As the central office for NIH, OD establishes NIH policy and broad themes for the agency to pursue, such as ensuring a sustainable scientific workforce, based on national needs and scientific opportunities. In addition, the OD is responsible for coordinating the programs and activities that span NIH components, particularly research initiatives and issues involving more than 1 of the 27 ICs. OD is also responsible for ensuring that scientifically-based strategic planning is implemented in support of research priorities, and that NIH’s resources are sufficiently allocated for research projects identified in strategic plans. NIH conducts and sponsors biomedical research through its ICs, each of which is charged with a specific mission. ICs’ missions generally focus on a specific disease, a particular organ, or a stage in life, such as childhood or old age. The ICs support, plan, and manage their own research programs in keeping with OD policy and priorities. Within an IC, there can be a number of offices, centers, and divisions that focus on specific aspects of the IC’s mission. For example, NCI has a Division of Cancer Epidemiology and Genetics, as well as a Division of Cancer Treatment and Diagnosis. ICs accomplish their missions chiefly through extramural and intramural research. Extramural research accounted for more than 80 percent of NIH’s budget in fiscal year 2012. This research is conducted at 2,500 universities, medical schools, research organizations, and companies who are awarded extramural research grants or extramural research and development contracts through NIH’s competitive process. Twenty-four of the 27 ICs fund extramural research projects, and these ICs make final decisions on which extramural research projects to fund following a standard peer review process.what NIH considers “unsolicited” research and research training projects for which applications are submitted in response to broad funding opportunity announcements that span the breadth of the NIH mission. In addition, to encourage and stimulate research and the submission of research applications in specific areas, many ICs will issue solicitations that are more narrow in scope in the form of , requests for applications, and requests for proposals. When reviewing applications for extramural research projects, NIH follows a process of peer review, established by law.sequential levels of peer review. According to NIH officials, the first level involves panels of experts to assess the scientific merit of the proposed science. The second level involves panels of experts and leaders of non- science fields including patient advocates that, in addition to scientific merit, also consider the IC’s mission and strategic plan goals, public health needs, scientific opportunities, and portfolio balance. After NIH’s Most IC extramural funding is provided for This peer review system has two peer review process is concluded, IC directors make extramural funding decisions. Intramural research, which accounts for approximately 10 percent of NIH’s budget, is conducted by NIH scientists in NIH laboratories. This includes about 5,300 scientists and technical support staff who are employees, and another 5,000 young scientists at various stages of research training who come to NIH for a few years to work as non- employee trainees, including 3,800 postdoctoral fellows. All but 3 of the 27 ICs have an intramural research program, but the size, structure, and activities of the programs vary greatly. In January 2007, Congress directed NIH to establish an electronic system to categorize the research grants and activities of OD and all the ICs. In response, NIH created RCDC. Implemented in February 2008, RCDC uses a computer-based text-mining tool that recognizes words and phrases in project descriptions in order to assign NIH projects to at least one of 235 categories of diseases, conditions, and research areas that were developed for reporting to Congress and the public. NIH officials said that RCDC serves as NIH’s primary computerized reporting process to categorize its research funding. The system includes reporting tools that can be used to generate publically-available, web-based reports on total funding amounts for the research projects related to each RCDC category. Individual ICs at NIH set their own research priorities, and we found that the five selected ICs we reviewed did so considering similar factors and using various priority-setting approaches. Officials at all five of the ICs stated that their mission and available appropriations inform priority setting approaches. Officials at one IC noted that their IC’s mission provides context related to why the IC was developed initially and insight into the emerging areas of research. Officials stated that an IC’s appropriations not only set funding parameters, but may also influence priority setting if the appropriations include mandated spending by Congress for a specific disease. Some IC officials noted that because the costs of potential research projects generally exceed the available appropriation, the ICs generally must prioritize among research projects. In priority setting, IC officials also reported taking into consideration scientific needs and opportunities, gaps in funded research, the burden of disease in a population, and public health need, such as an emerging public health threat that needs to be addressed, like influenza. While individual ICs used different approaches to priority setting, all five selected ICs we reviewed reported using some combination of strategic planning, annual planning, and periodic review and evaluation of their research portfolios as part of their approach to priority setting. Strategic planning: All five ICs we interviewed developed strategic plans—consistent with law and NIH policy—to set priorities and goals for research funding. According to officials at selected ICs, the development of these plans is guided by various processes at each IC. Although these processes vary by IC, they include an opportunity to solicit input from stakeholders, including the scientific community, as well as review by IC staff and leadership. Examples of IC strategic planning activities include the following: NIAID used a framework organized around various scientific areas that encompassed its research to develop the strategic plans it published in 2000, 2008, and 2013. When developing the plans, NIAID convened groups of NIAID subject matter experts for each scientific area and considered input offered by external organizations and scientists to guide the process. The experts deliberated priorities identified for each scientific area and suggested revisions to the draft plan. For example, officials stated that NIAID has seen a shift in the emphasis on research efforts related to human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) from studying single-drug therapy to the current focus on finding improved HIV treatments and tools for preventing infection. This new focus was then incorporated as part of the strategic plan published in 2013. Draft strategic plans were reviewed by the NIAID Advisory Council. After a final review by the director of NIAID, the finalized plans were published on NIAID’s web site. NHLBI officials said that, as of November 2013, the IC was revising the strategic plan it published in 2007 and part of its strategic planning process under the direction of a new director appointed in 2012. As part of the revised process, NHLBI created the Strategic Investment and Management Steering Committee that will help establish strategic goals as well as advise leadership about whether proposed activities are consistent with the IC’s strategic plan. Officials stated that the strategic planning process will engage both NHLBI scientific staff as well as the larger extramural community because they are knowledgeable about research gaps within their respective fields. Further, NHLBI officials stated that input provided by stakeholders also helps to inform development of disease-specific planning documents, such as one for asthma and another on sleep disorders. Annual planning activities: In addition to the development of strategic plans, some IC officials we interviewed told us that they conduct annual planning activities as a part of their process to set priorities for research funding. They told us that these annual planning activities address ongoing and emerging needs. While the processes vary across the ICs in terms of the level of structure and formality, officials stated that during the annual planning process these ICs typically consider factors such as scientific needs, research gaps, scientific opportunities, public health needs, and the need to balance the various types of research conducted to address all areas of the mission. Examples of annual planning activities include the following: NIAID uses an annual planning process to develop and select initiatives that address special needs, gaps, and opportunities in relevant research areas. According to NIAID officials, these initiatives are developed through a structured process centered around two primary events—the annual Summer Policy Retreat and the annual Winter Program Review. NIAID staff also review their scientific areas for the latest information on burden of illness and state of scientific progress, which is used to inform the development of future initiatives. According to agency officials, NIAID staff use this information, as well as input from the scientific community, to prepare and present a concept of an initiative to NIAID’s National Advisory Council, which reviews, comments on, and decides whether to approve the initiative. Once an initiative has been approved, NIAID solicits research applications through a request for application, a program announcement, or a request for proposal. NIDDK uses an annual process that requires NIDDK scientific program staff within the IC’s divisions to review the research portfolio and to identify research opportunities. According to NIDDK, this effort is informed by a number of factors, such as ongoing input from the extramural research and health advocacy communities and recent research advances. They said that each division then presents initiative concepts built on these research opportunities at NIDDK senior leadership meetings. The NIDDK director prioritizes the initiative concepts and determines which will move forward based on consideration of merit and other factors. These concepts go through a clearance process, including review from the NIDDK National Advisory Council. NIDDK develops funding opportunity announcements based on these identified research opportunities, such as requests for application that address specific scientific questions or diseases. In addition, NIDDK conducts divisional planning and prioritization activities during monthly meetings, retreats, and other activities, including consideration of opportunities for funds to support targeted emphasis areas.