Notice Number: NOT-HL-18-624

Key Dates

Release Date: April 26, 2018
Estimated Publication Date of Funding Opportunity Announcement: 12/01/2018
First Estimated Application Due Date : 02/01/2019
Earliest Estimated Award Date:10/31/2019
Earliest Estimated Start Date: 12/31/2019

NOT-HL-18-620 Rescinded

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

This Notice updates and supercedes and replaces the previous Notice of Intent to Publish NOT-HL-18-620. This Notice provides clarification to intended funding information.

The National Heart, Lung and Blood Institute intends to promote a new initiative to establish cohorts in rare heart, lung, blood, and/or sleep (HLBS) diseases that enables multidisciplinary teams to conduct natural history and mechanistic studies that provide the evidence base for future clinical trials and improved diagnostics. These studies will help to advance fundamental insights into key molecular, genomic, clinical, environmental and behavioral determinants of rare HLBS diseases and their outcomes leading to diagnostic and therapeutic strategies.

The NHLBI is interested in applications that will address questions relevant to the NHLBI mission, address gaps in the NHLBI?s portfolio of rare disease cohorts and that align with the Institute '’s Strategic Vision (https://www.nhlbi.nih.gov/about/documents/strategic-vision ).

NHLBI intends to utilize the UG3/UH3 activity code, a bi-phasic, milestone-driven cooperative agreement. Details of the planned FOA are provided below.

This Notice is being provided to allow potential applicants sufficient time to develop responsive proposals. The FOA is expected to be published in October 2018 with anticipated application receipt dates in February 2019 and February 2020.

This Notice rescinds and replaces NOT-HL-18-620.

Research Initiative Details

This planned initiative will provide opportunities to efficiently advance rare disease research using genetics and deep phenotyping to characterize the disease and to identify disease sub-types; to use data science methods that integrate clinical and patient-reported outcomes (PROs) with laboratory, imaging and -omics data to understand the natural history of disease; to generate data that differentiate patients with the same morphological phenotype but different genetic mutations and severity of outcomes; to elucidate genotype-phenotype interactions and multisystem phenotyping to develop reliable and valid predictive tools to determine who will respond to which treatments and when to intervene; and to encourage innovative methods such as telemedicine to reach subjects with rare diseases located in remote locations or without access to a major academic medical center.

The goal of this initiative is to encourage creative and innovative research; as such, applications should propose studies investigating hypotheses and research questions not currently addressed in cohorts funding by the NHLBI.

The RFA will invite applications to propose cohorts that are created de novo or to re-establish study populations by enrolling patients from previously-funded cohorts, clinical trials or registries.

Although the funding information is yet to be determined, as a guidance NHLBI estimates that the typical total funding per year for the research described herein will be up to $1.5 million. The $1.5 million per year is an estimate for a typical rare disease cohort with a typical number of candidate research subjects. However, for rare diseases that are more common and from which larger cohorts can be assembled, the expectation is that the budget submitted would be appropriate for the size of the cohort and would be well justified in the submission.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.837, 93.838, 93.839, 93.840, 93.233

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Ellen M. Werner, PhD, MA
National Heart, Lung, and Blood Institute
301-435-0065
wernere@nhlbi.nih.gov