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U.S. Department of Health and Human Services

For Consumers

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Field Alert Report (FAR) Electronic Pilot Program Questions and Answers

 

1. What are the benefits of participating in the pilot program?
2. If the new automated program and FORM FDA 3331-Automated are adopted by FDA, what advantages are expected over the current procedure?
3. Will my participation in the pilot cause a disruption in my field alert reporting?
4. Does the use of automated form change the reporting responsibilities of the applicant holder?
5. If I participate in the pilot, can I be certain that I am complying with 21 CFR 314.81 through the automated form?
6. Do I have to notify my FAR monitor of my participation and or discontinuation in the pilot?
7. If I decide to submit FARs using the pilot system, must I continue to use the electronic system for the entire pilot?
8. How do I access the reporting forms?

 

1. What are the benefits of participating in the pilot program?
 
Pilot program participants will become familiar with changes to the electronic submission process, giving them a head start when FDA implements a fully automated reporting system in the future. 
 
In addition, participants in the pilot are encouraged to ask their FDA district FAR monitor questions regarding the pilot, and to provide feedback resulting from use of the new Form FDA 3331-Automated. Volunteers may contact their district FAR monitors via the e-mail addresses on page 2 of the automated form. Volunteers may be contacted for input on future portions of the project. In the long term, this new electronic submission process is expected to lead to a paperless system and provide industry a method that will eliminate the need for printing and scanning the actual form.
 
2. If the new automated program and FORM FDA 3331-Automated are adopted by FDA, what advantages are expected over the current procedure?
 
Use of the automated form will simplify the reporting process, automatically populate the e-mail address of the desired district via a “one-box click” mechanism, and standardize the subject line in the e-mail using information entered on the Form FDA 3331-Automated, thus eliminating any confusion regarding the content of the e-mail.
 
3. Will my participation in the pilot cause a disruption in my field alert reporting?
 
No. During the pilot program, volunteer participants will attach a signed PDF Form FDA 3331-Automated to the e-mail generated when filling out the automated form. This parallel process will ensure delivery of all signed field alert reports during the pilot. 
 
4. Does the use of automated form change the reporting responsibilities of the applicant holder?
 
No. The responsibilities of the application holder with respect to reporting field alerts remain the same. Applicants will continue to send reports to the district office responsible for the facility where the problem occurred or, for foreign applicants, the location of the US Agent for the firm.  
 
5. If I participate in the pilot, can I be certain that I am complying with 21 CFR 314.81 through the automated form?
 
Yes. Participants in the pilot program will be in compliance with the regulatory requirements as long as they meet the 3-day requirement for reporting and follow the directions in Form FDA 3331-Automated.
 
6. Do I have to notify my FAR monitor of my participation and or discontinuation in the pilot?
 
Notification is not required, but participants are encouraged to provide feedback to FAR monitors that FDA can use to evaluate the success of the pilot. Drug Field Alert Monitors can be found at the following link: http://www.fda.gov/ICECI/Inspections/IOM/ucm124063.htm
 
7. If I decide to submit FARs using the pilot system, must I continue to use the electronic system for the entire pilot?
 
No, firms may opt out at any time and follow the traditional method of FAR submission. However, we do ask that whenever possible the firm will follow-through with the electronic format for FU and finals to Initials that have been submitted electronically.
 
8. How do I access the reporting forms?
 
Both forms can be accessed using the following link:
 
Note: no matter which form option you select, you can save the template.