[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13928-13929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2019-0029; NIOSH-327]


Mesothelioma Registry Feasibility; Request for Information

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Request for information.

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SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH), within the Centers for Disease Control and Prevention (CDC), 
announces 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.

DATES: Comments must be received by July 8, 2019.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 
Tusculum Avenue, MS: C-48, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION: The fiscal year 2019 appropriations act 
charged NIOSH with initiating a feasibility study for a National 
Mesothelioma Registry.\1\ 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.
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    \1\ Department of Defense and Labor, Health and Human Services, 
and Education Appropriations Act, 2019 and Continuing Appropriations 
Act, 2019, HR 6157 (enacted). See also Department Of Defense for the 
Fiscal Year Ending September 30, 2019, and for Other Purposes, House 
of Representatives Conference Report No. 115-952 (2018). The 
conference report accompanies HR 6157 and explicitly directs NIOSH 
to ``initiate a feasibility study for a patient registry, which 
would include developing case finding methodology to determine 
incidence and prevalence, demographics, and risk factors.''
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    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.\2\ 
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. Because about half of those diagnosed with 
mesothelioma die within 1 year, to be of benefit to registrants, a 
registry would need to develop a case-finding methodology to enroll 
registrants as soon as possible after diagnosis to allow timely access 
to contemporary state-of-the-art therapy and clinical trials. It has 
been reported that many mesothelioma patients do not receive this level 
of care.\3\ 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.
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    \2\ U.S. Cancer Statistics: the Official Federal Cancer 
Statistics. https://www.cdc.gov/cancer/uscs/index.htm.
    \3\ Waller DA [2018], The Management of Malignant Pleural 
Mesothelioma in the USA 2004-13--A Decade of Lost Opportunity? J 
Thorac Dis 10(Suppl 9):S1044-S1046.
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    In order to study the feasibility of establishing a National 
Mesothelioma Registry, NIOSH requests information

[[Page 13929]]

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.

    Dated: April 2, 2019.
Frank J. Hearl,
Chief of Staff, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention, Department of Health and 
Human Services.
[FR Doc. 2019-06784 Filed 4-5-19; 8:45 am]
 BILLING CODE 4163-18-P