Request for Approval

REQUEST FOR APPROVAL UNDER THE GENERIC CLEARANCE
OF ASSESSMENT OF CHEMICAL EXPOSURES (ACE) INVESTIGATIONS DATA
COLLECTIONS (0923-0051)
Instruction: This form should be completed by the primary contact person from the ATSDR CIO that will
be sponsoring the investigation.
ATSDR is occasionally called upon to conduct Assessment of Chemical Exposures (ACE) investigations at
the request of state regional, local, or tribal health authorities seeking assistance to respond rapidly to
an acute chemical incident. ACE investigations are to be carried out in the event of an acute chemical
release of toxic substances. During these investigations, ATSDR and CDC staff provides epidemiological
assistance to describe the potential exposure and health status, identify needs of those impacted by the
chemical release, and asses the emergency response to the incident. The inviting agency will use the
information to direct the public health response and improve preparedness to decrease the morbidity
and mortality caused by future mass casualty incidents.
DETERMINE IF YOUR INVESTIGATION IS APPROPRIATE FOR THIS GENERIC CLEARANCE MECHANISM:
Instruction: Before completing and submitting this form, complete the checklist below. If you select
“yes” to the questions below, the ACE investigations Generic ICR mechanism can be used.
Criteria
Was ATSDR assistance requested by one or more external partners (e.g., state, local, regional, tribal,
health department (the requesting agency) where the release occurred?
[ X ] Yes [ ] No
Did the event involve the release of a toxic substance at levels that may cause acute human health
effects?
[ X ] Yes [ ] No
Did the event involve reports of people with acute health effects consistent with health effects of the
chemical listed on reference materials (ATSDR Toxicological Profiles, Safety Data Sheet, etc.)?
[ X ] Yes [ ] No
This surveillance activity will investigate potential causes of rash associated with the Flint water supply.
Is the ACE investigation urgent in nature (i.e., timely data are needed to inform rapid public health
action to prevent or reduce injury, disease, or death or provide other public health response)?
[ X ] Yes [ ] No
Is the ACE investigation a non-research public health response designed to prevent or control disease or
injury and reduce risk in the requesting agency’s jurisdiction, including improving the requesting
agency’s public health response?
[ X ] Yes [ ] No
Is the ACE investigation restricted to domestic incident and response under CERCLA?
[ X ] Yes [ ] No
Will one or more CDC/ATSDR staff (including trainees and fellows) be deployed to the field?
[ X ] Yes [ ] No
Will the data collection be completed in 90 days or less?
[ X ] Yes [ ] No
Did you select “Yes” to all criteria above? If yes, the ACE Investigations Generic ICR might be appropriate
for your investigation. → You may proceed with this form. If no, the ACE Investigations Generic ICR is
not appropriate for your investigation. → Stop completing this form now.

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TITLE OF INFORMATION COLLECTION: Flint Rash Investigation
DESCRIPTION OF THIS SPECIFIC COLLECTION
1. Chemical incident to be Investigated:
The city of Flint, Michigan changed from one source of drinking water to a different one. The second
source contained a higher amount of corrosive components in it than the first, which broke down
the biofilm coating inside the pipes bringing water to homes, allowing lead to leach into the drinking
water. An astute pediatrician noticed high blood lead levels in the children she tested. This
prompted her to looks at blood lead level data, and she saw a 3-5% increase in the prevalence of
high blood lead levels in children over a certain period. That raised the alarm, and started the probe
into what was happening.
There have been reported cases of rash potentially associated with Flint water exposure from
affected members of the public as well as some treating physicians. In response, the Michigan
Department of Health and Human Services (MDHHS) began an investigation. They are requesting
ATSDR Assessment of Chemical Exposures (ACE) assistance to quickly complete the investigation.
The objectives are to:




Characterize potential rash cases
Develop hypotheses for potential causes of rash associated with Flint water supply
Make recommendations for public health interventions aimed at mitigating any future risk
of rashes linked to Flint water exposure

The investigation will include a survey administered by telephone to persons reporting rash and a
review of medical charts for those who have received medical care for their rashes. Both
instruments were designed by MDHHS.
MDHHS is coordinating with the Environmental Protection Agency to offer water testing to persons
with rash concerns.
2. Characteristics of the Assessment:
[ ] Standard approval (up to 5 days) is requested for this assessment
[ ] 72 hour approval is requested for this assessment
[ X ] 24 hour approval is requested for this assessment
The Michigan Department of Health and Human Services (MDHHS) is investigating rashes associated
with the contaminated water and needs ATSDR assistance in completing the investigation in order
to quickly respond to the affected community.
3. Location of the Investigation:
Flint, Michigan
4. Agency Requesting Epidemiological Assistance/Name and Title of Requestor:
Jacqueline S. Scott, D.V.M., Ph.D., Director, Bureau of EMS, Trauma and Preparedness

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5. Target Population (check all that apply):
[ X ] Exposed Individuals (complete Question 7, Section A)
[ ] Households (complete Question 7, Section B)
[ ] Health Care Facility Staff (complete Question 7, Section C)
[ ] Veterinary Facility Staff
[ ] Other [insert]
6. Method of Data Collection (Check all that Apply):
[ X ] Questionnaire (specify mode)
[ ] Face-to-Face Interview
[ X ] Telephone Interview
[ ] Self-administered Paper-and-Pencil
[ ] Self-administered Internet
[ ] Focus Groups
[ X ] Medical Chart Abstraction
[ ] Hospital Survey
[ ] Laboratory Sample
[ ] Other. Please describe: [insert]
7. Data to be Collected:
MDHHS is requesting that the investigation continue with its IRB-approved form already in use.
Survey questions collect data about: demographics, history and description of rash illness,
additional symptoms experienced including hair loss, tap water usage, changed in water quality or
pressure, water filtration or treatment, water usage, medical care and treatment, general health
questions.
MDHHS has also developed a medical chart abstraction form to collect demographics, complaint,
signs and symptoms, and medical history.
8. Burden Estimate for Data Collection:
Exposed individuals (100)
Medical charts (100)

Minutes
20
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INVESTIGATION LEAD:
Name: Jevon McFadden, MD, MPH
Title: Medical Epidemiologist & Career Epidemiology Field Officer
Affiliation: Michigan Department of Health and Human Services
US EPA CONTACT:
Name: Mark Durno
Title: On Scene Coordinator (OSC), Homeland Security Advisor / Deputy Chief
Affiliation: US Environmental Protection Agency, Emergency Response Branch

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CDC/ATSDR SPONSORING PROGRAM: Assessment of Chemical Exposures (ACE) Program
NAME, TITLE, AND CONTACT INFORMATION OF PROGRAM CONTACT: Mary Anne Duncan,
Epidemiologist, [email protected], 404-567-3256.
CERTIFICATION:
[INSERT NAME OF ATSDR SPONSORING PROGRAM CONTACT], certify the following to be true:
1. The collection is voluntary.
2. Respondents will not be personally identified in any published reports of the study.
3. Information gathered will be primarily used to inform effective public health response.
ATSDR Sponsoring Program Primary Contact:

Stephanie I. Davis -S

Date:

Digitally signed by Stephanie I. Davis -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=1001232781, cn=Stephanie I. Davis -S
Date: 2016.02.24 17:17:29 -05'00'

Stephanie Davis (NCEH/ATSDR PRA Contact) for Mary Anne Duncan

02/24/2016

REQUESTED APPROVAL DATE:
2/25/2016
DATE REQUEST SUBMITTED TO THE INFORMATION COLLECTION REQUEST LIAISON:
2/24/2016

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Instructions for completing Request for Approval under the “Generic Clearance for Assessment of
Chemical Exposures Investigation”
TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the subject of the
request.
DESCRIPTION OF THIS SPECIFIC COLLECTION:
1. Chemical Incident to be Investigated: Instruction: Provide a summary of the event. The
summary should include all the information you know at this time about the event. At a
minimum, please provide the following information: 1) background necessary to understand
the importance of the event; 2) justification of the need for an assessment, including a
description of any data already available or data gaps that exists; and 3) an explanation of
how the information collected will be used to inform response, recovery, preparedness, or
mitigation measures. Use as much space as necessary (suggested length: 250-500 words).
2. The standard approval using this assessment is up to 5 days. If a 72 – 24-hour approval is
requested, an explanation must be provided as to why it is needed. Specifically, ATSDR
must make a case as to why collection must begin within 72 to 24 hours, and it must be
related to a public health need.
3. Location of the Investigation: Indicate the location where the investigation will occur,
including city and state or country.
4. Agency Requesting Epidemiological Assistance/Name and Title of Requestor: Specify the
name of the agency requesting epidemiological assistance. Include name and title of person
of the requestor. Attach the letter of invitation requesting support. The letter should include
the following information: 1) background on the event and 2) request for ATSDR assistance.
Sensitive information in the Letter of Invitation not appropriate for public dissemination
should be redacted.
5. Target Population: Select or provide a brief description of the targeted group or groups (e.g.,
the general public, health care providers, emergency responders, employees of the
company) for this collection of information.
6. Method of Data Collection: Check the data collection method(s) planned for this
investigation.
7. Type of Data to be collected from Exposed Individuals (Section A), Households (Section B),
and Responding health care facility staff (Section C): Check the type(s) of data to be
collected from potentially exposed persons during this investigation and the questions being
used. If questions from a module are being modified, please indicate so with a (*). List any
new modules being added.
8. Burden Estimate for Data Collection: Provide the estimate of time needed to answer the
Questions listed in 7. If other respondents are being surveyed, list them on the table. If any
survey will be longer than 30 minutes per individual, provide a justification for this burden.
INVESTIGATION LEAD: Indicate the name, title, and affiliation of the person who will be leading the
investigation.

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SPONSORING PROGRAM: Indicate the sponsoring CIO/Division/Branch for this investigation.
NAME, TITLE, AND CONTACT INFORMATION OF PROGRAM CONTACT: Indicate the name and title, and
contact information of the ATSDR Primary Contact for this Investigation.
CERTIFICATION: Please read the certification carefully. Type your name to validate that you are
providing certification. Note: If you incorrectly certify, the collection will be returned as improperly
submitted or it will be disapproved. Certification should be signed by the ATSDR Primary Contact for
this Investigation.
REQUESTED APPROVAL DATE: Indicate the date (MM/DD/YYYY) by which approval is needed.
DATE REQUEST SUBMITTED TO THE INFORMATION COLLECTION REQUEST LIAISON: indicate the date
(MM/DD/YYYY) the request is submitted to the Information Collection Request Liaison (ICRL).
E-mail the completed form to the Information Collection Request Liaison (ICRL), Stephanie Davis, at
[email protected]. If submitting outside business hours and immediate approval is needed, call
404.213.2967 to notify the ICRL of the submission.

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