NIH-NIAID: Drug Target Development and Validation for Antimicrobial-Resistant Pathogens (R21/R33)

Funding Opportunity Purpose

To support basic to translational research focused on characterization and validation of novel antimicrobial targets for development of new therapeutic interventions against select antimicrobial-resistant bacterial pathogens.

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Allergy and Infectious Diseases (NIAID)
Funding Opportunity Title	Drug Target Development and Validation for Antimicrobial-Resistant Pathogens (R21/R33)
Activity Code	R21/R33 Phased Innovation Award
FOA Number	RFA-AI-13-019
CFDA Numbers	93.855; 93.856

Key Dates

Posted Date	March 26, 2013
Open Date (Earliest Submission Date)	June 18, 2013
Letter of Intent Due Date(s)	June 18, 2013
Application Due Date(s)	July 18, 2013, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	July 18, 2013, by 5:00 PM local time of applicant organization.
Scientific Merit Review	November, 2013
Advisory Council Review	January, 2014
Earliest Start Date	April, 2014

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Funding Opportunity Description

Purpose/Research Objectives

Resistance to antimicrobial agents is an increasing contributor to morbidity, mortality and rising healthcare costs. In addition to antimicrobial conservation and hospital hygiene measures, there is a critical need for the development of novel therapeutic approaches to treat antimicrobial-resistant infections. Moreover, alternative approaches such as the development of adjunctive therapies to potentiate the activity of existing antimicrobials are needed. This initiative encourages the translation of basic research findings into the very early stages of antimicrobial therapeutics discovery and development for bacterial pathogens where resistance threatens effective treatment. The purpose of this initiative is to facilitate this translational effort by enabling researchers to assemble the appropriate expertise to design and execute studies to:  

• Characterize and validate novel antimicrobial targets.
• Characterize and validate novel adjunctive therapeutic targets.
• Determine the feasibility or use of the target for new interventions.
• Develop assays to screen for new therapeutic candidates against the target.
• Initiate pilot screening assays of proposed targets.

Specific Areas of Research Interest

This initiative is designed to capitalize on the numerous potential drug targets identified through basic research on pathogenesis and the immunobiology of infectious diseases. It is recognized that basic researchers often uncover important pathways, molecular associations, or host-pathogen interactions that may represent viable therapeutic targets. This initiative seeks to stimulate characterization and validation of these potential therapeutic targets for early phase therapeutic discovery and development activities. Of particular interest is the development of innovative and creative assay methods and validation of potential therapeutic targets that have previously been described.

Projects eligible for support include target development for: 1) small molecule inhibitors, 2) therapeutic antibodies and peptides, and 3) adjunctive therapeutics targeting resistance mechanisms that may not perpetuate the spread of resistance.

Applications should specifically target bacterial pathogens for which the high incidence of disease is driving the spread of resistance and there are limited options for clinical intervention.

Applications that do not address assay development and target validation for bacterial pathogens where antimicrobial resistance is currently a clinical concern will be deemed non-responsive and will not be reviewed. 

Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Funds Available and Anticipated Number of Awards	NIAID intends to commit $3.5 million in total costs in FY2014 to fund 15 to 20 applications in response to this FOA.
Award Budget	Support for the R21 phase cannot exceed two years and direct costs are limited to $275,000 over the R21 two-year period, with a maximum of $200,000 in direct costs allowed in any single year. The R33 award phase is limited to $300,000 in direct costs per year and cannot exceed three years. The NIAID anticipates that a maximum of fifty percent (50%) of the funded R21 phase awards will progress to the R33 award.
Award Project Period	The total project period for an application submitted in response to this FOA cannot exceed five years. Awards will support milestone-driven exploratory/feasibility “proof-of-concept” studies (two-year R21 phase), with possible rapid transition to expanded development (three-year R33 phase).

Eligible Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.