Burden memo Y2Q4

Appendix 1. Burden Memos.pdf

Emergency Epidemic Investigation Data Collections - Expedited Reviews

Burden memo Y2Q4

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:

2016002-XXX
Epi-Aid 2016-004
Ministry of Agriculture
Haiti
Undetermined risk factors associated with increase in bites from rabid dogs, resulting in
at least one human death, Gonaives, Haiti, 2015.
Purpose of Investigation: (Use Early September 2015, a four year old girl died from a rabies like illness in Gonaives,
as much space as necessary) Haiti. According to a preliminary investigation conducted late September, the child was
bitten on the stomach by an aggressive dog, owned by the household (dog died about a
week after the bite incident). Prior to her death, she exhibited clinical symptoms of
rabies: agitation, paralysis on the right side, and hydrophobia. She was not taken to the
hospital and the case was not officially reported through Haiti’s National Surveillance
System (NSS). Furthermore, a preliminary investigation by the Ministry of Agriculture
identified at least six dogs in this rural community with rabies-like illness and a Ministry
of Health investigation identified an additional 5 bite victims that had not sought
treatment nor reported the rabies exposure to a healthcare professional.
This was extremely concerning, given the case fatality of rabies is almost 100% if bite
victims do not seek care for post-exposure prophylaxis (PEP) treatment as soon as
possible. Furthermore, the breakdown of reporting to the NSS may adversely impact PEP
and canine rabies vaccination procurement, leading to a potential shortage when another
outbreak occurs. To develop effective prevention and control measures, an investigation
was conducted to identify additional cases and risk factors for rabies infection and careseeking behavior for those who were bitten.
The goal of this investigation were to:
1) Identify additional bite victims and refer for immediate treatment at a medical
center
2) Assess knowledge of rabies and barriers to care if bitten
3) Estimate the rabies vaccination rates among pet owners
4) Assess public health officials knowledge of treatment for rabies, availability of
PEP at their treatment center, and if and how they are reporting these cases to the
National Surveillance System
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

84 Days
11/2/2015
1/25/2016
Ryan Wallace
NCEZID/DHCPP/PRB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Community Survey
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 5

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

Our goals were to describe the epidemiology of the outbreak, and
assess treatment seeking behaviors and response capabilities in
order to to make recommendations for controlling the outbreak
and preventing cases of Haiti.

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):
We interviewed bite victims and community members about: their
vaccination behavior for their household pets (dogs and cats), had
contact with rabid animals, their knowledge about rabies, and their
health care seeking behavior after a bite.
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):
108
Total No. Sampled/Eligible to Respond (B): Not available.
Response Rate (A/B):
Denominator not available, therefore we cannot calculate response
rate.
Data Collection Instrument 2
Name of Data Collection Instrument: Medical Provider Interview Survey
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):
Our goals were to assess reporting capabilities and rabies
knowledge in order to to make recommendations for controlling
the outbreak and preventing cases of Haiti.
Cross-sectional Study (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):
We interviewed medical providers about their knowledge about
rabies and reporting of rabies into the National Sentinel
Surveillance System.
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):
9
Total No. Sampled/Eligible to Respond (B): Not available.
Response Rate (A/B):
Denominator not available, therefore we cannot calculate response
rate.
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Rabies Official Interview Survey

Healthcare staff
Rabies Officials

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Our goals were to assess reporting capabilities and rabies
knowledge in order to to make recommendations for controlling
the outbreak and preventing cases of Haiti.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Page 3 of 5

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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):
We interviewed rabies officials about their knowledge about rabies
and reporting of rabies into the National Sentinel Surveillance
System.
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):
10
Total No. Sampled/Eligible to Respond (B): Not available.
Response Rate (A/B):
Denominator not available, therefore we cannot calculate response
rate.

Data Collection Instrument 4
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Public Health Official Interview Survey

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Our goals were to assess reporting capabilities and rabies
knowledge in order to to make recommendations for controlling
the outbreak and preventing cases of Haiti.
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):
We interviewed public health officials about their knowledge about
Page 4 of 5

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
rabies and reporting of rabies into the National Sentinel
Surveillance System.
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):
7
Total No. Sampled/Eligible to Respond (B): Not available.
Response Rate (A/B):
Denominator not available, therefore we cannot calculate response
rate.

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 Survey
General
108
1
Public
Medical Providers Interview General
9
1
Survey
Public
Rabies Official Interview
General
10
1
Survey
Public
Public Health Official
State
7
1
Interview Survey
Employee

Burden per
Response in
Minutes (C)
10

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

60

9

60

10

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 5 of 5

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:

2016005-XXX
2016-007
Puerto Rico Department of Health

Undetermined risk of exposure for human-to-human spread of rabies following
mongoose-associated human rabies case among contacts of case patient, Puerto Rico,
2015
Purpose of Investigation: (Use The purpose of the investigation was to perform standardized risk assessments of
as much space as necessary) community members and healthcare workers who may have been exposed to the patient
during his infectious period to determine need for post-exposure prophylaxis.
Duration of Data Collection: 1 week
Date Began:
12/8/2015
Date Ended:
12/15/2015
Lead Investigator
Name:
Ashley Styczynski (lead EISO)
CIO/Division/Branch:
NCEZID/DHCPP/PRB
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Community Assessment
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):
To conduct contact tracing and standardized risk assessments for
persons with possible exposures to the case patient to ascertain
which individuals require post-exposure prophylaxis
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):
We interviewed patient community contacts to determine that
nature and extent of their exposure to the patient
Telephone Interview (describe):
We interviewed patient community contacts to determine that
nature and extent of their exposure to the patient
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Page 1 of 3

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
38
Total No. Sampled/Eligible to Respond (B): 39
Response Rate (A/B):
97%
Data Collection Instrument 2
Name of Data Collection Instrument: Healthcare Worker Assessment
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):
To conduct contact tracing and standardized risk assessments for
healthcare workers with possible exposures to the case patient to
ascertain which individuals require post-exposure prophylaxis
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):
We interviewed healthcare worker contacts to determine nature and
extent of contact with case patient
Telephone Interview (describe):
We interviewed healthcare worker contacts to determine nature and
extent of contact with case patient
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):

Page 2 of 3

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Response Rate (if applicable)
Total No. Responded (A):
39
Total No. Sampled/Eligible to Respond (B): 39
Response Rate (A/B):
100

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 Risk
General
38
1
Assessment
public/
(English/Spanish)
patients
Healthcare Worker
Healthcare
39
1
Assessment
workers

Burden per
Response in
Minutes (C)
15

Total Burden
in Hours
(A x B x C)/60*
9.5

15

9.75

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)

2016006-XXX
2016-008
North Carolina

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

90 days
December 13, 2015
February 12, 2015

Undetermined risk factors for ocular syphilis — North Carolina, 2015
The North Carolina Division of Public Health (NC DPH) reported an increase in cases of
syphilis with ocular manifestations, out of proportion to the rise in syphilis cases for the
state. At the time the Epi-Aid was called, 38 cases of ocular syphilis were reported in 2015,
compared to 12 cases in 2014. Ocular syphilis can be a serious manifestation of syphilis,
and can occur during any stage of syphilis. Ocular syphilis may lead to decreased visual
acuity including permanent blindness. In North Carolina, at least two cases of blindness
attributed to ocular syphilis occurred recently. To address this unexplained rise in cases,
an investigation was urgently needed. NC DPH requested CDC assistance with this
investigation to describe the cases and clinical course of ocular syphilis, identify factors
influencing risk for ocular syphilis and blindness and identify prevention and control
measures.

Sara Oliver, MD, MSPH
NCHHSTP/DSTDP/ESB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Data abstraction form
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):
Potential risk factors and the clinical course of those diagnosed
with ocular syphilis were described using data collected from
state surveillance data and medical record abstraction.
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):

Page 1 of 2

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): Charts from patients identified as a potential ocular syphilis case were
reviewed. All information was collected on the data abstraction form.
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
83
Total No. Sampled/Eligible to Respond (B): 83
Response Rate (A/B):
1 (100%)
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. Data
Federal Staff 5
16
Abstraction Form

Burden per
Response in
Minutes (C)
0

Total Burden
in Hours
(A x B x C)/60*
0
*All
Respondents
were Federal
Employees

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:

2016007-XXX
2016-009
Brazil Ministry of Health

Undetermined agent, source, mode of transmission, and risk factors for an outbreak of
Guillain-Barré Syndrome, Bahia – Brazil, 2016
Purpose of Investigation: (Use The purpose of the investigation was to perform a case-control study of GBS cases to
as much space as necessary) determine the cause of GBS and correlation with risk factors, exposures, or medical
history.
Duration of Data Collection: 3 weeks
Date Began:
1/18/2016
Date Ended:
2/5/2016
Lead Investigator
Name:
Jim Sejvar/Ashley Styczynski (lead EISO)
CIO/Division/Branch:
NCEZID/DHCPP/PPHO
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Case Control 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):
Cases and controls underwent in-person interviews to ascertain
information about activities, antecedent signs and symptoms of
illness, and exposures in the two months prior to onset of
neurologic illness for cases and the same time period for their
age-matched controls.
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Serum, whole blood, and urine samples were collected at the time of
interview and are undergoing testing for suspected infectious
pathogens.
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
A symptom and exposure questionnaire was administered to cases
and controls through face-to-face interviews (Appendices 1a and
1b).
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Page 1 of 3

Form Updated: 9/4/2014

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
Serum, whole blood, and urine samples were collected at the time of
interview and are undergoing testing for suspected infectious pathogens.
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
126
Total No. Sampled/Eligible to Respond (B): 126
Response Rate (A/B):
100%
Data Collection Instrument 2
Name of Data Collection Instrument: Chart Abstraction Form
Type of Respondent
General public
Other (describe):

Healthcare staff
Public health personnel

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):
Charts of suspected cases of GBS were reviewed to confirm the
diagnosis and record onset and types of symptoms present during
the neurologic illness and any preceding viral-like illness
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): Public health personnel from the CDC and Brazil MOH investigation
team performed medical chart reviews to gather objective information
about cases and controls after obtaining consent (Appendices 2a and 2b).
Biological Specimen Sample
Environmental Sample
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):
Response Rate (if applicable)
Total No. Responded (A):
74
Total No. Sampled/Eligible to Respond (B): 74
Response Rate (A/B):
100%

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 Control Questionnaire
General
126
1
(English and Portuguese)
public/
patients
Chart Abstraction Form
Public health 2
37
(English and Portuguese)
personnel

Burden per
Response in
Minutes (C)
15

Total Burden
in Hours
(A x B x C)/60*
32

30

37

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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