An Introduction to CVM
The Food and Drug Administration is the oldest comprehensive consumer protection agency in the U. S. federal government. Its origins can be traced back to the appointment of Lewis Caleb Beck in the Patent Office around 1848 to carry out chemical analyses of agricultural products, a function that the newly created Department of Agriculture inherited in 1862. Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs. Today, the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
The Center for Veterinary Medicine regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include animals from which human foods are derived, as well as food additives and drugs for pet (or companion) animals. CVM is responsible for regulating drugs, devices, and food additives given to, or used on, over one hundred million companion animals, plus millions of poultry, cattle, swine, and minor animal species.
- CVM's mission is to protect human and animal health. We foster public and animal health by approving safe and effective products for animals and by enforcing applicable provisions of the Federal Food, Drug, and Cosmetic Act (the Act) and other authorities.
- CVM is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. This authority is derived from the Federal Food, Drug, and Cosmetic Act. The Act was amended in 1968 to include sections which specifically address animal drugs. These amendments were designed to ensure that animal drugs are safe and effective for their intended uses and that they do not result in unsafe residues in foods.
- One of CVM's highest priorities is assuring the safety of the food supply. Due to the Center's work and the cooperative efforts of all FDA employees, the American food supply is among the safest in the world.
- The responsibilities of CVM have a direct effect on the safety of the human food supply and on the safety to animals of veterinary products.
- CVM works to educate consumers as well as the regulated industry; evaluates data on proposed veterinary products carefully before permitting them to be marketed; discovers violative marketed products through surveillance programs and initiates legal action, if necessary, to bring violators into compliance with the law; and conducts research to support Center activities.
In 1927, the Food, Drug, and Insecticide Administration, later known as the Food and Drug Administration (FDA), was formed. The Agency employed its first veterinarian, Dr. Henry Moskey, to evaluate vitamins and minerals in light of their claimed nutritional and treatment uses. A Veterinary Medical Branch was created in 1953 within the Bureau of Medicine, then part of the Department of Health, Education, and Welfare (DHEW). Recognizing the importance of animal health to the welfare of the country, the Secretary of DHEW established the Bureau of Veterinary Medicine (BVM) in 1965. At this time the major units within the Bureau were the Division of Veterinary Medical Review, Division of Veterinary New Drugs, and the Division of Veterinary Research. The number of units within BVM increased to five when the Secretary of DHEW approved a reorganization of BVM in 1970, which established two new divisions—Division of Compliance, and Division of Nutritional Sciences.
Within six years, the burden of increased responsibility and an ever-growing workload necessitated another major reorganization of the Bureau. This reorganization, which went into effect in 1976, divided the activities of the Bureau into four principal areas: (1) Pre-clearance review of applications and petitions for drugs and feed additives; (2) Post-marketing surveillance and compliance activities; (3) Research; and (4) Administration. In 1984, the Bureau of Veterinary Medicine became the Center for Veterinary Medicine (CVM). During the same year, the FDA created a Veterinary Medicine Advisory Committee (VMAC), which advises the Commissioner in discharging responsibilities as they relate to assuring safe and effective drugs, feeds and feed additives, and devices for animal use.
Today, CVM is an internationally recognized public health organization responsible for the evaluation, approval and surveillance of animal drugs, food additives, feed ingredients, and marketed animal devices. CVM works to increase the availability and diversity of safe and effective products that relieve animal pain and suffering, sustain their health, and improve animal productivity without compromising public health. CVM aligns and utilizes its resources wisely and makes practical use of state-of-the-art science and technologies to best accomplish its mission.
The Federal Human Capital Survey (FHCS), administered bi-annually to government agencies by the Office of Personnel Management (OPM), is a tool that measures employee perceptions regarding the critical areas of their work life that drive satisfaction, commitment, and retention in the workforce.
Based on the Best Places to Work (BPTW) taxonomy, derived from a model created to transform raw FHCS data into specific measures of workplace satisfaction, the following results were determined based on the most recent installment of the survey:
- 84% of CVM employees rated the Center favorably on the BPTW overall index of job satisfaction in the Federal Government—this is 21% higher than the government average! The index is comprised of the following items:
- I recommend my organization as a good place to work.
- Considering everything, how satisfied are you with your job?
- Considering everything, how satisfied are you with your organization?
- 85% of CVM employees rated the Center favorably in terms of Employee Skills/Mission Match.
- 85% of CVM employees rated the Center favorably in the area of Teamwork.
- 80% of CVM employees rated the Center favorably with regard to Supervisory Leadership.
High Performance Organization
Leadership Belongs to Everyone
CVM began exploring a High Performance Organization (HPO) Initiative in October 1996. The real work of HPO did not begin until January 1998 when all employees became familiar with HPO concepts after having attended a 2 ½ -day HPO workshop.
What is HPO? An HPO is one that pursues its vision and mission by improving systematically with feedback from internal and external stakeholders. It is rooted in the idea that leadership is a mindset, not a title--you lead from wherever in the organization you find yourself. An organization uses an HPO model as a way to see what is happening to itself and what it needs to do to improve its performance. This model helps an organization determine where it wants/needs to go, and having determined that, how to get there.
Determining our organizational direction comes about by creating a vision. We ask ourselves and our customers to help us determine what it is we should be accomplishing, then we can start looking at what we are doing now. Are they the right things done in the right ways for the right customers? Are we being effective in meeting the demands of our customers today? Are we prepared to meet their future demands/needs/wants?
Next, we can start looking at the strategies we will use to deliver the products and services wanted/needed by our customers. For example, do we use matrix teams, structural teams, individual efforts, a combination of both? Do we hire permanent employees or contractors? Do we have the right equipment? Do our people have the right competencies and have we established the ways in which they are to gain those competencies? Do the systems in place support use/implementation of those strategies?
We then create a strategic plan to define goals for the next 3-5 years. Goals are big picture, high-level areas for us to address. We subsequently create a tactical plan (1 year), which is more concrete, with measurable objectives.
All of these processes occur within an environment where managers solicit employees’ input and participation. The vision work of HPO continually occurs during regular Office and Division leadership meetings-- time during which the Office and Division step back from the urgencies of the regular workday to ask questions such as “Are we doing the right things in the right way?" and "Are we meeting the current needs of our stakeholders/customers?" These discussions most often occur in groups with people who know most about the issues at hand.
Throughout this continuous process, the Center is undergoing consistent transformation and continues its journey of higher performance within the context of a positive, supportive, and caring work environment.
Office of The Director
DEPUTY DIRECTOR FOR SCIENCE POLICY
Main Telephone: 240-276-9000
The Center Director serves as CVM’s primary representative and spokesperson concerning Center activities, interacting with the general public, industry, the media, other government agencies, and national and international organizations. The Office of the Director conducts communication and education programs, coordinates policy development and implementation, provides project management support for the Center, offers the services of the CVM Ombudsman, manages the Veterinary Medicine Advisory Committee, and coordinates the Center’s international activities. The Office of Animal Care and Use, located in the Office of the Director, coordinates accreditation and compliance with regulatory requirements of the Agency’s animal care and use programs, and provides consultation on these issues. The Center’s international work is also coordinated through the Office of the Director.
Office of Management
ASSOCIATE DIRECTOR FOR MANAGEMENT
PROGRAM AND RESOURCE MANAGEMENT STAFF
HUMAN CAPITAL MANAGEMENT STAFF
TALENT DEVELOPMENT STAFF
MANAGEMENT LOGISTICS STAFF
BUDGET PLANNING AND EVALUATION STAFF
Management Logistics Staff
Human Capital Management Staff
Program & Resource Management Staff
Budget Planning & Evaluation Staff
Main Telephone: 240-276-7000
The Office of Management (OM) is responsible for the day-to-day management and operations of CVM. More importantly, OM carries out its tasks through careful attention to its responsibility as a participating steward of the organization as a whole. The Office of Management is a service and support organization that specializes in administrative and technical problem solving and advocating CVM mission's needs. There are five staffs within OM: Management Logistics Staff, Human Capital Management Staff, Program & Resource Management Staff, Budget Planning & Evaluation Staff, and Talent Development Staff.
Office of Minor Use and Minor Species Animal Drug Development
Main Telephone: 240-276-9090
The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provided for the establishment of the Office of Minor Use and Minor Species Animal Drug Development. The Office reports directly to the CVM Director and is responsible for overseeing the development and legal marketing of new animal drugs for minor uses in major species (disease conditions that are rare in cattle, horses, swine, chickens, turkeys, dogs, and cats) and minor species (including pet animals such as ornamental fish, parrots, ferrets, guinea pigs, and iguanas, zoo animals; and species of agricultural importance such as sheep, goats, commercially produced fish such as catfish and tilapia, and honeybees).
Office of New Animal Drug Evaluation
Main Telephone: 240-276-8300
The Office of New Animal Drug Evaluation's (ONADE) major responsibility is to review information submitted by drug sponsors who desire to obtain approval to manufacture and market animal drugs. A new animal drug is deemed unsafe unless there is an approved new animal drug application. Virtually all animal drugs are "new animal drugs" within the meaning of the term in the Federal Food, Drug, and Cosmetic Act.
ONADE is divided into several different groups charged with the evaluation of animal drug submissions. Efficacy and safety information for the animals is evaluated by two therapeutic use groups (food animals and non-food animals), one group which evaluates production drugs and one group which evaluates generic drugs. Additional groups in the Office are responsible for reviewing other aspects of submissions. The human food safety group evaluates the safety to the public, the user (the producer or veterinarian), analytical methods, withdrawal times, and provides the drug tolerances, so that safe residue levels and conditions of use are provided to the public. The manufacturing chemistry group evaluates the manufacturing processes and quality control, while the scientific support group provides statistical support to ONADE and the rest of the Center.
Office of Surveillance and Compliance
Main Telephone: 240-453-6830
The Office of Surveillance and Compliance has primary responsibility for three of CVM’s four core functions: compliance-related actions, post-approval monitoring, and animal feed safety. The Office of Surveillance and Compliance monitors the safety and effectiveness of approved drugs after they enter the market. Working with the U.S. Department of Agriculture and State agencies, the Office monitors the occurrence of unsafe drug residues in meat, milk, and poultry products, and guides efforts to protect consumers through educational and enforcement activities related to drug residues. The Office coordinates enforcement actions against unapproved drugs that are on the market and that threaten public and animal health. The Office regulates the promotion and advertising of animal drugs to ensure that they are promoted in a truthful and non-misleading way, and each year receives more than 35,000 adverse drug events that are used to provide updated safety and effectiveness information to consumers.
Office of Research
Main Telephone: 301-210-4760
The Office of Research is the laboratory-based research arm of CVM and conducts applied research in support of regulatory decision-making related to each of CVM’s core functions. The Office of Research is housed in a state-of-the-art research complex located on 166 acres of land that includes approximately 38 acres of pasture, in Laurel, MD. In support of the drug review function, the Office of Research conducts studies in animal drug safety and effectiveness, anti microbial resistance mechanisms, metabolism, and standardization of test methods. The Office supports the compliance program of the Center through the development of analytical methods and evaluation of screening tests for detection of drug residues in imported and domestic food products. The Office of Research has an animal feed safety research program focusing on developing and evaluating microbiological and analytical methods for detection of natural and intentional contaminants (e.g., melamine, antimicrobial resistant bacteria, and the safety of new feed components, such as dried distiller’s grains).