Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century - DRAFT 9/29/2010The purpose of this document is to outline FDA’s strategic intentions and plans for the next five years (2011 – 2015). This document is intended to communicate the Commissioner’s key priorities, including cross-cutting strategic priorities, program-specific strategic goals, and long-term objectives. These goals and objectives provide the vehicle for focusing agency efforts to achieve FDA’s public health mission and to fulfill our role in supporting the larger mission and strategic goals of HHS. Crosswalks that highlight the relationship between FDA and HHS strategic goals and Healthy People 2020 Objectives can be found in Appendix A and Appendix B, respectively.Today, FDA is facing a critical set of public health challenges; challenges brought about by the unique demands of the 21st century. Science and technology are changing our world in dramatic ways; we are seeing an explosion of knowledge and capabilities emerging from many domains of research and from around the globe. In addition, we live in an increasingly globalized world, which has made ensuring the safety of food and drugs for the American people a global endeavor that integrates products and people across borders. It is clear that, today, FDA’s job is fundamentally different—and far more complex—than it was even a few years ago. Although it will not be easy, we will address these challenges and aim to fulfill our mission by embracing innovation and actively pursuing partnerships with federal, state, and local agencies; international authorities; academia; non-government organizations; and the private sector. The Food and Drug Administration (FDA) is seeking public comment on the draft Strategic Priorities FY 2011-2015 below. FDA has identified these strategic priorities and goals that will guide its efforts to achieve its public health mission. FDA is seeking public comment to help further refine these priorities and goals. Electronic comments should be submitted to www.regulations.gov.Food and Drug AdministrationFDA_85a3d7be-fbea-11df-a90e-29337a64ea2aThe U.S. Food and Drug Administration (FDA) is the agency within the U.S. Department of Health and Human Services (HHS) responsible for ensuring the safety and effectiveness of products that account for about 20 cents of every dollar spent by American consumers each year — products that touch the lives of every American every day. These include human and animal drugs, 80 percent of the food supply, biological products, medical devices, cosmetics, radiation-emitting devices, and tobacco products. Ensuring a safe and nutritious food supply and safe, effective, and innovative medical products requires a strong infrastructure and a dedicated workforce. FDA’s seven product and research centers and two major offices are staffed by more than 12,000 employees[1] around the world who work together to fulfill FDA’s fundamental public health mission: to promote and protect the health of the American people. FDA’s primary responsibility is to protect the American people from unsafe or mislabeled food, drugs, and other medical products and to make sure consumers have access to accurate, science-based information about the products they need and rely on every day. The agency also guides and oversees the development and availability of new medical products and new food products that harness the latest advances in science and technology to improve the health and well-being of American consumers.Margaret A. Hamburg, M.D.Commissioner of Food and Drugs FDA is dedicated to world-class excellence as a science-based regulatory agency with a public health mission. We aim to provide effective and innovative leadership—both domestically and internationally—to protect health, prevent illness, prolong life, and promote wellness._85a3deee-fbea-11df-a90e-29337a64ea2aFDA is charged with protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of foods, cosmetics, and radiation-emitting products; and regulating tobacco products. Specifically, FDA is responsible for advancing the public health by: Helping to speed innovations that make medicines and foods safer and more effective; Providing the public with the accurate, science-based information they need to use medicines and foods to improve their health; Regulating the manufacture, marketing, and distribution of tobacco products to protect the public and reduce tobacco use by minors; Addressing the Nation’s counterterrorism capability and ensuring the security of the supply of foods and medical products._85a3e0d8-fbea-11df-a90e-29337a64ea2aScience-Based Decision MakingFDA has a solemn responsibility to protect and promote the public health. This responsibility requires that FDA base its policies, regulations, and enforcement decisions on sound science. For our decisions to have credibility, we must continue to seek the most current scientific understanding by supporting the work of agency scientists and scientific advisory committees. Strengthening FDA as a public health agency requires a culture that encourages scientific exchange, respects alternative viewpoints along the path of decision making, and protects the integrity of its scientific review processes. Innovation/CollaborationWe have gained substantial knowledge through more than 100 years of building regulatory programs to ensure the safety and integrity of foods, medical products, and cosmetics. But we also recognize that the promises of science and technology require us to seek new approaches to performing our mission, particularly because competition for scarce public resources makes it difficult to simply scale-up past solutions to meet rising demands. By investing in the field of regulatory science, FDA is fostering innovations that we hope will enhance our effectiveness and productivity for years to come. We cannot achieve our vision and address the challenges of the 21st century by working alone. To make rapid and efficient improvements in public health and drive innovation, we must harness the best ideas from a broad range of stakeholders and leverage resources through collaboration with other federal, state, and local regulatory and public health agencies; non-government organizations; consumer and patient organizations; academic medical centers and research universities; the private sector; and the public. For example, FDA is collaborating with state and local food safety authorities to develop standards and training that will establish a more integrated and coordinated national food safety system. The Critical Path Initiative (CPI), an agency effort to modernize the sciences for developing, evaluating, manufacturing, and using FDA-regulated products, has long recognized the importance of collaboration to leverage critical expertise and resources in driving scientific innovation. Building on CPI, FDA’s Advancing Regulatory Science Initiative recently established a formal collaboration with the National Institutes of Health to advance regulatory science and build the capacity needed to ensure the safety and effectiveness of innovative new products and technologies. TransparencyOne of the most pressing FDA-wide goals is promoting transparency in FDA’s operations, activities, processes, and decision making, as well as making information and data available in user-friendly formats while also protecting confidential and proprietary information. Transparency can enhance FDA’s work and — more important — increase the trust and confidence of employees, policymakers, stakeholders, and the public. In response to a Presidential memorandum on transparency and open government, FDA established a Transparency Task Force to develop and implement recommendations for making useful and understandable information about FDA activities and decision making more readily available to the public in a timely and user-friendly manner. FDA will continue to engage the public in identifying ways to improve transparency at the agency.Accountability Consistent with our strong commitment to public service, we will maintain the highest degree of individual and professional accountability in the conduct of our work. Currently, we set measurable goals and openly monitor performance within the agency to make sure we continue to meet our commitments. We hold staff members and executives accountable for achieving organizational goals through annual performance plans that are aligned with our strategic priorities. And we monitor program performance by holding quarterly meetings with program managers and agency executives and sharing program performance data with the public through a new initiative called FDA-TRACK. We understand the importance of FDA’s work to the health and welfare of our nation, and we will continue to hold ourselves accountable for delivering on that responsibility. Cross-Cutting Strategic PrioritiesSelect four cross-cutting areas to serve as strategic priorities over the next five years._85a3e268-fbea-11df-a90e-29337a64ea2a2.0CommissionerThe Commissioner has selected four cross-cutting areas to serve as strategic priorities over the next five years. These include efforts to: 1) Advance Regulatory Science and Innovation; 2) Strengthen the Safety and Integrity of the Global Supply Chain; 3) Strengthen Compliance and Enforcement Activities to Support Public Health; and 4) Address the Unmet Public Health Needs of Special Populations. In addition to the four priorities ... “Manage for Operational Excellence and Accountability” is another essential cross-cutting area, which is one of the four strategic goals that will be addressed in the next section.Regulatory Science and InnovationAdvance Regulatory Science and Innovation_85a3e808-fbea-11df-a90e-29337a64ea2a2.1Before FDA can make a decision to approve a new product, we must determine what it means for that product to be safe and effective. We must develop the appropriate standards and guidance for making approval decisions. The science, the tools, and the standards we need to assess and evaluate the efficacy, quality, and performance of a food or medical product form what we call regulatory science. A robust regulatory science program will strengthen biomedical advances, food safety, and many other aspects of FDA’s work. Advances in regulatory science are critical to effectively translate cutting-edge developments in science and technology into promising products and therapies for the Americans who need them. Americans cannot take full advantage of the breakneck speed of biomedical research unless we also achieve innovations in regulatory science. Just as biomedical research has evolved over the past few decades, regulatory science must also evolve in important and powerful ways. Advancements in regulatory science also will help to prevent foodborne illnesses and, when they occur, to identify the source of contamination quickly, limiting the scope of the outbreak. These advances will benefit every American by increasing the accuracy and efficiency of regulatory review and by reducing adverse health events, drug development costs, and the time-to-market for new medical technologies. Over the next five years, FDA will create and execute a strategic plan for expanding and modernizing the field of regulatory science within the agency and throughout the country. This plan will complement FDA’s National Center for Toxicological Research (NCTR) strategic plan, which focuses on advancing scientific approaches and tools critical for FDA to translate science into regulation and public health. At the same time, we will work to strengthen science as a whole within FDA. The agency charged with judging the safety and efficacy of drugs and other medical products—and monitoring the safety of those products as long as they are on the market—must possess a scientific capability equal to that task and become engaged in mission-critical fields of applied research, including systems biology, wireless healthcare devices, nanotechnology, medical imaging, robotics, cell- and tissue-based products, regenerative medicine, and combination products. In that spirit, FDA has already begun identifying strategies to recruit and retain outstanding scientists and will work collaboratively with other agencies, industry, and academia to define and advance science in high-priority areas critical to the health of individuals, the national healthcare system and global public health. The strategic plan for advancing regulatory science will pave the way for a range of regulatory activities, including setting standards for products that address unmet public health needs, identifying and mitigating the spread of disease using informatics, modernizing toxicology and hazard assessments, protecting the food supply, and regulating tobacco. The plan will enable FDA to leverage the latest in science and technology, along with FDA know-how, to bring a new generation of medical products—personalized therapies, stem-cell therapies, and genetic diagnostics, among others—to the American people.Scientific Approaches and ToolsSupport the advancement of new scientific approaches and tools to promote efficient regulatory decisions and individualized public-health decisions through the Advancing Scientific Approaches and Tools Initiative (ASATI)._85a3ea60-fbea-11df-a90e-29337a64ea2a2.1.1Signature Initiative: ADVANCING SCIENTIFIC APPROACHES AND TOOLS INITIATIVE - FDA supports the advancement of new scientific approaches and tools to promote efficient regulatory decisions and individualized public-health decisions through the Advancing Scientific Approaches and Tools Initiative (ASATI). ASATI’s main objective is to research, develop, and validate new approaches and tools that will help identify consumer risks and benefits to medical products and foods. In support of this initiative, FDA’s National Center for Toxicological Research (NCTR) is developing and validating biomarkers and biometric methods to aid in the effective characterization of consumer risks and benefits, including those related to developmental exposure. In addition, NCTR is continuing to research the utilization of computational approaches and new technologies to evaluate human health outcomes, as well as new methods to identify, quantify, and characterize potential microbial and chemical contaminants in foods, feeds, and other FDA-regulated products. In FY 2010, NCTR initiated research to identify a systems-biology approach (including genomic, proteomic, and metabolomic approaches) for prevention-oriented biomarker analyses. In addition, NCTR initiated research to find in silico (computer simulated) approaches for predictive toxicology to enhance product safety and decrease animal usage. Research also has focused on the identification and characterization of novel biomarkers that will help identify potential for obesity, diabetes, cardiovascular disease and neurodegeneration. Another important aspect of ASATI is the support that NCTR scientists provide to FDA’s regulatory activities by providing technical expertise, training, and consultation to FDA’s Product Center and ORA scientists. In addition, a major role of NCTR scientists is the training of regulatory scientists at all levels, both nationally and internationally to improve safety standards and promote public health.Global Supply ChainStrengthen the Safety and Integrity of the Global Supply Chain_85a3ec54-fbea-11df-a90e-29337a64ea2a2.2Today, maintaining the safety of America’s food and medical products is a serious challenge. Complex global supply chains, international trade, the foreign sourcing and manufacture of regulated products, and the increase in the volume and complexity of imported products have forced FDA to reevaluate its approach to supply-chain safety. We have seen the warning signs: contaminated heparin, melamine-tainted milk products, counterfeit glucose monitor test strips, to name just a few. Globalization presents a host of internal and external challenges to the design, development, manufacturing, and distribution of regulated food and medical products—challenges that impede the prevention, detection, intervention, and response to product safety. Challenges Presented by Globalization: * Increasing volume of imported products * Greater complexity in imported products * More foreign facilities supplying the United States * Incomplete regulatory information about supply chains * Patch work of foreign, federal, and state oversight of product safety * Greater opportunities for economic fraud * National security threats * Antiquated FDA law – relatively unchanged since 1906 * Workload that has outstripped FDA resources * Insufficient legal authorities and enforcement tools * Corporations lacking accountability * Current import regulatory system, an honor system FDA predicts that more than 20 million import lines of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry in Fiscal Year (FY) 2010, more than three times the number of imports 10 years ago. Today, there are more than 130,000 importers of record and about 300 ports of entry in the United States. The array of regulated products comes from 300,000-plus facilities in more than 150 different countries. The growing challenges of globalization have far outstripped the nation’s resources for inspection and quality monitoring, and the inability to maintain adequate oversight means potential risk to consumers grows every year. Addressing these challenges will require a paradigm shift — to a focus on prevention, on stopping threats before they ever become reality. The border must be viewed as a final checkpoint for preventive controls, rather than the primary line of defense against unsafe imports. FDA must require more—and better—information about product supply chains and monitor this information throughout the product life cycle, and regulatory standards must foster corporate responsibility to identify, protect, and control risks. Such an effort will entail more and better coordination among foreign, federal, and state counterparts as well as novel and updated enforcement tools. We must create a greater global safety net that consists of a global alliance of regulators, new authorities to allow for the creation of proactive tools for food safety, adequate funding to allow for more inspections, and updated systems (including IT support) to assist with the increased workload. These changes are essential if we are to protect product safety in a way that Americans expect and deserve.Analytical ToolsContinue to implement the Analytical Tools Initiative (ATI). _85a3f1f4-fbea-11df-a90e-29337a64ea2a2.2.1Signature Initiative: ANALYTICAL TOOLS INITIATIVE - FDA continues to implement the Analytical Tools Initiative (ATI), established to explore new or previously unused technologies for analysis and directed screening in the field and for rapid or high throughput analysis in the laboratory. The ATI was established to bridge the gap between industry/academia and FDA scientists on new technologies and applications to FDA-regulated products. The ATI’s main objective is to provide rapid analytical tools for field investigators and/or FDA scientists. In support of this initiative, FDA is assessing tools for the field investigator and analyst. Field deployable kits and instruments are being evaluated to incorporate into the “investigator’s toolbox” tools that can be used at the site of sample collection. Instruments for the laboratory, such as hand-held devices, are also being evaluated to enhance laboratory capacity and capability. In FY 2010, FDA is training field staff on the use of Counterfeit Detector 3 (CD3), a hand-held device for import personnel to detect suspected counterfeit drugs and/or packaging. FDA is also training field staff on the use of a portable X-ray Fluorescence (XRF) device capable of detecting toxic elements in imported products such as foods and dietary supplements. The focus of interest for toxic elements is primarily for the five elements Lead (Pb), Cadmium (Cd), Mercury (Hg), Arsenic (As), and Selenium (Se), although additional media and additional analyte targets may be identified in the future. Once training is completed, these devices will be deployed to investigators located at ports of entry.Public HealthStrengthen Compliance and Enforcement Activities to Support Public Health_85a3f528-fbea-11df-a90e-29337a64ea2a2.3To protect the public health and ensure that FDA-regulated and approved products are safe and effective, the agency must act swiftly and aggressively to guarantee effective enforcement of and compliance with FDA laws and regulations. FDA enforcement actions affect not only the manufacturing and distribution of foods, drugs, biologics, medical devices, tobacco, and cosmetics, but also their development and marketing. Enhancing FDA’s compliance and enforcement programs will strengthen the agency’s focus on preventing problems and responding rapidly when violations occur. FDA is implementing a number of new programs designed to sharpen the effectiveness and timeliness of its regulatory, compliance, and enforcement systems. The agency is establishing deadlines for industry to respond to significant inspection findings, which will enable FDA to take enforcement action more rapidly if a manufacturer has not corrected violations documented after an inspection. FDA will also be implementing processes to prioritize follow-up inspections after the agency has issued a Warning Letter, classified a major recall, or taken other significant enforcement actions. These processes will ensure that violative products are no longer available to the American public and that necessary corrective actions are taken to prevent harmful products from being manufactured and sold. Ensuring that products are safely manufactured, processed, and delivered to the American consumer will require the cooperation of a broad network of FDA field offices, local, state, and territorial regulatory authorities, and foreign government officials. In the next five years, FDA will work more closely with these regulatory and enforcement partners to share laboratory and enforcement data. When regulatory and enforcement partners are able to act more quickly than FDA, FDA will collaborate with them and encourage them to take the immediate action in response to violations; FDA will remain involved in enforcement and compliance actions by notifying the public about the violative products and helping ensure longer term corrections are instituted. This increased collaborative approach will enable faster identification of threats to the public health while strengthening our ability to determine the appropriate corrective actions that manufacturers must take to reduce the likelihood of harmful products being manufactured.Special PopulationsExpand Efforts to Meet the Needs of Special Populations_85a3f780-fbea-11df-a90e-29337a64ea2a2.4Special PopulationsWomenMinoritiesPediatric PopulationChildrenTherapeutic breakthroughs and clear and timely public health information should be available to all Americans. There are numerous challenges to achieving this goal. For example, historically, women and minorities have been underrepresented in clinical trials, making it difficult to assess whether a medical product will be safe and effective for them. Underrepresetation is also true for the pediatric population; because many medical products are tested only in adults, questions regarding dosing and side effects for children often go unanswered. Assuring that products are safe and effective for people with rare diseases is particularly challenging, because the patient populations are too small to support standard clinical trials. For these groups, there may be fewer—or riskier—available therapies. FDA is committed to reducing this risk through targeted scientific programs and culturally sensitive outreach efforts. As we entered the 21st century most therapies being used in children still had not been adequately studied in them. As a result of legislative research incentives and mandates, there had been 385 labeling changes with new pediatric information in the label as of June 2010. Over 15% of the studied products were shown not effective in children and 20% had new safety information specific for children identified. Despite this progress, much work remains to be done. Over the next five years we need to develop validated endpoints for neonates if we are to treat this vulnerable population with knowledge instead of guesses. We also need to explore why so many products that work in adults appear to not work in children—is it dosing or differences in pathophysiology? Additional efforts will focus on understanding the long term safety of products, including devices, used chronically in children. The limited number of children with certain conditions means pediatric trials require many sites and are global in nature. In efforts to ensure children are enrolled in scientifically and ethically sound trials, FDA will expand its collaboration with the European Medicines Agency, Japan, and Health Canada, and will establish liaisons for collaboration with Latin America. FDA will be supporting scientific advances in women’s health through grants for FDA and collaborative regulatory science research. Building on ongoing activities, we will also plan to host new internal and external scientific dialogues and workshops to identify gaps and opportunities in women’s health research. The challenges are not only scientific. FDA must make available targeted public health information that is appropriate for the target population. Language barriers create additional challenges. FDA is planning an array of targeted activities to meet these challenges. This year, FDA will create a new Office of Minority Health to address an array of challenges to reducing health disparities in the United States. With a new leader, reporting directly to the Commissioner, FDA will have a focal point for the ongoing and new activities to meet the public health needs of minority populations. FDA is already undertaking obesity prevention programs targeting minority populations. We are part of a coalition of Latino consumers and providers called "Latino Initiatives Committee Por Tu Familia," which plans educational workshops to promote healthy behaviors. FDA manages partnership agreements with national and community-based organizations to increase access to FDA health information for Hispanic Americans, Asian-Americans and Pacific Islanders, and Native Hawaiians. We are exploring additional partnerships to improve health literacy for underserved populations and to diversify options for FDA’s distribution of health information. FDA recognizes that communications must be adapted to meet the needs of many groups who differ with respect to literacy, language, culture, race/ethnicity, disability, and other factors. As part of FDA’s Strategic Plan for Risk Communication, FDA committed to specific actions designed to improve our capacity to effectively communicate with different populations. These include: training FDA staff on health literacy and basic risk communication principles, considerations, and applications; partnering with consumer and patient organizations to increase availability of FDA communications in a variety of languages and for literacy-challenged audiences; and regularly measuring plain language and appropriate reading level for audiences targeted by communications. Social media tools can help meet some of FDA’s communication challenge. We are planning to use social networks to create a virtual community of organizations and individuals to disseminate FDA science-based information on women’s health. We will also be collaborating with other government partners, to integrate FDA information on women’s health into their programs. FDA is committed to do its part to bring the best science and public health to all Americans.Rare DiseasesTake steps to meet the needs of patients with rare diseases_85a3fd84-fbea-11df-a90e-29337a64ea2a2.4.1Patients with Rare DiseasesSignature Initiative: SCIENTIFIC INNOVATION FOR RARE DISEASE THERAPIES - An estimated 6,000 rare diseases, most of which are serious or life-threatening, affect more than 25 million Americans. Because each disease, by definition, affects fewer than 200,000 Americans, market incentives may be insufficient to drive the investment needed to develop medical products to prevent, diagnose, and treat these conditions. Because the patient populations are small, product testing presents significant scientific challenges calling for innovative approaches. FDA has identified this issue as a priority and is taking steps to meet the needs of these patients. Perhaps our best known work to advance therapeutics for rare diseases is our orphan drug program. This program fosters clinical study of promising therapies, designates eligible orphan drugs, and confers marketing exclusivity and other benefits designed to spur product development. This important program anchors FDA’s efforts to meet the public health needs of people with rare diseases. We are working to build on this foundation. For example, FDA established two new expert review groups, the Rare Disease Review Group and the Neglected Disease Review Group, consisting of FDA staff scientists from an array of pre-clinical and clinical disciplines. These groups are currently evaluating FDA activities and will be recommending options to the FDA Commissioner for further supporting and facilitating the development and evaluation of medical products for these conditions. As part of this review, the groups will take into account the recommendations of an Institute of Medicine (IOM) study of national policy for rare disease research and related medical product regulation, due at the end of September 2010. In February 2010, FDA created a position of Associate Director for Rare Diseases in the Center for Drug Evaluation and Research (CDER), to help develop scientific and regulatory innovations for development and evaluation of new treatments for patients with rare diseases. Building on this new capacity, FDA is planning a series of scientific workshops to address important and difficult rare disease research issues and is developing a “rare disease database” to establish the natural history of rare diseases to assist with planning trials to test rare disease therapies. We are enhancing collaborations to increase transparency, share advice, and establish new programs with an array of public and private research and patient advocacy groups.Long-Term Objectives[Identify] Long-Term Objectives _85a400b8-fbea-11df-a90e-29337a64ea2a3Food Safety and NutritionAdvance Food Safety and Nutrition_85a4039c-fbea-11df-a90e-29337a64ea2a3.1FDA recognizes the need for a comprehensive food safety system from farm to table that is prevention-oriented and based on scientific and risk-based principles. A prevention-oriented food safety system will allow FDA to shift focus into ensuring systems are in place to prevent harm, rather than only reacting to harm once it has been identified. The recent findings of the President’s Food Safety Working Group identified three core principles required to transition to a modern and coordinated food safety system: prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery. For a food safety system to be effective, all involved must play their respective roles — from the agricultural producers to the food processors to the transporters, retailers, and consumers. And FDA must establish science-based preventive controls to achieve high rates of compliance both domestically and internationally and ensure adequate scientific capacity to support public health decision making. In support of this goal, FDA and HHS are working with Congress to enact legislation that will give FDA new authorities that are critical to improving the safety of the food supply. Advancing food safety and nutrition is and will continue to be a primary FDA focus. With the creation of the Office of Foods and the One Mission, One Program Initiative, we are unifying the FDA Foods Program and enhancing its ability to meet today’s great challenges and opportunities in food and feed safety, nutrition, and other critical areas. The FDA Food Program includes three major operating units — the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the foods-related activities of the Office of Regulatory Affairs (ORA). The Program also draws on the resources and expertise of FDA’s National Center for Toxicological Research (NCTR) and key Office of the Commissioner (OC) staff offices. The One Mission, One Program Initiative focuses on how these organizations can work together to implement the vision of an integrated, prevention-oriented, and risk-based food safety system. Desired Public Health Outcomes * Reduce illness, harm, and deaths from food and feed * Reduce the rates of chronic diseases associated with food by promoting consumer nutrition information and supporting consumption of a healthy diet by the U.S. population Food SupplyEnsure the Safety of the Food Supply from Farm to Table_85a40b12-fbea-11df-a90e-29337a64ea2a3.1.1FDA recognizes that to ensure the safety of foods and fulfill its public health mission, the agency must embrace new approaches. FDA will focus on building a prevention-oriented, science- and risk-based food safety system. The foundation of FDA’s approach is ensuring that preventive controls are in place, from production (or farm) through consumption (or table). The goal is to identify potential threats to the food supply and to counteract them before they harm American consumers. To ensure the safety of the food supply, FDA has aligned its priorities to three long-term objectives: 1) establishing science-based preventive controls throughout the farm to table continuum; 2) achieving high rates of compliance with preventive controls, both domestically and internationally; and 3) ensuring adequate scientific capacity to support public health decision making. Trends and Challenges FDA works to ensure that the nation’s food supply is safe, sanitary, wholesome, and accurately labeled and in doing so has seen a number of recent trends and challenges: Increased globalization and complexity of the food supply chain Critical gaps in the coverage of the food supply Declining resources for food safety activities Continually evolving technologies around and threats to the food supply Emerging food safety hazards Increased globalization and complexity of the food supply chain is a major challenge to ensuring the safety of imported products. Globalization is responsible for the ever-increasing volume and diversity of foods entering the United States. Currently, FDA has limited ability to monitor the safety of imported food and can only physically examine about 2 percent of the products exported by foreign food facilities annually. In the last five years, the number of imported food entries has doubled: more than 240,000 foreign establishments in 200 countries and territories export foods to the United States each year. The safety of food imports is essential to public health and to public confidence in America’s food supply. To respond to this challenge, FDA will establish a comprehensive prevention-focused imported food safety program. This initiative will shift the burden of import compliance from the limited FDA inspection force to importers and other stakeholders participating in the foreign food supply chain. It will improve consumer protection by allowing FDA to make better-informed decisions about the admissibility of imported food and allow FDA to target products that pose the greatest risk. The current scope of this program will cover imported foods and drugs intended for food-producing animals. More than 3,000 federal, state, territorial, tribal, and local regulatory agencies have some oversight over the food supply, including more than one million food establishments (restaurants, grocery stores, cafeterias, schools, and correctional facilities), 150,000 domestic registered food facilities and two million farms. FDA and its regulatory and public health partners often work independently, under different legislative authorities, and are driven by distinct objectives and perspectives on priorities. As laid out in the Foods Safety Working Group’s reform agenda, FDA is working to build an integrated national food safety system with the federal, state, territorial, tribal, and local regulatory agencies to enhance and leverage state and local food safety efforts. We are also working to develop greater capacity to detect and contain foodborne outbreaks for the benefit of consumers and the food industry. The system is designed to unify and strengthen the national foodborne disease surveillance, investigation, and response systems at the state and local levels to fully exploit the power of new technology and advanced methods to reduce the burden of foodborne disease. The threats to the food supply are constantly changing, and new food safety hazards are emerging. The technologies used to produce and process foods are becoming increasingly complex and require specialized training to evaluate for foodborne pathogens. Laboratory techniques must also be developed to ensure that timely and accurate tests are available to FDA both for routine inspection sampling and in the case of a foodborne illness outbreak investigation. The variety of agents associated with foodborne illness has grown over the last few decades, and new threats, such as melamine and cyanuric acid, continue to emerge. In addition, changes in consumption and availability of food mean more consumers are eating ready-to-eat foods, eating outside of the home, and eating fresh fruit and vegetables year-round. FDA is responsible for providing consumers with clear information about the most important safe food handling, preparation, and storage practices, as well as providing accurate and timely food safety information to the public in the event of an outbreak. FDA will play an enhanced leadership role on food-safety education and work in partnership with the food industry, consumer, and public health organizations; educators; state and local food safety partners; and other federal agencies to elevate the contribution of consumer education to reducing foodborne illness.Preventive ControlsEstablish science-based preventive controls throughout the farm to table continuum_85a40f4a-fbea-11df-a90e-29337a64ea2a3.1.1.1Highest RisksPrioritize development of targeted preventive controls to address highest risks first_85a412f6-fbea-11df-a90e-29337a64ea2a3.1.1.1.1Knowledge GapsIdentify and prioritize knowledge gaps_85a419a4-fbea-11df-a90e-29337a64ea2a3.1.1.1.2MeasurementMeasure the public health effects of the preventive controls_85a41e04-fbea-11df-a90e-29337a64ea2a3.1.1.1.3ComplianceAchieve high rates of compliance with preventive controls both domestically and internationally_85a42160-fbea-11df-a90e-29337a64ea2a3.1.1.2Food Safety SystemUtilize resources and information from public health, industry, and regulatory partners to create an integrated food safety system_85a42782-fbea-11df-a90e-29337a64ea2a3.1.1.2.1Inspection, Investigation, and Enforcement Create a modernized inspection, investigation, and enforcement system_85a42b88-fbea-11df-a90e-29337a64ea2a3.1.1.2.2Incident Preparedness, Response, and CommunicationImprove incident preparedness, response, and communication_85a42ef8-fbea-11df-a90e-29337a64ea2a3.1.1.2.3OversightDevelop and implement an import oversight plan_85a4363c-fbea-11df-a90e-29337a64ea2a3.1.1.2.4Scientific CapacityEnsure adequate scientific capacity to support public health decision making_85a43c90-fbea-11df-a90e-29337a64ea2a3.1.1.3Predictive Capabilities and Risk AnalysisStrengthen predictive capabilities and enhance risk analysis to improve decision making _85a44046-fbea-11df-a90e-29337a64ea2a3.1.1.3.1Regulatory Research and MethodsPrioritize, integrate, and enhance regulatory research and methods development_85a4474e-fbea-11df-a90e-29337a64ea2a3.1.1.3.2Dietary Practices and NutritionPromote Healthy Dietary Practices and Nutrition_85a44b90-fbea-11df-a90e-29337a64ea2a3.1.2The public health focus of the Foods Program also centers on the promotion of healthful dietary practices through truthful and informative labeling on packaged and other foods. American consumers can use this information to make healthier choices about the food they eat and help them reduce the risk of chronic disease and facilitate optimal health. Reducing the chronic disease burden of the U.S. population depends, in large part, on consumers having the knowledge to make wise food choices as well as the motivation to make those choices consistently at all stages of their lives. To promote healthy dietary practices and nutrition, FDA has aligned its priorities to support two goals: 1) to increase the availability of safe and nutritious new food products; and 2) to provide clear and timely information to promote better nutrition and reduce the risk of chronic diseases, such as obesity, by strengthening food labeling to promote healthful dietary practices. Trends and Challenges - According to data from the CDC, chronic diseases cause 7 out of 10 deaths each year and account for about 75 percent of the $2 trillion that America spends on healthcare each year. Difference in intake of calories, dietary fat, sodium, and certain carbohydrates are linked to chronic diseases—obesity, diabetes, and hypertension—that are reaching epidemic proportions. CDC data indicate that more than 30 percent of the American adult population, or 60 million people, are obese. Policy and environmental change initiatives that make healthy choices in nutrition and physical activity available, affordable, and easy will likely prove most effective in combating obesity, when combined with physical activity. FDA will focus its efforts to address the public health problems of obesity and chronic disease by reducing the levels of sodium in processed and restaurant foods. This initiative will empower consumers and motivate food producers to develop more healthful food products. The Front of Package labeling initiative will also enable FDA to address the public health problems of obesity and chronic disease by improving nutrition labeling on food packages and on restaurant menus—an essential tool for consumers to construct healthier diets. These initiatives will also encourage the reduction of levels of sodium in processed and restaurant foods. Moreover, several education and outreach efforts, such as the educational program, SPOT THE BLOCK, and the Web-based program, Healthy Weight Management, are underway to promote healthful choices by consumers and build awareness of nutrition labels. Alongside efforts to modernize nutrition labeling of foods, FDA will undertake similar efforts in pet food labeling to protect and improve animal health. FDA is leading efforts in new pet food labeling regulations and other initiatives to provide factual and pertinent nutritional information to pet owners and allow them to make better choices in pet food products to improve the health and well being of animals.Consumer InformationProvide clear and timely information so consumers can choose a healthier diet and reduce the risk of chronic disease and obesity_85a44f28-fbea-11df-a90e-29337a64ea2a3.1.2.1ConsumersLabeling and MenusImprove nutrition labeling on food packages and on restaurant menus as a tool for consumers seeking to construct healthier diets_85a455cc-fbea-11df-a90e-29337a64ea2a3.1.2.1.1DinersGrocery ShoppersPet Food LabelingImplement the revised pet food labeling and definitions and standards for animal feed ingredients_85a45a86-fbea-11df-a90e-29337a64ea2a3.1.2.1.2Pet OwnersProduct ReformulationEncourage product reformulation to increase the availability of nutritious food products_85a45e6e-fbea-11df-a90e-29337a64ea2a3.1.2.2Foods ProgramProvide vision, strategy, and commitment across FDA to build a unified FDA Foods Program that works effectively to prevent foodborne illness and improve nutrition._85a46512-fbea-11df-a90e-29337a64ea2a3.1.3Foods Program Executive Leadership TeamThe work of unifying the food-related activities of CFSAN, CVM, and ORA is being led by the Foods Program Executive Leadership Team, which is chaired by the Deputy Commissioner for Foods and includes the senior leaders of the three operating units and the Office of Foods. The Team is acting as a strategic, deliberative body, with mutual responsibility for ensuring both the success of the Foods Program as a whole and that all elements of the program operate in an integrated way to fulfill the Program’s public health mission.Signature Initiative: FOODS – ONE MISSION, ONE PROGRAM INITIATIVE - In December 2009, FDA launched the One Mission, One Program Initiative, which is aimed at providing vision, strategy, and commitment across FDA to build a unified FDA Foods Program that works effectively to prevent foodborne illness and improve nutrition in a dynamic and innovative U.S. food marketplace—and an increasingly complex global food system. Ten core groups, composed of more than 100 FDA employees throughout the Foods Program, have been chartered to design key elements of the future unified FDA Foods Program: * Preventive controls * Risk-informed decision making * Inspection and compliance strategy * Import safety * Federal/state integration * Incident preparedness and response * Science, technology, and research integration * Information systems * Strategic communications * Resource planning The deliverable from the One Mission, One Program initiative will be a “Roadmap to Food Safety” strategic implementation plan that will be published on the FDA website at the end of 2010.Medical ProductsPromote Public Health by Advancing the Safety and Effectiveness of Medical Products_85a469d6-fbea-11df-a90e-29337a64ea2a3.2A key priority for FDA is improving the safety and effectiveness of medical products, both through rigorous review of clinical studies and manufacturing process information before products are approved as well as through monitoring actual patient experiences and manufacturing quality once they are on the market. We aim to fulfill FDA’s public health mission by supporting smart prescribing, working to prevent intentional and unintentional misuse, educating consumers on safe use, and readily recognizing and responding to emerging safety concerns. We are also fostering the development of innovative new therapies by setting clear standards and guidelines for evaluating safety and effectiveness so that the regulatory process can keep pace with advances in science and technology. By taking advantage of improvements in scientific computing and by developing affiliated technologies (e.g., improved product tracking methods), FDA is working to develop a new generation of information collection and analysis methods to improve our understanding of the real-world health outcomes from medical products. The long-term goal is to identify product problems sooner and to gain a richer understanding of how medical products affect populations and subpopulations every day. This way, we can not only take any necessary immediate actions to protect the public health, but also use that knowledge to support improvements in medical product development and health care delivery practices. Desired Public Health Outcomes: * Increase years of healthy life by increasing access to life-saving and life-enhancing medical products * Reduce the number of deaths and injuries associated with the quality and unsafe use of FDA- regulated medical products Drug Safety and EffectivenessAdvance Human Drug Safety and Effectiveness_85a46dd2-fbea-11df-a90e-29337a64ea2a3.2.1HumansThe Human Drugs Program performs an essential public health task by ensuring that drugs available to consumers are safe and effective. We regulate over-the-counter and prescription drugs, including biological therapeutics and generic drugs. FDA’s authorities also include review of products not typically considered to be medicinal. For example, fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens qualify as drugs and are subject to the regulatory review process. The Human Drugs Program evaluates all new and generic drugs prior to entering the market and serves as a consumer watchdog for the more than 10,000 currently marketed drugs to ensure they continue to maintain approved standards. Trends and Challenges: The drug review process has evolved considerably since passage of the Federal Food, Drug, and Cosmetic Act in 1938. Initially, drug applications were only required to contain an investigational drug’s safety information. In 1962, the Kefauver-Harris Amendments to the FD&C Act required data to support a drug’s efficacy for its intended use. The drug development and distribution landscape has changed dramatically over the same period of time, and today, FDA’s responsibility and reach is global: up to 40 percent of the drugs Americans take are imported and up to 80 percent of the active pharmaceutical ingredients in those drugs originate from foreign sources. The drug review life cycle begins during the premarket investigational phase and continues through postmarket manufacturing inspections and adverse events monitoring. New challenges posed by globalization, out-sourcing, and increasingly large, multi-facility clinical trials require FDA to refocus its drug review process into one that enables full product life cycle review. Multi-disciplinary review teams are involved in different facets of the regulatory review process. As a result, it is critical that decision making on a drug product throughout its life cycle is clearly documented, communicated, and well-supported. FDA has a three-pronged plan to achieve its mission to ensure consumer access to safe and effective drugs. They are illustrated by the long-term objectives captured in Table 3 below and the key strategies associated with each objective. Drug AvailabilityPromote public health by ensuring the availability of safe and effective new drugs _85a4743a-fbea-11df-a90e-29337a64ea2a3.2.1.1Methods, Models, and ToolsIdentify and develop new scientific methods, models, and tools to improve the quality, safety, predictability, and efficiency of new drug development_85a499c4-fbea-11df-a90e-29337a64ea2a3.2.1.1.1Drug DevelopersPharmaceutical CompaniesPremarket ReviewsConduct rigorous science-based premarket review to ensure that drugs that will be marketed to the public are safe and effective_85a4a2ac-fbea-11df-a90e-29337a64ea2a3.2.1.1.2Patient AwarenessEnsure patient awareness of drug benefits and risks through effective communication of drug information_85a4aac2-fbea-11df-a90e-29337a64ea2a3.2.1.1.3PatientsDrug Quality and IntegrityProtect public health by ensuring the quality and integrity of marketed drug products_85a4afd6-fbea-11df-a90e-29337a64ea2a3.2.1.2Global Supply ChainSecure the global supply chain to ensure that drugs are being manufactured and distributed to conform to established quality standards_85a4b4ae-fbea-11df-a90e-29337a64ea2a3.2.1.2.1Drug Quality OversightImprove drug quality oversight capacity through expanded use of risk-based methods_85a4bd28-fbea-11df-a90e-29337a64ea2a3.2.1.2.2Public AwarenessEnsure public awareness of drug quality and integrity issues through effective consumer communications_85a4c246-fbea-11df-a90e-29337a64ea2a3.2.1.2.3Drug UsageProtect public health by promoting the safe use of marketed drugs_85a4c6c4-fbea-11df-a90e-29337a64ea2a3.2.1.3Postmarket SurveillanceConduct postmarket surveillance to ensure early detection of new safety signals_85a4cf52-fbea-11df-a90e-29337a64ea2a3.2.1.3.1StudiesConduct rigorous studies to understand new drug safety signals and effectively manage emerging risks_85a4d4de-fbea-11df-a90e-29337a64ea2a3.2.1.3.2AwarenessEnsure patient and health professional awareness of drug risks and parameters for safe use_85a4d9fc-fbea-11df-a90e-29337a64ea2a3.2.1.3.3PatientsHealth ProfessionalsPromotion and MarketingOversee drug promotion and marketing to ensure that marketed drug labeling and advertising is truthful and not misleading_85a4e71c-fbea-11df-a90e-29337a64ea2a3.2.1.3.4Quality Systems FrameworkDesign a quality systems framework to enhance regulatory review and cross-cut business processes,_85a4ecc6-fbea-11df-a90e-29337a64ea2a3.2.1.4Signature Initiative: QUALITY SYSTEMS FOR THE HUMAN DRUGS PROGRAM - The Human Drugs Program is designing a quality systems framework to enhance regulatory review and cross-cut business processes in support of consistent, scientifically sound, high-quality work products. This framework will enable a culture of continual process review and improvement, with performance measures that focus attention on how to best accomplish the program’s mission. The new quality system will be supported by a set of strategic objectives designed to ensure that the program has the correct set of expertise, strong management, integrated supporting infrastructure, and clear lines of communication to support rigorous, well-informed decision making. BiologicsAdvance Biologics Safety and Effectiveness _85a4f16c-fbea-11df-a90e-29337a64ea2a3.2.2The Biologics Program is responsible for protecting and enhancing the public health through the regulation of biological and related products, including blood, vaccines, allergenics, tissues, and cellular and gene therapies, and works with other federal agencies, foreign governments, and international organizations such as the World Health Organization (WHO). The program reviews and licenses safe and effective new biological products. The program also plays an important role in protecting the public against threats to the safety of blood, blood products, tissues, cellular and other products from emerging infectious diseases. The program also facilitates the critical process to license safe and effective biological products to protect the public against agents of bioterrorism. Trends and Challenges: FDA responds to the challenges of pandemic influenza, bioterrorism, and emerging infectious diseases by facilitating the development of products to protect the public against these threats and approving products that have been demonstrated to be safe and effective. FDA has facilitated the development of influenza pandemic vaccines through expedited regulatory pathways and supports efforts to increase manufacturing capacity using both new and existing technologies and to develop faster methods for testing the potency of influenza vaccines. As a member of the FDA team, the Biologics Program works with the Public Health Emergency Medical Countermeasures Enterprise and industry on a broad array of projects aimed at making our nation better prepared for threats of biological, chemical, and radiological/nuclear terrorism through the development of new countermeasures. FDA has worked in the global community to improve human health in the world’s populations over many years—it is clear that protection of global public health against infectious disease threats leads to improved public health in the United States as well. With the advent of a globalized enterprise for the development and marketing of medical products in the 21st century, that paradigm has vastly expanded in scope, requiring greater engagement with our global partners. Serving as a WHO Collaborating Center for Biological Standardization, FDA will continue its substantial contribution to WHO’s biologics portfolio, including efforts to develop standards for biological products, its regulatory capacity building initiatives, and its vaccine prequalification process, which is a cornerstone of global access to vaccines. Not-for-profit foundations and other non-governmental organizations are increasingly important contributors to global efforts to facilitate the development of medical products for the world’s unmet needs and have newly recognized the need to address regulatory pathways as part of their efforts. Harmonization of existing product standards and prospective harmonization in newly emerging therapies remains an important means to facilitate global access to safe and effective products, as is sustaining regulatory dialogue on important scientific and regulatory concerns on globally marketed products. FDA will improve its coordination and management of these rapidly growing international arenas and continue exploring creative new paradigms to respond to these needs. Ensuring the safety of biological products is a core mission strengthened by the Food and Drug Administration Amendments Act of 2007 (FDAAA). As authorized by FDAAA, FDA is conducting collaborative pharmacoepidemiological research to test hypotheses on potential biological product safety issues arising from clinical trials and reports of adverse events linked to the use of those products. FDA is striving to build product safety for biological products through their life cycle. Advances in science and technology show great promise for the development of new safe and effective biological products. FDA is working to address the use of advanced technologies and methods and relevant scientific discoveries—such as newly identified clinical biomarkers, adaptive clinical trial designs, and genomics—in regulatory guidance documents for industry. FDA will advance regulatory research that supports product review and the corresponding review processes to reflect the new generation of product evaluation tools and the innova­tive products we expect to see over the next decade. Continued updating of FDA’s business practices will improve the connectivity of agency databases, simplifying the storage, tracking, and retrieval of review documents and communications. Sustaining the changes necessary to prepare for the integration of advanced methods into product review will require sustained effort. For FDA to perform its role effectively in regulating the biologics industry, FDA has developed the following objectives and key strategies shown in Table 4.National PreparednessIncrease the nation’s preparedness to address threats as a result of bioterrorism, pandemic and emerging infectious diseases_85a4f978-fbea-11df-a90e-29337a64ea2a3.2.2.1InfluenzaIncrease the nation’s preparation for pandemic influenza_85a4ff40-fbea-11df-a90e-29337a64ea2a3.2.2.1.1High-Priority Medical ProductsFacilitate development, evaluation, and availability of high-priority medical products (including medical countermeasures)_85a5059e-fbea-11df-a90e-29337a64ea2a3.2.2.1.2Reagents, Methods, and PoliciesDevelop reagents, evaluate new methods, and implement policies that maintain a continued safe and adequate supply of blood and tissues during emergencies_85a50e18-fbea-11df-a90e-29337a64ea2a3.2.2.1.3International CollaborationImprove global public health through international collaboration, including research and information sharing_85a513cc-fbea-11df-a90e-29337a64ea2a3.2.2.2Research and Information-SharingPromote research and information-sharing globally to address diseases and emerging threats impacting human populations_85a518cc-fbea-11df-a90e-29337a64ea2a3.2.2.2.1Global AccessFacilitate global access to vaccines and biological products that address critical health needs_85a52114-fbea-11df-a90e-29337a64ea2a3.2.2.2.2HarmoniztionHarmonize existing regulatory standards, where feasible, and work towards prospective harmonization of standards on new biological product areas to promote global public health_85a526e6-fbea-11df-a90e-29337a64ea2a3.2.2.2.3International CooperationCooperate with international scientific efforts to establish and maintain reference materials and standards for biologics_85a52c5e-fbea-11df-a90e-29337a64ea2a3.2.2.2.4Biological Product SafetyEnsure the safety of biological products_85a53492-fbea-11df-a90e-29337a64ea2a3.2.2.3Manufacturing Capacity and Product QualityFacilitate increased biologics manufacturing capacity and improved product quality_85a53a6e-fbea-11df-a90e-29337a64ea2a3.2.2.3.1Safety and Quality MonitoringImprove the use of healthcare data to enhance monitoring the safety and quality of licensed biological products_85a53fdc-fbea-11df-a90e-29337a64ea2a3.2.2.3.2Epidemiological and Risk AssessmentEnhance statistical data analysis and mathematical models for improved epidemiological and risk assessments of regulated products_85a548ba-fbea-11df-a90e-29337a64ea2a3.2.2.3.3Risk Management and CommunicationPromote safe product use through effective risk management and risk communication_85a54ec8-fbea-11df-a90e-29337a64ea2a3.2.2.3.4Science and TechnologyEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products_85a553fa-fbea-11df-a90e-29337a64ea2a3.2.2.4Regulatory OversightIntegrate genomics, proteomics, high-sensitivity gene sequencing and other cutting-edge scientific technologies into regulatory oversight to expedite product development and review_85a55cce-fbea-11df-a90e-29337a64ea2a3.2.2.4.1EfficacyImprove the evaluation of efficacy of products in clinical trials through the use of biomarkers and adaptive designs_85a562be-fbea-11df-a90e-29337a64ea2a3.2.2.4.2Regulatory ResearchAdvance regulatory research to facilitate product review, including development of relevant animal models_85a56804-fbea-11df-a90e-29337a64ea2a3.2.2.4.3Stem Cell InitiativeEnable FDA to interact with industry and other stakeholders and better anticipate scientific and regulatory challenges that may arise in the review of investigational and licensing applications for novel stem cell products._85a5704c-fbea-11df-a90e-29337a64ea2a3.2.2.5Biologics ProgramSignature Initiative: STEM CELL INITIATIVE - Stem cells are specialized cells that have the remarkable potential to develop into many different cell types in the body, and stem cell therapies aim to harness the power of different cell types to fight disease, restore normal function, repair injuries, replace lost cells, and regenerate failing organs. On March 9, 2009, the President issued Executive Order (EO) 13505, Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, which lifted the ban on federal funding for promising embryonic stem cell research. FDA regulates stem cells as a novel biologic therapy; in fact, the agency’s authority extends to products comprised of, or derived from, human cells, tissues, or cellular or tissue-based products, and gene therapy products. Because of the advancing state of science and the EO, FDA anticipates a significant increase in new investigational drug applications and biologics license applications for stem cell products. With more submissions, FDA also anticipates increased inquiries from the scientific community and stakeholders requesting input on product development, required preclinical studies, clinical trial design, and regulatory policy. The Biologics Program’s Stem Cell Initiative will enable FDA to interact with industry and other stakeholders and better anticipate scientific and regulatory challenges that may arise in the review of investigational and licensing applications for novel stem cell products—and advance scientific and regulatory policy. This initiative will promote dialogue and educational efforts with the scientific and product development communities and foster partnerships and collaborations with experts in the field. The educational exchange will benefit both FDA and stakeholders, as it will ensure that product development proceeds with an appropriate understanding of the regulatory requirements. These efforts of promoting dialogue and education and fostering partnerships and collaborations can be achieved through short- and long-term projects led by FDA staff, such as workshops, Webinars, and guidance development. In addition to these efforts, FDA may collaborate with experts in the field through development of outside partnerships and an expanded fellowship program. Much work remains to understand how to use stem cells for therapies to treat disease, and it is imperative that FDA remain up to date on scientific development in this rapidly developing area so that policies reflect the most current scientific knowledge. To stay at the forefront and address regulatory science gaps in our understanding of stem cell-based therapies, FDA is also expanding in-house research while working collaboratively with other government agencies, such as the National Institutes of Health and the National Institute of Standards and Technology, to identify, develop, and evaluate methods to characterize products that will be predictive of clinical functionMedical DevicesAdvance Medical Device Safety and Effectiveness _85a57696-fbea-11df-a90e-29337a64ea2a3.2.3Medical Device ProgramFDA’s Medical Device Program protects and promotes the public health by ensuring the safety, effectiveness and quality of all medical devices—from very simple items like tongue depressors or thermometers to very complex technologies such as heart pacemakers and dialysis machines. The Medical Device Program also protects the public from unnecessary exposure to radiation from radiation-emitting products, such as microwave ovens, cell phones, x-ray equipment, lasers, medical ultrasound and MRI machines, and many other consumer, industrial, and medical products. The program also monitors mammography facilities to make sure their equipment is safe and properly run. The device program’s public health mission focuses on all the stages in a product’s life cycle, from development and design through obsolescence. We monitor medical devices and radiological products for continued safety once they are in use, fostering medical device innovation, and providing the public with the accurate, science-based information needed to improve health. Trends and Challenges: In a rapidly and continuously evolving scientific and global-market landscape, the device program is taking steps to meet challenges for the 21st century. Two significant efforts that will help the device program meet the challenges of the future include: 1) activities to improve the quality, consistency, and predictability of regulatory decision making and 2) activities to facilitate medical device innovation. By strengthening our premarket review programs, we are working to improve the quality, consistency, and predictability of our regulatory decision making in the context of a rapidly changing scientific landscape. The goals and actions FDA will undertake are part of the key strategy, “Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions.” As part of this strategy, FDA plans to, among other efforts, complete a comprehensive assessment of the 510(k) program and take steps to facilitate the seamless incorporation of new scientific information available throughout the total product life cycle into regulatory decision making. Our responsibility to the public is: 1) to protect public health by ensuring the safety and effectiveness of medical devices and using enforcement tools wisely and 2) to promote public health by facilitating innovation and fostering a culture of quality and prevention among industry. To fulfill this two-fold mandate, we must embrace both parts of our mission. Although FDA and other government partners have important collaborative roles to play in the life cycle of a medical device, the government may be able to do more to encourage the development of new devices, especially for unmet medical needs. The goals and actions FDA will undertake under this initiative are part of the key strategy, “Proactively Facilitate Innovation and Address Unmet Public Health Needs.” FDA has already established a Council on Medical Device Innovation, which comprises participants from the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Defense, the Defense Advanced Research Projects Agency, and the Department of Veteran Affairs. The Council held its first public meeting on June 24, 2010, with the goal of looking for ways to proactively facilitate device innovation to address unmet public health needs, including the identification of potential government barriers to the development of devices. Product Life Cycle ApproachFully implement a total product life cycle approach that enables well-supported regulatory decisions at any stage of a device’s cycle_85a57c2c-fbea-11df-a90e-29337a64ea2a3.2.3.1Compliance Information and FunctionsEnhance and integrate premarket, postmarket, and compliance information and functions_85a5858c-fbea-11df-a90e-29337a64ea2a3.2.3.1.1Guidance and RegulationImprove guidance and regulation development_85a58bd6-fbea-11df-a90e-29337a64ea2a3.2.3.1.2Cross-Center ComplianceDevelop a cross-center compliance strategy_85a59180-fbea-11df-a90e-29337a64ea2a3.2.3.1.3Unmet Public Health NeedsProactively facilitate innovation and address unmet public health needs_85a59a2c-fbea-11df-a90e-29337a64ea2a3.2.3.2Medical DevicesFoster development of medical devices to respond to unmet public health needs_85a5a0ee-fbea-11df-a90e-29337a64ea2a3.2.3.2.1Personalized MedicineDevelop a personalized medicine program_85a5a6a2-fbea-11df-a90e-29337a64ea2a3.2.3.2.2510(k) Program Strengthen Medical Devices Premarket Review / Assessment of the 510(k) Program _85a5b228-fbea-11df-a90e-29337a64ea2a3.2.3.3Signature Initiative: Strengthening Medical Devices Premarket Review—Assessment of the 510(k) Program - To fully implement a total product life cycle approach means that, at any stage of a device or radiation-emitting product’s life cycle, we must make well-supported regulatory decisions that take into consideration all the relevant information available to us. A major component of this long-term objective is our effort to strengthen premarket review by completing a comprehensive, two-part assessment of the premarket notification, or 510(k), program. Early in FY 2010, FDA commissioned the IOM to conduct an independent review of the 510(k) program and to recommend any administrative, regulatory, and/or statutory changes deemed appropriate. While IOM works on its assessment of the 510(k) program, we are conducting our own internal evaluation. Our assessment focuses on actions we should take in the short term and under existing authority to strengthen the 510(k) program and to improve the consistency of our decision making. In addition, the internal assessment is taking into account external input we received at a public meeting and through a public docket. An FDA report outlining findings and recommendations of the internal assessment was released in 2010 for public comment. Based on public input, FDA will then decide which recommendations to adopt.Animal DrugsAdvance Animal Drug Safety and Effectiveness _85a5b8c2-fbea-11df-a90e-29337a64ea2a3.2.4Animal Drugs ProgramAnimal OwnersThe Animal Drugs Program is responsible for fostering public and animal health by regulating the drugs, devices, and food additives used to feed and sustain animal health and by enforcing applicable legislative provisions. It therefore plays a prominent role in the strategic areas of Food Safety and Nutrition as well as Drug and Device Safety and Effectiveness. -------------------------------------------------------------------------------- CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over 150 million companion animals, plus billions of poultry, cattle, swine, and minor animal species. -------------------------------------------------------------------------------- FDA approvals affect several hundred animal drug applications, including generics, for food-producing animals, and FDA approves many of these drugs for administration through animal feed. FDA’s review process requires efficiently evaluating new animal drugs, some of which represent innovative new technologies. FDA also conducts surveillance, monitors compliance to prevent marketing of unsafe products, and coordinates enforcement actions against products associated with adverse events. Trends and Challenges FDA faces a “revolution” of new science technologies and emerging regulatory science questions for today and tomorrow. The central challenge for FDA is to protect consumers by making use of the best possible science while supporting the efficient development of new products. Due to its broad regulatory mission, FDA scientists must stay current with respect to emerging technologies developed by academia and regulated industries while concurrently maintaining expert competencies in established technologies. The capacity to meet these requirements is dependent upon program growth in emerging areas such as nano-technology, biosensors, proteomics, genomics, and metabolomics. The capacity to continue such innovation requires the infusion of new ideas through scientific exchange and adoption of next generation high-throughput analytical technologies. Pathways are needed to increase the availability of legally marketed new animal drugs. There are a significant number of unapproved new animal drugs that are being sold and marketed to animal owners and veterinarians, including new animal drugs compounded from bulk drug substances. In that spirit, FDA plans to foster the development of regulatory frameworks for legal marketing and approval of unapproved drugs and develop an enforcement strategy for the removal of unapproved drugs. This framework will help ensure that safe and effective new animal drugs are legally available and that unsafe or ineffective products are not manufactured and distributed. The animal drug review life cycle begins during the pre-market investigational phase and continues through post-market activities, including adverse event monitoring. The new challenges posed by innovative new technologies and increased globalization requires a review process that draws together both pre- and postmarket functions, helps prioritize and manage risk, and optimizes the use of resources. FDA will use a comprehensive regulatory approach for integrating pre- and postapproval and compliance functions for animal drug products. The Animal Drugs Program plans to explore optimum approaches for implementing and integrating product life cycle processes, addressing the needs of small sponsors, and identifying and optimizing potential for collaborative review processes throughout the organization. With the integration of facilities, the exchange of scientific information, and of staff expertise, potential problems with regulated products will be identified sooner in the life cycle of a product and can be dealt with quickly. Safe animal feed and pet food helps ensure healthy animals and people. Establishing a framework for coordinating federal and state veterinary diagnostic laboratories to respond to high priority chemical and microbial feed contamination events will further strengthen our ability to prevent the occurrence of feed safety problems and if necessary to respond quickly to animal injury and death. Veterinary diagnostic laboratories examine animal tissues for infectious agents, toxins, and other causes of disease in diagnostic samples submitted by veterinary practitioners serving pet owners and other animal owners. FDA plans to initiate strategic alliances with state veterinary diagnostic laboratories and develop a mechanism to resource state veterinary diagnostics laboratories. This network will provide the means for quick identification of reports of animal injury associated with animal feed contamination and establish protocols for immediate veterinary diagnostic reporting to FDA. In support of its mission, the Animal Drugs Program established goals and objectives to ensure that resources are planned, allocated, and managed commensurate with the agency’s public health responsibility for evaluating, approving, and monitoring animal drugs, food additives, feed ingredients, and animal devices. Table 6 summarizes the Animal Drugs Program goals and objectives. AccessIncrease access to safe and effective animal drugs_85a5bebc-fbea-11df-a90e-29337a64ea2a3.2.4.1Major SpeciesIncrease the availability of safe and effective animal drugs for major species_85a5c8ee-fbea-11df-a90e-29337a64ea2a3.2.4.1.1Aquaculture and Minor SpeciesIncrease the availability of safe and effective animal drugs for aquaculture and other minor species and uses_85a5cfa6-fbea-11df-a90e-29337a64ea2a3.2.4.1.2Pre- and Postapproval and ComplianceDevelop comprehensive regulatory approach for integrating pre- and postapproval and compliance functions_85a5d5c8-fbea-11df-a90e-29337a64ea2a3.2.4.1.3Unsafe Animal DrugsReduce risk of harm from unsafe use of marketed animal drugs_85a5dece-fbea-11df-a90e-29337a64ea2a3.2.4.2Electronic ReportingDevelop strategy to increase electronic reporting of ADEs_85a5e590-fbea-11df-a90e-29337a64ea2a3.2.4.2.1Tissue Residue InspectionsDevelop and implement a risk-ranking system for tissue residue follow-up inspections_85a5ec02-fbea-11df-a90e-29337a64ea2a3.2.4.2.2Milk Residue TestingReinstitute milk residue testing for antibiotics other than beta lactams_85a5f698-fbea-11df-a90e-29337a64ea2a3.2.4.2.3Substandard and Illegally Marketed animal DrugsReduce risk of harm from substandard and illegally marketed animal drugs_85a5fda0-fbea-11df-a90e-29337a64ea2a3.2.4.3Unapproved Animal DrugsDevelop a work plan for addressing unapproved new animal drugs_85a6043a-fbea-11df-a90e-29337a64ea2a3.2.4.3.1Enforcement StrategyDevelop an enforcement strategy that addresses the illegal compounding of new animal drugs_85a61010-fbea-11df-a90e-29337a64ea2a3.2.4.3.2Biotechnology Program ProcessPilot a program grounded in risk-based, full life cycle regulatory oversight and a team-based review process to further strengthen the Animal Drugs biotechnology program._85a617e0-fbea-11df-a90e-29337a64ea2a3.2.4.4Signature Initiative: BIOTECHNOLOGY PROGRAM PROCESS - FDA is piloting a program grounded in risk-based, full life cycle regulatory oversight and a team-based review process to further strengthen the Animal Drugs biotechnology program. It is based on having a complete understanding of the nature of genetically engineered animals and the potential risks they may pose pre- and postmarket (safety) and making sure that the introduced traits continue to be appropriately expressed (effectiveness). Part of the goal of the pilot program is to maximize the existing resources across the Animal Drugs Program in a matrixed format by engaging professionals of the appropriate expertise regardless of their administrative unit, to enhance the continuity of pre- and postmarket activities and to provide internal peer review of the Center’s assessments and actions. The pilot program uses a matrix format for all offices within the Animal Drugs Program during a product’s evaluation life cycle. Because of its interdisciplinary nature, FDA’s current veterinary biomedical and food safety capacities are challenged by their traditional administrative structures; this pilot program has been established to find an effective mechanism to improve the agency’s ability to address this technology in an efficient and proactive manner. With the approval of the first “biopharm” animal in February 2009, FDA demonstrated to the fledgling industry that not only are such applications theoretically possible, but approvals would be issued by the agency, along with the requirement for regulatory oversight. In addition, the genetically engineered animals that have been in development for several years are now reaching regulatory maturity.TobaccoEstablish an Effective Tobacco Regulation, Prevention, and Control Program_85a61e5c-fbea-11df-a90e-29337a64ea2a3.3SmokersTobacco CompaniesTobacco GrowersYouthOn June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act, and FDA gained regulatory authority over tobacco products. To enforce the new law, Congress authorized the creation of the Center for Tobacco Products, or CTP. With more than 400,000 Americans losing their lives to tobacco-related illness each year and 4,000 children a day trying their first cigarette, the need for effective federal regulation has never been greater. -------------------------------------------------------------------------------- FDA issued a final rule containing a broad set ofrequirements to significantly curb access and the appeal of cigarettes and smokeless tobacco products to children and adolescents. Published March 19, 2010, the new rule became effective on June 22, 2010. -------------------------------------------------------------------------------- Soon after its creation, the Tobacco Program launched an ambitious multi-pronged strategy. It began in September 2009 with the appointment of a Center director and enactment of the congressionally mandated ban on candy- and fruit-flavored cigarettes. Since then, the Tobacco Program and its newly formed leadership team have been laying the foundation for regulating tobacco products by using a new population health standard. FDA’s action agenda rests on four public health pillars: 1) developing a science base; 2) creating effective regulatory tools; 3) providing industry with sound guidance; and 4) rigorously enforcing the law. Together, these principles form the framework for effective regulation of tobacco products — one of the nation’s leading causes of preventable death. Trends and Challenges Tobacco product regulation poses distinct challenges for FDA. FDA must build from scratch its expertise in developing and issuing effective regulations. FDA is also examining how to best fulfill its mission in partnership with federal, state, and local public health agencies. These agencies play a vital role in informing and protecting American consumers from the harmful effects of tobacco, and their work is fundamental to FDA’s success. The Tobacco Program is also conducting an unprecedented outreach effort to receive input, keep stakeholders informed, and educate consumers. FDA is committed to providing Americans with the information they need to protect their children and to make choices about tobacco use for themselves. By focusing on the risk of tobacco products, crafting communication strategies to reduce product initiation and use, developing its research agenda, collaborating with its partners, and being as transparent as possible, FDA is committed to making the suffering caused by tobacco products a part of America’s past—not its future. Desired Public Health Outcomes: * Reduce the number of deaths and diseases associated with the use of tobacco products * Reduce the number of youth from accessing and using tobacco products in the U.S. Regulatory FrameworkEstablish regulatory framework for tobacco products_85a628c0-fbea-11df-a90e-29337a64ea2a3.3.1Science BaseDevelop a science base for the regulation of tobacco products_85a63018-fbea-11df-a90e-29337a64ea2a3.3.1.1RegulationsDevelop and issue regulations required by statute_85a636c6-fbea-11df-a90e-29337a64ea2a3.3.1.2GuidanceDevelop and issue guidance documents to implement statutory and regulatory provisions_85a640c6-fbea-11df-a90e-29337a64ea2a3.3.1.3Enforcement StrategyDevelop and implement a strategy to enforce statutory and regulatory provisions to protect the public health_85a6483c-fbea-11df-a90e-29337a64ea2a3.3.1.4InformationProvide the public with accurate, trustworthy, and accessible information about tobacco products_85a64f08-fbea-11df-a90e-29337a64ea2a3.3.2Communication and Public EducationDevelop a research and an evaluation agenda for effective communication and public education strategies_85a65886-fbea-11df-a90e-29337a64ea2a3.3.2.1Public Health RisksDevelop a communication and public education strategy to address the public health risks of tobacco products_85a65ff2-fbea-11df-a90e-29337a64ea2a3.3.2.2Initiation and UseDevelop a communication and public education strategy to help reduce the initiation and use of tobacco products_85a6674a-fbea-11df-a90e-29337a64ea2a3.3.2.3CollaborationDevelop opportunities to collaborate with other partners to further the Center’s mission and public health goals_85a6726c-fbea-11df-a90e-29337a64ea2a3.3.2.4TransparencyBe as transparent as possible with the public and other stakeholders_85a67a28-fbea-11df-a90e-29337a64ea2a3.3.2.5Excellence and AccountabilityManage for Organizational Excellence and Accountability _85a68108-fbea-11df-a90e-29337a64ea2a3.4Managing for operational excellence and accountability across strategic program areas will ensure an effective framework for implementing the program initiatives within OC and across FDA Centers and field offices. The agency has established operational excellence and accountability objectives to ensure that resources are planned, allocated, and managed to best ensure delivery of the services that are critical to the fulfillment of FDA’s mission. Human Capital ManagementRecruit, develop, retain, and strategically manage a world-class workforce _85a68b30-fbea-11df-a90e-29337a64ea2a3.4.1FDA’s ability to recruit, develop, and retain a diverse workforce depends on a fully integrated, FDA-wide human capital management program that hires and retains skilled employees who can meet current and future challenges. Successful recruiting, training, career management, compensation, promotion management, performance management, and leadership will contribute toward recruiting and maintaining a high performing and diverse workforce. FDA will establish and implement a 2011-2012 strategic human capital plan by October 1, 2010, that incorporates workforce and succession planning to assist in identifying and prioritizing our human capital needs. FDA will maximize its use of recruitment and retention flexibilities and ensure that they are used consistently and appropriately across the entire agency, as well as transparent, clearly defined, and well documented. FDA will continuously monitor the effectiveness and efficiency of these investments, and will evaluate and report on their effectiveness regularly. FDA will work in partnership with OPM and HHS to maximize the use of the new HHS Accelerated Hiring Plan. Using this new plan as a baseline, FDA will develop and implement agency-wide policies and procedures that will fully support all new timelines and processes. FDA continuously evaluates and improves its Human Capital Plan to ensure that it fully supports its goal of being an employer of choice within the public health and safety community—one that recruits, develops, retains, and rewards high-quality employees. FDA will continue to be considered one of America’s best places to work.Human Capital PlanEstablish and implement Strategic Human Capital Plan_85a692c4-fbea-11df-a90e-29337a64ea2a3.4.1.1Recruitment and RetentionUse recruitment and retention flexibilities effectively_85a699e0-fbea-11df-a90e-29337a64ea2a3.4.1.2Hiring ProcessWork with OPM and HHS to accelerate hiring process_85a6a386-fbea-11df-a90e-29337a64ea2a3.4.1.3OPMHHSFinancial ManagementEnsure program integrity and responsible stewardship through effective administration of fiduciary responsibilities_85a6ab24-fbea-11df-a90e-29337a64ea2a3.4.2FDA will ensure program integrity and responsible stewardship through effective administration of our fiduciary responsibilities. FDA will ensure that financial statements are accurate, financial data of a proprietary nature is protected, corporate accounting adheres to prevailing standards and requirements, and that accurate financial information is reported on a timely basis to stakeholders inside and outside FDA. The agency’s vision is based on the principle that every person involved in the financial process plays a part in ensuring the integrity of financial data and compliance with financial regulations. FDA will work collaboratively to promote an agency-wide understanding of financial management principals; strengthen financial management systems, practices, controls, and reporting to ensure financial accountability; meet statutory and regulatory requirements; and provide timely, reliable, and useful financial information. This work will ensure protection of the agency’s financial resources in an ethical and transparent manner on behalf of the agency’s mission. Oversight and CultureEnsure vigorous oversight of financial reporting process to sustain a culture of honesty and high ethical standards_85a6b27c-fbea-11df-a90e-29337a64ea2a3.4.2.1Financial PlanningImplement timely, collaborative, and transparent financial planning process that ensures most effective allocation of limited resources to support the FDA’s mission_85a6bc0e-fbea-11df-a90e-29337a64ea2a3.4.2.2Systems, Practices, Controls, and Reporting Strengthen financial management systems, practices, controls, and reporting to ensure financial accountability; meet statutory and regulatory requirements; and provide timely, reliable, and useful financial information _85a6c3fc-fbea-11df-a90e-29337a64ea2a3.4.2.3Information TechnologyImplement an IT modernization program to support state-of-the-art networked information and shared data resources_85a6cb2c-fbea-11df-a90e-29337a64ea2a3.4.3Effective IT support and strategic planning is critical to accomplishing FDA’s goals and mission. FDA’s current five-year Information Technology Strategic Plan (ITSP) under development will define FDA IT goals and speak to the support function of not only the FDA strategic priorities outlined by this document, but also of HHS goals. FDA IT Goals will directly support FDA’s mission by: * Developing a comprehensive action plan that optimizes the use of resources to achieve HHS and FDA goals for public health and safety, as well as developing and implementing technology solutions * Partnering with programs and industry to provide the innovative information technology that makes it possible to collaborate across government and globally * Maintaining a secure environment in which security, privacy, and confidentiality are addressed per U.S. Government laws, regulations, and directives * Managing IT projects and investments to demonstrate progressive incremental improvements supporting achievement of FDA program and high-priority initiative objectives FDA is in the midst of completing an ambitious infrastructure modernization program to lay the foundation for modern, networked information and shared data resources. The transformation of our infrastructure through the migration to new, modernized data centers will enhance our technical ability to improve our information systems to support mission needs. These data centers will also give us the high performance and data storage we need today and are designed to accommodate our growth as FDA changes to meet its expanding public health mission. The modern, fault-tolerant architecture of these data centers protects our systems from internal and external security threats, and the robust electrical and cooling support systems ensure continuous operations under adverse conditions.Computing EnvironmentManage IT products and services to create a secure, reliable, and effective computing environment_85a6d4b4-fbea-11df-a90e-29337a64ea2a3.4.3.1ServicesProvide effective services based on continuous, customer-focused improvement of IT management processes_85a6dd10-fbea-11df-a90e-29337a64ea2a3.4.3.2SolutionsEnsure that agency program and administrative components work collaboratively and proactively to plan and implement effective solutions_85a6e490-fbea-11df-a90e-29337a64ea2a3.4.3.3Real Property InfrastructureEnsure facilities infrastructure provides dynamic capabilities_85a6efd0-fbea-11df-a90e-29337a64ea2a3.4.4FDA will ensure that the facilities and laboratories that are necessary to support its strategic priorities are incorporated at the inception of program development. Accomplished through facilities improvements and alterations to address new requirements, the solicitation of adequate laboratory capabilities from the private sector, and agreements with other Federal, State, and local agencies with the appropriate capabilities, FDA will consistently improve its ability to meet the facility needs for its dynamic goals.Laboratory CapabilitiesCoordinate available laboratory capabilities with stated research agenda and mission critical laboratory needs_85a6f7e6-fbea-11df-a90e-29337a64ea2a3.4.4.1Laboratory Modernization Implement modernization of current laboratory infrastructure/inventory_85a6ffde-fbea-11df-a90e-29337a64ea2a3.4.4.2Strategic CommunicationsImprove the management of FDA by providing ongoing oversight, evaluation, and analysis of policies and programs and by ensuring effective strategic communications_85a70a06-fbea-11df-a90e-29337a64ea2a3.4.5For FDA to achieve its mission of promoting and protecting the public health, the agency must have a well-defined communications strategy to address the information needs and concerns of both internal and external audiences. An FDA strategic communication strategy will ensure the agency has clear and concise messages about its work and will ensure those messages reach the right audiences using the most effective channels. Communication ChannelsEvaluate and improve key agency communication channels, including the FDA website_85a71230-fbea-11df-a90e-29337a64ea2a3.4.5.1CoordinationMore effectively coordinate development and execution of internal and external agency communications_85a719ec-fbea-11df-a90e-29337a64ea2a3.4.5.2Strategic Plan for Risk CommunicationsImplement the FDA Strategic Plan for Risk Communications_85a72464-fbea-11df-a90e-29337a64ea2a3.4.5.3Process ImprovementFoster a culture of continual business process improvement to improve the overall operation and effectiveness of FDA_85a72cde-fbea-11df-a90e-29337a64ea2a3.4.6The agency will maintain a culture of continual business process improvement to strengthen the overall operation and effectiveness of FDA. Business process improvements supported by collaboration and knowledge management tools will foster input from FDA programs, stakeholder, and advisory groups, such as the FDA Science Board, to help define and meet FDA scientific, regulatory and administrative needs and priorities. Collaboration supporting scientific outreach, training, and research and development activities will advance FDA’s mission with sister agencies, global regulatory partners, academia, innovators, and consumers. The ability to better coordinate efforts will increase quality, productivity, and transparency for selected business processes.Performance ManagementImplement program performance management through the FDA-TRACK initiative_85a734ae-fbea-11df-a90e-29337a64ea2a3.4.6.1Evaluation and Improvement ProjectsConduct targeted program evaluations and business process improvement projects_85a74188-fbea-11df-a90e-29337a64ea2a3.4.6.2Open GovernmentImprove transparency, collaboration, and participation_85a74a02-fbea-11df-a90e-29337a64ea2a3.4.7President Obama has committed his Administration to an unprecedented level of openness in government. Following the leadership and commitment of President Obama and HHS Secretary Kathleen Sebelius to transparent and open government, FDA launched FDA’s Transparency Initiative in June 2009. As detailed in the HHS Open Government Plan, FDA will move forward to implement a series of changes to foster open government, including the continued development of FDA Basics, a Web-based resource that provides basic information about the agency and its work, and FDA-TRACK, FDA's agency-wide program performance management system. When fully implemented, FDA-TRACK will monitor more than 90 FDA program offices through key performance measures that will be gathered on a monthly basis. FDA will explore additional strategies to enhance transparency of FDA's operations and decision making processes, including the recommendations of the Transparency Task Force to make more information about the regulatory process available to the public and improve transparency to industry to foster a more efficient and cost-effective regulatory process. FDA will continue to seek input from the public and pursue opportunities to collaborate with others so that the agency can more effectively protect and promote the public health.TransparencyImplement the recommendations of the Commissioner’s Transparency Task Force _85a753a8-fbea-11df-a90e-29337a64ea2a3.4.7.1Transparency Task ForceHHS Open Government PlanImplement FDA’s responsibilities under the HHS Open Government Plan_85a75f4c-fbea-11df-a90e-29337a64ea2a3.4.7.2HHSImplementationImplement the agency’s Strategic Priorities through a tiered planning framework._85a766fe-fbea-11df-a90e-29337a64ea2a4Senior Leadership of FDAFDA will implement the agency’s Strategic Priorities through a tiered planning framework. First—and above all—the senior leadership of FDA will integrate these priorities into annual budget formulation and implementation planning. At the program level, each Center and the Office of Regulatory Affairs will develop plans that reflect program-specific strategies and metrics for monitoring progress toward achieving strategic objectives. And at the agency level, cross-program work groups will develop plans—such as the Strategic Plan for Risk Communication, Strategic Human Capital Plan, and the Information Technology Strategic Plan—to address cross-cutting strategies. OC will coordinate the alignment of program-specific and cross-program strategies with the goals and priorities of the Secretary of Health and Human Services and other government-wide priorities. Progress will be monitored by aligning annual executive performance plans and program performance metrics with long-term objectives and strategies. Program performance will be reviewed on a quarterly basis through the FDA-TRACK initiative and through periodic senior leadership reviews. _85a76e38-fbea-11df-a90e-29337a64ea2a2010-09-292015-09-302010-11-29http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htmOwenAmburOwen.Ambur@verizon.net