FDA-TRACK Update: FDA’s Executive Secretariat is ensuring faster response to your correspondence

On Track: The FDA-TRACK Monthly Newsletter FDA-TRACK Feature: Executive Secretariat Correspondence Measures The Office of the Executive Secretariat (OES) controls and processes all agency public correspondence directed to the Commissioner.  OES has shown improvements on its external correspondence measures by keeping the number of correspondence overdue to a minimum.  The number of overdue external correspondence was reduced from 131 in FY13 to 78 in FY14 because OES has implemented new processes to ensure that correspondence is answered on time.  A weekly overdue and pending correspondence report is sent to the Centers and Offices requesting updates and reminding them of deadlines.  The Supervisor for the Correspondence team follows up with emails and meets weekly with the Director and Deputy Director of OES to report the status of the correspondence.  When deadlines cannot be met, OES sends an acknowledgement letter to the requestor. What's New in December 2014 New performance data are available for the dashboards below. Cross Agency FDA Safety and Innovation Act (FDASIA)-TRACK   Center for Biologics Evaluation and Research (CBER) CBER Dashboard: CBER completed the scientific collaboration and management of the Cooperative Agreement with the WHO (World Health Organization) for year 2. The cooperative agreement continues to be a successful public health collaboration between the FDA and the WHO by enhancing access to safe and effective vaccines.  Although this portion of the project is complete, CBER will continue this cooperative agreement into FY15 with a focus on the initiatives to further enhance pharmacovigilance capacity building to strengthen global vaccine safety monitoring.  Center for Food Safety and Applied Nutrition (CFSAN) CFSAN Dashboard: In FY14, the Office of Nutrition, Labeling and Dietary Supplements completed 100% of its New Dietary Ingredient (NDI) notification reviews and new/reformulated infant formula notification reviews within their targeted timeframes. Center for Veterinary Medicine (CVM) CVM Dashboard: In FY14, the Office of New Animal Drug Evaluation met 100% of their targeted timeframes for their Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA) related performance measures. Office of International Programs (OIP) OIP Dashboard: During FY14, 259 inspections were completed by in-country investigators and detailees, exceeding the FY13 total by 79 inspections. Office of Regulatory Affairs (ORA) ORA Dashboard: During FY14, the number of state, local and tribal regulatory agencies in the U.S. and its Territories enrolled in the draft Voluntary National Retail Food Regulatory Program Standards increased by 60.  The Program Standards are designed to help retail food regulatory programs enhance the services they provide to the public and provide a means of recognition for those programs that meet these standards. January 2015 Upcoming Performance Data Updates Center for Devices and Radiological Health (CDRH) Center for Drug Evaluation and Research (CDER) Office of the Commissioner (OC) Administrative Offices FDA-TRACK is an agency-wide performance management system that monitors FDA programs through key performance measures and projects. These measures and projects are updated quarterly. Subscriber Services: Manage Preferences  |  Unsubscribe  |  Help with this service Stay Connected:   This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420