Burden memo - Y3Q1

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)

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

2016008-XXX
2016-015
American Samoa Government, Department of Public Health
Investigation and response to an outbreak of Zika virus disease – American Samoa, 2016
1. Review and summarize syndromic surveillance data for rash illness and facilitate
laboratory testing for evidence of Zika virus infections.
2. Provide technical assistance to describe the epidemiology of suspected and
confirmed Zika virus disease cases to direct prevention and control efforts.
3. Provide technical assistance to local authorities to establish surveillance systems
to identify Zika virus infections in pregnant women, evaluate for possible
congenital infections, and identify Guillain Barré syndrome cases possibly
associated with Zika virus infection.
4. Assist with education and increasing awareness of healthcare providers, and the
general public regarding Zika virus disease.
February 12, 2016
March 11, 2016
Jessica Healy
CSELS, OPHSS, CDC

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Patient specimen sampling
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):
Specimens from suspected Zika virus cases were obtained and tested
for presence of or antibodies against suspected infectious pathogens
(e.g., Zika, dengue, chikungunya viruses) at CDC.
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):
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 Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): Clinical information abstracted from medical records.
Biological Specimen Sample
Serum samples were collected from suspected Zika virus disease cases
to be tested at CDC.
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
99
Total No. Sampled/Eligible to Respond (B): 99
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)
Patient specimen sampling
Patients
99
1

Burden per
Response in
Minutes (C)
5

Total Burden
in Hours
(A x B x C)/60*
9

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:

2016009-XXX
2016-017
Brazilian Ministry of Health

Assessment of the association of Zika virus infection and microcephaly – Brazil, 2015–
2016
Purpose of Investigation: (Use In October 2015, the Secretary of Health of Pernambuco State was alerted by clinicians
as much space as necessary) to a potential increase in the number of cases of microcephaly; an investigation was
launched. On 22 October, the Secretariat confirmed the finding and alerted the national
authorities. The following day, the Brazil Ministry of Health sent a notification through
International Health Regulations of the occurrence of 26 cases of microcephaly in
Pernambuco. On November 11, Brazil declared a national public health emergency and
engaged in discussion with international partners.
As of January 16, 2016, a total of 3,893 cases of microcephaly had been reported to
national authorities from 21 Brazilian States. The majority (86%; 3,402) of cases have
been reported in the northeast of the country, including Paraíba State, which had reported
665 cases of microcephaly as of 16 January 2016. To date, Zika virus RNA has been
identified in specimens (i.e., brain tissue, placenta, and amniotic fluid) from several
infants with microcephaly and from fetal losses in women infected with Zika virus
during pregnancy. However, it is not currently known how many of the cases of
microcephaly being reported in Brazil are associated with Zika virus infection.
On 28 December 2015, U.S. Centers for Disease Control and Prevention (CDC) received
official request to assist the Brazil Ministry of Health (MOH) to more thoroughly and
rapidly evaluate the potential association of Zika virus infection during pregnancy and
subsequent microcephaly in infants. The final results of this investigation will be used to
identify prevention and control measures for Zika virus infection and its sequelae.

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

The objectives of the investigation included:
1) describing the potential association of Zika virus infection and microcephaly and
other negative outcomes.
2) describing the clinical characteristics and current outcome of children with
microcephaly associated with Zika virus infection.
3) providing guidance on public messaging and support with additional aspects of
outbreak response.
46 days
February 12, 2016
March 23, 2016
J. Erin Staples
NCEZID/DVBD/ADB

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

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Mothers of case and control infants completed a questionnaire
including questions about familial history of birth defects,
pregnancy history (e.g., any complications, gestational age of
infant when born) and potential exposures and illnesses during
pregnancy. The questionnaire also asked about basic
demographic as well as information on the infant as to any
medical problems the infant might have and some basic
developmental questions. Also, to identify cases of infection, a
blood sample was collected from both the mother and infant.
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
To identify cases of infection, a blood sample was collected from both
the mother and infant. The specimen was sent to CDC and tested for
Zika and dengue viruses.
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Mothers were interviewed face-to-face by Brazilian MOH staff
about exposures and habits during pregnancy and infant health.
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 specimens will be tested at CDC for Zika virus and dengue virus
(a closely related virus that elicit antibodies that can cross-react on Zika
virus assays) IgM antibodies using an enzyme-linked immunosorbent
assay (ELISA) per methods described elsewhere. For samples testing
positive for Zika or dengue virus IgM antibodies, plaque reduction
neutralization test using a 90% cut-off (PRNT90) will be performed
using Vero cells for Zika and dengue viruses. For infants who test
negative for IgM antibodies against Zika virus, their serum sample will
be tested by RT-PCR for Zika viral RNA. Specimen collection, storage,
and transport have been performed according to local procedures and
protocols.
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
613
Total No. Sampled/Eligible to Respond (B): 637
Response Rate (A/B):
96%
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Data Collection Instrument 2
Name of Data Collection Instrument: Chart Extraction Form
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Public health personnel from the CDC and Brazil MOH investigation team

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
For case infants (with microcephaly), medical charts were
reviewed to determine test results for congenital infectious
disease and to obtain imaging and clinical laboratory findings.
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): Public health personnel from the CDC and Brazil MOH investigation
team performed medical chart reviews for cases only to determine test
results for congenital infectious diseases as well as obtain imaging and
clinical laboratory findings.
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
165
Total No. Sampled/Eligible to Respond (B): 189
Response Rate (A/B):
87.3%

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)

Page 3 of 4

Form Updated: 9/4/2014

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

Chart Abstraction

Type of
Respondent
General
public (cases
and controls)
Other (1-2
US federal
staff and 1
non-federal
staff)

No.
Respondents
(A)
613

3

No. Responses
per Respondent
(B)
1

Burden per
Response in
Minutes (C)
30

Total Burden
in Hours
(A x B x C)/60*
307

55

30

83

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:

2016010-XXX
2016-014
Wisconsin

Undetermined source of Elizabethkingia meningoseptica bloodstream infection among
Wisconsin residents — Wisconsin, 2016
Purpose of Investigation: (Use 1) Identify common source of infection though patient interviews and abstracted
as much space as necessary)
clinical data.
2) If one or more exposures emerge as suspected source of infection, evaluate
association though epidemiological analysis and environmental investigation.
Based on findings from objectives 1 and 2, develop interventions to prevent further
infections.
Duration of Data Collection:
Date Began:
2/15/2016
Date Ended:
5/12/2016
Lead Investigator
Name:
Lina I Elbadawi
OPHSS CSELS DSEPD
CIO/Division/Branch:
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Case Investigation Form
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Proxies (closest relative) for patients who could not be interviewed (deceased, dementia,
hospitalized at time of interview)

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Collection of demographic, and exposure data
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):
Face to face or telephone interview of patients or proxies
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):
Response Rate (if applicable)
Total No. Responded (A):
61
Total No. Sampled/Eligible to Respond (B): 61
Response Rate (A/B):
100%
Data Collection Instrument 2
Name of Data Collection Instrument: Appendix 2: Medical Abstraction Form
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
CDC and WI Division of Public Health staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Clinical exposures
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): Abstraction of records
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):

Page 2 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Appendix 3: Case Series

Healthcare staff
Laboratory staff
CDC and WI Division of Public Health staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Case-series
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): Collect variables describing patient history and clinical course
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)
Case Investigation Form
Patients and
61
1
proxies
Page 3 of 4

Burden per
Response in
Minutes (C)
75

Total Burden
in Hours
(A x B x C)/60*
77

Form Updated: 9/4/2014

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

Medical Abstraction Form
Case Series Form

Case Series Form

State health
department
staff
Federal staff
State health
department
staff
Federal staff

4

5

75

25

8
9

6
5

0
60

0
45

3

3

0

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 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:

2016011-XXX
2016 - 020
Puerto Rico Department of Health

Rapid assessment of blood collection and use in Puerto Rico to prevent transfusiontransmitted Zika virus infection - Puerto Rico, 2016
Purpose of Investigation: (Use 1) Quantify blood collections and use within affected area, including all blood collection
as much space as necessary) organizations and healthcare facilities, and estimating of proportion of recipients at
highest risk of poor outcome (e.g., pregnant women, neonates); 2) Quantify the
proportion of platelet and plasma collections within affected area that are subjected to
pathogen reduction technology; 3) Assist partners in identifying safe sources of blood
products for transfusion within affected area to prevent transfusion transmitted Zika; 4)
Assist with response planning for investigation of suspected transfusion-transmitted Zika
virus; 5) Assist partners with identifying resources needed to ensure sustainability of
local blood services during the Zika virus epidemic.
Duration of Data Collection: 15 days
Date Began:
February 10, 2016
Date Ended:
February 24, 2016
Lead Investigator
Name:
Amber Vasquez
CIO/Division/Branch:
NCEZID/DHQP/Prevention and Response Branch
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: PR Zika blood collection and use survey
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Medical Directors and Supervisors of Blood Collection Organizations and Hospitals

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Blood collection assessment: Information obtained from blood
collection organizations and hospitals for characterization of local
blood collection methods and blood product utilization. Data
used to estimate the volume of blood products needed for
transfusions to recipients and the volume which could be
subjected to pathogen reduction technology. Information used to
inform the maintenance of a safe and available blood supply and
prevent transmission of Zika virus infection through transfusions.
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)
Page 1 of 2

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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):
Information obtained through face-to-face interviews with the
directors and supervisors of blood collection agencies and hospitals
Telephone Interview (describe):
Information obtained through telephone interviews to the directors
and supervisors of blood collection agencies and hospitals
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Self-administered electronic questionnaire – encrypted and
password protected – distributed to blood collection agencies and
hospitals
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
63
Total No. Sampled/Eligible to Respond (B): 68
Response Rate (A/B):
92.6%

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)
Blood Collection and Use
Blood
63
1
Survey
Collection
Organizations;
Hospitals

Burden per
Response in
Minutes (C)
60

Total Burden
in Hours
(A x B x C)/60*
63

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:

2016012-XXX
2016-023
Illinois Department of Public Health

Undetermined source, mode of transmission, and risk factors for an outbreak of group A
Streptococcus among residents of a long term care facility — Chicago, Illinois, 2016
Purpose of Investigation: (Use 1.
To evaluate the causes and extent of the ongoing group A Streptococcus
as much space as necessary) outbreak, including risk factors for carriage and disease among residents.
2.
To assess current infection control practices and provide recommendations for
enhanced control to halt further spread of group A Streptococcus in the facility. Infection
control practices at the facility will be assessed by Federal staff directly observing
practices in the facility; OMB approval not requested for this component.
3.
To identify other measures for disease control which may include performing
additional screening for group A streptococcal carriage and implementation of antibiotic
treatment to protect facility residents and staff.
Duration of Data Collection: 2 weeks
Date Began:
3/21/16
Date Ended:
4/1/16
Lead Investigator
Name:
Chris Van Beneden
CIO/Division/Branch:
CDC/NCIRD/DBD/RDB
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Appendix 1. Invasive GAS in LTCF 2016 Employee 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)
Employees and wound care team staff completed a questionnaire
Descriptive Study (describe):
to assess risk factors for infection with group A Streptococcus,
their infection control practices, and possibility of household
contacts who are infected with group A Streptococcus.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Isolates of group A Streptococcus from the facility staff were
forwarded to CDC Streptococcus Laboratory for molecular typing
following local procedures. Clinical specimens were collected and
processed by the facility itself as part of routine clinical care and
infection control practices.
Other (describe):
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):
Self-administered Paper-and-Pencil Staff of the facility who came in contact with the patients or were
identified as potential sources of group A Streptococcus
Questionnaire (describe):
transmission at the facility were asked to complete a questionnaire.
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Group A streptococcal isolates from staff of the facility were forwarded
by the Illinois Department of Public Health to the Streptococcus
Laboratory at CDC for molecular typing following local procedures for
collection and transport (results to be listed on Appendix 2).
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
182
Total No. Sampled/Eligible to Respond (B): 242
Response Rate (A/B):
75%
Data Collection Instrument 2
Name of Data Collection Instrument: Appendix 2. Resident Record Extraction Form
Type of Respondent
General public
Healthcare staff
Laboratory staff
Patients
Restaurant staff
Other (describe): Federal, state, and facility staff will assist with medical record abstraction
Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Performed a case-control study to determine various risk factors
Case-Control Study (describe):
for group A streptococcal disease among the residents of the
facility
Other (describe):
Environmental Assessment (describe):
Isolates of group A Streptococcus from the facility residents were
Laboratory Testing (describe):
forwarded to CDC Streptococcus Laboratory for molecular typing
following local procedures. Clinical specimens were collected and
processed by the facility itself as part of routine clinical care and
infection control practices.
Other (describe):
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):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical records of residents were abstracted by the investigative team to
Medical Record Abstraction
characterize the epidemiology of the outbreak and determining the risk
(describe):
factors and possible sources transmission.
Group A streptococcal isolates from residents of the facility were
Biological Specimen Sample
forwarded by the Illinois Department of Public Health to the
Streptococcus Laboratory at CDC for molecular typing following local
procedures for collection and transport.
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
48
Total No. Sampled/Eligible to Respond (B): 48
Response Rate (A/B):
100%
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Appendix 3. Wound Care Survey

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Wound care team staff completed a questionnaire to assess risk
Descriptive Study (describe):
factors for infection with group A Streptococcus, their infection
control practices.
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 Each wound care team members completed a questionnaire.
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):
7
Total No. Sampled/Eligible to Respond (B): 7
Response Rate (A/B):
100%

(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. Invasive GAS
Healthcare
182
1
in LTCF 2016 Employee
staff
Survey
Appendix 2. Resident
State and
4
12
Record Extraction Form
local
Appendix 3. Wound Care
Healthcare
7
1
Survey
staff

Burden per
Response in
Minutes (C)
15

Total Burden
in Hours
(A x B x C)/60*
45.5

45

36

15

2

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

0920-1011
2016013-XXX
Uganda Ministry of Health

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

3 weeks
04/1/2016
04/22/2016

Undetermined sources and risk factors for a Rift Valley Fever Outbreak—Uganda
To assist the Ugandan Ministry of Health and the Ugandan Viral Research Institute
(UVRI) conduct a serosurvey on humans and livestock in Kabale District, Uganda.

Trevor Shoemaker
NCEZID/DHCPP/VSPB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Human 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):
Villagers and their livestock were assessed with a serosurvey and
risk factor and knowledge/attitudes/practice survey
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):
Interview done at designated sites in the village
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 taken at time of interview
Environmental Sample
Other (describe):
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Response Rate (if applicable)
Total No. Responded (A):
657
Total No. Sampled/Eligible to Respond (B): 657
Response Rate (A/B):
100%
Data Collection Instrument 2
Name of Data Collection Instrument: Livestock 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):
Livestock questionnaire administered recording information
about all animals from which a blood specimen was collected
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):
Animal owner or herdsman gave responses to questionnaire
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 specimen collected from all animals
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
1,052
Total No. Sampled/Eligible to Respond (B): 1,052
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)

Page 2 of 3

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Data Collection Instrument
Name
Risk Factor Questionnaire
Livestock Questionnaire

Type of
Respondent
General
Public
General
Public

No.
Respondents
(A)
657
1,052

No. Responses
per Respondent
(B)
1

Burden per
Response in
Minutes (C)
20

Total Burden
in Hours
(A x B x C)/60*
219

1

1

1052

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:

2016014-XXX
2016-026
Connecticut Department of Public Health

Undetermined risk factors for E.coli O157 among visitors to a goat farm—Connecticut,
2016
Purpose of Investigation: (Use 1.) Identify risk factors for E.coli O157 infection at this event by conducting a cohort
as much space as necessary) investigation among event attendees
2.) Identifying potential environmental sources of infection through on-site assessments
and unstructured interviews
3.) Develop public health recommendations for the goat dairy to prevent future outbreaks
at this venue and address gaps in community understanding of risk factors for
transmission of E. coli O157
Duration of Data Collection: 10 days
Date Began:
March 28, 2016
Date Ended:
April 8, 2016
Lead Investigator
EIS Officer
Name:
Kelly Gambino Shirley
CIO/Division/Branch:
NCEZID/DFWED/ORPB
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Telephone Interview 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):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
A case control study was conducted among visitors to

the goat dairy from March 1, 2016 to March 25, 2016.
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):
A telephone interview was conducted using a

standardized questionnaire to query visitors to the goat
dairy about activities and exposures.
Self-administered Paper-and-Pencil
Questionnaire (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 Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
73
Total No. Sampled/Eligible to Respond (B): 106
Response Rate (A/B):
69%

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)
Telephone Interview Form
Visitors to
73
1
goat farm

Burden per
Response in
Minutes (C)
30

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

2016015-XXX
#2016-029

Undetermined agent, source, mode of transmission, and risk factors for Guillain-Barre
Syndrome in the setting of Zika virus transmission – Colombia, 2016
Purpose of Investigation: (Use To perform a case-control study to determine a possible association of Guillain-Barre
as much space as necessary) Syndrome and previous Zika virus infection
Duration of Data Collection:
Date Began:
Date Ended:
Lead Investigator
Name:
CIO/Division/Branch:

4/12/16
4/26/16
Jim Sejvar
NCEZID/DHCPP/OID

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Case Control Form (English & Spanish versions)
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):
Evaluation of risk factors and exposures among GBS patients and
neighborhood controls
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Serologic assays to be performed on blood specimens to determine
antecedent Zika and/or dengue virus infections
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Face-to-Face interviews using the specified questionnaire
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 collected by phlebotomist for serologic testing
Page 1 of 3

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
129
Total No. Sampled/Eligible to Respond (B): 141
Response Rate (A/B):
91.5%
Data Collection Instrument 2
Name of Data Collection Instrument: Chart abstraction form (English & Spanish versions)
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):
Review of medical records of cases to determine inclusion
criteria
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): Data collected from medical records of patients suspected to have GBS
to determine whether they met the case definition
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
N/A
Total No. Sampled/Eligible to Respond (B): N/A
Response Rate (A/B):
N/A

Page 2 of 3

Form Updated: 9/4/2014

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

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 form
General
129
1
public
Chart abstraction form
Public health 8
11
personnel

Burden per
Response in
Minutes (C)
15

Total Burden
in Hours
(A x B x C)/60*
33

20

30

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:

2016016-XXXX
2016-031
Arizona Department of Health Services

Undetermined transmission and risk factors for multidrug-resistant
Mycobacterium tuberculosis among Tribal members — Arizona, 2016
Purpose of Investigation:
1) Determine the chain or chains of transmission
(Use as much space as
2) Identify and prioritize contacts
necessary)
3) Estimate the scope of transmission
4) Develop a plan for contacts with presumed multidrug-resistant
TB infection and ensure that treatment and evaluation
recommendations are made in close consultation with clinical
TB experts in the management of drug-resistant TB
5) Facilitate communications among involved agencies to assist
with the coordination of contact investigations
Duration of Data Collection: 2 weeks
Date Began:
5/9/2016
Date Ended:
5/20/2016
Lead Investigator
Name:
Krista Powell
CIO/Division/Branch:
CDC, Division of TB Elimination
Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection
Case Abstraction Form
Instrument:
Type of Respondent
General public
Healthcare staff
Laboratory staff
Other (describe): Medical and Public Health Charts

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Investigators collected data to describe the demographic
features of patients, determine the frequency of clinical and
social risk factors for TB disease, and identify contacts.
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):
Page 1 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Self-administered Paper-andPencil Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction
Federal staff on the investigation team abstracted patient
(describe):
medical/public health records.
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):
Data Collection Instrument 2
Name of Data Collection
Instrument:
Type of Respondent

Case Interview Form

General public
Healthcare staff
Other (describe): Patient proxy

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Investigators conducted semi-structured, face-to-face
interviews of patients or their proxies meeting the outbreak
TB case definition to estimate infectious periods, identify
contacts exposed during the infectious period, and
determine potential transmission sites.
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): Investigators met in person with case and proxy to conduct
semi-structured interview.
Telephone Interview (describe):
Self-administered Paper-andPencil Questionnaire (describe):
Self-administered Internet
Page 2 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):
Data Collection Instrument 3
Name of Data Collection
Instrument:
Type of Respondent

2
2
100%

Tuberculosis Contact Screening Form

General public
Healthcare staff
Other (describe): Contacts to case(s)

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Investigators conducted semi-structured, face-to-face
interview of contacts to cases to estimate infectious
periods, identify additional contacts exposed during the
infectious period, and determine potential transmission
sites.
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): Investigators met in person with contacts to conduct semistructured interview.
Telephone Interview (describe):
Self-administered Paper-andPencil Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Page 3 of 4

Form Updated: 9/4/2014

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):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond
(B):
Response Rate (A/B):

1
43
2.3%

(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
Type of
Respondents per Respondent
Instrument Name
Respondent
(A)
(B)
Case Abstraction Form
Chart
2
2
Case Interview Form
Case/Proxy 2
1
Tuberculosis Contact
Contact
1
1
Screening Form

Burden per
Response in
Minutes (C)
0
60
15

Total Burden
in Hours
(A x B x C)/60*
0
1
1

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