Proposed Data Collection Submitted for Public Comment and Recommendations
Federal Register, Volume 80 Issue 79 (Friday, April 24, 2015)
Federal Register Volume 80, Number 79 (Friday, April 24, 2015)
Notices
Pages 23004-23006
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-09524
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
60Day-15-15ZI; Docket No. CDC-2015-0024
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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection entitled Metal and Nonmetal Miner Health Program (MNMHP). The MNMHP proposes to gather health data on metal and nonmetal miners to identify opportunities for reducing the incidence and severity of disease.
DATES: Written comments must be received on or before June 23, 2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0024 by any of the following methods:
Federal eRulemaking Portal: Regulation.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. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.
Please note: All public comment should be submitted 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 the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.
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 OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
Proposed Project
Metal and Nonmetal Miner Health Program (MNMHP)--New--National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC)
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Background and Brief Description
This is a new information collection request seeks data collection approval for a public health surveillance project. The proposed information collection will provide much needed health data pertaining to an estimated 66,000 workers in the metal and nonmetal (MNM) mining industry in the United States. Additionally, approximately 81,000 contractors worked in the metal, nonmetal, and sand/stone/gravel mining sectors in 2013; this information collection will provide health data on those contractors working in the metal and nonmetal mining sectors.
Metal and nonmetal (MNM) mining is an important industry throughout the United States, providing materials for the manufacture of many common items, such as electronics and medications, and employing approximately 25% of the total U.S. mining workforce. Work in this industry exposes miners to recognized hazards including noise, heat, repetitive stress, sleep deprivation, fumes, diesel exhaust, silica and other mine dusts, and radon gas, but the extent to which modern mining practices have mitigated these hazards is unknown. Little is known about the health status of this population of workers, in part because no comprehensive health surveillance system exists for the MNM mining sector.
The Federal Mine Safety and Health Act of 1977 authorized NIOSH to ``conduct such studies, research, experiments, and demonstrations as may be appropriate to improve working conditions and practices in coal or other mines.'' Surveillance of general occupational illnesses, injuries, and exposures is an important part of NIOSH responsibilities as authorized by the Occupational Safety and Health Act of 1970 (29 CFR 671).
Comprehensive health surveillance data are critical in estimating and reducing prevalence of occupational illness. A National Academies review of NIOSH research programs in 2007 emphasized that mining production is expected to increase and incorporate new technologies in the next decade, and that an informed assessment of health and safety issues is necessary to ensure that NIOSH research remains relevant. This program will address a number of high priority goals set by NIOSH to advance and coordinate research across the Institute. These goals include the following: Prevent and reduce work-related airways diseases; prevent and reduce work-related interstitial lung diseases; advance cross-cutting issues that affect all work-related respiratory diseases, in particular surveillance, exposure assessment, and emerging issues; reduce the incidence of musculoskeletal disorders in mine workers; reduce the incidence and mortality of work-related cardiovascular disease; and improve the health and safety of working people through research and surveillance to better understand work organization characteristics and their associations with health and safety outcomes.
NIOSH proposes to implement a health surveillance program to assess the health status and burden of disease among MNM mine workers. This program will provide current information on a sector of the mining workforce that is not available elsewhere, thereby closing a current knowledge gap. The information will enable NIOSH to develop targeted workplace interventions and health programs directed toward a high risk population of workers. Mining researchers will be able to prioritize research on occupational illnesses. The mining industry will be able to develop, adapt, and promote policies to reduce unhealthy exposures and improve overall miner health.
Data collection will take place at selected mine sites and in mining communities in the United States, focusing initially on the western states of the United States where metal mining is concentrated. NIOSH will collaborate with health and safety leaders from western MNM mines, labor, academic researchers, and other NIOSH researchers to identify mines interested in participating in the health assessments. A mobile health clinic will visit each participating site for a number of days, during which NIOSH will solicit voluntary participation from mine employees and contractors. Program staff will collaborate with mine operators and labor representatives to determine the best method to recruit participants.
Data collection from consenting individuals working, or having previously worked, in the MNM mining sectors will include: Completion of a questionnaire, measurements of height, weight and blood pressure, collection of a fingerstick blood sample for measurement of cholesterol and hemoglobin A1C levels, pulmonary function testing, and a chest radiograph. The purpose of the questionnaire is to determine prevalence of certain health conditions and risk factors for disease, and to characterize miners' working conditions and workplace exposures. Information will be collected on demographics, occupation, work status, working conditions and occupational exposures, work stress, musculoskeletal disorders, hearing, sleep and fatigue, chronic disease and chronic disease risk factors, and respiratory health. Responding to any of the questions in the questionnaire will be optional; participants may choose to opt out of any portion of the questionnaire, or any of the individual biometric tests. In such cases, participants will still be eligible for remaining tests in which they choose to participate.
All data collection activities will be conducted in full compliance with the CDC regulations to maintain the privacy of data obtained on persons and to protect the rights and welfare of human subjects, as contained in Title 28 of the Code of Federal Regulations, Parts 22 and 46.
Overall, there are no direct costs to MNMHP participants. The total estimated annualized burden hours are 5,213. This estimate is based on the following:
Consent form signature: Miners who elect to participate will be asked to read and sign a consent form describing the purpose of the research, risks and benefits of participation, what to expect for participants, data security, and voluntary participation. The consent has been modified to be readable at approximately an eighth grade level. The consent will take approximately 5 minutes to read and sign.
Questionnaire completion: Miners who elect to participate in the MNMHP will complete an electronic questionnaire, which takes an average of approximately 23 minutes, with a range of 19-30 minutes. Up to 5% of miners may prefer to complete the questionnaire in hardcopy format, which is estimated to take up to 25% longer to complete.
Measurements of height, weight and blood pressure: Miners will be asked to sit quietly for approximately 5 minutes, after which their blood pressure will be measured. Afterward, their height and weight will be measured. In total, these measurements take approximately 10 minutes. No forms are required.
Collection of a fingerstick blood sample for measurement of cholesterol and hemoglobin A1C levels: Miners will be asked to provide a fingerstick blood sample, which will be used to measure cholesterol and hemoglobin A1C (for diabetes). The sample collection will take approximately 5-10 minutes, and the results will be available in approximately 5-10 minutes. However, the miners will proceed to other testing stations (chest radiography and pulmonary function testing) while waiting for the results of their fingerstick blood tests, and therefore no
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extra time is required beyond the blood sample collection. No forms are required.
Pulmonary function testing: This test requires approximately 15-20 minutes to complete. No forms are required.
Chest radiograph: Chest radiography will take approximately 5 minutes. No forms are required.
B Reader Physicians: Physicians provide classifications of chest radiographs by completing a standard NIOSH chest radiograph classification form, which uses the International Labour Office classification system for determination of pneumoconiosis. Each image requires two readings, and according to the Coal Workers' Health Surveillance Program (CWHSP), approximately 7% of the images require at least one additional reading. The CWHSP estimates that it takes each B Reader approximately three minutes to complete each form.
Estimated Annualized Burden Hours
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Average
Number of Number of burden/ Total burden
Type of respondent Form name respondents responses per response (in (in hrs)
respondent hrs)
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Miners........................ Form # 2,375 1 30/60 1,188
questionnaire.
Miners........................ Form # 125 1 40/60 83
questionnaire
(hardcopy).
Miners........................ Height, weight, 2,500 1 10/60 417
blood pressure--
No form
required.
Miners........................ Fingerstick--No 2,500 1 10/60 417
form required.
Miners........................ Spirometry Test-- 2,500 1 20/60 833
No form
required.
Miners........................ Radiograph--No 2,500 1 10/60 417
form required.
Miners........................ Consent form.... 2,500 1 5/60 208
B Reader Physician............ Form 2.8........ 10 550 3/60 275
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Total..................... ................ .............. .............. .............. 3,838
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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. 2015-09524 Filed 4-23-15; 8:45 am
BILLING CODE 4163-18-P
