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Tuesday, July 16, 2013

Susceptibility and Variability in Human Response to Chemical Exposure

Funding Opportunity Number: EPA-G2013-STAR-J1
Synopsis of Program: 
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing research to study life stage and/or genetic susceptibility in order to better characterize the sources of human variability in response to chemical exposure.  The adverse outcome pathways (AOP) concept has the potential to serve as a framework for using susceptibility indicators, biomonitoring, and high throughput screening (HTS) data in an integrated manner to predict population responses to novel, potentially harmful, chemicals. While much emphasis has been placed on improved biomonitoring and HTS approaches, research is needed to understand the underlying factors that influence human susceptibility and to develop tools and methods for the identification and use of susceptibility indicators in this context. 
This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research.  Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects).  This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D.  Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children.  Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D).  All applications must include a Human Subjects Research Statement (HSRS, as described in Section IV.B.5.c), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.C and V.D of this solicitation.Catalog of Federal Domestic Assistance (CFDA) Number: 66.509
Solicitation Opening Date: June 10, 2013
Solicitation Closing Date: September 10, 2013, 11:59:59 pm Eastern Time
Eligibility Contact: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov); phone: 703-308-7224
Technical Contact: Mitch Lasat (lasat.mitch@epa.gov); phone: 703-347-8099

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