Notice of Intent to Publish a Funding Opportunity Announcement (FOA) for the Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers (U54)

Notice Number: NOT-AR-13-020

Key Dates
Release Date: June 7, 2013

Estimated Publication Date of Announcement: July 12, 2013
First Estimated Application Due Date: September 13, 2013
Earliest Estimated Award Date: March 14, 2014
Earliest Estimated Start Date: April 1, 2014

Related Announcements
RFA-AR-13-012

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Neurological Disorders and Stroke (NINDS), intend to promote an ongoing initiative by publishing a Funding Opportunity Announcement (FOA) to solicit new or renewal applications for Wellstone Muscular Dystrophy Cooperative Research Centers.

The NIH expects to make one Center award in response to this upcoming FOA, contingent upon the scientific merit of the applications and availability of funds.

The NIH established this Centers of Excellence program in 2003 as part of an ongoing effort to enhance and intensify research on the muscular dystrophies. These Centers were described in the MD-CARE Act (Public Law 107-84 of 2001 and 110-361 of 2008), and were named in honor of the late Senator Paul D. Wellstone. The theme of each Center must focus on one or more of the muscular dystrophies, which include Duchenne, Becker, myotonic, facioscapulohumeral, limb-girdle, congenital, oculopharyngeal, Emery-Dreifuss and others.

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 July 2013 with an expected receipt date at the end of August 2013.

This FOA will utilize the U54 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into translational and clinical muscular dystrophy research to consider organizing a collaborative group to prepare an application for this new FOA. Successful applicants will foster the translation of new scientific findings and technological developments into novel treatments or other strategies for improving the lives of muscular dystrophy patients. Each Center should involve clinical research with direct interactions between researchers and muscular dystrophy patients. Appropriate clinical studies could include early stage clinical trials, patient-oriented studies that facilitate future trials, natural history studies, biomarker identification or validation, biopsychosocial studies, etc. Each Center may also contain basic and/or preclinical translational research, as long as efforts are directed toward the steps required for therapeutic development, including therapeutic target identification, characterization, and validation, development of diagnostics and biomarkers to characterize or stratify patient populations, in vitro assay development, animal model development and characterization, candidate therapeutic efficacy screening, preclinical therapeutic optimization and FDA-required activities leading to an investigational new drug (IND) application. Applicants should propose multi-disciplinary and collaborative studies that will significantly accelerate progress toward effective treatments or other improvements in patients' lives. Research problems should require substantial collaborative efforts to solve, and thus are best carried out in a center setting. Each Center should have at least one core facility that shares its services or resources with the national or international muscular dystrophy research community and another core that promotes training, education and outreach activities. Centers supported through this FOA will participate in annual meetings with the existing Centers in the program to promote communication and collaborations.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Glen H. Nuckolls, Ph.D.
Director, Muscle Disorders and Therapies Program
Division of Musculoskeletal Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
U.S. Department of Health and Human Services
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872 (for couriers use 20817)
Telephone: 301-594-4974
Email: nuckollg@mail.nih.gov

John D. Porter, Ph.D.
Program Director, Neuromuscular Disease
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
6001 Executive Boulevard, Room 2142
Bethesda, MD 20892-9523 (for courier services, use Rockville, MD 20852)
Telephone: (301) 496-5739
FAX: (301) 402-1501
Email: porterjo@ninds.nih.gov

Tiina Urv, Ph.D.
Program Director
Intellectual and Developmental Disabilities Branch
Center for Developmental Biology and Perinatal Medicine
Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), NIH
6100 Executive Boulevard
Room 4B09D, MSC 7510
Bethesda, MD 20892
Telephone: (301) 402-7015
Email: tu36j@nih.gov