American Recovery and Reinvestment Act of 2009
NIH Challenge Grants in Health and Science Research (RFA-OD-09-003)
NIH Office of Rare Diseases Research (ORDR)

NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009 – 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research.

This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds. The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.

NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: “a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy.” Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.

The application due date is April 27, 2009.

Frequently Asked Questions about the NIH Office of Rare Diseases Research Challenge Topics can be found here.

For the Office of Rare Diseases Research (OD/ORDR), the Challenge Topics are:

Broad Challenge Area	Specific Challenge Topic
(03) Biomarker Discovery and Validation	03-OD(ORDR)-101* Validating biomarkers for functional outcomes in rare diseases. This initiative will provide a program of an expert consultative group to work with research investigators in the design to validate biomarkers and collect the data necessary to relate the biomarker with functional outcome in rare diseases. This program will be designed to stimulate development of new treatment trials. Contact: Dr. Rashmi Gopal-Srivastava, 301-402-4336, gopalr@mail.nih.gov NIH Partners that have shown an interest in this topic: ODS, NIDCR, NIA, NCI, NICHD, NIAAA, NINDS, NIAMS, NIAID, NINR
(07) Enhancing Clinical Trials	07-OD(ORDR)-101* Library of standardized patient registry questions Develop standardized questions and data elements that can be used when developing rare diseases patient registries. Having a standardized library of data elements will enable cross-indication analyses of patient populations, speed the development and deployment of patient registries, and allow registries to exchange and aggregate patient registry data. Contact: Dr. Rashmi Gopal-Srivastava, 301-402-4336, gopalr@mail.nih.gov NIH Partners that have shown an interest in this topic: NIDCR, NCI, NIAAA, NINDS, NIAMS 07-OD(ORDR)-102* Rare disease genetic patient registry Support for an efficient infrastructure and expert staff in developing a registry capable of asking for rare-disease-specific information and capturing genetic results across any number of rare diseases, thereby ensuring patients are identified for trials as treatments become available. Contact: Dr. Rashmi Gopal-Srivastava, 301-402-4336, gopalr@mail.nih.gov NIH Partners that have shown an interest in this topic: NHGRI, NIDCR, NCI, NICHD, NIAAA, NINDS, NIAMS, NIAID
(15) Translational Science	15-OD(ORDR)-101* Pilot projects for prevention, early detection and treatment of rare diseases Design research projects to provide preliminary results to demonstrate feasibility of novel approaches to rare diseases. Potential approaches to research in rare diseases could include but will not be limited to: identification of molecular targets for rare diseases; development of models (vertebrate, invertebrate, computational); development of micro arrays and tissue micro arrays which are applicable to screening or detection of rare diseases; development of tools for drug discovery (e.g. development of assays for screening compounds); and clinical trials. Contact: Dr. Rashmi Gopal-Srivastava, 301-402-4336, gopalr@mail.nih.gov NIH Partners that have shown an interest in this topic: NHGRI, ODS, NIDCR, NIA, NCI, NICHD, NIAAA, NINDS, NIAMS, NIAID, NINR 15-OD(ORDR)-102* Collaborative translational research platform for rare diseases. Create a collaborative platform by disease area to allow researchers to create virtual project teams, update status reports, collaboratively score targets and nominate molecules for screening. Having these data in a centralized, common system should reduce redundancy and potentially identify non-obvious associations of research across the rare disease spectrum. Contact: Dr. Rashmi Gopal-Srivastava, 301-402-4336, gopalr@mail.nih.gov NIH Partners that have shown an interest in this topic: NIDCR, NIA, NCI, NIAAA, NINDS, NIAMS, NIAID

For general information on ORDR’s implementation of NIH Challenge Grants, contact:
IC Challenge Program Coordinator:
Dr. Stephen C. Groft
Phone: 301-402-4336
E-mail: grofts2@od.nih.gov

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