Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 68629 

Application No. Drug Applicant 

ANDA 090177 ....... Oxycodone and Acetaminophen Tablets, 3.25 milligrams 

(mg); 2.5 mg, 325 mg; 5 mg, 325 mg; 7.5 mg, 325 mg; 10 

mg, 500 mg; 7.5 mg, 650 mg; 10 mg.

Dr. Reddy’s Laboratories, Inc., U.S. Agent for Dr. Reddy’s 

Laboratories SA, 107 College Rd. East, Princeton NJ 

08540. 

ANDA 091313 ....... Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15 

mg, 20 mg, 30 mg.

Do. 

ANDA 091670 ....... Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mg ............ Do. 

ANDA 203107 ....... Oxycodone HCl Capsules, 5 mg ............................................ Do. 

ANDA 203335 ....... Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mg.Do. 

ANDA 203807 ....... Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mg .............. Do. 

ANDA 204092 ....... Oxycodone HCl Oral Solution 100 mg/5 milliliters ................. Do. 

ANDA 205386 ....... Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg, 

60 mg, 100 mg.

Do. 

ANDA 206329 ....... Fentanyl Citrate Tablets, Equivalent to (EQ) 0.1 mg base, 

EQ 0.2 mg base, EQ 0.3 mg base, EQ 0.4 mg base, EQ 

0.6 mg base, EQ 0.8 mg base.

Do. 

ANDA 206953 ....... Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg 

base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg base.

Do. 

ANDA 207270 ....... Morphine Sulfate Tablets, 15 mg, 30 mg ............................... Do. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of November 3, 

2023. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on November 3, 

2023 may continue to be dispensed 

until the inventories have been depleted 

or the drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: September 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21992 Filed 10–3–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of the President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders Meeting and 

Solicitation for Written Comments 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Intergovernmental and 

External Affairs, White House Initiative 

on Asian Americans, Native Hawaiians, 

and Pacific Islanders. 

ACTION: Notice of meeting and 

solicitation for written comments. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

announces the next meeting of the 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders (Commission) and 

the solicitation of written comments 

regarding the advancement of equity, 

justice, and opportunity for Asian 

American, Native Hawaiian, and Pacific 

Islander (AA and NHPI) communities. 

The meeting is open to the public and 

will be held in Washington, DC on 

October 25 and October 26, 2023. 

Virtual attendance will be available 

through livestream. The Commission is 

working to accomplish its mission to 

provide independent advice and 

recommendations to the President on 

ways to advance equity, justice, and 

opportunity for AA and NHPI 

communities. 

DATES: The Commission will meet on 

October 25, 2023, from 9:00 a.m. Eastern 

Time (ET) to 4:30 p.m. ET and October 

26, 2023, from 9:00 a.m. ET to 2:00 p.m. 

ET. The final location and agenda will 

be posted on the website for the 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders: https:// 

www.hhs.gov/about/whiaanhpi/ 

commission/index.html when this 

information becomes available. 

ADDRESSES: Members of the public may 

attend virtually. Registration is required 

through the following link: https:// 

www.eventbrite.com/e/meeting-of-thepresidents-advisory-commission-on-aaand-nhpis-tickets-715434733547?aff=

oddtdtcreator. 

FOR FURTHER INFORMATION CONTACT: 

Viviane Chao, Designated Federal 

Officer, President’s Advisory 

Commission on Asian Americans, 

Native Hawaiians, and Pacific Islanders, 

U.S. Department of Health and Human 

Services, Office of the Secretary, Office 

of Intergovernmental and External 

Affairs, Hubert H. Humphrey Building, 

Room 620E, 200 Independence Ave. 

SW, Washington, DC 20201; email: 

AANHPICommission@hhs.gov; 

telephone: (202) 690–6060. 

SUPPLEMENTARY INFORMATION: The 

meeting is the seventh in a series of 

Federal advisory committee meetings 

regarding the development of 

recommendations to advance equity, 

justice, and opportunity for AA and 

NHPI communities. The meeting is open 

to the public and will be live streamed. 

The Commission, co-chaired by HHS 

Secretary Xavier Becerra and the U.S. 

Trade Representative Ambassador 

Katherine Tai, advises the President on: 

the development, monitoring, and 

coordination of executive branch efforts 

to advance equity, justice, and 

opportunity for AA and NHPI 

communities in the United States, 

including efforts to close gaps in health, 

socioeconomic, employment, and 

educational outcomes; policies to 

address and end anti-Asian bias, 

xenophobia, racism, and nativism, and 

opportunities for the executive branch 

to advance inclusion, belonging, and 

public awareness of the diversity and 

accomplishments of AA and NHPI 

people, cultures, and histories; policies, 

programs, and initiatives to prevent, 

report, respond to, and track anti-Asian 

hate crimes and hate incidents; ways in 

which the Federal Government can 

build on the capacity and contributions 

of AA and NHPI communities through 

equitable Federal funding, grantmaking, 

and employment opportunities; policies 

and practices to improve research and 

equitable data disaggregation regarding 

AA and NHPI communities; policies 

and practices to improve language 


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68630 Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices 

access services to ensure AA and NHPI 

communities can access Federal 

programs and services; and strategies to 

increase public-and private-sector 

collaboration, and community 

involvement in improving the safety 

and socioeconomic, health, educational, 

occupational, and environmental wellbeing of AA and NHPI communities. 

Information is available on the 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders website at https:// 

www.hhs.gov/about/whiaanhpi/ 

commission/index.html. The names of 

the 25 members of the President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders are available at https:// 

www.hhs.gov/about/whiaanhpi/ 

commission/commissioners/index.html. 

Purpose of Meeting: The President’s 

Advisory Commission on Asian 

Americans, Native Hawaiians, and 

Pacific Islanders, authorized by 

Executive Order 14031, will meet to 

discuss full and draft recommendations 

by the Commission’s six Subcommittees 

on ways to advance equity, justice, and 

opportunity for Asian American, Native 

Hawaiian, and Pacific Islander 

communities. The Subcommittees are: 

Belonging, Inclusion, Anti-Asian Hate, 

Anti-Discrimination; Data 

Disaggregation; Language Access; 

Economic Equity; Health Equity; and 

Immigration and Citizenship Status. 

Background: Asian American, Native 

Hawaiian, and Pacific Islander 

communities are among the fastest 

growing racial and ethnic populations 

in the United States according to the 

U.S. Census Bureau. However, in recent 

years, AA and NHPI individuals have 

faced increasing hate crimes and 

incidents that threaten their safety, as 

well as harmful stereotypes that often 

ignore socioeconomic, health, and 

educational disparities impacting these 

diverse communities. 

During the COVID–19 pandemic, 

tragic acts of anti-Asian violence 

increased and cast a shadow of fear and 

grief over many AA and NHPI 

communities. However, even before the 

pandemic, AA and NHPI communities 

in the United States have faced 

persistent xenophobia, religious 

discrimination, racism, and violence. 

At the same time, AA and NHPI 

communities were overrepresented in 

the pandemic’s essential workforce in 

healthcare, food supply, education, and 

childcare, with more than four million 

AA and NHPIs manning the frontlines. 

Many AA and NHPI workers, families, 

and small businesses also faced 

devastating economic losses during this 

time. 

Additionally, health and economic 

inequities faced by Native Hawaiian and 

Pacific Islander communities worsened 

during the COVID–19 pandemic, with 

evidence suggesting they were twice as 

likely to die from the disease compared 

to white counterparts. 

The challenges AA and NHPI 

communities face are often exacerbated 

by a lack of adequate data 

disaggregation and language access. The 

President’s Advisory Commission on 

Asian Americans, Native Hawaiians, 

and Pacific Islanders works to advise 

the President on executive branch 

efforts to address these challenges and 

advance equity, justice, and opportunity 

for AA and NHPI communities. 

Public Participation at Meeting: 

Members of the public may attend 

virtually. Registration is required 

through the following link: https:// 

www.eventbrite.com/e/meeting-of-thepresidents-advisory-commission-on-aaand-nhpis-tickets-715434733547?aff=

oddtdtcreator. 

Written public comments: Written 

comments are welcomed throughout the 

development of the Commission’s 

recommendations to promote equity, 

justice, and opportunity for Asian 

Americans, Native Hawaiians, and 

Pacific Islanders and may be emailed to 

AANHPICommission@hhs.gov at any 

time. Respond concisely and in plain 

language. You may use any structure or 

layout that presents your information 

well. You may include links to online 

material or interactive presentations. 

Clearly mark any proprietary 

information and place it in its own 

section or file. Your response will 

become Government property, and we 

may publish some of its non-proprietary 

content. 

Authority: Executive Order 14031. 

The President’s Advisory Commission 

on Asian Americans, Native Hawaiians, 

and Pacific Islanders (Commission) is 

governed by provisions of the Federal 

Advisory Committee Act (FACA), Public 

Law 92–463, as amended (5 U.S.C. 

App.), which sets forth standards for the 

formation and use of Federal advisory 

committees. 

Krystal Ka’ai, 

Executive Director, White House Initiative on 

Asian Americans, Native Hawaiians, and 

Pacific Islanders, President’s Advisory 

Commission on Asian Americans, Native 

Hawaiians, and Pacific Islanders. 

[FR Doc. 2023–21981 Filed 10–3–23; 8:45 am] 

BILLING CODE 4150–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Special Diabetes Program for Indians 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2024–IHS–SDPI–0001. 

Assistance Listing (Catalog of Federal 

Domestic Assistance or CFDA) Number: 

93.237. 

Key Dates 

Application Deadline Date: November 

29, 2023. 

Earliest Anticipated Start Date: 

January 1, 2024. 

I. Funding Opportunity Description 

Statutory Authority 

The Indian Health Service (IHS) is 

accepting applications for the Special 

Diabetes Program for Indians (SDPI— 

formerly Community-Directed SDPI). 

This program is authorized under the 

Snyder Act, 25 U.S.C. 13; the Transfer 

Act, 42 U.S.C. 2001(a); and Section 

330C of the Public Health Service Act, 

codified at 42 U.S.C. 254c–3. The 

Assistance Listings section of SAM.gov 

(https://sam.gov/content/home) 

describes this program under 93.237. 

Background 

Diabetes is a complex and costly 

chronic disease that requires 

tremendous long-term efforts to prevent 

and treat. Although diabetes is a 

nationwide public health problem, 

American Indian/Alaska Native (AI/AN) 

people are disproportionately affected. 

In 2019, 14.5 percent of AI/AN people 

aged 18 years or older had diagnosed 

diabetes, compared to 7.4 percent of 

non-Hispanic white people [CDC, 2021. 

https://www.cdc.gov/diabetes/data/ 

statistics-report/diagnoseddiabetes.html]. In addition, AI/AN 

people have higher rates of diabetesrelated morbidity and mortality than the 

general U.S. population [O’Connell, 

2010 (https://diabetesjournals.org/care/ 

article/33/7/1463/39326/RacialDisparities-in-Health-StatusAcomparison-of); Cho, 2014 (http://

ajph.aphapublications.org/doi/full/ 

10.2105/AJPH.2014.301968)]. Strategies 

to address the prevention and treatment 

of diabetes in AI/AN communities are 

urgently needed. 

In response to the burgeoning diabetes 

epidemic among AI/AN people, 

Congress established the SDPI through 

the Balanced Budget Act of 1997. SDPI 

is a $150 million per year program that 

provides awards for diabetes treatment 

and prevention services. The IHS 


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