2014-04971. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Coal Workers' Health Surveillance Program (CWHSP)—(0920-0200, Expiration 06/30/2014)—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 current ICR incorporates all four components that fall under the CWHSP. Those four components include: Coal Workers' X-ray Surveillance Program (CWXSP), B Reader Program, Enhanced Coal Workers' Health Surveillance Program (ECWHSP), and National Coal Workers' Autopsy Study (NCWAS).

The CWHSP is a congressionally-mandated medical examination program for monitoring the health of underground coal miners, established under the Federal Coal Mine Health and Safety Act of 1969, as amended in 1977 and 2006, PL-95-164 (the Act). The Act provides the regulatory authority for the administration of the CWHSP. This Program 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 4,420 estimated annualized hours of burden is based on the following:

• Coal Mine Operators Plan (2.10)—Under 42 CFR 37.4, every coal operator and construction contractor for each underground coal mine must submit a coal mine operator's plan every 3 years, providing information on how they plan to notify their miners of the opportunity to obtain the chest radiographic examination. To complete this form with all requested information (including a roster of current employees) takes approximately 30 minutes.
• Facility Certification Document (2.11)—X-ray facilities seeking NIOSH-approval to provide miner radiographs under the CWHSP must complete an approval packet 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 from x-ray facilities in relation to coal miner examinations. In addition to completing this form, the process of capturing the chest image takes approximately 15 minutes.
• Chest Radiograph Classification Form (2.8)—Under 42 CFR part 37, NIOSH utilizes a radiographic classification system developed by the International Labour Office (ILO), in the determination of pneumoconiosis among underground coal miners. Physicians (B Readers) fill out this form regarding their interpretations of the radiographs (each image has at least two separate 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 Testing—Miners participating in the ECWHSP component of the Program are asked to perform a spirometry test which requires no additional paperwork on the part of the miner, but does require approximately 15 to 20 minutes for the test itself. Since spirometry testing is offered as part of the ECWHSP only, the 2,500 respondents listed in the burden table below account for about half of the total participants in the CWHSP.
• Pathologist Invoice—42 CFR 37.202 specifies procedures for 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—42 CFR 37.203 provides the autopsy specifications. 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 are 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 the occupational history and 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

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden/ response (in hrs)
Coal Mine Operators	Form 2.10	200	1	30/60
X-ray Facility Supervisor	Form 2.11	100	1	30/60
X-ray—Coal Miners	No form required	5,000	1	15/60
Coal Miners	Form 2.9	5,000	1	20/60
B Reader Physicians	Form 2.8	10,000	1	3/60
Physicians taking the B Reader Examination	Form 2.12	100	1	10/60
Spirometry Test—Coal Miners	No form required	2,500	1	20/60
Pathologist	Invoice—No standard form	5	1	5/60
Pathologist	Pathology Report—No standard form	5	1	5/60
Next-of-kin for deceased miner	Form 2.6	5	1	15/60

Leroy 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.