Notice2024-13904
Proposed Data Collection Submitted for Public Comment and Recommendations
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 25, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Abstract
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 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].
Full Text
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<title>Federal Register, Volume 89 Issue 122 (Tuesday, June 25, 2024)</title>
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[Federal Register Volume 89, Number 122 (Tuesday, June 25, 2024)]
[Notices]
[Pages 53103-53105]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[60Day-24-0051; Docket No. ATSDR-2024-0002]
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 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 August 26,
2024.
ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2024-0002 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. 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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. ATSDR will post, without change, all relevant
comments to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal
eRulemaking portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#8fe0e2edcfecebeca1e8e0f9"><span class="__cf_email__" data-cfemail="90fffdf2d0f3f4f3bef7ffe6">[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;
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; and
5. Assess information collection costs.
Proposed Project
Assessment of Chemical Exposures (ACE) Investigations (OMB Control
Number 0923-0051, Exp. 10/31/2024)--Revision--Agency for Toxic
Substances and Disease Registry (ATSDR).
Background and Brief Description
The Agency for Toxic Substances and Disease Registry (ATSDR) is
requesting to revise the Assessment of Chemical Exposures (ACE)
Investigations information collection project and seeks a three-year
OMB approval to assist state and local health departments after toxic
substance spills or other acute environmental incidents. ATSDR has
successfully completed three
[[Page 53104]]
investigations to date, and would like to continue this impactful
information collection. See below for a brief summary of information
collections approved under this tool:
<bullet> During 2015, in U.S. Virgin Islands there was a methyl
bromide exposure at a condominium resort. Under this ACE investigation,
pest control companies were made aware that methyl bromide use is
prohibited in homes and other residential settings. Additionally,
clinicians were made aware of 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 exposed to Flint municipal water who 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 exposed to the Flint municipal water
and sought care from dermatologists. The follow-up interviews resulted
in improvement of the exam and referral processes that were still
ongoing at the time.
ACE Investigations have focused on performing rapid epidemiological
assessments to assist state, regional, local, or tribal health
departments (requesting agencies) to respond to or prepare for acute
environmental incidents. 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 used 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
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 self-administered 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 also like to broaden who we
may assist to include other federal public health agencies. ATSDR
proposes revisions to select information collection forms, which will
be deployed online or using handheld devices whenever possible to
reduce burden, and to adjust the number of responses and time per
response for several forms. Because of this addition of online self-
administration we are expecting to be able to survey more respondents
than previously done during large disasters. A brief Eligibility
Screener will be conducted before the General or Epi CASE survey to
make sure they were in the area at the time of the incident, before
consenting them to be surveyed. The number of people to be screened
will be increased to 2,500 responses per year. The shorter Epi CASE
survey has been modified to incorporate the symptom checker showcard
into the survey so that it can be easily self-administered online, and
questions on functional disabilities were added as requested by
stakeholders adding two minutes and 1,000 respondents. The General
survey will also have an online option. For simplicity, adolescents
will no longer be eligible to take the General Survey and the Child
Survey will become a module of the General Survey for adults to answer
for their minor children. At stakeholder direction, ATSDR has added
modules to the General Survey for responder, pets, and livestock
health, and a community resilience qualitative question bank. The
General Survey has also added questions requested by stakeholders on
functional disabilities and maternal and child health. The two existing
long-term mental health screeners are replaced by three shorter
versions and the race/ethnicity questions are now consistent with
revised OMB Standards. Qualitative questions were added to several
sections throughout the survey. These changes add to the time of the
survey and the online self-administration option allows for an increase
in respondents (60 minutes, 1000 responses annually). The Household
Survey will be removed because of little use. The Hospital Survey for
emergency department nurses and other health professionals on how they
handled the response is unchanged (40 responses per year; 17 hours). We
are modifying the Medical Chart Abstraction Form with slight question
changes suggested by a medical toxicologist, and by adding functional
disability questions and modifying the race/ethnicity questions to the
OMB Standard. This results in no change to burden (250 responses per
year; 125 hours).
ATSDR anticipates one ACE investigation per year and is requesting
OMB approval for 4,815 annual responses and for 1,508 annual burden
hours. Participation in ACE investigations is voluntary and there are
no anticipated costs to respondents other than their time.
[[Page 53105]]
Estimated Annualized Burden Hours
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Average
Number of Number of Burden per Total burden
Type of respondents Form name respondents Responses per response (in (in hours)
respondent hours)
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Residents, first responders, Eligibility 2,500 1 2/60 83
business owners, employees, Screener. 1,000 1 17/60 283
customers. Epi CASE Survey.
General survey.. 1,000 1 60/60 1,000
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..................... ................ 4,565 .............. .............. 1,508
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-13904 Filed 6-24-24; 8:45 am]
BILLING CODE 4163-18-P
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