Florida Senate - 2025                        COMMITTEE AMENDMENT
       Bill No. SB 1356
       
       
       
       
       
       
                                Ì758458WÎ758458                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/19/2025           .                                
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       The Committee on Education Postsecondary (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 the state’s children’s hospitals to collaborate
   86  with leaders in the genetic industry and build and support a
   87  culture of collaborative research and the development of cutting
   88  edge genetic and precision medicine in the state. The consortium
   89  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 appointed by the Governor.
  124         e.One member appointed by the President of the Senate.
  125         f.One member appointed by the Speaker of the House of
  126  Representatives.
  127         3.The board shall be responsible for the promotion and
  128  oversight of the consortium, including, but not limited to, the
  129  nomination and appointment of members of the consortium.
  130         (c)Beginning October 15, 2026, and annually thereafter,
  131  the consortium shall provide a report to the Governor, the
  132  President of the Senate, and the Speaker of the House of
  133  Representatives on research projects, research findings,
  134  community outreach initiatives, and future plans for the
  135  consortium.
  136         Section 2. For the 2025-2026 fiscal year, the sum of $5
  137  million in recurring funds is appropriated from the General
  138  Revenue Fund to the Florida Institute for Pediatric Rare
  139  Diseases.
  140         Section 3. For the 2025-2026 fiscal year, the sum of $20
  141  million in nonrecurring funds is appropriated from the General
  142  Revenue Fund to the Florida Institute for Pediatric Rare
  143  Diseases for the implementation of the Sunshine Genetics Pilot
  144  Program established in s. 1004.4211, Florida Statutes.
  145         Section 4. This act shall take effect July 1, 2025.
  146  ================= T I T L E  A M E N D M E N T ================
  147  And the title is amended as follows:
  148         Delete everything before the enacting clause
  149  and insert:
  150                        A bill to be entitled                      
  151         An act relating to the Florida Institute for Pediatric
  152         Rare Diseases; creating s. 1004.4211, F.S.;
  153         establishing the Florida Institute for Pediatric Rare
  154         Diseases within the Florida State University College
  155         of Medicine; providing the goals of the institute;
  156         requiring the institute to establish and administer
  157         the Sunshine Genetics Pilot Program for a specified
  158         period; providing the purpose of the pilot program;
  159         providing institute responsibilities and duties
  160         relating to the pilot program; providing requirements
  161         for participation in the pilot program and data
  162         collection and release in the pilot program; defining
  163         the term “health care practitioner”; providing
  164         reporting requirements for the pilot program;
  165         establishing the Sunshine Genetics Consortium for
  166         specified purposes; requiring the consortium to be
  167         administered at the institute by an oversight board;
  168         providing for the membership and terms of the board;
  169         providing meeting and reporting requirements for the
  170         consortium; providing appropriations; providing an
  171         effective date.