[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