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Animal Drugs and Feeds

<< Return to FY 2007 Budget Summary

 

  FY 2005
Actual
FY 2006
Enacted 1/
FY 2007
Estimate
Increase
or Decrease
Program Level $98,022,000 $98,882,000 $105,031,000 +$6,149,000
Center $62,898,000 $64,040,000 $69,253,000 +$5,213,000
FTE 369 385 406 +21
Field $35,124,000 $34,842,000 $35,778,000 +$936,000
FTE 241 228 230 +2
Program Level FTE 610 613 636 +23
Budget Authority $90,484,000 $89,581,000 $95,494,000 +$5,913,000
Center $55,360,000 $54,739,000 $59,716,000 +$4,977,000
Field
$35,124,000 $34,842,000 $35,778,000 +$936,000
Pandemic Preparedness
0 0 $4,868,000 +$4,868,000
FTE 0 0 14 +14
Trigger Needs for ADUFA
+$2,475,000
FTE
+17
Cost of Living
+$1,299,000
Strategic Redeployment
-$2,729,000 -$2,729,000
FTE
-8 -8
Budget Authority FTE 571 537 560 +23
User Fees $7,538,000 $9,301,000 $9,537,000 $236,000
 ADUFA Center $7,538,000 $9,301,000 $9,537,000 +$236,000
User Fee FTE 39 76 76 --

1/ Includes a one percent rescission.

 

 Historical Funding and FTE Levels
Fiscal Year Program Level Budget Authority User Fees Program Level FTE
2003 Actual $87,659,000 $87,659,000 $0 596
2004 Actual $84,441,000 $83,358,000 $1,083,000 595
2005 Actual $98,022,000 $90,484,000 $7,538,000 610
2006 Enacted $98,882,000 $89,581,000 $9,301,000 613
2007 Estimate $105,031,000 $95,494,000 $9,537,000 636

 

Statement of Budget Request

 

The Animal Drugs and Feeds Program is requesting $105,031,000 in program level resources to accomplish its mission, including activities:

  • 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, and other authorities;
  • Process premarket applications as quickly as possible to increase the availability and diversity of safe and effective veterinary products that relieve animal pain and suffering, while ensuring that these products are safe, wholesome and free of drug residue when they reach the consumer; and,
  • Monitor marketed animal drugs and feed products to minimize harm to humans or animals that might arise from the use of these products. The Program accomplishes this work through science-based review of drug experience reports, nationwide monitoring systems, and compliance programs conducted by FDA field offices that include inspections, sample collections, analysis, investigations, and appropriate regulatory actions to control volatile goods and firms.

 

Program Description

 

The Animal Drugs and Feeds Program is administered by FDA's Center for Veterinary Medicine (CVM) and supported by our Office of Regulatory Affairs (ORA) field force. The authority to regulate animal drugs and medicated feeds is derived from the Food, Drug, and Cosmetic Act, which Congress amended in 1968 to include new authorities relating to animal drugs. These amendments ensure that animal drugs are safe and effective for their intended uses and that the drugs do not result in unsafe residues in foods.

In November 2003, the Animal Drug User Fee Act (ADUFA) provided the authority for FDA to collect user fees for its animal drug review work. ADUFA is intended to supplement the appropriated resources for conducting the animal drug review program. These resources provided by the law will help the Program's scientists keep pace with the rapid advances in science and medicine that drive the quality of health care for animals.

In 2004, Congress enacted the Minor Use and Minor Species Animal Health Act, a statute designed to help make more medications legally available to veterinarians and animal owners to treat minor animal species and also uncommon diseases in the major animal species. The Act is designed to help pharmaceutical companies overcome the financial roadblocks they face in providing animal drugs that have limited demand.

The safety of the food supply is a paramount concern for the Program, as the average American consumes nearly 200 pounds of meat and fish, 30 pounds of eggs, and 585 pounds of dairy products each year. While most of these food products are regulated by the USDA, FDA ensures that animal drugs and feeds used in the care of food producing animals do not result in unsafe residues in food harvested or produced from these animals. ORA supports CVM by conducting preapproval inspections of both domestic and foreign establishments and other premarket-related activities. These activities include bioresearch monitoring of clinical research and laboratory method validations needed for premarket application decisions, and inspections of manufacturing facilities to determine if the factory is able to manufacture the product to the specifications stated in the application.

 

The Program's scope is far-reaching, its customers include:

  • 140 million dogs and cats
  • 6 million horses
  • 9 billion chickens
  • 275 million turkeys
  • 95 million cattle
  • 60 million pigs
  • 6 million sheep
  • 296 million humans in the U.S.

ORA also supports CVM by conducting post market inspections such as Bovine Spongiform Encephalopathy (BSE) and other high risk inspections on an annual basis. In addition to overseeing regulated products on a surveillance or "for cause" basis, ORA staff also responds to emergencies and investigates incidents of product tampering and terrorist events or natural disasters.

CVM's priorities include, but are not limited to, public and animal health activities such as animal drug review, antibiotic resistance, prevention of BSE and the safety of food derived from genetically modified animals.

 

Performance Analysis

 

During the latest performance period (FY 2005), the Animal Drugs and Feeds program expects to successfully achieve the target for its ADUFA performance goal when data becomes available in January 2007, and did meet its two field performance targets for FY 2005. The program met the FY 2004 performance goal when final data became available in January 2006. Additional information about the ADUFA goals and results are provided in the Performance Detail section and will be available in the FY 2005 ADUFA Performance Report.

With the passage of the Animal Drug User Fee Act (ADUFA) of 2003 and the resulting availability of user fees, the Program changed its new animal drug review performance goals to reflect the more ambitious performance target plans under ADUFA. Since the ADUFA fee structure is predicated on supplementing existing appropriated funding, the performance goal target below is dependent upon a sustained level of base and user fee resources. See the Performance Analysis Appendix for detailed discussion of the performance goal and target highlighted below.

Performance Highlight:

FY 2007 Goal Target FY 2004 Results Context
Complete review and action on 90% of original NADAs & reactivations of such applications received during FY 2007 within 200 days. CVM completed review and action on 100% of original NADAs & reactivations of such applications received during FY 2004 within 295 days. The user fee program reflects the implementation of a five (5) year plan to improve the performance for animal drug review.

 

Program Resource Changes

 

Pandemic Preparedness: + $4,868,000 and 14 FTE

The National Strategy for Pandemic Influenza, issued by President Bush November 1, 2005, guides our nation's preparedness and response to an influenza pandemic, with the intent of (1) stopping, slowing or otherwise limiting the spread of a pandemic to the United States; (2) limiting the domestic spread of a pandemic, and mitigating disease, suffering and death; and (3) sustaining infrastructure and mitigating impact to the economy and the functioning of society. The Strategy charges the U.S. Department of Health & Human Services with leading the federal pandemic preparedness.

FDA will focus resources on developing an analytical method to detect the two major antiviral drug classes in tissues. The validated method would allow U.S. federal laboratories to detect, quantify the amount and confirm the identity of any of the known and possibly similar black market antiviral agents. Specifically, FDA will:

  • Prohibit extra label use of antiviral drugs and ensure that drugs are not used in veterinary medicine that increase drug resistance, compromising the treatment of people for avian influenza;
  • Develop methodology for detecting antiviral residues in poultry and coordinate with USDA to sample and test poultry products at import inspection stations, and poultry processing plants for traces of antiviral residues;
  • Develop and implement plans for containment and disposal of animal feed that has or may have been contaminated with avian flu agents;
  • Participate in exercises with other federal and state agencies to ensure proper policies and programs are in place, and adequate response capabilities are available and educate producers, veterinarians, feed industry and others about the public health threat posed by avian influenza;
  • Support research projects, with a focus on analytical methods for detecting illegal use of certain drugs and other compounds;
  • Assist with appropriate enforcement actions to protect human and/or animal health (e.g., quarantine of animal products or articles);
  • Provide extensive outreach and training in manufacturing quality. Conduct timely and efficient inspections of manufacturing facilities to assure product quality and prevent problems that threaten safety or availability of products essential to respond to the pandemic threat; (Field Activity)
  • Improve FDA's capacity to conduct domestic and import surveillance and respond to reports of food or foodborne illness associated with viruses; and, (Field Activity)
  • Issue custom alerts to prevent the illegal importation of antivirals. (Field Activity)

Appropriated User Fee Trigger Needs -- Maintaining Animal Drug Review and Medical Device Review Programs: + $ 2,475,000 and + 17 FTE

To meet the statutory requirements for collecting Animal Drug and Medical Device User Fees, FDA must spend a minimum amount of appropriated resources, indexed to the cost of living, on the review process. If the appropriation and/or spending do not meet these minimum requirements (known as user fee triggers), then the agency is unable to receive the supplemental user fee funding and the programs terminate. The additional budget authority is needed to ensure that the trigger requirements are met. The Agency's request amount is $7,425,000 and 45 FTE. For the Animal Drug Review Program, the Center for Veterinary Medicine's portion is $2,475,000 and 17 FTE.

Cost of Living-Pay: + $1,299,000

FDA's request for pay inflationary costs is essential to accomplishing its public health mission. Payroll costs account for over sixty-percent of our total budget, and the Agency is no longer able to absorb this level of inflation on such a significant portion of its resources. The increase will allow FDA to maintain staffing levels, including a national cadre of specially trained scientific staff. The total estimate for pay increases is $20,267,000. The Animal Drugs and Feeds portion of this increase is $1,299,000. These resources are vitally important for FDA to fulfill its mission to protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use.

Animal Drugs and Feeds Reductions - $2,729,000 and -8 FTE

To fund FY 2007 priority initiatives such as Pandemic Preparedness, FDA re-deployed resources from base programs. To accomplish this strategic redeployment and fund new, high priority initiatives, Animal Drugs and Feeds reductions include: research, postmarket activities, and the Generally Recognized as Safe (GRAS) notification system.

 

User Fees

 

Current Law Fees

Animal Drug User Fee Act (ADUFA): + $236,000

The Animal Drug User Fee Act of 2003 (ADUFA) amends the Federal Food, Drug and Cosmetic Act and authorizes FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications. ADUFA helps the FDA, through a strengthened animal drug pre-market review program, to provide greater public health protection by ensuring that animal drug products that receive FDA approval as safe and effective are readily available for both companion animals and animals intended for food consumption. Additional resources provided by ADUFA will also help FDA scientists keep pace with the rapid advances in science and medicine that drive the quality of health care for our animals. ADUFA will help provide a cost-efficient, high quality animal drug review process that is predictable and performance driven. In FY 2007, FDA will work with Congress on the reauthorization of the Animal Drug User Fee Act. This increase of $236,000 will cover inflationary costs, as well as overhead and rent costs, for additional staff associated with the Act.

 

Proposed Fees (Reclassified as Mandatory - Non-Add)

Reinspection User Fee (Mandatory): $2,050,000 and 17 FTE (Non-Add)

The Administration is proposing authorizing legislation that requires establishments to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements. Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $22.0 million in revenue, an amount sufficient to fully fund reinspections. The Animal Drugs and Feeds program component of this user fee is $2,050,000 and 17 FTE.

Food and Animal Feed Export Certification User Fee: $63,000 (Non-Add)

The Administration is proposing legislation authorizing FDA to collect user fees for issuing food and animal feed export certificates. Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007. FDA currently funds this activity through discretionary appropriations. Imposing a fee would generate $3.5 million in revenue, an amount sufficient to fully fund the export certificate program. Private sector exporters would bear the cost of the program, but would reap its benefits through the Agency's enhanced ability to facilitate exports of their products. The Animal Drugs and Feeds program component of this user fee is $63,000.

 

Justification of Base

 

FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products

 

The Program will use base resources to better enable consumers to make informed decisions weighing benefits and risks of FDA-regulated products as well as to promote improved patient and consumer safety by reducing risks. These activities include safety of animal-derived food and preparation for terrorist actions.

 

Food Safety

Millions of people get sick annually from contaminated food they eat. Some foodborne illnesses are due to harmful or illegal residues in animal products, while other illnesses are due to microbiological infection. To safely manage animal drug use domestically and internationally and have safe food from farm to table, we must have the knowledge to make proactive, sound science based decisions. In pursuit of this, FDA will:

  • Monitor, sample, and investigate reports of pesticide, chemical, and microbiological contamination of animal feed and take enforcement actions as appropriate.
  • Screen and survey animal feeds and animal feed components for the presence of bacterial pathogens.
  • Review previously approved new animal antimicrobial drug submissions with respect to antimicrobial resistance and human food safety considerations.
  • Review new animal food additive submissions to improve safety of edible animal products.

 

FDA Releases 2003 NARMS Retail Meat Annual Report

FDA has recently published its 2003 National Antimicrobial Resistance Monitoring System (NARMS) Retail Meat Annual Report, which reports on the prevalence of antimicrobial resistance among zoonotic foodborne bacteria. The report provides data on the prevalence of antimicrobial resistant foodborne and commensal bacteria among retail meats, comprising results from nearly 5000 samples. The results generated by the NARMS retail meat program will establish a reference point for analyzing trends of antimicrobial resistance among these foodborne bacteria.

The NARMS retail meat surveillance program is a collaboration that includes the FDA, CDC and 10 participating FoodNet laboratories in the United States.

  • Continue to develop a comprehensive risk-based Animal Feed Safety System.
  • Continue to support the WHO's Global Salmonella Surveillance.
  • Maintain early warning systems by collecting information from Drug Experience Reports and Adverse Event Reports.

 

Research

FDA is responsible for the post-approval monitoring of retail meats for drug resistant foodborne pathogens under the National Antimicrobial Resistance Monitoring System (NARMS), and molecular typing of those pathogens as part of the national PulseNet program. FDA conducts research to understand the microbiology of animal feeds and the dissemination of resistant organisms via livestock feeds. The Agency also develops analytical methods to detect the presence of toxins, drugs, pesticides and other substances that could be used to intentionally contaminate U.S. animal feed supplies. FDA supports food safety and counterterrorism research activities to:

  • Monitor for the prevalence of enteric bacteria in retail meats and the changes in their susceptibilities to a panel of antimicrobial agents that are important in human and animal medicine.
  • Identify food animal species that may be associated with transmission of antimicrobial resistance to human bacterial pathogens.,
  • Develop and validate multi-residue drug screening methods and methods to detect the presence of prohibited toxic and microbiological substances that could be introduced into U.S. animal feed supplies.

 

FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health

 

Under this Agency strategic goal, it is FDA's intent to increase the number of safe and effective new animal drug products, including generic drugs, by increasing the predictability, efficiency and effectiveness of development as well as rapid, transparent and predictable review of applications.

 

Premarket Review

The availability of safe and effective animal drugs assures food animal producers that products will be safe, wholesome, and free of harmful drug residues when they reach the consumer. With the inception of the Animal Drug User Fee Act (ADUFA) of 2003, the Agency has been able to provide greater public health protection by ensuring that an adequate supply of animal drug products are approved to be safe and effective, and readily available for both companion animals and food animals. FDA will:

  • Further implement ADUFA and increase the availability of safe and effective animal products while working with regulated industry to minimize drug development time.
  • Met all the performance goals defined under ADUFA for FY 2007.
  • Conduct pre-submission conferences, meetings, and workshops with industry and develop policy and practical guidance documents as necessary to industry.
  • Conduct Bio-Research Monitoring inspections of studies for pending new animal drug applications, including Sponsor-Monitor, Clinical Investigator, and Good Laboratory Practice. Evaluate applications for the Application Integrity Policy to assure the accuracy and conduct of studies to support approval of new animal drugs.
  • Continue to work with the generic animal drug sponsors by meeting with the Animal Drug Alliance.
  • Continue with the preparation of implementing regulations for the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) to help make more medications legally available to veterinarians and animal owners to treat minor animal species and also uncommon diseases in the major animal species.

 

Biotechnology

  • Continue work with other Federal agencies to clearly define FDA's role in the regulation of animal biotechnology products.
  • Provide educational information on biotechnology products and work with animal biotechnology firms while a policy on transgenic animals is prepared.

 

Research

FDA supports the drug review function by conducting studies in animal drug safety and efficacy, antimicrobial resistance mechanisms, metabolism, standardization of test methods, and pharmcokinetics/pharmacodynamics. The goal of these efforts is to provide a science base for guideline development. FDA will:

  • Conduct method validation for new drug approvals for food producing animals; and,
  • Resolve new and emerging scientific issues that impact FDA's ability to make approval decisions.

 

FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight

 

Base resources will be used to conduct science-based risk management in all FDA regulatory activities; so that FDA's resources can provide the most health promotion and protection at the least cost for the public.

 

Bovine Spongiform Encephalopathy (BSE)

BSE or "Mad Cow Disease" is a transmissible, slowly progressive, fatal, neurological disease of cattle, caused by an abnormal form of cell protein. It is transmitted when meat and bone meal derived from infected cattle is used as a supplement in cattle feed. To prevent the establishment and spread of BSE through animal feed, FDA finalized a regulation in 1997 entitled "Animal Proteins Prohibited from use in Animal Feed" that prohibits the use of mammalian protein in ruminant feed. FDA will:

  • Prepare and implement final regulation that prohibits the use of certain high risk bovine tissues, such as brain and spinal cord in all animal feed.
  • Maintain database and a web-based, dynamic report summarizing the most current results of firms subject to BSE inspections.
  • Evaluate effects of risk management on the spread and the rate of elimination, with the help of the Harvard BSE Risk Assessment simulation.
  • The main focus of FDA's domestic BSE control program continues to be the collaborative program with our state regulatory counterparts to inspect facilities for compliance with the BSE/ruminant feed ban. FDA continues to expand inspection coverage into lower risk firms, while maintaining annual inspections of the higher risk facilities (renderers and feed mills) that process with prohibited material. (Field Activity)
  • FDA implemented an advanced analytical procedure for detection of prohibited material in animal feed into an assignment issued for 900 domestic and 900 import feed samples. This novel approach combines light microscopy with polymerase chain reaction (PCR) to determine and detect DNA from ruminants and non-ruminant mammalian species, supporting the BSE/Ruminant Feed Ban. (Field Activity)
  • Following the finding of a BSE positive animal in Texas, FDA, USDA/APHIS, the Texas Animal Health Commission (TAHC), and the Texas Feed and Fertilizer Control Service (TFFCS) successfully conducted a feed investigation with two main objectives; to identify all protein sources in the animal's feed history that could potentially have been the source of the BSE agent, and to verify that cattle leaving the herd after 1997 that were identified by USDA/APHIS as animals of concern (e.g. progeny and feed cohorts), were rendered at facilities in compliance with the BSE/ruminant feed ban regulation. (Field Activity)
  • Awarded contracts with state and local governments to perform BSE, feed manufacturers and illegal tissue residue inspections. Began designing eSAF to include the feed and BSE programs, which will be piloted in FY06. Auditor training was conducted for feed contracts. Reviewed and awarded Cooperative Agreement grants for BSE infrastructure improvement in eight states. The Agency and the States maintained and continued to develop new partnerships (e.g., BSE inspections) that have contributed to the exchange of inspection and sampling data and have facilitated the receipt of training and distribution of equipment to the states. (Field Activity).

 

Tissue Residues

  • Investigate reports of drug, pesticide, and chemical contaminant residue violations in edible animal tissues and take enforcement actions as appropriate.
  • Leverage FDA's Tissue Residue Information Management System with USDA's Residue Violation Information System on residue violators/violations to maintain tissue residue and feed contaminants compliance programs.
  • Provide technical support on residue findings of fluoroquinolones in imported seafood.

 

Animal Drug Compounding

Develop intervention measures over the shipment, receipt, and use of bulk active pharmaceutical ingredients in compounding animal drugs.

 

Zoonotic Diseases

Zoonotic diseases that have serious impact on human health are on the increase worldwide. Measures to control the spread of disease with a public health impact falls under the Public Health Service Act and the regulation is shared between FDA and CDC.

  • Provide educational outreach to veterinarians, pet suppliers, pet and other animal owners about zoonotic diseases such as monkeypox and Salmonella from pet turtles.
  • Investigate and take regulatory action where appropriate for violations of Public Health Service Act regulations restricting the sale and movement of animals that serve as a source of zoonotic diseases.

 

Counterterrorism

FDA's mission includes protecting the health and safety of all food producing, companion and other non-food animals, and assuring that food from animals is safe for human consumption. FDA must work to develop profiles of possible or probable food threats and points of attack. We must have the capacity to quickly and accurately identify outbreaks at any point in the food chain and to take prompt action to mitigate their effects. Base funding will enable FDA to:

  • Seek industry input to perform a risk analysis of the vulnerability of livestock and poultry feed.
  • Facilitate the sharing of information between existing databases and organizations and fill in any gaps that we identify in this "network" of database systems and other contacts.
  • Strengthen relationships with state partners and expand contracting efforts with state labs to provide surveillance and surge capacity related to counter terrorism activities.
  • Work with Iowa State University on a database that assists "first responders" by providing:quick identification of labs that have the capability to analyze feed and/or animal tissues for the presence of a chemical or biological agent.
  • Maintain a comprehensive inventory of registered animal drug establishments and listed animal drug products to assess the availability or anticipated shortage of animal drug products that would be needed to deal with terrorist attacks.
  • Work with CDC on a bioterrorism surveillance system for companion animals that can be used as an early detection mechanism for antibiotic resistant microbes and bioterrorist agents.

 

Animal Drug Production

Assuring the production, storage, and distribution of animal drugs and feeds containing animal drugs are in conformance with current good manufacturing practice helps to assure drug products are safe and effective and properly labeled. More specifically, FDA will:

  • Participate in the risk-based GMP Initiative activities.
  • Implement the pilot program for Voluntary Self Inspection Program for medicated feed manufacturers with a history of compliance-permitting the Agency to focus regulatory oversight on firms that are not in compliance or lack inspectional history.

 

Research

CVM is developing methods to detect material, prohibited by the Bovine Spongiform Encephalopathy (BSE) feed regulation, that could compromise animal feed safety. The availability of practical, validated methods to detect protein from different animal species could improve effectiveness and efficiency in the enforcement of the BSE feed regulation. CVM also supports the Center's illegal tissue residue compliance program through the development of analytical methods and the evaluation of screening tests for detection of drug residues in imported and domestic food products. FDA will:

  • Complete the validation of a real-time Polymerase Chain Reaction method that is capable of detecting cattle, swine, sheep, goats, horses, or deer material along with poultry, goose, and turkey to further enhance FDA's ability to detect potentially violative animal feeds. This effort includes the ability to identify up to three or four different prohibited species in a single reaction;
  • Evaluate commercially available rapid tests for animal proteins in animal feeds; and,
  • Develop and validate multi-residue drug screening methods.

FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century

This includes improvements through the planning, development and implementation of Agency and Center management programs and policies, such as:

  • Support and enhance employees' abilities to efficiently work with integrated IT systems to reach CVM goals;
  • Enhance the Center's Activity-Based Costing/Activity Time Reporting system, and integrate it into the business culture of the Center's operations in order to manage, define and assign the costs of doing business; and,
  • Direct the development and implementation of the competency-based Staff College and accompanying curriculum

 

Selected FY2005 Accomplishments

 

FDA Strategic Goal: Enhancing Patient and Consumer Protection and Empowering Them with Better Information about Regulated Products

 

Bovine Spongiform Encephalopathy (BSE)

The U.S. Food and Drug Administration (FDA) announced new measures to help further protect consumers against the agent thought to cause bovine spongiform encephalopathy (BSE, also known as "mad cow disease").

 

FDA Proposes "Mad Cow" Regulation

The Agency is proposing to amend its animal feed regulations to prohibit from use in the food or feed of all animals certain high risk cattle materials that can potentially carry the BSE-infectious agent. All of the proposed prohibitions, except for those related to tallow, have already applied to cattle feed since 1997.

The proposed regulation builds on a series of firewalls that include FDA's 1997 feed (e.g. for cattle and sheep), but allows these materials to be used in feed for non-ruminant species. The removal of high-risk materials from all animal feed -- including pet food -- will protect against the transmission of the agent of BSE that could occur either through cross-contamination of ruminant feed with non-ruminant feed or feed ingredients during feed manufacture and transport, or intentional or unintentional misfeeding of non-ruminant feed to ruminants on the farm.

 

Antimicrobial Resistance

 

FDA Announces Final Decision About Veterinary Medicine

FDA announced the Agency's final decision to no longer allow distribution or use of the antimicrobial drug enrofloxacin, class of drugs known as fluoroquinolones, for the purpose of treating bacterial infections in poultry. Scientific data showed that the use of this drug in poultry caused resistance to emerge in Campylobacter, a bacterium that causes foodborne illness. These resistant bacteria multiply in the digestive tracts of poultry and persist and spread through transportation and slaughter. They are a significant cause of foodborne illness in the U.S. Antimicrobial treatment is recommended for people with severe illness as well as the very young, the elderly, and people with certain medical conditions. Complications of such infections can include reactive arthritis and, more rarely, blood stream infections. Early treatment can mitigate symptoms and may decrease the risk of complications.

Fluoroquinolones used in humans are ineffective if used to treat these bacteria infections that are resistant to them. This failure can significantly prolong the duration of the infections and may increase the risk of complications. The proportion of infections that are resistant to this class of drugs has increased significantly since the use of this antimicrobial drug in poultry was approved in the U.S.

  • A database has been developed that is searchable from the web containing a listing of all antimicrobials approved for use in food animals.
  • Partnered with scientists at the United States Department of Agriculture (USDA) and relatedness among isolates; Universities in characterizing antimicrobial resistance, susceptibility and genetic.
  • Participated in the cooperative agreement with Mexico to determine the prevalence of Salmonella species and antibiotic-resistant E .coli in humans.
  • Completed development of a standardized in vitro susceptibility testing method for Campylobacter and incorporated the method into the NARMS program.
  • Completed the laboratory phase of a contract with the American Type Culture Collection to analyze antimicrobial susceptibility among banked historical collections of Salmonella, E. coli and Campylobacter. This will allow us to examine the historical susceptibility of pathogens to antimicrobial agents, to better understand the temporal trends of resistance development.

 

FDA Releases 2003 NARMS Retail Meat Annual Report

FDA has recently published its 2003 National Antimicrobial Resistance Monitoring System (NARMS) Retail Meat Annual Report, which reports on the prevalence of antimicrobial resistance among zoonotic foodborne bacteria. The report provides data on the prevalence of antimicrobial resistant foodborne and commensal bacteria among retail meats, comprising results from nearly 5000 samples. The results generated by the NARMS retail meat program will establish a reference point for analyzing trends of antimicrobial resistance among these foodborne bacteria. 

The NARMS retail meat surveillance program is a collaboration that includes the FDA, CDC and 10 participating FoodNet laboratories in the United States.

 

National Antimicrobial Resistance Monitoring System (NARMS)

  • The NARMS retail meat surveillance program switched from a convenience sampling scheme to a more statistically robust randomized sampling scheme.
  • Continued to improve NARMS testing methods including development and implementation of a Campylobacter broth microdilution method approved by the Clinical and Laboratory Standards Institute in 2005. This method is being used in Canada, Europe, Central South America, and WHO training laboratories worldwide.
  • Strengthened NARMS program by establishing a DNA fingerprinting database of Salmonella and Campylobacter isolated from NARMS retail meats. The database will provide useful information on multidrug resistance foodborne pathogens.
  • Released the second annual NARMS retail meat report September 30, 2005. This report provides 2003 data on the prevalence of antimicrobial resistant foodborne pathogens and commensal bacterial among retail meat and poultry samples, comprising results from nearly 5000 samples.
  • Partnered with other active and passive surveillance systems (e.g. FoodNet, PulseNet) to help public health officials better understand the dynamics of foodborne illness attribution in the United States.
  • Continued efforts to maximize cooperation and communication between FDA, USDA, and the CDC to increase efficient use of resources in addressing problems of mutual interest as well as harmonize data reporting.
  • Met with panel of outside experts for external review of all three arms of the NARMS program.

 

Food Safety and Surveillance

  • The draft framework for the Animal Feed Safety System was released in February 2005 and a second public meeting was held in April 2005 to present and receive public input. This document covers regulation of the labeling, production and distribution of all feed ingredients and mixed feeds at all stages of manufacture, distribution and use.
  • Completed development and instillation of cultural methods to be used in screening feeds and feed commodities for the presence of the Bacillus cereus group. This is part of our efforts to investigate issues of importance to animal feed security and support development of the Animal Feed Safety System.
  • Conducted Health Hazard Evaluations for several marketed veterinary drug products, determining their recall classifications and recommending the depth of recall based on the seriousness of potential health hazard to animals and/or humans.
  • Revised the Feed Contaminants Program 7371.003 Compliance Policy Guide so the agency is now included routinely as a laboratory to receive feed samples from FDA field investigators resulting from their annual feed mill inspections, allowing regular input into the microbiology and residue related issues associated with animal feeds.

 

Adverse Drug Events (ADEs)

  • The FDA Veterinary Medicine Advisory Committee made recommendations on the voluntary recall of the veterinary heartworm prevention drug product PROHEART 6 for dogs. Steps to eliminate or mitigate the safety issues associated with ProHeart 6 could not be found and FDA did not recommend returning the product to the market.
  • The Center received over 33,000 adverse experience reports, an increase of approximately 4,700 from FY 2004.
  • The Center began participation during the year in a pilot program that is intended to facilitate the electronic submission of adverse drug experiences reports.

 

FDA Strategic Goal: Increasing Access to Innovative Products and Technologies to Improve Health


DRUG PURPOSE
RUMENSIN (monensin) First drug ever approved for the claim "increased milk production efficiency" in dairy cattle. Cows make more milk consuming less feed. The drug improves energy efficiency by influencing the cow's gut flora toward a more energy efficient digestive population. It was approved previously in different classes (beef cattle, poultry) for different purposes (improved weight gain, treat coccidiosis).
REBALANCE (pyrimethamine and sulfadiazine) An antiprotozoal product indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.
TRIBUTAME (chloroquine phosphate, embutramide, lidocaine) A euthanasia product for dogs. The product is approved but not yet marketed, pending final product scheduling by DEA.
CYDECTIN f moxidectin) Injectable Solution for Beef and Nonlactating Dairy Cattle - for the treatment and control of various internal and external parasites in beef and nonlactating dairy cattle.
DRAXXIN (tulathromycin) Injectable Solution - for 1) treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni and for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni; and 2) treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and Haemophilus parasuis.
SPECTRAMAST LC Sterile Suspension (ceftiofur hydrochloride, 125 mg/mL) For the treatment of clinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli.
SPECTRAMAST DC Sterile Suspension (ceftiofur hydrochloride, 500 mg/mL) For the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.


Developed guidance to expedite the approval process including revision and republication of a new toxicology section for Guidance for Industry (GFI) #3, General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals. We also published for comment draft GFI #123, Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for Use in Animals.

 

Minor Use and Minor Species Animal Health Act of 2004 (MUMSAHA)

  • Establishment of the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) early in the fiscal year. By Mid-September, 2005, OMUMS had initiated the review process on more than 50 requests for Designation of drugs intended for minor use or minor species and had granted 5 of those requests. Designation provides for 7 years of marketing exclusivity upon approval of a designated drug, a significant incentive for sponsors to pursue approval.
  • On September 27, 2005, the Center published the proposed Designation regulations which establish formal procedures to implement a major portion of the MUMS act. This is the first of three sets of implementing regulations required to be published by the MUMS legislation.

 

Animal Drug User Fee Act (ADUFA)

  • On March 17, 2005, FDA posted the FY 2004 Performance Report to Congress for ADUFA. FDA met or exceeded all the review timeframes defined under ADUFA for FY 2004 for applications and submissions that were submitted in FY 04. As of September 30th, 2005, FDA has met or exceeded all of the performance goals defined under ADUFA for FY 2005 for applications and submissions that have been acted on.
  • FDA has made substantial progress in recruiting for its review staff and will meet its goal of having 50 percent of additional FDA review staff recruited and on-board by the first quarter of FY 2006.

 

Generics

  • Worked with generic animal drug sponsors by meeting on a regular basis with the Animal Drug Alliance.

 

Biotechnology

  • Worked with additional sponsors of animal biotechnology products to ensure that their progress is responsible but not unduly burdened as the Federal government prepares a policy on transgenic animals.
  • The Animal Biotechnology Working Group developed seminar programs, courses and a rotating detail program to continue to ensure that personnel are aware of the critical issues, possess the scientific skills, and are familiar with the regulatory environment necessary to address the rapidly evolving and highly technical issues associated with animal biotechnology.
  • Continued the development of a transgenic animal policy. The Center participated in on-going White House-level deliberations to evaluate the role of genetically engineered animals in the Coordinated Framework for the Regulation of Biotechnology.
  • Worked to update the draft Risk Assessment on Animal Clones and their Progeny, Proposed Risk Management Plan, and a draft Guidance for Industry (GFI) on the use of cloning technology in animal breeding and release of clones and their progeny into the food supply.

 

FDA Strategic Goal: Improving Product Quality, Safety, and Availability through Better Manufacturing and Product Oversight

 

Bovine Spongiform Encephalopathy (BSE)

  • FDA animal feed experts joined the USDA team to provide technical expertise in an audit conducted by the Canadian Food Inspection Agency in response to the detection of two cases of BSE in Canada in 2004. Records were reviewed, meetings were held and facilities across Canada were inspected. USDA issued a report of its findings on February 25, 2005.
  • Issued 10 Warning Letters for animal proteins prohibited in ruminant feed, and 15 class II recalls involving 15 firms and 25 products in response to violations of the BSE rule.
  • Provided BSE inspection training to FDA investigators as well as state inspectors during the fiscal year.
  • Provided personnel and expertise on BSE and animal feed issues to the U.S. Department of Agriculture in support of its efforts to reopen foreign markets for U.S. beef.
  • Continued the development of a real-time Polymerase Chain Reaction (PCR) based method capable of detecting cattle, swine, sheep, goats, horses, or deer material along with poultry, goose, and turkey for use in analyzing samples of animal feeds and feed ingredients in support of the animal protein prohibition. "Real-time" means that we can detect the presence of prohibited material as the reaction is taking place, so we do not have to further process the sample.
  • Completed the evaluation of a third commercially available diagnostic test marketed for the detection of ruminant proteins in animal feed. Like the other diagnostic tests previously evaluated, this test was much less sensitive than the methods the Agency uses (microscopy and PCR) for analysis of animal feed.
  • FDA implemented an advanced analytical procedure for detection of prohibited material in animal feed into an assignment issued for 900 domestic and 900 import feed samples. This novel approach combines light microscopy with polymerase chain reaction (PCR) to determine and detect DNA from ruminants and non-ruminant mammalian species, supporting the BSE/Ruminant Feed Ban. (Field Activity)
  • Following the finding of a BSE positive animal in Texas, FDA, USDA/APHIS, the Texas Animal Health Commission, and the Texas Feed and Fertilizer Control Service successfully conducted a feed investigation with two main objectives. The first objective was to identify all protein sources in the animal's feed history that could potentially have been the source of the BSE agent. The second objective was to verify that cattle leaving the herd after 1997 that were identified by USDA/APHIS as animals of concern, such as progeny and feed cohorts, were rendered at facilities in compliance with the BSE/ruminant feed ban regulation. (Field Activity)
  • Awarded contracts with state and local governments to perform BSE, feed manufacturers and illegal tissue residue inspections. Auditor training was conducted for feed contracts. (Field Activity)
  • Reviewed and awarded Cooperative Agreement grants for BSE infrastructure improvement in eight states. The Agency and the States maintained and continued to develop new partnerships (e.g., BSE inspections) that have contributed to the exchange of inspection and sampling data and have facilitated the receipt of training and distribution of equipment to the states. (Field Activity)

 

Tissue Residue

  • Completed a major revision of the Tissue Residue Compliance Program and implemented on August 1, 2005 to include instructions for investigating residues in seafood and other animal derived foods such as honey.
  • Successfully converted the Residue Violation Information System which contains information on all tissue residue violations/violators identified since 1988, to a web based application that uses an Oracle Relational Database and is shared with FSIS.
  • Studied the correlation of drug residue levels in tissues and fluids of beef steers, for use in the development of rapid screening test kits and completed their study of the long-term kidney depletion of gentamicin in beef steers.
  • Handled 83 feed recall events during FY 2005. Twenty of these recalls were related to drugs used in feeds, and six were due to BSE feed regulation issues - the feed contained or could have contained prohibited material and did not have the required caution statement.
  • Evaluated two commercially available rapid screening test kits, to determine if the tests could detect the presence of aflatoxins in finished feeds. Aflatoxins, a carcinogen, are naturally occurring mycotoxins that can contaminate corn and other grains, a potential for harm to animals consuming the feed.

 

Animal Drug Compounding

  • Inspected compounding pharmacies to reduce the risk of compounded veterinary drug products in food-producing and non-food-producing animals. Outcomes to date resulted in fewer than 40 percent of the completed inspections being considered for some form of regulatory action. Five warning letters have been issued.
  • Developed methods for a wide range of animal drug compounds. In the first phase of method development (during FY 2005), we validated a procedure for surveillance of 27 animal drug compounds from nine chemical classes.
  • In cooperation with ORA, provided FDA training to compliance officers, program monitors, and investigators on compounding animal drugs and compounding pharmacies, provided in-depth instruction, newly developed training, outreach materials and education on the AMDUCA, attendant regulations, proper drug use and residue avoidance.

 

Zoonotic Diseases

 

Salmonella in Turtles

  • The FDA amended the current regulation to reflect a change in responsibility for administering the regulation from FDA's Center for Food Safety and Applied Nutrition to FDA's Center for Veterinary Medicine. This action was taken to enable the agency to more effectively administer the provisions of the regulation.
  • FDA has investigated reports of salmonella in children ages 2-9 who have been in contact with pet turtles. FDA has issued warning letters in some of these cases and prepared information fact sheets explaining the human health hazards associated with turtles for FDA investigators and consumers.

 

MonkeyPox

We processed 153 requests for permission to transport animals under an interim final rule adopted by the FDA and the CDC in response to an outbreak of monkeypox.Most of the requests involved the shipment of wild prairie dogs and others were for movement from one zoo to another, moving to research institutions and educational purposes.

 

Dioxin

Issued an assignment for a nationwide survey to assess dioxin levels in rendered fat from swine, cattle, poultry, and mixed animal species; in yellow grease (restaurant fats/oils); and in agents (such as clay and diatomaceous earth) used to filter and/or bleach mammalian and poultry fats and presented data at an October 2004 scientific meeting on dioxin levels in grains, grain byproducts, fish meal, fish oil and forages.

 

Aquaculture

Modified the Compliance Program Guidance Manual 7371.006, Illegal Residues in Meat and Poultry to include residues in domestic seafood which will provide guidance to the FDA Field on how to conduct follow-up to residue violations in domestic aquacultured seafood.

 

Counterterrorism

  • Examined the potential use of certain veterinary antimicrobials for human use in a worse case emergency as requested by the National Security Council.
  • Trained a segment of the Renderers and Protein Blenders industry on performing risk analysis of their industry to try and prevent deliberate contamination events.
  • Participated in TOPOFF 3. One of the challenging agents was plague, which may be transmitted and perpetuated by the companion animal population, with fleas as a vector. Helped to develop a public guide entitled "Controlling Fleas on Your Pet: Recommendations for Pet Owners".
  • Assisted the Department of Homeland Security and other agencies in the completion of a draft National Preparedness Goal and the Target Capabilities list that will help states prepare for a wide range of emergencies including accidental or deliberate disease outbreaks, natural disasters, and nuclear and contamination events involving food and livestock.
  • Participated in the Agricultural Intelligence Group meeting regularly to exchange information and ideas about food security, and educated constituent organizations how to perform vulnerability assessments of animal feed production facilities.
  • Began to develop analytical methods to detect the presence of toxins, drugs, pesticides and other substances that could be introduced into the U.S. animal feed supplies by bioterrorists.

 

FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21st Century

 

Under this strategic goal, the Program supports the FDA's efforts to strengthen its infrastructure, enhance employee performance, and take other steps to build a high functioning organization. Some of the accomplishments include:

  • Played an active role on the Performance Work Statement Team/MEO Team in the effort to ensure that these functions remained in the agency, while working to save money for both the government and the taxpayers.
  • The PV Works (Vet) pilot application and database, a commercially-off-the-shelf product that provides an animal health drug safety system designed for both animal and human reactions to veterinary pharmaceuticals, were successfully installed on the CVM server.
    • Test accounts were created for ten FDA reviewers to access and test the PV-Works pilot.
    • Over 25 animal adverse event cases input by two animal drug sponsors were forwarded to FDA and loaded into PV-Works for use by FDA reviewers. Several cases of human exposure input by the two firms were also loaded.
  • The Consolidated Reporting Environment (CRE) supports the implementation of the full dataset from the Activity Time Reporting (ATR) system, and the relevant reference data from the Submission Tracking and Reporting System (STARS).
    • Implemented a robust reporting environment supporting the implementation of a dataset with the capability of adding additional source systems.
    • Released the CRE production system.
    • Leveraged the financial and activity characteristics of capture data.
  • Continued to support and enhance the partnering of employees and IT by implementing a web content management system (RedDot).
  • Played an internal role in the agency's implementation of Unified Financial Management System (UFMS), which replaced five accounting systems that had been used previously across the operating divisions in the agency.
  • Continued to implement its Activity-Based Costing program. We made numerous enhancements to improve the information derived from Activity Time Reporting, ensuring that we have the most accurate and up-to-date information available; this improved our reporting and tracking capability.
  • The Staff College obtained accreditation through the Maryland State Board of Veterinary Medical Examiners for its Scientific Seminar Series titled Antimicrobial Resistance - Human, Poultry, Swine, Bovine, and Disease Modeling.
  • The Staff College has begun the integration of an automated interview tool that is tied to the CVM Competency Model. This will ensure identification and selection of the best-qualified candidates that are learning agile (can continue to learn and remain current with changing medicine, science and technology) and who possess the necessary technical, team, leadership, and management competencies.
  • The Staff College enhanced learning activities and educational opportunities by providing seminar series and courses presenting information on new and emerging scientific issues. In addition to ongoing courses, we introduced two new series:
    • The New Reviewer Training aimed to reduce the learning curve of new reviewers by 6 to 12 months, from the current 18-month timeframe, and
    • The Drug Manufacturing Series implemented to enhance Center employees understanding and application of the drug review process.

 

Animal Drugs And Feeds
Program Activity Data (PAD)
PROGRAM WORKLOAD AND OUTPUTS [1] / FY 2005 Actuals FY 2006 Estimates FY 2007 Estimates
New Animal Drug Applications (NADAs):[2]      
Received 11 10 8
Completed 9 10 10
Approved 7 7 7
Pending[3] 5 5 3
New Animal Drug Application Supplements: 2 [4]
Received 451 482 482
Completed 449 482 500
Approved 319 362 464
Pending 3 159 159 141
Abbreviated New Animal Drug Applications (ANADAs): 2
Received 49 48 48
Completed 46 50 50
Approved 13 14 14
Pending 3 50 48 48
Abbreviated New Animal Drug Application Supplements: 2 4
Received 116 118 118
Completed 97 106 111
Approved 71 75 75
Pending 3 99 111 118
Investigational New Animal Drug (INAD) Files: [5]
Received 1,888 1,888 1,888
Completed 1,767 1,888 1,900
Pending 3 386 386 374
Generic Investigational New Animal Drug (JINAD): 5
Received 335 335 335
Completed 229 308 335
Pending 3 173 200 200
Food (Animal) Additive Petitions 6 9 15 15

 

PROGRAM WORKLOAD AND OUTPUTS 1/ FY 2005 Actuals FY 2006 Estimates FY 2007 Estimates
Investigational Food Additive Petitions 31 35 35

Production & Manufacturing Defect Reports

Received------------------------------------------------ à

Reviewed----------------------------------------------- à

 

2,948

1,788

 

2,900

1,780

 

2,900

1,780

Adverse Experience Reports (AERs)

Received------------------------------------------------ à

Reviewed----------------------------------------------- à

 

33,183

18,591

 

33,000

19,000

 

33,000

19,000

Animal/Medicated Feed Partnership Agreements 27 27 27
PROGRAM OUTPUTS- DOMESTIC INSPECTIONS
Pre-Approval /BIMO Inspections
72 140 110
Drug Process and New ADF Program Inspections 230 210 210
BSE Inspections 3,025 3,760 3,760
Feed Contaminant Inspections 13 15 15
Illegal Tissue Residue Program Inspections 203 245 245
Feed Manufacturing Program Inspections 369 240 40
State Contract Inspections: BSE 3,309 4,562 4,562
State Contract Inspections: Feed Manufacturers 457 347 347
State Contract Inspections: Illegal Tissue Residue 370 750 600
State Partnership Inspections: BSE and Other 988 900 900
Total Above FDA and State Contract Inspections 9,036 11,169 10,789
Total Domestic Reinspections (Non-add) 173 173 173
State Animal Drugs/Feeds Funding $1,300,000 $1,700,600 $1,800,000
BSE Grant Increase $3,000,000 $3,000,000 $3,000,000
State Contract for Tissue Residue $220,000 $220,000 $210,000
Total State Funding $4,520,000 $4,920,600 $5,010,000
Domestic Laboratory Samples Analyzed 1,841 1,770 1,730
PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS
Foreign Pre-Approval/Bioresearch Monitoring Program Inspections 26 45 45
Foreign Drug Processing and New ADF Program Inspections 12 10 10
Total Above Foreign FDA Inspections 38 55 55
Total Foreign Reinspections (Non-add) 3 3 3
Import Field Exams/Tests 4,298 4,500 4,500
Import Laboratory Samples Analyzed 753 1,120 900
Import Physical Exam Subtotal 5,051 5,620 5,400
Import Line Decisions 212,254 235,602 261,518
Percent of Import Lines Physically Examined 2.38% 2.39% 2.06%

[1] FY 06 & 07 performance estimates are dependent upon a sustained level of base and user fee resources. The estimates do not include invited labeling change supplement applications because it is not possible to accurately project sponsor or CVM requests for this type of application.

[2] Includes originals and reactivations. If the application is not approvable, the sponsor may submit additional information until the Agency is able to approve the application.

[3] Reflects submissions (received during the fiscal year) which still require review.

[4] A supplemental application is a sponsor request to change the conditions of the existing approval. They can be significant (a new species or indication), or routine (product manufacturing changes).

[5] An INAD or JINAD file is established at the request of the sponsor to archive all sponsor submissions for a phased drug review including: request for interstate shipment of an unapproved drug for study, protocols, technical sections, data sets, meeting requests, memos of conference and other information.

[6] Non-drug substances added to animal feed are considered Food Additive Petitions and require review and approval.

 

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