[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14143-14145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0020]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Coal Workers' Health Surveillance Program (CWHSP)--(0920-0020)--
Reinstatement with Change--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 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. The Program was originally 
authorized under the 1969 Federal Coal Mine Health and Safety Act and 
is currently authorized under the 1977 Federal Mine Safety and Health 
Act and its subsequent amendments (the Act). The Act provides the 
regulatory authority for

[[Page 14144]]

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 20,282 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 
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. In addition to completing 
this form, acquiring the chest image from the miner takes approximately 
15 minutes.
     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.
     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 five 
minutes for administration of this form to the miner by an employee at 
the facility.
     Spirometry Results Notification Form (2.15)--This new form 
replaces 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. In addition to completing this form, acquiring an 
acceptable spirometry test from the miner takes approximately 15 
minutes.
     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 five 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.
    There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Coal Mine Operator....................  2.10....................             388               1           30/60
Coal Mine Contractor..................  2.18....................             575               1           30/60
Radiograph Facility Supervisor........  2.11....................              40               1           30/60
Coal Miner............................  2.9.....................          14,560               1           20/60
Coal Miner--Radiograph................  No form required........          14,560               1           15/60
B Reader Physician....................  2.8.....................              10            3014            3/60
Physicians taking the B Reader          2.12....................             100               1           10/60
 Examination.
Spirometry Facility Supervisor........  2.14....................             100               1           30/60
Spirometry Facility Employee..........  2.13....................          14,560               1            5/60
Spirometry Technician.................  2.15....................          14,560               1           20/60
Coal Mine--Spirometry.................  No form required........          14,560               1           15/60
Pathologist...........................  Invoice--No standard                   5               1            5/60
                                         form.

[[Page 14145]]

 
Pathologist...........................  Pathology Report--No                   5               1            5/60
                                         standard form.
Next-of-kin for deceased miner........  2.6.....................               5               1           15/60
----------------------------------------------------------------------------------------------------------------


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. 2015-06160 Filed 3-17-15; 8:45 am]
 BILLING CODE 4163-18-P