Senate Bill 2468

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    Florida Senate - 1999                                  SB 2468

    By Senator Kirkpatrick





    5-1561-99

  1                      A bill to be entitled

  2         An act relating to economic development;

  3         expressing legislative intent to foster the

  4         development of the health technology industry;

  5         amending s. 212.08, F.S.; providing a sales tax

  6         exemption on purchases of certain machinery and

  7         equipment used in health technology production

  8         and research and development; amending s.

  9         499.015, F.S.; exempting certain medical device

10         manufacturers from specified registration and

11         fee provisions of the Florida Drug and Cosmetic

12         Act; requiring documentation to support such

13         exemption from the act; amending s. 499.041,

14         F.S.; eliminating devices from the category of

15         registered products triggering payment of an

16         annual product registration fee; requiring the

17         State University System and the University of

18         Miami to report to the Legislature on

19         evaluation of certain business incubator,

20         clinical trial, intellectual property, and

21         technology transfer activities; requiring

22         consultation with specified entities as part of

23         such evaluation; requiring the State Board of

24         Community Colleges to report to the Legislature

25         on the development of curriculum to support the

26         workforce needs of the health technology

27         industry; requiring Enterprise Florida, Inc.,

28         to convene a task force to study the impact of

29         securities transactions laws on the ability of

30         the health technology industry to raise

31         capital; requiring a report to the Legislature

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    Florida Senate - 1999                                  SB 2468
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  1         on recommendations for revising such laws;

  2         providing an effective date.

  3

  4         WHEREAS, Enterprise Florida, Inc., has a sector

  5  strategy devoted to Florida's health technology industry, and

  6         WHEREAS, the health technology industry represents a

  7  valued and growing sector of Florida's economy, and

  8         WHEREAS, the health technology industry employs more

  9  than 250,000 Floridians at a high average wage and is a

10  significant contributor to state and local tax revenue, and

11         WHEREAS, the health technology industry is dominated by

12  small employers and entrepreneurs that look to the state, its

13  communities, economic development organizations, community

14  colleges, and universities to provide an environment that will

15  nurture its development, and

16         WHEREAS, the health technology industry improves the

17  quality of life for all Floridians, and

18         WHEREAS, the Florida Legislature recognizes the

19  importance of this industry to our state, NOW, THEREFORE,

20

21  Be It Enacted by the Legislature of the State of Florida:

22

23         Section 1.  It is the intent of the Legislature to

24  encourage and facilitate the location and expansion of the

25  state's health technology industry. This industry sector

26  creates high-wage, value-added jobs that strengthen and

27  diversify the state's economy.

28         Section 2.  Paragraph (j) of subsection (5) of section

29  212.08, Florida Statutes, 1998 Supplement, is amended to read:

30         212.08  Sales, rental, use, consumption, distribution,

31  and storage tax; specified exemptions.--The sale at retail,

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    Florida Senate - 1999                                  SB 2468
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  1  the rental, the use, the consumption, the distribution, and

  2  the storage to be used or consumed in this state of the

  3  following are hereby specifically exempt from the tax imposed

  4  by this chapter.

  5         (5)  EXEMPTIONS; ACCOUNT OF USE.--

  6         (j)  Machinery and equipment used in health technology

  7  and silicon technology production and research and

  8  development.--

  9         1.  Industrial machinery and equipment purchased for

10  use in health technology facilities or silicon technology

11  facilities certified under subparagraph 5. to manufacture,

12  process, compound, or produce health technology products or

13  silicon technology products for sale or for use by these

14  facilities are exempt from the tax imposed by this chapter.

15         2.  Machinery and equipment are exempt from the tax

16  imposed by this chapter if purchased for use predominately in

17  research and development or manufacturing in a health

18  technology facility, or if purchased for use predominately in

19  silicon wafer research and development activities in a silicon

20  technology research and development facility certified under

21  subparagraph 5.

22         3.  In addition to meeting the criteria mandated by

23  subparagraph 1. or subparagraph 2., a business must be

24  certified by the Office of Tourism, Trade, and Economic

25  Development as authorized in this paragraph in order to

26  qualify for exemption under this paragraph.

27         4.  For items purchased tax exempt pursuant to this

28  paragraph, possession of a written certification from the

29  purchaser, certifying the purchaser's entitlement to exemption

30  pursuant to this paragraph, relieves the seller of the

31  responsibility of collecting the tax on the sale of such

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    Florida Senate - 1999                                  SB 2468
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  1  items, and the department shall look solely to the purchaser

  2  for recovery of tax if it determines that the purchaser was

  3  not entitled to the exemption.

  4         5.a.  To be eligible to receive the exemption provided

  5  by subparagraph 1. or subparagraph 2., a qualifying business

  6  entity shall apply to Enterprise Florida, Inc. The application

  7  shall be developed by the Office of Tourism, Trade, and

  8  Economic Development in consultation with Enterprise Florida,

  9  Inc.

10         b.  Enterprise Florida, Inc., shall review each

11  submitted application and information and determine whether or

12  not the application is complete within 5 working days. Once an

13  application is complete, Enterprise Florida, Inc., shall,

14  within 10 working days, evaluate the application and recommend

15  approval or disapproval of the application to the Office of

16  Tourism, Trade, and Economic Development.

17         c.  Upon receipt of the application and recommendation

18  from Enterprise Florida, Inc., the Office of Tourism, Trade,

19  and Economic Development shall certify within 5 working days

20  those applicants who are found to meet the requirements of

21  this section and notify the applicant, Enterprise Florida,

22  Inc., and the department of the certification. If the Office

23  of Tourism, Trade, and Economic Development finds that the

24  applicant does not meet the requirements of this section, it

25  shall notify the applicant and Enterprise Florida, Inc.,

26  within 10 working days that the application for certification

27  has been denied and the reasons for denial. The Office of

28  Tourism, Trade, and Economic Development has final approval

29  authority for certification under this section.

30         6.a.  A business certified to receive this exemption

31  may apply once each year for the exemption.

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  1         b.  The first claim submitted by a business may include

  2  all eligible expenditures made after the date the business was

  3  certified.

  4         c.  To apply for the annual exemption, the business

  5  shall submit a claim to the Office of Tourism, Trade, and

  6  Economic Development, which claim indicates and documents the

  7  sales and use taxes otherwise payable on eligible machinery

  8  and equipment. The claim must also indicate, for program

  9  evaluation purposes only, the average number of full-time

10  equivalent employees at the facility over the preceding

11  calendar year, the average wage and benefits paid to those

12  employees over the preceding calendar year, and the total

13  investment made in real and tangible personal property over

14  the preceding calendar year or, for the first claim submitted,

15  since the date of certification. The department shall assist

16  the Office of Tourism, Trade, and Economic Development in

17  evaluating and verifying information provided in the

18  application for exemption.

19         d.  The Office of Tourism, Trade, and Economic

20  Development may use the information reported on the claims for

21  evaluation purposes only and shall prepare an annual report on

22  the exemption program and its cost and impact. The annual

23  report for the preceding fiscal year shall be submitted to the

24  Governor, the President of the Senate, and the Speaker of the

25  House of Representatives by September 30 of each fiscal year.

26  This report may be submitted in conjunction with the annual

27  report required in s. 288.095(3)(c).

28         7.  A business certified to receive this exemption may

29  elect to designate one or more state universities or community

30  colleges as recipients of up to 100 percent of the amount of

31  the exemption for which they may qualify. To receive these

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    Florida Senate - 1999                                  SB 2468
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  1  funds, the institution must agree to match the funds so earned

  2  with equivalent cash, programs, services, or other in-kind

  3  support on a one-to-one basis in the pursuit of research and

  4  development projects as requested by the certified business.

  5  The rights to any patents, royalties, or real or intellectual

  6  property must be vested in the business unless otherwise

  7  agreed to by the business and the university or community

  8  college.

  9         8.  As used in this paragraph, the term:

10         a.  "Predominately" means at least 50 percent of the

11  time in qualifying research and development.

12         b.  "Research and development" means basic and applied

13  research in the science or engineering, as well as the design,

14  development, and testing of prototypes or processes of new or

15  improved products. Research and development does not include

16  market research, routine consumer product testing, sales

17  research, research in the social sciences or psychology,

18  nontechnological activities, or technical services.

19         c.  "Silicon technology products" means raw silicon

20  wafers that are transformed into semiconductor memory or logic

21  wafers, including wafers containing mixed memory and logic

22  circuits; related assembly and test operations; active-matrix

23  flat panel displays; semiconductor chips; and related silicon

24  technology products as determined by the Office of Tourism,

25  Trade, and Economic Development.

26         d.  "Health technology products" means drugs; surgical,

27  medical, and dental instruments and supplies; ophthalmic

28  goods; laboratory apparatus; laboratory analytical

29  instruments; optical instruments and lenses; and related

30  health technology products as determined by the Office of

31  Tourism, Trade, and Economic Development.

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    Florida Senate - 1999                                  SB 2468
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  1         Section 3.  Subsection (8) is added to section 499.015,

  2  Florida Statutes, 1998 Supplement, to read:

  3         499.015  Registration of drugs, devices, and cosmetics;

  4  issuance of certificates of free sale.--

  5         (8)  Notwithstanding any other requirement of ss.

  6  499.001-499.081, medical device manufacturers whose devises

  7  are approved by, registered, and listed with the U.S. Food and

  8  Drug Administration are exempt from the provisions of ss.

  9  499.015 and 499.041(6). However, the device manufacturer must

10  submit evidence of such registration, listing, and approval at

11  the time it submits its application for a permit to do

12  business in the state, as required in s. 499.013(2)(d).

13  Evidence of U.S. Food and Drug Administration approval and

14  registration includes:

15         (a)  A copy of the premarket notification letter (510K)

16  for Class II devices;

17         (b)  A U.S. Food and Drug Administration premarket

18  approval number for Class III devices;

19         (c)  A U.S. Food and Drug Administration registration

20  number for subcontract medical device manufacturers who

21  manufacture components of devices for manufacturers; or

22         (d)  A U.S. Food and Drug Administration registration

23  number for medical device manufacturers whose devices are

24  exempt from premarket approval.

25         Section 4.  Subsection (6) of section 499.041, Florida

26  Statutes, is amended to read:

27         499.041  Schedule of fees for drug, device, and

28  cosmetic applications and permits, investigational drug

29  applications, product registrations, and free-sale

30  certificates; trust fund.--

31

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    Florida Senate - 1999                                  SB 2468
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  1         (6)  A person that is required to register drugs,

  2  devices, or cosmetic products under s. 499.015 shall pay an

  3  annual product registration fee of not less than $5 or more

  4  than $15 for each separate and distinct product in package

  5  form.  The registration fee is in addition to the fee charged

  6  for a free-sale certificate. However, a person that is

  7  required to register devices under s. 499.015 is not exempt

  8  from paying the free-sale certificate fee.

  9         Section 5.  The State University System and the

10  University of Miami shall evaluate the feasibility of

11  establishing additional health technology business incubators

12  similar to the University of Florida's Sid Martin

13  Biotechnology Institute at appropriate state universities or

14  the University of Miami and shall evaluate the enhancement and

15  expansion of current facilities to support health technology

16  companies. The State University System and the University of

17  Miami shall evaluate establishing cooperative clinical trial

18  programs in conjunction with their medical schools. The State

19  University System shall also evaluate and recommend ways to

20  support, improve, encourage, and facilitate the creation of

21  and the collaboration with Florida-based businesses in

22  licensing State University System intellectual property and

23  the collaboration of State University System employees with

24  Florida businesses in research and technology transfer

25  efforts. The State University System and the University of

26  Miami shall consult with the Health Technology Advisory

27  Council of Enterprise Florida and Bio+Florida as part of these

28  evaluations and recommendations. The State University System

29  and the University of Miami shall report recommendations to

30  the Governor, the President of the Senate, and the Speaker of

31  the House of Representatives by December 1, 1999.

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  1         Section 6.  The State Board of Community Colleges shall

  2  report to the Governor, the President of the Senate, and the

  3  Speaker of the House of Representatives by December 1, 1999,

  4  on the board's efforts to develop health technology curriculum

  5  to support the workforce needs of the health technology

  6  industry.

  7         Section 7.  Enterprise Florida, Inc., shall convene a

  8  task force comprised of the Office of Tourism, Trade, and

  9  Economic Development, the Florida Health Technology Advisory

10  Council, Bio+Florida, the Florida Bar, and the Department of

11  Banking and Finance to review and evaluate chapter 517,

12  Florida Statutes, to determine its impact on the ability of

13  Florida's health technology firms to raise capital. Enterprise

14  Florida, Inc., shall report to the Governor, the President of

15  the Senate, and the Speaker of the House of Representatives by

16  December 1, 1999, the recommendations of the task force to

17  modify and improve the laws to enhance opportunities for

18  capital formation, consistent with the protection of Florida

19  investors.

20         Section 8.  This act shall take effect July 1, 1999.

21

22            *****************************************

23                          SENATE SUMMARY

24    Provides a sales tax exemption on purchases of machinery
      and equipment used in health technology production and
25    research and development. Exempts certain medical device
      manufacturers from registration and fees under the
26    Florida Drug and Cosmetic Act. Requires the State
      University System and the University of Miami to report
27    to the Legislature on their evaluation of business
      incubator, clinical trial, intellectual property, and
28    technology transfer activities. Requires reports by the
      State Board of Community Colleges and Enterprise Florida,
29    Inc.

30

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