The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), has announced the opening of a docket to obtain information on the feasibility of a registry designed to track mesothelioma cases in the United States, as well as recommendations on enrollment, data collection, confidentiality, and registry maintenance. The purpose of such a registry would be to collect information that could be used to develop and improve standards of care and to identify gaps in mesothelioma prevention and treatment.
Comments may be submitted electronically, through the Federal eRulemaking
Portal: http://www.regulations.gov, or by sending a hard copy to the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226. All written submissions received must include the agency name (Centers for Disease Control and Prevention, HHS) and docket number (CDC-2019-0029; NIOSH-327) for this action. All relevant comments, including any personal information provided, will be posted without change to http://www.regulations.gov. Comments must be received by July 8, 2019. Comment now.
Mesothelioma is a rare cancer of the body's lining tissue, most commonly the lining of the chest and lungs (pleura) and the lining of the abdomen (peritoneum). The most common risk factor for mesothelioma is prior asbestos exposure. Mesothelioma treatments are limited and survival is generally poor. NIOSH is the Federal agency that develops new knowledge in the field of occupational safety and health and transfers that knowledge into practice. NIOSH has a strong interest in preventing mesothelioma and helping people with the disease, since the most common known cause is exposure to asbestos, a dangerous occupational hazard for many workers.
Cancer is a reportable disease in every state. Data about new cases of mesothelioma are reported to state or local cancer registries, annually submitted to CDC or the National Cancer Institute (NCI), and then compiled by CDC in the U.S. Cancer Statistics database. U.S. Cancer Statistics: the Official Federal Cancer Statistics. https://www.cdc.gov/cancer/uscs/index.htm.
However, existing cancer registries collect only limited information about potential risk factors and issues occurring over time, such as treatment complications. In addition to the limitations on the scope of existing surveillance systems, it may take 6 months or more from the time of diagnosis until mesothelioma cases are initially reported to a cancer registry, and then another 1-2 years to be reported in U.S. Cancer Statistics.
Ideally, the case-finding methodology would be national in scope and identify most people diagnosed with mesothelioma, thus allowing researchers to use this current data to determine incidence and prevalence, demographics, and risk factors, as required by the 2019 appropriations act.
A National Mesothelioma Registry could address the limitations of existing registries by reducing case reporting delays, collecting detailed information regarding risk and prognostic factors, and by engaging with researchers to better enable them to identify gaps in the current understanding of mesothelioma prevention and treatment and improve the standard of care for current and future patients.
In order to study the feasibility of establishing a National Mesothelioma Registry, NIOSH requests information from the public on the potential usefulness of a registry and potential approaches to establishing and operating it. Accordingly, NIOSH seeks input and advice from all interested parties in response to the following questions:
1. Would a registry be an effective tool in improving mesothelioma patient care? If yes, please describe how a registry could be used to improve current care.
2. Would a registry be an effective tool in facilitating clinical mesothelioma research? If yes, please describe how a registry could be used to facilitate clinical mesothelioma research.
3. Would a registry be an effective tool in facilitating basic or epidemiological mesothelioma research? If yes, please describe how a registry could be used to facilitate basic or epidemiological research.
4. What are the best potential approaches to recruiting and enrolling mesothelioma patients in a registry as soon as possible after diagnosis? What barriers can be anticipated? How can these barriers be overcome?
5. What information should be collected by a mesothelioma registry? How would that information be useful for improving patient care or facilitating clinical, basic, or epidemiological research?
6. What services should a registry provide to mesothelioma patients, clinicians, researchers, and other interested stakeholders?
7. Who should have access to information gathered by a mesothelioma registry?
8. How could a mesothelioma registry protect the confidentiality of information about registry participants yet still be used for patient care and research? Please describe how personally identifiable information should be protected.
9. Are there particular types of organizations that would be best suited to host or manage a National Mesothelioma Registry? If so, please explain the advantages and disadvantages of the recommended types of organizations.
10. What types of resources would be needed to establish and maintain or participate in a National Mesothelioma Registry, including for clinical sites that diagnose patients, cancer registries and state public health departments, a central data center, and potentially other participants involved in recruiting and enrolling patients, gathering and storing information, providing various services, and following patients over time?
11. Is there other information that NIOSH should consider in assessing the potential usefulness, feasibility, and potential approaches to establishing and operating a National Mesothelioma Registry? If yes, please describe.
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