Transcriptfda.doc

U.S. FOOD AND DRUG ADMINISTRATIONPRIVATE

PRE-PROPOSAL CONFERENCE

DOCUMENT CONTROL ROOMS

WEDNESDAY,

JUNE 11, 2007

The Conference convened at 9:00 a.m. in Room 2205 of Building 22 of the White Oak Campus of the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland.

*At 10:49 a.m., the Conference reconvened in Room 1315.

TABLE OF CONTENTS

Opening Remarks

General Information

FDA Presentation

Questions and Answers

Adjourn

P R O C E E D I N G S

9:12 A.M.

MR. HENIG: I can't hear you, so I want to make sure that everybody hears what we have to say because the information that we're going to provide you we feel is very crucial to your ability to provide us with the best possible proposal that you can, both technical and cost.

I'd like to introduce our people here. My name is Paul Henig, I'm the Project Officer on this contract. Patricia Pemberton is the Contracting Officer. And Wendy Aaronson, she is the Director of the Division of Document Records Management which is associated with Office of Business Support Process -- Process Support, excuse me, Process Support. So the Document Room is managed out of Wendy's shop.

There's a couple of issues that I want to make sure that you're aware of. Certainly the one is that the limited time that we have. I'll ask that you not ask questions until we have our question and answer session which is later on in the program. That will assist us in making the presentation fall within the hour time frame that we've committed to.

Other than that, I think we'd like to go to the agenda real quick. It's pretty self-explanation. Remarks, we've just finished that. General Information, that's contract information that Patricia will provide. Then from there we'll go to Wendy's and my presentation which we'll talk about the facility locations, operations, and the other element that I think is very crucial is the process flow. That's very important and as we go into the presentation, you'll -- we'll stress areas that you really need to focus on. Then of course, we'll have to adjourn, go downstairs to the office. We'll break up into smaller groups and from that point we'll -- I'll take you around and show you this site here. This is only one facility that we manage. But it will give you a good understanding of the process and how the flow, the document flow occurs from start to finish.

And then we'll go into the question and answer session and then closing remarks.

So on that, I'll turn it over to Patricia.

MS. PEMBERTON: Good morning, and welcome to the FDA Document Control Room Process. This has been the bane of my existence.

(Laughter.)

Mainly because of the magnitude, along with the other duties as assigned. I want to go over a couple of general points that we need to keep in mind. If you have to use the little girls and boys room, you must be escorted, so please let one of -- they're my contract specialists, but I call them my escorts today. Okay? They're special.

And what Paul did not mention is that we have several project officers on this project. Paul is the lead. We also have Elizabeth Canter who is also a project officer. Are there any more that came? We have about seven or eight?

MR. HENIG: Six.

MS. PEMBERTON: Six project officers. Please turn off all electrical devices in terms of cell phones. This meeting is not to be recorded and we have Mr. Neal Gross here, our recorder.

The questions that you have already submitted in response to this RFP we're currently working on it. I was up late working on the responses. We were not able to have them ready for this meeting, but you will have the opportunity to submit additional questions after this pre-proposal conference.

This preproposal conference is for information purposes only. Nothing is binding unless it is executed in an amendment, an official amendment to the RFP.

Any questions you want to submit after this -- during this preproposal meeting will be recorded and will be submitted as part -- I told her if my kids call, pick up. Sorry.

The questions will be recorded and we will put them, post them on the Fed. Bus. Ops. link.

Did everyone sign in on the sheet, the sign in sheet? That sheet will become available on the Fed. Bus. Ops. It will be posted also.

Do we have any questions?

(Pause.)

All right, Paul. Let me do the structure of the contract.

I receive a lot of questions and concerns in relations to the way the contract, the pricing schedule was constructed. I have this copy.

We have a general umbrella contract which is called the master contract and then we'll go into issue task orders against it. This pricing schedule attachment nine will be used for evaluation purposes which means that you are to submit it with your pricing fully loaded, fully burdened, as part of your proposal. This will be awarded upon the award of the contract. So this is the base. This is the first task, if you want to say it that way.

Every so often we have -- and Paul, correct me if I'm wrong, we have a project officer that will approach us and say I have a simple task let's say $25,000 and we'll issue a task using the T & M portion of the contract which is -- I don't think I -- it's not on here. But there's a section for the time and material portion. However, when we issue the task it becomes a firm fixed agreement, not a T & M, a firm fix. So when you price that T & M portion, that's going to be used for negotiation when it comes to issuing the task, but we want to see the rates up front fully-loaded, fully burdened. The back portion of it, the option years, and this portion belongs to Wendy's group, right?

This is Wendy's group. You are to price the option years out on this section, using the same number of hours. Is that clear? All right.

Now we also have, we're going to talk about the technical and the cost proposal. Well, for those of you who have been in the business long, you know submit your package separate. You have a technical section and a cost proposal which is actually the business proposal. No information in relation to your cost proposal should be filed in the technical proposal and a number of questions came up on that issue and I issued a mod, I think it was yesterday or the day before yesterday, clarifying that issue. One note I want you to pay attention to in relation to T & M arrangement -- is Stanley Fujii here? That was our small business rep.

Can you guys run downstairs and see if he's there? Thanks.

F.9, I'm trying to remember from my memory, was revised. That is critical. F.9.1 was removed in its entirety. A mod was issued to that effect. That basically outlined how the teaming arrangement was going to be evaluated. We decided to take it out completely. However you chose to team, that's entirely up to you. However, subcontracting limitation clause does apply. I forgot what that one was, but anyway. That's what the prime has to do, 51 percent of the work.

So in relation to teaming arrangements, if you want to team with another 8a, that's entirely up to you if chose to team with a large business, that's entirely up to you. However, once we do the technical eval. and we move to the point of award, a letter will be sent to SBA with the name of the company with your proposal and they will give us the okay to contract directly with you. So you have to be an 8a. You have to demonstrate that you are doing 51 percent of the work. There's no exception to that rule. There will be no exception to that rule.

I think this is where Paul comes in. Okay?

MR. HENIG: My goal here is to basically give you again a good feel for how the various facilities interact with one another and also what key operations are performed in those facilities.

We'll start with the Central Document Room because that's basically where the material initially comes in and that's where the process of the review material, the applications submissions come in.

From there, in that facility, if you look at your handout, I don't want to go through a whole lot of detail in this because I think the handouts will hopefully answer a lot of your questions. I'm sorry, do we have any additional --

This chart here, what I really want to show is that the Central Document Room interacts with White Oak. There's three buildings there. It also interacts with the Gaither Scanning Facility. That's a key element there. And then also certainly with the retirement process with the Federal Records Center.

Now the Central Document Room, their operations are very standard in the sense that they -- you have mail receipts scanning, processing and distribution. And there's the courier services from the various facilities that CDER interacts with are usually twice a day. However, they can change depending on the volume of material that comes in and also the volume of priority documents that arrive at the CDR. These are time sensitive and require an expedited processing.

Again, then we have certainly our records management of the facility out at CDR is a main contributor for document storage, as well as document retirement. So the shelving capacity out there is I believe around 100,000 linear feet. It's both jacket files, as well as box files. But in the RFP there is more information on the specifics. So I would refer you to that document.

Once the material is basically initially processed through the CDR, it then comes to the White Oak campus. And the White Oak campus here, there are three building and each building basically is responsible for a certain I would say division or office, I guess. The building that we're in here, building 22, supports the office -- okay, here we go.

Building 22, it's responsible for supporting the application, the IND applications, the NDA applications, BLAs, all that really kind of focuses into the Office of New Drug.

From there, it's also again as you see through the handout here, the operations are somewhat similar in the sense that they receive new material in from the CDR. They have to identify the priority. They have to triage and then from there it goes into the processing sequence of events. And then from that, once that's taken care of it's then forwarded, distributed to the reviewers where they then perform their review process.

Those are key elements of -- when we do the tour, I'll be able to point out specific areas and I think that will certainly help you in identifying kind of a flow and Wendy will also provide additional information again, when she presents her section on flow process, on process and flow process.

Building 21 is more or less the Document Room downstairs, what we call DR1. That handles the reviewers that are in this building. It also handles the reviewers that are in Building 21 which is just adjacent here. But the Document Room is only in this building. There is not a Document Room in Building 21. So that's important to note. So you have transferring documents from one building to the next. I want to make sure that you're aware of that.

Building 51 now supports the Office of Compliance -- DDMAC, which is the Division of Drug Marketing, Advertising and Communications.

In that building there, there is a Document Room for the Compliance Document Room. It also handles the DDMAC Document Room and on top of that Compliance has a subgroup which is what we call the DSI which is the District Offices and Inspections Group. They have their own separate Document Room. But this contract manages all three of those Document Rooms over in that facility.

Again, please note your questions and we'll certainly be more than happy to answer them in the Question and Answer section.

Again, I'm trying to give you an overall view of the process flow because that's very important to us and will certainly make you a better bidder as far as creating a proposal that's going to be stellar.

The OGD facility in some ways is kind of off by itself. It is -- there are two facilities. There's Metro Park I and Metro Park II. Those are the key processing facilities for OGD. Metro Park II is where the Document Room is housed. That is where the receipt of new review material enters. It enters into the Metro Park II Document Room. From there it gets triaged. It gets identified as high priority and from there, then it goes to the reviewers for their review.

The Metro Park I Document Room operates more as like a satellite to the main Document Room in Metro Park II. It also supports those OGD government employees in Metro Park I. The Metro Park I Document Room, the satellite Document Room supports those individuals in that room as does the Metro Park II support the employees, the reviewers in Metro Park II. Did I confuse you? Yes, okay.

Let me go back here. I was getting confused and I know this stuff. The distinction I want to make here is that again, getting back. In Metro Park II, that holds the main Document Room. So the most or the processing of the documents is primarily performed in that Document Room in the Metro Park II Document Room.

The reason that we have a Document Room in Metro Park I is primarily to support the government employees or the reviewers in that Metro Park I facility. So there's really no processing going on in there. It's more or less going to be primarily a pass through, I should say, to the reviewer community.

Does that help?

Now the Wilkins Avenue is an off-site facility and the primary purpose of that is to -- is our over-flow facility. Because of the limitations that we have in both the Metro Park II and Metro Park I facilities, we cannot house all of the review material. So therefore we use the Wilkins facility as a catch-all for all of the overflow material.

However, it's also very important to understand that there are requests from the reviewer community for documents that are housed in the Wilkins facility. So therefore, you have to understand when you're doing your proposal here that it's very important that there is courier service from the -- I'll call it the OGD campus which houses both Metro Park I and II to the Wilkins off-site facility. And usually those runs are twice a day. But again, it also will depend on the volume of the requests that we get and also the urgency of the request. So that will certainly change.

Wendy's presentation, I want to emphasize that although there were some --

MS. AARONSON: We're going to try to move this along because we've got a site tour and that's probably going to help out a lot.

Okay, I'm going to kind of quickly go over the flow because I think Paul somewhat discussed it while he was talking about the operations performed at each site. So this is a very, very -- yes?

(Off-mic question.)

I'm sorry. You've got the handout in your -- you've got this picture in your handout.

Okay, so if you think of the start, that's where it all begins. Industry sends in their submissions, these submissions being the applications, INDs, NDAs, BLAs. Master files. CDR is also the receipt of all of the adverse event reports. VGDS are these voluntary generic data submissions. They're just another submission type. They get paper. Lots of paper.

CDR receives it. They open, date stamp, log it in. They perform a high-level sort to kind of put it into the different buckets, if you will, the different application types because depending on the application type different data are going to be abstracted. So that's the reason for that process. Also, different things have different priorities.

If it's an electronic submission, kind of follows the different path, again because we've got the Electronic Document Room staff here at White Oak and there's some marginal -- they identify the material, perform some data entry in CDR, but send the electronic media immediately over here so that it can be loaded and available to the reviewers. So it goes through this process flow. The submission is loaded. The notification goes out to the project managers and reviewers. There's a backup and archive and that's it.

If it is an original IND or an NDA it goes through -- there's some processing that occurs at CDR. Currently, at this time and I want to stress that these are the current processes, but there's some processing going on at CDR in terms of again data abstraction, entry into the data bases, jacketing, bar code labeling, etcetera. And then that gets sent over to DR1 and you'll see in the next process flow that will get distributed.

If it's the DMF, it goes over to the DMF staff. Again, they're located at CDR. They do their data abstraction, data entry into DARRTS, jacket, label, bar code, file. When master files are -- master files are not reviewed until there's an application that references it. So that staff is really -- once they've done the data extraction and filing, what they're doing is retrieval and distribution upon the request for the reviewer.

Okay, so I think that kind of gives the process flow at CDR. Again, it's somewhat of a repeat of what Paul was discussing, but since we're not going over to the CDR, we've got a few pictures. This is mail coming in. And going through the x-ray scanner, you read that in the SOW about an x-ray scanner, so the mail is scanned, coming through -- that's your typical delivery. Sorting through all of the FedEx boxes and another sort. And a picture of the CDR. Files and files. I think that's it -- this is a work station in the master file area. What you see in front of you is basically a day's work, I mean a day's receipt of new -- these are new master files. The master files are jacketed, archived -- there are two copies that come in for the master files and they're all jacketed, archived and a duplicate copy being the review copy. Your master file section.

Okay, so now we're on to the flow at the DR1. So things are now sent off. They've done their primary sort, separated out the electronic submissions, DMFs, original, INDs, everything -- 15-day reports get sent to the courier that handles the adverse event MedWatch reports. And the DDMAC stuff is separated out as well and that gets sent over to DDMAC. Sometimes OGD stuff comes into the Central Document Room. That gets couriered over to OGD. So you can almost envision that's DR1, but there are other

-- there could be other process flows, depending on the application type. But there's the same theme. Identifying, see what it is, data abstraction and distribute and file.

So okay, if it's an original IND or an NDA, because of the time, the timeliness that's required in getting these to the project managers, as soon as they are received, they're hand-delivered to the Chief Project Manager. Any updates are performed and then the applications are distributed to the reviewers.

I'm going to stop right there, just kind of hold it because that's kind of the same -- that process flow will also occur if it's not an original IND or an NDA or a BLA. In other words, it's an amendment to one of these application types. The document again is sorted and distributed to the staff, the Document Room staff to abstract the information, preform data entry. They notify the project manager if it's a high priority submission. Those submissions were identified in the Statement of Work. They notify the project manager if it's a high priority submission because they want that PM to be on top of it.

They -- so it's that proactive, sometimes PMs get -- the Project Manager and the Review Division gets pretty busy and they don't want to come look at their work. I mean they just get busy. But by notifying the Project Manager, they know that they need to do something.

So after the data are abstracted, the document is jacketed. A bar code label is created, and it's scanned in INVAS. As you found in the Statement of Work is the Document Accountability System, the Volume Accountability System.

After being jacketed, the bar code is scanned, it's scanned out to the PM where it actually goes on to a PM shelf and I have a picture of those. It goes on to the PM shelves. The PM comes down to look at it, to verify that the data are accurate to make any additions. Any additions, updates are then performed by the Document Room. And now we go into the same Process Room. From there you get distributed. You get it distributed to the reviewers. The reviewers perform their review and return the documents when completed.

I might add that for all -- for IND and NDA master files, the reviewers check in the communications, whether they be letters, memos, telecons, meeting summaries. Those documents are entered into an electronic archive system for INDs and master files. All of the back-end, what I would call the back-end data entry are performed by the reviewers for NDAs, BLAs, that data entry is performed by the Document Room staff, you know, identifying what the document, what the communication is, the author, and some very basic data.

The documents then are picked up from the Review Divisions. They're scanned back into the accountability system. If there's any additional data entry required, in other words, the communications, that's done at this time; closing assignments; and the document is filed in the active file room, which is downstairs in this building. After a while, we run out of space, so after a while those -- there's a shifting of files over to CDR for an intermediate-type storage and then we have a retirement schedule. That's basically the process flow.

This is the spot chaser cart. When the documents come in to the White Oak campus, they're delivered at a loading dock. The stock chaser takes them to the document room. Unloading, as you can see, all documents are put on pallets and shrink-wrapped. There's priority documents, electronic submissions. An example of a typical NDA. This is an example of a work station and actually a small amount of the morning's work and the bar coding station and this a picture of the PM shelves.

This is where the PM, the Project Manager from the Review Division comes and looks at the documents and verifies that they've been coded correctly and they make any additions. If there are additions, they get placed on another shelf in the Document Room to pick up and perform the updates.

This gentleman, this is now the file-back. He's sorting through the documents to be filed back into the file room, and this is the file room here in Building 22. These are division files. They're essentially, they're paper files of communications that were created prior to the electronic archive system which was in 2002, yes, I think it was 2002. So if a Project Manager wants to find a communication prior to 2002, they may want to come to these files.

The shred bins, everyone has seen these things. As you might expect, there's a lot of shred. So yes. I don't know how -- it doesn't take long to fill up these, but we have -- there's a shred contractor that comes and picks them up regularly, so that's not a problem. This is a work station for the Electronic Document Room staff, a sample of their server.

I might as well go through the processing time constraints. We've pulled out -- you know, we've stressed timeliness. If there's anything that a reviewer, Project Manager wants, that's timeliness. And there are certain documents that are very -- that are on very previous time clocks and I can't emphasize enough the need for timeliness because that's what the reviewers see most.

So what we've done is just kind of a table of what the processing steps are and what our expected standards are. For the most part, three working days to get things into the door, identified into the system and on the Project Manager's shelf within three working days. Electronic submissions, because you don't have all of this paper stuff, all the jacketing and bar coding, we're looking at a one working day turnaround.

Priority -- for priority documents, we're looking at two working days for priority documents and three working days for non-priority. So you know, get the -- this is all in your handout and of course, we've also -- it's not -- oh, I'm sorry.

Okay, we'll provide that. We'll provide that.

Okay, and the DDMAC, we've got a one working day for priority and two working days for nonpriority. Office of Generic Drugs, it looks like we've only got an electronic media processing time frame. And for the DMS, the idea again, they're not on a review clock, unless the reviewer requests them. And then that means they need the documents rather quickly. So the time frame there is based on a request, not as much as on the receipt.

However, you can't -- sometimes an application might come in before the master file, so you may end up getting a request prior to the master file even being received and sometimes prior to processing. So you just have to be aware that even though there may not be a time identified for the processing of master files, if they get requested, then there is a need for acting on it.

With the electronic document room, we've got basically one-day turnaround for processing and loading.

That's basically it. I'm trying to rush through this because there's another large group coming in at 10 o'clock and we really apologize. We were trying to get a larger room for a longer period of time, but room spaces are at a premium and to be quite honest with you we didn't know that there was going to be so many people, so the original room that we booked was not very large.

Yes?

PARTICIPANT: When you provide the time constraints --

COURT REPORTER: I'm sorry, could you please come to the table?

PARTICIPANT: When you provide the time constraints slides would it be possible to provide some metrics on numbers of documents of each type?

MS. AARONSON: I believe there are some --

MS. PEMBERTON: There's a chart in the RFP as an attachment that kind of outlines the load or the volume of this work process.

PARTICIPANT: Okay, and then we'll be able to relate to it that way?

MS. PEMBERTON: Yes.

PARTICIPANT: Thank you.

MS. AARONSON: Okay, they're chomping at the bit outside here and there will be some additional time for questions. So I'm going to close up shop now and you all, while I do this, you all will kind of coordinate everyone to move to the other room.

MR. HENIG: There, we'll break into groups and then we'll go on the site tour. Hopefully that will assist --

MS. AARONSON: Remember, you have to be escorted, so I don't know how you guys are working this out.

This might be also a good time to go to the men's or ladies' rooms.

MR. HENIG: There will be more time for questions during the breakout.

MS. AARONSON: Yes.

(Off the record.)

PARTICIPANT: One of the major objectives is to reduce paper, but there's only

MS. PEMBERTON: There's someone speaking.

PARTICIPANT: One of the major objectives is to reduce paper, but it seems to be that it's the same processing and archiving and no conversion. Are you interested in docketing conversion at all as an alternative solution?

MR. HENIG: Yes.

MS. PEMBERTON: However, I was told by Elizabeth Canter, one of the project managers, is that they have a process that was probably approved by let's say Congress that they have to do something in a certain manner and this is what's taken time to do this total conversion. They have to wait until they get the okay from Congress or someone on the Hill. We're open to innovative processes, but not alternative to what we currently have. Does that make sense?

PARTICIPANT: Yes.

MS. PEMBERTON: Okay.

PARTICIPANT: Is Document Tracker the DocTrac, is that a commercial product or is that an FDA-developed product?

MR. HENIG: Wendy, I guess would be the one.

MS. PEMBERTON: We have a question.

PARTICIPANT: DocTrac. Is DocTrac, is that a commercial product or is that an FDA-developed product?

MS. AARONSON: I do not know. However, Russ -- FDA. Some of the systems were around long before I joined the group.

PARTICIPANT: In one of the sections of the proposal you're asking for a certain number of copies. You have the word eight --

MS. PEMBERTON: I made an amendment which clarified it to six copies.

PARTICIPANT: You have a lot of standards to meet -- have to meet 99 percent of the time. Do you have metrics that tell us how you measure that 99 percent?

They're all through the document you --

MS. AARONSON: That's correct.

PARTICIPANT: And they're all measured differently, but we don't have how they're measured.

MS. AARONSON: That's correct. We have databases and right now to be quite honest with you right now, we're not measuring that. Okay? I have to be honest. We're not measuring that. However, with the development of new database, specifically DARTS, we're on creating reports to help us with that audit and measuring that accuracy.

PARTICIPANT: If a contractor does not meet the requirements set forth in the quality standard you spoke about a moment ago, how is that conveyed back to the contractor, in the form of a disincentive? Is it a percentage of the fee? Is this a firm fixed fee environment?

MS. AARONSON: Well, right now --

MS. PEMBERTON: We don't have a chart or a measurement to dock the contractor if they're not performing. However --

MS. AARONSON: We have and we will be and we frequently work and discuss issues with the contractor. The whole idea is to have quality service, quality work and the -- and in the environment, when you reach a certain limit of quality, let's say things in terms of timeliness, decrease, you don't want to get to the point where you to get to where it's bad. You want action, some kind of alert and that's the idea, to work together with the contractor, what are the barriers, is there a training issue, is there something -- and we realize, it's not always the contractors. The submissions themselves, again, I have to be honest with you, are not always well marked as to what they are.

So by looking at the corrections, looking at timeliness, I can tell you my goal is to be more proactive, identify is it a training issue where the documents brings -- staff doesn't quite understand what the document is? Is it a submitter issue? Are they not following the guidances? Do we need to make the guidances more clear? Is it a form problem? We're always reevaluating the forms. Is it capturing the right information? So it's a team effort and acknowledge that it's not a perfect process.

PARTICIPANT: Thank you. The 240 FTEs, one, the fact that it's 8a. I wonder how many 8as are around the table --

(Participant's voice obscured by noise from outside.)

MR. HENIG: Can we please close the door?

MS. PEMBERTON: Will you let them know to hold it down or come in?

Can you repeat your question? Please louder so we can capture --

PARTICIPANT: The requirement, and I have read the last two amendments, perhaps you addressed it in this, but the requirement on Attachment 9 to cost out in the proposal with approximately 240 subcontractuals and FTEs, is that realize since this is an 8a competition to request the 8as in this room to submit all 240 resumes for the first base year?

MS. PEMBERTON: That's a question that Wendy and Paul are researching as we speak as to the necessity for requiring all the resumes, rather than just the key personnel.

PARTICIPANT: Thank you.

PARTICIPANT: Is there an incumbent, and if so, is the incumbent eligible to bid as a prime?

MS. PEMBERTON: Yes, on both. The incumbent is Alitiq and will be in the Fed. Bus. amendment and yes, they are eligible to bid.

Any other questions?

PARTICIPANT: A 60,000 quick question maybe --

MS. AARONSON: It sounds like linear feet of shelf space.

PARTICIPANT: Are there any future designs to consolidate the Twinbrook locations in Gaithersburg to this campus?

MS. AARONSON: Excellent question. That is our Office of Generic Drugs. They were -- it was in the plan to move them last -- this year actually. Well, it was in the spring of this year and those plans were changed last minute and so until a future building is built, the Office of Generic Drugs will remain in Rockville, to my knowledge, but that's a moving target.

However, you saw that there was a facility at Wilkins, on Wilkins Avenue in Rockville. That's kind of central Rockville, and then the Office of Generic Drugs is at Metro Park North and what I would call Northern Rockville near Gaithersburg. And Facilities is in the process of looking for another location closer to the Metro Park North area so that one can then move the Wilkins Avenue documents over at least closer to that North Rockville vicinity.

PARTICIPANT: Can I ask a related question? It's obvious in the solicitation that the Central Document Room is scheduled to be moved. When is that going to happen?

MS. AARONSON: The Central Document Room is going to be moved?

PARTICIPANT: That's what the special tasks say.

MS. AARONSON: We'll get back to you on that one. We'll have to look at that.

PARTICIPANT: All right.

PARTICIPANT: I have a question. Did you cover the number of pages required? The number of pages to be submitted in the proposal, the technical -- I couldn't find, whether it was a 100 pages or do you write until you think you have a winning proposal, I don't know. Is there a number of pages.

MS. PEMBERTON: Let me put it this way. As long as your proposal -- I am not going to limit the pages. If you need to take 20 pages to address the evaluation criteria, that is fine. But you have to be able to demonstrate all of the issues and the areas that we requested. It might take you 20 pages. It make take someone else 100 pages.

However, we don't want to search for the key issues.

I'm sorry, this gentleman.

PARTICIPANT: Is the courier vehicle a GFE or is that contractor provided?

MS. PEMBERTON: The vehicle? I think it's FDA's.

PARTICIPANT: It's FDA's vehicle.

MS. PEMBERTON: I believe so.

MS. AARONSON: The car, the vehicle. Is it FDA's or contractor provided?

MS. PEMBERTON: FDA's.

PARTICIPANT: So they'll be putting in the gas, too.

MS. AARONSON: I don't handle the financials. I just handle the operations.

PARTICIPANT: Will there be an opportunity to submit other questions before --

MS. PEMBERTON: Yes, you have until the 13th, Friday, to submit additional questions.

Any SBA questions or human arrangement questions? Any other questions?

PARTICIPANT: Are you considering extending the deadlines beyond June 27th?

MS. PEMBERTON: Not at this time. That's it. Thank you very much. I'm glad this day is over.

And you will be escorted out.

(Whereupon, at 11:01 a.m., the pre-proposal conference was concluded.)

NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS

1323 RHODE ISLAND AVE., N.W.

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