Medical Device Epidemiology Network Registry Task Force Report; Availability, Web Site Location and Request for Comments, 51567-51568 [2015-20948]
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Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–21001 Filed 8–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Institute for Occupational
Safety and Health (BSC, NIOSH)
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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
aforementioned committee:
Time and Date: 8:30 a.m.–3:00 p.m., EDT,
September 22, 2015.
Place: Patriots Plaza I, 395 E Street SW.,
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Status: Open to the public, limited only by
the space available. The meeting room
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meeting is also open to the public via
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by webcast, please see the NIOSH Web site
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call (404–498–2539) at least five business
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Teleconference is available toll-free; please
dial (888) 397–9578, Participant Pass Code
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to address the BSC, NIOSH are requested to
contact the Executive Secretary for
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below). Alternatively, written comments to
the BSC may be submitted via an on-line
form at the following Web site: https://
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Purpose: The Secretary, the Assistant
Secretary for Health, and by delegation the
Director, Centers for Disease Control and
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to conduct directly or by grants or contracts,
research, experiments, and demonstrations
relating to occupational safety and health and
to mine health. The Board of Scientific
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Matters for Discussion: NIOSH Director’s
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Participation in Research, Systematic Review
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Occupational Exposure Banding, and an
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niosh/bsc/).
Contact Person for More Information: John
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CDC, 1600 Clifton Road NE., MS–E20,
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other committee management activities for
both the CDC and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–20999 Filed 8–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Advisory Board on Radiation and
Worker Health: Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Advisory Board on Radiation and
Worker Health, Department of Health
and Human Services, has been renewed
for a 2-year period through August 3,
2017.
For information, contact Mr.
Theodore Katz, Designated Federal
Officer, Advisory Board on Radiation
and Worker Health, Department of
Health and Human Services, 1600
Clifton Road, M/S E20, Atlanta, Georgia
30341, telephone 404/498–2533, or fax
404/498–2570.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–21000 Filed 8–24–15; 8:45 am]
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51567
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2048]
Medical Device Epidemiology Network
Registry Task Force Report;
Availability, Web Site Location and
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA) is announcing the
availability of the report and Web site
location where the Agency has posted
the report entitled ‘‘Recommendations
for a National Medical Device
Evaluation System: Strategically
Coordinated Registry Networks to
Bridge the Clinical Care and Research,’’
developed by the Medical Device
Epidemiology Network’s Medical
Device Registry Task Force. In addition,
FDA has established a docket where
stakeholders may provide comments.
DATES: Submit either electronic or
written comments by October 26, 2015.
ADDRESSES: Submit electronic
comments on this document to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Danica Marinac-Dabic, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4110,
Silver Spring, MD 20993–0002, 301–
796–6689, email: Danica.marinacdabic@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA’s Center for Devices and
Radiological Health is responsible for
protecting the public health by assuring
the safety and effectiveness of medical
devices and radiation-emitting products.
A key part of this mission is to monitor
medical devices and radiological
products for continued safety and
effectiveness after they are in use and to
help the public get the accurate,
science-based information they need to
improve their health.
In September 2012, the FDA
published a report, ‘‘Strengthening Our
National System for Medical Device
Postmarket Surveillance,’’ that proposed
E:\FR\FM\25AUN1.SGM
25AUN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
51568
Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices
a strategy for improving the current
system for monitoring medical device
safety and effectiveness. In April 2013,
the FDA issued an update to the
September 2012 report that incorporated
public input received and described the
next steps towards fulfilling the vision
for building a national postmarket
surveillance system. These reports can
be found at FDA’s Web site https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHReports/ucm301912.htm.
One of these next steps consisted of
establishing a multistakeholder Medical
Device Registry Task Force to promote
the development of national and
international device registries for
selected products (Ref. 1). Under a
cooperative agreement with the FDA,
Duke University convened the Medical
Device Registry Task Force as a part of
the Medical Device Epidemiology
Network public-private partnership in
2014. The Task Force membership
included representatives from a broad
array of stakeholder groups and areas of
expertise including patients, provider
organizations, hospitals, health plans,
industry, government agencies, as well
as methodologists and academic
researchers.
The Medical Device Registry Task
Force was charged to: (1) Identify
existing registries that may contribute to
the system; (2) leverage ongoing registry
efforts focused on quality improvement,
reimbursement, patient-centered
outcomes and other activities to best
meet the needs of multiple stakeholders;
(3) identify priority medical device
types for which the establishment of a
longitudinal registry is of significant
public health importance; (4) define
registry governance and data quality
practices that promote rigorous design,
conduct, analysis, and transparency to
meet stakeholder needs; and (5) develop
strategies for the use of registries to
support premarket approval and
clearance (Ref. 1).
This notice announces the availability
and Web site location of the Medical
Device Registry Task Force’s report,
entitled ‘‘Recommendations for a
National Medical Device Evaluation
System: Strategically Coordinated
Registry Networks to Bridge the Clinical
Care and Research.’’ FDA invites
interested persons to submit comments
on this report. We have established a
docket where comments may be
submitted (see ADDRESSES). We believe
this docket is an important tool for
receiving feedback on this report from
interested parties and for sharing this
information with the public. To access
‘‘Recommendations for a National
Medical Device Evaluation System:
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17:10 Aug 24, 2015
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Strategically Coordinated Registry
Networks to Bridge the Clinical Care
and Research’’ report, visit FDA’s Web
site https://www.fda.gov/AboutFDA/
CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHReports/ucm301912.htm.
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Reference
The following reference has been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. We have verified the
Web site address, but we are not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.
1. ‘‘Strengthening Our National System for
Medical Device Postmarket Surveillance:
Update and Next Steps,’’ April 2013,
available at https://www.fda.gov/downloads/
MedicalDevices/Safety/
CDRHPostmarketSurveillance/
UCM348845.pdf.
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20948 Filed 8–24–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
SUMMARY:
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Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 11C–26, Rockville, MD
20857; (301) 443–6593, or visit our Web
site at: https://www.hrsa.gov/
vaccinecompensation/.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
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Agencies
[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51567-51568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20948]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2048]
Medical Device Epidemiology Network Registry Task Force Report;
Availability, Web Site Location and Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the report and Web site location where the Agency has
posted the report entitled ``Recommendations for a National Medical
Device Evaluation System: Strategically Coordinated Registry Networks
to Bridge the Clinical Care and Research,'' developed by the Medical
Device Epidemiology Network's Medical Device Registry Task Force. In
addition, FDA has established a docket where stakeholders may provide
comments.
DATES: Submit either electronic or written comments by October 26,
2015.
ADDRESSES: Submit electronic comments on this document to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Danica Marinac-Dabic, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993-0002,
301-796-6689, email: Danica.marinac-dabic@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's Center for Devices and Radiological Health is responsible for
protecting the public health by assuring the safety and effectiveness
of medical devices and radiation-emitting products. A key part of this
mission is to monitor medical devices and radiological products for
continued safety and effectiveness after they are in use and to help
the public get the accurate, science-based information they need to
improve their health.
In September 2012, the FDA published a report, ``Strengthening Our
National System for Medical Device Postmarket Surveillance,'' that
proposed
[[Page 51568]]
a strategy for improving the current system for monitoring medical
device safety and effectiveness. In April 2013, the FDA issued an
update to the September 2012 report that incorporated public input
received and described the next steps towards fulfilling the vision for
building a national postmarket surveillance system. These reports can
be found at FDA's Web site https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.
One of these next steps consisted of establishing a
multistakeholder Medical Device Registry Task Force to promote the
development of national and international device registries for
selected products (Ref. 1). Under a cooperative agreement with the FDA,
Duke University convened the Medical Device Registry Task Force as a
part of the Medical Device Epidemiology Network public-private
partnership in 2014. The Task Force membership included representatives
from a broad array of stakeholder groups and areas of expertise
including patients, provider organizations, hospitals, health plans,
industry, government agencies, as well as methodologists and academic
researchers.
The Medical Device Registry Task Force was charged to: (1) Identify
existing registries that may contribute to the system; (2) leverage
ongoing registry efforts focused on quality improvement, reimbursement,
patient-centered outcomes and other activities to best meet the needs
of multiple stakeholders; (3) identify priority medical device types
for which the establishment of a longitudinal registry is of
significant public health importance; (4) define registry governance
and data quality practices that promote rigorous design, conduct,
analysis, and transparency to meet stakeholder needs; and (5) develop
strategies for the use of registries to support premarket approval and
clearance (Ref. 1).
This notice announces the availability and Web site location of the
Medical Device Registry Task Force's report, entitled ``Recommendations
for a National Medical Device Evaluation System: Strategically
Coordinated Registry Networks to Bridge the Clinical Care and
Research.'' FDA invites interested persons to submit comments on this
report. We have established a docket where comments may be submitted
(see ADDRESSES). We believe this docket is an important tool for
receiving feedback on this report from interested parties and for
sharing this information with the public. To access ``Recommendations
for a National Medical Device Evaluation System: Strategically
Coordinated Registry Networks to Bridge the Clinical Care and
Research'' report, visit FDA's Web site https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm.
II. Request for Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
III. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. We have
verified the Web site address, but we are not responsible for
subsequent changes to the Web site after this document publishes in the
Federal Register.
1. ``Strengthening Our National System for Medical Device
Postmarket Surveillance: Update and Next Steps,'' April 2013,
available at https://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf.
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20948 Filed 8-24-15; 8:45 am]
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