NIH: NIEHS SBIR Phase IIB Awards for Validation and Commercialization of Approaches to Reduce Animal Use in Toxicology Testing (U44) [RFA-ES-15-016]

This FOA provides additional support to SBIR/STTR Phase II grantees for the validation and commercialization of methods that either replace or reduce the number of animals (referred to as alternative test methods) used in in vivo toxicology screening and testing requirements set forth by US federal government agencies.
Date deadline

This FOA provides additional support to SBIR/STTR Phase II grantees for the validation and commercialization of methods that either replace or reduce the number of animals (referred to as alternative test methods) used in in vivo toxicology screening and testing requirements set forth by US federal government agencies.

Proposed projects must address non-clinical toxicology testing requirements currently used or required by a US federal government agency.  Applicants must submit a Validation and Commercialization Plan, which should include details on a specific US federal agency’s required endpoint(s) being assessed and a description of anticipated impact on the 3Rs of animal use (reduction, refinement and/or replacement) with adoption and implementation of the alternative test method. A listing of the different agency regulations and guidelines, by topic, can be found on the NTP website athttp://ntp.niehs.nih.gov/pubhealth/evalatm/regs-guidelines/.

A minimum requirement for this funding opportunity is proposal of an alternative test method that can be utilized either as a stand-alone replacement or developed for use as part of a weight-of-evidence approach,.  Applications should consider validation guidelines outlined by the Organisation for Economic Co-operation and Development (OECD), http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?doclanguage=en&cote=env/jm/mono(2005)14), in their validation plan.  US federal agencies may have additional requirements for acceptance of alternative test methods that should be considered in the further testing and validation of these methods or ICH guidelines.   Highest priority will be given to alternative test methods that can serve as stand-alone replacements for animal-based tests currently used or required by US federal agencies. As a cooperative agreement, small business concerns (SBCs) will be expected to work with NIH program staff and the Steering Committee, which may include members of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), to develop and implement the final validation plan for the proposed alternative test method.  ICVAAM, which has representatives from multiple US federal agencies, will assist in coordinating validation steps including additional requirements that specific US federal agencies may have for acceptance of the alternative test method. 

For more information, visit http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-15-016.html#sthash.RkhaNQYE.dpuf

Please direct any questions to Sri Nahadur at NadadurS@niehs.nih.gov