2011-9922. 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 the CDC Reports Clearance Officer at [phone] or send an e-mail 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)—OMB 0920-0020- Reinstatement With Change—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

This submission will incorporate the National Coal Workers' X-Ray Surveillance Program 42 CFR 37 (0920-0020) and National Coal Workers' Autopsy Study 42 CFR part 37.204 (0920-0021) into one complete package which will be called the Coal Workers' Health Surveillance Program (CWHSP). Upon OMB approval, 0920-0021 will be discontinued. 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-91-173 (the Act). The Act provides the regulatory authority for the administration of the CWHSP. This Program, which includes both a health surveillance and an autopsy component, has been useful in providing tools 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. During the early 1970s, one out of every three miners examined through the CWHSP who had worked at least 25 years underground had evidence of pneumoconiosis on their chest x-ray. An analysis among over 25,000 miners who participated in the x-ray Programs from 1996 to 2002 indicated that the proportion of affected individuals had decreased to about one in 20. However, recent surveillance analyses and research studies have confirmed that the prevalence of `black lung' disease is increasing, there is regional clustering of rapidly progressive pneumoconiosis cases, and coal miners have a higher risk of disease if they perform certain jobs, work in smaller mines, or are from certain geographic areas. Importantly, young coal miners are developing the disabling and lethal forms of `black lung'.

Demographic and logistical information is gathered from coal mine operators and participating x-ray facilities. Participating miners also provide health and work histories, and participating physicians report radiographic findings. The Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health, Division of Respiratory Disease Studies, 1095 Willowdale Road, Morgantown, WV 26505, also called the Appalachian Laboratory for Occupational Safety and Health (ALOSH), is charged with administration of this Program.

From October 1, 1999 through September 30, 2002, the Mine Safety and Health Administration (MSHA), in consultation with NIOSH, conducted a pilot health surveillance program for both underground and surface miners (The Miners' Choice Program). The Miners' Choice Program has been continued as an extension of the CWHSP (currently called the Enhanced Coal Workers' Health Surveillance Program—ECWHSP). This extension of the CWHSP currently operates utilizing a mobile examination unit which travels to mining regions to provide locally accessible and more comprehensive health surveillance, including chest radiography, spirometry, and blood pressure screening.

Under the Act, the provision of periodic chest x-ray examinations is specifically mandated, and the x-rays are to be supplemented by such other tests as the Secretary deems necessary. In addition to radiographically-apparent pneumoconiosis, miners are at risk for the development of chronic obstructive pulmonary disease (COPD). Chest radiographs alone cannot provide a measure of airflow obstruction and therefore often miss important lung disease. For this reason, spirometry, a simple breathing test, is an additional component that is particularly useful for the health assessment of miners. Periodic medical history and spirometry tests have been recommended by NIOSH for both surface and underground coal miners since 1995, to facilitate preventive actions, increase miners' participation in programs for early detection of disease, and improve the derivation of representative estimates of the burden, distribution, and determinants of occupational lung disease in relation to coal mining in the U.S. Finally, unrecognized hypertension has previously been observed among many miners, and the ECWHSP offers blood pressure screening as a safe, simple, and inexpensive test, which can help target initiation of proven health conserving medications.

The National Coal Workers' Autopsy Study (NCWAS) provides standardized lung specimens for ongoing scientific research as well as information to the next-of-kin regarding the presence and extent of coal workers' pneumoconiosis (black lung) in the lungs of the deceased miner. The Consent Release and History Form is primarily used to obtain written authorization from the next-of-kin to perform an autopsy on the deceased miner. Because a basic reason for the post-mortem examination is research (both epidemiological and clinical), a minimum of essential information is collected regarding the deceased miner, including occupational history and smoking history. The data collected are used by scientists for research purposes in defining the diagnostic criteria for pneumoconiosis and in correlating pathologic changes with exposures and x-ray findings.

There are no costs of the NCWAS to respondents other than their time. The total estimated burden hours are 4,470.

Type of respondent	Form name	Number of respondents	Responses per respondent	Average burden per response (in hours)
Physicians B Readers	Roentgenographic Interpretation Form—CDC/NIOSH (M) 2.8	10,000	1	3/60
	Interpreting Physician Certification Document—CDC/NIOSH (M) 2.12	300	1	10/60
Miners	Miner Identification Document—CDC/NIOSH (M) 2.9	5,000	1	20/60
	No form—X-ray	5,000	1	15/60
	No form—Spirometry	2,500	1	20/60
Coal Mine Operators	Coal Mine Operator's Plan—CDC/NIOSH (M) 2.10	200	1	30/60
Supervisor at X-ray Facilities	Facility Certification Document—CDC/NIOSH (M) 2.11	100	1	30/60
Pathologist	No form—Invoice	50	1	5/60
	No form—Final Diagnosis Report	50	1	5/60
Next-of-Kin	Consent, Release, and History Form—CDC/NIOSH (M) 2.6	50	1	15/60

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.