Notice of Correction to RFA-HL-26-007 "Single Source: Bench to Bassinet Congenital Heart disease Advancing New understanding in GEnomics Cohort (B2B CHANGE Cohort) Data Coordinating Center (U01 Clinical Trial Not Allowed)"
Notice Number:
NOT-HL-25-004

Key Dates

Release Date:

January 15, 2025

Related Announcements

  • January 10, 2025 - Single Source: Bench to Bassinet Congenital Heart disease Advancing New understanding in GEnomics Cohort (B2B CHANGE Cohort) Data Coordinating Center (U01 Clinical Trial Not Allowed). See NOFO RFA-HL-26-007

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) is announcing a correction to milestones language for RFA-HL-26-007 “Single Source: Bench to Bassinet Congenital Heart disease Advancing New understanding in GEnomics Cohort (B2B CHANGE Cohort) Data Coordinating Center (U01 Clinical Trial Not Allowed)". Changes are shown in bold italics below.

Section I. Notice of Funding Opportunity Description

Currently reads in RFA-HL-26-007

Milestones

A key characteristic of this NOFO is completion of core milestones. A core milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to achieve completion of the Program on time and on budget.

Core milestones that are of particular interest include, but are not limited to:

  • Develop study protocols for recruitment, clinical examination, events ascertainment, and retention of participants
  • Develop study protocols to ensure appropriate management of relevant databases for tracking and data capture
  • Complete and finalize protocol and informed consent documents
  • OSMB approval of a common protocol
  • IRB approval of final protocol and consent and/or assent
  • Establish consortium agreements with sites.
  • Initiate recruitment at (or before) the 4th quarter of 2nd year of UG3
  • Enrollment of at least 1 of the projected cohort participants
  • Enrollment of 25%, 50%, 75%, and 100% of the projected recruitment for all study participants
  • Completion of baseline exams by consortium sites.
  • Collection of data related to relevant clinical endpoints.
  • Implementation of the Data Management and Sharing Plan
  • Working collaboratively with the sites and Steering Committee on post-exam activities including: participant (morbidity and mortality) surveillance, etc, analysis of data collected on cohort participants
  • Development and distribution of findings from the exam in the form of lay summaries for the study participants, manuscripts/publications, and a Data Book for the scientific community and stakeholders

NHLBI policies regarding milestones and relevant clinical research/studies policies are described in the following: NHLBI Accrual of Human Subjects (Milestones) Policy

This is a non-competitive funding opportunity intended to fund a single award. NHLBI is announcing its intent to issue a single source cooperative agreement to Cincinnati Children’s Hospital Medical Center for the transition of the Bench-to-Bassinet (B2B) Program Administrative Coordinating Center into a B2B CHANGE (Congenital Heart disease Advancing New understanding in GEnomics) Cohort Data Coordinating Center (CC). This award is single-source in order to continue and maintain long-term infrastructure investments. The award will enable the current PCGC Administrative Coordinating Center to build on its existing infrastructure, including its robust datahub, to support the goals of the B2B CHANGE Cohort.

Modified to read in RFA-HL-26-007 (changes shown in bold italics):

Milestones

A key characteristic of this NOFO is completion of core milestones. A core milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to achieve completion of the Program on time and on budget.

Core milestones that are of particular interest include, but are not limited to:

  • Develop study protocols for recruitment, clinical examination, events ascertainment, and retention of participants
  • Develop study protocols to ensure appropriate management of relevant databases for tracking and data capture
  • Complete and finalize protocol and informed consent documents
  • OSMB approval of a common protocol
  • IRB approval of final protocol and consent and/or assent
  • Establish consortium agreements with sites.
  • Initiate recruitment at (or before) the 4th quarter of 2nd year of UG3
  • Enrollment of at least 1 of the projected cohort participants
  • Enrollment of 25%, 50%, 75%, and 100% of the projected recruitment for all study participants
  • Completion of baseline exams by consortium sites.
  • Collection of data related to relevant clinical endpoints.
  • Implementation of the Data Management and Sharing Plan
  • Working collaboratively with the sites and Steering Committee on post-exam activities including: participant (morbidity and mortality) surveillance, etc, analysis of data collected on cohort participants
  • Development and distribution of findings from the exam in the form of lay summaries for the study participants, manuscripts/publications, and a Data Book for the scientific community and stakeholders

NHLBI policies regarding milestones and relevant clinical research/studies policies are described in the following: NHLBI Accrual of Human Subjects (Milestones) Policy

This is a non-competitive funding opportunity intended to fund a single award. NHLBI is announcing its intent to issue a single source cooperative agreement to Cincinnati Children’s Hospital Medical Center for the transition of the Bench-to-Bassinet (B2B) Program Administrative Coordinating Center into a B2B CHANGE (Congenital Heart disease Advancing New understanding in GEnomics) Cohort Data Coordinating Center (CC). This award is single-source in order to continue and maintain long-term infrastructure investments. The award will enable the current PCGC Administrative Coordinating Center to build on its existing infrastructure, including its robust datahub, to support the goals of the B2B CHANGE Cohort.

 All other aspects of RFA-HL-26-007 remain unchanged.

Inquiries

Please direct all inquiries regarding this Notice to:

Scientific/Research Contact(s)

Bryanna Schwartz, MD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-594-8868
Email: [email protected]  

Charlene Schramm, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0510
Email: [email protected]