Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices 76219 

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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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powder, 0.012 mg/inh, was withdrawn 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 

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 

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 leoangelo.gumapas@

psc.hhs.gov, 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 


ddrumheller on DSK120RN23PROD with NOTICES1
76220 Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices 

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 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 213 / Monday, November 6, 2023 / Notices 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 

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 

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, 


ddrumheller on DSK120RN23PROD with NOTICES1