1 STATE OF FLORIDA DEPARTMENT OF BUSINESS AND …

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STATE OF FLORIDA

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

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DRUG WHOLESALE DISTRIBUTOR ADVISORY COUNCIL

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________________________________________________________

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COUNCIL MEETING

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(Via Telephone Conference)

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TRANSCRIPT OF PROCEEDINGS

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DATE:

August 16, 2018

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TIME:

9:30 a.m. - 10:12 a.m.

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Stenographically reported by:

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Deborah Alff, RPR

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COUNCIL MEMBERS ATTENDING:

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Steve Mays, Chair, Prescription Drug Wholesalers

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Jeenu Phillips, Vice Chair, Board of Pharmacy

Joseph Lavino, CVS Health, Retail Pharmacy

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Michael Mone, Primary Prescription Drug Wholesalers

Scott Brock, Pharmaceutical Manufacturers

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Dean Ellis, Secondary Prescription Drug Wholesalers

Jeffrey Tuller, Primary Prescription Drug Wholesalers

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Patrick Barnes, Hospital Pharmacist

Peter Hart, Medical Gas

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Jennifer Goldman, Physician

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DBPR STAFF ATTENDING:

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Drew Winters, Division Director

Dinah Greene, Government Operations Consultant

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ALSO PRESENT:

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D. Ty Jackson, GrayRobinson, P.A.

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Shannon B. Hartsfield, Holland & Knight, LLP

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I N D E X

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AGENDA ITEM

PAGE

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_________________________________________________________

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"TAB 1" CHAIR'S REPORT - STEVE MAYS, CHAIR

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a. Joseph Lavino - Introduction

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b. CDR Exam Review - Steve Mays/Michael Mone

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c. Nominations for Chair & Vice Chair

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d. May 10, 2018 Meeting Transcript

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"TAB 2" DIVISION DIRECTOR'S REPORT - DREW WINTERS

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a. DDC Rules Report

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b. 61N-1.0155 Establishment, security, storage

Exemptions for Virtual Manufacturers and

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Broker only

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"TAB 3" NABP UPDATE - JEENU PHILIP

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a. Language regarding the definition of

suspicious orders

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b. A central reporting system (where NABP

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acts as a repository)

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"TAB 4" Other Business

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Certificate of Reporter

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TALLAHASSEE, FLORIDA 850-222-5491

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P R O C E E D I N G S

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(Whereupon, the meeting was called to

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order at approximately 9:33 a.m.)

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CHAIRMAN MAYS: Good morning, everybody.

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My name is Steve Mays. I would like to call this

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meeting of the Drug Wholesale Distributor Advisory

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Council to order.

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I just want to remind everyone that we do have

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a court reporter on the line, and that you need to

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identify yourself each time before you speak so the

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court reporter will know who is speaking for the

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record. If you don't, I may interrupt you to

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remind you to identify yourself, or she may.

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For anyone who's on the phone -- which

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everyone is on the phone today -- to please mute

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your line when you're not speaking and that will

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cut down a lot on some of the background noise that

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we hear often. And also, please, do not put us on

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hold so we don't have to listen to anyone's paid

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commercial announcement or music.

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Ms. Greene, I think we're ready for a roll

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call.

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MS. GREENE: Yes, sir.

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Jeenu Philip?

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DR. PHILIP: Present.

FOR THE RECORD REPORTING, INC. TALLAHASSEE, FLORIDA 850-222-5491

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MS. GREENE: Joseph Lavino?

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MR. LAVINO: Present.

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MS. GREENE: Michael Mone?

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MR. MONE: Present.

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MS. GREENE: Scott Brock?

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MR. BROCK: I'm here.

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MS. GREENE: Arlene Elliott?

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(No response.)

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MS. GREENE: Dean Ellis?

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MR. ELLIS: Here.

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MS. GREENE: Jeffrey Tuller? Jeffrey Tuller?

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(No response.)

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MS. GREENE: Patrick Barnes?

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MR. BARNES: Here.

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MS. GREENE: Peter Hart?

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MR. HART: Present.

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MS. GREENE: Jennifer Goldman?

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DR. GOLDMAN: Present.

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MS. GREENE: You have a quorum, Mr. Chair.

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CHAIRMAN MAYS: Okay. Thank you, Dinah.

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I want to start the meeting off as usual by

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reading the goals of council as stated in

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Chapter 499, Florida Statutes, 499.01211, Drug

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Wholesale Distributor Advisory Council.

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"The council shall review this part and the

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rules adopted to administer this part

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annually, provide input to the department

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regarding all proposed rules to administer

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this part, make recommendations to the

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department to improve the protection of

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prescription drugs and public health, make

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recommendations to improve coordination with

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other states' regulatory agencies and the

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federal government concerning the wholesale

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distribution of drugs, and make

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recommendations to minimize the impact of

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regulation of the wholesale distribution

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industry while ensuring protection of the

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public health."

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So having said that, we do have a few items

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on the Chair's Report today. The first order of

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business is to officially welcome Joseph Lavino

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as our new council member representing retail

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pharmacy. Joseph is currently employed by CVS

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Health as legal counsel for pharmacy regulatory

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affairs. He's also a Pharm.D. and a J.D.

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So, Joseph, would you like to tell us a little

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bit more about yourself, or do you have any words

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for the council?

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MR. LAVINO: Sure, Steve. Thanks for the

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introduction. And hello, everybody. Thanks for

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having me. I really look forward to contributing

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to this council. As Steve had mentioned, I am

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in-house counsel for CVS --

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(Telephone interference.)

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MR. LAVINO: I'm a licensed pharmacist in both

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Florida and in Massachusetts. I currently reside

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in Massachusettes. In my day-to-day capacity as

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legal counsel for CVS, I advise the corporation on

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various aspects of pharmacy practice, including

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implementation of the TFCSA across the enterprise,

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which was a major contributing factor to my

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interest in serving on this council.

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So, again, thanks for having me. I look

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forward to working with all of you.

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CHAIRMAN MAYS: Joe, we certainly welcome you

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to the council. Anyone else, anyone have any

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questions for Joe before we move on?

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MR. MONE: This is just Michael. Hi, Joe.

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CHAIRMAN MAYS: The next thing on the agenda

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is the CDR exam review. So I think we had the

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group come in and speak to us at the last council

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meeting about asking for our assistance in

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reviewing the exam to see if there's any

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improvements that could be made to it. And I know

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Michael Mone had volunteered to lead that task.

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And I had accompanied him to Tallahassee, I think

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it was about a month or so ago, maybe it was last

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month, and went through the review.

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And, Michael, I'd like for you, if you would,

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to provide everybody a little bit of an overview of

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what took place.

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MR. MONE: This is Michael Mone.

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Council members and to all staff and guests,

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Steve and I sat down with the testing folks and

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looked through a representative sample of

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examination questions, and also looked at some

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examination questions that whose performance in the

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past had been difficult for candidates to determine

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whether or not the exam development process in the

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item bank was an accurate reflection of what is

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necessary to be known by candidates taking the

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examination, as well as whether the examination was

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designed appropriately for the level of the

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candidates.

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And what we came away with after going through

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several hours of exam items review, as well as

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looking at the blueprint that the candidates would

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study from, and the statutes in the areas that were

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necessary, we came away with the conclusion that

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the exam is properly developed; it is properly

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sourced; it is accurately representative of what a

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candidate should know. And, in fact, this could be

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other opportunities to write new items for the

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examination to bring us to having a more robust

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item bank so that items would not necessarily be

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over-used.

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We looked at the statistics. We looked at

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everything you could possibly look at, and came

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away with the conclusion that the examination is

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an appropriate examination. There's things with

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every examination that could be done. The most

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important thing would be to get new items into the

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item bank.

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MR. WINTERS: Mr. Chair, this is Drew Winters,

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Division Director. I just want to take a moment

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and kind of speak a little bit to that because I

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wanted to, one, thank Michael and yourself for

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taking that opportunity to review and having that

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outside information brought to us so we could do

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that. And I think that the review that we did was

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an outstanding one and, again, is something that we

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welcome the input the council through Mr. Mone to

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take the time and do that.

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I also wanted to mention that I think that

FOR THE RECORD REPORTING, INC. TALLAHASSEE, FLORIDA 850-222-5491

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