Burden Memo - Y2Q3

Appendix 1. Burden Memos.pdf

Emergency Epidemic Investigation Data Collections - Expedited Reviews

Burden Memo - Y2Q3

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:

2015012-XXX
Indiana Department of Health

Undetermined risk factor and mode of transmission for HIV infection among persons
injecting an opioid painkiller—Indiana, 2015
Purpose of Investigation: (Use The purpose of this investigation was to identify risk practices that contributed to the
as much space as necessary) rapid transmission of HIV in Scott County, IN as well as access to and utilization of the
emergency public health interventions implemented in response to the HIV outbreak.
The specific objectives of this investigation included:
1. Identify high-risk behaviors of PWID to understand drug use practices, sexual
practices, and other potential pathways of HIV and HCV transmission in this
outbreak
2. Understand the facilitators and barriers to accessing treatment and prevention
programs

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

The findings from this investigation will directly contribute to control of the ongoing
HIV outbreak in Scott County by collecting the necessary data i) to inform
recommendations to reduce new HIV infections and ii) to increase demand for and
uptake of prevention services. Findings will be summarized and disseminated in a timely
manner to key public health response partners, including ISDH, Scott County
Department of Health, and local health care providers.
5 days
08/31/2015
09/04/2015
Dita Broz, PhD, MPH
CDC/NCHHSTP/DHAP/BCSB

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

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
A qualitative investigation design was utilized to collect in-depth
information on key risk factors contributing to this rural HIV
outbreak, to inform current public health interventions, including
the syringe service program and treatment of HIV and substance
use disorder.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (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)
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 interviews using a semi-structured, open-ended
interview guide (see Appendix 1) were conducted to collect
information about risk behaviors, utilization of preventive and
health care services and any emerging topics not yet identified
through the ongoing outbreak investigation efforts.
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):
25
Total No. Sampled/Eligible to Respond (B): 31
Response Rate (A/B):
81%
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
Type of
Respondents
per Respondent
Data Collection Instrument
Name
Respondent
(A)
(B)
HIV Risk Factors Interview
General
25
1
Guide
Public

Burden per
Response in
Minutes (C)
90

Total Burden
in Hours
(A x B x C)/60*
37.5

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:

2016003-XXX
2016-005
Illinois Department of Public Health

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

14 days
11/5/2015
11/18/2015

Undetermined source, mode of transmission, and risk factors for an Outbreak of Group A
Streptococcus among residents of a long term care facility —Illinois, 2015
Purpose of Investigation: (Use The Illinois Department of Public Health identified a cluster of Group A Streptococcus
as much space as necessary) cases in a long term care facility in Sangamon county, Illinois. These infections began in
February, 2015 and resulted in 69 group A streptococcal positive individuals since that
time. There were 12 invasive cases in residents with 4 deaths. Despite infection control
measures implemented by the facility, screening cultures and implementation of mass
treatment, invasive group A streptococcal infections continue to occur. The Illinois
Department of Health requested assistance with the following objectives:
1. To evaluate the causes and extent of the ongoing Group A Streptococcus
outbreak, including risk factors for carriage and infection among residents and
staff.
2. To assess current infection control practices and provide recommendations for
enhanced control to halt further spread of Group A Streptococcus in the facility.
3. To identify other measures and actions to control the outbreak which may
include, performing additional screening for Group A Streptococcal carriage,
assessing Group A Streptococcus disease incidence in the community, and
implementing treatment to protect facility residents and staff.

Katherine Fleming-Dutra
NCIRD/DBD/RDB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: 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)
Descriptive Study (describe):
Staff working at the facility were asked about their job
characteristics, work practices, patient contact and specific signs
and symptoms of group A streptococcal disease over the last 6
months to understand their potential role in transmission of group
A streptococcal disease at the facility.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Page 1 of 3

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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 A questionnaire was provided to the staff at the facility for
Questionnaire (describe):
completion.
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):
166
Total No. Sampled/Eligible to Respond (B): 206
Response Rate (A/B):
80.58%
Data Collection Instrument 2
Name of Data Collection Instrument: Resident record extraction form
Type of Respondent
General public
Other (describe):

Healthcare staff
Federal 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):
Matched case control study to evaluate various risk factors for
group A streptococcal disease among the residents of the facility
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):
Page 2 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): Medical records abstracted for history of group A streptococcal disease,
underlying medical conditions, procedures, devices or other activities
that could be considered as risk factors.
Biological Specimen Sample
Environmental Sample
Other (describe):
Facility records examined for admission and room history of the cases
and controls
Response Rate (if applicable)
Total No. Responded (A):
NA
Total No. Sampled/Eligible to Respond (B): NA
Response Rate (A/B):
NA
Complete the following burden table. Each data collection instrument should be included as a separate row.
Burden Table (insert rows for additional respondent types if needed)
No.
No. Responses
Type of
Respondents
per Respondent
Data Collection Instrument
Name
Respondent
(A)
(B)
GAS Employee Survey
Employees of 166
1
the long term
care facility
GAS Resident Record
Federal staff 4
8
Extraction Form

Burden per
Response in
Minutes (C)
15

Total Burden
in Hours
(A x B x C)/60*
42

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 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:

2016004-XXXX
2016-006
Missouri Department of Health and Senior Services
Dr. George Turabelidze, State Epidemiologist
Undetermined Source of an outbreak of Legionnaires’ Disease among Hotel A Visitors
— Hannibal, MO 2015.
Purpose of Investigation: (Use On June 29 2015, CDC detected within their travel surveillance system two initial
as much space as necessary) laboratory-confirmed cases of legionellosis (onsets of illness March 7, 2015 and June 7,
2015). Questioning revealed that both individuals reported staying in Hotel A within their
incubation period. An additional case of legionellosis then was reported; this individual
also reported staying at Hotel A and had an onset of illness of October 12, 2015. The third
patient died from his illness. At the time of the request, the source of this outbreak
remained unknown. Upon the identification of two initial cases, an environmental
assessment was completed without any sampling. With the third case, the whirlpool spa
was disinfected and five environmental samples were collected. All environmental
samples are negative to date. Autopsy of lung tissue from deceased case demonstrated
Legionella pneumophila serogroup 1 growth on culture. Sequence-based type testing is
pending. Given heightened concern regarding the undetermined source of transmission and
need for environmental capacity building within local and state health departments, the
Missouri Department of Health requested CDC’s assistance with an investigation to
identify prevention and control measures.
The objectives were:
1)
Assist in the environmental assessment of the risk of Legionnaires’ disease at
Hotel A
2)
Develop and implement plans for additional environmental sampling and
remediation to control the outbreak
3)
Educate and train local and state epidemiologists and environmental public health
staff on how to conduct environmental assessments and environmental sampling
techniques for Legionnaires’ disease control and prevention
4)
Educate hotel staff and building management on epidemiology, disease
transmission, and prevention.

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

The Epi-Aid involved training and educating of local and health department staff on
Legionella epidemiology, environmental assessment and environmental sampling
techniques. Furthermore, face-to-face discussions with building management and
maintenance regarding hotel hot water system design, whirlpool spa, swimming pool, and
cooling tower maintenance. An environmental assessment form was used by state and local
health department staff to determine environmental risk factors within the hotel facility
(Appendix 1). Once risk sites were identified, water sampling was conducted and
environmental samples will be recorded on data sample sheet (Appendix 2).
1 day
11/10/2015
11/10/2015
Laura Cooley
Medical Epidemiologist
CDC/NCIRD/DBD/RDB

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Legionella Environmental Assessment Form
Type of Respondent
Page 1 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
General public
Healthcare staff
Laboratory staff
Patients
Restaurant staff
Other (describe): State and Local Health Departments and building management & maintenance 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):
X Environmental Assessment (describe): 1)
Assisted in the environmental assessment of the risk of
Legionnaires’ disease at Hotel A
2)
Developed and implemented plans for additional
environmental sampling and remediation to control the outbreak
Laboratory Testing (describe):
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
X Face-to-face Interview (describe):
We spoke to building management and maintenance staff regarding
design of potable hot water system including cooling tower,
whirlpool spa, and pool (Appendix 1).
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):
6
Total No. Sampled/Eligible to Respond (B): 6
Response Rate (A/B):
100%
Data Collection Instrument 2
Name of Data Collection Instrument: Sample Data Sheet
Type of Respondent
General public
X Other (describe):

Healthcare staff
Laboratory staff
Patients
Local and State health departments involved in investigation

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Page 2 of 4

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
X Laboratory Testing (describe):
Environmental samples sent to CDC lab for identification of
Legionella by culture or PCR.
Other (describe):
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Telephone Interview (describe):
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
X Environmental Sample
Environmental water and swab samples will be collected and recorded
on data sheet (appendix 2).
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
7
Total No. Sampled/Eligible to Respond (B): 7
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)
Appendix 1 Legionella
State and
6
1
Environmental Assessment
Local Health
Form
Departments
and building
management
&
maintenance
staff
Appendix 2: Sample Data
State and
7
1
Sheet
Local Health
Department

Burden per
Response in
Minutes (C)
120

Total Burden
in Hours
(A x B x C)/60*
12

180

21

Return completed form and a blank copy of each final data collection instrument within 5 business days of data collection
completion to the EEI Information Collection Request Liaison, Danice Eaton ([email protected]).
Page 3 of 4

Form Updated: 9/4/2014

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

Page 4 of 4

Form Updated: 9/4/2014


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