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 June 25, 2024, to obtain comments from the public and affected agencies. ATSDR received one comment 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. 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. The current OMB approval for this information collection expires 10/31/2024. ATSDR has successfully completed three investigations to date. With the uses of this valuable mechanism, ATSDR 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, awareness among pest control companies that methyl bromide is currently 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, ACE Investigations teams conducted a rash investigation in Flint, Michigan. Persons exposed to Flint municipal water who had current or worsening rashes surveyed were referred too free dermatologist screening if desired. Findings revealed that when the city was using water from the Flint River, where there were large swings in chorine, pH, and hardness, which could be one possible explanation for the eczema-related rashes.
• During 2016, ACE Investigations teams also conducted a follow-up investigation for people who were exposed to the Flint municipal water and sought care from the free dermatology exam. The follow-up interviews resulted in improving 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 (the 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 Investigations 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 tailored series of draft survey forms used in the field to collect data that will meet the goals of each 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 method, ATSDR expects to be able to survey many more people than during previous large disasters. A brief Eligibility Screener will be conducted before the General or Epi CASE survey to make sure respondents 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 (now 17 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 we have 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 mental health screeners are replaced by three shorter ones and the Race/Ethnicity questions are now consistent with OMB guidance. 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 (now 60 minutes, 1000 responses annually). The Household Survey will be removed because of little use. The Hospital Survey for Emergency Department (ED) nurses and other health professionals on how they handled the response is unchanged (40 responses per year; 17 hours). ATSDR is 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 new OMB standards. This will have no effect on overall burden (250 responses per year; 125 hours).

ATSDR anticipates approximately one ACE investigation per year. ATSDR requests approval 1,508 annual burden hours. Participation in ACE investigations is voluntary and there are no anticipated costs to respondents other than their time.