Recorded July 19, 2018
In this presentation I will explain the process that will occur when CVM needs to reopen a completed Environmental Impact technical section. Sometimes you may qualify for a 60-day review time so I will also explain which submissions would qualify for this. The 60-day review time is a new process that will be implemented on October 1 as part of the ADUFA reauthorization.
I will go over the background of why this new process will be implemented, what changes to the conditions of use would (and would not) result in the reopening of the technical section, what types of submissions would qualify for a 60-day review time (which would be claims of categorical exclusions), how CVM would communicate the reopening of the technical section, and the new questions that will be added to the eSubmitter template to incorporate this new process.
It is possible that, after CVM has reviewed a target animal safety, effectiveness, or residue chemistry data submission, the conditions of use of a proposed drug will change from what was originally planned. And sometimes these changes occur after other technical sections have been completed. These changes may not affect all completed technical sections, but there is a chance that these changes would affect a completed Environmental technical section. And depending on what those changes are, your technical section complete letter may become invalid when you got to submit your administrative NADA package. If we have to reopen the Environmental technical section and you have already submitted all your other technical sections, this could delay your time to approval because each technical section has a 180-day review time.
And therefore, as part of the ADUFA reauthorization, we will allow certain submissions to qualify for a 60-day resubmission time upon resubmission of the Environmental technical section if all your other technical sections have been submitted.
I will be building a flow diagram during the presentation to help explain the process. First, you will have to have received an Environmental technical section complete letter from CVM for the proposed action. And at some point after receiving that letter, the conditions of use of the drug may have changed from what you thought it would be when you submitted your Environmental submissions. These changes may be considered a new or expand use of the drug as compared to the use pattern reviewed under the environmental technical section. Or the changes may be minimal such that they result in a similar or reduced use of the drug.
If there was a new or expanded use of the drug, the technical section would be reopened because we would not have fully evaluated the potential for the environmental impacts to occur during our review. If the changes result in a similar or reduced use pattern, then the technical section would remain complete.
So now I will explain what changes to the conditions of use may (or may not) affect the status of your Environmental technical section.
If the Environmental technical section is reopened, then a new P-submission must be submitted. Reopening the technical section could happen if you originally submitted a CatEx or if you submitted an environmental assessment. But what I am discussing today will only apply to submissions in which a CatEx was originally submitted and accepted.
Reopening the technical section when a CatEx was accepted would occur when the changes to the conditions of your use either affect the eligibility of the proposed drug for the CatEx that was accepted (meaning that it no longer qualifies for that specific catex) or the technical section would also be reopened if the changes result in an increase in use of the drug as compared to the use pattern evaluated under the original CatEx request.
An increase in use would include an expansion of the animal species or classes subject to the approval or an increase in the dose, duration, or frequency of the administered drug. We may also reopen the technical section if there is a change in the marketing status.
But not all changes will result in the Environmental technical section being reopened. It would remain complete if the changes to the conditions of use are more restrictive, meaning that the dose, duration, frequency, or animal classes subject to the approval are less than what was evaluated with the CatEx. And a new P-submission also would not be needed if the changes do not affect the overall intended use of the drug. This would be something like an alteration in the wording of an indication or the terminology for a specific class of cattle or established name.
If the changes to the conditions of use do not result in a new or expanded use pattern, then the technical section will remain complete because we have already adequately evaluated the potential for environmental impacts to occur when it was thought that the drug use would be greater.
But if your use pattern is new or expanded beyond what was evaluated in your CatEx, your technical section would be reopened. If the action still qualifies for a CatEx listed in the regulations under 21 CFR 25.33, you would qualify for a 60-day review time. But if not, you would not get a 60-day review time because an EA would be needed and we cannot review an EA in 60 days.
Assuming that you had originally submitted a CatEx and your technical section is reopened, I will now explain what types of submissions would qualify for a 60-day review time.
As part of the ADUFA reauthorization, it was agreed that the Environmental Impact technical section will be reviewed within 60 days after resubmission when (1) a CatEx was previously accepted, (2) when all other technical sections have been submitted (meaning that one or more technical sections could still be under review), and (3) when there was a change to the conditions of use after the original CatEx was evaluated and accepted, as I just explained.
And although it is not listed in the goals letter, we want to point out that in order to qualify for a 60-day review time, the action must still qualify for a CatEx and the technical section must be resubmitted under the INAD. Now, the resubmitted CatEx can be different from the CatEx citation originally submitted, it just has to meet the qualifications of one of the CatEx citations listed in the regulations.
But if it no longer qualifies for a CatEx, then an EA would be needed and you would not qualify for the 60-day review time.
This process also does not apply to technical sections that were originally completed with an Environmental Assessment or submitted under a JINAD file.
Here again is the overview of the new change that will be implemented on October 1. So how will you know if your technical section has been reopened and whether you qualify for a 60-day review time?
So now I am going to explain how we will communicate a reopened technical section and what you will need to do in eSubmitter when resubmitting the new CatEx.
So, it may be CVM or you who first realize that the technical section may need to be reopened. If you realize this before CVM does, please contact us. If the technical section does need to be reopened, we will schedule a teleconference to discuss whether the CatEx is still appropriate and whether the resubmission qualifies for the 60-day review time.
As noted before, if you do qualify for the 60-day review time and you are in the end-game of your project, meaning that you are expecting to submit the NADA package upon receiving that final letter. Even if you submit with the 60-day review time, the Environmental technical section could still become the last P-submission. So, the goal is to communicate as early as possible so we can determine the correct path forward without delaying the time to approval.
After the teleconference, we would send an official letter in the mail stating that the technical section has been reopened and qualifies for a 60-day review time upon resubmission. So, the submission type for this letter would be a Q-submission under the INAD file, which is an Agency-initiated submission.
When this new process begins on October 1st, there will also be new questions added to the eSubmitter template when you submit a CatEx under a P-submission in an INAD file.
The first new question will ask: “Have you or CVM identified changes to the conditions of use that would affect your Environmental Impact technical section complete for a pending proposed action?” In cases like this, you would answer “yes”.
Then the next question will ask “Has CVM offered you a 60-day review time with the resubmission of this technical section?”
If the technical section was reopened but we did not offer a 60-day review time because an EA is needed, you would answer “no” to this question. You would only answer “yes” if a teleconference was held and CVM told you that you qualify for a 60-day review time. If you answer “yes” and there is no Q-submission on file documenting this agreement, then we would have to refuse-to-review the submission. There is no option for us to reset the clock from 60- to 180-days when this happens.
A few final reminders.
As mentioned before, depending on when you resubmit your CatEx, Environmental could still become your last P-submission. And we would not expedite this review to close it out at the same time as another technical section. So, it is important that we work together to catch issues these early and stay on track with your timeline.
Also, if the resubmitted CatEx is incomplete or inaccurate, we would try to resolve this by asking for an amendment. But if you’re not eligible for a 60-day review time because you were not offered this option, the submission would be a refuse to review. So even if you think you would be eligible for a 60-day review time, we need to have this discussed in a teleconference and have it officially documented in your INAD file before you resubmit.
And finally, there are some comments that are important for any Environmental technical section that is submitted to CVM, whether it is a CatEx or an EA, or whether it is submitted under an INAD or JINAD.
The Environmental technical section needs to reflect the conditions of use that that will be on the final labeling. And you can submit this technical section at any time during the approval process, but we always recommend waiting to submit until you are fairly confident that the conditions of use will not change prior to approval because it may affect the status of your technical section.
So, when you are getting closer to your approval, go back and verify that the conditions of use submitted in your Environmental technical section reflect the labeling. If it doesn’t, please contact us as soon as possible so we can efficiently resolve the issue and determine whether your technical section can remain complete or if it needs to be reopened.
If you have any questions, you can always contact your Project Manager or the Leader of the Environmental Safety Team. Thank you.