Announcement of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders Meeting and Solicitation for Written Comments, 68629-68630 [2023-21981]
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Federal Register / Vol. 88, No. 191 / Wednesday, October 4, 2023 / Notices
Application No.
Drug
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.
Oxycodone Hydrochloride (HCl) Tablets, 5 mg, 10 mg, 15
mg, 20 mg, 30 mg.
Oxycodone and Aspirin Tablets, 325 mg; 4.8355 mg ............
Oxycodone HCl Capsules, 5 mg ............................................
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg; 50 mg; 40 mg; 30 mg.
Clozapine Tablets, 25 mg, 50 mg, 100 mg, 200 mg ..............
Oxycodone HCl Oral Solution 100 mg/5 milliliters .................
Morphine Sulfate Extended-Release Tablets, 15 mg, 30 mg,
60 mg, 100 mg.
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.
Buprenorphine HCl and Naloxone HCI Tablets, EQ 2 mg
base, EQ 0.5 mg base; EQ 8 mg base, EQ 2 mg base.
Morphine Sulfate Tablets, 15 mg, 30 mg ...............................
ANDA 091313 .......
ANDA 091670 .......
ANDA 203107 .......
ANDA 203335 .......
ANDA 203807 .......
ANDA 204092 .......
ANDA 205386 .......
ANDA 206329 .......
ANDA 206953 .......
ANDA 207270 .......
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is hereby withdrawn as of November 3,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application is withdrawn, including any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
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.
lotter on DSK11XQN23PROD with NOTICES1
AGENCY:
Notice of meeting and
solicitation for written comments.
ACTION:
VerDate Sep<11>2014
20:21 Oct 03, 2023
Jkt 262001
Applicant
Dr. Reddy’s Laboratories, Inc., U.S. Agent for Dr. Reddy’s
Laboratories SA, 107 College Rd. East, Princeton NJ
08540.
Do.
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Do.
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Do.
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Do.
Do.
Do.
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/ 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,
SUMMARY:
PO 00000
Frm 00071
68629
Fmt 4703
Sfmt 4703
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
E:\FR\FM\04OCN1.SGM
04OCN1
lotter on DSK11XQN23PROD with NOTICES1
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/. 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/.
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.
VerDate Sep<11>2014
20:21 Oct 03, 2023
Jkt 262001
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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
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 (https://
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
E:\FR\FM\04OCN1.SGM
04OCN1
Agencies
[Federal Register Volume 88, Number 191 (Wednesday, October 4, 2023)]
[Notices]
[Pages 68629-68630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21981]
-----------------------------------------------------------------------
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/ 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-the-presidents-advisory-commission-on-aa-and-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:
[email protected]; 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
[[Page 68630]]
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
well-being 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/. 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/.
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-the-presidents-advisory-commission-on-aa-and-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 [email protected] 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