[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)
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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).....................................
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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