Notice of Correction to Cover Instructions for RFA-DK-18-501 Limited Competition for the Continuation of the Childhood Liver Disease Research Network (ChiLDReN) Clinical Centers (U01 Clinical Trial Required)

Notice Number: NOT-DK-19-006

Key Dates
Release Date: November 19, 2018

Related Announcements
RFA-DK-18-501

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The purpose of this Notice is to correct language in Section IV.2 Application and Submission Information, Content and Form of Application Submission, SF424(R&R) Cover to move the additional instruction related to the Introduction to Application to the Research Strategy.

Current Language:

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

The additional instruction must be followed:

In the Introduction to Application, the PI/PD should state their willingness to comply with the Other Special Performance Requirements as noted in Section I.

PHS 398 Research Plan

Research Strategy: Applications for the CCs must include a scientific research strategy for the purposes of assessment of PD/PI knowledge and identification of current research challenges in thepediatric liver diseases studied by ChiLDReN. The Scientific research strategy must include a pilot and feasibility clinical trial. A scientific translational strategy is permitted, but is in addition to the pilot and feasibility clinical trial strategy, entirely optional, and may not be used in lieu of the required pilot and feasibility clinical trial strategy. The scientific research strategy should utilize the currently available ChiLDReN data, biospecimen repository, or enrolled patients. The scientific research strategy may encompass a range of analyses analogous to an ancillary study concept in scope that will exploit the vast data, biosample repositories and patient enrollees of the ChiLDReN Network. With over 100,000 serum/plasma/urine/tissue specimens collected by the ChiLDReN Network for these rare pediatric liver conditions, this repository of data and biosamples represents an abundant opportunity to utilize these resources for advancing our understanding of these diseases. In addition to the 1100 biliary atresia DNA samples, the Network also has within its inventory approximately 1700 DNA specimens from corresponding parents; 2200 frozen liver specimens across the liver diseases studied within the Network; and 340 biliary atresia bile duct specimens. Scientific research strategy should advance our understanding or fill a knowledge gap of the disease at either the clinical or translational level. Examples of topics may include but are not limited to: quality of life; defining risk factors for disease progression or regression; defining clinical risks for developing extra-hepatic complications; refining the natural history of cholestatic liver disease; biomarkers for liver fibrosis, liver function, and portal hypertension; defining micro RNA species associated with disease state or progression; defining the role of autotaxin in cholestatic liver disease; determining proteomic signatures for disease diagnosis or progression; determining the role of altered developmental signaling in disease pathogenesis.

Revised Language:

SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy:

The PI/PD should state their willingness to comply with the Other Special Performance Requirements as noted in Section I.

Applications for the CCs must include a scientific research strategy for the purposes of assessment of PD/PI knowledge and identification of current research challenges in thepediatric liver diseases studied by ChiLDReN. The Scientific research strategy must include a pilot and feasibility clinical trial. A scientific translational strategy is permitted, but is in addition to the pilot and feasibility clinical trial strategy, entirely optional, and may not be used in lieu of the required pilot and feasibility clinical trial strategy. The scientific research strategy should utilize the currently available ChiLDReN data, biospecimen repository, or enrolled patients. The scientific research strategy may encompass a range of analyses analogous to an ancillary study concept in scope that will exploit the vast data, biosample repositories and patient enrollees of the ChiLDReN Network. With over 100,000 serum/plasma/urine/tissue specimens collected by the ChiLDReN Network for these rare pediatric liver conditions, this repository of data and biosamples represents an abundant opportunity to utilize these resources for advancing our understanding of these diseases. In addition to the 1100 biliary atresia DNA samples, the Network also has within its inventory approximately 1700 DNA specimens from corresponding parents; 2200 frozen liver specimens across the liver diseases studied within the Network; and 340 biliary atresia bile duct specimens. Scientific research strategy should advance our understanding or fill a knowledge gap of the disease at either the clinical or translational level. Examples of topics may include but are not limited to: quality of life; defining risk factors for disease progression or regression; defining clinical risks for developing extra-hepatic complications; refining the natural history of cholestatic liver disease; biomarkers for liver fibrosis, liver function, and portal hypertension; defining micro RNA species associated with disease state or progression; defining the role of autotaxin in cholestatic liver disease; determining proteomic signatures for disease diagnosis or progression; determining the role of altered developmental signaling in disease pathogenesis.

All other aspects of this Funding Opportunity Announcement remain the same.

Inquiries

Please direct all inquiries to:

Edward Doo, M.D.
Director, Liver Diseases Research Program
Division of Digestive Diseases
and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4524
Email: ed56o@nih.gov