[Federal Register Volume 89, Number 122 (Tuesday, June 25, 2024)]
[Notices]
[Pages 53103-53105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     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 www.regulations.gov.

    Please note:  Submit all comments through the Federal 
eRulemaking portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; 
Email: [email protected].

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:
     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.
     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.
     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:
     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 used 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, 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)
----------------------------------------------------------------------------------------------------------------
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