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HHS Federal Program Inventory

Food and Drug Administration (FDA)

Budget Authority (in millions of dollars)/1

 FY 2012FY 2013FY 2014
Discretionary2,5062,5212,558

1/ FDA also receives user fees in a number of programs, including Foods, Biologics and Tobacco.

1.1.    Foods Program

The mission of the Foods Program is to protect and promote the health of humans and animals by ensuring the safety of the American food supply, animal feed and cosmetics, as well as the safety and effectiveness of animal drugs and devices. Outbreaks of foodborne illness and contamination events have a substantial impact on public health – an estimated 48 million foodborne illnesses occur every year resulting in an estimated 128,000 hospitalizations and 3,000 deaths.

Congress recognized the unique challenges faced by FDA in the area of food safety in the 21st century, and gave the Agency a modern legislative mandate to meet these challenges by enacting the FDA Food Safety Modernization Act of 2011 (FSMA).  FSMA directs FDA to build a food safety system based on the public health principle of comprehensive prevention, an enhanced focus on risk‐based resource allocation, and partnership across the public and private sectors to minimize hazards from farm to table.

The Foods Program focuses on securing high rates of compliance with science-based food safety and labeling standards by implementing integrated, prevention-oriented, and risk-based programs to protect the safety and security of foods and cosmetics and to ensure that food labels contain useful and reliable information.

  • Supported Strategic Goal:  Advance the health, safety, and well-being of the American people
  • Supported Strategic Objective:  Reduce the occurrence of infectious disease

1.2.    Human Drugs

FDA's Human Drugs Program is responsible for ensuring the safety and efficacy of prescription, generic, and over-the-counter drugs that are available to Americans. The Program is also responsible for monitoring marketed drugs to ensure patient safety, and monitoring drug quality to ensure the safety of the drug supply chain.

The Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs’ (ORA) field drugs program comprise FDA’s Human Drugs Program, which operates with funding from appropriations and user fees. CDER promotes and protects public health by ensuring safe and effective drugs are available to Americans, supporting the FDA priorities of improving healthcare quality and reducing healthcare costs. ORA ensures the safety and efficacy of human drugs through pre-market and post market inspections of domestic and foreign manufacturers. ORA works closely with CDER in identifying which manufacturing sites to inspect and determining appropriate regulatory actions to take when significant violations are found.

  • Supported Strategic Goal:  Strengthen health care
  • Supported Strategic Objective:  Improve health care quality and patient safety

1.3.    Biologics

The FDA Biologics Program began in 1902 with the passage of the Biologics Control Act. The program began in the Department of Treasury’s Hygienic Laboratory, later became part of the NIH in 1930, and finally was transferred to the FDA as the Bureau of Biologics. In 1988, the bureau became the Center for Biologics Evaluation and Research (CBER), which with the Office of Regulatory Affairs’ (ORA) Field Biologics Program, comprises the FDA Biologics Program.

The Biologics Program protects and promotes public health by ensuring the safety, purity, potency and effectiveness of biological products for the prevention, diagnosis, and treatment of a wide variety of human diseases, conditions or injuries. Most products that CBER regulates are complex biological entities including live agents and cells that involve novel and cutting-edge technologies and evolving science. The Biologics Program also protects public health against the threat of emerging infectious diseases, neglected tropical diseases, and potential bioterrorism agents. CBER ensures the safety, purity, potency and effectiveness of biological products, including vaccines and allergenic products, blood and blood products, cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of a wide variety of human diseases, conditions or injuries. The ORA Field Biologics Program supports the Biologics Program by assessing industry compliance, conducting risk-based inspections, assuring rights of human subjects, and monitoring recalls and complains. 

  • Supported Strategic Goal:  Strengthen health care
  • Supported Strategic Objective:  Improve health care quality and patient safety

1.4.    Animal Drugs and Feeds

The Animal Drugs and Feeds Program began in 1968 with the amendment of the Federal Food, Drug and Cosmetic (FD&C) Act to include new authorities for regulating animal drugs, devices, and additives used in animal feed. The Program supports FDA’s mission by approving safe and effective products for animals and by enforcing applicable provisions of the FD&C Act and other authorities.

The program provides timely premarket review of new animal drugs, ensuring that approved drugs are being used appropriately, providing scientific research solutions that ensure safety of the animal derived food and health products, and putting measures in place to minimize the illegal sale of unapproved drugs and preventing marketing of unsafe products. These efforts contribute to a food supply that is safe for both humans and animals, and protects billions of poultry, cattle, swine, horses and minor animal species, as well as more than 150 million companion animals in the United States. A combination of appropriations and user fee programs fund the regulatory process to assure product safety and effectiveness. User fees are authorized under the Animal Drug User Fee Act, the Animal Generic Drug User Fee Act, the FDA Export Reform and Enhancement Act, and FSMA.

  • Supported Strategic Goal:  Strengthen health care
  • Supported Strategic Objective:  Improve health care quality and patient safety

1.5.    Devices and Radiological Health

The Devices and Radiological Health Program began in 1976 with the passage of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. The program operates with appropriations and user fees. The Devices Program is responsible for the regulation of all medical devices, from simple articles such as tongue depressors to complex robotic equipment for surgery and cutting-edge diagnostic products such as implantable defibrillators. To protect the public from unnecessary exposure to radiation, the Devices Program also regulates radiation-emitting products that include microwave ovens, X-ray equipment, and medical ultrasound and MRI machines. In addition, the program monitors mammography facilities to make sure the equipment is safe and properly run.

The Center for Devices and Radiological Health (CDRH) assures that patients and providers have timely and continued access to safe, effective, and high quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science- based information about the products it oversees. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States.

  • Supported Strategic Goal:  Strengthen health care
  • Supported Strategic Objective:  Improve health care quality and patient safety

1.6.    National Center for Toxicological Research

The National Center for Toxicological Research (NCTR) was established in 1971 as a national scientific resource to conduct peer reviewed research that translates knowledge and technology into processes that improve FDA’s ability to assess the safety of regulated products. NCTR supports HHS and FDA strategic priorities by advancing regulatory science and innovation with new scientific tools, technologies, methods, early predictors of toxicity risk, and research data. NCTR provides colleagues with technical advice and training and leads national and international collaborations that enhance FDA’s basis for sound, science-based regulatory decisions worldwide and that improve global public health. FDA risk decisions and guidance documents use NCTR’s research data to improve patients’ safety and quality of life and to generate health-care savings.

  • Supported Strategic Goal:  Advance scientific knowledge and innovation
  • Supported Strategic Objective:  Advance the regulatory sciences to enhance food safety, improve medical product development, and support tobacco regulation

1.7.    Center for Tobacco Products

FDA’s Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. FDA executes its regulatory and public health responsibilities in three subprograms that support its strategic objectives:  reducing initiation of tobacco product use, decreasing the harms of tobacco products, and encouraging cessation among tobacco product users. To achieve its goals, FDA relies on its statutory authorities to regulate the manufacturing, marketing, and distribution of tobacco products.

  • Supported Strategic Goal:  Advance the health, safety, and well-being of the American people
  • Supported Strategic Objective:  Promote prevention and wellness

1.8.    FDA Headquarters and Program Support

FDA Headquarters (HQ) provides Agency-wide program direction and administrative services to ensure that FDA's consumer and patient safety programs are effectively and efficiently managed. Below are the seven primary HQ components responsible for providing Agency-level oversight and advice to FDA leadership and programs:  Office of the Commissioner, Office of Chief Counsel, Office of the Chief Scientist, Office of Operations, Office of Foods and Veterinary Medicine, Office of Medical Products and Tobacco, and Office of Global Regulatory Operations and Policy.

  • Supported Strategic Goal:  Increase efficiency, transparency and accountability of HHS programs
  • Supported Strategic Objective:  Strengthen financial, performance, and risk management to ensure program integrity, reduce improper payments and achieve program outcomes

1.9.       Indefinite User Fees

The User Fee program consists of the export certification and color certification user fees.

  • Export Certification:  FDA is required to issue certificates for the export of food, human drugs, animal drugs, animal feed, and devices. The certificates state that the product meets certain requirements of law. The purpose of the certificates is to promote the export of products made in the United States and to facilitate international trade. FDA’s ability to issue certificates in a timely fashion depends on FDA securing the resources necessary to offset the costs associated with issuing export certificates.
  • Color Certification:  The Federal Food, Drug and Cosmetic Act requires the certification of color additives. This program, which is administered by FDA's Center for Food Safety and Applied Nutrition, involves assessing the quality and safety of color additives used in foods, drugs, and cosmetics.
  • Supported Strategic Goal:  Increase efficiency, transparency and accountability of HHS programs
  • Supported Strategic Objective:  Strengthen financial, performance, and risk management to ensure program integrity, reduce improper payments and achieve program outcomes

1.10.                Buildings and Facilities

The Building and Facilities Program (B&F) is a critical element of FDA’s real property asset management program and provides direct support to accomplishing FDA’s public health mission. B&F supports FDA’s strategic goal to transform administrative systems and infrastructure to support FDA operations. Accordingly, funding is provided for new construction of mission critical laboratory, office, and support space as well as for renovations and needed repairs and improvements to 86 existing FDA-owned facilities located at six sites in the U.S. and Puerto Rico where operations critical to FDA’s public health mission are being conducted.

  • Supported Strategic Goal:  Increase efficiency, transparency and accountability of HHS programs
  • Supported Strategic Objective:  Improve HHS environmental, energy, and economic performance to promote sustainability

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