Work with the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) to develop a pilot to identify firms manufacturing and shipping over-the-counter and/or active pharmaceutical ingredients (OTC/API) drugs to the U.S., obtain reliable information about their products, processes and inspect them as needed to determine if they are operating in compliance with cGMPs. Using a focused approach on those OTC manufacturing firms never visited by FDA investigators, the India Office will conduct telephonic Official Establishment Inventory (OEI) clean-up calls to provide HQ (CDER & ORA) with information, enabling up-to-date registration and drug listing information to increase the Agency’s understanding about the manufacturing processes and capacities of these firms within India. The results of these OEI questionnaires will be entered into FDA databases and help target limited FDA inspectional resources towards the most at-risk facilities and help to increase FDA's understanding of India’s OTC manufacturing compliance. These results will enable HQ to have a broader understanding of the risk posed by OTC drug manufacturers in India that export these products to the U.S.OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.COMPLETEDON TRACKA. Develop proposal9/1/2010Completed9/1/2010B. Discuss proposal with CDER & ORA to obtain consensus agreement9/15/2010Completed9/15/2010C. Develop a screening protocol and reporting mechanism2/1/2011Completed10/1/2010D. Define investigation plan and schedule for FY11/FY123/1/2011Completed10/13/2010E. Initiate telephone questionnaires according to plan3/31/2011Completed3/15/2011F. Jointly review collected data to ascertain firms to be inspected6/15/2011<i>(10/28/2011</i>Completed10/28/2011G. Begin inspecting firms6/15/2011<i>(10/28/2011</i>Completed10/28/2011H. Review with CDER Compliance data collected after 15 firms called6/30/2011Completed7/14/2011I. Review data collected to ascertain process to update Center’s OEI database6/30/2011Completed8/10/2011J. Complete 30 OEI questionnaires9/30/2011Completed9/30/2011K. Complete surveillance inspections of OTC firms based on the agency’s risk model in questionnaires completed9/30/2011Completed9/30/2011L. Complete 100 OEI questionnaires (1)N/AN/AN/A(1) Milestone was not completed while this project was tracked in FDA-TRACK.http://www.fda.gov/AboutFDA/Transparency/track/ucm206185.htmFDA-TRACK Office of International Programs Dashboard