Notice2021-19753
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 14, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Coal Workers' Health Surveillance Program (CWHSP). 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). HHS proposes to revise the National Institute for Occupational Safety and Health (NIOSH) CWHSP regulations by amending existing regulatory text to allow compensation for pathologists who perform autopsies on coal miners at a market rate, on a discretionary basis as needed for public health purposes.
Full Text
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<title>Federal Register, Volume 86 Issue 175 (Tuesday, September 14, 2021)</title>
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[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51157-51159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19753]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-21-0020; Docket No. CDC-2021-0095]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: 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 the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Coal Workers' Health Surveillance
Program (CWHSP). 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). HHS proposes to
revise the National Institute for Occupational Safety and Health
(NIOSH) CWHSP regulations by amending existing regulatory text to allow
compensation for pathologists who perform autopsies on coal miners at a
market rate, on a discretionary basis as needed for public health
purposes.
DATES: CDC must receive written comments on or before November 15,
2021.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0095 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, Mailstop H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://Regulations.gov">Regulations.gov</a>.
Please note: Submit all Federal comments through the Federal
eRulemaking portal (regulations.gov) or by U.S. mail to the address
listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, Mailstop H21-8, Atlanta, Georgia 30329; phone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#452a2827052621266b222a33"><span class="__cf_email__" data-cfemail="422d2f20022126216c252d34">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
Proposed Project
Coal Workers' Health Surveillance Program (CWHSP), (OMB Control No.
0920-0020, Exp. 09/30/2021)--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 a Revision Information Collection
Request (ICR) to revise the data collection instruments being utilized
within the Coal Workers' Health Surveillance Program (CWHSP). This
request incorporates all components of 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, and also in
documenting trends and patterns in the prevalence of coal workers'
pneumoconiosis (`black lung' disease) among U.S. coal miners.
HHS proposes to revise the CWHSP regulations (42 CFR part 37) by
amending existing regulatory text to allow compensation for
pathologists who perform autopsies on coal miners at a market rate, on
a discretionary basis as needed for public health purposes. These
changes to 42 CFR 37 have necessitated this revision ICR.
The total estimated annualized burden hours of 11,741 is based on
the following collection instruments:
<bullet> 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 four 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.
<bullet> 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.
<bullet> Miner Identification Document (2.9)--Miners who elect to
participate in the CWHSP must fill out this document which requires
approximately 20
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minutes. This document records demographic and occupational history, as
well as information required under the regulations in relation to the
examinations.
<bullet> 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 at least two
separate interpretations, and approximately 7% of the images require
additional interpretations). Based on prior practice it takes the
physician approximately three minutes per form.
<bullet> 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.
<bullet> Spirometry Facility Certification Document (2.14)--This
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.
<bullet> Respiratory Assessment Form (2.13)--This 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 this form to be administered to the miner by an employee at the
facility.
<bullet> Spirometry Results Notification Form (2.15)--This form 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.
<bullet> 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.
<bullet> 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 five minutes of additional
burden is estimated for the pathologist's report.
<bullet> 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.
<bullet> Authorization for Payment of Autopsy Form (2.19)--Revised
42 CFR part 37.204 outlines a need for a physician pathologist to
obtain written authorization from NIOSH and agreement regarding payment
amount for services specified in Sec. 37.202 (a) by completing the
Authorization for Payment of Autopsy form and submitting it to the
CWHSP for authorization prior to completing an autopsy on a coal miner.
This is a new form. It will be completed by the pathologist who intends
on conducting an autopsy and the form will collect: Demographic
information on the deceased miner, characteristics of the miner's
pneumoconiosis (if known by the pathologist), demographic and medical
licensure information from the requesting pathologist, and proposed
payment amount to complete the autopsy in accordance with Sec. 37.203.
It is estimated that 15 minutes is required for the pathologist to
complete this form.
CDC requests OMB approval for an estimated 11,741 annual burden
hours. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
Respondents respondent (in hours) hours
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Coal Mine Operator............ 2.10............ 220 1 30/60 110
Coal Mine Contractor.......... 2.18............ 160 1 30/60 80
Radiograph Facility Supervisor 2.11............ 20 1 30/60 10
Coal Miner.................... 2.9............. 8,500 1 20/60 2833
Coal Miner--Radiograph........ No form required 8,500 1 15/60 2125
B Reader Physician............ 2.8............. 10 1,760 3/60 880
Physicians taking the B Reader 2.12............ 220 1 10/60 37
Examination.
Spirometry Facility Supervisor 2.14............ 15 1 30/60 8
Spirometry Facility Employee.. 2.13............ 8,500 1 5/60 708
Spirometry Technician......... 2.15............ 8,500 1 20/60 2833
Coal Miner--Spirometry........ No form required 8,500 1 15/60 2125
Pathologist................... 2.19............ 4 1 15/60 1
Pathologist................... Invoice--No 4 1 5/60 1
standard form.
Pathologist................... Pathology 4 l 5/60 1
Report--No
standard form.
Next-of-kin for deceased miner 2.6............. 4 1 15/60 1
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Total..................... ................ .............. .............. .............. 11,741
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-19753 Filed 9-13-21; 8:45 am]
BILLING CODE 4163-18-P
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