Agency Forms Undergoing Paperwork Reduction Act Review

Federal RegisterOct 21, 1999

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-00-04]

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 (404) 639-7090. Send written

comments to CDC, Desk Officer; Human Resources and Housing Branch, New

Executive Office Building, Room 10235; Washington, DC 20503. Written

comments should be received within 30 days of this notice.

Proposed Project

Gene-Environment Interactions in Beryllium Sensitization and

Disease Among Current and Former Beryllium Industry Workers--NEW--

National Institute for Occupational Safety and Health (NIOSH).

Beryllium is a light weight metal with wide application in modern

technology. The size of the U.S.A. Workforce at risk of beryllium

exposure is estimated at approximately 30,000, with exposed workers in

primary production, nuclear power and weapons, aerospace, scrap metal

reclaiming, specialty ceramics, and electronics industries. Demand for

beryllium is growing worldwide, which means that increasing numbers of

workers are likely to be exposed. An acute pneumonitis due to

occupational exposure to beryllium was common in the 1940s and 1950s,

but has virtually disappeared with improvements in work-site control

measures. Even with the improved controls, as many as 5% of currently-

exposed workers will develop chronic beryllium disease (CBD).

CBD is a chronic granulomatous lung disease mediated through a

poorly understood immunologic mechanism in workers who become

sensitized. Sensitization can be detected using a blood test, that is

used by the industry as a screening tool. The screening test for

sensitization was first reported in 1989, but many questions remain

about the natural history of sensitization and disease, as well as

exposure risk factors. Sensitized workers, identified through workplace

screening programs, undergo clinical diagnostic tests to determine

whether they have CBD. The proportion of sensitized workers who have

beryllium disease at initial clinical evaluation has varied form 41-

100% in different workplaces. Sensitized workers often develop CBD with

follow-up, but whether all sensitized workers will eventually develop

beryllium disease is unknown. Early diagnosis at the subclinical stage

and careful follow-up seems prudent in that CBD usually responds to

corticosteroid treatment. However, the efficacy of screening in

preventing adverse outcomes of the disease has not yet been evaluated.

While recent research has suggested that a genetic determinant of the

immune response could be a susceptibility factor, this has not been

well characterized.

The National Institute of Occupational Safety and Health (NIOSH)

wants to determine how beryllium workers and former workers develop

beryllium disease and how to prevent it. Through the proposed study,

NIOSH has the opportunity to contribute to the scientific understanding

of this disease in the context of environmental and genetic etiologic

factors. The goals of this investigation are to: (1) determine the

incidence of beryllium sensitization or disease over a 6-year period;

(2) seek an association with exposure measurements; (3) identify a

genetic determinant of susceptibility to CBD; and (4) characterize that

genetic determinant to ascertain if it is associated with clinical

impairment or progression of disease. Through a greater understanding

of the environmental and genetic risk factors associated with the onset

and progression of CBD, NIOSH will be able to develop strategies for

both primary and secondary prevention applicable to beryllium-exposed

workers. The total annual burden hours are 250.

[[Page 56797]]

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Hours per

Respondents Number of Responses per response (in

respondents respondent hrs.)

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Former Workers............................................... s60,175 1 0.5

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Dated: October 13, 1999.

Nancy Cheal,

Acting Associate Director for Policy, Planning, and Evaluation, Centers

for Disease Control and Prevention (CDC)

[FR Doc. 99-27193 Filed 10-20-99; 8:45 am]

BILLING CODE 4163-18-M

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