[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Notices]
[Pages 74094-74096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0020]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden and maximize the utility 
of government information, invites the general public and other Federal 
agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. To request more information on the below 
proposed project or to obtain a copy of the information collection plan 
and instruments, call 404-639-7570 or send comments to Leroy A. 
Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an 
email to [email protected].
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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 the use of automated collection 
techniques or other forms of information technology; and (e) estimates 
of capital or start-up costs and costs of operation, maintenance, and 
purchase of services to provide information. Burden means the total 
time, effort, or financial resources expended by persons to generate, 
maintain, retain, disclose or provide information to, or for, a Federal 
agency. This includes the time needed to review instructions; to 
develop, acquire, install and utilize technology and systems for the 
purpose of collecting, validating and verifying information, processing 
and maintaining information, and disclosing and providing information; 
to train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information. Written comments should be received within 60 days of this 
notice.
    Proposed Project--Coal Workers' Health Surveillance Program 
(CWHSP)(OMB Control No. 0920-0020, Expiration Date 2/28/2015)--
Revision--National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    NIOSH would like to submit an Information Collection Request (ICR) 
to revise the data collection instruments being utilized within the 
Coal Workers' Health Surveillance Program (CWHSP). On May 1, 2014, the 
Mine Safety and Health Administration (MSHA) published final rule 30 
CFR parts 70, 71, 72, 75, and 90. The new MSHA rule added surface coal 
miners, a respiratory health assessment, and spirometry testing for 
chronic obstructive pulmonary disease (COPD) to the previously mandated 
chest x-ray examination program. These additions are being referred to 
as the Expanded CWHSP (an additional component under the current 
CWHSP).
    This request incorporates all components that now fall under the 
CWHSP. Those components include: Coal Workers' X-ray Surveillance 
Program (CWXSP), B Reader Program, Enhanced Coal Workers' Health 
Surveillance Program (ECWHSP), Expanded Coal Workers' Health 
Surveillance Program, and National Coal Workers' Autopsy Study (NCWAS). 
The CWHSP is a congressionally-mandated medical examination program for 
monitoring the health of coal miners and was originally established 
under the Federal Coal Mine Health and Safety Act of 1969 with all 
subsequent amendments (the Act). The Act provides the regulatory 
authority for the administration of the CWHSP. This Program, which 
operates in accordance with 42 CFR part 37, is useful in providing 
information 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. The total estimated annualized 
burden hours of 13,471 is based on the following collection 
instruments:
     Coal Mine Operator Plan (2.10) and Coal Contractor Plan 
(2.18)--Under 42 CFR part 37, every coal operator and coal contractor 
in the U.S. must submit a plan approximately every 4 years, providing 
information on how they plan to notify their miners of the opportunity

[[Page 74095]]

to obtain the medical examination. Completion of this form with all 
requested information (including a roster of current employees) takes 
approximately 30 minutes.
     Radiographic Facility Certification Document (2.11)--X-ray 
facilities seeking NIOSH approval to provide miner radiographs under 
the CWHSP must complete an approval packet including this form which 
requires approximately 30 minutes for completion.
     Miner Identification Document (2.9)--Miners who elect to 
participate in the CWHSP must fill out this document which requires 
approximately 20 minutes. This document records demographic and 
occupational history, as well as information required under the 
regulations in relation to the examinations.
     Chest Radiograph Classification Form (2.8)--NIOSH utilizes 
a radiographic classification system developed by the International 
Labour Office (ILO) in the determination of pneumoconiosis among coal 
miners. Physicians (B Readers) fill out this form regarding their 
interpretations of the radiographs (each image has two separate 
interpretations, and approximately 7% of the images require additional 
interpretations). Based on prior practice it takes the physician 
approximately 3 minutes per form.
     Physician Application for Certification (2.12)--Physicians 
taking the B Reader examination are asked to complete this registration 
form which provides demographic information as well as information 
regarding their medical practices. It typically takes the physician 
about 10 minutes to complete this form.
     Guidelines for Spirometry in the ECWHSP Mobile (Internal 
use, no form number assigned)--Miners (both active and former) 
participating in the ECWHSP component of the Program are offered a 
spirometry test. This form is administered by a NIOSH employee (or 
contractor) in the ECWHSP Mobile Unit during the initial intake process 
and takes approximately 5 minutes to complete. This information is 
required to make sure that the test can be done safely and that the 
miner is physically capable of performing the spirometry maneuvers.
     Spirometry Facility Certification Document (2.14)--This 
new form is analogous to the Radiographic Facility Certification 
Document (2.11) and records the spirometry facility equipment/staffing 
information. Spirometry facilities seeking NIOSH approval to provide 
miner spirometry testing under the CWHSP must complete an approval 
packet which includes this form. It is estimated that it will take 
approximately 30 minutes for this form to be completed at the facility.
     Respiratory Assessment Form (2.13)--This new form is 
designed to assess respiratory symptoms and certain medical conditions 
and risk factors. It is estimated that it will take approximately 5 
minutes for this form to be administered to the miner by an employee at 
the facility.
     Spirometry Results Notification Form (2.15)--This new form 
will replace previous forms 2.15, 2.16 and 2.17. It is used to: Collect 
information that will allow NIOSH to identify the miner in order to 
provide notification of the spirometry test results; assure that the 
test can be done safely; record certain factors that can affect test 
results; provide documentation that the required components of the 
spirometry examination have been transmitted to NIOSH for processing; 
and conduct quality assurance audits and interpretation of results. It 
is estimated that it will take the facility approximately 20 minutes to 
complete this form.
     Pathologist Invoice--Under the NCWAS, the invoice 
submitted by the pathologist must contain a statement that the 
pathologist is not receiving any other compensation for the autopsy. 
Each participating pathologist may use their individual invoice as long 
as this statement is added. It is estimated that only 5 minutes is 
required for the pathologist to add this statement to the standard 
invoice that they routinely use.
     Pathologist Report--Under the NCWAS the pathologist must 
submit information found at autopsy, slides, blocks of tissue, and a 
final diagnosis indicating presence or absence of pneumoconiosis. The 
format of the autopsy reports is variable depending on the pathologist 
conducting the autopsy. Since an autopsy report is routinely completed 
by a pathologist, the only additional burden is the specific request 
for a clinical abstract of terminal illness and final diagnosis 
relating to pneumoconiosis. Therefore, only 5 minutes of additional 
burden is estimated for the pathologist's report.
     Consent, Release and History Form (2.6)--This form 
documents written authorization from the next-of-kin to perform an 
autopsy on the deceased miner. A minimum of essential information is 
collected regarding the deceased miner including an occupational 
history and a smoking history. From past experience, it is estimated 
that 15 minutes is required for the next-of-kin to complete this form.
    As indicated by the below burden table, the total annualized burden 
hours for this request are 13,471. There are no costs to respondents 
other than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of        burden/      Total  burden
             Type of  respondents                              Form name                    respondents   responses  per   response  (in     (in hrs)
                                                                                                            respondent         hrs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coal Mine Operator...........................  2.10.....................................             388               1           30/60             194
Coal Mine Contractor.........................  2.18.....................................             575               1           30/60             288
X-ray Facility Supervisor....................  2.11.....................................              40               1           30/60              20
Coal Miner...................................  2.9......................................          14,560               1           20/60           4,853
B Reader Physician...........................  2.8......................................          31,000               1            3/60           1,550
Physicians taking the B Reader Examination...  2.12.....................................             100               1           10/60              17
NIOSH employee (or contractor)...............  Guidelines for Spirometry in the ECWHSP             4,560               1            5/60             380
                                                Mobile Unit_No Form # assigned (internal
                                                document).
Spirometry Facility Supervisor...............  2.14.....................................             200               1           30/60             100
Spirometry Facility Employee.................  2.13.....................................          14,560               1            5/60           1,213
Spirometry Technician........................  2.15.....................................          14,560               1           20/60           4,853
Pathologist..................................  Invoice _No standard form................               5               1            5/60               1

[[Page 74096]]

 
Pathologist..................................  Pathology Report_No standard form........               5               l            5/60               1
Next-of-kin for deceased miner...............  2.6......................................               5               1           15/60               1
                                                                                         ---------------------------------------------------------------
    Total....................................  .........................................  ..............  ..............  ..............          13,471
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-29219 Filed 12-12-14; 8:45 am]
BILLING CODE 4163-18-P