[Federal Register Volume 72, Number 81 (Friday, April 27, 2007)]
[Notices]
[Pages 21022-21023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-07AY]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Joan Karr, CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to
[email protected].
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 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 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. Eligible
workers for this survey include those hired between implementation of a
comprehensive program (2000-01) 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 will thus be compensated for their time by their
employer. Former workers will participate during their own time.
Estimate of Annualized Burden Hours
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Number of Avg. burden/
Respondents Number of responses/ response (in Total burden
respondents respondent hours) (in hours)
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Current Workers................................. 239 1 45/60 179
Former Workers.................................. 340 1 45/60 255
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Total....................................... 579 434
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[[Page 21023]]
Dated: April 23, 2007.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E7-8075 Filed 4-26-07; 8:45 am]
BILLING CODE 4163-18-P