National Center for Toxicological Research Annual Report Research Accomplishments and Plans FY 2015 – FY 2016 Page 0 of 193 Table of Contents Preface – William Slikker, Jr., Ph.D. ................................................................................... 3 NCTR Vision ......................................................................................................................... 7 NCTR Mission ...................................................................................................................... 7 NCTR Strategic Plan ............................................................................................................ 7 NCTR Organizational Structure .......................................................................................... 8 NCTR Location and Facilities .............................................................................................. 9 NCTR Advances Research Through Outreach and Collaboration ................................... 10 NCTR Global Outreach and Training Activities ............................................................... 12 Global Summit on Regulatory Science .................................................................................................12 Training Activities .................................................................................................................................14 NCTR Scientists – Leaders in the Research Community .................................................. 15 Science Advisory Board .................................................................................................... 19 Function ...............................................................................................................................................19 FY 2015 Accomplishments ...................................................................................................................19 SAB Membership Roster ......................................................................................................................20 Office of Scientific Coordination (OSC) ............................................................................ 22 Introduction .........................................................................................................................................22 FY 2016 Plans .......................................................................................................................................25 IntraAgency Agreement with National Institute of Environmental Health Sciences/National Toxicology Program ........................................................................... 26 Introduction .........................................................................................................................................26 NCTR/ORA Nanotechnology Core Facility ....................................................................... 29 Introduction .........................................................................................................................................29 FY 2015 Accomplishments ...................................................................................................................31 FY 2016 Plans .......................................................................................................................................35 Center for Tobacco Products (CTP)/NCTR Inhalation Toxicology Core Facility (InhaleCore) ...................................................................................................................... 36 Introduction .........................................................................................................................................36 FY 2015 Accomplishments ...................................................................................................................37 FY 2016 Plans .......................................................................................................................................37 Veterinary Services ........................................................................................................... 38 Introduction .........................................................................................................................................38 FY 2015 Accomplishments ...................................................................................................................39 FY 2016 Plans .......................................................................................................................................40 Cooperative Research and Development Agreements ................................................... 41 Women’s Health Research at NCTR ................................................................................. 42 FY 2015 Accomplishments ...................................................................................................................42 FY15 and FY16 NCTR Projects Supported by OWH .......................................................... 46 Page 1 of 193 Minority Health Research ................................................................................................ 47 Division of Biochemical Toxicology Summary of Activities ............................................ 49 Introduction .........................................................................................................................................49 FY 2015 Accomplishments ...................................................................................................................49 FY 2016 Plans .......................................................................................................................................53 Contributions to FDA’s Strategic Priorities/Goals ................................................................................55 Division of Bioinformatics and Biostatistics Summary of Activities ............................... 57 Introduction .........................................................................................................................................57 FY 2015 Accomplishments ...................................................................................................................58 FY 2016 Plans .......................................................................................................................................62 Contributions to FDA’s Strategic Priorities/Goals ................................................................................63 Division of Genetic and Molecular Toxicology Summary of Activities ........................... 65 Introduction .........................................................................................................................................65 FY 2015 Accomplishments ...................................................................................................................66 FY 2016 Plans .......................................................................................................................................69 Contributions to FDA’s Strategic Priorities/Goals ................................................................................71 Division of Microbiology Summary of Activities ............................................................. 74 Introduction .........................................................................................................................................74 FY 2015 Accomplishments ...................................................................................................................75 FY 2016 Plans .......................................................................................................................................80 Division of Neurotoxicology Summary of Activities ........................................................ 85 Introduction .........................................................................................................................................85 FY 2015 Accomplishments ...................................................................................................................86 FY 2016 Plans .......................................................................................................................................89 Contributions to FDA’s Strategic Priorities/Goals ................................................................................90 Division of Systems Biology Summary of Activities ........................................................ 92 Introduction .........................................................................................................................................92 FY 2015 Accomplishments ...................................................................................................................93 FY 2016 Plans .......................................................................................................................................99 Contributions to FDA’s Strategic Priorities/Goals ..............................................................................100 NCTR Objective 1.1 – Integrated Product Assessment.................................................. 101 NCTR Objective 1.2 – Advance Regulatory Science Through the Development of New Tools and Approaches .................................................................................................... 125 NCTR Objective 1.3 – Approaches for Promoting Individualized