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FDA Leveraging: A Program-by-Program Extraction of Leveraging References
From the FY 2001 Annual Performance Plan & Report

February 1, 2000
Office of Planning

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Important Note: This report draws the leveraging-related information directly from the program sections of the FY 2001 Annual Performance Plan. It has been organized by program, and within each program, by program strategic goal. Most programs have two program strategic goals, the first representing pre-market, and the second representing post-market. Programs had been asked specifically to address leveraging at the strategic goal level, so you will see leveraging descriptions for most program strategic goals.

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Strategic Goal 1: Provide consumers quicker access to new food ingredients and dietary supplements, while assuring their safety and effectiveness.

FDA's ability to provide timely and expeditious review of new food ingredients and dietary supplements depends on enhanced communication, collaboration, and cooperation with the food industry, academia, consumers, professional organizations, and health care organizations. Several approaches to leveraging FDA's review efforts have been noted in previous sections. First, one process improvement initiative involves extensive consultation with potential petitioners before they file, and working closely with petitioners after they have filed, to quickly resolve problems encountered during review. Investing time early in the product development process will provide valuable feedback to potential petitioners and save FDA and the petitioner time during the review process. Second, the FDA's use of contract personnel for some petition review will permit FDA reviewers to focus their efforts on the more complex applications. Multidisciplinary review teams will continue to help rapidly resolve new and ongoing safety issues related to petition reviews.

Strategic Goal 2: Reduce the health risks associated with food and cosmetic products by preventing human exposure to hazards, monitoring product quality and correcting problems that are identified.

FDA's ability to fulfill its mission to assure the safety of food and cosmetic products depends upon enhanced communication, collaboration, and cooperation with the food industry, states, academia, consumers, professional organizations, domestic and international health care organizations, foreign governments, and international standard setting organizations. To accomplish this, FDA does the following:

In FY 2001, the Agency will focus on enhancing information exchange with industry, academia, and trade associations. The following are examples of the public health benefits of the Agency's outreach and communication initiatives.

To improve the coverage for the entire food supply, FDA will work with USDA, CDC, other federal agencies and states to establish an integrated food safety system for the nation. These federal and state partners collaborated extensively during 1998 and continue to collaborate in 1999 on issues related to the development of an integrated food safety system, including roles and responsibilities, outbreak response coordination and investigation, information sharing and data collection, minimum uniform standards and laboratory operation and coordination. In FY 01, FDA will continue to work with federal and state agencies to increase efforts toward making an integrated food safety system a reality. Effective coordination between all the collaborating food safety agencies involved in ensuring the safety of foods offers the best opportunity to significantly improve protection for consumers and achieve substantial reductions in the annual number of food-borne illnesses.

Other FDA leveraging activities include:

The Agency will continue existing collaborations with industry and academia to build upon research activities. The National Center for Food Safety and Technology (Moffett Center) and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) are key components of FDA's efforts to achieve established food safety objectives, especially those under the FSI and Produce and Imports Food Safety Initiative (PIFSI). These partnerships with academia and industry allow for more efficient use of research resources and enhance the quality of food safety and nutrition research and public health policy. The additional resources requested for FY 01 will permit FDA to expand risk assessment efforts in JIFSAN and the Moffett Center to fill critical gaps in its ability to assess exposure to foodborne hazards. This expanded risk assessment research effort will enhance FDA's ability to more rapidly and accurately characterize the nature and size of the risk to human health associated with foodborne hazards, as well as the effects of intervention. More rapid and accurate risk assessment techniques are critical to Agency efforts to provide consumers greater protection against potential hazards posed by foodborne pathogens and other contaminants.


Strategic Goal 1: Reduce human suffering and enhance public health by providing quicker access to important, lifesaving drugs, and assuring availability of safe and effective drugs.

FDA's ability to provide expeditious drug review is dependent upon enhanced collaboration and cooperation with industry, academia, professional societies and health care organizations. Agency scientists must maintain close communication with product sponsors throughout the product research and development phase. The ability to address problems early in the process prevents larger, costly difficulties and delays from occurring later in the review. This is, in essence, realizing major health benefit gains for a relatively small up-front investment. Additionally, opening access to outside expertise is an excellent way to leverage the Agency's limited science resources and apply the expanded knowledge when it is relevant in the review process.

Strategic Goal 2: Prevent unnecessary injury and death to the American public caused by adverse drug reactions, injuries, medication errors and product problems.

FDA draws on outside resources to strengthen its ability to assure the quality and safety of approved drugs. Research collaboration is an excellent method of leveraging external scientific expertise with that of the Agency. A prime example is the PQRI, a nonprofit foundation that serves as a vehicle for FDA, industry and academia to collaborate on key issues in pharmaceutical product quality through research and expert group analysis.

Many examples of leveraging exist in the Agency's compliance activities. FDA works with regulatory scientists in state and local organizations as well as national and international experts. Industry has widely participated in FDA-sponsored workshops to explain safety issues. One example is FDA's informal partnership to share test methods and procedures for drugs with regulatory scientists in the United Kingdom, Germany, Australia, Canada and the Netherlands. Combining samples has allowed the FDA to assemble a database of pharmaceutical ingredients, which serves as a reference in stopping the use of counterfeit drug ingredients. FDA has also worked with industry in technical workshops on laboratory testing of drugs.

The Agency looks upon consumers as partners in safe drug use. Communication is a critical element in managing risk associated with approved medical products. FDA has measured the usefulness of drug label information to the consumer and redesigned the label for OTC drugs, with prescription labels to follow. In partnership with national consumer organizations, FDA is disseminating educational information to consumers and health professionals about choosing the right medications, taking medications correctly and reporting adverse reactions. More drug information targeted to consumers is being made available on the Agency's web site. "Take Time to Care" is an outreach program directed to women about the safe use of medications. In cooperation with over 80 national organizations, including the National Association of Chain Drug Stores, FDA expects to reach 6.5 million women and positively affect their use of medications.


Strategic Goal 1: Ensure the expeditious availability of safe and effective human drugs, including biologics, for the prevention, diagnosis, and treatment of disease.

CBER's vision statement (CBER Vision: 2004) includes the following statement: "CBER demonstrates international leadership in regulation through development of innovative regulatory strategies and standards, a managed regulatory process, coordinated research, and use of partnerships." The efficient use of resources through leveraging is a CBER strategic goal. CBER will examine the feasibility of using external resources to perform some application review functions. CBER collaborates with other Department of Health and Human Services (DHHS) agencies (the Centers for Disease Control and Prevention [CDC], the National Institutes of Health [NIH], and the National Vaccine Program Office [NVPO]), the Department of Defense, and the Department of Veterans Affairs on issues relating to biological products. CBER actively participates in several staff fellow programs under the National Research Council (NRC), the NIH, and the Oak Ridge Institute for Science and Education (ORISE). Through these programs, CBER enhances the educational programs offered by academic institutions, strengthens its scientific and technical resource base, transfers its knowledge and technology to the academic community, and supports a growing national commitment to scientific education. Cooperative Research and Development Agreements (CRADAs), under the Federal Technology Transfer Act of 1986, are utilized by CBER.

FDA scientists continue to play an active role in many national and international groups and organizations involved in setting vaccine policy and utilization, including: the Interagency Group of the NVPO; the National Vaccine Advisory Committee; the Advisory Commission on Childhood Vaccines; the Advisory Committee on Immunization Practices; the Committee on Infectious Diseases of the American Academy of Pediatrics; the World Health Organization; the Children's Vaccine Initiative; and national vaccines control agencies such as the National Institute of Biological Standardization and Control (in the UK). For vaccine-related issues, FDA continues to work closely with the NIH (especially National Institute of Allergy and Infectious Diseases [NIAID]), and the CDC. The Office of Vaccines Research and Review continues to play an active role on committees related to AIDS, such as the NIH HIV Vaccine Selection Committee.

CBER personnel have played key roles in CISET, the PHS Interagency Working Group on Influenza Pandemic Preparedness, the Adult Immunization Plan, and the TB vaccine development plan.

Strategic Goal 2: Reduce the risk of biologics products on the market through assuring product quality and correcting problems associated with their production and use.

FDA continues its efforts to leverage the Agency's enforcement capability internationally by working toward mutual recognition agreements (MRAs) with the European Community and other nations so imports entering the United States meet the same high quality and safety standards of U.S. produced products.

FDA will continue to collaborate closely with other government and non-government regulatory organizations such as the National Institute of Health, Centers for Disease Control and Prevention, state health agencies, the American Red Cross, and the American Association of Blood Banks to assure that all policies are mutually consistent in guarding the safety of the nation's blood supply.


Strategic Goal 1: Increase the availability and diversity of safe and effective animal drugs and feeds.

The Animal Drugs and Feeds Program informs and assists product sponsors throughout the approval process starting with the pre-submission conference. The focus is to inform and assist firms in complying with the new legislation and streamline the product review process through phased review. Instead of waiting until all stages of product development are completed before contacting FDA, phased review helps industry stay on course through the drug development process by communicating requirements (or standards or criteria) for approval at each stage of development.

Staff College programs have been developed in FDA as a means of developing intellectual capital. The addition of a CVM Staff College will allow CVM to increase and maintain the scientific expertise in the Center, especially as it relates to animal science and veterinary medicine issues. The Staff College will use dollars to outsource the planning and implementation of training programs tailored to the needs of in-house scientists.

Collaboration with other agencies such as the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) is accomplished through interagency agreements. FDA also funds extramural research via contract and cooperative agreements and through collaboration with the University of Maryland known as the Joint Institute for Food Safety and Applied Nutrition (JIFSAN).

Strategic Goal 2: Reduce the risks associated with marketed animal products.

In order to assure that foods from animals are safe for human consumption, FDA works with other government agencies, state and local governments, and the private sector to take action to prevent or minimize potential public health hazards through development of early warning systems, investigations, risk assessment, scientific research, educational initiatives and regulatory action.

CVM partners with other federal and state agencies, our stakeholders, and regulated industry to develop and sponsor workshops, symposia, and publications with a focus on prevention in order to assure the public that accurate information is disseminated and that marketed animal drugs and feeds are safe and effective.

CVM is making a strong effort to educate its partners in industry by publishing and disseminating guidance, training initiatives in targeted high-risk compliance areas, and in working more closely with industry to resolve problems.

FDA is also involved in international harmonization activities that will remove trade barriers while ensuring the American public that imported products meet FDA's standards related to safety and efficacy. Part of the harmonizaton effort includes the development of Mutual Recognition Agreements (MRAs) that will address international equivalency issues. FDA must be able to assure the public that the processes used in other countries are as good as the processes in this country and the resulting products are safe for the intended use. Harmonization activities have been initiated with the European Union and Japan. The assessment of member state regulatory systems is an essential step in the harmonization process.

FDA is dedicated to expanding the National Antimicrobial Resistance Monitoring System (NARMS) by initiating the collection of bacterial isolates from other countries. We decided to begin the expansion by collecting isolates from a neighboring country. Mexico was chosen because it borders on the US, it supports our initiative to partner with Latin American countries, and it is cost effective. The purpose is to identify bacterial trends in Mexico and take action to prevent a foodborne outbreak in the US. In FY 99, we laid the groundwork to establish the international relationship that will ensure the projects success.


Strategic Goal 1: Provide quicker access to important, life-saving and health-enhancing medical devices, while assuring their safety and effectiveness.

FDA will be able to improve its ability to receive and distribute device-related scientific information into, around, and out of the organization in an efficient manner. Current plans include:

FDA is moving towards regulatory requirements that are consistent from nation to nation, which benefits both FDA and industry. Toward that end, FDA is recognizing an increasing number of international standards as a way to satisfy part of our 510(k) requirements. FDA has signed a Mutual Recognition Agreement with the European Union and has assumed chairmanship of the Global International Harmonization Task Force.

Strategic Goal 2: Reduce the risk of medical devices and radiation-emitting products on the market by assuring product quality and correcting problems associated with their production and use.

FDA will maintain inspection coverage of a growing number of Class II and Class III foreign device firms by working more closely with foreign regulatory bodies and conducting inspections most needed to develop joint inspection standards thus improving the safety of future U.S. device imports. This includes joint inspections of high-risk device manufacturers with European Union Conformance Assessment Bodies. Foreign workload is expected to increase by approximately 20 to 25%. Due to the workload increase, additional resources are necessary to maintain the present coverage rate for all firms. No class I manufacturers will be inspected.

In the area of Bioresearch Monitoring, recent feedback from Institutional Review Boards (IRBs) has shown that many need a better understanding of the differences between drug and medical device clinical trials. To respond to this need, FDA has increased outreach to IRBs. We've encouraged them to access our web page, and we've increased our participation in IRB seminars and workshops.


Strategic Goal 1: Develop new strategies and methods to test/predict toxicity and assess/detect risk for FDA regulated products (new and on the market).

One of the Agency's and the NCTR's highest priorities is to increase the ability of FDA reviewers to evaluate and predict rapidly and accurately the adverse effects of FDA regulated human products. This capability is critical to the Agency's ability to carry out its mission to analyze the safety and efficacy of FDA-regulated products during the premarket application review process. The human response to a toxic agent is a complex process.

NCTR researchers continue to develop laboratory methods that closely mimic human genetic response and predict human genetic damage due to drug interactions. Other NCTR programs through partnerships and collaborative projects with other federal agencies, use human data they have collected to understand the mechanisms of carcinogenesis, particularly as they are related to individual susceptibility (Performance Goal 2).

Human studies are conducted by our scientists in collaboration with peers at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER); other agencies (for example, the Environmental Protection Agency (EPA), the National Institute for Environmental Health Sciences (NIEHS), the National Toxicology Program (NTP); and universities, and medical centers around the world. International collaborative studies exploring human biomarkers will help to identify and potentially screen subpopulations at higher risk for developing certain types of cancer. This will improve the FDA's ability to determine and ultimately manage risk both in the United States and in collaboration with regulators and scientists throughout the world.

Strategic Goal 2: Develop computer-based systems (knowledge base) that predict human toxicity to enhance the efficiency and effectiveness of premarket product reviews.

An Agency-wide need, as identified by the NCTR Stakeholders, is the application of unique computer-based predictive systems to aid in assessing human toxicity to optimize non-clinical and clinical predictability. The NCTR, in partnership with other FDA centers, government agencies and industries, is developing a computer-based predictive system that can predict the toxicological activity of a compound by using biological indicators of damage, chemical structures via molecular modeling, and advanced mathematical and computational tools.

Performance Goal 3 within this strategic goal is designed to build on the prototype knowledge base system established to assess estrogenic compounds. Data developed at the NCTR on the toxicity of estrogen and anti-estrogen compounds, coupled with data obtained through scientific collaborations (government, industry, and academia) and published in the literature is incorporated into a learning set for predictive computations. The NCTR adapted statistical techniques and applied computational techniques to construct this model system. This knowledge will now be applied to other receptor binding systems such as androgens, anti-thyroid compounds, and chemicals effecting the neuroendocrine system. This technology will save FDA and other agencies both time and money in evaluating over 85,000 chemicals which require testing under legislative mandate.

The Agency needs to maintain a strong scientific computing capability to devise better tools to facilitate product approval. NCTR uses Center and on-site contractor resources (FTEs and dollars) from analytical chemistry, computational science, neurotoxicology, genetic and reproductive toxicology, and molecular epidemiology to achieve this performance goal. The novelty of this approach is the combination of several disciplines focused on a common goal. NCTR has also partnered with the Chemical Manufacturers Association (CMA) to develop the capabilities needed.

Strategic Goal 3: Conduct research to understand mechanisms of toxicity, assess new product technology, and provide methods for use in FDA standards development and product risk surveillance.

This goal includes three performance goals that address the Agency strategy for developing science-based product and process standards. Research supported through an interagency agreement with the NIEHS/NTP permits the NCTR to enhance rodent bioassay studies to include those based on mechanisms of toxic action to improve bioassay interpretation and potentially speed up product review and ultimately reduce the costs of pre-clinical trials (Performance Goal 4). Currently, the NCTR is conducting special studies on three compounds of special concern to the FDA: chloral hydrate, malachite green, and urethane in the presence of alcohol. Recently, phototoxicology facilities have been completed to evaluate the harmful effect of skin exfoliants, such as alpha hydroxy acid. Additionally, NCTR is conducting long-term multi-generation studies of compounds that disrupt normal endocrine function. These studies provide data on how estrogens and anti-estrogens may affect the developing fetus.

In collaboration with the FDA's CFSAN, Center for Veterinary Medicine (CVM) and as part of the Food Safety Initiative (Performance Goal 5), the NCTR is developing methods to identify markers of foodborne pathogens and to assess whether these microorganisms are undergoing change, thus becoming more virulent. To address the question of human risk from foodborne pathogens, NCTR scientists are working to build biologically based dose-response models of microbial infection to assess survival, growth, and infectious components of microbial risk. Research within this goal capitalizes on partnerships with other FDA centers and with other agencies such as the United States Department of Agriculture (USDA). Working with CFSAN and CVM, NCTR has committed resources to investigate the safety of genetically modified foods.

The Presidential Initiative to combat terrorist activities is a combined activity of the Department of Justice, Federal Emergency Management Agency, Department of Health and Human Services, Department of Defense (DOD), Veterans Administration, and state and local health departments. A focus of this activity is to enhance research and development to provide new capabilities to identify and to respond to potential chemical and biological threats of terrorism. NCTR is developing novel techniques to identify newly arising bacteriological and chemical contaminants in the food supply (Performance Goal 6). These techniques can crossover to provide methods of assessment for potential biochemical terrorist capabilities. To accomplish these goals, the NCTR needs continued review and input from other FDA centers, and outside experts to encourage and promote FDA-relevant research. NTP studies require the NCTR to maintain an accredited animal facility that includes a quality assurance staff, pathology capabilities, computerized record keeping, and high-quality animal husbandry and diet preparation support. The scientific expertise to support these goals range from analytical chemists to microbiology, biochemistry, molecular biology, neurotoxicology and biometry.


Strategic Goal: Reduce the easy access to tobacco products and inform and enlist the support of stakeholders, including retailers and the public, to assist in reducing young people's use of and demand for tobacco products.

FDA enforces the restrictions currently in effect primarily through the commissioning of state and local regulatory officials, who conduct unannounced purchase attempts using young people under the age of 18. FDA currently uses a multitude of media and approaches to ensure the greatest reach and utility of its messages. FDA maintains a toll free hot line and an Internet site, which provide retailers and the general public with easy access to brochures; materials and answers to frequently asked questions. As of January, 2000, the hotline has received more than 9,500 calls from retailers and consumers requesting materials, asking questions about the program, or reporting concerns. FDA also has provided retailers with in-store materials. In FY 1998 and 1999, the Agency mailed retailer kits to stores selling tobacco products. In addition, advertising is placed on radio, in newspapers, and on billboards reminding retailers of their responsibility.

The Agency has begun analyzing methods to monitor industry compliance with the restrictions on advertising even though these provisions are not yet in effect. For example, the tobacco rule prohibits all outdoor advertising within 1,000 feet of schools and playgrounds, as measured from the perimeter of the property. FDA has looked at satellite or computer mapping technology as an aid in determining the appropriate 1,000-foot area around schools and public playgrounds. This technology can then be made available to state and local government agencies as well as to private groups who can report violations to FDA. Similarly, the tobacco rule requires that all advertising appear in black and white text-only format except in publications read primarily by adults, as measured by a percentage and gross number of adult readers. FDA has met with industry officials in an attempt to identify an appropriate methodology for measuring adult and youth readership of publications.

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