App 1_Burden Memos

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)

202001-0920-007
Council of State and Territorial Epidemiologists
2019-nCoV Investigation, United States, 2020

In December of 2019, an outbreak of a novel coronavirus (SARS-Cov-2), capable of
causing severe illness, was identified in in central China. This virus rapidly spread to
countries throughout the world including the US. In January of 2020, the first known
case of COVID-19 was identified in the US and cases were expected to increase. At that
time, human-to-human transmission of the virus had been confirmed. However, how
easily or sustainably the virus was spreading between people was not known. In response
to this emergency, the Council of State and Territorial Epidemiologists (CSTE) requested
CDC assistance with a multi-state response to COVID-19. The forms approved under
this EEI GenIC were used to respond to this request.
Objectives of Investigation
The objectives of the investigation were to identify cases and contacts of cases who were
at risk for illness, understand the risk factors for disease and transmission, describe the
clinical characteristics of disease, and identifying ways to control transmission. The data
gathered from this investigation were used to inform the U.S. public health response to
COVID-19 and aid efforts to prevent and control the spread of the virus.

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

This memo describes the burden associated with the use of the three forms approved
under the EEI GenIC. Because of the evolving nature of the pandemic, forms used were
sometimes modified from the original in individual investigations. Final versions of the
forms are attached.
1. 2019-nCoV Case Report Form. This form was used to provide information on
COVID 19 cases, including demographic information, clinical presentation and
course, medical history, 2019-nCoV laboratory testing, and exposure history.
2. 2019-nCoV Patient Under Investigation (PUI) Form. This form was used to
provide information on individuals who were under investigation as a potential
2019-nCoV case. It was combined with the case report form on February 24th, to
reduce burden to states.
3. Combined CRF PUI form
4. 2019-nCoV Household/Close Contact Investigation Form. This form provided
information on close contacts of 2019-nCoV cases who were at risk for infection.
5. 2019 nCoV Household Questionnaire. This form provided information on
households of 2019-nCoV cases who were at risk for infection.
6. 2019 nCoV Household member symptom diary. This form provided information
on symptoms of household members of cases at risk for infection.
7. 2019 nCoV Household animal questionnaire. This form provided information on
pets of 2019-nCoV cases who were at risk for infection.
8. 2019 nCoV Household close out form. This form provided information on
household of 2019-nCoV cases who were at risk for infection.
90 days
1/25/2020
4/23/2020
Dan Jernigan
Incident Manager, CDC - National Center for Immunization and Respiratory Diseases

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Page 1 of 10

Form Updated: 9/4/2014

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

2019 nCoV Case Report Form

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Information is gathered and reported by public health department officials but obtained from
patients or their medical records

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):
Also used in field studies to investigate risk factors and
symptoms of cases.
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Reporting form used to report cases to CDC
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
When used for field investigations, face-to-face interviews were
one way of obtaining information.
Telephone Interview (describe):
When used for field investigations, telephone interviews were one
way of obtaining information.
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): When used for field investigations, medical record abstraction was one
way of obtaining information.
Biological Specimen Sample
Environmental Sample
Other (describe):
Instrument is used for reporting cases to CDC. Data are reported by
public health officials but can be gathered through patient interviews
and/or medical record abstraction
Response Rate (if applicable)
Total No. Responded (A):
114,205
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 2
Name of Data Collection Instrument:
Type of Respondent
General public

Page 2 of 10

2019 nCoV PUI Form

Healthcare staff

Laboratory staff

Patients

Restaurant staff

Form Updated: 9/4/2014

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

Information was gathered and reported by public health department officials but obtained
from patients or their medical records

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Information is gathered and reported by public health department
officials but obtained from patients or their medical records. This form
was used early in the time period of the epidemic to collect
information on suspected cases. The case report form was solely used
after February 24, 2020
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
Patient interviews either face-to-face or by telephone were the most
common method of data collection.
Telephone Interview (describe):
Patient interviews either face-to-face or by telephone were the most
common method of data collection.
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): Although a less common method, information was sometimes obtained
from clinical records.
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable) N/A
Total No. Responded (A):
19,923
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Page 3 of 10

Combined CRF PUI form

Healthcare staff
Laboratory staff
Patients
Restaurant staff
Information is gathered and reported by public health department officials but obtained from
patients or their medical records
Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):
Also used in field studies to investigate risk factors and
symptoms of cases.
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Reporting form used to report cases to CDC
Data Collection Mode (check all that apply)
Survey Mode (indicate which mode(s) below):
Face-to-face Interview (describe):
When used for field investigations, face-to-face interviews were
one way of obtaining information.
Telephone Interview (describe):
When used for field investigations, telephone interviews were one
way of obtaining information.
Self-administered Paper-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe): When used for field investigations, medical record abstraction was one
way of obtaining information.
Biological Specimen Sample
Environmental Sample
Other (describe):
Instrument is used for reporting cases to CDC. Data are reported by
public health officials but can be gathered through patient interviews
and/or medical record abstraction
Response Rate (if applicable)
Total No. Responded (A):
268,269
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 4
Name of Data Collection Instrument: 2019 nCoV Household Close Contact Investigation
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

x

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
This form was used in investigations that followed close contacts
of 2019-nCoV cases who were at risk for infection.
Page 4 of 10

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
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):
Information from close contacts was collected through face-to face
or telephone interviews.
Telephone Interview (describe):
Information from close contacts was collected through face-to-face
or telephone interviews.
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) N/A
Total No. Responded (A):
318
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 5
Name of Data Collection Instrument: 2019 nCoV Household Questionnaire
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

x

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
This form was used in investigations that followed close contacts
of 2019-nCoV cases who were at risk for infection.
Cross-sectional Study (describe):
Cohort Study (describe):
Case-Control Study (describe):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Page 5 of 10

Form Updated: 9/4/2014

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):
Information from close contacts was collected through face-to face
or telephone interviews.
Telephone Interview (describe):
Information from close contacts was collected through face-to-face
or telephone interviews.
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) N/A
Total No. Responded (A):
106
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 6
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

2019 nCoV Household member symptom diary

Healthcare staff

Laboratory staff

x

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
This form was used in investigations that followed close contacts
of 2019-nCoV cases who were at risk for infection.
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):
Information from cases close contacts was collected through face-to
face or telephone interviews.
Telephone Interview (describe):
Information from cases and close contacts was collected through
face-to-face or telephone interviews.
Self-administered Paper-and-Pencil
Questionnaire (describe):
Page 6 of 10

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) N/A
Total No. Responded (A):
318
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 7
Name of Data Collection Instrument: 2019 nCoV Household animal questionnaire
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

x

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
This form was used in investigations that followed close contacts
of 2019-nCoV cases who were at risk for infection.
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):
Information from close contacts was collected through face-to face
or telephone interviews.
Telephone Interview (describe):
Information from close contacts was collected through face-to-face
or telephone interviews.
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 7 of 10

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Response Rate (if applicable) N/A
Total No. Responded (A):
106
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 7
Name of Data Collection Instrument: 2019 nCoV Household Close Contact Investigation
Type of Respondent
General public
Other (describe):

Healthcare staff

Laboratory staff

x

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
This form was used in investigations that followed close contacts
of 2019-nCoV cases who were at risk for infection.
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):
Information from close contacts was collected through face-to face
or telephone interviews.
Telephone Interview (describe):
Information from close contacts was collected through face-to-face
or telephone interviews.
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) N/A
Total No. Responded (A):
106
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a
Data Collection Instrument 8
Name of Data Collection Instrument:
Type of Respondent
Page 8 of 10

2019 nCoV Household close out form

Form Updated: 9/4/2014

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

Healthcare staff

Laboratory staff

x

Patients

Restaurant staff

Data Collection Methods (check all that apply)
Epidemiologic Study (indicate which type(s) below)
Descriptive Study (describe):
This form was used in investigations that followed close contacts
of 2019-nCoV cases who were at risk for infection.
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):
Information from close contacts was collected through face-to face
or telephone interviews.
Telephone Interview (describe):
Information from close contacts was collected through face-to-face
or telephone interviews.
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) N/A
Total No. Responded (A):
106
Total No. Sampled/Eligible to Respond (B): n/a
Response Rate (A/B):
n/a

(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)
Data Collection Instrument
Name

Page 9 of 10

Type of
Respondent

No.
Respondents
(A)

No. Responses
per Respondent
(B)

Burden per
Response in
Minutes (C)

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

Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
1. 2019-nCoV Case Report
Form

2. 2019 nCoV Patient Under
Investigation Form
3. Combined CRF and PUI
form

4. 2019 nCoV
Household/Close Contact
Investigation Form
5. 2019 nCoV Household
Questionnaire
6. 2019 nCoV Household
member symptom diary
7. 2019 nCoV Household
animal questionnaire
8. 2019 nCoV Household
close out form

Information
reported by
public health
official
gathered
from patient
Case/patient

228,409

1

30

114,205

39,859

1

30

19,923

Information
reported by
public health
official
gathered
from patient
Case or
contact of the
case
Case or
contact of the
case
Case or
contact of the
case
Case or
contact of the
case
Case or
contact of the
case

536,537

1

30

268,269

318

1

30

159

106

1

30

53

318

1

30

159

106

1

30

53

106

1

30

53

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 10 of 10

Form Updated: 9/4/2014