Notice of a Supplemental Award to Education Development Center for the Home Visiting Collaborative Improvement and Innovation Network 2.0 Cooperative Agreement, 37459-37460 [2020-13338]
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Federal Register / Vol. 85, No. 120 / Monday, June 22, 2020 / Notices
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Dated: June 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
37459
(84 FR 3467), in FR Doc. 2019–02032,
the following correction is made:
1. On page 3467, in the table, the
entry for ANDA 077736 is removed. The
approval of ANDA 077736 was
withdrawn effective November 2, 2018.
In the Federal Register of April 2,
2018 (83 FR 13994), FDA denied a
hearing and issued an order
withdrawing approval of multiple
ANDAs for polyethylene glycol 3350,
effective May 2, 2018. Breckenridge’s
ANDA 077736 was included in the
April 2018 notice. In the Federal
Register of July 30, 2018 (83 FR 36604),
FDA subsequently published a notice
granting a temporary stay of the
effective date of the April 2018 notice,
extending the withdrawal of approval of
the ANDAs to November 2, 2018. Thus,
the approval of ANDA 077736 was
withdrawn effective November 2, 2018.
Dated: June 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13346 Filed 6–19–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0163]
Hospira, Inc., et al.; Withdrawal of
Approval of 12 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of February 12, 2019. The
document announced the withdrawal of
approval of 12 abbreviated new drug
applications (ANDAs) from multiple
applicants. The document erroneously
included ANDA 077736 for
Polyethylene Glycol 3350 Powder for
Oral Solution, 17 grams/scoopful, held
by Breckenridge Pharmaceutical, Inc.
(Breckenridge). This document corrects
that error.
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.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 12, 2019
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of a Supplemental Award to
Education Development Center for the
Home Visiting Collaborative
Improvement and Innovation Network
2.0 Cooperative Agreement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of a Supplemental
Award to Education Development
Center for Home Visiting Collaborative
Improvement and Innovation Network
2.0 Cooperative Agreement.
AGENCY:
HRSA announces the award
of a supplemental award of
approximately $330,000 per year to the
Education Development Center (EDC)
for the Home Visiting Collaborative
Improvement and Innovation Network
2.0 (HV CoIIN 2.0) for fiscal years (FY)
2020, 2021 and 2022. The supplement
will allow the recipient to build a
continuous quality improvement (CQI)
health equity framework for the
Maternal, Infant and Early Childhood
Home Visiting Program (MIECHV).
FOR FURTHER INFORMATION CONTACT:
Monique Fountain Hanna, Chief
Medical Officer, Division Home Visiting
and Early Childhood Systems, HRSA,
5600 Fishers Lane, Room 18N180,
SUMMARY:
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37460
Federal Register / Vol. 85, No. 120 / Monday, June 22, 2020 / Notices
Rockville, MD 20857, Phone: (215) 861–
4385, or Email: MFountain@hrsa.gov.
SUPPLEMENTARY INFORMATION:
Intended Recipient of Award:
Education Development Center, Inc.
Amount of Non-Competitive Award:
Approximately $330,000/year for FY
2020, FY 2021, and FY 2022.
Budget Period: 09/01/2019–08/31/
2020; 09/01/2020–08/31/2021; 09/01/
2021–08/31/2022.
CFDA Number: 93.110.
Authority: Social Security Act, Title V,
§ 511 (42 U.S.C. 711).
Justification: The MIECHV Program,
an evidence-based home visiting
program, seeks to improve maternal and
child health outcomes and address
various social determinants that impact
health equity such as reducing child
abuse and neglect, addressing family
violence, promoting child development
and school readiness, and improving
family economic self-sufficiency for
families considered most at-risk. In
support of HRSA’s FY 2019–FY 2022
Strategic Goals focused on health
equity, the MIECHV Program proposes
to develop a home visiting specific
health equity framework utilizing
quality improvement as a methodology.
The HVCoIIN 2.0 is designed to
facilitate the delivery and accelerate the
improvement of home visiting services
provided by MIECHV Program
recipients, including subrecipient local
implementing agencies (LIAs) utilizing
continuous quality improvement
methodologies. The CoIIN provides a
platform and strategy for collaborative
learning and quality improvement
toward common measurable aims—
rapid-cycle tests of change ideas.
The HVCoIIN has three main priority
areas. Priority Area #2 is focused on
‘‘testing of new change ideas.’’ This
priority area is designed to develop and
subsequently refine discrete sets of
change ideas based on evidence in the
field and relevance to home visiting
implementation. The grantee will carry
out all the activities pertaining to the
development of the health equity
framework. Proposed activities will
include:
• Identify a health equity framework
and adapt for MIECHV;
• Develop theory of change, (how and
why the desired change is expected to
happen); key driver diagrams, (the
Grantee/organization name
Grant No.
Education Development Center, Inc .....................................
UF4MC26525
Thomas J. Engels,
Administrator.
[FR Doc. 2020–13338 Filed 6–19–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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18:08 Jun 19, 2020
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State
FY 2020 funding
FY 2021 funding
FY 2022 funding
$328,797
$329,980
$324,637
MA
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Mentored Patient-Oriented Research Review
Committee.
Date: July 23–24, 2020.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health (NIH),
One Rockledge Center, 6705 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Stephanie Johnson Webb,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, National Institutes
of Health, 6705 Rockledge Drive, Room 208–
V, Bethesda, MD 20892, (301) 827–7992,
stephanie.webb@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: June 16, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–13319 Filed 6–19–20; 8:45 am]
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relationship between the overall aim of
the project, the drivers that contribute
directly to the aim) change ideas,
measures and proposed tests of change;
• Implement a quality improvement
strategy such as: Breakthrough Series,
Plan-Do-Study-Act Cycles, to test and
eventually demonstrate improvements
in program outcomes through a health
equity collaborative; and pilot test with
MIECHV awardees over 12–18 months;
• Apply the health equity framework
that demonstrated improvements to
twelve current HV CoIIN 2.0 scale topics
(developmental screening,
breastfeeding, and maternal depression)
and new topic CoIINs (intimate partner
violence and well child care); and
• Create a final health equity CoIIN
playbook with measures, refined tests of
change that can be used to spread
lessons learned across home visiting
programs. EDC was awarded a 5-year
HV CoIIN cooperative agreement on
September 1, 2017. They have
successfully led the first national effort
utilizing CQI methods to assist awardees
in improving MIECHV Program
implementation, performance measures
and evidence based maternal and child
health outcomes.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; ‘‘Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19).’’
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]]>Agencies
[Federal Register Volume 85, Number 120 (Monday, June 22, 2020)]
[Notices]
[Pages 37459-37460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13338]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of a Supplemental Award to Education Development Center
for the Home Visiting Collaborative Improvement and Innovation Network
2.0 Cooperative Agreement
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of a Supplemental Award to Education Development Center
for Home Visiting Collaborative Improvement and Innovation Network 2.0
Cooperative Agreement.
-----------------------------------------------------------------------
SUMMARY: HRSA announces the award of a supplemental award of
approximately $330,000 per year to the Education Development Center
(EDC) for the Home Visiting Collaborative Improvement and Innovation
Network 2.0 (HV CoIIN 2.0) for fiscal years (FY) 2020, 2021 and 2022.
The supplement will allow the recipient to build a continuous quality
improvement (CQI) health equity framework for the Maternal, Infant and
Early Childhood Home Visiting Program (MIECHV).
FOR FURTHER INFORMATION CONTACT: Monique Fountain Hanna, Chief Medical
Officer, Division Home Visiting and Early Childhood Systems, HRSA, 5600
Fishers Lane, Room 18N180,
[[Page 37460]]
Rockville, MD 20857, Phone: (215) 861-4385, or Email:
[email protected].
SUPPLEMENTARY INFORMATION:
Intended Recipient of Award: Education Development Center, Inc.
Amount of Non-Competitive Award: Approximately $330,000/year for FY
2020, FY 2021, and FY 2022.
Budget Period: 09/01/2019-08/31/2020; 09/01/2020-08/31/2021; 09/01/
2021-08/31/2022.
CFDA Number: 93.110.
Authority: Social Security Act, Title V, Sec. 511 (42 U.S.C.
711).
Justification: The MIECHV Program, an evidence-based home visiting
program, seeks to improve maternal and child health outcomes and
address various social determinants that impact health equity such as
reducing child abuse and neglect, addressing family violence, promoting
child development and school readiness, and improving family economic
self-sufficiency for families considered most at-risk. In support of
HRSA's FY 2019-FY 2022 Strategic Goals focused on health equity, the
MIECHV Program proposes to develop a home visiting specific health
equity framework utilizing quality improvement as a methodology.
The HVCoIIN 2.0 is designed to facilitate the delivery and
accelerate the improvement of home visiting services provided by MIECHV
Program recipients, including subrecipient local implementing agencies
(LIAs) utilizing continuous quality improvement methodologies. The
CoIIN provides a platform and strategy for collaborative learning and
quality improvement toward common measurable aims--rapid-cycle tests of
change ideas.
The HVCoIIN has three main priority areas. Priority Area #2 is
focused on ``testing of new change ideas.'' This priority area is
designed to develop and subsequently refine discrete sets of change
ideas based on evidence in the field and relevance to home visiting
implementation. The grantee will carry out all the activities
pertaining to the development of the health equity framework. Proposed
activities will include:
Identify a health equity framework and adapt for MIECHV;
Develop theory of change, (how and why the desired change
is expected to happen); key driver diagrams, (the relationship between
the overall aim of the project, the drivers that contribute directly to
the aim) change ideas, measures and proposed tests of change;
Implement a quality improvement strategy such as:
Breakthrough Series, Plan-Do-Study-Act Cycles, to test and eventually
demonstrate improvements in program outcomes through a health equity
collaborative; and pilot test with MIECHV awardees over 12-18 months;
Apply the health equity framework that demonstrated
improvements to twelve current HV CoIIN 2.0 scale topics (developmental
screening, breastfeeding, and maternal depression) and new topic CoIINs
(intimate partner violence and well child care); and
Create a final health equity CoIIN playbook with measures,
refined tests of change that can be used to spread lessons learned
across home visiting programs. EDC was awarded a 5-year HV CoIIN
cooperative agreement on September 1, 2017. They have successfully led
the first national effort utilizing CQI methods to assist awardees in
improving MIECHV Program implementation, performance measures and
evidence based maternal and child health outcomes.
----------------------------------------------------------------------------------------------------------------
Grantee/organization name Grant No. State FY 2020 funding FY 2021 funding FY 2022 funding
----------------------------------------------------------------------------------------------------------------
Education Development Center, UF4MC26525 MA $328,797 $329,980 $324,637
Inc.
----------------------------------------------------------------------------------------------------------------
Thomas J. Engels,
Administrator.
[FR Doc. 2020-13338 Filed 6-19-20; 8:45 am]
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