[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Notices]
[Pages 10369-10371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-11-0020]


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 Carol E. Walker, 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

    Coal Workers' Health Surveillance Program (CWHSP)-OMB 0920-0020, 
exp. 4/31/2011--Revision The National Institute for Occupational Safety 
and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    This submission will incorporate the National Coal Workers' X-Ray 
Surveillance Program 42 CFR part 37 (0920-0020) and National Coal 
Workers' Autopsy Study 42 CFR 37.204 (0920-

[[Page 10370]]

0021) into one complete package which will be called the Coal Workers' 
Health Surveillance Program (CWHSP). Upon OMB approval, 0920-0021 will 
be discontinued. CWHSP is a congressionally-mandated medical 
examination program for monitoring the health of underground coal 
miners, established under the Federal Coal Mine Health and Safety Act 
of 1969, as amended in 1977 and 2006, Public Law 95-164 (the Act). The 
Act provides the regulatory authority for the administration of the 
CWHSP. This Program, which includes both a health surveillance and an 
autopsy component, has been useful in providing tools for protecting 
the health of miners (whose participation is entirely voluntary), and 
also in documenting trends and patterns in the prevalence of coal 
workers' pneumoconiosis (`black lung' disease) among miners employed in 
U.S. coal mines. During the early 1970s, one out of every three miners 
examined through the CWHSP who had worked at least 25 years underground 
had evidence of pneumoconiosis on their chest x-ray. An analysis among 
over 25,000 miners who participated in the x-ray Programs from 1996 to 
2002 indicated that the proportion of affected individuals had 
decreased to about one in 20. However, recent surveillance analyses and 
research studies have confirmed that the prevalence of `black lung' 
disease is increasing, there is regional clustering of rapidly 
progressive pneumoconiosis cases, and coal miners have a higher risk of 
disease if they perform certain jobs, work in smaller mines, or are 
from certain geographic areas. Importantly, young coal miners are 
developing the disabling and lethal forms of `black lung'.

Coal Workers' Health Surveillance Program (CWHSP)

    Demographic and logistical information is gathered from coal mine 
operators and participating x-ray facilities. Participating miners also 
provide health and work histories, and participating physicians report 
radiographic findings. The Centers for Disease Control and Prevention's 
National Institute for Occupational Safety and Health, Division of 
Respiratory Disease Studies, 1095 Willowdale Road, Morgantown, WV 
26505, also called the Appalachian Laboratory for Occupational Safety 
and Health (ALOSH), is charged with administration of this Program.
    From October 1, 1999 through September 30, 2002, the Mine Safety 
and Health Administration (MSHA), in consultation with NIOSH, conducted 
a pilot health surveillance program for both underground and surface 
miners (The Miners' Choice Program). The Miners' Choice Program has 
been continued as an extension of the CWHSP (currently called the 
Enhanced Coal Workers' Health Surveillance Program--ECWHSP). This 
extension of the CWHSP currently operates utilizing a mobile 
examination unit which travels to mining regions to provide locally 
accessible and more comprehensive health surveillance, including chest 
radiography, spirometry, and blood pressure screening.
    Under the Act, the provision of periodic chest x-ray examinations 
is specifically mandated, and the x-rays are to be supplemented by such 
other tests as the Secretary deems necessary. In addition to 
radiographically-apparent pneumoconiosis, miners are at risk for the 
development of chronic obstructive pulmonary disease (COPD). Chest 
radiographs alone cannot provide a measure of airflow obstruction and 
therefore often miss important lung disease. For this reason, 
spirometry, a simple breathing test, is an additional component that is 
particularly useful for the health assessment of miners. Periodic 
medical history and spirometry tests have been recommended by NIOSH for 
both surface and underground coal miners since 1995, to facilitate 
preventive actions, increase miners' participation in programs for 
early detection of disease, and improve the derivation of 
representative estimates of the burden, distribution, and determinants 
of occupational lung disease in relation to coal mining in the U.S. 
Finally, unrecognized hypertension has previously been observed among 
many miners, and the ECWHSP offers blood pressure screening as a safe, 
simple, and inexpensive test, which can help target initiation of 
proven health conserving medications.
    The National Coal Workers' Autopsy Study (NCWAS) provides 
standardized lung specimens for ongoing scientific research as well as 
information to the next-of-kin regarding the presence and extent of 
coal workers' pneumoconiosis (black lung) in the lungs of the deceased 
miner. The Consent Release and History Form is primarily used to obtain 
written authorization from the next-of-kin to perform an autopsy on the 
deceased miner. Because a basic reason for the post-mortem examination 
is research (both epidemiological and clinical), a minimum of essential 
information is collected regarding the deceased miner, including 
occupational history and smoking history. The data collected are used 
by scientists for research purposes in defining the diagnostic criteria 
for pneumoconiosis and in correlating pathologic changes with exposures 
and x-ray findings.
    There are no costs of the NCWAS to respondents other than their 
time. Overall, there are no direct costs to CWHSP participants.
    The total estimated annualized burden hours is 4120.
    This estimate is based on the following:
     Pathologist Invoice--It is estimated that only 5 minutes 
is required for the pathologist to put a statement on the invoice 
affirming that no other compensation is received for the autopsy.
     Pathologist Report--Since an autopsy report is routinely 
completed by a pathologist, the only additional burden is the specific 
request of abstract of terminal illness and final diagnosis relating to 
pneumoconiosis. Therefore, only 5 minutes of additional burden is 
estimated for the autopsy report.
     Consent, Release and History Form (2.6)--From past 
experience, it is estimated that 15 minutes is required for the next-
of-kin to complete this form.
     Roentgenographic Interpretation Form (2.8)--Physicians (B 
Readers) fill out this form regarding their interpretations of the x-
rays (each x-ray has at least two separate interpretations). Based on 
prior practice it takes the physician approximately 3 minutes per form.
     Interpreting Physician Certification Document (2.12)--
Physicians taking the B Reader Examination are asked to complete this 
registration form that takes approximately 10 minutes.
     Miner Identification Document (2.9)--Miners who elect to 
participate in either the CWHSP must fill out this document which 
requires approximately 20 minutes. The actual shooting of the chest 
image takes approximately 15 minutes.
     Miners participating in the ECWHSP portion of the Program 
are asked to perform a spirometry test which requires no additional 
paperwork, but does require approximately 15 to 20 minutes for the test 
itself. The 2500 respondents listed in the burden table below account 
for about \1/2\ of the total participants.
     Coal Mine Operators Plan (2.10)--Mine operators are 
required to file a Mine X-ray Plan with NIOSH every 3 years. To 
complete this form with all requested information (including a roster 
of current employees) takes approximately 30 minutes.
     Facility Certification Document (2.11)--X-ray facilities 
seeking NIOSH-approval to provide miner x-rays under the CWHSP must 
complete an approval packet. It is anticipated that since the

[[Page 10371]]

CWHSP will soon be accepting digital images as well as the traditional 
analog x-ray films, the number of x-ray facilities participating will 
increase over the next several years. This increase is reflected in 
this submission. The forms associated with this approval process 
require approximately 30 minutes for completion.

                                           Estimated Annualized Burden
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                                                                                      Average
                                                     Number of       Number of        burden/      Total burden
                   Respondents                      respondents    responses per   response  (in     (in hrs)
                                                                    respondent         hrs)
----------------------------------------------------------------------------------------------------------------
Invoice-Pathologist.............................              50               1            5/60               4
Report-Pathologist..............................              50               1            5/60               4
Consent, Release and History Form--Next-of-Kin..              50               1           15/60              13
(Form 2.6)......................................
Roentgenographic Interpretation Form--Physicians          10,000               1            3/60             500
 (Form 2.8).....................................
Interpreting Physician Certification Document--              300               1           10/60              50
 Physicians.....................................
(Form 2.12).....................................
Miner Identification Document--Coal Miners......           5,000               1           20/60           1,666
(Form 2.9)......................................
Spirometry Test--Coal Miners....................           2,500               1           20/60             833
X-ray--Coal Miners..............................            5000               1           15/60             750
Coal Mine Operators Plan--Mine Operators........             200               1           30/60             100
(Form 2.10).....................................
Facility Certification Document--X-ray                       100               1           30/60             200
 Facilities.....................................
(Form 2.11).....................................
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           4,120
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    Dated: February 16, 2011.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2011-4165 Filed 2-23-11; 8:45 am]
BILLING CODE 4163-18-P