Burden memo - Y1Q4

Appendix 1. Burden Memos.pdf

Emergency Epidemic Investigation Data Collections - Expedited Reviews

Burden memo - Y1Q4

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:
Purpose of Investigation: (Use
as much space as necessary)

2015003-XXX
Arizona Department of Health Services
Undetermined risk factors for dengue virus infection— Arizona, 2014.
Dengue is a potentially fatal acute febrile illness that is transmitted by Aedes species
mosquitoes. Dengue is endemic throughout the tropics and sub-tropics worldwide, and
recent outbreaks in the United States have occurred in Florida, Hawaii, and Texas. Prior
outbreaks in south Texas have occurred in association with dengue epidemics in northern
Mexico. During 2008–2013, the mean number of travel-associated dengue cases reported
by Arizona to ArboNET, the national arboviral surveillance system, was 4 (range: 0–12).
Thus far in 2014, a total of 72 travel-associated, laboratory-positive dengue cases have
been identified in Arizona, most of which occurred in Yuma and were associated with
recent travel to northern Mexico, where an epidemic is ongoing. The clinical course of
these patients has not yet been fully described. Although locally acquired dengue cases
have not yet been identified, the number of travel-associated cases, potential underidentification of clinically apparent dengue cases, and ~75% rate of asymptomatic
infection together suggest that locally acquired dengue virus (DENV) infections are likely
occurring. To develop effective prevention and control measures for locally acquired
infections, an investigation is needed to determine the extent to which locally acquired
infections is occurring and to identify risk factors for infection.
The Arizona Department of Health Services requested CDC assistance with an
investigation in Yuma, Arizona to: 1) Identify unreported travel-associated or locally
acquired dengue cases by conducting household-based cluster investigations around the
homes of reported, laboratory-positive dengue cases. Household and individual
questionnaires (Appendices 1 and 2) will be collected from participants, immature
mosquitoes from water containers in and around the house will be collected to count
mosquito larvae and mosquitoes will be collected from the home (Appendix 3), and serum
specimens will be collected and tested by RT-PCR and IgM ELISA to detect current and
recent DENV infection, respectively (Appendix 2); 2) Conduct entomologic surveillance
for Aedes mosquitoes in conjunction with the cluster investigations, including testing of
serum specimen collected in the household investigation for serologic evidence of recent
Aedes mosquito bites (Appendix 2); 3) Abstract the medical records (Appendix 4) of
clinically apparent, laboratory-positive dengue cases to describe their clinical course.
Medical records will be abstracted by federal staff on the investigation team. Specimen
collection, storage, and transport will done according to local procedures and protocols.
CDC also assisted Arizona with conducting web-based and/or in-person trainings with
local physicians on the clinical management of dengue.
Information collected in this investigation will be used to inform local prevention and
control measures, including development of educational materials in Spanish and English
for the public to prevent additional dengue cases.

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

12 weeks
12/15/2014
3/13/2015
Jefferson Jones, MD MPH
CDC and Arizona Department of Health Services

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Page 1 of 6

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
General public
Other (describe):

Household questionnaire

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Describe household-level risk factors for Aedes spp. mosquito
bites
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):
Administered face-to-face at household; recruited by knocking on all
doors within 50 meters of lab-confirmed dengue case patient.
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):
115
Total No. Sampled/Eligible to Respond (B): 170
Response Rate (A/B):
68%
Data Collection Instrument 2
Name of Data Collection Instrument: Individual 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):
Describe individual-level risk factors for Aedes spp. mosquito
Page 2 of 6

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
bites; recruited by knocking on all doors within 50 meters of labconfirmed dengue case patient.
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):
Administered face-to-face at household
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Blood sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
194
Total No. Sampled/Eligible to Respond (B): Not recorded at individual level
Response Rate (A/B):
Unknown
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Immature mosquito survey form.

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Describe level of containers, containers with water, containers
with Aedes spp. larvae in households.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Page 3 of 6

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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
Team recorded data from observations of household yards. Also used
tools to look for larvae in water-containing containers.
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
115
Total No. Sampled/Eligible to Respond (B): 170
Response Rate (A/B):
68%
Data Collection Instrument 4
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Informed consent form

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):
NONE
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):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Signed form, answered questions if person had any
Response Rate (if applicable)
Total No. Responded (A):
194
Total No. Sampled/Eligible to Respond (B): Not recorded at individual level
Response Rate (A/B):
Unknown
Data Collection Instrument 5
Name of Data Collection Instrument: Dengue case investigation form
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Patients
Health department personnel filled using medical records

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Describe clinical data of dengue 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):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): Used standardized medical abstraction form on medical records requested
from known medical facilities.
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
68
Total No. Sampled/Eligible to Respond (B): 68
Response Rate (A/B):
100
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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)

Data Collection
Instrument Name
Household
questionnaire
Individual
questionnaire
Immature mosquito
survey form.
Informed
consent/assent form
Dengue case
investigation form

Data
Collection
Type of
Respondent
Mode
Public
In-person
interview
Public
In-person
interview
Public
Field
investigation
Public
In-person
interview
Medical
Chart
record staff abstraction

No.
Respondents
(A)
115

Burden per
No. Responses
Response
per Respondent in Minutes
(B)
(C)
1
20

Total Burden
in Hours
(A x B x
C)/60*
38

194

1

20

65

113

1

30

57

194

1

5

16

68

1

20

23

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 6 of 6

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:

2015004-XXX
2015-005
Kansas Department of Health and Environment

Undetermined risk factors for mucormycosis among immunocompromised patients —
Kansas, 2014
Purpose of Investigation: (Use Mucormycosis is a serious, often fatal infection, caused by a group of angioinvasive
as much space as necessary) molds. These infections most commonly affect the rhinocerebral area and occur typically
in persons with marked immunosuppression.
On December 1, 2014, the Centers for Disease Control and Prevention (CDC) was
notified by the Kansas Department of Health and Environment (KDHE) of a cluster of
mucormycosis infections among patients in a bone marrow transplant (BMT) unit in
Hospital A in Kansas. The hospital reported four rhinocerebral mucormycosis infections
and one pulmonary mucormycosis infection which had occurred in the prior two months.
A possible source of these infections was thought to be construction on the BMT unit,
which occurred from May to October of 2014. However, because several of the cases had
presented after the construction was completed, Hospital A was concerned that there may
be additional relevant exposures in this cluster that might still be unidentified. Hospital A
states that they typically identify one case of rhinocerebral mucormycosis in this patient
population per year.

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

Hospital A and the KDHE requested CDC assistance to: 1) conduct case-finding; 2)
determine if significantly higher number of infections has occurred as compared with
historical baseline; 3) characterize epidemiological and clinical aspects of case-patients,
including exposures of interest; 4) conduct an epidemiological study to evaluate potential
association between exposures and cases; and 5) provide recommendations for
preventative measures and remediation.
18 days
12/29/2014
1/15/2014
Tiffany Walker
NCEZID/DFWED/Mycotic Diseases

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Mucormycosis_Infection Prevention and Control Questions
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):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Hypothesis generation
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Questions were administered via a face-to-face unstructured
interview.
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):
29
Total No. Sampled/Eligible to Respond (B): 29
Response Rate (A/B):
100%
Data Collection Instrument 2
Name of Data Collection Instrument: Mucormycosis_Medical Record Abstraction Form
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Public Health professionals (CDC employees, state employees, and trainees)

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):
Evaluate risk factors associated with rhinocerebral mucormycosis
among patients (cases and controls) with hematological
malignancies admitted to Unit 41 and Unit 42 of Hospital A from
May 23-December 1, 2014
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Page 2 of 4

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
X Medical Record Abstraction
Used abstraction tool to obtain demographic, risk factor and outcome data
(describe):
from the electronic medical record
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
3
Total No. Sampled/Eligible to Respond (B): 3
Response Rate (A/B):
100%
Data Collection Instrument 3
Name of Data Collection Instrument:
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):
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
Page 3 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Response Rate (A/B):

(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)
Appendix 1: Infection
Hospital staff 29
1
Prevention and Control
Questions for Investigation
of Mucormycosis Outbreak
in BMT Unit Undergoing
Construction
Appendix 2: Investigation of
Mucormycosis Disease
among Bone Marrow
Transplant Patients

State pubic
health staff;
medical
student

3

4

Burden per
Response in
Minutes (C)
20

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

90

16

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:

2015005-XXX
2015-007
Mozambique National Institute of Health
Undetermined risk factors for severe illness and death among funeral attendees,
Mozambique, 2014

Purpose of Investigation: (Use On January 12th, 2015, an outbreak of severe illness and fatalities was reported among
as much space as necessary) people who attended a funeral on January 9th, 2015 in Tete Province, Mozambique.
Seventy-three deaths and 177 cases were reported by the Ministry of Health. The illness
affected men, women, and children of different ages, with the youngest case occurring in a
2 year old child. Initial field investigation by the National Institute of Health in
Mozambique suggested that the illness resulted from consumption of a traditional
beverage, and that the illness is most likely due to a chemical toxin. Because of a potential
environmental etiologic agent, the Mozambique Ministry of Health requested the
assistance of the National Center for Environmental Health/Agency for Toxic Substances
and Disease Registry in investigating the cause of illnesses and fatalities associated with
attendance at the funeral event.
The objectives of this investigation were to assist the Mozambique Ministry of Health in
the following:
1)
Identify the cause of the outbreak;
2)
Confirm route of exposure;
3)
Determine the risk factors for illness and death;
4)
Determine if testing of biologic samples is useful, and if so, determine for which
chemical agents to test (Division of Laboratory Sciences).
The investigation began with a descriptive study of affected funeral attendees to identify
potential risk factors and exposures of interest. The characteristics of the persons affected
were described. Questionnaires were administered in-person to cases to evaluate for
clinical disease. CDC is also assisting with a toxicological investigation to include testing
of previously collected (by Mozambique National Institute of Health) de-identified
biological samples from case patients for potential etiologies as needed. CDC
investigators will not have access to personally identifiable laboratory data, nor will they
have access to any identifying keys.
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

02/06/2015
02/08/2015
Amelia Kasper
NCEH/DEHHE/Health Studies Branch

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Tainted Beverage_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)
Page 1 of 4

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):

Questionnaire-based inquiry of ongoing symptoms of disease

Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Visits to 3 neighborhoods to interview people with documented
histories of neurological symptoms 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):
17
Total No. Sampled/Eligible to Respond (B): 17
Response Rate (A/B):
100
Data Collection Instrument 2
Name of Data Collection Instrument: Tainted Beverage_Medical Record Abstraction
Type of Respondent
General public
Other (describe):

Healthcare staff
Medical records only

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Collected data to describe patient population, disease course
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):

Page 2 of 4

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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): Vital signs, physical examination, clinical narrative, laboratory data
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
65
Total No. Sampled/Eligible to Respond (B): 65
Response Rate (A/B):
100
Data Collection Instrument 3
Name of Data Collection Instrument:
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):
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):
Page 3 of 4

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):

(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)
Tainted
General
17
1
Beverage_Questionnaire
public
Tainted Beverage_Medical
Medical
4
17
Record Abstraction
records only

Burden per
Response in
Minutes (C)
20

Total Burden
in Hours
(A x B x C)/60*
6

30

34

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:

2015006-XXX
Epi-Aid 2015-012
Louisiana Department of Health and Hospitals Office of Public Health

Undetermined mode of transmission and risk factors for potential Burkholderia
pseudomallei exposures among non-human primates, and persons employed at or
inspecting a primate research center — Louisiana, 2015
Purpose of Investigation: (Use On 15 December 2014, CDC was contacted about potential cases of melioidosis in two
as much space as necessary) non-human primates (NHP) housed in a primate research center. The center houses
approximately 5000 NHPs within multiple enclosed pens with outdoor field cages or
runs. The facility employs about 300 staff. Melioidosis is an infectious disease caused by
the gram-negative bacterium Burkholderia pseudomallei. It is extremely rare in the
United States, and most cases are associated with travel to endemic regions, such as
Southeast Asia and Australia.
Testing performed at the CDC Zoonoses and Select Agent Laboratory (ZSAL) for both
NHPs was positive for B. pseudomallei on 18 December 2014 by Burkholderia spp. LRN
real-time PCR and was confirmed by the LRN algorithm for B. pseudomallei on 19
December 2014. Further genotyping by ZSAL, including MLST and MLVA, revealed both
NHPs were infected with the reference strain 1026b, the reference strain used in a
research facility separated from the primate colony by approximately one mile. An initial
investigation was conducted by CDC Division of Select Agents and Toxins (DSAT) and
USDA Select Agents Program staff from 19-23 January 2015. On 23 January, a member of
the USDA inspection team developed an illness that included melioidosis in the
differential diagnosis. She presented for medical treatment on 31 January in Tennessee
and again at Emory hospital on 5 February, 2015 and was hospitalized. A serum specimen
obtained during the second clinical visit was tested using Indirect Hemagglutination
Assay for antibodies to B. pseudomallei and the titer was 1:160, indicating potentially
recent or distant exposure to the organism. Detailed travel history revealed distant
travel and exposure to soil in a country endemic for B. pseudomallei; however given the
patient's recent visit to the primate research center concerns were raised for possible
exposure during the investigation by CDC and USDA.

The CDC Bacterial Special Pathogens Branch (BSPB) epidemiology team was
deployed to Covington LA on February 9th 2015. The main goals included:
1. Identify other primates exposed to Bp
2. Investigate the route of exposure that caused the primates to become
infected with Bp
3. Evaluate the risk of exposure to Tulane employees
4. Assist other agencies in evaluating environmental contamination
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

February 9th 2015
March 30th 2015
Leisha Nolen
OID/NCEZID/BSPB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Risk Assessment Questionnaire
Page 1 of 3

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Type of Respondent
General public
Other (describe):

X Healthcare staff
X Laboratory staff
Patients
Veterinary clinic workers and those accessing research area

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):
X Other (describe):
Risk assessment questionnaire
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
XSelf-administered Paper-and-Pencil
One page questionnaire that asked about laboratory exposures, PPE
Questionnaire (describe):
use, predisposing health conditions
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):
276
Total No. Sampled/Eligible to Respond (B): 300
Response Rate (A/B):
92%
Data Collection Instrument 2
Name of Data Collection Instrument: Exposure history
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):
Page 2 of 3

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Other (describe):
Environmental Assessment (describe):
X Laboratory Testing (describe):
Blood samples were collected from individuals at risk of Bp exposure.
Demographic information and information regarding previous risk
behaviors were collected.
Other (describe):
Data Collection Mode (check all that apply)
X Survey Mode (indicate which mode(s) below):
XFace-to-face Interview (describe):
Staff members were asked questions prior to blood donation
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
XBiological Specimen Sample
Blood samples were collected by LA DHH staff members
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
89
Total No. Sampled/Eligible to Respond (B): 120
Response Rate (A/B):
74%

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)
Risk Assessment
Staff
276
1
Questionnaire
Exposure history
Staff
89
1

Burden per
Response in
Minutes (C)
5

Total Burden
in Hours
(A x B x C)/60*
1380

10

890

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


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