Notice2024-19614
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 3, 2024
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 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).
Full Text
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<title>Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)</title>
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[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71273-71275]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19614]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-0020; Docket No. CDC-2024-0060]
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 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).
DATES: CDC must receive written comments on or before November 4, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0060 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.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, MS 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://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#bdd2d0dffdded9de93dad2cb"><span class="__cf_email__" data-cfemail="d4bbb9b694b7b0b7fab3bba2">[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
[[Page 71274]]
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. 03/31/2025)--Extension--National Institute for
Occupational Safety and Health (NIOSH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Coal Workers' Health Surveillance Program (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 and in documenting trends and patterns in the prevalence
of coal workers' pneumoconiosis (`black lung' disease) among U.S. coal
miners. CDC requests an Extension for this data collection initiative.
There are no changes requested at this time.
The total estimated annualized burden hours of 4,070 is based upon
participation rates from the past five years (FY19-FY24) using the
following data 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 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.
Additionally, NIOSH approved radiograph facilities, per 42 CFR part
37, use the form to report the findings of the initial clinical read
(required) for each radiograph. It takes the qualified and licensed
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: (1) collect information that will allow NIOSH to identify the
miner in order to provide notification of the spirometry test results;
(2) assure that the test can be done safely; (3) 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 (4) 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 are
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)--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.
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.
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<bullet> Request for Medical Records Form--Miners wishing to
receive copies of their CWHSP chest x-rays and related files must fully
complete, sign, and email this form to <a href="/cdn-cgi/l/email-protection#6704100f14172704030449000811"><span class="__cf_email__" data-cfemail="2645514e55566645424508414950">[email protected]</span></a>. The form can also
be mailed or faxed using the address and fax listed on the form. It is
estimated that five minutes is required for the coal miner to complete
this form.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Average
No. of No. of responses burden per Total
Type of respondent Form name respondents per respondent response burden
(in hours) hours
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Coal mine operator.............. 2.10.............. 268 1 30/60 134
Coal Mine Contractor............ 2.18.............. 165 1 30/60 83
Radiograph Facility Supervisor.. 2.11.............. 20 1 30/60 10
Coal Miner...................... 2.9............... 4,345 1 20/60 1,448
Coal Miner--Radiograph.......... No form required.. 4,788 1 15/60 1,197
B Reader Physician.............. 2.8............... 10 899 3/60 450
Qualified and Licensed Physician 2.8............... 4,788 1 3/60 240
(NIOSH Approved Radiograph
Facility).
Physicians taking the B Reader 2.12.............. 110 1 10/60 18
Examination.
Spirometry Facility Supervisor.. 2.14.............. 15 1 30/60 8
Spirometry Facility Employee.... 2.13.............. 619 1 5/60 52
Spirometry Technician........... 2.15.............. 619 1 20/60 206
Coal Miner--Spirometry.......... No form required.. 619 1 15/60 155
Request for Medical Records..... Request for 779 1 5/60 65
Medical Records
Form.
Pathologist..................... 2.19.............. 4 1 15/60 1
Pathologist..................... Invoice--No 4 1 5/60 1
standard form.
Pathologist..................... Pathology Report-- 4 l 5/60 1
No standard form.
Next-of-kin for deceased miner.. 2.6............... 4 1 15/60 1
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Total....................... .................. .............. ................ ........... 4,070
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2024-19614 Filed 8-30-24; 8:45 am]
BILLING CODE 4163-18-P
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