Appx 1_Burden Memo

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
GenIC No.:
2020001-XXX
EPI AID No. (if applicable):
Requesting entity (e.g.,
Council of State and Territorial Epidemiologists
jurisdiction):
Title of Investigation:
E-cigarette associated pulmonary illness
Purpose of Investigation:
Introduction
(Use as much space as
211 possible cases of severe pulmonary disease associated with e-cigarette use
necessary)
were reported in 24 states from June 28, 2019 to August 26, 2019, including 1
case-patient death. No etiology has been identified. All case-patients report a
history of e-cigarette use. Some case-patients report a history of vaping liquids
containing tetrahydrocannabinol (THC) compounds.
On August 14 and August 16, the Wisconsin and Illinois Departments of Health,
respectively, requested assistance from the Centers for Disease Control and
Prevention (CDC) to assist with the investigation of the cases of illness in their
states. Since that time, other state and local jurisdictions have requested that CDC
facilitate the investigation by aggregating case-patient information at the national
level. A multi-state centrally coordinated investigation to severe pulmonary
disease associated with e-cigarette use will assist each state/local/territory
jurisdiction in making rapid, practical decisions for actions to prevent and control
the public health problem. This approach will streamline and strengthen the
response, as opposed to multiple state and jurisdictional investigations for the
same public health issue.
With technical assistance from CDC, states have worked collaboratively to
develop a standardized case definition, medical chart abstraction short form, and
case interview short form.
Data collections for this investigation were first initiated following OMB
approval on 8/29/2019 under the Emergency Epidemic Investigations (EEI)
Generic ICR (OMB # 0920-1011, exp 1/31/2020). Per the terms of the EEI
Generic ICR, data collection was approved for 90 days and therefore the
previously approved EEI GenIC expired on 11/27/2019. During that period, the
total data collection entailed 1810 standardized case interviews, 2108 medical
chart abstractions and 48 specimen manifest forms during the investigation of
severe pulmonary disease associated with e-cigarette use (called E-Cigarette or
Vaping Associated Lung Injury or EVALI). Data collection was not completed
within the original 90 days because new cases were still being reported to CDC
from states and territories; therefore, another GenIC approval was requested from
OMB that was approved and collection began on 11/26/2019 and was approved
for 90 days. Data from state health departments was submitted securely to CDC
using the Data Collation and Integration for Public Health Event Response
(DCIPHER) platform.
On 11/8/2019, CDC reported results from 29 EVALI patient who underwent
bronchoalveolar lavage (BAL) and found that all 29 samples contained vitamin E
acetate and 23 of 26 samples contained THC ingredients. While at the time it
appeared that vitamin E acetate is associated with EVALI, the evidence was not
yet sufficient to rule out contribution of other chemicals of concern to EVALI.
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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
This GenIC requested OMB approval to continue to collect data from patients
with probable or confirmed cases of EVALI.
Since the start of the outbreak, we were able to streamline the chart abstraction
and interview forms included in the initial EEI GenIC approved by OMB in
August, 2019 in by identifying the most essential information needed for the
investigation to identify cases and associated risk factors for illness. These two
forms were replaced by a single National Case Report Form (National Case
Report Form – Standard Version, Appendix 1).
The National Case Report Form – Standard Version is completed by
clinicians or healthcare department staff through medical record abstraction of
EVALI cases and includes demographic information, detailed information on past
substance use, symptoms, laboratory and radiology findings, hospitalization,
interventions, and diagnostic tests performed. The burden for this form is one
hour. This form provides the detailed information necessary to inform our
understanding of risk factors and clinical course of disease.
In lieu of the National Case Report Form – Standard Version, clinicians or
healthcare staff may choose to complete a shorter form (National Case Report
Form – Abbreviated Version). For respondents who are not able to complete the
longer form, this shorter form provides the minimum information necessary to
track case counts. This form is also completed by medical record abstraction and
includes demographic information and less detailed information about vaping or
e-cigarette use and clinical information. The burden for this form is 30 minutes.
When this GenIC was submitted,1500 new cases over the next 90 days were
anticipated. This was based on the details provided in case reports received by
CDC. CDC estimated that new cases reported from 11/26/2019 and the end of
this 90 day collection, would be submitted using the National Case Report Form
– Standard Version (Appendix 1) for half of the cases (750) and the National
Case Report Form – Abbreviated Version (Appendix 2) for the other half of the
cases (750); for an estimated total of 1500 cases. It was anticipated that
approximately half of the states would opt to use the shorter form because many
states report having less staff time available for data collection as the
investigations has progressed.
To supplement information collected through the national case report forms, we
received approval for one additional data collection instrument.
Upon request from states, CDC is accepting bronchoalveolar lavage (BAL)
samples, blood and urine samples for analysis from confirmed EVALI cases. To
submit these samples to CDC, public health laboratory staff of health
departments complete the Specimen Manifest Form (Appendix 3) with
information about the sample. This form takes approximately 10 minutes per
specimen submitted to complete. At the time of this current approval, CDC had
received 48 specimens using this form and anticipated receiving an additional 100
specimens.

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Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
At the conclusion of this GenIC information collection period, a total of 848
National Case Report Form – Standard Version were collected; 0 National Case
Report Form – Abbreviated Version were collected and 40 Specimen Manifest
forms were collected.

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

90 days
11/26/2019
2/24/2020
Peter Briss, MD
NCCDPHP/OD

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection
National Case Report Form – Standard Version
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):
This form is used to submit information on EVALI cases
including demographic information, information on past
substance use, symptoms, laboratory and radiologic
findings, hospitalization, interventions, and diagnostic tests.
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-andPencil 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):
Total No. Sampled/Eligible to Respond
(B):
Response Rate (A/B):

Data Collection Instrument 2
Name of Data Collection
Instrument:
Type of Respondent
General public
Other
(describe):

Medical record abstraction of cases by state health department
staff

848
NA
NA

Specimen Manifest Form

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):
Public health laboratory staff collected specimens
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-andPencil Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
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Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Other (describe):
Medical Record Abstraction
(describe):
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
Total No. Sampled/Eligible to Respond
(B):
Response Rate (A/B):

Specimen collection

40
NA
NA

(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
National Case Report
Form – Standard Version
Specimen Manifest Form

Type of
Respondent
Health
department
staff
Laboratory
staff

No.
Respondents
(A)
848

No. Responses
per Respondent
(B)
1

Burden per
Response in
Minutes (C)
60

Total Burden
in Hours
(A x B x
C)/60*
848

40

1

10

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]

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Form Updated: 9/4/2014