Notice Number: NOT-OD-09-011

Key Dates
Release Date: October 31, 2008
Responses Due By:  July 1, 2009

Issued by
National Institutes of Health, Office of Rare Diseases (ORD) (http://rarediseases.info.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov). 

This Request for Information (RFI) is part of the Office of Rare Diseases (ORD) effort to provide basic and clinical researchers with research tools – specifically monoclonal antibodies against proteins involved in rare diseases.  The NeuroMab Facility, which was funded initially by NINDS and NIMH, was established to generate monoclonal antibodies against membrane proteins found in the nervous system.  The Facility was later expanded with funding from the NIH Blueprint and the NIH Roadmap Epigenomics Program so that monoclonal antibodies against neurodevelopmental proteins and proteins important to the epigenetic research community could be made.  Projects currently being done by the NeuroMab Facility can be found here: http://www.neuromab.org/CurrentProjects.htm.  Information from this RFI will be collected by NINDS on behalf of ORD.

Information Requested

Purpose
We are requesting target nominations for monoclonal antibodies that would be useful for basic research and clinical studies of rare diseases. 

Background
The Office of Rare Diseases (ORD) was established in 1993 within the Office of the Director of the National Institutes of Health (NIH), the Federal focal point for health research.  ORD coordinates and supports rare diseases research, responds to research opportunities for rare diseases, and provides information on rare diseases.  Rare diseases are defined as those diseases or conditions that affect fewer than 200,000 persons in the United States.  As instructed in the Rare Diseases Act of 2002, ORD established 1) a centralized clearinghouse for rare diseases information and 2) the Rare Diseases Clinical Research Network.  To provide additional research resources and tools to the rare diseases research community, the ORD in collaboration with NINDS is requesting target nominations for production of monoclonal antibodies directed against proteins involved in rare diseases. The NIH-funded NeuroMab Facility (http://www.neuromab.org) will generate mouse monoclonal antibodies against each selected protein target and distribute the resulting validated monoclonal antibodies at low cost to users. 

Rare Disease Target Nomination
The NIH Office of Rare Diseases is now accepting nominations for targets for monoclonal antibodies to be used in basic and clinical research of the 6000 or more rare diseases.
To nominate a target please follow the weblink http://www.ninds.nih.gov/funding/target_nominations/ and the instructions therein. You will be asked to provide information concerning: 

• the biological importance of the target molecule
• the importance of the proposed antibody to the study of rare diseases
• the availability and suitability (or lack thereof) of existing polyclonal and/or monoclonal antibodies
• reagents that could be provided by you or another laboratory (please identify the lab if possible) to aid in the development and characterization of these antibodies
• your willingness (or another lab’s willingness) to participate in screening a limited number of hybridoma clones to identify those clones which produce useful monoclonal antibodies. 

ORD and NINDS staff with input from external scientific experts will prioritize the nominations for the monoclonal antibody production queue.  Groups of five to ten target nominations will be prioritized as they are collected.  The NIH-funded NeuroMab Facility (http://www.neuromab.org) will generate mouse monoclonal antibodies against each selected protein target and distribute - at low cost to end users – the resulting monoclonal antibodies. 

Responses

Nominations must be submitted electronically through the following weblink: http://www.ninds.nih.gov/funding/target_nominations/.  Responses will be accepted through July 1, 2009.  Responses to any individual elements of the RFI are optional. The NIH site will permit anonymous responses. Responders should be aware that the information provided will be analyzed and may appear in various reports. Additionally, the government cannot guarantee the confidentiality of the information provided.

Inquiries

Specific questions about this RFI should be directed to the contacts listed below:

Randall R. Stewart, Ph.D.
Program Director for Channels, Synapses and Circuits
National Institute of Neurological Disorders & Stroke
National Institutes of Health
6001 Executive Blvd., Room 2135
Bethesda, MD 20892-9523
Phone: 301-496-1917
Fax: 301-402-1501
E-mail: [email protected]

David J. Eckstein, Ph.D.
Senior Health Scientist Administrator
Office of Rare Diseases, National Institutes of Health
6100 Executive Blvd, Suite 3B-01
Bethesda, MD 20892-7518
Phone: 301-402-4336
Fax: 301-480-9655
E-mail: [email protected]