[Federal Register Volume 84, Number 235 (Friday, December 6, 2019)]
[Notices]
[Pages 66902-66904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0020; Docket No. CDC-2019-0109]


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).

DATES: CDC must receive written comments on or before February 4, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0109 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note: Submit all 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, MS-

[[Page 66903]]

D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

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; and
    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.
    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 an Information Collection Request (ICR) 
to revise the data collection instruments being utilized within the 
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). 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 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 
adding a provision to allow NIOSH to suspend or revoke physician B 
Reader certification for any B Reader suspected of violating the B 
Reader Code of Ethics or routinely providing chest radiograph 
classifications in practice that are determined by the CWHSP to be 
inaccurate. In addition to the B Reader provisions, HHS would also 
amend 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 11,757 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 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.
     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 
Labor 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.
     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 
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 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.
     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.
     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

[[Page 66904]]

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.
     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.
     DRAFT Authorization for Payment of Autopsy Form (2.XX)--
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.
    There are no costs to respondents other than their time. The total 
estimated burden being requested is 11,757 hours.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents   responses  per   response  (in       hours
                                                                     respondent       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
B Reader Physician Challenge    No form required               2               4           30/60               4
 to Disciplinary Action and
 Appeal of Decertification
 Decision.
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...................  Invoice--No                    4               1            5/60               1
                                 standard form.
Pathologist...................  Pathology                      4               1            5/60               1
                                 Report--No
                                 standard form.
Next-of-kin for deceased miner  2.6.............               4               1           15/60               1
Autopsy Prior Authorization...  0.1585..........               4               1           15/60               1
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          11,757
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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. 2019-26370 Filed 12-5-19; 8:45 am]
 BILLING CODE 4163-18-P