[Federal Register Volume 72, Number 81 (Friday, April 27, 2007)]
[Notices]
[Pages 21022-21023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8075]


-----------------------------------------------------------------------

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 
omb@cdc.gov.
    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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Avg. burden/
                   Respondents                       Number of      responses/     response  (in   Total burden
                                                    respondents     respondent        hours)        (in hours)
----------------------------------------------------------------------------------------------------------------
Current Workers.................................             239               1           45/60             179
Former Workers..................................             340               1           45/60             255
                                                 ---------------------------------------------------------------
    Total.......................................             579                                             434
----------------------------------------------------------------------------------------------------------------



[[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