2014-12535. Proposed Data Collections Submitted for Public Comment and Recommendations

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404-639-7570 or send comments to LeRoy Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [e-mail].

Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice.

Proposed Project

Assessment of Chemical Exposures (ACE) Investigations—New—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 generic clearance for the Assessment of Chemical Exposures (ACE) Investigations to assist state and local health departments after toxic substance spills or chemical incidents. ACE investigations are a component of the National Toxic Substance Incidents Program (NTSIP). NTSIP was introduced in 2010 as a comprehensive agency approach to toxic substance incident surveillance, prevention, and response. This three-part program includes a proposal for state-based surveillance for toxic substance releases, a national database of toxic substance incidents combining data from many sources, and the ACE investigations.

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; and

4. identify cohorts that may be followed and assessed for persistent health effects resulting from acute releases.

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 multi-disciplinary 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 Rapid Response Registry 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. In the past, ACE investigations have been performed in response to requests for assistance from state, regional, local, or tribal health departments under OMB No. 0920-0008, which expires July 31, 2014. 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.)	Total burden (in hrs.)
ACE Investigation on Respondents	General Survey	800	1	30/60	400
	Household Survey	120	1	15/60	30
	Rapid Response Registry Form	50	1	7/60	6
	Hospital Survey	40	1	30/60	20
	Medical Chart Abstraction Form	250	1	30/60	125
	Veterinary Chart Abstraction Form	30	1	20/60	10
Total					591

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.