2014-04970. 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 [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

An Investigation of Lung Health at an Indium-Tin Oxide Production Facility—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. The Occupational Safety and Health Act, Public Law 91-596 (section 20[a][1]), authorizes NIOSH to conduct research to advance the health and safety of workers. NIOSH is proposing to conduct a study regarding the lung health of workers at an indium-tin oxide production facility.

Indium-tin oxide (ITO) is a sintered material used in the manufacture of devices such as liquid crystal displays, touch panels, solar cells, and architectural glass. Indium lung disease is a novel, potentially fatal industrial disease that has occurred in workers making, using, or recycling ITO. This project aims to understand and prevent this occupational lung disease by investigating the relationship between exposure and lung health among current ITO manufacturing workers.

CDC requests Office of Management and Budget (OMB) approval to collect standardized information from current employees of the ITO production facility through an informed consent document, an interviewer-administered questionnaire, and a contact information form. As part of the same project, employees will be offered the opportunity to participate in medical testing and personal air sampling.

The questionnaire will collect contact information, demographic information, respiratory symptoms and diagnoses, work history, and cigarette smoking history. The questionnaire will allow NIOSH to report individual medical test results to each participant and to analyze aggregate data from the workforce to determine risk factors for abnormal lung health indices derived from the medical test results. The individual results will be used by employees and their personal physicians to make medical decisions, such as whether to pursue additional testing. The aggregate results will be used by NIOSH, facility management, and employees in ongoing efforts to reduce exposures and monitor key health indices.

For this study, we will recruit all current employees of the ITO production facility. Participation is voluntary. We anticipate approximately 100 study participants. Employees who wish to participate in the questionnaire and medical testing will review and sign an informed consent document. Employees who wish to participate in the personal air sampling and would like to receive personal results will complete a contact information form. Participants who wish to release medical records to NIOSH or to have NIOSH release the results of our medical testing to a personal physician will need to complete the appropriate records release forms.

The questionnaire will be administered privately at the workplace during normal working hours by trained NIOSH staff. Employees who are not available at the workplace during the study will be offered the opportunity to respond to the questionnaire at a later date by telephone.

There are no costs to participants other than their time.

The total estimated burden for the one-time collection of data is 254 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Current ITO production facility employees	Recruitment letter	100	1	5/60
	Consent to participate in a research study	95	1	15/60
	Authorization to disclose health information	95	1	5/60
	Indium facility questionnaire	95	1	20/60
	Medical testing	95	1	100/60
	Script for collection of industrial hygiene samples	95	1	5/60
	Personal air sampling results contact information form	95	1	5/60
	Exposure monitoring	95	1	5/60

Leroy 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.