Notice Number: NOT-NS-10-020
Release Date: June 25, 2010
Response Due By: August 6, 2010
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
The National Institute of Neurological Disorders & Stroke (NINDS) is considering issuing a series of Funding Opportunity Announcements (FOAs) for the NINDS Epilepsy Centers without Walls Program to Promote Collaborative Research in the Epilepsies, a newly envisioned cooperative agreement program that will engage the epilepsy research community in collaborations to solve challenges related to the Epilepsy Research Benchmarks (http://www.ninds.nih.gov/research/epilepsyweb/2007_benchmarks.htm). The purpose of this Request for Information (RFI) is to solicit input that will help guide the development of this new program.
The epilepsies are a diverse group of chronic neurological disorders characterized by spontaneous, recurring seizures. Collectively, these disorders are estimated to affect approximately 3 million Americans of all ages and ethnic groups, with a lifetime risk to age 80 of 3%. The highest incidence of epilepsy is in early childhood, and the population with the fastest growing incidence is the elderly. For a majority of people with epilepsy, medicines and/or surgical interventions can control seizures, yet seizures will continue in about one-third of cases even with the best available treatment, sometimes leading to devastating consequences. Moreover, many anti-epileptic treatments have adverse side effects, and no effective interventions exist to prevent the development of epilepsy in those at risk. Beyond seizures, sudden unexplained death in epilepsy (SUDEP) and comorbid conditions, such as depression and cognitive and behavioral impairments, are increasingly recognized as part of a broader spectrum of problems associated with epilepsy.
NINDS is the lead NIH Institute for research on the epilepsies and has supported important contributions to past and recent advances. However, many challenges remain for epilepsy research. To further accelerate progress toward the goals of no seizures, no side effects, and the prevention of epilepsy in those at risk, NINDS is implementing new initiatives for epilepsy research, including the NINDS Epilepsy Centers without Walls Program to Promote Collaborative Research in the Epilepsies. This program will support multicenter, multidisciplinary consortia to solve specific research challenges that will lead to advances in prevention, diagnosis, or treatment of the epilepsies and related comorbidities. The program will bring together the best investigators, regardless of geographic location, and is a novel and innovative approach to harnessing the best research to address difficult needs in a particular field. The NINDS expects to issue the first of a series of Request for Applications (RFA) for this program in fall 2010. The first RFAs are likely to focus on human epilepsy genetics or animal models of epileptogenesis and pharmacoresistance for translational drug development. An RFA soliciting planning grant applications for a Center without Walls on Sudden Unexpected Death in Epilepsy (SUDEP) is also anticipated in fall 2010.
Recent and planned NINDS workshops on these topics will be one source of input into the key challenges the Centers without Walls program should address. NINDS will hold workshops in the areas of human epilepsy genetics and animal models of epileptogenesis and pharmacoresistance in late summer, 2010. NINDS previously held a workshop on SUDEP in November 2008. A summary of the meeting, which includes research priorities identified during the proceedings, is in preparation.
The first workshop will focus on the state of the science for current large scale epilepsy genetic efforts. The workshop will assess the readiness for broad collaboration in a US-based consortium and how to remove barriers to collaboration in this area. It is hoped that consensus can begin to be reached on topics such as: priorities, phenotyping standards, retroactive use of samples and data, informatics and data systems issues, informed consent for future studies, functional validation studies, data sharing and publication policies.
The second workshop is expected to focus on animal models of epileptogenesis or pharmacoresistance suitable for translational research studies. The purpose of this workshop is to assess the utility of available models for developing and testing new therapies to prevent epileptogenesis, to modify the course of epilepsy, or to control seizures in conditions that remain resistant to currently available treatment options. The workshop will explore the relevance of these models for specific clinical populations (i.e., people who develop epilepsy after traumatic brain injury, stroke, prolonged status epilepticus, etc.), regulatory barriers for trial design, and validation requirements and candidate criteria for preclinical intervention studies.
NINDS is seeking information that will be useful in developing the upcoming workshops and the Epilepsy Center without Walls solicitations. Specifically, NINDS requests input on the following areas (please note that it is not required to address all areas in order to respond; feel free to focus on those items in which you are most interested in addressing):
Responses should be submitted electronically via the web-based form available at http://www.ninds.nih.gov/research/epilepsyweb/feedback.htm.
Replies to individual questions are optional, and the site will permit anonymous responses. Responses will be accepted through August 6, 2010.
Responses to this RFI are voluntary and may be anonymous. Any identifiers (e.g., names, institutions, e-mail addresses, etc) will be removed when responses are compiled. Only the processed, anonymized results will be shared internally with scientific working groups convened by the NIH, as appropriate. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and/or the National Institute of Neurological Disorders and Stroke (NINDS). The NIH does not intend to award a grant or contract to pay for the preparation of any information submitted or for the NIH’s use of such information. Respondents not be notified of the NIH evaluation of the information received. No basis for claims against the NIH shall arise as a result of a response to this request for information or the NIH’s use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement. Responses will be held confidential. Proprietary information should not be sent.
Specific questions about this RFI should be directed to the contact listed below:
Brandy Fureman, PhD
Program Director, Epilepsies
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
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