Strategic Priorities: Strategic Goals and Long-Term Objectives
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3.1 Advance Food Safety and Nutrition4
FDA recognizes the need for a comprehensive food safety system from farm to table that is prevention-oriented and based on sound science 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 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, warehousers, transporters, retailers, and consumers. And FDA must establish science-based preventive controls and achieve high rates of compliance both domestically and internationally and ensure adequate scientific capacity to support public health decision making. The recently passed FDA Food Safety Modernization Act gives FDA new authorities to help achieve our goals and improve the safety of the food supply.
“FDA is committed to ensuring that the U.S. food supply continues to be among the safest in the world.”
Dr. Margaret Hamburg, before the Senate Committee on Health, Education, Labor and Pensions, October 2009
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 FDA Food Safety Modernization Act and the vision of an integrated, prevention-oriented, and risk-based food safety system.
 For purposes of this document, the term “food” includes human food, animal food/feed (including pet food), components, i.e. ingredients, of both food and feed, and dietary supplements for humans, except as otherwise noted.
Desired Public Health Outcomes
- Reduce adverse health effects and deaths from unsafe food and feed
- Reduce the rates of chronic diseases associated with food by providing consumer nutrition information that supports choice of a healthy diet by the U.S. population
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3.1.1 Ensure the Safety of the Food Supply from Farm to Table
FDA 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. This will include development and training in new inspection approaches. 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 standards for science-based preventive controls throughout the farm to table continuum; 2) achieving high rates of compliance with preventive control standards, both domestically and internationally; and 3) ensuring adequate scientific capacity to support risk-based public health decision making.
Trends and Challenges
FDA works to ensure that the nation’s food supply is safe, sanitary, wholesome, and accurately and properly labeled and in doing so has seen a number of recent trends and challenges:
· Increased globalization and complexity of the food supply chain;
· Declining resources for food safety activities;
· Continually evolving technologies around and threats to the food supply; and,
· 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 primarily 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 and 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 as mandated by the FDA Food Safety Modernization Act. 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.
Multiple 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), more than 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 may have differing objectives and perspectives on priorities. As envisioned in the FDA Food Safety Modernization Act, 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 integrated national food safety system is designed to unify and strengthen foodborne disease surveillance, investigation, and response systems 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 of FDA investigators to evaluate whether production and processing technologies are adequately controlling 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 provides consumers with clear information about the most important safe food handling, preparation, and storage practices, and provides 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.
Table 1. Summary of Long-Term Objectives for Food Safety
|Long-Term Objectives||Key Strategies|
|18.104.22.168 Establish standards for science-based preventive controls throughout the farm to table continuum|
- Prioritize development of targeted preventive control standards to address highest risks first
- Identify and prioritize knowledge gaps
- Measure the public health effects of the preventive controls
|22.214.171.124 Achieve high rates of compliance with preventive control standards both domestically and internationally|
- Utilize resources and information from public health, industry, and regulatory partners to create an integrated food safety system
- Create a modernized inspection, investigation, and enforcement system
- Improve incident preparedness, response, and communication
- Develop and begin implementing an import oversight plan
|126.96.36.199 Ensure adequate scientific capacity to support risk-based public health decision making|
- Strengthen predictive capabilities and enhance risk analysis to improve decision making
- Prioritize, integrate, and enhance regulatory research and methods development
3.1.2 Promote Healthy Dietary Practices and Nutrition
The 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. Excesses 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 and chronic disease.
Efforts to update the Nutrition Facts panel and FDA’s proposed rules on restaurant menu and vending machine labeling will also enable FDA to address the public health problems of obesity and chronic disease by improving nutrition information readily available to consumers — 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, a school-based program and teacher professional development program on nutrition developed with the National Science Teachers Association, and the Web-based program, Healthy Weight Management, are underway to promote healthful choices by consumers and build awareness of nutrition labels.
FDA will also focus its efforts to address the public health problem of chronic disease by reducing the levels of sodium in processed and restaurant foods. This initiative will empower consumers and also motivate food producers to develop more healthful food products.
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.
Table 2. Summary of Long-Term Objectives for Dietary Practices and Nutrition
|Long-Term Objectives||Key Strategies|
|188.8.131.52 Provide clear and timely information so consumers can choose a healthier diet and reduce the risk of chronic disease and obesity|
- Improve nutrition labeling on food packages and on restaurant menus as a tool for consumers seeking to construct healthier diets
- Implement the revised pet food labeling and definitions and standards for animal feed ingredients
|184.108.40.206 Encourage product reformulation to increase the availability of nutritious food products|
- Establish a sustained, multi-faceted coordinated effort to reduce the level of sodium in processed food
- Foster improved product formulation through labeling and other initiatives
FDA FOOD SAFETY MODERNIZATION ACT
The passage of the FDA Food Safety Modernization Act, the first major overhaul of our food safety law in over 70 years, transforms FDA’s food safety program by providing it with new public health mandates and enhanced tools for ensuring the safety of the food supply in the 21st Century. The central purpose of the new law is to better protect public health by preventing food safety problems, rather than primarily reacting to problems after they occur.
For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls.
- The legislation transforms FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them. It does so by requiring food facilities to evaluate the hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary.
- It also requires FDA to establish science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious illnesses or death.
Inspection and Compliance
The legislation recognizes that inspection is an important means of holding industry accountable for their responsibility to produce safe products. FDA will meet this expectation by:
- Applying its inspection resources in a risk-based manner; and,
- Innovating in its inspection approaches to be the most efficient and effective with existing resources.
Imported Food Safety
The legislation provides significant enhancements to FDA’s ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year. More specifically, relative to import food safety, the legislation:
- Requires importers to perform supplier verification activities to ensure imported food is safe;
- Authorizes FDA to refuse admission to imported food if the foreign facility or country refuses to allow an FDA inspection;
- Authorizes FDA to require certification, based on risk criteria, that the imported food is in compliance with food safety requirements; and,
- Provides an incentive for importers to take additional food safety measures by directing FDA to establish a voluntary program through which imports may receive expedited review of their shipments if the importer has taken certain measures to assure the safety of the food.
The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies – Federal, state, local, territorial, tribal, and foreign – to achieve our public health goals. It also recognizes the importance of building the capacity of state, local, territorial and tribal food safety programs. Among other provisions, it directs the Secretary to improve training of state, local, territorial and tribal food safety officials and authorizes grants for training, conducting inspections, building capacity of labs and food safety programs, and other food safety activities.
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3.2 Promote Public Health by Advancing the Safety and Effectiveness of Medical Products
A 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. FDA aims to fulfill its 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.
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3.2.1 Advance Human Drug Safety and Effectiveness
The 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.
According to Dr. Hamburg, “we are in the beginning of a new era for drug safety where protecting public health means that FDA’s responsibility doesn’t end when we grant a product market approval; that is merely the first check point in ensuring safety.”
Trends and Challenges
The drug review process has evolved considerably since passage of the Federal Food, Drug, and Cosmetic (FD&C) 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 effectiveness 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 be 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.
Table 3. Summary of Long-Term Objectives for Human Drugs
|Long-Term Objectives||Key Strategies|
|220.127.116.11 Promote public health by ensuring the availability of safe and effective new drugs|
- Identify and develop new scientific methods, models, and tools to improve the quality, safety, predictability, and efficiency of new drug development
- Conduct rigorous science-based premarket review to ensure that drugs that will be marketed to the public are safe and effective
- Ensure patient awareness of drug benefits and risks through effective communication of drug information
|18.104.22.168 Protect public health by ensuring the quality and integrity of marketed drug products|
- Secure the global supply chain to ensure that drugs are being manufactured and distributed to conform to established quality standards
- Improve drug quality oversight capacity through expanded use of risk-based methods
- Ensure public awareness of drug quality and integrity issues through effective consumer communications
|22.214.171.124 Protect public health by promoting the safe use of marketed drugs|
- Conduct postmarket surveillance to ensure early detection of new safety signals
- Conduct rigorous studies to understand new drug safety signals and effectively manage emerging risks
- Ensure patient and health professional awareness of drug risks and parameters for safe use
- Oversee drug promotion and marketing to ensure that marketed drug labeling and advertising are truthful and not misleading
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.
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
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3.2.2 Advance Biologics Safety and Effectiveness
The 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. Additionally, the program 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. Timely integration of advanced methods into product review will require sustained efforts.
Under the recently enacted Patient Protection and Affordable Care Act (Public Law 111-148), FDA has been given the authority and responsibility to regulate Biosimilar Biological Products, a newly defined class of medical products.
FDA is carefully evaluating the newly enacted biosimilar provisions contained in the health care legislation to determine how best to implement these new provisions. FDA has established a cross-center working group that has been charged with the responsibility for establishing policies and procedures to implement the new provisions in a manner that best serves the public health.
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.
Table 4. Summary of Long-Term Objectives for Biologics
|Long-Term Objectives||Key Strategies|
|126.96.36.199 Increase the nation’s preparedness to address threats as a result of bioterrorism, pandemic and emerging infectious diseases|
- Increase the nation’s preparation for pandemic influenza
- Facilitate development, evaluation, and availability of high-priority medical products (including medical countermeasures)
- Develop reagents, evaluate new methods, and implement policies that maintain a continued safe and adequate supply of blood and tissues during emergencies
|188.8.131.52 Improve global public health through international collaboration, including research and information sharing|
- Promote research and information-sharing globally to address diseases and emerging threats impacting human populations
- Facilitate global access to vaccines and biological products that address critical health needs
- Harmonize existing regulatory standards, where feasible, and work towards prospective harmonization of standards on new biological product areas to promote global public health
- Cooperate with international scientific efforts to establish and maintain reference materials and standards for biologics
|184.108.40.206 Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products|
- Integrate genomics, proteomics, high-sensitivity gene sequencing and other cutting-edge scientific technologies into regulatory oversight to expedite product development and review
- Improve the evaluation of effectiveness of products in clinical trials through the use of biomarkers and adaptive designs
- Advance regulatory research to facilitate product review, including development of relevant animal models
|220.127.116.11 Ensure the safety of biological products|
- Facilitate increased biologics manufacturing capacity and improved product quality
- Improve the use of healthcare data to enhance monitoring the safety and quality of licensed biological products
- Enhance statistical data analysis and mathematical models for improved epidemiological and risk assessments of regulated products
- Promote safe product use through effective risk management and risk communication
STEM CELL INITIATIVE
Stem cells are specialized cells that have the remarkable potential to develop into many different cell types in the body. 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 function.
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3.2.3 Advance Animal Drug 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.
The Animal Drugs and Feeds 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.
The Animal Drugs and Feeds Program is responsible for regulating drugs, devices, and food additives given to, or used on, over 150 million companion animals (e.g., cats and dogs), plus billions of poultry, cattle, swine, and minor animal species.
FDA approvals affect several hundred animal drug applications, including generics, for companion and 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.
FDA is interested in increasing 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. The Agency is concerned that the safety and effectiveness of these marketed products has not been demonstrated. FDA recognizes that the continued availability of a number of these products is important to meet the health needs of animals. The focus is not on revising the current new animal drug approval process. FDA is interested in examining additional mechanisms that utilize FDA’s existing regulatory framework as well as novel strategies not currently employed by the agency to increase the number of approved or otherwise legally marketed animal drugs. In that spirit, FDA plans to ask stakeholders for ideas on pathways to increase the number of legally marketed animal drug products. In addition, FDA is working on and developing an enforcement strategy for the removal of unapproved animal drugs. This two-prong approach will help ensure that safe and effective new animal drugs are legally available and that unsafe or ineffective products are not manufactured and distributed.
To minimize the development of antimicrobial resistance, FDA believes that additional steps need to be taken to ensure the judicious use of medically important antimicrobial drugs in animal agriculture. FDA is providing a framework to inform the public as well as shape policy regarding the appropriate or judicious use of medically important antimicrobial drugs in food-producing animals. The framework includes phasing in measures that would limit medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation. The recommended limitations reduce overall medically important antimicrobial drug use levels, thereby reducing antimicrobial resistance, while still maintaining the availability of these drugs for appropriate use. FDA remains committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a practical strategy to address antimicrobial resistance concerns that is protective of both human and animal health.
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 post-market functions, helps prioritize and manage risk, and optimizes the use of resources. FDA will use a comprehensive regulatory approach for integrating pre- and post-approval and compliance functions for animal drug products. The Animal Drugs and Feeds 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 support 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 and Feeds 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 5 summarizes the Animal Drugs and Feeds Program objectives and key strategies.
Table 5: Summary of Long-Term Objectives for Animal Drugs
|Long-Term Objectives||Key Strategies|
|18.104.22.168 Enhance knowledge of emerging science and technologies|
- Develop/expand science education and outreach programs focused on emerging science
- Incorporate/expand emerging science into regulatory mission requirements
- Adopt next generation high-throughput analytical technologies
|22.214.171.124 Reduce risk of harm from substandard and illegally marketed animal drugs|
- Develop a regulatory framework for legal marketing of unapproved drugs
- Develop a work plan for addressing unapproved new animal drugs
- Develop an enforcement strategy that addresses the illegal compounding of new animal drugs
|126.96.36.199 Ensure the judicious use of medically important antimicrobials|
- Issue final guidance on the judicious use of medically important antimicrobial drugs in food-producing animals
- Develop and issue additional guidance for industry regarding implementation of the recommendations outlined in the judicious use guidance
- Work collaboratively with other agencies and FDA stakeholders in implementing sound strategies for phasing in the judicious use guidance recommendations
- Issue revised order of prohibition on extra-label use of cephalosporin drugs
- Evaluate data on the use of antimicrobials in ethanol production
|188.8.131.52 Increase access to safe and effective animal drugs and reduce risk of harm from unsafe use of marketed animal drugs|
- Facilitate the introduction of innovative products and processes to FDA increasing the certainty of the regulatory pathway for these products
- Develop comprehensive regulatory approach for integrating pre- and post-approval and compliance functions
- Develop strategy to increase electronic reporting of Adverse Drug Events
- Develop and implement a risk-ranking system for tissue residue follow-up inspections
- Reinstitute milk residue testing for antibiotics other than beta lactams
|184.108.40.206 Enhance response to food/feed and drug safety events|
- Establish partnerships with veterinary diagnostic laboratories in developing the Veterinary Laboratory Response Network (VEtIRN) to respond to high priority chemical and microbial feed/drug contamination events
- Develop risk-based preventive controls for animal feed facilities to ensure the safety of animal feed
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 and Feeds 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 post-market (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 and Feeds Program in a matrixed format by engaging professionals with the appropriate expertise regardless of their administrative unit, to enhance the continuity of pre- and post-market 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 and Feeds 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.
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3.2.4 Advance Medical Device Safety and Effectiveness
FDA’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. In addition, the program 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. FDA monitors medical devices and radiological products for continued safety once they are in use, foster medical device innovation, and provide 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 predictability, consistency, and transparency 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 completed a comprehensive assessment of the 510(k) program and our use of science in our regulatory decision making and then announced steps it will take to improve the predictability, consistency, and transparency of our premarket review programs.
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 innovative medical devices. 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.” As part of this strategy, FDA plans to work with our federal government partners and external constituencies to facilitate the development of innovative medical technologies and devices.
Table 6. Summary of Long-Term Objectives for Medical Devices
|Long-Term Objectives||Key Strategies|
|220.127.116.11 Fully implement a total product life cycle approach that enables well-supported regulatory decisions at any stage of a device’s cycle|
- Enhance and integrate premarket, postmarket, and compliance information and functions by taking actions to:
- Strengthen Premarket Review
- Align scientific resources throughout program
- Optimize data collection and analysis
- Address challenges associated with globalization
- Enhance compliance capability
|18.104.22.168 Proactively facilitate innovation and address unmet public health needs|
- Foster development of innovative medical devices
- Develop a personalized medicine program
STRENGTHENING MEDICAL DEVICE PREMARKET REVIEW —510(K) AND SCIENCE REPORTS
To fully implement a total product life cycle approach means that, at any stage of a device or radiation-emitting product’s life cycle, FDA must make well-supported regulatory decisions that take into consideration all the relevant information available to us. Two major components of this long-term objective are our efforts to strengthen premarket review and to incorporate new science as predictably as is feasible into our decision making.
In September 2009, the 510(k) Working Group was charged with evaluating how well the 510(k) program was meeting its public health goals and exploring actions CDRH should take to strengthen it. At the same time, the Task Force on the Utilization of Science was charged with making recommendations on how the Center can quickly incorporate new science — including evolving information, novel technologies, and new scientific methods — into its decision making in as predictable a manner as is practical. These two groups outlined their findings and recommendations in two reports, “CDRH Preliminary Internal Evaluations (Volumes I and II),” that were released August 2010. The overall objective of the reports was to foster medical device innovation and improve patient safety.
FDA solicited and received a range of perspectives in developing the reports and on the recommendations contained in the preliminary reports at two public meetings and three town hall meetings, through three open public dockets and many meetings with stakeholders. Focusing efforts on making significant progress to implement actions that will have the greatest impact on fostering medical device innovation, enhancing regulatory predictability, and improving patient safety, in January 2011, FDA released its “Plan of Action for Implementation of 510(K) and Science Recommendations.” The document outlines which recommendations from the preliminary reports FDA intends to implement in 2011, as well as the projected timeline for completion or reaching a major milestone.
In addition to the FDA reports, the Institute of Medicine (IOM) is conducting an independent evaluation of the 510(k) program, and is expected to issue its report in mid-2011.
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3.3 Establish an Effective Tobacco Regulation, Prevention, and Control Program
FDA issued a final rule containing a broad set of requirements to significantly curb access to, 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.
On June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act, and FDA gained regulatory authority over tobacco products. Congress authorized the creation of the Center for Tobacco Products, or CTP, to oversee the implementation of the law. 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.
CTP’s mission is to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others.
CTP’s leadership team has been laying the foundation for regulating tobacco products by using a new population health standard. FDA’s action agenda rests on these public health principles: 1) developing and implementing science-based policy, regulations, and programs; 2) educating the public about tobacco products and their harms and risks; and 3) rigorously enforcing the law. Together, these principles form the framework for effective regulation of tobacco products — the nation’s leading cause of preventable death.
Trends and Challenges
Because there is no known safe tobacco product, the Tobacco Control Act establishes a new regulatory standard for FDA; product regulation will be based on whether it is “appropriate for the protection of the public health,” rather than the “safe and effective” standards used to guide drug or device regulations. This standard is to be based on available medical, scientific and other technological evidence to protect the public health and determined with respect to the risks and benefits to the population as a whole, including users and non-users of tobacco products.
Additionally, 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 nation’s 1-2 million tobacco product retailers are important new partners in FDA’s efforts to decrease youth initiation through tobacco product regulations. CTP is 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, and collaborating with its partners, 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 accessing and using tobacco products in the United States
Table 7. Summary of Long-Term Objectives for Tobacco
|Long-Term Objectives||Key Strategies|
|3.3.1 Develop and implement science-based policy, regulations, enforcement strategies, and compliance programs to protect the public health|
- Develop a science base for the regulation of tobacco products
- Based on the best science, use tobacco products regulatory authorities provided in the Tobacco Control Act to reduce the health consequences of tobacco use on the population by developing and issuing regulations and guidance to implement statutory and regulatory provisions
- Develop and implement rigorous compliance and enforcement programs to protect the public health
|3.3.2 Provide the public with accurate, trustworthy, and accessible information about tobacco products|
- Develop a research and an evaluation agenda for effective communication and public education strategies
- Develop a communication and public education strategy to address the public health risks of tobacco products
- Develop a communication and public education strategy to help reduce the initiation and use of tobacco products
- Develop opportunities to collaborate with other partners to further the Center’s mission and public health goals
- Commit to transparency with the public and other stakeholders
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3.4 Managing for Organizational Excellence and Accountability
Managing for operational excellence and accountability across strategic program areas will ensure an effective framework for implementing the program initiatives within the Office of the Commissioner (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 Management
FDA’s ability to recruit, develop, and retain a diverse workforce depends on a fully integrated, FDA-wide human capital management program that aggressively recruits, hires and retains skilled high-performing employees who can meet current and future challenges of the agency. Successful recruitment, training and development including leadership development, career management, performance management, and succession planning will enable FDA to retain a high performing and diverse workforce. FDA has established a strategic human capital plan that incorporates workforce and succession planning to assist in identifying and prioritizing our human capital needs. FDA will target its use of recruitment and retention flexibilities to FDA’s mission critical occupations and ensure they are used consistently and appropriately to recruit and retain the nation’s top talent to ensure we are an employer of choice and that we meet our critical mission in serving the American public. FDA will work in partnership with OPM and HHS to maximize the use of the Hiring Reform initiatives which include more efficient processes in hiring and on-boarding talent. The new HHS Accelerated Hiring Process was implemented in July 2010 on an agency-wide level. In FY 2011, using this new process, FDA will assess baseline data using FDA-TRACK and FDA will develop and implement, in collaboration with HHS, improved agency-wide policies and procedures that will fully support all new timelines and processes. FDA will also continuously evaluate and improve our human capital planning processes to ensure we achieve the goal of being an “employer of choice” within the public health and safety community — an agency that recruits, develops, retains, and rewards high-performing employees. FDA will continue to be one of America’s best places in Government to work.
FDA 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 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, and accordance with appropriation law. FDA will work collaboratively to promote an agency-wide understanding of financial management principles; 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.
Information Technology (IT)
Effective 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 identify 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 an IT action plan that optimizes the use of IT resources to support FDA (and HHS) business priorities and goals, seeking to develop and implement technology solutions that grow as FDA’s needs change;
· 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 in accordance with U.S. Government laws, regulations, and directives; and,
· Managing IT projects and investments to demonstrate progressive incremental improvements supporting achievement of FDA program and high-priority initiative objectives.
FDA is near completion of an ambitious infrastructure modernization program to lay the foundation for modern, networked computing 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 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.
Real Property Infrastructure
FDA 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.
For 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.
The 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.
President 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, to better explain the basis for FDA’s decisions, and to 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.
Table 8. Summary of Long-Term Objectives for Operational Excellence and Accountability
|Long-Term Objectives||Key Strategies|
|3.4.1 Recruit, develop, retain, and strategically manage a world-class workforce|
- Establish and implement Strategic Human Capital Plan
- Use recruitment and retention flexibilities that are targeted to FDA’s mission critical occupations and promote inclusion and diversity at all levels of the workforce
- Partner with HHS to implement strategies that promote improvements in the accelerated the hiring process
- Implement hiring strategies to ensure a diverse FDA workforce that is reflective of the nation and comply with Presidential Executive Orders regarding equal opportunity employment
|3.4.2 Ensure program integrity and responsible stewardship through effective administration of fiduciary responsibilities|
- Ensure vigorous oversight of financial reporting process to sustain a culture of honesty and high ethical standards
- Implement timely, collaborative, and transparent financial planning process that ensures most effective allocation of limited resources to support the FDA’s mission
- 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
|3.4.3 Implement an IT modernization program to support state-of-the-art networked information and shared data resources|
- Manage IT products and services to create a secure, reliable, and effective computing environment
- Provide effective services based on continuous, customer-focused improvement of IT management processes
- Ensure that agency program and administrative components work collaboratively and proactively to plan and implement effective solutions
|3.4.4 Ensure facilities infrastructure provides dynamic capabilities|
- Coordinate available laboratory capabilities with stated research agenda and mission critical laboratory needs
- Implement modernization of current laboratory infrastructure/inventory
|3.4.5 Improve the management of FDA by providing ongoing oversight, evaluation, and analysis of policies and programs and by ensuring effective strategic communications|
- Evaluate and improve key agency communication channels, including the FDA website
- More effectively coordinate development and execution of internal and external agency communications
- Implement the FDA Strategic Plan for Risk Communications
|3.4.6 Foster a culture of continual business process improvement to improve the overall operation and effectiveness of FDA|
- Implement program performance management through the FDA-TRACK initiative
- Conduct targeted program evaluations and business process improvement projects
|3.4.7 Improve transparency, collaboration, and participation|
- Implement the recommendations of the Commissioner’s Transparency Task Force
- Implement FDA’s responsibilities under the HHS Open Government Plan
4For purposes of this document, the term “food” includes human food, animal food/feed (including pet food), components, i.e. ingredients, of both food and feed, and dietary supplements for humans, except as otherwise noted.
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