NINDS ADMINISTRATIVE SUPPLEMENTS: TESTING OF CANDIDATE DRUG TREATMENTS FOR NEURODEGENERATION IN RODENT MODELS RELEASE DATE: March 4, 2003 NOTICE: NOT-NS-03-003 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) The National Institute of Neurological Disorders and Stroke (NINDS) announces an administrative supplement program of up to $1 million in Fiscal Year 2003 to facilitate the testing of candidate drugs in rodent models of neurodegeneration. This administrative supplement program is issued in response to recommendations from the NINDS Strategic Plan (http://www.ninds.nih.gov/about_ninds/strategic_plan.htm) and the Parkinson's Disease Research Agenda (http://www.ninds.nih.gov/about_ninds/plans/nihparkinsons_agenda.htm). The program is intended to facilitate the identification of new treatments for neurodegenerative disorders through evaluation of promising drugs identified or evaluated in ongoing, peer-reviewed projects. Principal Investigators with Research Project (R01), Exploratory/Development (R21), Phase II SBIR (R44), Program Project (P01), Specialized Center (P50 or U54), and Cooperative Agreement (U01) grants funded by NINDS are eligible to apply. This program is designed to support the testing of candidate therapies for chronic neurodegenerative disorders in rodent models. The animal model of disease under study should have demonstrable value for drug testing, with mechanistic relevance to the disease of interest and reliable outcome measures. Outcome measures may include behavioral changes, biochemical or histological measures, or survival. The proposed drug(s) should have clearly demonstrated promise as treatments for neurodegeneration based on data from previous in vitro, animal or clinical testing. In addition to testing the efficacy of individual drugs, an important goal of this program is to generate data that can be used to compare the promise of different drugs within a disease area. This information will be valuable in prioritizing active compounds for clinical testing. Therefore, at the outset of the program, NINDS will facilitate discussions among investigators who share a disease focus. To the extent possible, these discussions will be aimed at reaching a consensus about testing protocols. It is acceptable to purchase commercial or institutional services to conduct the drug trials. Requests for salary may be included, in proportion to time directly devoted to the supplemental project. Evidence should be presented that the results of the supplemental assistance will enhance the pursuit of the Specific Aims of the original research project, without constituting an expansion of scope. Supplements are one-time awards and will not extend to subsequent budget periods. DATA SHARING At the end of the supplemental project period (one year from the award date of the supplement), the NINDS will arrange a meeting of the investigators funded under this program to present the results of the tests. The goals of the meeting will be to discuss the relative effectiveness of compounds tested, define steps to clinical evaluation of effective compounds, and consider effective compounds for testing in other neurodegenerative disease models. In their proposals, applicants should discuss their willingness to share their data, under confidentiality, within the group of investigators funded under this program. This will be an important factor for review. HOW TO APPLY Submission of requests should be made electronically. Supplement requests should be submitted via Email to: drugtests@ninds.nih.gov with the Principal Investigator's name (last name, first name) and grant number (e.g., R01NS01234-05) on the subject line. Per the NIH Guide Notice OD-00-009 (http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-00-009.html), the supplemental request must be submitted to the above e-mail address by an authorized business official at the grantee institution. Electronic submission by the authorized institutional official is understood as an expression of institutional approval and indicates that all internal procedures have been properly completed. Include the following sections in an attached file in MSWord, WordPerfect, or PDF format: 1. A cover page citing this NOTICE and requesting an administrative supplement, including the PI name, grant number and title, amount requested, name and title of the institutional official, and phone, email, and address information for both the PI and institutional official. Document the approval from the Institutional Animal Care and Use Committee (IACUC) for the rodent model. For P01s and P50s and U54s, the named PI must submit a request for a supplement to a subproject. 2. A letter (5-page limit) describing the project, including an abstract, a rationale for the choice of animal model and drug(s) and the design of the rodent trial. The project description should include the information listed in the Review Criteria section below. The applicant should describe the relationship of the project to the Specific Aims of the parent grant. Evidence should be presented that the results of the supplemental assistance will enhance the pursuit of the Specific Aims of the original research project without constituting an expansion of scope. 3. A modular budget with appropriate justifications for requested direct costs and associated Facilities and Administrative Costs. 4. Specific Aims of the original grant. Applicants unable to submit an electronic application should submit a complete written application, signed by an authorized business official at their institution, to Dr. Jill Heemskerk at the address listed at the end of this notice. REVIEW CRITERIA Applications will be reviewed administratively, and it is expected that a resulting Supplemental Notice of Grant Award will be issued within three months of the receipt deadline. All funding decisions are final and are not subject to appeal. Review criteria will include the relevance of the rodent model to neurodegenerative disease, quality of the rationale for the selection of the drug, the scientific merit of the design of the rodent trial, and the willingness to share resulting data with other investigators funded under this program. Applicants should provide the following information for consideration in review: 1. A brief description of the rodent model, including genotype, phenotype and background strain, and the relevance of the model to the neurodegenerative disease of interest. List any relevant publications describing the construction of the model and its use in drug testing. 2. The rationale for the choice of drug and dose to be tested. Provide information about the potency of the drug in experimental assays or clinical settings, and relate this to the expected achievable dose in the rodent model. Describe how the dose and route of administration in the trial will be selected. 3. A description of the trial design including description of outcome measures and the rationale for their choice, positive and negative controls, and method for determining sample size. Describe at what stage and with what frequency the drug will be administered. 4. A data-sharing plan that addresses the willingness of the investigator to share data with other investigators in the program under confidentiality at a conference to be held at the end of the supplement period. BUDGET INFORMATION Supplements will be awarded as direct costs in modular amounts of $25,000 and are one-time awards. Any Facilities and Administrative (indirect) Costs should also be specified in the budget request. For R01s, R21s, and R44s, the maximum request for direct costs is $50,000. For P01s, P50s, U54s, and U01s, the maximum is $100,000. Although the awarded budgets will be modular, applicants should provide a budget justification that details the budget items requested, including Facilities and Administrative costs. If the planned drug testing will not be fully supported by the supplemental funds from NINDS, the sources and amounts of additional funds should be specified. NINDS will commit $1 million in total costs to fund applications for supplements submitted in response to this Notice. Awards pursuant to this Notice are contingent upon the availability of funds and the receipt of a sufficient number of applications of high scientific merit. Receipt dates: April 7, 2003 June 30, 2003 Earliest Award date: June 9, 2003 August 29, 2003 INQUIRIES Direct inquiries regarding the program to: Dr. Jill Heemskerk Technology Development Group National Institute of Neurological Disorders and Stroke 6001 Executive Blvd. NSC Room 2229 Bethesda, MD 20892 (USPS) Rockville, MD 20852 (FedEx and other couriers) Tel: (301) 496-1779 Fax: (301) 480-1080 Email: jill_heemskerk@ninds.nih.gov Direct inquiries regarding fiscal matters to: Dianna Jessee Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., NSC Room 3259 Bethesda, Maryland 20892 (USPS) Rockville, MD 20852 (FedEx and other couriers) Tel: 301-496-7416 Fax: 301-402-0219 Email: jesseed@ninds.nih.gov
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