Revision of HHS National Environmental Policy Act Compliance Procedures To Incorporate Federal Flood Risk Management Standard Procedures, 76219-76221 [2023-24348]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
FORADIL (formoterol fumarate)
inhalation powder, 0.012 mg/inh, is the
subject of NDA 020831, held by
Novartis Pharmaceuticals Corp., and
initially approved on February 16, 2001.
FORADIL is indicated for treatment of
asthma in patients 5 years of age and
older as an add-on to a long-term
asthma control medication such as an
inhaled corticosteroid; prevention of
exercise-induced bronchospasm (EIB) in
patients 5 years of age and older; and
maintenance treatment of
bronchoconstriction in patients with
chronic obstructive pulmonary disease.
In a letter dated September 30, 2015,
Novartis Pharmaceuticals Corp. notified
FDA that FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/
inh, was being discontinued, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In the
Federal Register of June 21, 2018 (83 FR
28856), FDA announced that it was
withdrawing approval of NDA 020831,
effective July 23, 2018.
K&L Gates LLP submitted a citizen
petition dated June 21, 2023 (Docket No.
FDA–2023–P–2536), under 21 CFR
10.30, requesting that the Agency
determine whether FORADIL
(formoterol fumarate) inhalation
powder, 0.012 mg/inh, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/
inh, was not withdrawn for reasons of
safety or effectiveness. The petitioner
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17:53 Nov 03, 2023
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has identified no data or other
information suggesting that FORADIL
(formoterol fumarate) inhalation
powder, 0.012 mg/inh, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
FORADIL (formoterol fumarate)
inhalation powder, 0.012 mg/inh, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/
inh, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: November 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–24506 Filed 11–3–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Revision of HHS National
Environmental Policy Act Compliance
Procedures To Incorporate Federal
Flood Risk Management Standard
Procedures
Assistant Secretary for
Administration, U.S. Department of
Health and Human Services (HHS).
ACTION: Notice; request for comments.
AGENCY:
HHS is proposing a revision
to its floodplain management
procedures to include climate science if
an action takes place in a floodplain.
DATES: Interested parties should submit
written comments to FOR FURTHER
INFORMATION CONTACT section shown
below on or before December 6, 2023 to
be considered in the formation of the
final procedures.
SUMMARY:
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CDR
Leo Angelo Gumapas, Environmental
Engineering Program Chief, at 202–669–
6942 or by email at leoangelo.gumapas@
psc.hhs.gov, for clarification of content.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
E.O. 13690 of January 30, 2015—
Establishing a Federal Flood Risk
Management Standard and a Process for
Further Soliciting and Considering
Stakeholder Input—was issued to
improve the nation’s resilience to
flooding and to better prepare for the
impacts of climate change. In amending
and building upon E.O. 11988—
Floodplain Management—which was
issued in 1977, E.O. 13690 and the
associated FFRMS reinforce the
important tenets and concepts
articulated in E.O. 11988, such as
avoiding actions in or impacting a
floodplain and minimizing potential
harm if an action must be located in a
floodplain. When avoiding a floodplain
is not possible, E.O. 13690 calls for
agencies to improve the resilience of
communities and federal actions.
On August 15, 2017, E.O. 13807 was
issued, which revoked E.O. 13690.
Accordingly, the ‘‘Revised Guidelines
for Implementing Executive Order
11988, Floodplain Management’’ and its
supplementary policy were withdrawn.
On May 20, 2021, E.O. 14030, reinstated
E.O. 13690 and all supplementary
policies.
HHS’s current floodplain management
procedures are published in the General
Administration Manual Part 30:
Environmental Protection (GAM–30)
section 30–40–40 Floodplain
Management, and they are based on E.O.
11988. The GAM–30 was last updated
on February 25, 2000, and it is based on
outdated laws and regulations. Program
Support Center (PSC) √ Real Estate,
Logistics, Operations (RLO) √ Real
Property Management Service (RPMS) √
Real Property Policy and Strategy
(RPPS) drafted HHS FFRMS procedures
based on E.O. 13690 to update GAM–30
Section 30–40–40 Floodplain
Management.
The Council on Environmental
Quality (CEQ) reviewed HHS’s FFRMS
procedures and provided favorable
comments on December 2022.
Procedure Revisions
Revised General Administration
Manual, HHS Part 30, Environmental
Protection
Part 30—Environmental Protection
30–40 Natural Asset Review
30–40–40 Floodplain Management
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Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
Purpose: Executive Order (E.O.) 13690
on Establishing a Federal Flood Risk
Management Standard (FFRMS) and a
Process for Further Soliciting and
Considering Stakeholder Input (2015),
establishes a Federal Flood Risk
Management Standard to ensure each
Federal agency takes actions to enhance
the Nation’s resilience to current and
future flooding and better prepare the
United States for the impacts of climate
change, such as sea level rise and
extreme weather events. E.O. 13690 and
the associated FFRMS amended and
built upon E.O. 11988 on Floodplain
Management (1977), which requires
agencies to take action to reduce the risk
of flood loss, to minimize the impacts of
floods on human safety, health, and
welfare, and to restore and preserve the
natural and beneficial values served by
floodplains. E.O. 13690 modernizes E.O.
11988 by increasing the vertical flood
elevation and expanding corresponding
horizontal extent of the floodplain to
consider changing flood hazards due to
climate change and other processes, and
by encouraging climate-conscious
resilient design if there are no
practicable locations outside the
expanded floodplain.
Definitions
Base Flood. ‘‘Base Flood’’ means that
flood which has a one percent of greater
chance of occurrence in any given year.
Base Flood Elevation (BFE). ‘‘BFE’’
means the computed elevation to which
the floodwater is anticipated to rise
during the base flood.
Base Floodplain. ‘‘Floodplain’’ means
the area subject to flooding by the base
flood, the flood that has a one percent
or greater chance of flooding in any
given year.
Climate-Informed Science Approach
(CISA). ‘‘CISA’’ means the flood hazard
area (vertical flood elevation and
corresponding horizontal extent) that
results from using the best-available,
actionable hydrologic and hydraulic
data and methods that integrate current
and future changes in flooding based on
climate science.
Critical Action. ‘‘Critical Action’’
means any activity for which even a
slight chance of flooding is too great,
e.g., elderly housing proposals.
Federal Flood Risk Management
Standard (FFRMS). ‘‘FFRMS’’ means the
floodplain determined using one of the
three approaches: CISA, 0.2PFA, and
FVA.
Freeboard Value Approach (FVA).
‘‘FVA’’ means the flood hazard area that
results from adding an additional 2 feet
to the BFE and expanding to the
corresponding horizontal extent for noncritical actions, and by adding an
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additional 3 feet to the BFE and
expanding to the corresponding
horizontal extent for critical actions.
Horizontal Extent. ‘‘Horizontal
Extent’’ means the horizontal land area
flooded by the vertical extent (extra
flood elevation beyond the BFE).
Nature-Based Approach. HHS
OPDIVs/STAFFDIVs, where possible,
must use natural systems, ecosystem
processes, and natural features and
nature-based approaches in
development of alternatives for
proposed action.
Vertical Extent. ‘‘Vertical Extent’’
means the additional flood height above
the BFE.
0.2-Percent-Annual-Chance (500-year)
Flood Approach (0.2PFA). ‘‘0.2PFA’’
means the area subject to flooding by
the 0.2-percent annual chance flood.
Responsibilities: Each OPDIV/
STAFFDIV has the responsibility under
E.O. 13690 to act on Federally Funded
Projects to reduce the risk of flood loss,
to minimize the impact of floods on
human safety, health, and welfare, and
to restore and preserve the natural and
beneficial values served by floodplains
in carrying out its responsibilities for:
Acquiring, managing, and disposing of
Federal lands and facilities
Providing Federally undertaken,
financed, or assisted construction,
substantial improvements, and
substantial damages to structures and
facilities
Conducting Federal activities and
programs affected land use, including
but not limited to, water and related
land resources planning, regulating,
and licensing activities.
Each OPDIV/STAFFDIV shall
determine whether the site in which
their action would occur could
potentially be inundated by floodwaters
using FFRMS and shall use this
information to make an informed
decision to either avoid siting in the
determined flood hazard area or design
the action to be more resilient to the
associated flood hazard. Each OPDIV/
STAFFDIV shall evaluate the potential
effects of any actions it may take in a
FFRMS floodplain in accordance with
the floodplain assessment procedures in
this section. It must also ensure that its
planning programs and budget requests
reflect consideration of flood hazards
and floodplain management.
Integration with NEPA. OPDIVs/
STAFFDIVs are to evaluate the potential
effects of a proposed action in a
floodplain in accordance with the
procedures for National Environmental
Policy Act (NEPA) review in HHS
General Administration Manual Part
30–50. If an environmental assessment
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(EA) or environmental impact statement
(EIS) is required to be prepared for the
proposed action, a floodplain
assessment as described Paragraph E of
this section, shall be included in the EA
or EIS.
Floodplain Assessment (E.O. 13690)
Determine if Proposed Action is in a
FFRMS floodplain: First, determine if
Federally Funded Project is a critical
action, which impacts floodplain
determinations for the FVA approach.
Second, evaluate the vertical extent and
corresponding horizontal extent to
establish the FFRMS floodplain using
one of the three approaches in the
following is the order of preference
pending data availability:
CISA
0.2PFA
FVA
Involve Public in Decision-making
Process: Notify the public such as a
notice in a local newspaper or posting
in an accessible public space for the
area where the action is under
consideration. Public notifications and
all supporting communications and
activities should be accessible to all
(e.g., plain language, culturally
responsive, and accommodating),
including but not limited to those with
disabilities or limited English
proficiency. All public notifications are
required to follow all guidance and
regulation regarding 508 compliance,
the use of plain language, and limited
English proficiency. If completing an EA
or EIS, then include floodplain notice in
Description of Proposed Action and
Alternatives or Notice of Intent,
respectively.
Identify and Evaluate Practicable
Alternatives to Locating in FFRMS
Floodplain: OPDIVs/STAFFDIVs shall
use input from public comments on
practicable alternatives, including, if
possible, nature-based solutions.
Identify Adverse and Beneficial
Impacts: Identify adverse and beneficial
impacts, including stimulating
floodplain development, which may
result from the project. Analyze the
following factors: (1) Natural
environment (water resources,
hydrology, topography, habitat); (2)
Social concerns (environmental justice,
visual quality/aesthetics, historic and
cultural values, land use patterns), (3)
Economic Aspects (costs of
construction, transportation, relocation,
natural features, and ecosystem
processes), and (4) Legal considerations
(deeds, leases).
Mitigate Adverse Impacts: Minimize
impacts identified and restore and
preserve the beneficial values served by
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Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices
floodplains. The analysis shall discuss
the following: Alternatives to the
proposed action that may avoid adverse
effects and incompatible development
in the floodplain, including the
alternatives of no action or location at
an alternate site. Proposed buildings
and structures located in FFRMS
floodplain shall be programmed and
designed to latest version of the
American Society of Civil Engineers
‘‘Flood Resistant Design and
Construction’’ (ASCE/SEI 24–14)
provisions to mitigate the adverse
effects of the proposed action.
Senior Real Property Official
Approval: No action shall take place
involving HHS Federal Real Property in
an FFRMS floodplain without a finding
by the Senior Real Property Officer that
the only practicable alternative
consistent with the law and with the
policy set forth in E.O. 13690 requires
siting in a FFRMS floodplain. The
action involving HHS Federal Real
Property proposed for Senior Real
Property Official approval shall be
designed to minimize potential harm to
or within the FFRMS floodplain. The
Senior Real Property Official shall
approve proposed actions requiring an
EA or EIS on projects involving HHS
Federal Real Property affecting FFRMS
floodplains.
Re-Evaluate Alternatives: Use any
new information obtained from Public
Notice to determine if the proposed
project is still applicable. Reissue public
notice with Finding of No Significant
Impact or Record of Decision if EA or
EIS is drafted, respectively.
Announce and Explain Decision to
the Public (Notice): Notify the public of
the draft decision by publishing such as
a notice in a local newspaper or posting
in an accessible public space, dating the
notice and the posting at removal.
For programs subject to E.O. 12372,
the public notice shall be sent to the
appropriate state and local reviewing
agencies the geographic areas affected.
A public review period of 30 days after
the issuance of the public notice shall
be allotted before any action is taken.
Implement the Proposed Federally
Funded Project: Implement the
Federally Funded Project with
appropriate mitigation measures. Design
and construction contracts shall include
any mitigation measures are identified
through the process. Ensure through
independent 3rd party construction
quality assurance that mitigation
measures are fully implemented.
Licenses, permits, loans, or grants:
Each OPDIV/STAFFDIV shall take
FFRMS into account when formulating
or evaluating any water and land use
plans and shall require land and water
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17:53 Nov 03, 2023
Jkt 262001
resources use appropriate risk
management measures to mitigate the
degree of hazard involved. Adequate
provision shall be made for the
evaluation and consideration of flood
hazards determined by FFRMS for the
licenses, permits, loan, or grant-in-aid
programs that an OPDIV/STAFFDIV
administers. OPDIVs/STAFFDIVs shall
also encourage and provide appropriate
guidance to applicants to evaluate the
effects of their proposal in FFRMS
floodplains prior to submitting
applications for Federal licenses,
permits, loans, or grants.
Authorization or Appropriation
Requests: OPDIVs/STAFFDIVs shall
indicate in any requests for new
authorizations or appropriations
whether the proposed action is in
accord with Executive Order 13690 if
the proposed action will be in a
floodplain.
Guidance: The following resources
provides guidance for Implementation
of FFRMS. FFRMS Floodplain
Determination Job Aid.
Reducing Flood Losses through the
International Codes: Coordinating
Building Codes and Floodplain
Management Regulations, 5th Edition,
September 2019
Protecting Building Utility Systems
from Flood Damage: Principles and
Practices for the Design and
Construction of Flood Resistant
Building Utility Systems, Federal
Emergency Management Agency
(FEMA) P–348, Edition 2, February 2017
Cheryl R. Campbell,
Assistant Secretary for Administration.
[FR Doc. 2023–24348 Filed 11–3–23; 8:45 am]
BILLING CODE 4150–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Board of Scientific
Counselors, National Institute
Environmental Health Sciences,
December 03, 2023, 07:00 p.m. to
December 05, 2023, 04:45 p.m., NIEHS,
Rodbell Auditorium, 111 TW Alexander
Drive, Research Triangle Park, NC 27709
which was published in the Federal
Register on October 05, 2023, 88 FR
69209.
Meeting is being amended to reflect
updated agenda.
Name of Committee: Board of Scientific
Counselors, National Institute Environmental
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76221
Health Sciences ESBSC December 3–5, 2023
Meeting.
Date: December 3–5, 2023.
Closed: December 03, 2023, 7:00 p.m. to
8:00 p.m.
Agenda: Discussion of BSC Reviews.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 04, 2023, 8:30 a.m. to
10:00 a.m.
Agenda: Meeting Overview and Q & A
Session.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 04, 2023, 10:15 a.m. to
11:55 a.m.
Agenda: Q & A Session.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium 111 TW Alexander, Drive
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Closed: December 04, 2023, 11:55 a.m. to
12:40 p.m.
Agenda: 1:1 Sessions with Investigators.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Closed: December 04, 2023, 12:40 p.m. to
1:30 p.m.
Agenda: Working Lunch.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 04, 2023, 1:35 p.m. to 2:25
p.m.
Agenda: Q & A Session.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Closed: December 04, 2023, 2:25 p.m. to
2:40 p.m.
Agenda: 1:1 Session with Investigator.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 04, 2023, 2:55 p.m. to 4:25
p.m.
Agenda: Poster Session.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
Research Triangle Park, NC 27709 (Hybrid
Meeting).
Open: December 04, 2023, 3:30 p.m. to 4:20
p.m.
Agenda: Q & A Session.
Place: National Institute Environmental
Health Sciences (NIEHS), Rodbell
Auditorium, 111 TW Alexander Drive,
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Agencies
[Federal Register Volume 88, Number 213 (Monday, November 6, 2023)]
[Notices]
[Pages 76219-76221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24348]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Revision of HHS National Environmental Policy Act Compliance
Procedures To Incorporate Federal Flood Risk Management Standard
Procedures
AGENCY: Assistant Secretary for Administration, U.S. Department of
Health and Human Services (HHS).
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: HHS is proposing a revision to its floodplain management
procedures to include climate science if an action takes place in a
floodplain.
DATES: Interested parties should submit written comments to FOR FURTHER
INFORMATION CONTACT section shown below on or before December 6, 2023
to be considered in the formation of the final procedures.
FOR FURTHER INFORMATION CONTACT: CDR Leo Angelo Gumapas, Environmental
Engineering Program Chief, at 202-669-6942 or by email at
[email protected], for clarification of content.
SUPPLEMENTARY INFORMATION:
Background
E.O. 13690 of January 30, 2015--Establishing a Federal Flood Risk
Management Standard and a Process for Further Soliciting and
Considering Stakeholder Input--was issued to improve the nation's
resilience to flooding and to better prepare for the impacts of climate
change. In amending and building upon E.O. 11988--Floodplain
Management--which was issued in 1977, E.O. 13690 and the associated
FFRMS reinforce the important tenets and concepts articulated in E.O.
11988, such as avoiding actions in or impacting a floodplain and
minimizing potential harm if an action must be located in a floodplain.
When avoiding a floodplain is not possible, E.O. 13690 calls for
agencies to improve the resilience of communities and federal actions.
On August 15, 2017, E.O. 13807 was issued, which revoked E.O.
13690. Accordingly, the ``Revised Guidelines for Implementing Executive
Order 11988, Floodplain Management'' and its supplementary policy were
withdrawn. On May 20, 2021, E.O. 14030, reinstated E.O. 13690 and all
supplementary policies.
HHS's current floodplain management procedures are published in the
General Administration Manual Part 30: Environmental Protection (GAM-
30) section 30-40-40 Floodplain Management, and they are based on E.O.
11988. The GAM-30 was last updated on February 25, 2000, and it is
based on outdated laws and regulations. Program Support Center (PSC)
Real Estate, Logistics, Operations (RLO) Real
Property Management Service (RPMS) Real Property Policy and
Strategy (RPPS) drafted HHS FFRMS procedures based on E.O. 13690 to
update GAM-30 Section 30-40-40 Floodplain Management.
The Council on Environmental Quality (CEQ) reviewed HHS's FFRMS
procedures and provided favorable comments on December 2022.
Procedure Revisions
Revised General Administration Manual, HHS Part 30, Environmental
Protection
Part 30--Environmental Protection
30-40 Natural Asset Review
30-40-40 Floodplain Management
[[Page 76220]]
Purpose: Executive Order (E.O.) 13690 on Establishing a Federal
Flood Risk Management Standard (FFRMS) and a Process for Further
Soliciting and Considering Stakeholder Input (2015), establishes a
Federal Flood Risk Management Standard to ensure each Federal agency
takes actions to enhance the Nation's resilience to current and future
flooding and better prepare the United States for the impacts of
climate change, such as sea level rise and extreme weather events. E.O.
13690 and the associated FFRMS amended and built upon E.O. 11988 on
Floodplain Management (1977), which requires agencies to take action to
reduce the risk of flood loss, to minimize the impacts of floods on
human safety, health, and welfare, and to restore and preserve the
natural and beneficial values served by floodplains. E.O. 13690
modernizes E.O. 11988 by increasing the vertical flood elevation and
expanding corresponding horizontal extent of the floodplain to consider
changing flood hazards due to climate change and other processes, and
by encouraging climate-conscious resilient design if there are no
practicable locations outside the expanded floodplain.
Definitions
Base Flood. ``Base Flood'' means that flood which has a one percent
of greater chance of occurrence in any given year.
Base Flood Elevation (BFE). ``BFE'' means the computed elevation to
which the floodwater is anticipated to rise during the base flood.
Base Floodplain. ``Floodplain'' means the area subject to flooding
by the base flood, the flood that has a one percent or greater chance
of flooding in any given year.
Climate-Informed Science Approach (CISA). ``CISA'' means the flood
hazard area (vertical flood elevation and corresponding horizontal
extent) that results from using the best-available, actionable
hydrologic and hydraulic data and methods that integrate current and
future changes in flooding based on climate science.
Critical Action. ``Critical Action'' means any activity for which
even a slight chance of flooding is too great, e.g., elderly housing
proposals.
Federal Flood Risk Management Standard (FFRMS). ``FFRMS'' means the
floodplain determined using one of the three approaches: CISA, 0.2PFA,
and FVA.
Freeboard Value Approach (FVA). ``FVA'' means the flood hazard area
that results from adding an additional 2 feet to the BFE and expanding
to the corresponding horizontal extent for non-critical actions, and by
adding an additional 3 feet to the BFE and expanding to the
corresponding horizontal extent for critical actions.
Horizontal Extent. ``Horizontal Extent'' means the horizontal land
area flooded by the vertical extent (extra flood elevation beyond the
BFE).
Nature-Based Approach. HHS OPDIVs/STAFFDIVs, where possible, must
use natural systems, ecosystem processes, and natural features and
nature-based approaches in development of alternatives for proposed
action.
Vertical Extent. ``Vertical Extent'' means the additional flood
height above the BFE.
0.2-Percent-Annual-Chance (500-year) Flood Approach (0.2PFA).
``0.2PFA'' means the area subject to flooding by the 0.2-percent annual
chance flood.
Responsibilities: Each OPDIV/STAFFDIV has the responsibility under
E.O. 13690 to act on Federally Funded Projects to reduce the risk of
flood loss, to minimize the impact of floods on human safety, health,
and welfare, and to restore and preserve the natural and beneficial
values served by floodplains in carrying out its responsibilities for:
Acquiring, managing, and disposing of Federal lands and facilities
Providing Federally undertaken, financed, or assisted construction,
substantial improvements, and substantial damages to structures and
facilities
Conducting Federal activities and programs affected land use, including
but not limited to, water and related land resources planning,
regulating, and licensing activities.
Each OPDIV/STAFFDIV shall determine whether the site in which their
action would occur could potentially be inundated by floodwaters using
FFRMS and shall use this information to make an informed decision to
either avoid siting in the determined flood hazard area or design the
action to be more resilient to the associated flood hazard. Each OPDIV/
STAFFDIV shall evaluate the potential effects of any actions it may
take in a FFRMS floodplain in accordance with the floodplain assessment
procedures in this section. It must also ensure that its planning
programs and budget requests reflect consideration of flood hazards and
floodplain management.
Integration with NEPA. OPDIVs/STAFFDIVs are to evaluate the
potential effects of a proposed action in a floodplain in accordance
with the procedures for National Environmental Policy Act (NEPA) review
in HHS General Administration Manual Part 30-50. If an environmental
assessment (EA) or environmental impact statement (EIS) is required to
be prepared for the proposed action, a floodplain assessment as
described Paragraph E of this section, shall be included in the EA or
EIS.
Floodplain Assessment (E.O. 13690)
Determine if Proposed Action is in a FFRMS floodplain: First,
determine if Federally Funded Project is a critical action, which
impacts floodplain determinations for the FVA approach. Second,
evaluate the vertical extent and corresponding horizontal extent to
establish the FFRMS floodplain using one of the three approaches in the
following is the order of preference pending data availability:
CISA
0.2PFA
FVA
Involve Public in Decision-making Process: Notify the public such
as a notice in a local newspaper or posting in an accessible public
space for the area where the action is under consideration. Public
notifications and all supporting communications and activities should
be accessible to all (e.g., plain language, culturally responsive, and
accommodating), including but not limited to those with disabilities or
limited English proficiency. All public notifications are required to
follow all guidance and regulation regarding 508 compliance, the use of
plain language, and limited English proficiency. If completing an EA or
EIS, then include floodplain notice in Description of Proposed Action
and Alternatives or Notice of Intent, respectively.
Identify and Evaluate Practicable Alternatives to Locating in FFRMS
Floodplain: OPDIVs/STAFFDIVs shall use input from public comments on
practicable alternatives, including, if possible, nature-based
solutions.
Identify Adverse and Beneficial Impacts: Identify adverse and
beneficial impacts, including stimulating floodplain development, which
may result from the project. Analyze the following factors: (1) Natural
environment (water resources, hydrology, topography, habitat); (2)
Social concerns (environmental justice, visual quality/aesthetics,
historic and cultural values, land use patterns), (3) Economic Aspects
(costs of construction, transportation, relocation, natural features,
and ecosystem processes), and (4) Legal considerations (deeds, leases).
Mitigate Adverse Impacts: Minimize impacts identified and restore
and preserve the beneficial values served by
[[Page 76221]]
floodplains. The analysis shall discuss the following: Alternatives to
the proposed action that may avoid adverse effects and incompatible
development in the floodplain, including the alternatives of no action
or location at an alternate site. Proposed buildings and structures
located in FFRMS floodplain shall be programmed and designed to latest
version of the American Society of Civil Engineers ``Flood Resistant
Design and Construction'' (ASCE/SEI 24-14) provisions to mitigate the
adverse effects of the proposed action.
Senior Real Property Official Approval: No action shall take place
involving HHS Federal Real Property in an FFRMS floodplain without a
finding by the Senior Real Property Officer that the only practicable
alternative consistent with the law and with the policy set forth in
E.O. 13690 requires siting in a FFRMS floodplain. The action involving
HHS Federal Real Property proposed for Senior Real Property Official
approval shall be designed to minimize potential harm to or within the
FFRMS floodplain. The Senior Real Property Official shall approve
proposed actions requiring an EA or EIS on projects involving HHS
Federal Real Property affecting FFRMS floodplains.
Re-Evaluate Alternatives: Use any new information obtained from
Public Notice to determine if the proposed project is still applicable.
Reissue public notice with Finding of No Significant Impact or Record
of Decision if EA or EIS is drafted, respectively.
Announce and Explain Decision to the Public (Notice): Notify the
public of the draft decision by publishing such as a notice in a local
newspaper or posting in an accessible public space, dating the notice
and the posting at removal.
For programs subject to E.O. 12372, the public notice shall be sent
to the appropriate state and local reviewing agencies the geographic
areas affected. A public review period of 30 days after the issuance of
the public notice shall be allotted before any action is taken.
Implement the Proposed Federally Funded Project: Implement the
Federally Funded Project with appropriate mitigation measures. Design
and construction contracts shall include any mitigation measures are
identified through the process. Ensure through independent 3rd party
construction quality assurance that mitigation measures are fully
implemented.
Licenses, permits, loans, or grants: Each OPDIV/STAFFDIV shall take
FFRMS into account when formulating or evaluating any water and land
use plans and shall require land and water resources use appropriate
risk management measures to mitigate the degree of hazard involved.
Adequate provision shall be made for the evaluation and consideration
of flood hazards determined by FFRMS for the licenses, permits, loan,
or grant-in-aid programs that an OPDIV/STAFFDIV administers. OPDIVs/
STAFFDIVs shall also encourage and provide appropriate guidance to
applicants to evaluate the effects of their proposal in FFRMS
floodplains prior to submitting applications for Federal licenses,
permits, loans, or grants.
Authorization or Appropriation Requests: OPDIVs/STAFFDIVs shall
indicate in any requests for new authorizations or appropriations
whether the proposed action is in accord with Executive Order 13690 if
the proposed action will be in a floodplain.
Guidance: The following resources provides guidance for
Implementation of FFRMS. FFRMS Floodplain Determination Job Aid.
Reducing Flood Losses through the International Codes: Coordinating
Building Codes and Floodplain Management Regulations, 5th Edition,
September 2019
Protecting Building Utility Systems from Flood Damage: Principles
and Practices for the Design and Construction of Flood Resistant
Building Utility Systems, Federal Emergency Management Agency (FEMA) P-
348, Edition 2, February 2017
Cheryl R. Campbell,
Assistant Secretary for Administration.
[FR Doc. 2023-24348 Filed 11-3-23; 8:45 am]
BILLING CODE 4150-24-P