Notice of Intent to Re-Issue a Funding Opportunity Announcement (FOA) Data Management and Coordinating Center (DMCC) for Rare Diseases Clinical Research Network (RDCRN) (U01)

Notice Number: NOT-TR-18-003

Key Dates
Release Date: November 7, 2017

Estimated Publication Date of Announcement: March 2018 
First Estimated Application Due Date:  August 2018 
Earliest Estimated Award Date:  June/August 2019 
Earliest Estimated Start Date:  June/August 2019 

Related Announcements
NOT-TR-18-002

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is to indicate the intent to re-issue Funding Opportunity Announcement (FOA) "Data Management and Coordinating Center (DMCC) for Rare Diseases Clinical Research Network (RDCRN) (U01)" and to alert potential applicants of the objectives of this cooperative research program.  The FOA will be open to current Data Management and Coordinating Center (DMCC) (RFA-TR-13-003) awardees as well as to new applicants.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.  

The FOA is expected to be published in Spring 2018 with the expected application due date in Fall 2018. 

The Data Management and Coordinating Center (DMCC) FOA will utilize the U01 activity code.  Additional information about the planned FOA is provided below.

Research Initiative Details

The purpose of the Rare Diseases Clinical Research Network Program is to facilitate clinical research in rare diseases through support for: 1) collaborative clinical research in rare diseases, including observational studies and clinical trials; 2)  pilot/demonstration clinical research projects; (3) training of clinical investigators in rare diseases research; 4) clinical data management that incorporates novel approaches and technologies for data management, data collection, data mining, and data sharing across rare diseases, data types, and platforms; and 5) access to information related to rare diseases for basic and clinical researchers, academic and practicing physicians, patients, and the lay public.  Each RDCRCN must include a consortium of clinical investigators, institutions, and relevant organizations, including active engagement of patient organizations, for the study of a group of a minimum of three rare diseases, or a therapeutic area or concept (e.g., genetic mutation, organ or organelle).

The DMCC will focus on innovative ways to provide the infrastructure and support to the individual sites in their activities relevant to items 1-3 as well as a focus on issues relevant to items 4 and 5.This cooperative research program will facilitate identification of biomarkers for disease risk, disease severity/activity, or measures of clinical outcome appropriate for use in clinical trials and to encourage development of new approaches to diagnosis, prevention, or treatment of rare diseases.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Anne Pariser, M.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-402-4338
Email: anne.pariser@nih.gov