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The Foods and Veterinary Medicine Program-encompassing the Office of Foods and Veterinary Medicine (OFVM), the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), related activities under the Office of Global Regulatory Operations and Policy, and the Office of Regulatory Affairs (GO/ORA)-is responsible for promoting public health by preventing foodborne illness, fostering good nutrition, and improving the safety and efficacy of animal health products. The Program also ensures FDA regulations and guidance provide clear and reliable direction and assistance to industry, both inside and outside the United States, with a goal to obtain high rates of compliance with standards necessary to protect public health and meet consumer and stakeholder expectations.


Contents:

Foods and Veterinary Medicine (FVM) Program’s Strategic Plan Fiscal Years 2016–2025

Completed Measures and Key Projects

Note: Information is as of June 30, 2017. The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.


GOAL 1- Food Safety: Protect America’s Consumers and Animals from Foreseeable Hazards

Objective 1.1 – Establish and gain high rates of compliance with science-based preventative control standards across the global farm-to-table continuum.

I. Safety and Compliance Measures 

A. Assess industry safety and compliance through the use of environmental sampling

  1. Total number of firms with environmental samples taken during the month
  2. Total number of sub-samples as related to the environmental samples during the month
  3. Total number of firms that had positive environmental samples during the month
  4. Total number of positive findings (may or may not be actionable depending on sampling location) during the month
  5. Number of recall recommendations during the month entered in the Recall Enterprise System (RES) resulting from environmental positives
  6. Number of domestic compliance actions (warning letters, injunctions, seizures) taken during the month related to environmental positive findings (subset of enforcement actions)
  7. Number of positive findings added to the Whole Genome Sequencing database
  8. Number of positive findings with a clinical match to a known foodborne illness pathogen
  9. Number of recall recommendations resulting from a Whole Genome Sequencing Match
  10. Number of domestic compliance actions (warning letters, injunctions, seizures) taken during the month related to a found Whole Genome Sequencing match

B. Assess Reportable Food Registry (RFR) process and impact on compliance activities

  1. Total number of RFR submissions received in the month
  2. Total number of Risk Control Reviews (RCRs) initiated for Primary RFR entries in the month
  3. Total number of seizures and injunctions in the month that are linked to a previous RFR entry

II. Regulatory Development Measures

A. Develop smart regulatory guidelines to improve industry compliance rates

  1. Percentage of low-acid canned and acidified food violations reduced due to implementation of new "smart" filing form.

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III. Training Cadre of Regulators Measures

A. Enable FDA to produce more effective regulatory outcomes by improving the quality of the inspections program

  1. Percentage of FDA regulators trained on new preventive controls for human food regulation and conducting inspections against the Preventive Controls for Human Food regulation
  2. Percentage of state regulators trained on new preventive controls for human food regulation and conducting inspections against the Preventive Controls for Human Food regulation

IV. Training and Outreach to Industry Measures

A. Increase knowledge by industry of regulatory requirements, FDA policy, and science related to food safety and food processing

  1. Percentage of the domestic food industry subject to the preventive controls regulation participating in training conducted by FDA or funded by FDA or training using FDA-recognized curricula

V. GenomeTrackr Measures

A. Develop GenomeTrakr Network and increase number of whole genomes in GenomeTrakr Database

  1. Cumulative number of sequences generated from archived collections of isolates in Office of Regulatory Affairs to enhance compliance and enforcement databases

VI. Export Certificate Request Measures

A. Provide clear and current direction to foreign governments seeking official assurance that products exported to their countries meet specific U.S. regulations

  1. Percentage of export certificates for drug related products issued within 20 days
  2. Percentage of export certificates for animal food related products issued within 20 days

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Objective 1.2 – Improve prevention, detection, and response to foodborne illness outbreaks and other food and feed safety incidents.

I. Regulatory Review Measures

A. Improve efficiency of regulatory case reviews by utilizing electronic management system

  1. Percentage of regulatory cases referred to OFS that were reviewed within the timeframe given to OFS in the Case Management System (measures time in OFS only) in the month

II. Health Hazard Events (HHEs) and Recalls Measures

A. Ensure animal and human safety by evaluating exposure to and characterizing severity of hazards in pet food, animal food, drug and devices

  1. Percentage of HHEs completed by due date

III. Vet-LIRN Case Investigation Measures

A. Develop a network to coordinate facilities, equipment and professional expertise of veterinary diagnostic laboratories to respond to high priority chemical and microbial feed/drug contamination events.

  1. Number of jerky pet treat related case investigations

  2. Number of non-jerky pet treat related case investigations

  3. Number of proficiency tests and training


Objective 1.3 – Strengthen the ability of consumers to play a proactive role in minimizing food safety risks.

I. Web Presence Measures

A. Maintain an online web presences to enable the public to interact with CFSAN and monitor CFSAN website and capture viewership data to determine its usefulness to the public.

  1. Number of website page views, top pages viewed, top search engine used to view site, and average number of seconds spent on site 


Objective 1.4 – Strengthen the ability of consumers to play a proactive role in minimizing food safety risks.

I. Pre-Market Review Measures

A. Increase access to safe dietary supplements by reviewing notifications for new dietary ingredients (NDIs)

  1. Percentage of NDI notification reviews completed during the month within 75 days of filing

  2. Median number of days to complete NDI notification reviews during the month

  3. Percentage of NDI notification reviews completed to which FDA objected

B.  Increase rate of access to safe food ingredients and packaging materials by reviewing food and color additive petitions, notices for GRAS substances, and notifications for food contact substances

  1. Percentage of food and color additive petition reviews completed during the quarter within 360 days of filing
  2. Total number of food and color additive petition actions published in the Federal Register during the quarter
  3. Percentage of GRAS notice reviews completed by CFSAN during the quarter within 180 days of filing
  4. Percentage of food contact substance notification reviews completed during the month within 110 days of original or amended receipt

II. Center for Veterinary Medicine (CVM) Generally Recognized as Safe (GRAS) Notification Measures

A. Review and act on the GRAS notification applications filed on or after June 4, 2010 within 300 days after filing date

  1. Percentage of GRAS notifications reviewed by CVM within 300 days   

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Objective 1.5 – Strengthen the ability of consumers to play a proactive role in minimizing food safety risks.

I. GenomeTrackr Measures

A. Develop GenomeTrakr Network and increase number of whole genomes in GenomeTrakr Database

  1. Number of GenomeTrakr laboratories operational
  2. Number of IFSH Industry WGS Workgroup Members

I. Key Projects

  1. Promote Safe Production of Molluscan Shellfish for Human Consumption: Vibrio Forecasting and Assistance

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GOAL 2- Nutrition: Foster an Environment to Promote Healthy and Safe Food Choices

Objective 2.1 – Provide and support accurate and useful nutrition information and education so consumers can choose healthier diets consistent with the Dietary guidelines for Americans and other evidence-based recommendations.

Measures are under development and will be available once finalized.

Objective 2.2 – Monitor and assess emerging nutrition science as well as chances in the composition of foods in the marketplace in relation to the nutritional and health status of Americans.

Measures are under development and will be available once finalized.

Objective 2.3 – Encourage and facilitate new products and product reformulation to promote a healthier food supply.

I. Pre-market Review Measures

A. Increase access to safe infant formula by reviewing notifications for new or reformulated infant formulas

  1. Percentage of new or reformulated infant formula notification reviews completed during the month within 90 days of filing

  2. Median number of days to complete new or reformulated infant formula notification reviews during the month

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GOAL 3- Animal Health: Protect Human and Animal Health by Enhancing the Safety and Effectiveness of Animal Health Products

Objective 3.1 – Improve access to safe and effective animal drug products.

Measures are under development and will be available once finalized.

Objective 3.2 – Reduce risks in the manufacturing, production, distribution, and use of FDA-regulated animal health products.

Measures are under development and will be available once finalized.

Objective 3.3 – Strengthen detection and surveillance of problems with FDA-regulated animal health products.

I. Warning Letter Review Measures

A. Expedite the CVM review time for warning letters drafted by ORA districts and submitted to CVM for review

  1. Percentage of warning letter recommendation packages reviewed within 25 days

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GOAL 4- Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health

Objective 4.1 – Achieve optimal risk-informed resource allocation throughout the FVM Program.

I. Analytical Regulatory Package Review Measures

A. Improve efficiency of analytical regulatory package reviews (to speed food safety enforcement actions) by utilizing electronic management systems and reducing analytical review timeframes

  1. Percentage of analytical package reviews received via FDA's electronic Compliance Management System (CMS) that meet Office of Compliance (OC) timeframes as specified in CMS in the quarter
Objective 4.2 – Optimize the development and deployment of the FVM Program’s scientific expertise and organizational capacity to better understand and detect hazards and devise preventive interventions.

I. Color Certification and Cosmetic Registration Program Measures

A. Maintain highest level of efficiency in reviewing color additive regulatory packages (Compliance Management System (CMS) case reviews) (to speed enforcement actions related to potentially harmful color additives in food, dietary supplements, and cosmetics) by using electronic management systems that minimize review times.

  1. Percentage of color additive regulatory package reviews received via FDA's electronic Compliance Management System (CMS) that meet Office of Compliance (OC) timeframes as specified in CMS in the quarter

II. Communication and Outreach Measures

A. Inform and engage stakeholders by effectively communicating cosmetic safety information based on the post-market surveillance of cosmetic products and ingredients and industry globalization. Expand use of social media and other languages to maximize the reach of our safety and regulatory messaging. Ensure prompt response.

  1. Total number of tweets in the quarter and percent change in tweets compared with prior quarter
  2. Number of translated web pages and number of page visits to these translation
  3. Percentage of media responses provided by due date in the quarter

III. GenomeTrackr Measures

A. Develop GenomeTrakr Network and increase number of whole genomes in GenomeTrakr Database.

  1. Number of isolates sequenced by  the GenomeTrackr Network
  2. Cumulative number of compliance actions/cases supported by WGS (in conjunction with OAO)

IV. Key Projects

  1. Sequencing-based Analytical Methods for Microbial Contaminant Detection
  2. New Technologies/Methodologies to Assess Chemical Food Safety
  3. Establishment of a Parasitology Program to Align with the Scientific and Operational Activities of FDA/CFSAN’s mission
  4. GenomeTrackr Program
  5. Human Pathogen on Plants (HPOP)

Objective 4.3 – Attract, retain, and optimally deploy the skilled workforce required to lead, manage, and execute the FVM Program’s public health mission. 

Measures are under development and will be available once finalized.

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Page Last Updated: 09/07/2017
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