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]

Download as PDF Federal Register / Vol. 85, No. 120 / Monday, June 22, 2020 / Notices SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 14, 2020, the committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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VerDate Sep<11>2014 18:08 Jun 19, 2020 Jkt 250001 For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Yvette Waples (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). 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 The approval of ANDA 077736 was withdrawn effective November 2, 2018.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] BILLING CODE 4164–01–P [FR Doc. 2020–13345 Filed 6–19–20; 8:45 am] BILLING CODE 4164–01–P 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: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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: E:\FR\FM\22JNN1.SGM 22JNN1 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] BILLING CODE 4165–15–P 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. VerDate Sep<11>2014 18:08 Jun 19, 2020 Jkt 250001 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] BILLING CODE 4140–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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).’’ E:\FR\FM\22JNN1.SGM 22JNN1

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]


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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

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]
BILLING CODE 4165-15-P