20876 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 

1Toxic Wastes and Race at Twenty 1987—2007. 

A Report Prepared for the United Church of Christ 

Justice & Witness Ministries. Principal Authors: 

Bullard R, Mohai P, Saha R, Wright B. 2007. 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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. 

NASONEX (mometasone furoate) 

nasal spray, 0.05 mg/spray 50 (mcg), is 

the subject of NDA 020762, held by 

Organon LLC, and initially approved on 

October 1, 1997. NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg) is a corticosteroid 

indicated for: 

• Treatment of nasal symptoms of 

allergic rhinitis in patients 2 years of age 

and older; 

• treatment of nasal congestion 

associated with seasonal allergic rhinitis 

in patients 2 years of age or older; 

• prophylaxis of seasonal allergic 

rhinitis in patients 12 years of age or 

older; and 

• treatment of nasal polyps in 

patients 18 years of age or older. 

In a letter dated December 4, 2020, 

Merck Sharp and Dohme Corp., a 

subsidiary of Merck and Co., Inc., 

notified FDA that NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg) was being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Aurobindo Pharma Ltd. submitted a 

citizen petition dated January 14, 2022 

(Docket No. FDA–2022–P–0077), under 

21 CFR 10.30, requesting that the 

Agency determine whether NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg), 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 NASONEX (mometasone 

furoate) nasal spray, 0.05 mg/spray 50 

(mcg) was not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that NASONEX 

(mometasone furoate) nasal spray, 0.05 

mg/spray 50 (mcg) was withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

NASONEX (mometasone furoate) nasal 

spray, 0.05 mg/spray 50 (mcg) from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list NASONEX (mometasone 

furoate) nasal spray, 0.05 mg/spray 50 

(mcg), 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: April 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07563 Filed 4–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information (RFI): 2022 

HHS Environmental Justice Strategy 

and Implementation Plan Draft Outline 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services (HHS). 

ACTION: Notice of request for 

information. 

SUMMARY: The Department of Health and 

Human Services (HHS) is issuing this 

Request for Information (RFI) to receive 

input from the public on HHS’ draft 

outline to further the development of 

the 2022 Environmental Justice Strategy 

and Implementation Plan. Consistent 

with the policy of this administration 

directing HHS to make achieving 

environmental justice part of its 

mission, HHS would like to identify 

priority actions and strategies to best 

address environmental injustices and 

health inequities for people of color, 

disadvantaged, vulnerable, low-income, 

marginalized, and indigenous 

populations. With the engagement of 

and input from the public, the 2022 

Environmental Justice Strategy and 

Implementation Plan will serve as a 

guide to confront environmental and 

health disparities and implement a 

multifaceted approach that will serve 

vulnerable populations and 

communities disproportionately 

impacted by environmental burdens. 

DATES: To be assured consideration, 

comments must be received at the email 

address provided below, no later than 

midnight Eastern Time (ET) on May 19, 

2022. HHS will not reply individually to 

responders but will consider all 

comments submitted by the deadline. 

Do not provide confidential information 

as comments may be published or 

otherwise used for agency purposes. 

ADDRESSES: Please submit all responses 

via email to OASHcomments@hhs.gov 

as a Word document or in the body of 

an email. 

FOR FURTHER INFORMATION CONTACT: Dr. 

LaToria Whitehead, Senior Public 

Health Analyst, email: ceq6@cdc.gov, 

phone: (770) 488–3633. 

SUPPLEMENTARY INFORMATION: The 

mission of the U.S. Department of 

Health and Human Services is to 

enhance the health and well-being of 

Americans, by providing for effective 

health and human services and by 

fostering sound, sustained advances in 

the sciences underlying medicine, 

public health, and social services. For 

years studies have demonstrated that 

people of color and disadvantaged, 

vulnerable, low-income, marginalized, 

and indigenous populations are 

disproportionately burdened by 

environmental hazards.1 These 

populations are often exposed to 

unhealthy land uses, poor air and water 

quality, dilapidated housing, lead 

exposure, and other environmental 

threats that drive health disparities. 

Many of these communities are 

underserved and surrounded by social 

inequities such as job insecurity, 

underemployment, linguistic isolation, 

underperforming schools, noise, 

crowded homes, lack of access to 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 20877 

2Bullard RD, Johnson GS, Torres AO. 

Environmental Health and Racial Equity in the 

United States. Building Environmentally Just, 

Sustainable, and Livable Communities. 

Washington, DC: American Public Health 

Association Press. 2011. 

3Morello-Frosch R, Zuk M, Jerrett M, 

Shamasunder B. Understanding the Cumulative 

impacts of inequalities in Environmental Health: 

Implications for Policy. Health Affairs. 2011. 

4Cushing L, Morello-Frosch R, Wander M, Pastor 

M. The Haves, the Have-Nots, and the Health of 

Everyone: The Relationship Between Social 

Inequality and Environmental Quality. Annual 

Review of Public Health. 2015. 

5U.S. Environmental Protection Agency (EPA). 

Environmental Justice. Environmental Justice | US 

EPA. 

6Executive Order 14008. ‘‘Tackling the Climate 

Crisis at Home and Abroad.’’ 86 FR 7619 (January 

27, 2021). See https://www.federalregister.gov/ 

documents/2021/02/01/2021-02177/tackling-theclimate-crisis-at-home-and-abroad. 

7U.S. Department of Health and Human Services 

(HHS). 2012 Environmental Justice Strategy and 

Implementation Plan. See 2012 HHS 

ENVIRONMENTAL JUSTICE STRATEGY AND 

IMPLEMENTATION PLAN. 

healthy foods and transportation, and 

limitations on access to and 

participation in the decision-making 

processes.2 3 The combination of 

environmental risks and social 

inequities creates a cumulative, 

disproportionate impact that hinders 

optimal health and environmental 

justice for these populations.4 The 

Environmental Protection Agency 

defines Environmental Justice (EJ) as 

‘‘the fair treatment and meaningful 

involvement of all people regardless of 

race, color, national origin, or income 

with respect to the development, 

implementation, and enforcement of 

environmental laws, regulations, and 

policies’’.5

On January 27, 2021, President Biden 

directed the Department of Health and 

Human Services to make achieving 

environmental justice part of its mission 

by developing programs, policies, and 

activities to address the 

disproportionately high and adverse 

human health, environmental and 

climate-related and other cumulative 

impacts on disadvantaged 

communities.6 In 1994, President 

Clinton signed Executive Order 12898, 

Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations, also directing federal 

agencies to ‘‘make achieving 

environmental justice part of its mission 

by identifying and addressing, as 

appropriate, disproportionately high 

and adverse human health or 

environmental effects of its programs, 

policies, and activities on minority 

populations and low-income 

populations.’’ Executive Order 12898 

required each agency to develop an 

agency-wide environmental justice 

strategy specific to that agency’s 

mission. In response, HHS issued its 

first Environmental Justice Strategy in 

1995. Federal environmental justice 

efforts were reinvigorated in 2010 and 

in 2012, and again, HHS responded with 

release of an updated Environmental 

Justice Strategy and Implementation 

Plan.7 Currently, to support the 

executive order initiatives, and to 

pursue the Administration’s policy 

priorities for environmental justice, a 

revised strategy focused on short-term 

concrete actions, alongside thoughtful 

long-term planning, is required. OASH 

has convened and tasked the HHS 

Environmental Justice Working Group 

to develop the 2022 HHS Environmental 

Justice Strategy and Implementation 

Plan. 

The purpose of this Request for 

Information (RFI) is to seek public 

comment on the 2022 HHS 

Environmental Justice Strategy and 

Implementation Plan Draft Outline. The 

goal of the HHS Environmental Justice 

Strategy and Implementation Plan is to 

provide direction for HHS efforts, 

pursue the Administration’s policy 

priorities and identify priority actions 

for environmental justice. The draft 

outline provides a general overview and 

a platform of how the plan will be 

structured. Within the outline, each 

strategic element is aligned to priority 

actions that HHS will carry out. Please 

see the Draft Strategy Outline below, 

followed by a request for information in 

the form of questions to the public. 

U.S. Department of Health and Human 

Services 2022 Environmental Justice 

Strategy and Implementation Plan Draft 

Outline 

The 2022 HHS Environmental Justice 

Strategy and Implementation Plan will 

likely include six interrelated strategic 

elements that mirror the 2012 HHS 

Environmental Justice Strategy. The 

elements include two new strategic 

elements: (1) Partnerships and 

Community Engagement and (2) 

Performance Measures. The additional 

elements align to Executive Order 12898 

to engage and partner with 

disadvantaged populations in building 

sustainable and healthy communities 

and creating performance measures to 

evaluate the process and the outcomes 

of activities that address adverse 

environmental conditions. The six 

proposed strategic elements are: 

(1) Services 

(2) Partnerships and Community 

Engagement 

(3) Policy Development and 

Dissemination 

(4) Research and Data Collection, 

Analysis, and Utilization 

(5) Education and Training 

(6) Performance Measures 

For each strategic element, the 2022 

HHS EJ Strategy will include priority 

actions to be undertaken by designated 

HHS Operating Divisions and Staff 

Divisions. 

I. Services 

Æ Priority Action(s) 

D Increase linguistic and culturally 

appropriate outreach to racial and 

ethnic minority, low-income, and 

Indigenous populations, and Native 

American persons with 

disproportionately high and adverse 

environmental exposures to raise 

their awareness of the availability of 

technical assistance for applying for 

HHS funding. 

D Expand funding opportunities to 

disadvantaged communities for 

economic development and social 

services. 

II. Partnerships and Community 

Engagement (Public Engagement) 

Æ Priority Action(s) 

D Establish partnerships with 

disadvantaged communities to 

assess and address disproportionate 

environmental exposures and 

health risks. 

D Partner with offices and 

departments with Title VI 

enforcement and compliance 

responsibilities to address 

environmental injustices and 

ensure that disadvantaged 

communities can effectively 

participate in and benefit from 

federally funded public health and 

social service programs and 

activities without discrimination. 

D Work with federal partners and 

various stakeholders to provide 

coordinated technical assistance 

and support to programs focused on 

disadvantaged communities. 

D Promote actions and seek resources 

to overcome participation barriers 

such as language and culture. 

III. Policy Development and 

Implementation 

Æ Priority Action(s) 

D Identify and provide technical 

assistance to HHS programs covered 

under the Justice40 Initiative to 

ensure 40 percent of the overall 

benefits the programs provide flow 

to disadvantaged communities. 

D Provide home cooling, 

weatherization, and/or low-cost 

home energy assistance to 

communities disproportionately 

affected by extreme weather events. 


jspears on DSK121TN23PROD with NOTICES1
20878 Federal Register / Vol. 87, No. 68 / Friday, April 8, 2022 / Notices 

D Fund and implement training and 

workforce development programs 

that build skills and careers related 

to climate, natural disasters, 

environment, clean energy, clean 

transportation, housing, water and 

wastewater infrastructure, and 

legacy pollution reduction. 

IV. Research and Data Collection, 

Analysis, Utilization 

Æ Priority Action(s) 

D Support research that explores the 

multiple and complex factors 

contributing to minority health 

disparities, including but not 

limited to environmental factors 

acting independently or 

dependently across multiple social 

levels. 

D Support the spectrum of community 

engaged research including 

community-based participatory 

research and community led 

research. Additionally, strengthen 

authentic community engagement 

in planning, implementing, 

evaluating, and disseminating 

effective interventions for diseases 

disproportionately affecting 

disadvantaged communities and 

vulnerable populations. 

D Coordinate the design, 

dissemination, and utilization of an 

environmental justice and social 

vulnerability data dashboard and 

index, for identifying, tracking, and 

addressing environmental burden 

and health inequities in 

disadvantaged communities. 

D Report research data to 

communities using culturally 

appropriate and accessible 

methods. 

V. Education and Training 

Æ Priority Action(s) 

D Provide data, training, and technical 

assistance to disadvantaged 

communities and vulnerable 

populations at higher risk for 

exposure to harmful environmental 

and health hazards. 

D Deliver comprehensive training to 

increase opportunities for 

individuals from disadvantaged, 

overburdened, and underserved 

communities to obtain careers in 

environmental cleanup, 

construction, hazardous waste 

removal, and emergency response. 

D Develop guidance and templates to 

assist states and tribes in the 

communication of environmental 

and health risks to households and 

communities. 

D Develop environmental justice 

training programs for Federal staff, 

primary health care and public 

health professionals, and policy and 

other decision-makers. 

VI. Performance Measures (Evaluation) 

Æ Priority Action(s) 

D Develop milestones and provide 

periodic progress to demonstrate 

accountability and progress. 

HHS is requesting information from 

the public regarding the following 

questions: 

Environmental Justice Core Principles 

1. What Environmental Justice Core 

Principles should be included in the 

HHS EJ Strategy to advance 

environmental justice for disadvantaged 

communities? 

2. How should HHS incorporate 

Environmental Justice Core Principles in 

the HHS EJ Strategy? 

Strategic Elements 

1. Do the Strategic Elements reflect 

relevant areas of environmental justice 

that address the needs of disadvantaged 

communities? 

2. Are there additional Strategic 

Elements that should be included in the 

HHS EJ Strategy? 

Priority Actions 

1. Do the Priority Actions capture the 

urgent, environmental justice issues of 

today? 

2. If not, what additional Priority 

Actions should be included within the 

HHS EJ Strategy? 

Research and Data Tools 

1. What research methods, research 

questions, and data tools should HHS 

use to address environmental justice 

and social determinants of health? 

Additional Information 

1. What other strategies can be 

included within the 2022 HHS 

Environmental Justice Strategy and 

Implementation Plan to address 

environmental justice and health equity 

issues for disadvantaged populations? 

HHS encourages all potentially 

interested parties—individuals, 

associations, governmental, nongovernmental organizations, academic 

institutions, and private sector 

entities—to respond. HHS is interested 

in the questions listed above, but 

respondents are welcome to address as 

many or as few as they choose and to 

address additional areas of interest not 

listed. To facilitate review of the 

responses, please reference the question 

category and number in your response. 

Arsenio Mataka, 

Senior Advisor, Office of the Assistant 

Secretary for Health, Department of Health 

and Human Services. 

[FR Doc. 2022–07514 Filed 4–7–22; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

RIN 0917–AA21 

Reimbursement Rates for Calendar 

Year 2022 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice. 

SUMMARY: Notice is provided that the 

Acting Director of the Indian Health 

Service (IHS) has approved the rates for 

inpatient and outpatient medical care 

provided by the IHS facilities for 

Calendar Year 2022. 

SUPPLEMENTARY INFORMATION: The 

Acting Director of the Indian Health 

Service (IHS), under the authority of 

sections 321(a) and 322(b) of the Public 

Health Service Act (42 U.S.C. 248 and 

249(b)), Public Law 83–568 (42 U.S.C. 

2001(a)), and the Indian Health Care 

Improvement Act (25 U.S.C. 1601 et 

seq.), has approved the following rates 

for inpatient and outpatient medical 

care provided by IHS facilities for 

Calendar Year 2022 for Medicare and 

Medicaid beneficiaries, beneficiaries of 

other federal programs, and for 

recoveries under the Federal Medical 

Care Recovery Act (42 U.S.C. 2651– 

2653). The inpatient rates for Medicare 

Part A are excluded from the table 

below. That is because Medicare 

inpatient payments for IHS hospital 

facilities are made based on the 

prospective payment system, or (when 

IHS facilities are designated as Medicare 

Critical Access Hospitals) on a 

reasonable cost basis. Since the 

inpatient per diem rates set forth below 

do not include all physician services 

and practitioner services, additional 

payment shall be available to the extent 

that those services are provided. 

Inpatient Hospital per Diem Rate 

(Excludes Physician/Practitioner 

Services) 

Calendar Year 2022 

Lower 48 States: $4,239 

Alaska: $3,583 

Outpatient per Visit Rate (Excluding 

Medicare) 

Calendar Year 2022 

Lower 48 States: $640 


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