Mesothelioma Registry Feasibility; Request for Information, 13928-13929 [2019-06784]
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13928
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
to respondents other than the time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Epidemiologists .................................
CJD ..................................................
Kawasaki Syndrome ........................
Reye Syndrome ...............................
Acute Flaccid Myelitis ......................
10
25
50
100
2
10
1
1
20/60
15/60
20/60
30/60
7
63
17
50
Total ...........................................
...........................................................
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137
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–06815 Filed 4–5–19; 8:45 am]
BILLING CODE 4163–18–P
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
Centers for Disease Control and
Prevention, HHS.
ACTION: Request for information.
AGENCY:
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: https://
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–
SUMMARY:
jbell on DSK30RV082PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:45 Apr 05, 2019
Jkt 247001
0029; NIOSH–327) for this action. All
relevant comments, including any
personal information provided, will be
posted without change to https://
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 NIOSHregs@cdc.gov.
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.
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
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.’’
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
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-ofthe-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.
In order to study the feasibility of
establishing a National Mesothelioma
Registry, NIOSH requests information
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.
E:\FR\FM\08APN1.SGM
08APN1
jbell on DSK30RV082PROD with NOTICES
Federal Register / Vol. 84, No. 67 / Monday, April 8, 2019 / Notices
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?
VerDate Sep<11>2014
17:45 Apr 05, 2019
Jkt 247001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–R–64 and CMS–
10699]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
June 7, 2019.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
SUMMARY:
PO 00000
Frm 00068
Fmt 4703
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13929
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–R–64 Indirect Medical Education
and Direct Graduate Medical
Education
CMS–10699 Information Collection
Requirements Associated with Drug
Pricing Transparency and Supporting
Regulations in 42 CFR 403.1202
Under the 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.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
E:\FR\FM\08APN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
