Florida Senate - 2025                        COMMITTEE AMENDMENT
       Bill No. CS for SB 1356
       
       
       
       
       
       
                                Ì909844EÎ909844                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/02/2025           .                                
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       The Committee on Fiscal Policy (Burton) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 1004.4211, Florida Statutes, is created
    6  to read:
    7         1004.4211The Florida Institute for Pediatric Rare
    8  Diseases; the Sunshine Genetics Pilot Program; the Sunshine
    9  Genetics Consortium.—
   10         (1)The Florida Institute for Pediatric Rare Diseases is
   11  established within the Florida State University College of
   12  Medicine as a statewide resource for pediatric rare disease
   13  research and clinical care. The purpose of the institute is to
   14  improve the quality of life and health outcomes for children and
   15  families affected by rare diseases by advancing knowledge,
   16  diagnosis, and treatment of pediatric rare diseases through
   17  research, clinical care, education, and advocacy.
   18         (2)The goals of the institute are to:
   19         (a)Conduct research to better understand the causes,
   20  mechanisms, and potential treatments for pediatric rare
   21  diseases, including leveraging emerging research methods.
   22         (b)Develop advanced diagnostic and genetic screening tools
   23  and techniques to enable health care providers to identify rare
   24  diseases in newborns and children more rapidly, accurately, and
   25  economically.
   26         (c)Provide comprehensive multidisciplinary clinical
   27  services and care for children with rare diseases. Such care may
   28  include, but is not limited to, patient, family, and caregiver
   29  support and resources to help navigate the challenges associated
   30  with these conditions, support groups, and patient advocacy.
   31         (d)Educate and train health care professionals, including,
   32  but not limited to, genetic counselors, pediatricians,
   33  scientists, and other specialists in the field of pediatric rare
   34  diseases.
   35         (e)Establish collaborations with other research
   36  institutions, medical centers, patient and family advocacy
   37  organizations, and government agencies whenever deemed
   38  appropriate by the institute director to share expertise, raise
   39  awareness, and promote a collective effort to tackle pediatric
   40  rare diseases.
   41         (3)(a)The institute shall establish and administer the
   42  Sunshine Genetics Pilot Program to be administered for a period
   43  of 5 years. The pilot program shall provide newborn genetic
   44  screening, including, but not limited to, whole genome
   45  sequencing. Genetic screening shall be performed by the
   46  institute and institutional members of the oversight board upon
   47  approval of the oversight board.
   48         (b)The institute may establish partnerships with Florida
   49  universities and colleges and health care service providers to
   50  promote and assist in the implementation of the pilot program.
   51         (c)The pilot program shall be an opt-in program and a
   52  parent of a newborn must provide consent to participate in the
   53  pilot program.
   54         (d)The institute and institutional members of the
   55  oversight board shall release clinical findings of a newborn’s
   56  screening to the newborn’s health care practitioner and the
   57  newborn’s parent. As used in this paragraph, the term “health
   58  care practitioner” means a physician or physician assistant
   59  licensed under chapter 458; an osteopathic physician or
   60  physician assistant licensed under chapter 459; an advanced
   61  practice registered nurse, registered nurse, or licensed
   62  practical nurse licensed under part I of chapter 464; a midwife
   63  licensed under chapter 467; a speech-language pathologist or
   64  audiologist licensed under part I of chapter 468; a dietitian or
   65  nutritionist licensed under part X of chapter 468; or a genetic
   66  counselor licensed under part III of chapter 483.
   67         (e)The institute shall:
   68         1.Maintain a secure database to collect and store all
   69  pilot program data, including, but not limited to, newborn
   70  genomics sequence data and deidentified newborn data.
   71         2.Provide deidentified newborn data to members of the
   72  consortium pursuant to a data sharing agreement to support
   73  ongoing and future research.
   74         (f)By December 1, 2030, the institute shall provide a
   75  report on the Sunshine Genetics Pilot Program to the Governor,
   76  the President of the Senate, and the Speaker of the House of
   77  Representatives. The report must include, at a minimum:
   78         1.Study population and enrollment metrics.
   79         2.Whole genome sequencing metrics.
   80         3.Clinical and public health impact.
   81         4.Cost effectiveness and economic benefits.
   82         (4)(a)The Sunshine Genetics Consortium is established to
   83  create a network of clinical and academic research
   84  professionals, geneticists, and physicians from state
   85  universities and this state’s children’s hospitals to
   86  collaborate with leaders in the genetic industry and build and
   87  support a culture of collaborative research and the development
   88  of cutting-edge genetic and precision medicine in the state. The
   89  consortium shall:
   90         1.Integrate state-of-the-art genomic sequencing
   91  technologies.
   92         2.Advance research and the development of cutting-edge
   93  genetic and precision medicine.
   94         3.Leverage advancements in artificial intelligence
   95  utilization in genomics.
   96         4.Develop educational opportunities for clinicians on
   97  genomic tools.
   98         5.Support the growth and education of geneticists to meet
   99  demand.
  100         6.Solicit and leverage funds from nonprofits, private
  101  industry, and others for the purpose of expanding the Sunshine
  102  Genetics Pilot Program and to support genetic screenings by
  103  institutional members of the oversight board.
  104         7.Promote patient care that supports families with
  105  children diagnosed with genetic disorders.
  106         8.Report on the use of deidentified newborn data by
  107  members of the consortium.
  108         (b)1.The consortium shall be administered at the institute
  109  by an oversight board. The board shall convene at least once
  110  every 6 months.
  111         2.The oversight board for the consortium shall consist of
  112  the director of the institute, who shall serve as chair, and the
  113  following voting members, who shall serve 2-year terms:
  114         a.One member nominated by the dean of the University of
  115  Florida’s College of Medicine and approved by the university’s
  116  president.
  117         b.One member nominated by the dean of the University of
  118  South Florida’s College of Medicine and approved by the
  119  university’s president.
  120         c.One member nominated by the dean of the University of
  121  Miami’s School of Medicine and approved by the university’s
  122  president.
  123         d.One member nominated by the dean of Florida
  124  International University’s School of Medicine and approved by
  125  the university’s president.
  126         e.One member nominated by Nicklaus Children’s Hospital and
  127  approved by the hospital’s president and chief executive
  128  officer.
  129         f.One member appointed by the Governor.
  130         g.One member appointed by the President of the Senate.
  131         h.One member appointed by the Speaker of the House of
  132  Representatives.
  133         3.The board shall be responsible for the promotion and
  134  oversight of the consortium, including, but not limited to, the
  135  nomination and appointment of members of the consortium.
  136         (c)Beginning October 15, 2026, and annually thereafter,
  137  the consortium shall provide a report to the Governor, the
  138  President of the Senate, and the Speaker of the House of
  139  Representatives on research projects, research findings,
  140  community outreach initiatives, and future plans for the
  141  consortium.
  142         (5)The provisions of this section shall be implemented to
  143  the extent of available appropriations contained in the annual
  144  General Appropriations Act for such purpose.
  145         Section 2. This act shall take effect July 1, 2025.
  146  
  147  ================= T I T L E  A M E N D M E N T ================
  148  And the title is amended as follows:
  149         Delete everything before the enacting clause
  150  and insert:
  151                        A bill to be entitled                      
  152         An act relating to the Florida Institute for Pediatric
  153         Rare Diseases; creating s. 1004.4211, F.S.;
  154         establishing the Florida Institute for Pediatric Rare
  155         Diseases within the Florida State University College
  156         of Medicine; providing the purpose of the institute;
  157         providing the goals of the institute; requiring the
  158         institute to establish and administer the Sunshine
  159         Genetics Pilot Program for a specified period;
  160         providing the purpose of the pilot program; providing
  161         institute responsibilities and duties relating to the
  162         pilot program; providing requirements for
  163         participation in the pilot program and data collection
  164         and release in the pilot program; defining the term
  165         “health care practitioner”; providing reporting
  166         requirements for the pilot program; establishing the
  167         Sunshine Genetics Consortium for specified purposes;
  168         requiring the consortium to be administered at the
  169         institute by an oversight board; providing for the
  170         membership and terms of the board; providing reporting
  171         requirements for the consortium; specifying that
  172         implementation of the act is subject to appropriation;
  173         providing an effective date.