Florida Senate - 2025 COMMITTEE AMENDMENT Bill No. CS for SB 1356 Ì909844EÎ909844 LEGISLATIVE ACTION Senate . House Comm: RCS . 04/02/2025 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— 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 1004.4211 The 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.