education and Professional Development
Centers for Disease Control and Prevention
2400 Century Center, MS E-92
Office: 404.498.6389
[email protected]

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Form Updated: 9/4/2014


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