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Agency Forms Undergoing Paperwork Reduction Act Review

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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 (404) 639-5960 or send an e-mail to Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice.

Proposed Project

Long-Term Efficacy of a Program to Prevent Beryllium Disease—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Beryllium is a lightweight metal with many applications. Exposed workers may be found in the primary production, nuclear power and weapons, aerospace, scrap metal reclamation, specialty ceramics, and electronics industries, among others. The size of the USA workforce at risk of chronic beryllium disease (CBD), from either current or past work-related exposure to the metal, may be as high as one million. Demand for beryllium is growing worldwide, which means that increasing numbers of workers are likely to be exposed.

Exposure to beryllium can lead to sensitization and cause an immunologic granulomatous lung disease. Sensitization is a cell-mediated allergic-type response that may be detected in the peripheral blood with the beryllium lymphocyte proliferation test (BeLPT), which is used by the industry as a surveillance tool. Workers found to be sensitized may be clinically evaluated for CBD with tests including bronchoalveolar lavage and transbronchial biopsy. Cross-sectional studies in various beryllium workplace populations have identified sensitization in the range of less than 1% to 14% of workers. The proportion of sensitized workers who have beryllium disease at initial clinical evaluation has varied from 10 to 100% in different workplaces. Sensitized workers not initially diagnosed with CBD are often diagnosed with the disease upon follow-up, but whether all sensitized workers will eventually develop beryllium disease is unknown. Industry screening programs have enabled the identification of CBD in persons without apparent symptoms, often early in disease progression (often referred to as “subclinical disease”). Progression from sensitization to subclinical disease to clinical impairment, while difficult to predict for any one individual, is not uncommon.

Currently, there are no preventive programs that have been demonstrated to have long-term effectiveness in preventing beryllium sensitization and CBD among beryllium-exposed workers. In the United States, recent short-term evidence (i.e., average work tenure 16 months, maximum four years) at one facility suggests that the comprehensive Start Printed Page 57582preventive program that was implemented by company management beginning in 2000 has successfully reduced the incidence of beryllium sensitization, as defined by the occurrence of confirmed abnormal BeLPTs. However, the follow-up has thus far been limited to current workers, the duration has been too short to document a reduced incidence of CBD, and it is possible that sensitization has been delayed, rather than prevented. Evaluation of this program's effectiveness would therefore be more complete by including individuals who have left employment and documenting whether: (1) The program was effective at two other facilities at which it was implemented, (2) the program prevented beryllium sensitization over a longer period of time (i.e., up to eight years); and (3) the program prevented CBD, which generally takes longer to develop.

Study Design

This proposed study is designed to evaluate the effectiveness of a comprehensive preventive program at three beryllium plants. Approximately 579 eligible workers for this survey include those hired between implementation of a comprehensive program (2000) and December 31, 2008, including any already known to be sensitized. NIOSH will offer all eligible current and former workers the BeLPT to identify sensitization and administer a work and medical history questionnaire.

There are no costs to former worker respondents except their time to participate in the interview; current workers will participate during work hours and thus compensated by their employer, and former workers will participate during their own time. The total estimated annualized burden hours are 193.

Estimated Annualized Burden Hours

Type of respondentsNumber of respondentsNumber responses per respondentAverage burden/ response (in hours)
Former workers113145/60
Current workers80145/60
Participant Consent and Authorization for Release of Information193115/60
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Dated: October 2, 2007.

Maryam I. Daneshvar,

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

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[FR Doc. E7-19878 Filed 10-9-07; 8:45 am]