[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11296-11298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-20-0051; Docket No. ATSDR-2020-0005]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing effort to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ``Assessment of Chemical 
Exposures (ACE) Investigations.'' The purpose of ACE Investigations is 
to focus on performing rapid epidemiological assessments to assist 
state, regional, local, or tribal health departments (the requesting 
agencies) to respond to or prepare for acute environmental incidents.

DATES: ATSDR must receive written comments on or before April 26, 2021.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2020-0005 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
    <bullet> Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. ATSDR will post, without change, all relevant 
comments to Regulations.gov.

    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed 
above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email: 
<a href="/cdn-cgi/l/email-protection#204f4d42604344430e474f56"><span class="__cf_email__" data-cfemail="d2bdbfb092b1b6b1fcb5bda4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Assessment of Chemical Exposures (ACE) Investigations (OMB Control 
No. 0923-0051)--Reinstatement with

[[Page 11297]]

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 
Revision of ``Assessment of Chemical Exposures (ACE) Investigations'' 
information collection request (ICR) (OMB Control No. 0923-0051; 
Expiration Date 03/31/2021). 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. ATSDR would like to continue these impactful 
information collections. A brief summary of recent information 
collections approved under this tool includes the following:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> Characterize exposure and acute health effects of the 
affected community to inform health officials and the community;
    <bullet> Identify needs (i.e., medical, mental health, and basic) 
of those exposed during the incidents to aid in planning interventions 
in the community;
    <bullet> Determine the sequence of events responsible for the 
incident so that actions can be taken to prevent future incidents;
    <bullet> 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
    <bullet> 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, and 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 quickly 
tailored series of draft survey forms used in the field to collect data 
that will 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 former ACE Short Form, now modified as the Epidemiologic 
Contact Assessment Symptom Exposure (Epi CASE) Survey, 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 collected by face-to-face 
interviews, telephone interviews, written surveys, mailed surveys, or 
on-line surveys can be collected. Medical charts may also be considered 
for review. 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 and 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 (900 responses per 
year; 30 hours) will be added prior to administering consent for our 
surveys. The Epi CASE Survey, formerly the ACE Short Form, 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; 333 hours), the Household 
Survey (120 responses per year; 20 hours) and for the Hospital Survey 
(40 responses per year; 17 hours). 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 3,110 annual responses (increase of 1,820 
responses per year) and for 775 annual hours (increase of 184 hours per 
year). Participation in ACE investigations is voluntary and there are 
no anticipated costs to respondents other than their time.

[[Page 11298]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent        (in hr)         (in hr)
----------------------------------------------------------------------------------------------------------------
Residents, first responders,    Eligibility                  900               1            2/60              30
 business owners, employees,     Screener.                 1,000               1           15/60             250
 customers.                     Epi CASE Survey.
                                General Survey..             800               1           25/60             333
Residents.....................  Household Survey             120               1           10/60              20
Hospital staff................  Hospital Survey.              40               1           25/60              17
Staff from state, local, or     Medical Chart                 25              10           30/60             125
 tribal health agencies.         Abstraction
                                 Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             775
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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. 2021-03703 Filed 2-23-21; 8:45 am]
BILLING CODE 4163-18-P


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