[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Notices]
[Pages 57581-57582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-08-07AY]


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) 639-5960 or send an e-mail 
to [email protected]. 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

[[Page 57582]]

preventive 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
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                                                                                      Number      Average burden/
                       Type of respondents                           Number of     responses per      response
                                                                    respondents     respondent      (in hours)
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Former workers..................................................             113               1           45/60
Current workers.................................................              80               1           45/60
Participant Consent and Authorization for Release of Information             193               1           15/60
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    Dated: October 2, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E7-19878 Filed 10-9-07; 8:45 am]
BILLING CODE 4163-18-P