Q

I went to the CVM web page to download a copy of the word processing file for requesting meetings, and I can't find it. Where can I get this?

A

The Center is no longer distributing word processing versions of the forms used in its electronic submission program. We prefer that participants use the SMART PDF form available on the web page.

Q

I hear about a SMART form that the Center has published on it WEB page. We have not started to use this and our system is working fine now. Am I going to have to change my system to continue participation in the Center's program?

A

The submission specific guidance is currently being rewritten to require the SMART form. This form enforces some CVM's processing rules at the submitter's level, so that once someone starts using it, it reduce submission rejections because of incorrect information. It also does not have a manual logging intervention requirement so it cuts down on delivery time and resources needed to process it to the Review Division.

Q

What advantages do the SMART forms have? How will it help me?

A

The SMART form communicates with the Center's logging system STARS and logs submission directly into the system without manual intervention. This means that the submission goes from your outbox to the Reviewing Division's mailbox in minutes. It also sends your receipt back as a form that you may export information into any database or internal system. Also the optimizer flag problem for renaming the old oracle generated PDF receipt is gone with this new SMART receipt version.

Q

When will this new requirement be mandatory?

A

As soon as the guidance is made available on the Agency's Electronic Submission Dockets. Until that time we strongly suggest you start integrating the new forms into your system. Because of increasing workload and the manual processing involved, receipts for unSMART forms may not be issued within the 2 day commitment in the current guidance, although we will try to continue to meet this performance requirement.

Q

How do I enter alternative dates for a meeting?

A

Enter the primary date in the space in Line 1. PROPOSED DATE(S) AND TIME(S) under the Section I. Request. Any alternative dates can be entered in Section III. Itemized Agenda (Attached). CVM will contact you to finalize the time of the meeting.

Q

I have a formatted agenda in a word processing format and when I cut and paste it into Section III. Itemized Agenda I loose all formatting, or I want to attach background materials or a copy of the slides for the meeting. How can I do that?

A

You can easily attach information by processing the word processing files, power point slide files, graphic files, etc. into PDF format and then attaching them to the form. Use the Insert Pages option under the Documents menu item in Adobe Acrobat.

Q

Can I submit minutes of a meeting electronically?

A

No. In order to submit any information in electronic format only, the specifications have to be posted on the Agency's electronic submission Docket. We are discussing the possibility of a form and guidance for that type of submission.

Q

There is no short purpose of meeting in the form. Where would I put that information?

A

A We are revising the form to add a short purpose of submission field - this will be written to the STARS purpose of submission field when the sponsor uses the SMART form.

Q

What submission types is the Center planning to add to the Electronic Dockets and accept electronically?

A

The Center is working on Guidance for Industry documents for formatting information submitted to support a New Animal Drug Application, Stability Data submitted as an XML file, and is working with other Centers in the Agency to identify other information requirements where Agency-wide specifications are applicable.