Burden memo

Appendix 1. Burden Memo_0920-1011.pdf

Emergency Epidemic Investigation Data Collections - Expedited Reviews

Burden memo

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)

2015009-XXX
2015-028
Dr. Nicholas Muraguri, Director of Medical Services of Kenya Ministry of Health
Widespread Outbreak of Cholera in Kenya, 2015
By the end of May, 2015, a multi-county outbreak of cholera in Kenya had
caused over 3000 cases across the country from the beginning of 2015. From
~January 1, 2015 to May 26, 2015, a total of 3,486 cases of cholera had been
reported with 71 deaths, of which 225 were laboratory confirmed as Vibrio
cholerae O1. Eleven of the 47 counties in Kenya reported cases with case
fatality ratios ranging from <1% to 6.8%.
In January 2015, the Kenyan Ministry of Health (MoH) in partnership with the
Field Epidemiology and Laboratory Training Program (FELTP) launched an
investigation of the outbreak and started implementing ongoing response efforts.
On June 3, 2015, the Kenya MoH contacted CDC to request assistance with the
epidemiological and laboratory investigation of this ongoing and widespread
cholera outbreak. On June 13, a team from the Division of Foodborne,
Waterborne, and Environmental Diseases deployed to join the investigation in
the field.
The short-term goals of the investigation were to inform status of current
outbreak response and identify critical points of intervention to stop transmission
of cholera. Developing public health recommendations to strengthen existing
surveillance systems for detection of and response to outbreaks of cholera and
other communicable diseases were the long-term goals of the investigation.

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

July 6, 2015
July 14, 2015 (excluding Sunday, July 12)
Rupa Narra
NCEZID/DFWED/DWBD

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection
Community Questionnaire
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):
Knowledge, Attitudes, and Practices Survey
Environmental Assessment
Page 1 of 5

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
(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): Surveys were carried out by local, trained enumerators in the
local dialect
Telephone Interview (describe):
Self-administered Paper-andPencil Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction
(describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond
(B):
Response Rate (A/B):
Data Collection Instrument 2
Name of Data Collection
Instrument:
Type of Respondent

1418
Unknown
Unknown

Community Health Extension Worker Questionnaire

General public
Healthcare staff
Laboratory staff
Patients
Restaurant staff
Other (describe): Community Health Extension Workers (liaison between the community and health
care facilities/health care 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):
Knowledge, Attitudes, and Practices Survey
Environmental Assessment
(describe):
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Page 2 of 5

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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): Survey was given by trained enumerators, FELTP residents,
or EIS Officers
Telephone Interview (describe):
Self-administered Paper-andPencil Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction
(describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond
(B):
Response Rate (A/B):
Data Collection Instrument 3
Name of Data Collection
Instrument:
Type of Respondent
General public
Other (describe):

51
Unknown
Unknown

Health Care Worker 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):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Knowledge, Attitudes, and Practices Survey
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): Survey was given by trained enumerators, FELTP residents,
or EIS Officers
Telephone Interview (describe):
Self-administered Paper-andPencil Questionnaire (describe):
Page 3 of 5

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):
Total No. Sampled/Eligible to Respond
(B):
Response Rate (A/B):
Data Collection Instrument 4
Name of Data Collection
Instrument:
Type of Respondent
General public
Other (describe):

61
Unknown
Unknown

Health Care Facility Checklist

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):
Health Care Facility Checklist assessing supplies available
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): Survey was given by FELTP residents or EIS Officers
Telephone Interview (describe):
Self-administered Paper-andPencil Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction
(describe):
Biological Specimen Sample
Environmental Sample
Page 4 of 5

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

44
Unknown
Unknown

(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)
Community Questionnaire
General
1418
1
Public
Community Health
Community
51
1
Extension Worker
Health
Questionnaire
Extension
Workers
Health Care Worker
Health Care
61
1
Questionnaire
Workers
Health Care Facility
Health Care
44
1
Checklist
Workers

Burden per
Response in
Minutes (C)
30

Total Burden
in Hours
(A x B x C)/60*
709

20

17

25

26

15

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

2015010-XXX
2015-029
Republic of Congo, Ministry of Health

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

7 days
July 13, 2015
July 19, 2015

Undetermined risk factors for human monkeypox in the Republic of Congo, 2015
CDC assisted the Republic of Congo Ministry of Health to identify the behavioral and
environmental risk factors for acquiring monkeypox among populations in and around
Impfondo.

Andrea McCollum
NCEZID/DHCPP/PRB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Monkeypox Risk 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):
This was a descriptive analysis of the knowledge of sources and
risk factors for infection in and around Impfondo, ROC.
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):
Interviewees were engaged in face-to-face encounters at each
household. Questions were asked directly from the survey and
interviewee responses filled in by the interviewer. Interviews were
conducted by teams of CDC and Ministry of Health staff.
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Page 1 of 2

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):
182
Total No. Sampled/Eligible to Respond (B): 182
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)
Monkeypox Risk
General
182
1
Assessment Form
Public

Burden per
Response in
Minutes (C)
20

Total Burden
in Hours
(A x B x C)/60*
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 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:
Purpose of Investigation: (Use
as much space as necessary)

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

2015011-XXX
2015-032
Pennsylvania Department of Health
Undetermined source, mode of transmission, and risk factors for Nontuberculous
mycobacterium infections among cardiothoracic surgical patients - Pennsylvania
Nontuberculous mycobacterium (NTM) are generally free-living organisms that are
ubiquitous in the environment and have been recovered from surface water, tap water,
and soil. These organisms can also be present on clothing, hair, and skin and are
capable of causing severe infection, especially among immunocompromised patients.
On July 20, 2015, CDC was notified by the Pennsylvania Department of Health (PA
DOH) of eight possible cases of Mycobacterium avium complex (MAC), a type of
NTM, infections among cardiothoracic surgery patients who had procedures at a single
facility (hospital A) between 2008 and 2015. All of these patients had undergone open
heart procedures. All procedures involved the use of heater-cooler units, some of
which have previously been implicated in transmitting NTM through aerosolized
particles in cardiothoracic surgical cases in Europe. However, the source, mode of
transmission, and risk factors for MAC infection in the current investigation were not
determined. PA DOH requested CDC assistance with an on-site investigation to
determine the source, modes of transmission, and risk factors for NTM infections
among hospital A patients in order to prevent further cases.
3 weeks
7/27/15
8/14/15
Joe Perz and Kiran Perkins
NCEZID/DHQP/PRB

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

Healthcare staff
Laboratory staff
Chart abstraction by federal employees

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
To describe the initial cases reported by Hospital A
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 4

Form Updated: 9/4/2014

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
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): To describe the initial cases reported by Hospital A
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
20
Total No. Sampled/Eligible to Respond (B): 20
Response Rate (A/B):
100%
Data Collection Instrument 2
Name of Data Collection Instrument: Case-Control Abstraction Form
Type of Respondent
General public
Other (describe):

Healthcare staff
Laboratory staff
Chart abstraction by federal employees

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):
Chart abstraction for unmatched case control study of the
outcome of NTM infections among cardiothoracic surgical
patients
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): Chart abstraction for unmatched case control study of the outcome of
Page 2 of 4

Form Updated: 9/4/2014

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

Short Abstraction Form

Healthcare staff
Laboratory staff
Chart abstraction by federal employees

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
To describe patients identified during case-finding for patients
with a history of NTM cultures between 2010 and 2015 who had
undergone any type of surgical procedure at Hospital A
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): To describe patients identified during case-finding for patients with a
history of NTM cultures between 2010 and 2015 who had undergone
any type of surgical procedure at Hospital A
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Page 3 of 4

48
Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Total No. Sampled/Eligible to Respond (B): 48
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)
Abstraction Form
Federal
4
20
employee
Abstraction Form – Case
Federal
4
68
Control Study
employee
Short Abstraction Form
Federal
4
48
employee

Burden per
Response in
Minutes (C)
n/a

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

n/a

n/a

n/a

n/a

n/a = no burden to the public; data abstracted by 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 4 of 4

Form Updated: 9/4/2014


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