2018-00141. 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 August 30, 2017 to obtain comments from the public and affected agencies. ATSDR did not receive 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 [phone] or send an email to [e-mail]. 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 [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

Assessment of Chemical Exposures (ACE) Investigations OMB Control No: 0923-0051 (Expiration Date: 03/31/2018)—Revision—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) revision of generic clearance information collection request 0923-0051 titled “Assessment of Chemical Exposures (ACE) Investigations” to assist state and local health departments after toxic substance spills or chemical incidents. The PRA clearance for this information collection request expires 3/31/2018. In this revision, we are renaming the form previously titled the Rapid Response Registry Form as the ACE Short Form. This revision better describes the use of the ACE Short Form in time-limited investigations where longer surveys are not possible. We do not use the form to establish registries. In addition, we are removing two insurance questions from the ACE Short Form, as they are not currently asked in the longer surveys. There are no changes to the requested burden hours.

ATSDR has successfully completed three investigations to date using this PRA clearance and would like to continue this impactful information collection. Briefly summarized below are the accomplishments of this information collection:

• During 2015, in U.S. Virgin Islands there was a methyl bromide exposure at a condominium resort. Under this ACE investigation, awareness was raised among pest control companies that methyl bromide was prohibited for use in homes and other residential settings. Additionally, awareness was raised for 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.
• During 2016, 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, ACE team also conducted a follow-up investigation for people who were exposed to the Flint municipal water and sought care from the free dermatologists. Data analysis for this project is in process and results are pending. However, the follow-up interviews resulted in improving the exam and referral processes that were still on going at the time.

The ACE investigations 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 chemical releases.

The main objectives for performing these rapid assessments are to:

1. Characterize exposure and acute health effects of respondents exposed to toxic substances from discrete, chemical releases and determine their health statuses;

2. Identify needs (i.e. medical and basic) of those exposed during the releases to aid in planning interventions in the community;

3. Assess the impact of the incidents on health services use and share lessons learned for use in hospital, local, and state planning for chemical incidents.

Because each chemical incident is different, it is not possible to predict in advance exactly what type of and how many respondents will need to 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, pet owners, and those passing through the affected area.

Data will be collected by the multidisciplinary ACE team consisting of staff from ATSDR, the Centers for Disease Control and Prevention (CDC), and the requesting agencies. ATSDR has developed a series of draft survey forms that can be quickly tailored in the field to collect data that will meet the goals of the investigation. They 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 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 pets, and demographic data. Hospital personnel are asked about the surge, response and communication, decontamination, and lessons learned.

Depending on the situation, data may be collected by face-to-face interviews, telephone interviews, written surveys, mailed surveys, or on-line surveys. Medical and veterinary charts may also be reviewed. In rare situations, an investigation might involve collection of clinical specimens.

ATSDR anticipates up to four ACE investigations per year. The number of participants has ranged from 30-715, averaging about 300 per year. Therefore, the total annualized estimated burden will be 591 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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)
Residents, first responders, business owners, employees, customers	General Survey ACE Short Form	800 50	1 1	30/60 7/60
Residents	Household Survey	120	1	15/60
Hospital staff	Hospital Survey	40	1	30/60
Staff from state, local, or tribal health agencies	Medical Chart Abstraction Form Veterinary Chart Abstraction Form	250 30	1 1	30/60 20/60

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.