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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Foods and Veterinary Medicine Dashboard

 

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Since mid-March 2020, FDA operations and FDA oversight of the U.S. food supply have been significantly impacted by the COVID-19 pandemic. The Agency's priorities during this time period have been the safety of our staff, conducting mission-critical activities, including inspections, responding to foodborne disease outbreaks, sampling and testing of imported food, and managing recalls. We have also worked to support continuity of the food supply chain, which includes keeping food and agricultural workers safe to allow continued production of food. Given these priorities, and state and local travel restrictions, FDA adjusted its approach to oversight activities.

For additional information, visit FDA's Food Safety and the Coronavirus Disease 2019 and FDA Efforts to Ensure Product Safety web pages.

FDA's Foods and Veterinary Medicine (FVM) 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.

Each FDA-TRACK program area collects, analyzes, and reports its performance measures and results. Explore the progress CFSAN is making towards the strategic goals below:

FVM Program’s Strategic Plan FY 2016 - 2025

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. Percentage of firms with positive environmental samples taken during the month
  2. Percentage of sub-samples with positive findings during the month
  3. Number of recall recommendations during the month entered in the Recall Enterprise System (RES) resulting from environmental positives
  4. Number of domestic compliance actions (warning letters, injunctions, seizures) taken during the month related to environmental positive findings (subset of enforcement actions)
  5. Number of positive findings added to the Whole Genome Sequencing (WGS) database
  6. Number of positive findings with a clinical match to a known foodborne illness pathogen
  7. Number of recall recommendations resulting from a WGS match
  8. Number of domestic compliance actions (warning letters, injunctions, seizures) taken during the month related to a found WGS 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

II. 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

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 Office of Food Safety (OFS) that were reviewed within the timeframe given to OFS in the Case Management System (measures time in OFS only) in the month

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 – Enhance the safety of food and feed additives and dietary supplements

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 Generally Recognized as Safe (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

Objective 1.5 – Strengthen existing partnerships with international, federal, state, local, tribal, and territorial agencies to improve the effectiveness and efficiency of the FDA's food safety program for government and industry

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 Institute for Food Safety and Health (IFSH) Industry WGS Workgroup Members

B. Key Projects

  1. Environmental Microbiology and Foodbourne Outbreaks
 

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 changes 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
 

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

Measures are under development and will be available once finalized.

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 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 new translated web pages about cosmetics safety and number of visits to all translated webpages about cosmetics safety
  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 the Office of Analytics and Outreach)

IV. Key Projects

  1. Establishment of a Parasitology Program to Align with the Scientific and Operational Activities of FDA/CFSAN’s mission

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.

Note: 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.

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