E5-8102. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

NCEH/ATSDR Exposure Investigations (EIs)—New—National Center for Environmental Health (NCEH) and the Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

This is a brief summary of a joint clearance between the NCEH and ATSDR, (hereafter ATSDR will represent both ATSDR and NCEH). ATSDR is mandated pursuant to the 1980 Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and its 1986 Amendments, the Superfund Amendments and Reauthorization Act (SARA) to prevent or mitigate adverse human health effects and diminished quality of life resulting from the exposure to hazardous substances in the environment. Exposure Investigations (EIs) is an approach developed by ATSDR that employs targeted biologic (e.g., urine, blood, hair samples) and environmental (e.g., air, water, soil, or food) sampling to determine whether people are or have been exposed to unusual levels of pollutants at specific locations (e.g., where people live, spend leisure time, or anywhere they might come into contact with contaminants under investigation). After a chemical release or suspected release into the environment, ATSDR's EIs are used by public health professionals, environmental risk managers, and other decision makers to determine if current conditions warrant intervention strategies to minimize or eliminate human exposure. EIs are usually requested by officials of a state health agency, county health departments, the Environmental Protection Agency, the general public, and ATSDR staff.

All of ATSDR's biomedical assessments and some of the environmental investigations involve participants. Participation is completely voluntary. To assist in interpreting the sampling results, a survey questionnaire appropriate to the specific contaminant will be administered to participants. ATSDR collects contact information (e.g., name, address, phone number) to provide the participant with their individual results. Name and address information are broken into nine separate questions (data fields) for computer entry. General information, which includes height, weight, age, race, gender, etc., is needed primarily on biomedical investigations to assist with results interpretation. General information can account for approximately 28 questions per investigation. Some of this information is investigation-specific; not all of this data is collected for every investigation. ATSDR is seeking approval for a set of 57 potential general information questions.

ATSDR also collects information on other possible confounding sources of chemical(s) exposure such as medicines taken, foods eaten, etc. In addition, ATSDR asks questions on recreational or occupational activities that could increase exposure potential. This information represents an individual's exposure history. To cover these broad categories, ATSDR is also seeking approval for the use of sets of topical questions. Of these, ATSDR will use approximately 12-15 questions about the pertinent environmental exposures per investigation. This number can vary depending on the number of chemicals being investigated, the route of exposure (breathing, eating, touching), and number of other sources (e.g., products, jobs) for the chemical(s).

Typically, the number of participants in an individual EI ranges from 10 to less than 50. Questionnaires are generally needed in less than half of the EIs (approximately 10-15 per year).

Areas for the complete set of topical questions include the following:

(1) Media specific which includes: air (indoor/outdoor); water (water source and plumbing); soil, and food (gardening, fish, game, domestic animals).

(2) Other sources such as: occupation; hobbies; household uses or house construction; lifestyle (e.g., smoking); medicines and/or health conditions, and foods.

There are no costs to the respondents other than their time. The estimated total burden hours are 375.

Estimate of Annualized Burden Table

Respondents per response	No. of respondents	Responses per respondent	Average burden
Exposure Investigation Participants	750	1	30/60

Dated: December 23, 2005.

Betsey Dunaway,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.