Field Alert Report Form: Questions and Answers
- How do I access the reporting form?
- I have a copy of Form FDA 3331 (or Form FDA 3331-automated). May I use it to submit FARs?
- Will FDA accept paper submissions?
- If I submitted the initial FAR using Form FDA 3331 or Form FDA 3331-automated, may I submit the follow-up or final using Form FDA 3331a?
- If I forget to attach necessary documents to my email, what should I do?
- Are the expandable fields for entering FAR information limited?
- May I copy and paste graphs and tables into the form?
- When submitting a follow-up or final FAR, does any of the initial information need to be retained and resubmitted?
- What address should be entered in the “Reporting Establishment” section at the end of the form?
- Do I need special software to use the Form FDA 3331a?
- If the “Submit by Email” button is not functioning on Form FDA 3331a, how can I submit my FAR?
- What files should be attached to the email when submitting the FAR?
- Why am I getting an error when I try to print my completed Form FDA 3331a to a read only PDF file?
- Whom do I contact if I have additional questions?
- Q. How do I access the reporting form?
A. The form and instructions can be accessed here:
- Form FDA 3331a Instructions: Type 3331a in the Keyword search box
- Q. I have a copy of Form FDA 3331 (or Form FDA 3331-automated). May I use it to submit FARs?
A. Forms FDA 3331 and FDA Form 3331-automated are now obsolete. FDA encourages all of industry to use Form FDA 3331a instead. Form FDA 3331a, which has been approved by the Office of Management and Budget (OMB), incorporates suggested changes from firms that participated in a pilot project that was launched in May 2013 to automate the FARs submission process.
Advantages of Form FDA 3331a include the following:
Differences between Form FDA 3331 and Form FDA 3331a are as follows:
- Many fields are expandable, eliminating the need for continuation pages.
- Activating the “Submit by Email” button on the form allows for the following:
- Automatic creation of an email addressed to both the selected district office and CDER. CDER will process the extensible markup language (XML) data for both CDER and CBER FARs.
- Automatic attachment of the XML data (the pdf version of Form 3331a will still need to be attached manually).
- Automatic creation of a standardized subject line for the email that pulls information from the FAR.
- A signature by a firm’s authorized represenative is no longer required. This eliminates the need for firms to print, sign, and scan the form, simplifying the process of FAR submission.
- The order of fields has changed slightly and the fields have been renumbered accordingly. For example, the previous field #7—Dosage Form, Strength, Package Size—has been split into two fields:
- 7a. Dosage Form
- 7b. Dosage Strength and Package Size
- The problem and reporting firm sections now have separate fields for individual address components.
- There is now a field for the email address of the authorized representative submitting the FAR.
- There are now two fields to enter the reporting establishment’s facility establishment identifier (FEI) and Data Universal Numbering System (DUNS) number.
- The fields for “Lot Numbers” and “Expiration Dates” have been merged into a single field.
- There is no longer a continuation page button.
- The following fields are now expandable:
- NDC (National Drug Code) Number
- Dosage Strength and Package Size
- Lot Number and Expiration Date
- How was problem discovered
- State Problem
- Describe Root Cause of Problem
- Describe Corrective Action Taken (if any) to Prevent Recurrence of Problem
- Remarks
- Q. Will FDA accept paper submissions?
A. FDA encourages all of industry to use Form FDA 3331a to submit FARs electronically but we will accept paper submissions. Although submission of FARs solely in an electronic format is not required under 21 CFR 314.81(b)(1) at this time, we recommend using the automated (XML) version of Form FDA 3331a. Form FDA 3331a can also be saved as a PDF document, printed and submitted in paper format, if preferred or when necessary, to satisfy the reporting requirements under 21 CFR 314.81(b)(1).
- Q. If I submitted the initial FAR using Form FDA 3331 or Form FDA 3331-automated, may I submit the follow-up or final using Form FDA 3331a?
A. Yes, all follow-up and final FARs can be submitted using Form FDA 3331a, regardless of which version of the form was used for the initial submission.
- Q. If I forget to attach necessary documents to my email, what should I do?
A. If you forget to attach the FAR PDF or other related documents, re-send the initial email to the original recipients with the necessary documents attached, and add the words “MISSING ATTACHMENT” to the beginning of the email’s subject line. If the XML file was mistakenly deleted from the original email, resubmit the email with no change in the subject line.
- Q. Are the expandable fields for entering FAR information limited to a specific number of characters?
A. No, the expandable fields, which follow below, are not limited:
- NDC Number
- Dosage Strength and Package Size
- Lot Number and Expiration Date
- How was problem discovered
- State Problem
- Describe Root Cause of Problem
- Describe Corrective Action Taken (if any) to Prevent Recurrence of Problem
- Remarks
- Q. May I copy and paste graphs and tables into the form?
A. No, you may not copy and paste graphs or tables into Form FDA 3331a. Furthermore, please do not add them as additional pages to the PDF. If needed, graphs and tables may be attached as separate documents to the email generated by the “Submit by Email” button.
- Q. When submitting a follow-up or final FAR, do I include any of the initial information submitted in the initial submission?
A. To match follow-up and final FARs to the initial submission, it is helpful if boxes 1–9 contain the same information as the initial FAR. If the scope of the FAR has expanded, boxes 4, 7b, and 8 may be updated with the additional information and boxes 10–14 may include the new information.
- Q. What address should be entered in the “Reporting Establishment” section at the end of the form?
A. The name of the application holder should be entered in the “Reporting” section unless the application holder is located in a foreign country. In that case, the name and address of the application holder’s U.S. agent should be included in the “Reporting Establishment” section.
- Q. Do I need special software to use Form FDA 3331a?
A. Aside from Adobe Acrobat Reader and an email client, no additional software or licenses are required to use Form FDA 3331a.
- Q. If the “Submit by Email” button is not functioning on Form FDA 3331a, how can I submit my FAR?
A. Check with your IT department to ensure that you have the proper Adobe Acrobat Reader installed. If you still have a problem submitting the FAR, contact your ORA district office. (Contact information is found on page ii of Form FDA 3331a.)
- Q. What files should be attached to the email when submitting the FAR?
A. All FAR submissions should have a least two attachments, the first is the XML data file that is automatically attached when the email is generated, this allows us to process the FAR data efficiently, the second is the read-only PDF of the completed 3331 form, this gives us a locked copy of the submission as the official record and a version that can be shared within the agency. Other attachments maybe included if needed for charts, tables or images that cannot be entered in the 3331 form, but please remember the text fields in the new 3331 form are expandable so additional attachments for text data are not necessary.
- Q. Why am I getting an error when I try to print my completed Form FDA 3331a to a read only PDF file?
Create a read only PDF of the completed FDA Form 3331a using Adobe Acrobat or Adobe Reader. This is the version of the FAR PDF file that should be attached to the email generated by the Submit Button on the FDA Form 3331a along with the XML file. Additional instructions for creating read only files in Adobe.
For additional information, contact your ORA district office. (Contact information is found on page ii of Form FDA 3331a.)