Notice of Award of a Sole Source Cooperative Agreement To Fund International Union Against Tuberculosis and Lung Disease (The Union), 19596-19597 [2024-05771]
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19596
Federal Register / Vol. 89, No. 54 / Tuesday, March 19, 2024 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–05775 Filed 3–18–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Award of a Sole Source
Cooperative Agreement To Fund
Ministry of Health of Mozambique
(MISAU)
Summary of the Award
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces the
award(s) of approximately $10,000,000,
for Year 1 funding to MISAU. The(se)
award(s) will support the GRM through
MISAU to continue to address
Tuberculosis (TB) and human
immunodeficiency virus (HIV) as a
public health problem through the
expansion of access to quality HIV
prevention, care, and treatment services
to reduce remaining gaps among
children, adolescents, key populations
(KP) and men. Funding amounts for
years 2–5 will be set at continuation.
DATES: The period for this award will be
September 30, 2024, through September
29, 2029.
FOR FURTHER INFORMATION CONTACT:
Scott Salo, Center for Global Health,
Centers for Disease Control and
Prevention, Avenida Marginal nr 5467
Sommerschield, Distrito Municipal de
KaMpfumo Caixa Postal 783 CEP 0101–
11 Maputo, Moc
¸ambique, Telephone:
404.553.7439, E-Mail: evf1@cdc.gov.
SUPPLEMENTARY INFORMATION: The sole
source award(s) will strengthen
technical, managerial, and institutional
capacities at MISAU to optimize some
of the following approaches: youth
appropriate HIV testing services, HIVrelated DREAMS services for
Adolescent Girls and Young Women,
pre-exposure prophylaxis services,
voluntary medical male circumcision
services, cervical cancer services, and
gender-based violence services. Other
approaches include maternal and child
health services, differentiated HIV
service delivery models, and HIV and
TB services.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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MISAU is in a unique position to
conduct this work, as it is the central
institution of public sector, which
according to the law of the Republic of
Mozambique, is responsible for the
implementation of health policy in the
public, private, and community
domains. MISAU, by law, has the
authority to lead, provide oversight,
monitor the implementation of
healthcare programs and services at
national level, and is mandated to
develop policies and guidelines, and
plan, manage, and coordinate all healthrelated activities including HIV/TB
services.
Recipient: Ministry of Health of
Mozambique (MISAU).
Purpose of the Award: The purpose of
this award is to to prepare MISAU to
sustain the gains of the national HIV
response through the development of a
measurable roadmap for sustainability
and support the Government of
Mozambique through MISAU to
continue to address HIV/TB as a public
health problem through the expansion
of access to quality HIV prevention,
care, and treatment services to reduce
remaining gaps among children,
adolescents, KP, and men.
Amount of Award: For MISAU, the
approximate year 1 funding amount will
be $10,000,000 in Federal Fiscal Year
(FYY) 2024 funds, subject to the
availability of funds. Funding amounts
for years 2–5 will be set at continuation.
Authority: This program is authorized
under Public Law 108–25 (the United
States Leadership Against HIV AIDS,
Tuberculosis and Malaria Act of 2003)
[22 U.S.C. 7601, et seq.] and Public Law
110–293 (the Tom Lantos and Henry J.
Hyde United States Global Leadership
Against HIV/AIDS, Tuberculosis, and
Malaria Reauthorization Act of 2008),
and Public Law 113–56 (PEPFAR
Stewardship and Oversight Act of 2013).
Period of Performance: The period for
this award will be September 30, 2024,
through September 29, 2029.
Dated: March 13, 2024.
Jamie Legier,
Acting Director, Office of Grants Services,
Centers for Disease Control and Prevention.
[FR Doc. 2024–05778 Filed 3–18–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Award of a Sole Source
Cooperative Agreement To Fund
International Union Against
Tuberculosis and Lung Disease (The
Union)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), announces the
award of approximately $500,000, for
Year 1 funding to The Union. The award
will continue developing and updating
Tuberculosis (TB) scientific and
programmatic resources, disseminating
TB best practices, and building TB
capacity. Funding amounts for years 2–
5 will be set at continuation.
DATES: The period for this award will be
September 30, 2024, through September
29, 2029.
FOR FURTHER INFORMATION CONTACT:
Victoria Tully, Center for Global Health,
Centers for Disease Control and
Prevention, 1600 Clifton Road, MS
US1–1 Atlanta, Georgia 30329,
Telephone: 404.718.2549, E-Mail: nts2@
cdc.gov.
SUPPLEMENTARY INFORMATION: The sole
source award will focus on developing
and updating scientific and
programmatic resources, disseminating
clinical and programmatic best
practices, and building capacity. These
activities are expected to equip health
officials, health professionals, and
health care and public health workers
with skills and knowledge based on the
latest TB recommendations.
The Union is in a unique position to
conduct this work, as it was given the
mandate: (1) to establish a Federation
amongst the national associations or
organizations engaged in the campaign
against TB, to coordinate their efforts
throughout the world, and to work in
collaboration with international
organizations to end TB disease; (2) to
organize scientific conferences and
congresses regarding TB; (3) to compare
national legislation in preventing and
controlling TB; (4) to collect
international TB statistics; (5) to
stimulate scientific and social
investigations regarding the
distribution, spread, prevention, and
treatment of TB in various countries;
and (6) to collect and distribute
SUMMARY:
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Federal Register / Vol. 89, No. 54 / Tuesday, March 19, 2024 / Notices
information to national organizations
included in The Union on all questions
concerning scientific and sociological
study on TB. The Union is uniquely
qualified to combat TB and lung disease
globally and to offer training and other
capacity-building activities leading to
health solutions for the poor in resource
limited countries, the key activities
under this NOFO, due to its WHOrecognized accomplishments and
leadership role in the global TB fight
since its founding in 1920.
Summary of the Award
Recipient: International Union
Against Tuberculosis and Lung Disease
(The Union).
Purpose of the Award: The purpose of
this award is to continue developing
and updating TB scientific and
programmatic resources, disseminating
TB best practices, and building TB
capacity.
Amount of Award: For The Union, the
approximate year 1 funding amount will
be $500,000 in Federal Fiscal Year
(FYY) 2024 funds, subject to the
availability of funds. Funding amounts
for years 2–5 will be set at continuation.
Non-PEPFAR Authority: This program
is authorized under section 307 of the
Public Health Service Act (42 U.S.C.
242l), as amended and section 301(a) of
the Public Health Service Act (42 U.S.C.
241(a)), as amended.
Period of Performance: The period for
this award will be September 30, 2024,
through September 29, 2029.
Dated: March 13, 2024.
Jamie Legier,
Acting Director, Office of Grants Services,
Centers for Disease Control and Prevention.
[FR Doc. 2024–05771 Filed 3–18–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1181]
Air Products and Chemicals, Inc.;
Withdrawal of Approval of a New Drug
Application and New Animal Drug
Application for Helium, USP
AGENCY:
Food and Drug Administration,
ddrumheller on DSK120RN23PROD with NOTICES1
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
application (NDA) 205864 and the new
animal drug application (NADA) 141–
395 for the designated medical gas
Helium, USP held by Air Products and
SUMMARY:
VerDate Sep<11>2014
19:45 Mar 18, 2024
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Chemicals, Inc., 1940 Air Products
Blvd., Allentown, PA 18106–5500 (Air
Products). Air Products notified the
Agency in writing that the drug product
was no longer marketed and requested
that the approval of the application be
withdrawn.
Approval is withdrawn as of
April 18, 2024.
DATES:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov; or Scott Fontana (HFV–
180), Center for Veterinary Medicine,
Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240–
402–0656, Scott.Fontana@fda.hhs.gov.
Air
Products has informed FDA that it is no
longer marketing the designated medical
gas Helium, USP and has requested that
FDA withdraw approval of NDA 205864
and NADA 141–395 under the processes
in § 314.150© (21 CFR 314.150(c)) and
§ 514.115(d) (21 CFR 514.115(d)). Air
Products has also, by its request, waived
its opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) or an NADA or
abbreviated new animal drug
application under § 514.115(d) is
without prejudice to refiling.
Therefore, approval of NDA 205864
and NADA 141–395, and all
amendments and supplements thereto,
are hereby withdrawn as of April 18,
2024. Introduction or delivery for
introduction into interstate commerce of
Helium, USP, without an approved new
drug application or an approved new
animal drug application violates
sections 505(a), 512(a), 301(a), and
301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a),
360b(a)(1), 331(a), and 331(d)). Any
Helium, USP manufactured by Air
Products pursuant to these applications
that is in inventory on April 18, 2024
may continue to be dispensed until the
inventories have been depleted or the
drug product has reached its expiration
date or otherwise become violative,
whichever occurs first.
SUPPLEMENTARY INFORMATION:
Dated: March 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05742 Filed 3–18–24; 8:45 am]
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19597
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics
Centers for Disease Control and
Prevention, Department of Health and
Human Services.
ACTION: Notice of meeting.
AGENCY:
Pursuant to the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) announces the following
advisory committee meeting. This
meeting is open to the public. The
public is welcome to attend in person or
to obtain the link to attend this meeting
by following the instructions posted on
the Committee website: https://
ncvhs.hhs.gov/meetings/full-committeemeeting-16/.
Name: National Committee on Vital
and Health Statistics (NCVHS) Meeting.
DATES: Thursday, April 11, 2024: 9:15
a.m.–5:30 p.m. EDT and Friday, April
12, 2024: 8:30 a.m.–3:00 p.m. EDT.
ADDRESSES: In-person/hybrid (includes
virtual attendance option).
FOR MORE INFORMATION CONTACT:
Substantive program information may
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, or via electronic mail to vgh4@
cdc.gov; or by telephone (301) 458–
4715. Summaries of meetings and a
roster of Committee members are
available on the NCVHS website https://
ncvhs.hhs.gov/, where further
information including an agenda and
instructions to access the broadcast of
the meeting will be posted.
Should you require reasonable
accommodation, please telephone the
CDC Office of Equal Employment
Opportunity at (770) 488–3210 as soon
as possible.
SUPPLEMENTARY INFORMATION:
Purpose: As outlined in its Charter,
the National Committee on Vital and
Health Statistics assists and advises the
Secretary of HHS on health data, data
standards, statistics, privacy, national
health information policy, and the
Department’s strategy to best address
those issues. Under the Health
Insurance Portability and
Accountability Act of 1996 (HIPAA),1
NCVHS advises the Secretary on
administrative simplification standards,
including those for privacy, security,
SUMMARY:
1 Public Law 104–191, 110 Stat. 1936 (Aug 21,
1996), available at https://www.congress.gov/104/
plaws/publ191/PLAW-104publ191.pdf.
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]]>Agencies
[Federal Register Volume 89, Number 54 (Tuesday, March 19, 2024)]
[Notices]
[Pages 19596-19597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05771]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Award of a Sole Source Cooperative Agreement To Fund
International Union Against Tuberculosis and Lung Disease (The Union)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS), announces the
award of approximately $500,000, for Year 1 funding to The Union. The
award will continue developing and updating Tuberculosis (TB)
scientific and programmatic resources, disseminating TB best practices,
and building TB capacity. Funding amounts for years 2-5 will be set at
continuation.
DATES: The period for this award will be September 30, 2024, through
September 29, 2029.
FOR FURTHER INFORMATION CONTACT: Victoria Tully, Center for Global
Health, Centers for Disease Control and Prevention, 1600 Clifton Road,
MS US1-1 Atlanta, Georgia 30329, Telephone: 404.718.2549, E-Mail:
[email protected].
SUPPLEMENTARY INFORMATION: The sole source award will focus on
developing and updating scientific and programmatic resources,
disseminating clinical and programmatic best practices, and building
capacity. These activities are expected to equip health officials,
health professionals, and health care and public health workers with
skills and knowledge based on the latest TB recommendations.
The Union is in a unique position to conduct this work, as it was
given the mandate: (1) to establish a Federation amongst the national
associations or organizations engaged in the campaign against TB, to
coordinate their efforts throughout the world, and to work in
collaboration with international organizations to end TB disease; (2)
to organize scientific conferences and congresses regarding TB; (3) to
compare national legislation in preventing and controlling TB; (4) to
collect international TB statistics; (5) to stimulate scientific and
social investigations regarding the distribution, spread, prevention,
and treatment of TB in various countries; and (6) to collect and
distribute
[[Page 19597]]
information to national organizations included in The Union on all
questions concerning scientific and sociological study on TB. The Union
is uniquely qualified to combat TB and lung disease globally and to
offer training and other capacity-building activities leading to health
solutions for the poor in resource limited countries, the key
activities under this NOFO, due to its WHO-recognized accomplishments
and leadership role in the global TB fight since its founding in 1920.
Summary of the Award
Recipient: International Union Against Tuberculosis and Lung
Disease (The Union).
Purpose of the Award: The purpose of this award is to continue
developing and updating TB scientific and programmatic resources,
disseminating TB best practices, and building TB capacity.
Amount of Award: For The Union, the approximate year 1 funding
amount will be $500,000 in Federal Fiscal Year (FYY) 2024 funds,
subject to the availability of funds. Funding amounts for years 2-5
will be set at continuation.
Non-PEPFAR Authority: This program is authorized under section 307
of the Public Health Service Act (42 U.S.C. 242l), as amended and
section 301(a) of the Public Health Service Act (42 U.S.C. 241(a)), as
amended.
Period of Performance: The period for this award will be September
30, 2024, through September 29, 2029.
Dated: March 13, 2024.
Jamie Legier,
Acting Director, Office of Grants Services, Centers for Disease Control
and Prevention.
[FR Doc. 2024-05771 Filed 3-18-24; 8:45 am]
BILLING CODE 4163-18-P
