NINDS ADMINISTRATIVE SUPPLEMENTS: OVERCOMING BARRIERS TO NEUROLOGICAL THERAPEUTICS DEVELOPMENT RELEASE DATE: October 30, 2003 NOTICE: NOT-NS-04-001 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 2004 to promote progress in pre-clinical neurological therapeutics development. This administrative supplement program is issued in response to recommendations from the NINDS Strategic Plan (http://www.ninds.nih.gov/about_ninds/plans/strategic_plan.htm). The program is intended to facilitate the identification of new treatments for neurological disorders from candidate therapies 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. The goal of this program is to open critical paths in pre-clinical therapeutics development by funding small, focused projects. Supported studies should be designed to demonstrate the promise of therapies to 1) reduce the barriers to commercial development or 2) justify NIH funding for additional pre-clinical or clinical development. Thus, proposals should demonstrate both a sound rationale for the proposed project and a feasible plan to support further development of the candidate therapy. The proposed intervention(s) should have clearly demonstrated promise as treatments for neurological disease based on data from previous in vitro, animal or clinical testing. Highest funding priority will be given to studies that are specifically designed to support an IND application for clinical testing, and that form part of a well-developed plan for pursuing an IND. Examples of studies to be funded under this program include: o Studies to test the efficacy of highly promising interventions in animal disease models o Pre-clinical safety, kinetic or metabolic studies of strongly supported therapeutic leads o Chemical optimization of strongly supported therapeutic leads o Screening of clinically approved drug collections in neurological models Studies that are not encouraged under this announcement include early stage exploratory studies, such as model development or target validation. Clinical studies will not be supported under this announcement. It is acceptable to purchase commercial or institutional services to conduct the proposed studies. 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. HOW TO APPLY Applicants should submit an original and five complete copies to Dr. Jill Heemskerk at the address listed at the end of this notice. The following sections should be included: 1. A cover page citing this NOTICE and including the following information: PI name, grant number and title, direct and indirect costs 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 any animal testing. For P01s and P50s and U54s, the named PI must submit a request for a supplement to a subproject. THIS COVER PAGE MUST BE SIGNED BY AN AUTHORIZED INSTITUTIONAL OFFICIAL. 2. A description of the project (5-page limit), including: o an abstract o a rationale for the candidate therapeutic o the design of the proposed study o the plans for further development following the supplemental study 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. o human subjects o vertebrate animals If research involving human subjects or vertebrate animals was previously approved as within the scope of the project, then include the corresponding information as in the PHS 398 Research Plan, sections e. Human Subjects and/or f. Vertebrate Animals for the supplemental project. If human subjects and/or vertebrate animals were not previously approved, they cannot be added through this administrative supplement. 3. A modular budget with appropriate justifications for requested direct costs and specifying Facilities and Administrative Costs. 4. Specific Aims of the original grant. POST-AWARD REQUIREMENTS A one-page report that specifically addresses the results of the supplement will be required. It should be included as an addition to the progress report of the parent grant, submitted the year following the supplement award. REVIEW CRITERIA Applications will be reviewed administratively, and it is expected that a resulting Supplemental Notice of Grant Award will be issued within four months of the receipt deadline. All funding decisions are final and are not subject to appeal. Review criteria will include: o the quality of the rationale for the candidate therapy o the scientific merit of the study design o the feasibility of the plans for further development following supplemental study o importance of the study in moving the candidate therapy toward the clinic BUDGET INFORMATION Supplements will be awarded as direct costs in modular amounts of $10,000 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 study 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: January 30, 2004 April 30, 2004 Earliest Award date: April 30, 2004 July 30, 2004 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) 402-1501 Email: jill_heemskerk@ninds.nih.gov Direct inquiries regarding fiscal matters to: Ken Bond Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., NSC Room 3246 Bethesda, Maryland 20892 (USPS) Rockville, MD 20852 (FedEx and other couriers) Tel: 301-496-9231 Fax: 301-402-0219 Email: bondk@ninds.nih.gov
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