Suspension of Community Eligibility, 3548-3550 [2020-00508]
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3548
Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Rules and Regulations
2. Add § 892.2070 to subpart B to read
as follows:
■
§ 892.2070
Medical image analyzer.
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(a) Identification. Medical image
analyzers, including computer-assisted/
aided detection (CADe) devices for
mammography breast cancer,
ultrasound breast lesions, radiograph
lung nodules, and radiograph dental
caries detection, is a prescription device
that is intended to identify, mark,
highlight, or in any other manner direct
the clinicians’ attention to portions of a
radiology image that may reveal
abnormalities during interpretation of
patient radiology images by the
clinicians. This device incorporates
pattern recognition and data analysis
capabilities and operates on previously
acquired medical images. This device is
not intended to replace the review by a
qualified radiologist, and is not
intended to be used for triage, or to
recommend diagnosis.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Design verification and validation
must include:
(i) A detailed description of the image
analysis algorithms including a
description of the algorithm inputs and
outputs, each major component or
block, and algorithm limitations.
(ii) A detailed description of prespecified performance testing methods
and dataset(s) used to assess whether
the device will improve reader
performance as intended and to
characterize the standalone device
performance. Performance testing
includes one or more standalone tests,
side-by-side comparisons, or a reader
study, as applicable.
(iii) Results from performance testing
that demonstrate that the device
improves reader performance in the
intended use population when used in
accordance with the instructions for
use. The performance assessment must
be based on appropriate diagnostic
accuracy measures (e.g., receiver
operator characteristic plot, sensitivity,
specificity, predictive value, and
diagnostic likelihood ratio). The test
dataset must contain a sufficient
number of cases from important cohorts
(e.g., subsets defined by clinically
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relevant confounders, effect modifiers,
concomitant diseases, and subsets
defined by image acquisition
characteristics) such that the
performance estimates and confidence
intervals of the device for these
individual subsets can be characterized
for the intended use population and
imaging equipment.
(iv) Appropriate software
documentation (e.g., device hazard
analysis; software requirements
specification document; software design
specification document; traceability
analysis; description of verification and
validation activities including system
level test protocol, pass/fail criteria, and
results; and cybersecurity).
(2) Labeling must include the
following:
(i) A detailed description of the
patient population for which the device
is indicated for use.
(ii) A detailed description of the
intended reading protocol.
(iii) A detailed description of the
intended user and user training that
addresses appropriate reading protocols
for the device.
(iv) A detailed description of the
device inputs and outputs.
(v) A detailed description of
compatible imaging hardware and
imaging protocols.
(vi) Discussion of warnings,
precautions, and limitations must
include situations in which the device
may fail or may not operate at its
expected performance level (e.g., poor
image quality or for certain
subpopulations), as applicable.
(vii) Device operating instructions.
(viii) A detailed summary of the
performance testing, including: test
methods, dataset characteristics, results,
and a summary of sub-analyses on case
distributions stratified by relevant
confounders, such as lesion and organ
characteristics, disease stages, and
imaging equipment.
Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00494 Filed 1–21–20; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2020–0005; Internal
Agency Docket No. FEMA–8613]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/national-floodinsurance-program-community-statusbook.
EFFECTIVE DATES: The effective date of
each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
FOR FURTHER INFORMATION: If you want
to determine whether a particular
community was suspended on the
suspension date or for further
information, contact Adrienne L.
Sheldon, PE, CFM, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 400 C
Street SW, Washington, DC 20472, (202)
212–3966.
SUMMARY:
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Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Rules and Regulations
The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
to be eligible for the sale of NFIP flood
insurance. A notice withdrawing the
suspension of such communities will be
published in the Federal Register.
In addition, FEMA publishes a Flood
Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard
Areas (SFHAs) in these communities.
The date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
SUPPLEMENTARY INFORMATION:
Community
No.
State and location
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Assistance Act not in connection with a
flood) may be provided for construction
or acquisition of buildings in identified
SFHAs for communities not
participating in the NFIP and identified
for more than a year on FEMA’s initial
FIRM for the community as having
flood-prone areas (section 202(a) of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
shown in the last column. The
Administrator finds that notice and
public comment procedures under 5
U.S.C. 553(b), are impracticable and
unnecessary because communities listed
in this final rule have been adequately
notified.
Each community receives 6-month,
90-day, and 30-day notification letters
addressed to the Chief Executive Officer
stating that the community will be
suspended unless the required
floodplain management measures are
met prior to the effective suspension
date. Since these notifications were
made, this final rule may take effect
within less than 30 days.
National Environmental Policy Act.
FEMA has determined that the
community suspension(s) included in
this rule is a non-discretionary action
and therefore the National
Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
Regulatory Flexibility Act. The
Administrator has determined that this
rule is exempt from the requirements of
the Regulatory Flexibility Act because
the National Flood Insurance Act of
1968, as amended, Section 1315, 42
U.S.C. 4022, prohibits flood insurance
coverage unless an appropriate public
body adopts adequate floodplain
Region VI
Texas:
Bee Cave, City of, Travis County .....
481610
Creedmoor, City of, Travis County ...
481697
Gonzales, City of, Gonzales County
480254
Gonzales County, Unincorporated
Areas.
Lakeway, City of, Travis County .......
480253
Mustang Ridge, City of, Caldwell and
Travis Counties.
Point Venture, Village of, Travis
County.
Rollingwood, City of, Travis County ..
481687
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481303
481691
481029
PO 00000
management measures with effective
enforcement measures. The
communities listed no longer comply
with the statutory requirements, and
after the effective date, flood insurance
will no longer be available in the
communities unless remedial action
takes place.
Regulatory Classification. This final
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866 of September 30,
1993, Regulatory Planning and Review,
58 FR 51735.
Executive Order 13132, Federalism.
This rule involves no policies that have
federalism implications under Executive
Order 13132.
Executive Order 12988, Civil Justice
Reform. This rule meets the applicable
standards of Executive Order 12988.
Paperwork Reduction Act. This rule
does not involve any collection of
information for purposes of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
List of Subjects in 44 CFR Part 64
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is
amended as follows:
PART 64—[AMENDED]
1. The authority citation for Part 64
continues to read as follows:
■
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp.; p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp.; p. 376.
§ 64.6
[Amended]
2. The tables published under the
authority of § 64.6 are amended as
follows:
■
Effective date authorization/cancellation
of sale of flood insurance in community
Current effective
map date
N/A, Emerg; April 12, 1988, Reg; January 22, 2020, Susp.
N/A, Emerg; July 20, 2018, Reg; January
22, 2020, Susp.
August 6, 1975, Emerg; June 15, 1979,
Reg; January 22, 2020, Susp.
November 8, 1973, Emerg; August 15,
1978, Reg; January 22, 2020, Susp.
June 27, 1977, Emerg; November 5,
1980, Reg; January 22, 2020, Susp.
N/A, Emerg; June 15, 2000, Reg; January 22, 2020, Susp.
N/A, Emerg; May 29, 2002, Reg; January 22, 2020, Susp.
February 3, 1975, Emerg; September 29,
1978, Reg; January 22, 2020, Susp.
January 22, 2020 ...
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3549
Date certain
Federal assistance
no longer available
in SFHAs
January 22, 2020.
.....do ......................
Do.
.....do ......................
Do.
.....do ......................
Do.
.....do ......................
Do.
.....do ......................
Do.
.....do ......................
Do.
.....do ......................
Do.
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3550
Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Rules and Regulations
Community
No.
State and location
San Leanna, Village of, Travis County.
The Hills, Village of, Travis County ...
481305
Volente, Village of, Travis County .....
481696
West Lake Hills, City of, Travis
County.
481030
480063
Region VII
Kansas: Butler County, Unincorporated
Areas.
Missouri: Maryville, City of, Nodaway
County.
200037
290264
Current effective
map date
N/A, Emerg; March 11, 1980, Reg; January 22, 2020, Susp.
N/A, Emerg; November 15, 2006, Reg;
January 22, 2020, Susp.
N/A, Emerg; April 15, 2004, Reg; January 22, 2020, Susp.
March 10, 1976, Emerg; July 17, 1978,
Reg; January 22, 2020, Susp.
.....do ......................
Do.
.....do ......................
Do.
.....do ......................
Do.
.....do ......................
Do.
June 23, 1975, Emerg; March 2, 1981,
Reg; January 22, 2020, Susp.
March 7, 1975, Emerg; September 18,
1985, Reg; January 22, 2020, Susp.
......do .....................
Do.
January 22, 2020 ...
* ......do =Ditto.
Code for reading third column: Emerg. —Emergency; Reg. —Regular; Susp. —Suspension.
Dated: January 6, 2020.
Eric Letvin,
Deputy Assistant Administrator for
Mitigation, Federal Insurance and Mitigation
Administration—FEMA Resilience,
Department of Homeland Security, Federal
Emergency Management Agency.
[FR Doc. 2020–00508 Filed 1–21–20; 8:45 am]
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BILLING CODE 9110–12–P
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Date certain
Federal assistance
no longer available
in SFHAs
Effective date authorization/cancellation
of sale of flood insurance in community
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January 22, 2020.
]]>Agencies
[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Rules and Regulations]
[Pages 3548-3550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00508]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Federal Emergency Management Agency
44 CFR Part 64
[Docket ID FEMA-2020-0005; Internal Agency Docket No. FEMA-8613]
Suspension of Community Eligibility
AGENCY: Federal Emergency Management Agency, DHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.
EFFECTIVE DATES: The effective date of each community's scheduled
suspension is the third date (``Susp.'') listed in the third column of
the following tables.
FOR FURTHER INFORMATION: If you want to determine whether a particular
community was suspended on the suspension date or for further
information, contact Adrienne L. Sheldon, PE, CFM, Federal Insurance
and Mitigation Administration, Federal Emergency Management Agency, 400
C Street SW, Washington, DC 20472, (202) 212-3966.
[[Page 3549]]
SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
List of Subjects in 44 CFR Part 64
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is amended as follows:
PART 64--[AMENDED]
0
1. The authority citation for Part 64 continues to read as follows:
Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.
Sec. 64.6 [Amended]
0
2. The tables published under the authority of Sec. 64.6 are amended
as follows:
----------------------------------------------------------------------------------------------------------------
Effective date
authorization/
Community cancellation of Current effective map Date certain Federal
State and location No. sale of flood date assistance no longer
insurance in available in SFHAs
community
----------------------------------------------------------------------------------------------------------------
Region VI
Texas:
Bee Cave, City of, Travis 481610 N/A, Emerg; January 22, 2020........ January 22, 2020.
County. April 12, 1988,
Reg; January
22, 2020, Susp.
Creedmoor, City of, 481697 N/A, Emerg; July .....do................. Do.
Travis County. 20, 2018, Reg;
January 22,
2020, Susp.
Gonzales, City of, 480254 August 6, 1975, .....do................. Do.
Gonzales County. Emerg; June 15,
1979, Reg;
January 22,
2020, Susp.
Gonzales County, 480253 November 8, .....do................. Do.
Unincorporated Areas. 1973, Emerg;
August 15,
1978, Reg;
January 22,
2020, Susp.
Lakeway, City of, Travis 481303 June 27, 1977, .....do................. Do.
County. Emerg; November
5, 1980, Reg;
January 22,
2020, Susp.
Mustang Ridge, City of, 481687 N/A, Emerg; June .....do................. Do.
Caldwell and Travis 15, 2000, Reg;
Counties. January 22,
2020, Susp.
Point Venture, Village 481691 N/A, Emerg; May .....do................. Do.
of, Travis County. 29, 2002, Reg;
January 22,
2020, Susp.
Rollingwood, City of, 481029 February 3, .....do................. Do.
Travis County. 1975, Emerg;
September 29,
1978, Reg;
January 22,
2020, Susp.
[[Page 3550]]
San Leanna, Village of, 481305 N/A, Emerg; .....do................. Do.
Travis County. March 11, 1980,
Reg; January
22, 2020, Susp.
The Hills, Village of, 480063 N/A, Emerg; .....do................. Do.
Travis County. November 15,
2006, Reg;
January 22,
2020, Susp.
Volente, Village of, 481696 N/A, Emerg; .....do................. Do.
Travis County. April 15, 2004,
Reg; January
22, 2020, Susp.
West Lake Hills, City of, 481030 March 10, 1976, .....do................. Do.
Travis County. Emerg; July 17,
1978, Reg;
January 22,
2020, Susp.
Region VII
Kansas: Butler County, 200037 June 23, 1975, ......do................ Do.
Unincorporated Areas. Emerg; March 2,
1981, Reg;
January 22,
2020, Susp.
Missouri: Maryville, City of, 290264 March 7, 1975, January 22, 2020........ January 22, 2020.
Nodaway County. Emerg;
September 18,
1985, Reg;
January 22,
2020, Susp.
----------------------------------------------------------------------------------------------------------------
* ......do =Ditto.
Code for reading third column: Emerg. --Emergency; Reg. --Regular; Susp. --Suspension.
Dated: January 6, 2020.
Eric Letvin,
Deputy Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration--FEMA Resilience, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2020-00508 Filed 1-21-20; 8:45 am]
BILLING CODE 9110-12-P
