[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
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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
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
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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.
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Pathologist........................... Pathology Report--No 5 1 5/60
standard form.
Next-of-kin for deceased miner........ 2.6..................... 5 1 15/60
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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. 2015-06160 Filed 3-17-15; 8:45 am]
BILLING CODE 4163-18-P