FDA is responsible for ensuring the safety of food and medical products marketed in the United States. FDA has opened overseas offices to assist it in the oversight of products manufactured overseas. While FDA’s overseas offices have only recently opened, other federal agencies have long- standing overseas offices and, in previous work, we have identified strategic and workforce planning as important in managing these offices. FDA is responsible for ensuring that products marketed in the United States meet the same statutory and regulatory requirements, whether they are produced in the United States or a foreign country. FDA also works with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements. FDA’s responsibilities for overseeing the safety of imported products are divided among its centers and offices. FDA’s six regulatory centers are each responsible for the regulation of specific types of products. In addition, the Office of Regulatory Affairs (ORA) performs fieldwork, such as inspecting foreign establishments and examining products at the U.S. border, on behalf of all the product centers to promote compliance with FDA requirements and the applicable laws. To enhance FDA’s activities in this regard, the centers and ORA also engage with foreign regulators and industry through a variety of activities, such as conducting and attending training workshops. In addition, each center and ORA has staff dedicated to managing these international activities. Responsibility for leading, managing, and coordinating all of FDA’s international activities and its overseas offices lies with the Office of International Programs (OIP), within the Office of the Commissioner. (See fig. 1) FDA, including OIP, has historically had staff based only in the United States. OIP engages with international health and regulatory partners on a variety of issues, including holding bilateral meetings, establishing confidentiality agreements with regulatory counterparts for sharing information on regulated products, and holding meetings to harmonize FDA and international regulatory requirements. FDA developed a proposal to establish the overseas offices in May 2008. The stated mission of the offices is to engage with foreign stakeholders to develop information that FDA officials can use to make better decisions about products manufactured in foreign countries for the U.S. market. FDA stated that establishing relationships with foreign stakeholders and gathering information are important responses to globalization, in part because the agency is not able to inspect all of the foreign establishments that manufacture products for the U.S. market. During this planning, FDA identified several broad categories of activities that would serve as the initial focus for the offices, with the expectation that they would evolve as OIP and the offices gained experience. These activities included (1) establishing relationships with U.S. agencies located overseas and foreign stakeholders, including regulatory counterparts and industry; (2) gathering better information locally on product manufacturing and transport to U.S. ports; (3) improving FDA’s capacity to conduct foreign inspections; and (4) providing assistance to build the capacity of counterpart agencies to better assure the safety of the products manufactured and exported from their countries. As of July 2010, most of the offices had opened overseas, and each of these had posts in multiple locations. (See fig. 2.) However, the Middle East Office staff continued to work in the United States while FDA was in the process of finalizing plans to locate the office overseas. Also, as of July 2010, the Europe Office was planning to open its post in Parma, Italy, by late fall 2010. The first FDA staff member was deployed overseas in November 2008, to the China Office, and most staff arrived overseas in the middle of 2009. FDA budgeted $29.9 million for the overseas offices in fiscal year 2009. For fiscal year 2010, the agency increased its budget for the overseas offices by $1 million, bringing the year’s total to $30.9 million. All staffing and administrative costs associated with the offices are included in these budgeted amounts. In addition to the regions covered by the overseas offices, OIP has domestic offices that cover other regions of the world, such as its Africa and Asia Office. FDA officials said it was important to staff the overseas offices with experienced personnel who could represent the agency and speak on its behalf in foreign countries. As of July 2010, FDA had a total of 42 staff assigned to the overseas offices. Of these, FDA had posted 24 staff overseas; planned to assign 1 person to Parma, Italy by fall 2010; had 3 staff for the Middle East Office, who were still working in the United States; and had 14 locally employed staff in India, China, and Latin America, some of whom have technical expertise, while others focus on administrative issues. Each office has a director in that country or region to whom all staff members report. The offices also all have technical experts responsible for engaging with foreign stakeholders and gathering information on food or medical products. In China and India, FDA also placed investigators, who conduct inspections. Like other overseas staff, the investigators are part of OIP for administrative purposes, but decisions regarding which establishments to inspect are made by ORA, which receives input on this from the centers. FDA officials stated that they did not assign investigators to Latin America because U.S.-based investigators can gain access to establishments in that region more quickly than in China or India. OIP staff in the United States also assist the overseas offices. FDA staff agreed to be posted overseas for an initial 2-year rotation. The Department of Health and Human Services (HHS) requires that its overseas staff commit to rotations of no more than 2 years per tour. However, they have the option to renew up to two times, for a total of 6 years in one country. In addition, HHS requires that staff spend a total of no more than 8 years overseas before returning to the United States for at least 1 year. (See app. II for more information on the development and structure of FDA’s overseas offices.) Strategic planning is utilized by agencies to manage their programs more effectively by clearly establishing goals and objectives and describing how program activities can serve those goals. Strategic planning can help agencies develop strategies to address current and future management challenges. In our prior work, we have identified a variety of leading practices for successful strategic planning. One of these practices is the development of a set of results-oriented performance measures. Agencies use performance measures to help evaluate program performance, demonstrate progress in achieving results, balance competing priorities, and inform decision making. Such results-oriented performance measures should, whenever possible, demonstrate a program’s contributions toward the long-term outcomes, or the results the agency expects a program to achieve. Given FDA’s mission to ensure the safety of food and medical products, we have previously noted that the agency’s long-term outcomes should focus on public health. Agencies can show their interim progress and contributions toward long-term outcomes using short-term and intermediate goals and measures. When long-term outcomes may be influenced by multiple agency programs and external factors, short-term and intermediate measures can also demonstrate a program’s specific contribution to a long-term outcome. In addition, workforce planning is utilized by agencies to align their workforce with current and future program needs and develop long-term strategies for recruiting, training, and retaining staff. Approaches to such planning can vary with each agency’s particular needs and mission, but should share certain principles, such as the identification of skills and competencies to fill critical workforce gaps and the strategies needed to recruit them. Workforce planning, in essence, helps agencies think strategically about how to put the right people in the right jobs at the right time. In a February 2010 report, we noted that FDA was not fully utilizing practices for effective strategic and workforce planning. We stated that most of FDA’s established performance measures were not results- oriented as they did not focus on the actual public health outcomes of FDA’s work. We also stated that FDA’s internal coordination between its centers and offices was one of the major management challenges facing the agency. We recommended, and FDA agreed, that the agency issue an up-to-date strategic workforce plan, make its performance measures more results-oriented, and more clearly align center and office program activities to FDA’s strategic goals. We have also previously reported on the importance of strategic and workforce planning for other federal agencies managing offices overseas. For example, in 2002, the U.S. Customs Service posted officials at foreign ports to screen cargo containers. We noted that long-term program success would require strategic plans that clearly establish the program’s goals and objectives, results-oriented performance measures, and a workforce plan. We have also noted challenges faced by other federal agencies with long-standing offices overseas. In our review of workforce planning by CDC, an agency within HHS that has 270 U.S. and 1,400 locally employed staff overseas, we noted that the agency has faced difficulties hiring and retaining staff posted overseas due, in part, to a lengthy hiring process and limited opportunities for promotion. In addition, we have previously reported on the Department of State’s challenges staffing qualified personnel to hardship locations overseas, which the agency defines as locations where differential pay incentives are provided to compensate staff for the severity or difficulty of the local conditions. FDA’s overseas offices are establishing relationships with foreign stakeholders and U.S. federal agencies located overseas, gathering information to assist regulatory decision making, conducting establishment inspections, and providing capacity building to foreign stakeholders in an effort to help ensure the safety of imported products. Though FDA officials cite specific benefits associated with the overseas offices, overseas officials report facing a variety of challenges that may limit their ability to enhance agency oversight. One of the primary activities for the newly established offices, after their initial set-up, has been to develop relationships with foreign stakeholders and other U.S. federal agencies located overseas. FDA has identified building relationships as a key step towards better understanding foreign regulatory processes, identifying possible collaborative activities, sharing information, and building capacity.