83 FR 15840 - Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 71 (April 12, 2018)

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).

[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15840-15842]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07563]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0200; Docket No. CDC-2018-0030]


Proposed Data Collections 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

[[Page 15841]]

Act of 1969 with all subsequent amendments (the Act).

DATES: CDC must receive written comments on or before June 11, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0030 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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 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 Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-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 Number 0920-
0020, expires 06/30/2018--Extension--for National Institute for 
Occupational Safety and Health (NIOSH), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    NIOSH would like to extend the Coal Workers' Health Surveillance 
Program (CWHSP) data collection project. This request incorporates all 
components of the CWHSP. Those components includes 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 of 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 20,281 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 that 
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 
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.
     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.
     Guidelines for Spirometry in the ECWHSP Mobile (Internal 
use, no form number assigned)--Miners (both active and former) 
participating in the ECWHSP component of the Program are offered a 
spirometry test. This form is administered by a NIOSH employee (or 
contractor) in the ECWHSP Mobile Unit during the initial intake process 
and takes approximately five minutes to complete. This information is 
required to make sure that the spirometry test can be done safely and 
that the miner is physically capable of performing the spirometry 
maneuvers.
     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

[[Page 15842]]

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 5 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 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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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Coal Mine Operator............  2.10............             388               1           30/60             194
Coal Mine Contractor..........  2.18............             575               1           30/60             288
X-ray Facility Supervisor.....  2.11............              40               1           30/60              20
Coal Miner....................  2.9.............          14,560               1           20/60           4,854
Coal Miner....................  No form.........          14,560               1           15/60           3,640
B Reader Physician............  2.8.............              10            3014            3/60           1,507
Physicians taking the B Reader  2.12............             100               1           10/60              17
 Examination.
Spirometry Facility Supervisor  2.14............             100               1           30/60              50
Spirometry Facility Employee..  2.13............          14,560               1            5/60           1,214
Spirometry Technician.........  2.15............          14,560               1           20/60           4,854
Coal Miner....................  No form.........          14,560               1           15/60           3,640
Pathologist...................  Invoice--No                    1               1            5/60               1
                                 standard form.
Pathologist...................  Pathology                      1               l            5/60               1
                                 Report--No
                                 standard form.
Next-of-kin for deceased miner  2.6.............               1               1           15/60               1
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          20,281
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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. 2018-07563 Filed 4-11-18; 8:45 am]
 BILLING CODE 4163-18-P