[Federal Register Volume 86, Number 100 (Wednesday, May 26, 2021)]
[Notices]
[Pages 28352-28354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-21-0051]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Agency 
for Toxic Substances and Disease Registry (ATSDR) has submitted the 
information collection request titled ``Assessment of Chemical 
Exposures (ACE) Investigations'' to the Office of Management and Budget 
(OMB) for review and approval. ATSDR previously published a ``Proposed 
Data Collection Submitted for Public Comment and Recommendations'' 
notice on 02/24/2021 to obtain comments from the public and affected 
agencies. ATSDR received no comments related to the previous notice. 
This notice serves to allow an additional 30 days for public and 
affected agency comments.
    ATSDR will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Assessment of Chemical Exposures (ACE) Investigations (OMB Control 
No. 0923-0051, Exp. 02/28/2021)--Reinstatement with Change--Agency for 
Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a three-year Paperwork Reduction Act (PRA) clearance for the 
generic clearance information collection request (Generic ICR) titled 
``Assessment of Chemical Exposures (ACE) Investigations'' (OMB Control 
No. 0923-0051; Exp. Date 02/28/2021). This request is a Reinstatement 
with Change.
    ATSDR conducts ACE Investigations to assist state and local health 
departments after acute environmental incidents. ATSDR has successfully 
completed five investigations to date using this valuable mechanism, 
and would like to continue these impactful information collections. A 
summary of recent information collections approved under this tool 
includes the following:
     During 2015, in U.S. Virgin Islands there was a methyl 
bromide exposure incident at a condominium resort severely injuring a 
family and causing symptoms in the first responders to the incident. 
ATSDR interviewed all potentially exposed persons who stayed or worked 
at the resort to look for signs of exposure. Under this ACE 
investigation, ATSDR raised awareness among pest control companies that 
methyl bromide is currently prohibited in homes and other residential 
settings. Additionally, ATSDR raised awareness among clinicians about 
the toxicologic syndrome caused by exposure to methyl bromide and the 
importance of notifying first responders immediately when they have 
encountered contaminated patients.

[[Page 28353]]

     During 2016, the ACE Team conducted a rash investigation 
in Flint, Michigan. Persons who were exposed to Flint municipal water 
and had current or worsening rashes were surveyed and referred to free 
dermatologist screening if desired. Findings revealed that when the 
city was using water from the Flint River, there were large swings in 
chorine, pH, and hardness, which could be one possible explanation for 
the eczema-related rashes.
     During 2016, the ACE Team also conducted a follow-up 
investigation for people who were referred to a dermatologist in the 
first Flint investigation. The follow-up interviews resulted in 
improvements in medical exam and referral processes that were still on-
going at the time.
    The ACE Investigations have focused on performing rapid 
epidemiological assessments to assist state, regional, local, or tribal 
health departments (the requesting agencies) to respond to, or prepare 
for acute chemical releases. The main objectives for performing these 
rapid assessments are to:
     Characterize exposure and acute health effects of the 
affected community to inform health officials and the community;
     Identify needs (i.e., medical, mental health, and basic) 
of those exposed during the incidents to aid in planning interventions 
in the community;
     Determine the sequence of events responsible for the 
incident so that actions can be taken to prevent future incidents;
     Assess the impact of the incidents on the emergency 
response and health services use and share lessons learned for use in 
hospital, local, and state planning for environmental incidents; and
     Identify cohorts that may be followed and assessed for 
persistent health effects resulting from environmental releases.
    Because each incident is different, it is not possible to predict 
in advance exactly what type of, or how many respondents will be 
consented and interviewed to effectively evaluate the incident. 
Respondents typically include, but are not limited to, emergency 
responders such as police, fire, hazardous material technicians, 
emergency medical services, and personnel at hospitals where patients 
from the incident were treated. Incidents may occur at businesses or in 
the community setting; therefore, respondents may also include business 
owners, managers, workers, customers, community residents, and those 
passing through the affected area.
    The multidisciplinary ACE Team consisting of staff from ATSDR, the 
Centers for Disease Control and Prevention (CDC), and the requesting 
agencies will be collecting data. ATSDR has developed a series of draft 
survey forms to be quickly tailored in the field to meet the goals of 
the investigation. ATSDR collections will be administered based on time 
permitted and urgency. For example, it is preferable to administer the 
General Survey to as many respondents as possible. However, if there 
are time constraints, the shorter Household Survey or the Epidemiologic 
Contact Assessment Symptom Exposure (Epi CASE) Survey (proposed to 
replace the former ACE Short Form), may be administered instead. The 
individual surveys collect information about exposure, acute health 
effects, health services use, medical history, needs resulting from the 
incident, communication during the release, health impact on children, 
and demographic data. Hospital personnel are asked about the surge, 
response and communication, decontamination, and lessons learned.
    Depending on the situation, data can be collected by face-to-face 
interviews, telephone interviews, written surveys, mailed surveys, or 
on-line surveys. Medical charts may also be reviewed. In rare 
situations, an investigation might involve collection of clinical 
specimens.
    ATSDR is proposing to increase the utility of this Generic ICR in 
response to stakeholder requests. We would like to expand the ACE 
toolkit to be more inclusive of other types of environmental incidents 
affecting the community which fall under ATSDR's mandate and, at times, 
the mandates of our partners in the CDC's National Center for 
Environmental Health (NCEH) and the National Center for Occupational 
Safety and Health (NIOSH). In addition to acute chemical releases, we 
propose to include radiological and nuclear incidents, explosions, 
natural disasters, and other environmental incidents.
    We propose revisions to select information collection forms, which 
will be deployed using handheld devices whenever possible to reduce 
burden, and to adjust the number of responses and time per response for 
several forms. A new brief Eligibility Screener (1,000 responses per 
year; 33 hours) will be added prior to administering consent for our 
General and Household Surveys. The Epi CASE Survey replaces the ACE 
Short Form, which has been modified for the expanded scope of eligible 
incidents requested (1,000 responses per year; 250 hours). To reduce 
time burden, there will be new field data entry screens and deletion of 
unused questions for the General Survey (800 responses per year; 373 
hours), the Household Survey (120 responses per year; 20 hours) and for 
the Hospital Survey (40 responses per year; 17 hours). There will be 
two optional short Mental Health Screeners added to the General Survey. 
One screener measures both acute stress disorder and major depressive 
disorder, and the other one is strictly focused on generalized anxiety 
disorder. We are retaining the Medical Chart Abstraction Form (250 
responses per year; 125 hours) but are removing the Veterinary Chart 
Abstraction Form as it has not been used in the past.
    ATSDR anticipates up to four ACE investigations per year. We are 
requesting approval for 3,210 annual responses (increase of 1,920 
responses per year) and for 818 annual hours (increase of 227 hours per 
year). Participation in ACE investigations is voluntary and there are 
no anticipated costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
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Residents, first responders, business   Eligibility Screener....           1,000               1            2/60
 owners, employees, customers.          Epi CASE Survey.........           1,000               1           15/60
                                        General Survey..........             800               1           28/60
Residents.............................  Household Survey........             120               1           10/60
Hospital staff........................  Hospital Survey.........              40               1           25/60

[[Page 28354]]

 
Staff from state, local, or tribal      Medical Chart                         25              10           30/60
 health agencies.                        Abstraction Form.
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-11146 Filed 5-25-21; 8:45 am]
BILLING CODE 4163-70-P