According to FDA, the goal of its regulatory science initiative is to develop and apply the best available scientific data, knowledge, methods, and tools to reduce uncertainty and make regulatory decisions more efficient and consistent. In doing so, the agency seeks to ensure public access to products that are manufactured or processed in a high quality manner and monitored to ensure safety and quality during real-world use. FDA’s 2011 strategic plan identified eight priority areas for regulatory science, of which seven related to medical products where the agency determined that new or enhanced engagement is essential to the continued success of the agency’s public health and regulatory mission. The agency then added an additional priority area related to global product safety in 2013. (See table 1.) FDA conducts work to advance regulatory science through intramural research and extramural collaborations, such as collaboration with other government agencies, academia, industry, patient organizations, professional associations, and other stakeholders. Targeted funding for regulatory science at FDA comes from a number of centers and offices, including the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiologic Health (CDRH), all within FDA’s Office of Medical Products and Tobacco. These centers are responsible for approving medical products (biologics, drugs, and devices, respectively) and monitoring their ongoing safety once approved. In addition, other offices support the regulatory mission of FDA, such as the Office of International Programs (OIP) in the Office of Global Regulatory Operations and Policy, and those under the Office of the Chief Scientist—whose mission is to provide strategic leadership, coordination and expertise—including the National Center for Toxicological Research (NCTR), the Office of Counterterrorism and Emerging Threats (OCET), the Office of Minority Health (OMH), the Office of Regulatory Science and Innovation (ORSI), and the Office of Women’s Health (OWH). (See fig. 1.) Additional broad regulatory science efforts may occur within these centers and offices as well as others at FDA. FDA does not have measurable goals, such as targets and time frames, to assess its progress in advancing regulatory science. Further, FDA does not consistently track information on center and office funding decisions for each FDA priority area, leaving it without important information needed to conduct strategic planning on the agency’s regulatory science priorities. FDA’s 2011 and 2013 strategic planning documents do not identify measurable goals, such as targets and time frames, for assessing progress in regulatory science. For example, the 2013 strategic planning document states that FDA will measure progress by enumerating and describing product-specific advisory committees and staff training opportunities related to the priority areas. However, the document neither sets any targets or time frames, nor establishes further outcome-based measures for what FDA hopes to achieve for either a given priority area or regulatory science in general. Likewise, FDA’s 2011 strategic planning document presents strategies for addressing the priority areas, but the document does not include measurable goals within these strategies. For example, it indicates that addressing the toxicology priority area would involve developing human and animal models to predict adverse responses, but it does not provide the number of models FDA intends to develop or the adverse responses for which the models are intended. FDA’s lack of specific measurable goals is reflected in the progress report that it completed for FDASIA. In that report, FDA includes examples of achievements but it does not specify overall results, such as the number of tests and technologies developed for the efficacy and safety of medical products, which the 2013 planning document indicated would help the manufacturing and quality priority area. In addition, FDA generally did not link the categories that it used to measure the adoption of regulatory science to a specific priority area. Specifically, in the progress report, only four of the eleven categories are linked to the FDA priority areas that they address. For example, while FDA reported one or more related FDA priority area for each guidance document included in the progress report, it did not provide the same information for the reported training examples or the projects included in the Drug Development Tool Qualification programs. According to our work on leading practices for strategic planning, an agency’s strategic goals should explain what results are expected from the agency and when to expect those results. It is also critical that the strategic planning documents describing these goals include specific actions and implementation schedules for how the agency is to achieve these goals. Without measurable goals, clear targets, and implementation time frames, FDA cannot provide a complete assessment of progress made in the regulatory science areas it has designated as priorities. According to FDA officials, it is difficult to measure the progress made in the priority areas because the priority areas are very broad and the underlying science is continually changing. Furthermore, the adoption of discoveries from regulatory science research can take years. Because the priority areas are managed across multiple organizational units, they are not being overseen by a specific center or office. However, we have previously recognized that while measuring the performance of science- related projects can be difficult, science-related agencies like FDA should still have clearly established goals. One of the centers that targets funding at regulatory science has a plan to track the progress of its regulatory science activities, but this plan does not include measurable goals that could be used to assess progress. Specifically, CDRH officials told us the center has drafted a logic model to identify and track the short- and long-term outcomes of funds it spends on regulatory science research. The center expects the model to be finalized in 2017. However, the current draft does not include measurable goals to assess progress. In addition, officials from most of the other centers and offices that obligated funds targeted at regulatory science activities in fiscal years 2010 through 2014 told us they are not developing such a model. One office also stated that the CDRH model may not be applicable to their work and that they may not have the resources needed to customize and implement such a model. In another effort, FDA officials indicated that the agency recently initiated internal discussions primarily to share information, and if feasible and desired, harmonize best practices within the agency. FDA officials also said that this group would discuss evaluation strategies and processes and perhaps eventually arrive at a common FDA approach to thinking about research outcomes and impact. This group first met in October 2015 to discuss current efforts, and FDA officials reported in April 2016 that it is still in the early stages of sharing information. FDA does not have the information necessary to track funding and conduct strategic planning agency-wide for its regulatory science priorities because most of the centers and offices did not collect information on the FDA priority areas that were addressed by the projects they funded. As a result, information on funding for each priority area is generally not readily available and therefore the majority of these centers and offices had to retrospectively assign FDA priority areas to each project at the time of our review. Six centers and offices—CDRH, NCTR, OCET, OIP, OMH, and OWH—fund regulatory science projects that address multiple FDA priority areas, but generally did not collect information about how funds are distributed across those priority areas. All six had to retrospectively identify associated FDA priority areas for our review. For example, while CDRH and NCTR collect some information about research priorities for the projects they fund, the information they collect does not fully align with the FDA priority areas. Specifically, CDRH collects information on its own set of priorities and NCTR collects information on FDA goals. While this information is partially aligned with the FDA priority areas, there is not a one-to-one correspondence, thus information on FDA priority areas is not readily available. According to NCTR officials, they began capturing information on the FDA priority areas in 2016. Further, OMH asks researchers to identify the unmet regulatory science need that their proposed research addresses, but the researchers are not asked to identify specific FDA priority areas. In addition, OCET and OIP officials told us that all of their funded projects are related to one FDA priority area, and therefore they do not collect information about other priority areas. However, there is no guarantee they will not fund projects related to other priority areas in the future. Further, while OIP told us they focus on just the FDA priority area global product safety, the data they provided for our review also identified an additional priority area, information sciences, as an FDA priority area being addressed by some of their projects. Three offices, CBER, CDER, and ORSI, collect some information on the FDA priority areas addressed by their targeted projects. CBER and CDER have not collected this information at the time of funding. Rather, CBER asks researchers to provide it as part of required annual reports and CDER officials indicated that CDER has made a similar request of researchers since 2012. Officials from both CBER and CDER said that in the near future their centers plan to track the FDA priority areas at the time projects are proposed for funding. ORSI asks researchers to identify FDA priority areas for its broad agency announcements, which are competitive funding announcements for extramural research programs and accounted for 21 percent of ORSI’s funding for the projects that we reviewed. ORSI does not ask this of researchers applying for its other regulatory science funding programs, although the announcements for the intramural grants state that the proposals should align with one or more of the eight original priority areas. For these other funding programs, ORSI confirms that a project proposal is related to regulatory science, but does not document any specific FDA priority area for that project. While each center or office may be funding projects that are generally consistent with the priority areas that FDA established, without consistent information from each center or office detailing those connections, the agency is not able to examine obligations across specific priority areas. Standards for internal control in the federal government state that complete and accurate data are needed to make operating decisions and to allocate resources. In addition, to ensure program goals are met, our work encourages agencies to manage efforts that cut across the agency.