Appx 1: Burden Memos (4th Qtr Oct-Dec 2019)

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)

2019004 - XXX
Wisconsin Division of Public Health
E-cigarette associated pulmonary illness
211 possible cases of severe pulmonary disease associated with e-cigarette use were
reported in 24 states from June 28, 2019 to August 26, 2019, including 1 case-patient death.
No etiology had been identified. All case-patients reported a history of e-cigarette use.
Some case-patients reported a history of vaping liquids containing tetrahydrocannabinol
(THC) compounds.
The National Center for Injury Prevention and Control (NCIPC), National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), National Center for
Environmental Health (NCEH), and National Institute for Occupational Safety and
Health (NIOSH) worked together to provide technical assistance, coordination, and
communication between states investigating those cases.
Data Collection Objectives
The objectives were to assist the state and local health departments with
• Establish criteria for identifying cases
• Better characterization of potential exposures and evaluate potential noninfectious etiologies
• Investigate clinical signs/symptoms, radiographic results, and clinical treatments
in cases.
This GenIC requested OMB approval was for the medical chart abstraction short form and
the case interview short form which were distributed to states who wished to voluntarily
use them to collect standardized data. The tool and questionnaire were based on
instruments developed by the states to support their own investigations. Additionally, a
specimen manifest form was created and used by public health laboratory staff to submit
bronchoalveolar lavage (BAL) samples, blood and urine samples to CDC for analysis. If
requested by the state, CDC provided staff to assist with data collection within their
jurisdiction. As part of public health response within each state, some states collected
identifying information for their own purposes, not at the request of CDC. Data included
potentially sensitive information (e.g., drug use) since preliminary information indicated
some case patients were exposed to product containing THC.
CDC used the secure data platform RedCap so that states would be able to securely
transmit data to CDC. At the request of states, participating states voluntarily shared deidentified data with CDC via the secure data platform; shared data included key variables
that were most critical for understanding the distribution and characteristics of cases
nationally and that identified risk factors across states. CDC aggregated key variable data
to better understand the distribution and characteristics of cases nationally and identified
shared risk factors across states.
At the time of the GenIC request, 206 cases were reported, and the GenIC estimated a
burden of 500 cases. As cases continued to be identified, the actual number of medical
chart abstractions, case interview respondents and specimen manifest respondents were
2,108, 1,810 and 48, respectively.

Duration of Data Collection:
Date Began:
Date Ended:
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90 days
8/29/2019
11/27/2019
Form Updated: 9/4/2014

Burden Memo for the Generic Clearance of Emergency Epidemic Investigation Data Collections
(0920-1011)
Lead Investigator
Name:
CIO/Division/Branch:

Joshua Schier
2019 Lung Injury Response

Complete the following for each instrument used during the investigation.
Data Collection Instrument 1
Name of Data Collection Instrument: Case Interview Short 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):
This was a descriptive investigation of patients with confirmed ecigarette associated acute pulmonary disease to systematically
collect information about potential exposures to e-cigarettes and
specific substances, e-cigarette associated behaviors, and
healthcare data related to acute presentations of illness.
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):
This was a descriptive investigation of patients with confirmed ecigarette associated acute pulmonary disease to systematically
collect information about potential exposures to e-cigarettes and
specific substances, e-cigarette associated behaviors, and healthcare
data related to acute presentations of illness.
Telephone Interview (describe):
State health department staff conducted telephone-based or inperson interviews of case-patients using a standardized case
interview form.
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):
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1810
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): 1
Response Rate (A/B):
1810
Data Collection Instrument 2
Name of Data Collection Instrument: Medical Chart Abstraction Short 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):
Other (describe):
Environmental Assessment (describe):
Laboratory Testing (describe):
Other (describe):
Records Abstraction
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): State health department staff collected medical records and conduct
medical chart abstraction.
Biological Specimen Sample
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
2108
Total No. Sampled/Eligible to Respond (B): 1
Response Rate (A/B):
2108
Data Collection Instrument 3
Name of Data Collection Instrument:
Type of Respondent
General public
Other (describe):

Page 3 of 5

Specimen Manifest 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)
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):
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-and-Pencil
Questionnaire (describe):
Self-administered Internet
Questionnaire (describe):
Other (describe):
Medical Record Abstraction (describe):
Biological Specimen Sample
Specimen collection
Environmental Sample
Other (describe):
Response Rate (if applicable)
Total No. Responded (A):
48
Total No. Sampled/Eligible to Respond (B): 1
Response Rate (A/B):
48

(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 Interview Short Form
patients
1810
1
Medical Chart Abstraction
Public health 2108
1
Short Form
staff
Specimen Manifest Form
Laboratory
48
1
staff

Burden per
Response in
Minutes (C)
60
60

Total Burden
in Hours
(A x B x C)/60*
1810
2108

10

8

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 4 of 5

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 5 of 5

Form Updated: 9/4/2014