[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]
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