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U.S. Department of Health and Human Services

About FDA

Electronic Submissions Training

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 OFAS published its draft guidance on electronic submissions in March 2010.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 These seven videos complement the agency’s 2010 draft guidance on electronic submissions that was previously posted on the Internet.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.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Assign OFAS Subject Matter Experts (SMEs) on electronic submissions

11/30/2012

Completed 11/14/2012

B. Complete analysis and preparation of draft training materials

1/31/2013

Completed 1/15/2013

C. Select and assign OFAS trainers to deliver web-based video training modules for industry (on-demand)

2/28/2013

Completed 2/12/2013

D. Compile SMEs’ feedback on training materials

3/1/2013

Completed 2/15/2013

E. Revise and submit finalized training materials

4/19/2013

Completed 4/12/2013

F. Conduct facilitator-led (train-the trainer) training sessions

4/30/2013

Completed 4/19/2013

G. Compile training feedback, organize video training format, and create video scripts for industry web-based training

5/31/2013

Completed 5/31/2013

H. Finalize and obtain CFSAN, FDA and HHS clearance on materials (video scripts) for industry web-based training

6/30/2013

Completed 7/9/2013

I. Complete coaching and preparing (rehearsals) OFAS trainers to record web-based training modules

7/19/2013

Completed 7/3/2013

J. Record and edit video training modules

8/15/2013

Completed 8/9/2013

K. Obtain CFSAN, FDA and HHS video clearance

9/15/2013

Completed 9/17/2013

L. Upload and host Web-based training

9/20/2013

Completed 9/20/2013

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

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. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.