NIH-RAID Administrative Supplements for Preclinical Efficacy Testing of Candidate Therapeutics

Notice Number: NOT-RM-09-010

Key Dates
Release Date:  March 5, 2009
Receipt Date: May 1, 2009

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) on behalf of NIH Roadmap for Medical Research (http://nihroadmap.nih.gov/)

Purpose

The National Institutes of Health Rapid Access to Interventional Development (NIH-RAID) Roadmap initiative announces the availability of administrative supplements to support preclinical efficacy testing of candidate therapeutics. This supplement program is intended to facilitate the discovery and development of novel therapeutic agents by providing funds for the in vitro or in vivo efficacy assessment of promising therapeutic candidates to determine their suitability for further preclinical development.

Background

The NIH Roadmap for Medical Research (http://nihroadmap.nih.gov/) has established a program called NIH-RAID (Rapid Access to Interventional Development) to make available, at no charge, certain critical resources needed for the development of new therapeutic agents. NIH-RAID is intended to reduce some of the common barriers between laboratory discoveries and clinical trials of new therapeutic entities, and projects in both the early and late stages of preclinical development are suitable for NIH-RAID applications. Approved NIH-RAID projects are completed using resources of the National Cancer Institute’s (NCI) Developmental Therapeutics Program (http://dtp.nci.nih.gov/) and the National Heart Lung and Blood Institute’s (NHLBI) Gene Therapy Resource Program (http://www.gtrp.org). Further information on the NIH-RAID program is available on the program website (http://nihroadmap.nih.gov/raid/).

Before a project is approved by the NIH-RAID program to access IND-enabling preclinical development services, there must be compelling data in support of the efficacy of the candidate therapeutic for treating the disease or aging condition. This administrative supplement program is intended to provide support for testing of promising leads that require additional preclinical efficacy data before advancing to the point where IND-directed development services are warranted. Supplemental funds may be used to support efficacy testing in relevant in vitro or in vivo models of disease, either within the home lab, through collaborations with academic investigators, or through contract research organizations with the appropriate expertise. Appropriate uses of funds include, but are not limited to, the expansion of efficacy studies to include additional disease models, and the testing of additional candidate therapeutics. The results of the supplemental funding should significantly enhance the pursuit of the Specific Aims of the funded project.

Eligibility

This program will support administrative supplements to Research Project (R01 or U01), Exploratory/Developmental (R21), MERIT (R37), STTR (R41, R42), SBIR (R43, R44), Program Project (P01), and Specialized Center (P50, U19, U54) grants. The NIH grant must have at least one year of active funding remaining as of the request submission date. Grants in a no-cost extension period will not be considered for support under this supplement program. Only one supplement request may be submitted per grant.

To be eligible, the NIH grant must be active, and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement MUST be within the general scope of the peer-reviewed activities and aims approved within the NIH grant.

IMPORTANT:  The research proposed by the NIH grantee in the supplement request must be within the original scope of the NIH-supported grant project.  The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project.  Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

Post-Award Requirements

Following completion of the supplemental work, a one-page summary of the results achieved with the supplemental funds should be included with the next progress report submitted for the original grant.

Submitting an Administrative Supplement Request

To be considered for an administrative supplement, submit a request in writing to the NIH-RAID office, not to the Division of Receipt and Referral, Center for Scientific Review. The request must be signed by the authorized Business Official and describe the need for additional funding and the categorical costs.

Requests under this notice should include:

  1. A cover page citing this Notice and including the PI name, grant number and title, amount of the requested supplement, the name and title of the institutional official, and the phone, email, and address information for both the PI and institutional official. Approval from the Institutional Animal Care and Use Committee (IACUC) for any use of vertebrate animals in the supplemental experiments should be documented. For P01s, P50s, and U54s, the PI must submit a request for a supplement to a subproject. The cover page must be signed by the PI and the institutional official.
  2.  A letter (5-page limit) describing the project, including an abstract, a description of the proposed experiments and their relationship to the original project’s Specific Aims, a discussion of the significance of the supplemental work, and a budget. The request should include all available in vitro or in vivo efficacy, pharmacology, and toxicology data.
  3. A Biographical Sketch of the PI.
  4. The Specific Aims from the grant.
  5. Documentation of institutional or other co-funding.
  6. Letters of Commitment

Selection Factors

Requests that are complete and relevantto the goals of the supplement program will be reviewed administratively by a committee of NIH staff. Incomplete applications will not be reviewed. The selection of requests for award will be based on scientific merit, significance, feasibility of the proposed work, rationale for the development of the candidate therapeutic, justification for the therapeutic strategy, strength of the preliminary data supporting the activity of the candidate, validity of the proposed model, innovation, and availability of funds. Preference will be given to supplement requests with the highest scientific impact and likelihood for success. The value added to the goals of the funded grant and its realistic scope will also be considered. Awards will be made no later than September 30, 2009.

Budget and Funding Information

Supplement requests for up to $50,000 in direct costs will be accepted. Multi-year supplements will not be considered. Facilities and Administrative (F&A) costs will be paid at negotiated rates. Applicants should provide a detailed budget justification for personnel costs, equipment, supplies, and other expenses. In fiscal year 2009, the NIH plans to commit approximately $2,000,000 total costs toward this administrative supplement program, with up to 25 awards anticipated.

How to Apply

Requests must be received on or before May 1, 2009. Do not send supplement requests to the Center for Scientific Review. Requesters should submit one electronic copy, as an e-mail attachment in PDF format, and four hard copies of the request (one of which must include the original signatures of the Principal Investigator (PI) and institutional official) to the NIH-RAID program contact listed at the end of this Notice.

Inquiries

Requesters are strongly encouraged to discuss their plans for responding to this Notice by phone or e-mail. Scientific inquiries should be directed to the NIH Program Officer who oversees the funded grant for which the administrative supplement is requested, as noted on the Notice of Grant Award. General inquiries about this supplement program can be directed to:

Tony Jackson
NIH-RAID Program Office
6001 Executive Boulevard, Room 2141
Bethesda, MD 20892
Telephone: (301) 594-4660
Email: nih-raid@mail.nih.gov


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