your argument next to number two thousand and nine thirteen sixty eight why ethical things against the united states here in the case and we have submitted to the court that there are two alternative interpretations of statute in addition to one of the f d a is adopted and the second of those interpretations we time that they receive the final technical exception with one exception in that one exception is that the way the f d a review works in any context whether it's part of this phase review process or whether it's part of the traditional  that i understand they will have all of the technical information right by the time the last techno technical section is right it right but what about the other stuff in the d n a is there some reason that the f d a does not because what f d a says and i understood them to say on thirty point three is that until the end a d a s submitted f d a may not have all of the information required by statute regulation and they give for example and they go through a whole bunch of example of things can make it you can if you've been proceeding by phase review you can change that you can make it you can submit and in eighty eight any point in time you want but if you want to incorporate the technical sections you've already submitted you have to applicant for a minute a traditional application the f d a issued a major deficiency where they said we need another study the applicant went and spent two years doing additional study submitted the additional study to  even insure the deficiency letter and said when you submitted what was required under three sixty b b that's when you would you attribute this period of an application being initially submitted and we don't care that it took you another two years to respond to a request for but the but the the point that's important is that the requirement that there be a complete letter that the m p s requirement the application ultimately be in some sense complete before they would deem it to be an obligation for these purposes is fundamentally at odds with what congress decided here in the what everyone agrees is the definitive legislative history congress explained that we decided not to use the word violence in the statute and instead we used the word initially submitted because yesterday in the past it understood the word files to requests for additional information but what if we instead were looking at the word complete the way i see think i understand it in the human context of the human drug trials to mean when you will believe you have at least initially submitted everything that would satisfy the requirements under for two reasons one the more testing data going on in reality more we're going to take in some of those were in response to incomplete letters and the record at one forty one one forty nine shows this one ology and the other is even then  different from the pre meetings they often have in the traditional setting where they meet with an applicant and discuss things and maybe getting data that is not an application as far as f d a is concerned all the separate data is being submitted to data is there until wyatt's tells us that it's there and it does so through is submission in the gift of the law and had actually sent a letter along with the last technical section indicating this completes our application we have n circumstances discussed in the one nine hundred ninety five guidance had there not been the appropriate responses to prior give and take over the separate section if they would have no doubt based on the ninety five guides issued to the deficiency letter  so we can accept this you have to go back and address many of the things we've previously discussed and then come back to us but isn't it it's already initially submitted fired that that would've been an application that i believe would have not been initially submitted because it would have been decision or not  proval at that point but initially submitted doesn't require approval initially submitted as when you phrased it you came up to judge moore was right and usually submitted is when the f t is on notice that the applicant believes he submitted everything w that is the first possible time event after you can be on notice that an application has been filed whether it's suffices for approval purposes and requires a resetting of a clock that's i agree that might be a different buy make sure i understand admits what the applicant believes to be a complete application if it accepts it and then has a few questions before it's prepared to approve now the questions if i understood what i thought i understood about the party's position those questions the back and forth do not keep the earliest the first submission from being in an initial submission right yes and no it doesn't if the minor according to what we've argued and the approval can occur within one hundred eighty day period that the statute sets out but they may be minor but they would still be significant enough to prevent approval without getting a sense factory answer direct me otherwise  initial submission occurred but in the assuming the f d a concludes that this application has three or four things that we need from the applicant here those four things can probably deep be done fairly quickly but we can't approve without them the submission that was made prior to the f d a request for those for clarifying points is still in nish will submission within the meaning of the statute correct yes and if it says it's an application seeking approval up particular uses or whatever of the that of the drug so for example here and you take me into the ruminating caps issue as far as f d a was concerned and again  application came in saying we're only seeking approval for dairy cattle and beef cattle and not pruning cows that we had an application which we could then look at to approve or not approve now when you say when the application came in do you mean that was in the submission or otherwise well i think that's correct we just we simply don't have that filled out completely but that's right and i again though i think this bill gets away from the fact that there is some formalism here that is necessary f d a doesn't isn't on notice one expert section in the center for been there in medicine some other data one of the other technical sections goes to another to go through all the expertise section f d a has made clear in its guidance in ninety five no one person is at  person the division director responsible for the evaluation of target animal safety technical section that's the person who is authorized to approve or not approve drugs that's a joint appendix to thirteen as one example where it shows up so the port but within ninety five guys it's very clear that all of these factions are going to various parts of these technical sections are going to various parts of the f d a and not to one person who knows that application is there the complete facsimile labeling the remove information act summary a complete identity of the african and what the applicants commitments are to the particular product and so forth and it is at that point that f d a is  is aware that an application has been initially submitted for some use of the particular drug product but maybe you said it and i missed it but again going back to the there was nothing we had before as to whether the a s the first time that the specific request for a particular uses me i don't think you mention the designation of the specific requested use authorization but that's in there somewhere i take i would application what uses the applicant is seeking approval up and that and you say that that doesn't come until now we're sort of focusing on the facts of this case even though we're talking about a rule that has much broader application but important part of what they were applying to get approval up at some point the application i believe tells the application tells at the it what it is is being sought and they prove all that's being s t i think the facts of the record in this court accept this are are clear and in fact there was a testing phase going on all through this process in the in the statute really does divide between the testing phase and approval phase in this report points out that there was a testing data being submitted all the way into january of ninety eight so does that mean in a regular not the phase for review but in a regular review that if the a took an initial submission looked at it further testing is necessary that the f d a would not then treat this as an end mishal submission and the time wouldn't click over to review time yet if the f again as i tried to answer earlier depending on whether the kind of information f d a is seeking can be obtained and reviewed was in one hundred eighty days it will consider the initial submission to be the date when the application came fundamental and even if it could be done on a rushed basis in one hundred eighty days that might still be sufficiently fundamental to keep the application from being initially submitted no i think if the yeah as i understand our back and forth on this has been that if it feels that the responses can be done within the hundred eighty day period and then approval therefore possible within the statutory one and not a period the initial submission has the dat application was initially submitted the other material that comes in does not change that date now i'm just a little bit confused your reliance to me seems so heavy on whether or not approval can be achieved within one hundred eighty days that just seems like an awfully weird way to interpret the words initially submitted i just don't see anything in the legislative history or in the statute that would suggest to me that that is somehow an appropriate way to interpret the language so i mean if you were to parse it on testing or something that i could say seems related to the statutory language and legislative history that would make little more sense to me but justify if you will where this hundred eighty day approval becomes the touchstone for whether  reset the clock depending on what f d a views as how serious it was in terms of the complete enough concept because you wouldn't want to let people take total advantage of this and say well it's officially submitted even though it's willfully deficient in lots and lots of obvious ways such as the submission of the first technical section running money you don't sell it so i mean it makes it makes some sense but it just seems a little counterintuitive to me to interpret initially submitted in terms of whether or not   that that might affect and major changes might affect its ability to approve them one of the technical sections that must be submitted a labeling section yes ok wouldn't labeling necessarily have to say what the intended scope of use the labeling that's what i don't understand because i've to let point we're at different we're at it we're at a point where data has been submitted to several different sections no one individual has looked at the whole material in order to  make a determination whether everything is actually complete as a whole until the administrators of an eighty a is submit it and at that point to dismiss it as i said to a single individual who then makes that  determination of whether the application is complete enough to begin the review process prior to that no one individual knows whether all the data is there no one individual knows what the approved what the the approved use is that the applicant seeks until the application itself is filed that's my understanding but going back to the fact of the matter is at any time and this is i think it's critical in any time head it's thought it wanted to immediately you submitted to application and submit that which is understood to be an application it could have submitted right after its last technical section a traditional it had its ducks in a row and therefore was on the way to a quick approval which was that page forty seven and that's proof by recycling so this is important to us approvals earlier than later are critical in order to make sure we get to the markets and more than in someone else let me be sure i understand with respect to your chevron are committing exactly what it is we'd be deferring to if i understand it correctly the regulation sixty point twenty two f really just looks to be pretty much the statutory language but you're asking us if i understand correctly to defer to is the three previous f d a decisions or a consistent line of f d a decisions in particular cases is that correct i think yes i think that's right and i think the regulation and this consistent one of interpretation within the animal drug application process is what we're seeking regulations and just to make sure i understand your spots the regulation itself doesn't really get you where you need to go correct without the interpretation of the regulation in the three rulings that f d a has has had in some of the cases and i think that's right and that's what we pointed out it right i think we try to make the point in our brief that to the extent that we say application complete enough for review we need a particular concept and that concept is reflected for example in those three decision government about whether everything in three sixty b b is submitted by the time the initial and the final technical sections but in the answer that is yes and the government has never in this case or otherwise pointed to anything in section three sixty b b a statute that is not submitted by the time that final technical sections but in what the government is and has done is they've introduced a new requirement and this is the basis for their decision is you need the complete letters and we'll just give you one example and part of that i think all we're going to review all the data and then we're going to shoot computers you can actually submit an application we're not going to let you submit an application until you submit all those complete letters to us and that's if they were to say you have an application and then it's going to be the sixteen days or something like that that we're period of f d a activity after the submission the administrative and supposed that the f d a arranged to have not just a single person getting this file and presumably doing something that doesn't involve a significant amount of scientific work but suppose they did have several months worth of further scientific inquiry a sort of double check on the scientists in each of the various sections to make sure that there wasn't some problem that creeps in from the lack of synergy between the various  sections and this would typically take say four five six months and might provoke questions back and forth from this one central office when your view of the process be different not not in the slightest your honor because the big critical question is when the elements of information that are required under sixty sixty three sixty b b are submitted to the f d a and we we can see that in this context as is always the case whether it's face review or traditional view there is a back and forth and there is a discussion with the f d a were additional data could be requested and that's the reason congress used the word initially said because there is that but i think your question does point out that out a further flaw in the government's position because the government explain do with the question of when the applicant is actually initially submitted an application to the you have got to get the f d a could have once earlier said we're going to take that information it we're going to assign one person to look at it that's just what the f d a is going to turn it has nothing to do with what the