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 Department of Health and Human Services Centers for Disease Control and Prevention [60-Day-11-0020]
 In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Carol E. Walker, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to 
                    *omb@cdc.gov.* *Comments are invited on:*
                     (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Coal Workers' Health Surveillance Program (CWHSP)-OMB 0920-0020, exp. 4/31/2011—Revision The 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 part 37 (0920-0020) and National Coal Workers' Autopsy Study 42 CFR 37.204 (0920-
                    ( print page 10370)
                    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, Public Law 95-164 (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'. Coal Workers' Health Surveillance Program (CWHSP) 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. Overall, there are no direct costs to CWHSP participants. The total estimated annualized burden hours is 4120. This estimate is based on the following: Pathologist Invoice—It is estimated that only 5 minutes is required for the pathologist to put a statement on the invoice affirming that no other compensation is received for the autopsy.
Pathologist Report—Since an autopsy report is routinely completed by a pathologist, the only additional burden is the specific request of abstract of terminal illness and final diagnosis relating to pneumoconiosis. Therefore, only 5 minutes of additional burden is estimated for the autopsy report.
Consent, Release and History Form (2.6)—From past experience, it is estimated that 15 minutes is required for the next-of-kin to complete this form.
Roentgenographic Interpretation Form (2.8)—Physicians (B Readers) fill out this form regarding their interpretations of the x-rays (each x-ray has at least two separate interpretations). Based on prior practice it takes the physician approximately 3 minutes per form.
Interpreting Physician Certification Document (2.12)—Physicians taking the B Reader Examination are asked to complete this registration form that takes approximately 10 minutes.
Miner Identification Document (2.9)—Miners who elect to participate in either the CWHSP must fill out this document which requires approximately 20 minutes. The actual shooting of the chest image takes approximately 15 minutes.
Miners participating in the ECWHSP portion of the Program are asked to perform a spirometry test which requires no additional paperwork, but does require approximately 15 to 20 minutes for the test itself. The 2500 respondents listed in the burden table below account for about1/2
                     of the total participants.
Coal Mine Operators Plan (2.10)—Mine operators are required to file a Mine X-ray Plan with NIOSH every 3 years. 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 x-rays under the CWHSP must complete an approval packet. It is anticipated that since the( print page 10371)
                    CWHSP will soon be accepting digital images as well as the traditional analog x-ray films, the number of x-ray facilities participating will increase over the next several years. This increase is reflected in this submission. The forms associated with this approval process require approximately 30 minutes for completion. Estimated Annualized Burden
Respondents
Number of
                             respondents
Number of
                             responses per  
                             respondent
Average 
                             burden/ 
                             response  
                             (in hrs)
Total burden
                             (in hrs)Invoice-Pathologist
50
1
5/60
4Report-Pathologist
50
1
5/60
4Consent, Release and History Form—Next-of-Kin
                             (Form 2.6)
50
1
15/60
13Roentgenographic Interpretation Form—Physicians (Form 2.8)
10,000
1
3/60
500Interpreting Physician Certification Document—Physicians
                             (Form 2.12)
300
1
10/60
50Miner Identification Document—Coal Miners
                             (Form 2.9)
5,000
1
20/60
1,666Spirometry Test—Coal Miners
2,500
1
20/60
833X-ray—Coal Miners
5000
1
15/60
750Coal Mine Operators Plan—Mine Operators
                             (Form 2.10)
200
1
30/60
100Facility Certification Document—X-ray Facilities
                             (Form 2.11)
100
1
30/60
200Total



4,120
 Dated: February 16, 2011. Carol E. Walker, Acting Reports Clearance Officer, Centers for Disease Control and Prevention.


[FR Doc. 2011-4165 Filed 2-23-11; 8:45 am] BILLING CODE 4163-18-P