About FDA

Description: OFAS is the lead for FDA's food and color additive petition processes, the consideration of independent determinations of GRAS status, the review of notifications for food contact substances, the final consultation for food derived from new plant varieties and the early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use. OFAS published its draft guidance on electronic submissions in March 2010. OFAS has a need to develop and deliver to its staff and to industry audiences training on electronic submissions processes for industry food ingredient submissions, including any supplements, updates and amendments to those submissions. This project has several tasks dedicated to develop face to face training and support OFAS scientists to train industry using video recorded web based training modules (on-demand).The objectives of this project are two-fold: (1) to provide FDA/CFSAN/OFAS staff with an understanding of the design and function of the electronic format for submissions and the operation of the FDA web portal and (2) to develop and deliver video recorded web-based training modules for industry. FDA scientists will deliver presentations for the web-based training that will include the FDA’s approach to preparing and submitting industry submissions in electronic format using the FDA’s web-based portal. This project deals with industry submissions sent electronically, thus, aiding industry in reducing their reliance on paper submissions. It also benefits FDA because electronic submissions reduce the cost to convert paper submissions to electronic format. It also allows reviewers to spend more time addressing food safety issues to improve public health by increasing review efficiency.

Accomplishment: In September 2013, OFAS launched a series of training videos to help industry with their electronic submissions. These seven videos complement the agency’s 2010 draft guidance on electronic submissions that was previously posted on the Internet. This series of training videos provides an overview to the electronic submission process and information specific to the different types of food ingredient and packaging submissions. The videos are available on the FDA website (http://www.fda.gov/food/ingredientspackaginglabeling/ucm368958.htm) for on-demand viewing. For OFAS, electronic submissions facilitate the review of the safety of food ingredients and packaging as well as relieving industry of the burden of producing paper submissions. In May 2013, OFAS staff completed training on the design and function of the electronic format for submissions and the operation of the FDA web portal.