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<key-projects><projects><title>Enhance FDA’s Science Decisions through the NTP</title><description>The missions of FDA and NTP overlap where toxicology data-gaps exist on chemicals/compounds/materials that are regulated by the FDA (1). This interagency agreement is in its 18th year supporting toxicology studies at FDA/NCTR, providing data for FDA and other regulatory agencies to protect the United States public.</description><dictionary></dictionary><outcome>Provide toxicology data for FDA risk assessment and risk management decisions by the FDA.</outcome><accomplishment>Meetings were held in May and November 2010 to discuss ongoing studies and newly proposed study designs that are part of the interagency agreement between the FDA and NTP/NIEHS that support the FDA risk-assessment process. The meetings are comprised of regulatory scientists and subject experts from the FDA Centers and ORA, NIEHS, and invited subject-matter experts from other government agencies, industry and academia. Ongoing studies that were discussed include dietary supplements, food contaminants, and medical device components. Newly proposed studies include Oxybenzone and Goldenseal.</accomplishment><table><title></title><row><type>main</type><milestone-description>1. Communicate NTP studies, programs, and summaries to FDA Centers</milestone-description><milestone-date>3/31/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/31/2010</milestone-completion-date></row><row><type>main</type><milestone-description>2. Establish Working Group on dietary supplements, herbals, and botanicals</milestone-description><milestone-date>4/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>5/17/2010</milestone-completion-date></row><row><type>main</type><milestone-description>3. Establish Working Group on sunscreen monograph (CDER initiative to define toxicity data gaps and coordinate studies with NTP and NCTR) ingredients</milestone-description><milestone-date>4/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>1/6/2010</milestone-completion-date></row><footnotes><note>(1) NTP is an intra-Agency program between the National Institutes of Health (NIH) and NCTR whereby NIH directs the toxicological research and NCTR performs the research.</note></footnotes></table></projects><glossary><word><text>NTP</text><definition>National Toxicology Program</definition></word><word><text>NIEHS</text><definition>National Institute of Environmental Health Sciences</definition></word><word><text>CDER</text><definition>Center for Drug Evaluation and Research</definition></word><word><text>Oxybenzone</text><definition>sunscreen</definition></word><word><text>Goldenseal</text><definition>dietary supplement</definition></word><word><text>NIH</text><definition>National Institutes for Health</definition></word></glossary><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm203296.htm</url><text>FDA-TRACK NCTR Dashboard</text></link><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm252974.htm</url><text>FDA-TRACK Research Glossary</text></link></related-links></key-projects>਍††਍਍਍਍਍਍਍